Home

Medfusion® Model 4000 pumpOperator`s Manual

1. If FlowSentry is disabled the bar graph is still shown however none of the icons or will ap pear on screen Post occlusion bolus reduction With large syringes fluid can accumulate or be stored in the line when an occlusion happens which is then delivered as a bolus when the occlusion is re leased This stored volume is the result of the volume of the syringe and infusion set increasing under pres sure This pump contains a feature for reducing this bolus upon occlusion release or occlusion bolus Using post occlusion bolus reduction the pump withdraws the plunger a predetermined amount to reduce stored bolus in the syringe However this feature does not totally eliminate the occlusion bolus Occlusion bolus will vary greatly with occlusion limit setting syringe size and the fluid infused The post occlusion bolus reduction feature decreases bolus on occlusion release to less than 0 3 mL WARNING Larger size syringes at occlusion setting HIGH may produce a post occlusion bolus larger than 0 3 mL due to excessive syringe plunger tip compli ance 93 Medfusion Model 4000 pump Operator s Manual Making changes during delivery At right is an illustration of a delivery screen There are eight options available during any standard infu sion While running an infusion you may e Lock Unlock the keypad e Change the Dosage Rate e Select certain Program Options
2. Alarm Message Motor Not Running Priority High Medfusion Model 4000 pump Operator s Manual Remedy The motor is not running which may be due to an erroneous possibly transient sensor signal or a mechanical and or electrical failure Press D Press to turn the pump off then back on If the alarm persists when the pump is turned back on immediately remove the pump from service for repair by a trained biomedical service technician Motor Rate Error High The motor is not running at the programmed rate which may be due to an erroneous possibly transient sensor signal or a mechanical and or electrical failure Press Press to turn the pump off then back on If the alarm persists when the pump is turned back on immediately remove the pump from service for repair by a trained biomedical service technician Occlusion Check Infusion Line High Check infusion line for blockage Clear or remedy any discovered occlu sion for example check the infusion set for closed stopcocks clamps check the tubing for kinks verify the patency of the tubing and the IV site etc Press lt to restart infusion once occlusion is located and cleared If this alarm occurs frequently and you have ruled out an ac tual occlusion the infusion set tubing may be too small for the rate or fluid viscosity you may want to consider enabling flow sentry or you may want to consider choosing a different occlusion alarm se
3. Minimum Bolus Minimum Maximum Bolus Recommended Bolus Average mL 0 0298 0 98767 19 8302 Average Error 11 09 1 23 0 85 Maximum Pos 14 12 0 32 0 38 Error Maximum Neg 44 71 3 52 1 369 Error Minimum 0 0040 0 0032 0 07520 Deviation mL Maximum 0 0152 0 0352 0 27220 Deviation mL IMPORTANT Minimum Bolus refers to the minimum bolus that can be set on the pump and which may be below the recommended minimum rate for the syringe NOTE 2 of the measured error may be due to syringe characteristics per ISO 7886 2 125 Medfusion Model 4000 pump Operator s Manual Occlusion Alarm For 1 mL Syringes the occlusion limit is fixed at Very High Very High 1 mL syringe only not selectable 50 psi 2585 mmHg 345 kPa For Syringes with a volume greater than 1 mL the user can set the occlusion limit from Very Low to High High 16 psi 827 mmHg 110 kPa Normal 12 psi 621 mmHg 83 kPa Low 8 psi 413 mmHg 55 kPa Very Low 4 psi 206 mmHg 28 kPa Maximum volume infused under single fault conditions 1 100 of the syringe size by volume Maximum delivery rate during bolus The configured maximum rate at which a bolus or loading dose can be delivered is Syringe size x5mL hr Syringe size x10mL hr or Syringe size Max mL hr see page 135 for further explanation Maximum delivery rate during Prime The priming delivery rate is 3
4. 59 Medfusion Model 4000 pump Operator s Manual WARNING Once the syringe and tubing system is connected to the patient raising the system above the patient even briefly can cause significant bolusing due to changes in hydrostatic pressure Lowering the system below the patient even brief ly can cause significant interruptions in flow due to changes in hydrostatic pressure This could cause improper pump operation resulting in inaccurate fluid delivery that could result in serious injury or death Place the pump as close to the patient s infu sion site as possible Once the system is primed connect the tubing to the patient and begin infusion 60 Options Options gives you access to program options that af fect the current infusion only The options available depend on the options that have been enabled for the profile and which have been customized for use using PharmGuard Toolbox 2 Any options in use return to the default selection whenever the pump is turned off or whenever the program is returned to the MAIN menu prior to beginning the next infusion These options are available when the pump is at the BEGIN INFUSION screen prior to starting an infu sion e Override Occlusion Limit e Override Alarm Loudness e Disable Enable Near Empty Alarm Tone e Disable Enable Volume Empty Alarm Tone e Bolus Dose e Delayed Start e KVO e Periodic Callback Alarm e Change to Dose Change to Volume
5. Syringe Infusion Pump Model 4000 should be observed to verify normal operation If ab normal performance is observed additional measures may be necessary such as reorienting or relocating the Medfusion Syringe Infusion Pump Model 4000 d Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 122 Medfusion Model 4000 pump Operator s Manual Recommended separation distances between portable and mobile RF communications equipment and the Medfusion Syringe Infusion Pump Model 4000 The Medfusion Syringe Infusion Pump Model 4000 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Syringe Infusion Pump Model 4000 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communica tions equipment transmitters and the Medfusion Model 4000 pump as recommended below according to the maxi mum output power of the communications equipment Separation distance according to frequency of transmitter m Rated Maximum 150 kHz to 80 MHz 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz output power or outside ISM bands in ISM bands transmitter w d 0 35VP deia dara d 2 3P 0 01 04 12 AZ 23 0 1 11 38 38 73 1 35 12 1 2 2 3 10 1 1 3 8 3 8 7 3 100 3 5 12 12 23 For transmitters rated at a maximum output power
6. Medfusion Model 4000 pump Operator s Manual Loading dose rate reduction The increased delivery rate of a loading dose may trigger an occlusion alarm depending on the occlusion limit settings in the pump and the resis tance in the line If this occurs the loading rate is automatically reduced to 70 The loading rate is reduced by increasing the loading time over the loading volume The loading rate continues to be reduced until resistance is below the set occlusion limit There could be a variety of reasons for this to occur including but not limited to the occlusion limit in use fluid medication viscosity the patient s infusion site setup etc 1 Press O to silence the alarm Loading dose delivery continues at the reduced rate The pump continues to monitor the infusion and may reduce the rate multiple times However the first alarm is the only one that produces an audible tone If the first alarm is silenced additional rate reductions will not cause an audible tone to sound however the amber yellow LED and the alarm message will display and can be cleared by pressing D If the loading rate reduces below the infusion rate or the loading time increases past the maximum loading time the loading dose is cancelled CANCEL stops the loading dose and returns to the normal delivery rate and screen Press O to silence the alarm The normal infusion delivery is continued Once the reason for the rate redu
7. 10 flow ml h flow ml h u o 10 20 30 40 50 60 70 80 90 100 110 time Min Trumpet curves over T2 period Minimum rate 1 mL hr 10 0 m TS 5 0 m E 120 o 10 20 30 40 50 60 70 80 90 100 110 time Min Error of Flow 2 5 50r ZEAR 10 0 Intermediate rate 5 mL hr 10 0 75 5 0 2 5 5 25 5 0 7 5 10 0 T min 2 5 Epmax 11 19 31 0 0 T T T T Trumpet Curve 0 54 Trumpet Curve 120 139 Medfusion Model 4000 pump Operator s Manual Communications The connectivity states available for Medfusion Model 4000 pumps are Ethernet and Wireless The pump display shows an icon indicating which inter face is active see page 11 Whenever communication with the PharmGuard Server is occurring the blue Communicating light a will be on See the Network Settings Manual for information in how to set up these interfaces The pump can be used with a PC running PharmGuard Toolbox 2 Software to configure the pump This process is described in the PharmGuard Toolbox 2 User s Manual and the Network Settings manual Magnetic Resonance Imaging MRI Information The Medfusion Model 4000 pump is MR Conditional according to the terminology specified in the American Society for Testing and Materials ASTM International Designation
8. 2 accuracy specification syringe accuracy is taken into account when programming the pump and or filling a syringe If accuracy is of prime concern use only syringes that meet the 2 requirement of the ISO 7886 2 Standard Failure to do so may result in medica tion in the syringe becoming depleted sooner or later than expected Use of cables other than as listed and with equip ment other than those specified may result in increased EMC emissions or decreased immunity of the pump It is recommended that when con necting the pump to a network using an Ethernet cable the network equipment should conform to EN IEC 60950 The pump should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the user should verify normal operation of the pump in the configura tion in which it is to be used To avoid electric shock before cleaning always switch electrically operated equipment off and disconnect from AC power source To avoid electric shock only trained biomedical service personnel may service this pump Service personnel should disconnect the AC power cord before servicing the pump Always maintain this pump following manufac turer recommended instructions in the Technical Service Manual Improperly maintained pumps may cause either under infusion or over infusion to patient To avoid electric shock users should never open the pump case or battery compartment for any reason
9. The highlight shows the pump s current default setting Use the number keys to choose the desired alarm loudness setting then press Enter To determine which setting meets your needs for the infusion use the number key to choose a loudness level then press Test Medfusion Model 4000 pump Operator s Manual 83 Medfusion Model 4000 pump Operator s Manual Disable enable FlowSentry The pump has an internal program for rapid occlu sion detection called FlowSentry The pump may have been configured to either turn this feature on or off To change the default configuration for a specific infusion use this option Note With certain PharmGuard Supported Syringes PSS Series 2 such as those for enteral delivery FlowSentry is automatically disabled and cannot be enabled 1 With the pump running or stopped press Options 2 Use the number keys to choose DISABLE FLOWSENTRY or ENABLE FLOWSENTRY only one of the above will be displayed depending on whether the rapid occlusion detection feature is currently active or not You may have to press More to see this option Disable enable near empty alarm tone The pump may be configured to have an alarm sound to indicate when a syringe is nearly empty Alarm triggering is calculated based on the syringe size used and the volume initially calculated see page 101 for an explanation of this alarm Use this option to enable or disable this featu
10. result in serious injury or death Main Menu returns to the Main Menu 8 When all delivery settings are confirmed as correct press lt to begin infusion 5 Medfusion Model 4000 pump Operator s Manual Volume weight time The volume weight time delivery mode ML KG TIME may be available on a pump Volume weight time infusion rate calculations allow programming by e Patient s weight e Volume of drug per kilogram of weight e Delivery time Use the number keys to set the patient s weight in kilograms Weight is limited to the indicated range Press Enter to accept the patient weight setting The pump may be customized with an additional patient weight confirmation screen If so re enter the patient weight then press Enter to accept the setting At the VOLUME KILOGRAM screen press the number keys to set the volume per weight setting Range limits here are determined by the installed syringe size patient weight and or the custom setup in the Configuration When the setting is correct press Enter to accept it The time setting screen appears Press the number keys to set the time in hours and minutes then press Enter At the BEGIN INFUSION screen all values are set and the pump pauses the pump may be configured with additional confirmation screens requiring you to confirm all settings twice before beginning the infusion Prior to connecting to the patient press lt lt to init
11. 25 Medfusion Model 4000 pump Operator s Manual Programming an Infusion Turn the pump on Below right is an illustration of a startup screen and a list of basic steps for turning the infusion pump on 1 Press and hold until the display turns PRIME BOLUS dark Verify the display shows all pixels on GO CEH lt then all pixels off The pump beeps twice one low beep and one high beep This is a test of the standard audible alarm and the battery backup audible alarm high tone The Alarm Infusing Communication and Lock indicators flash as the self test cycles and the startup screen appears The Device ID if it has one appears in the middle left corner In this example it is called HOSPITAL The pump serial number will appear at the middle right in this example it is M01234 Verify the display indicates successful completion of system startup self tests If the pump does not turn on with successful completion of self tests remove it from service and have it checked by a trained biomedical techni cian Note The BATTERY NoT WORKING alarm is not fully functional until the system startup self tests and processes are completed approximately two minutes after turning the pump on IMPORTANT Do not move the Syringe Plunger Driver or otherwise manipulate the pump until the startup tests are complete and the Profile selection screen appears Sensors are tested as part of
12. Continuous mode ml hr 39 D Data Handling Software Safety Features 128 Delayed start 78 87 Delivering a loading dose 69 Delivery mode 33 Display 8 Dose Day 42 Dose Hr 40 Dose Min 40 Dose Time 44 E ECMO Extracorporeal Membrane Oxygenation 7 Electromagnetic Compliance EMC 116 Ethernet State 11 Ethernet Port 9 Explosion risk warning 1 Medfusion Model 4000 pump Operator s Manual F FlowSentry rapid occlusion detection 6 92 Flush feature 88 135 G General Use Diagram 23 H Hard limits 14 19 133 Hardware related Software Safety Features 128 hyperbaric chamber use warning 1 Intermittent volume time 55 K Keep Vein Open KVO rate 74 Keypad 9 buttons or keys 10 Indicators 10 Keypad lock 98 Unlocking 98 Libraries Quick 15 Standard 15 Loading a syringe 34 Unloading a syringe 38 Loading dose 67 Continuing restarting a loading dose 70 Delivering a loading dose 69 Loading dose rate reduction 71 Locking the keypad 98 M Maintenance amp service 142 Mode 14 33 Body weight surface area infusions 46 Continuous 39 Dose Day 42 Dose Hr 40 Dose Min 40 Dose Time 44 Intermittent Volume Time 55 Recall last settings 57 Volume Time 54 MRI Magnetic Resonance Imaging 140 147 Medfusion Model 4000 pump Operator s Manual Near empty alarm tone disable enable 84 Network status 11 O Occlusion settings 92 Post occlusion bolus reduction 93 Options 61 136 Bolu
13. ImL 0 1mL 3mL 0 3mL 5mL 0 5mL 6mL 0 6mL 10mL ImL 12mL ImL 20mL ImL 30mL ImL 35mL ImL 50mL ImL 60mL ImL WARNING Use the smallest syringe size necessary to deliver the fluid or medication Using a large syringe at very low rates below Minimum Recommended Rate for the syringe may cause improper pump operation delayed occlusion sensing larger post occlusion bolus at higher occlusion limit settings delivery inaccuracies or other potential hazards Bolus Volume Delivering a bolus volume less then the recommended bolus volume for the syringe used may result in delivery inaccuracies Use an infusion set with the smallest diameter tubing avail able that does not result in excessive back pressure at the desired flow rate Consider priming loading bolus and flush rates when selecting an infusion set 132 Concentration and dosing units Drug Delivery Units Medfusion Model 4000 pump Operator s Manual Concentration Units Delivery Units Time Min Hr Day Millimoles Millimoles J J J V Milliequivalents Milliequivalents Vv Vv Vv V Units Units J Vv V V Milliunits V V V V Grams Grams V V V V Milligrams 4 V 4 M Milligrams Milligrams V J V 4 Micrograms V V V M Micrograms Micrograms V V V V Nanograms Vv V V M PharmGuard software limits PharmGuard software limits Delivery Mode Parameter Limit Type Limit
14. Press to turn Tesi the pump off then turn it back on If the alarm persists when the pump is turned back on immediately remove pump from service for repair by a trained biomedical technician System Failure System The pump has detected that a valid Configuration is not installed and the Configuration Required Fault pump cannot operate A possible cause of this alarm is that a firmware update and a Configuration were sent to the pump at the same time and when the firmware update was installed first the Configuration became incompatible and so was deleted If this is the case send a new Configuration to the pump Then turn the pump off and at the prompts install the new Configuration then turn the pump back on If this is not the cause remove the pump from service for repair by a trained biomed ical technician System Failure System Where xx xx xx indicates additional text for the specific type of failure XX XX XX Fault The pump display shows the MAIN menu with only the BIOMED menu available Some system failures result in a hardware watchdog alarm which results in an alarm tone sounding and may or may not be accom panied by a flashing red alarm indicator Press to turn off pump then back on If the alarm persists when the pump is turned back on immediately remove pump from service for repair by a trained biomedi cal technician System Advisory Alarms Alarm Message Priority Remedy
15. Service personnel should always discon nect the AC power cord before servicing the pump Medfusion Model 4000 pump Operator s Manual Never use a dropped or obviously damaged pump Withdraw it from service until a trained biomedi cal technician can test it There are potential health hazards associated with improper disposal of batteries electronics and contaminated used infusion sets and syringes Dispose of used batteries infusion sets syringes and other used accessories or a pump that has reached the end of its useful life in an environ mentally safe manner and according to any regu lations that may apply Medfusion Model 4000 pump Operator s Manual Cautions e Federal USA law restricts this device to sale by or on the order of a physician e ALWAYS verify that the software version of the pump displayed on screen during power up and Operator s Manual are the same Refer to this manual s front page o NEVER use sharp objects to depress keypad keys on the pump This may damage the pump by ren dering keypad keys inoperable e This pump is designed to be used in a horizon tal position If the pump is operated in a vertical position there is an increased potential for fluid leaking into the pump If fluid leakage into a pump is suspected remove it from use until a trained biomedical technician can test it e Always verify the stability of the object to which the pump is mounted for instance
16. Use the number keys to set the KVO rate within the minimum and maximum rates on screen When the KVO rate is set press Enter The KVO setting now appears on the screen If this is a new infusion prior to connecting to the patient press lt lt to initiate the priming sequence page 59 74 begin infusing at either the programmed KVO rate or the current infusion rate which ever is less A KVO rate can be set at the BEGIN INFUSION screen before starting an infusion or by pausing the pump during an infusion KVO can also be programmed as part of the drug program using PharmGuard Toolbox 2 Note The setting of KVO rates should be based on a physician s order or your facility s policies and proce dures for rate determination Enable Disable KVO Rate KVO rate can be enabled or disabled through custom pump configuration us ing PharmGuard Toolbox 2 Medfusion Model 4000 pump Operator s Manual WARNING Confirm All Settings Before starting any delivery always confirm the accuracy of all infusion values to the original order Programming the pump at a delivery rate other than that pre scribed will cause inappropriate delivery which can result in serious injury or death 6 Press lt to begin infusion 7 When the infusion reaches the programmed volume limit rather than stopping delivery the pump automatically begins delivery at the KVO rate or continues at the current rate if l
17. and Press lt 44 gt To PRIME to remind you of the prime sequence 1 Press lt lt to initiate priming 2 The priming screen opens To prime a loaded syringe press and hold lt lt while observing for fluid movement at the patient end of the system For safety reasons priming stops as soon as the finger is lifted from lt lt or after 15 seconds To continue priming beyond the 15 second cutoff release lt lt then press amp hold it again Priming Volume Not Counted in TVD The total priming volume accumulates on screen but is NOT counted in the Total Volume Delivered display This is because the tubing is not connected to the patient during priming and therefore not delivered to the patient The Priming infusion rate is 300 mL hr or the de fault maximum bolus rate for the syringe size being used whichever is lower Medfusion Model 4000 pump Operator s Manual WARNINGS e NEVER prime any syringe while connected to a patient infusion site as this may cause over infusion which could result in serious injury or death To avoid air embolism always purge all air from syringe and infusion lines before connecting to the patient e Periodically check the fluid pathway and all connec tions including the catheter administration set con nection for leaks Leaks in the system may cause fluid loss resulting in under delivery as well as allowing an opening for contamination PRIME BOLUS
18. and load the syringe as instructed on page 34 Main Menu returns to the Main Menu Chg Dose allows modifying the set dosage without starting from scratch Options allows selection from a list of variables e g bolus volume limit etc Clear Totals clears total volume delivered and PVD or PDD Medfusion Model 4000 pump Operator s Manual 7 Prior to connecting to the patient press lt lt to initiate the priming sequence page 59 If desired program a Bolus Dose Loading Dose or Volume Limit see Options page 61 WARNING Confirm All Settings Before starting any delivery always confirm the accuracy of all infusion values to the original order Programming the pump at a delivery rate other than that pre scribed will cause inappropriate delivery which can result in serious injury or death 9 When all delivery settings are confirmed as correct press lt to begin infusion 43 Medfusion Model 4000 pump Operator s Manual Dose Time The Dose Time mode may be available on a pump e Dose rate Program Dose Time by setting e Delivery Time At the selection menu choose DOSE TIME or choose a drug program that uses the infusion type Choose the syringe model and size and load the syringe as instructed on page 34 Drug concentration units i e g mL mg mL mceg mL mMol mL mEq mL or Units mL e Drug concentration e Drug delivery units e g g mg mcg ng mMo
19. medication concentration units The actual units available on a pump depends on the custom setup Press Enter to accept the medication concentration units Use the number keys to set medication concentration Concentration is limited to 4 digits Press Clear to clear an entry Press Backspace to erase a character Press the Enter key to accept the setting Use the number keys to set the delivery units The actual units available on a pump depends on the custom setup If only one delivery unit is available for the concentration units selected this screen will not appear Press Enter to accept the delivery units Use the number keys to set dose rate Range limits for dose rate are determined by syringe size and or the custom setup in the Configuration The high and low rate limits display on screen When the dose is correct press Enter At the BEGIN INFUSION screen all values are set and the pump pauses the pump may be configured with additional confirmation screens requiring you to confirm all settings twice before beginning the infusion e Volume limit KVO loading dose or bolus dose may also be programmed these options are only available if they have been enabled in the profile or specified in the Drug Program using PharmGuard Toolbox 2 At the selection menu choose either DOSE MIN or Dose HR or choose a drug program that uses the in fusion type Choose the syringe model and size and load the syringe as in
20. Configuration is a database of pump settings orga nized into Profiles Categories and Drug Programs The Configuration has global settings that are ap plicable to the pump operations The Configuration may have up to 16 Profiles Each Profile has a set of Profile level settings and also up to 8 Categories Each Category may contain up to 36 Drug Programs There is a special category called a Quick Library A Quick Library contains Drug Programs that have all infusion parameters pre specified to allow quick start of an infusion A Configuration is defined here as a stored record of infusion settings that load from memory These programs are stored in memory indefinitely over 10 years or until overwritten The Configuration is set up using PharmGuard Toolbox 2 When it is completed it should be validated by the person responsible for custom configuration before the pumps are delivered to a work area When are Drug Programs used Every unit department organization or hospital has standard ways of delivering medications or fluids The custom setup enables you to use programs of stored presets Using the PharmGuard Toolbox 2 Software the PharmGuard Toolbox 2 Administrator will estab lish the pump Configuration that implements the standard infusions for the unit department organi zation or hospital This process is described in the PharmGuard Toolbox 2 User s Manual Who can use these Drug Programs Anyone who is aut
21. F2503 08 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment Non clinical testing demonstrated that the Medfusion Model 4000 pump is MR Conditional The pump will not present a hazard or risk to the patient or MR user or significantly affect the MR im age quality if the pump is operated according to the specific guidelines as follows WARNING The pump must be positioned in an MR environment such that it is secured to a non moveable object and the magnetic fringe field does not exceed 150 gauss Exposing the Medfusion Model 4000 pump to magnetic fields that exceed 150 gauss pres ents a risk of becoming a projectile hazard and can lead to possible patient injury or death Irreversible damage to the pump can also occur rendering it inop erable MRI Related Testing In non clinical testing the Medfusion Model 4000 pump evaluations have included Magnetic Attraction projectile hazard MR interference with the pump and MR Image Distortion e Magnetic Attraction projectile hazard The Medfusion Model 4000 pump showed no attrac tion torque or force at 150 gauss static magnetic 140 field strength e MR Interference with the Pump The Medfusion Model 4000 pump operated normally while in the 150 gauss static magnetic field e MR Image Distortion No MR imaging inter ference was observed when tested with the Medfusion Model 4000 pump at 8 feet from
22. Profiles Categories or Delivery Modes and drug programs available on a pump are dependent on how the pump was configured and whether a custom Configuration was created using the PharmGuard Toolbox 2 performed by whomever is responsible for customizing the pump before it was delivered to a work area The actual screens on the pump may look very different from those shown here After successfully completing its system startup self tests the pump displays one of the following menus depending on the pump s configuration 30 Medfusion Model 4000 pump Operator s Manual Select a Profile Custom Configuration After successfully completing its system startup self tests a pump with a Custom Configuration with multiple profiles defined will display SELECT THE PROFILE Pumps can be configured so that all or some of the profiles require a passcode to access them If that is the case the appropriate passcode must be entered to access the profile Note If only a single Profile was set up for use on the pump using PharmGuard Toolbox 2 none of these screens will appear The pump will instead display the drug category selection screen following successful system startup self tests e The configuration profiles categories and drug programs available on the following screens are dependent on which were set up in the custom Configuration The actual screen on the pump may look very different from the ones sho
23. Range mL hr mL hr rate Hard and Soft User Defined Volume Time Volume Hard and Soft User Defined Time Hard and Soft User Defined Intermittent Volume Volume Hard and Soft User Defined Time Time Hard and Soft User Defined Time Between Starts Hard and Soft User Defined Dose Time Concentration Hard and Soft User Defined Dose Hard and Soft User Defined Time Hard and Soft User Defines Dose Kg Time Concentration Hard and Soft User Defined Body Weight Configurable User Defined Dose Hard and Soft User Defined Time Hard and Soft User Defined mL Kg Time Body Weight Hard MAX Soft High User Defined Limit Low and MIN cannot be set Volume kg Hard and Soft User Defined Time Hard and Soft User Defined Dose m Time Concentration Hard and Soft User Defined m Configurable User Defined Dose Hard and Soft User Defined Time Hard and Soft User Defined 133 Medfusion Model 4000 pump Operator s Manual PharmGuard software limits Delivery Mode Parameter Limit Type Limit Range Dose Hr Concentration Hard and Soft User Defined Dose Min Dose Hard and Soft User Defined Dose Day Dose Kg Hr Concentration Hard and Soft User Defined Dose Kg Min Body weight Configurable User Defined Dose Kg Day Dose rate Hard and Soft User Defined mL Kg Hr Body Weight Hard and Soft User Defined mL Kg Min Volume kg Hard and Soft User Defined Do
24. System Advisory Medium The base has detected a hardware failure the specific code is in the failed Base Hardware Failure value As soon as possible remove the pump from service for repair by a trained biomedical technician System Advisory Medium The pump base has experienced a hardware or software failure As soon Base Not Responding as possible remove pump from service for repair by a trained biomedical technician System Advisory Medium The base has an unknown hardware failure As soon as possible remove Base Unknown Failure the pump from service for repair by a trained biomedical technician System Advisory Medium The Configuration data is invalid due to user action or corruption The Configuration Invalid pump stores a copy of the Configuration in the base which can be ap plied to restore it Press to turn the pump off and at the prompt ap ply the update Press to restart the pump The Configuration should now be restored for use System Advisory Low The pump improperly powered down As soon as possible remove pump Improper Shutdown from service for repair by a trained biomedical technician System Advisory Medium The network settings are corrupt As soon as possible remove pump KB Data Integrity Failure from service for repair by a trained biomedical technician 108 Medfusion Model 4000 pump Operator s Manual Alarm Message Priority Remedy System Advisory Low
25. _ The scheduled Preventive Maintenance is due As soon as possible re Maintenance is move pump from service for testing and checkout by a trained biomedi Recommended cal technician This alarm will reactivate each time the pump is powered on until service is performed System Advisory Medium The network configuration reset command has been executed in the Network Configuration BIOMED menu No action required Reset System Advisory Low The pump s Time and Date settings have been lost As soon as possible Set Time and Date remove pump from service for testing and checkout by a trained bio medical technician System Advisory Low __ Infusion will continue using backup copy of xx data where xx repre xx Data Corrupted sents variable text indicating the specific data that is corrupted As soon as possible remove pump from service for testing and checkout by a trained biomedical service technician 109 Medfusion Model 4000 pump Operator s Manual Update s Available Notification When new Configurations or pump software are available and have been taught or sent to a pump the next time the pump is turned off a screen appears indicating there is an update available for installation Important There should be a well defined review and test process performed before installing a Configura tion onto pumps for use with patients The Configura tion should be developed sent to several test pumps for val
26. above or below the High or Low limit so long as it does not exceed the Min or Max If the soft limits are exceeded the pump prompts you to first silence an alarm then confirm or cancel the override condition as shown in the following screen It is possible that a pump is customized so that limits cannot be exceeded unless a user ID is entered If that is the case you will be prompted to enter an ID Limit style alerts are advisories that occur for various reasons usually during programming A non repeating audio alarm sounds and a message is displayed for 3 seconds To re display the alert mes sage press Q amp The pump records exceeded limits and attempts to exceed limits How pump settings and limits are prioritized There can be a number of limits imposed on pump settings for instance the rate is limited by the syringe size being used as well as any hard and or soft limits imposed in the drug program The most restrictive limit takes priority Additionally available Options for delivery can be set for profiles as well as individual drug programs In these cases the settings for the drug program take pri ority over profile settings For example the Bolus op tion may be enabled for a profile but a drug program within that profile may have the bolus option disabled User defined pump Configurations This chapter describes the Medfusion Model 4000 pump Configuration What are Configurations A
27. accept the setting and go to the BEGIN INFUSION screen The Delayed Start timer then appears in the upper right corner on screen counting down alternately with Press lt 4 gt KEY To START INFUSION IMMEDIATELY and the Drug Program name The User Callback alarm is disabled for this interval Delayed Start continues until the timer has counted to zero Delayed Start can be discontinued at any time by pressing lt or by setting Delayed Start to zero If this is a new infusion prior to connecting to the patient press lt lt to initiate the priming sequence page 59 WARNING Confirm All Settings Before starting any delivery always confirm the accuracy of all infusion values to the original order Programming the pump at a delivery rate other than that pre scribed will cause inappropriate delivery which can result in serious injury or death 6 When the counter reaches zero the pump automatically begins the infusion 78 Enable Disable Delayed Start The Delayed Start op tion can be enabled disabled through custom con figuration using PharmGuard Toolbox 2 Periodic callback alarm The Periodic callback alarm is an Option that causes an alarm to be generated at a programmed period of time Note During delivery of a loading dose bolus dose or flush delivery the periodic callback timer is sus pended then restarts once the optional delivery is complete For example if you
28. as it was loaded Just use the following steps Press to stop delivery Clamp or close infusion line from the syringe to patient Unthread the tubing from the Tubing Holders on the top left side of the pump Lift and swivel the syringe Barrel Clamp out of the way Squeeze the Plunger Release Lever on the syringe plunger and remove the syringe 38 Programming Infusions Continuous mode mL hr Continuous infusion is programmed by setting a flow rate in mL hr Actual range limits for flow rate are determined by syringe model and size see the table in Technical section page 130 of this manual and or the product literature supplied with PharmGuard Toolbox 2 or the PharmGuard Supported Syringes PSS Series 2 or by a custom configured maximum rate If needed and if the options have been enabled using PharmGuard Toolbox 2 a volume limit load ing dose or bolus dose can also be programmed Use the number keys and if needed the decimal point to set the flow rate Press Clear to clear an entry Press Backspace to erase a character Press the Enter key to accept the setting After all infusion values are set the pump pauses at the BEGIN INFUSION screen the pump may be configured with additional confirmation screens requiring you to confirm all settings twice before beginning the infusion If desired program a Bolus Dose Loading Dose or Volume Limit see Options page 61 Prior to connecting to
29. bolus is cancelled Press O to silence the alarm The normal infusion delivery is continued Once the reason for the rate reduction is cleared you may resume the bolus if desired See the pre vious page for instructions CANCEL stops the bolus and returns to the normal delivery rate and screen Loading doses A loading dose is a separate specified volume or dose of drug infused as a one time only bolus often at a different higher rate prior to the start of normal delivery It is an optional parameter of continuous de livery modes which allows a bolus volume or dose to be delivered over a specified time A loading dose may also be configured to be automatically prompted or included in the programming steps of a drug program Set up loading dose If programming a bolus at the BEGIN INFUSION screen 1 Set the delivery mode parameters When the pump is paused at the BEGIN INFUSION screen press Options Use the number keys to choose LOADING Dose You may have to press More to see this option Steps 3 through 5 are the bolus program ming screens If Autoprompt is Enabled in PharmGuard Toolbox 2 they are part of the nor mal infusion programming workflow 3 Ifthe initial infusion is programmed in one of the body weight modes e g Dose Kg Min the loading dose may be programmed in the parameters of that dose mode e g Mcg Kg or in Total Dose e g Mg Use the number keys to set t
30. can be ex ceeded so long as the Hard limits or the physical limits imposed by the syringe size in use are not exceeded 1 When attempting to enter or change infusion parameters of a drug program the soft limits are displayed on screen as H1GH and Low If a value is entered that is outside the range an audible alarm sounds and the message OUTSIDE RANGE LIMIT SILENCE ALARM TO CONTINUE appears Once the alarm is silenced the message CONFIRM LIMIT OVERRIDE appears If Override is pressed the value will be ac cepted If No is pressed the value entry screen reappears Hard limits Hard limits are the absolute maximum and minimum for a value When attempting to enter or change a numeric infu sion parameter of a drug program the Hard limits are displayed on screen as MAX and MIN values It is not possible to exceed a Hard limit Medfusion Model 4000 pump Operator s Manual Adjusted limits in reverse During set up the pump determines absolute mini mums and maximums based on the physical abili Reverse highlight ties of the pump such as syringe size among other things See the table on page 130 for minimum and maximum flow rates If the PharmGuard software limits are outside of the pump limits the pump ad justs the limits as appropriate When this occurs the limit priority alarm LIMITS ADJUSTED CANNOT DELIVER ALL Doses is sounded When the pump adjusts li
31. e Clear TVD e Press lt lt to set change or deliver a bolus e Press to pause or end the infusion delivery e Press to begin pump shutdown e Press O to silence an alarm Changing delivery rate The Medfusion Model 4000 pumps offer ways of changing delivery rate either before beginning an in fusion during delivery or when delivery is paused Changing rate during delivery The infusion rate can be changed during any deliv ery session except when using Intermittent delivery modes 1 From any delivery screen press CHG Rate or CHG Dose The ENTER RATE screen appears Infusion does not stop The current setting continues to be delivered until the new rate is entered Note the current setting is always shown in the top of the display Use the number keys to set the dose rate Rate is limited by the maximum and minimum delivery rate for syringe size If you decide you don t want to change the rate press CS The delivery rate does not change until Enter is pressed When the desired rate is displayed press Enter to accept the new setting The new rate is not effective until Enter is pressed 94 Medfusion Model 4000 pump Operator s Manual Changing the rate when paused The dosage rate can be changed at any time the pump is paused 1 With the pump paused at the BEGIN INFUSION screen press Chg Rate or Chg Dose Use the number keys to change the delivery rate Rate is limited by
32. enabled displays a list of custom drug programs Rather than the CHG Profile key displayed on stan dard library category screens the Quick Library will have Main Menu on the far left When Main Menu is pressed another selection screen is displayed with the additional categories and delivery modes for the selected profile The soft key on the far left of this screen reflects the name of the Quick library the above is an example only Press this key to re enter the Quick library The Quick library is exited when Main Menu is pressed The CHG Profile key responds the same here as with all others Medfusion Model 4000 pump Operator s Manual If there is only one profile on the pump and a Quick library is enabled the drug programs in the designat ed Quick Library will display on screen after the pump is turned on and completes its self tests The drug programs in a Quick Library have been cus tomized with default values for infusion parameters that may include syringe model and size dose vol ume weight delivery time etc Setting default values in the custom program allows the user to proceed from the drug program selection screen to the final confirmation screen provided the loaded syringe matches the default syringe in the drug program The Quick Library program s preset values are loaded automatically into the pump provided that you have loaded a syringe of the manufacturer and size pro grammed for this libr
33. have periodic callback set for 1 hour then deliver a bolus dose which lasts 10 minutes the periodic callback will actually occur at 1 hour and 10 minutes Programming periodic callback alarm 1 With the pump delivering an infusion or paused press Options 2 Use the number keys to choose PERIODIC CALLBACK ALARM You may need to press More to see it Set the callback alarm time in hours amp minutes The maximum periodic callback setting is 8 hours The default callback time is 2 00 Hr When the callback alarm time is correct press Enter to accept the setting and go to the BEGIN INFUSION screen If this is a new infusion prior to connecting to the patient press lt lt to initiate the priming sequence page 59 WARNING Confirm All Settings Before starting any delivery always confirm the accuracy of all infusion values to the original order Programming the pump at a delivery rate other than that pre scribed will cause inappropriate delivery which can result in serious injury or death Medfusion Model 4000 pump Operator s Manual Enable Disable Periodic Callback Alarm The Peri odic Callback Alarm option can be enabled disabled through custom configuration using PharmGuard Toolbox 2 79 Medfusion Model 4000 pump Operator s Manual 5 When ready press lt to begin infusion Once the infusion starts the Periodic Callback Alarm sounds a Medium priority alarm at the time
34. imme diately after selecting confirming the drug program Verify the infusion parameters before starting the delivery Certain data fields may not be programmed e g patient weight and require data entry before the infusion will proceed Displaying Quick library Options The steps in this section are hypothetical The Medfusion Model 4000 pump is shipped with a Medfusion Standard Con figuration and without any Profiles Categories and Drug Programs So the actual Quick libraries available depend entirely on the custom Configuration sent to the pump Medfusion Model 4000 pump Operator s Manual Using a Custom Configuration PharmGuard Toolbox 2 allows a facility to create a custom Configuration and send it to the pump for use If profiles are created in the Configuration the pump displays the Profile Menu If the desired profile isn t displayed on the first screen press More for additional selections 1 Ifa profile listing isn t displayed on the SELECT THE PROFILE menu press More to find it on another screen otherwise it is necessary to create that profile using PharmGuard Toolbox 2 For example if 4 at right is selected the GENERAL PEDS profile opens profiles names are customized per facility preference so will not be the same as those shown in the following screens Library categories in the profile are displayed Select a category from the menu For example if 1 at right is selected
35. in hours and minutes then press Enter 50 e Patient s weight Body surface area e Dose e Delivery time The pump calculates the correct flow rate in mL hr to achieve the required drug dose The patient weight body surface area is used to calculate dose limits To program a body weight surface area infusion choose a Drug Program with DosE KG TIME DosE M TIME Choose the syringe model and size and load the syringe as instructed on page 34 The following procedure is an example of how an infusion might be programmed The actual procedure depends on how the infusion was initially customized Medfusion Model 4000 pump Operator s Manual 5 At the BEGIN INFUSION screen all values are set and the pump pauses the pump may be configured with additional confirmation screens requiring you to confirm all settings twice before beginning the infusion Prior to connecting to the patient press lt lt to initiate the priming sequence page 59 Confirm the settings and start the infusion or use the menu keys shown at right to modify the settings WARNING Confirm All Settings Before starting any delivery always confirm the accuracy of all infusion values to the original order Programming Options allows selection from a list of variables e g the pump at a delivery rate other than that pre bolus volume limit etc scribed will cause inappropriate delivery which can Clear TVD clears total volume delivered
36. infusion can be started from a pause standby or delayed start screen inappropriate delivery which can result in serious Prior to connecting the tubing to the patient and injury or death starting an infusion press lt lt to initiate the priming sequence page 59 Start delivery from pause Whenever beginning an infusion setup and pro gressing all the way through the setup levels the pump pauses at the BEGIN INFUSION screen 1 Program an infusion 2 Verify all values are correct 3 Press lt PRIME BOLUS 4 The pump begins the infusion Q aa Soe 86 Starting delivery from standby or delayed start Start the infusion at any time when the pump is on standby or delayed start It is unnecessary to either cancel standby or wait until the standby period ends 1 To start infusion from standby or delayed start press lt Before starting the infusion you may also a Return to the Main menu b Change the Rate or Dose c Change delivery options such as volume limit or bolus dose d Clear Totals Stopping delivery An infusion can be stopped at any time in any delivery mode 1 Ifthere is an active alarm first silence it Press The infusing indicators turn off and the pump pauses You may restart the infusion or change settings and restart Or turn the pump off Continuing interrupted delivery An infusion can be continued from where it left off should it be inter
37. is the loudest Defines the maximum allowed value for the Body Surface Area infusion param eter Maximum Body Surface Area is a numeric value in the range 0 0001 to 4 m Defines the maximum bolus infusion rate allowed by the pump You can select from three rates Syringe Size x 5 mL hr example 5 mL syringe x 5 mL hr 25 135 Medfusion Model 4000 pump Operator s Manual Maximum Flow Rate Maximum Patient Weight Near Vol Empty Time Near Empty Alarm Priority Occlusion Limit Profile Passcode Program Dose Display Unlock Passcode Program Options mL hr maximum bolus rate Syringe Size x 10 mL hr example 5 mL syringe x 10 mL hr 50 mL hr maximum bolus rate or Syringe Size Max mL hr see the table on page 131 Defines the maximum flow rate allowed by the pump Maximum Flow Rate is a numeric value in the range 0 1 to 1130 mL hr Defines the maximum allowed value for the Patient Weight infusion parameter Maximum Patient Weight is a numeric value in the range 0 25 to 250 kg Defines the number of minutes remaining before a syringe is empty at which time a Syringe Near Empty Alarm will occur Near Empty Alarm Time is a nu meric value in the range 0 to 240 minutes Setting this value to zero will disable the Syringe Near Empty Alarm Defines the priority level at which to generate the Syringe Near Empty Alarm You can select from two levels Low or Medium Defines the pressure at which the pump will con
38. programmed rate is below that recommended for the syringe size no remedy required see Guidelines for enhanced pump performance page 24 Restricted Flow Bolus Cancelled Medium Bolus delivery was cancelled before completion While the pump was delivering a bolus the flow rate was restricted and initiated rate reduc tion which eventually fell below the main infusion rate or extended past the maximum bolus time Check the infusion line for occlusion 105 Medfusion Model 4000 pump Operator s Manual Alarm Message Restricted Flow Loading Cancelled Priority Medium Remedy Loading dose delivery was cancelled before completion While the pump was delivering a loading dose the flow rate was restricted and initiated rate reduction which eventually fell below the main infusion rate or extended past the maximum loading dose time Check the infusion line for occlusion Restricted Flow Rate Reduced Medium If the bolus or loading dose rate is high enough to trigger an occlusion alarm the software reduces the rate until the bolus loading dose is suc cessfully delivered or if the rate falls below a certain level or takes longer than the pump allows is cancelled With each rate reduction this pro cess repeats Once silenced the audible alarm tone will not reactivate even if the process repeats Set Volume Limit Before KVO Limit Programming of a KVO rate was attempted but there is n
39. symbol should not be touched Connections should only be made when ESD precautionary measures are used R Collect Separately a For an explanation of the symbols that appear on the pump keypad see Keypad Closeup and the tables that follow page 9 Medfusion Model 4000 pump Operator s Manual Introduction CAUTION ALWAYS verify that the software version of the pump displayed on screen during power up and Operator s Manual are the same Refer to this manual s front page The Medfusion Model 4000 pump is a small light weight and portable syringe infusion pump The pump offers a variety of delivery modes programmable to meet specific patient care needs The actual modes available in a given pump and their location on a given screen depend on the custom setup Fluids can be delivered from a variety of syringe sizes 1 60 mL and syringe manufacturers in various delivery modes The Medfusion Model 4000 pump is equipped with PharmGuard Medication Safety Software an intui tive system designed to enhance safety while main taining simplicity which can allow streamlined imple mentation and improved work flow A pump Configuration is created on a PC using the PharmGuard Toolbox 2 software and then the Configuration is sent to the pump The Configuration may contain global settings Profile definitions library definitions Drug Programs and syringe definitions see page 15 for discussion about librari
40. than 1 mL The oc clusion limit is a fixed value for 1 mL syringes The setting for 1 mL syringes is fixed at 50 psi meaning you are not able to change the setting The reason for this is that at lower pressure settings occlusion alarms would be frequent Pressures in the above table are only approximations This is because syringe friction affects the actual pres sure level Occlusion limit default is set up using PharmGuard Toolbox 2 which was completed by the person re sponsible for custom Configuration before the pumps 92 were delivered to a work area You can override the default Occlusion limit for a particular infusion from the OPTIONS menu if that option is enabled The pump takes the pressure measurement approxi mately every second e The right side of the bar is the most current read ing o The middle bar is the 1 minute average The far left bar is the 2 minute average Therefore e Ifthe graph slopes upward from left to right then the pump is headed toward occlusion e Ifthe graph is level then backpressure is steady FlowSentry rapid occlusion detection FlowSentry is an internal program unique to Medfusion syringe pumps that monitors and ana lyzes delivery pressure When activated FlowSentry alerts you to the existence of an occlusion much more rapidly than conventional occlusion alarm systems The sensitivity of the FlowSentry setting is deter mined by the select
41. than the minimum allowed for this item Please Than Min Value try a higher value Invalid Entry Limit There is a problem with the drug program selected and the pump can not deliver it Contact your PharmGuard Toolbox 2 Administrator who will have to review and correct the problem Invalid Infusion Parameter Low The combination of infusion parameters does not allow a valid flow Combination rate to be calculated Verify all infusion settings If the invalid combina tion is part of a Drug Program contact your PharmGuard Toolbox 2 Administrator who will have to review and correct the problem Invalid Syringe Size High Syringe size not recognized for the model selected or the syringe barrel clamp was lifted during delivery Review syringe sizes in the technical specifications section and do not lift the syringe barrel clamp during delivery If the alarm persists remove the pump from service for repair by a trained biomedical technician KVO in Progress Medium Informational message that volume limit has been reached and KVO infusion is in progress Press a Limits Adjusted Cannot Limit The PharmGuard Toolbox 2 specified soft limit values and syringe Deliver All Doses specified during programming would allow values to be entered that result in a rate outside the allowable limits The pump has adjusted the limits to keep the rate inside allowable limits Verify the values entered and the syringe size 104
42. that the syringe model and size displayed on the pump matches the model and size loaded into the pump Use of unapproved syringes may cause improper pump operation resulting in inaccurate fluid delivery or occlusion sensing or other potential hazards Inspect the syringe to identify the model and size Press a number key to select the syringe model being used Note If when the pump was powered up the sy ringe barrel clamp was pulled up and resting on the pump handle a CHECK SYRINGE BARREL CLAMP alarm may occur immediately upon selecting a syringe model manufacturer Press A to silence the alarm press Confirm then continue with these instructions for loading a syringe 3 It is now time to load the syringe The arrows shown on screen indicate that the syringe sensors detect that the syringe is not loaded 34 Note Pharmacy labels placed on the syringe may interfere with the pump s syringe sensors To avoid interference place pharmacy labels at least 1 inch from the flange so that the Syringe Barrel Clamp does not rest on a label and orient the syringe so the label faces upward and does not rest on the pump IMPORTANT Do not move the Syringe Plunger Driver or otherwise manipulate the pump until the startup tests are complete and the Profile selec tion screen appears Sensors are tested as part of the startup process and manipulating the pump during this process may cause it to detect false s
43. the isocenter of a 1 5T 64 MHz Siemens Symphony MR system Siemens Software 2002 Revision C under the following conditions battery only no AC cord back of the pump facing the MRI isocenter full body receiver coil most sensitive using standard spin echo fast spin echo and gradi ent spin echo pulse sequences Image Distortion Certain MRI receiver coils are sensitive to electronic emissions Therefore prior to patient examinations MR image scans should be completed while operat ing the Medfusion Model 4000 pump in the MR environment that is to be used for the examination to verify acceptable MR image quality Note that results vary between MRI systems due to differences in scan ning systems and receivers used The following are tips to minimize the possibility of image artifacts appearing e Ensure that the back of the pump faces the MRI isocenter during operation pump screen facing away from the MRI e Move the pump further from the isocenter of the MRI system if image artifacts appear e Operate the Medfusion Model 4000 pump on battery power in an MR environment The pres ence of a powered AC cord typically induces im age artifacts Furthermore the MRI technologist can improve the Signal to Noise Ratio SNR of the image typically reducing or eliminating image artifacts by adjusting any of the following variables e Use signal rich pulse sequences like Spin Echo where applicable e Decrease the Phase E
44. the maximum and minimum delivery rate for syringe size or by custom settings in the configuration The delivery rate entry does not change until Enter is pressed Exit without changing the rate by pressing When the desired new rate is displayed press Enter to accept the new setting PRIME BOLUS The pump is paused at the BEGIN INFUSION screen When ready to restart the infusion H LR Q cD press lt 95 Medfusion Model 4000 pump Operator s Manual Total volume program volume dose delivered The Medfusion Model 4000 pump monitors and maintains the total quantity of fluids being delivered during any given session of infusions Total Volume Delivered TVD is displayed at the top of the screen The TVD is the total volume delivered to the patient accumulated over multiple drug programs and infu sions and it will continue to accumulate until Clear TVD or Clear Totals is pressed or the pump is turned off TVD can be recalled using the Recall Last Settings feature see page 57 Displaying Program Volume Delivered PVD Program Dose Delivered PDD In most delivery modes you have the option of view ing either Program Volume Delivered or Program Dose Delivered On the display PVD or PDD accumulates as the volume or dose is delivered to the patient and ac cumulates for the current infusion only PVD PDD is automatically cleared when the infusion ends and the pump is retu
45. the patient press lt lt to initiate the priming sequence page 59 Confirm the settings and start the infusion or use the four menu keys to modify the settings WARNING Confirm All Settings Before starting any delivery always confirm the accuracy of all infusion values to the original order Programming the pump at a delivery rate other than that pre scribed will cause inappropriate delivery which can result in serious injury or death 6 When all delivery settings are confirmed as correct press lt to begin the infusion Medfusion Model 4000 pump Operator s Manual To program a Continuous mode infusion at the selec tion menu choose ML HR or choose a drug program that uses the continuous mode infusion type Choose the syringe model and size and load the syringe as instructed on page 34 Main Menu returns to the Main Menu Chg Rate allows modifying the set rate Options selection from a list of variables e g bolus volume limit etc Clear Totals clears total volume delivered and PVD or PDD 39 Medfusion Model 4000 pump Operator s Manual Dose Min and Dose Hr The Dose Min and or Dose Hr modes may be avail able on a pump Program them by setting 40 Drug concentration units i e g mL mg mL mceg mL mMol mL mEq mL or Units mL Drug concentration Drug delivery units e g g mg mcg ng mMol mEq or Units Dose rate Use the number keys to select the
46. the person s responsible for configuring pumps 20 Medfusion Model 4000 pump Operator s Manual PharmGuard Supported Syringes PSS Series 2 Each manufactured syringe has unique characteristics These characteristics differ by model and syringe size The Medfusion Model 4000 pump uses the specific characteristics to accurately deliver fluid Included with PharmGuard Toolbox 2 are several commonly used Medfusion Standard Syringes for a facility to choose from These syringes are chosen for use in a Configuration via PharmGuard Toolbox 2 PharmGuard Supported Syringes PSS Series 2 al low the addition of a wide range of available syringe models and sizes to PharmGuard Toolbox 2 for use in creating Drug Programs PSS Series 2 files must be added via PharmGuard Toolbox 2 when creating a custom Configuration Contact Smiths Medical for a complete list of available PharmGuard Supported Syringes PSS Series 2 The Medfusion Standard Syringe models and sizes are listed in the Technical Information section of this manual on page 130 Specific technical informa tion including syringe flow rate and minimum vol ume is also supplied in the literature accompanying PharmGuard Toolbox 2 and the PharmGuard Supported Syringes PSS Series 2 Refer to www smiths medical com or contact Customer Service for more information about available PharmGuard Supported Syringes PSS Series 2 WARNIN
47. the software will display a system fault screen turn on a continuous two tone audible alarm and stop all drug delivery Data Used in Calculations Critical data failure Calculations on data used in some way to control the delivery of drug are performed redundantly Medfusion Model 4000 pump Operator s Manual The two calculated values are then compared If the two values do not match the software will display a system fault screen turn on a continuous two tone audible alarm and stop all drug delivery Timer Data Registers Time base BGND time of day clock POST time of day clock timeout The data in the Real Time Clock is checked at regular intervals If the data is not reasonable the software will turn on a continuous two tone audible alarm and stop all drug delivery 129 Medfusion Model 4000 pump Operator s Manual Additional Technical Information Medfusion Standard Syringes Below is a table of the standard model syringes supplied with PharmGuard Toolbox 2 and included in the Medfusion Standard Configuration which can be used with the Medfusion Model 4000 pump Information regarding syringe flow rate and minimum volume for these syringes can be found on the next page and in the product literature supplied with the PharmGuard Toolbox 2 Model Manufacturer B D Becton Syringe Model Sizes 1 3 5 10 20 30 and 60 mL Luer Lok Dickinson lmL Tuberculin Monojec
48. ther continue the dose from where it left off restart a new dose or cancel the dose 1 Ifnecessary press O to silence the alarm Troubleshoot the alarm condition 2 Press lt 3 To continue the flush infusion from where it left off delivering only what was remaining press Yes Press No to cancel the remainder of the flush infusion and return to the MAIN menu Medfusion Model 4000 pump Operator s Manual 89 Medfusion Model 4000 pump Operator s Manual Volume and time 1 When the programmed infusion is complete or the SYRINGE EMPTY alarm activates and the pump alarms press D The BEGIN FLUSH SETUP screen appears If you do not want to start the flush at this point press No the pump will return to the BEGIN INFUSION screen If you do want to begin the flush setup press Yes Remove the syringe at the end of the infusion when prompted and replace with the flush syringe Press the number key to select the syringe model Load the syringe onto the pump verify the correct size is shown then press Enter Use the number keys to enter the desired amount of flushing infusate then press Enter The pump requires confirmation that the flush be delivered at the same rate as the previous infusion To deliver at the same rate press Yes the pump will then automatically calculate the delivery time To deliver at a different rate press No If No was pressed the FLUsH TIME screen appears Use the num
49. to identify battery message status T12 Poleclamp assembly amp use This section contains the instructions for assembling and using the poleclamp options available for the pump CAUTION This pump is designed to be used in a horizontal position If the pump is operated in a verti cal position there is an increased potential for fluid leaking into the pump If you suspect fluid has leaked into a pump remove it from service until a trained biomedical technician can test it Rotating detachable poleclamp standard With the Rotating Poleclamp catalog number 3000RPC you can align the poleclamp for mount ing on any vertical or horizontal pole bed rail or similar solid structure small enough to fit within the clamps jaws The light weight of the pump makes this convenient 1 Open the clamp jaws wide enough to easily slip around the pole 2 Tighten the clamp until it is securely fastened so the pump cannot be moved The rotating detachable poleclamp is packaged in two pieces that must be clipped together before it can be used e The L Bracket and clamp anchor with release lever is pre attached to the pump base with 2 flathead screws The Rotating poleclamp which must be slid onto the clamp anchor at the back of the pump Medfusion Model 4000 pump Operator s Manual CAUTION Always verify the stability of the object to which the pump is mounted for instance an IV pole using the
50. 00 mL hr or the default maximum bolus rate for the syringe size being used Syringe size x5mL hr Syringe size x10mL hr or Syringe size Max mL hr whichever is lower see page 135 Maximum Bolus Rate for further explanation Infusion rate range 0 01 mL hr to 1130 mL hr in increments of 0 01 0 1 mL hr depending on syringe size rate Refer to syringe tables on page 131 for Minimum Recommended Rate Bolus volume range Volume is limited to the maximum fill volume of the current syringe size and minimum volume is 1 600 the syringe size Note The Minimum Recommended Bolus Volume is 10 of syringe or 1 mL whichever is smaller Bolus volumes delivered that are less then the recommended minimum bolus volume for the syringe used may result in delivery inaccuracies Delivery modes user customized Intermittent Delivery Modes Dose kg time Continuous Delivery Modes Dose min hr day Dose kg min hour day Dose m2 time Dose m2 min hr day mL kg time mb he Volume time mL kg min hr Dose time Intermittent volume time Delivery Options user customized Volume Limit Toggle FlowSentry Bolus Dose Delayed Start Loading Dose Override Alarm Loudness KVO Toggle PVD PDD Standby Disable Enable Vol Empty Tone Override Occlusion Limit Disable Enable Near Empty Tone Periodic Callback 126 Medfusion Model 4000 pump Operator s Manual User defined librari
51. 2010 2011 Smiths Medical All rights reserved 2011 09 40 5760 51A smiths medtcal
52. Connected to Toolbox When External Commands are enabled in Biomed mode the pump can be connected to PharmGuard Toolbox 2 Network Configuration The Medfusion Model 4000 pump provides a telnet server to enable performance of configuration tasks Medfusion Model 4000 pump Operator s Manual through a simple command line interface from a tel net client program The pump accepts incoming connections from the network using telnet The telnet configuration inter face supports a user definable telnet password The pump must have External Commands enabled in biomed mode to use telnet Attaching the Pump to the Network See the Medfusion Model 4000 Network Settings Manual for instructions in how to attach the pump to the network Network status Briefly display the network status at any time while the pump is infusing by pressing Example of communications state icon Medfusion Model 4000 pump Operator s Manual Pump Customization and General Programming Custom Configuration Generally speaking pump customization is performed before a pump is used on a patient see the graph on page 13 Customization is accomplished using PharmGuard Toolbox 2 Once the custom Configuration is cre ated and validated PharmGuard Toolbox 2 or the PharmGuard Server is used to send it to one or more pumps When sending Configurations us ing the PharmGuard Server all Medfusion Model 4000 pumps configured to communicat
53. ERY screen ap pears To begin bolus delivery press Yes If you do not want to start the bolus right now press No If you want to change the bolus amount press CHG Bolus and repro gram the bolus items 3 through 5 in the preceding section WARNING Confirm All Settings Before starting any delivery always confirm the accuracy of all infusion values to the original order Programming the pump at a delivery rate other than that pre scribed will cause inappropriate delivery which can result in serious injury or death 3 If Yes was pressed the BOLUS DELIVERY screen appears with DELIVERING and the drug program name alternately appearing CANCEL stops the bolus and returns to the normal delivery rate and screen If No was pressed the pump returns to the delivery screen Note that the bolus infor mation appears on the screen Pressing lt lt will cause the BEGIN BOLUS DELIVERY screen to reappear where you can begin delivering the bolus see above 64 Medfusion Model 4000 pump Operator s Manual Continuing an interrupted bolus dose Should a High Priority alarm occur during bolus delivery or if or Cancel are pressed the bolus will stop You can then either continue the bolus from where it left off or cancel the bolus 1 Ifnecessary press O to silence the alarm Troubleshoot the alarm condition 2 Press lt 3 Either e Press Options then use the number keys to select B
54. G Only use the Medfusion Standard Syringes supplied with PharmGuard Toolbox 2 and included in the Medfusion Standard Configuration or the models and sizes available as part of the PharmGuard Supported Syringes PSS Series 2 and always confirm that the syringe model and size displayed on the pump matches the model and size loaded into the pump Use of unapproved syringes may cause improper pump operation resulting in inaccurate fluid delivery or occlusion sensing or other potential hazards 21 Medfusion Model 4000 pump Operator s Manual Navigating the pump menus There are some general rules for navigating pump menus Most of the pump programming steps are accomplished by looking to the display screen and pressing the softkey keys indicated For example PRIME BOLUS e comm E O Oo The screen shown above is an example of a BEGIN INFUSION screen Pressing softkey 1 opens the MAIN menu pressing softkey 2 initiates the screens for changing the dose value pressing softkey 3 opens the OPTIONS menu pressing softkey 4 clears the infusion volume and dose totals stored in pump memory The softkeys change for different screens and some screens will have only certain of the softkeys active or even no active softkeys Always look to the display to see what the softkeys are used for When programming a value or to enter a menu in most cases the number and decimal keys on the r
55. O O 000 OOO O CO O O ooog Medfusion Model 4000 pump Operator s Manual Key When pump is paused When pump is delivering Alain Silenced Silences audible alarm Allows opera Silences audible alarm Allows operator to i bi tor to switch the display backlight from switch the display backlight from bright to dim bright to dim or dim to bright Allows or dim to bright redisplay of the text for the last active alarm Power Silence certain active alarms Push and Silence certain active alarms some alarms hold to turn pump off must be silenced with O before will function Push and release then push and hold to turn pump off Menu keys softkeys Function is defined on the display Function is defined on the display Back D Reverts to a previous step or level Reverts to a previous step or level if adjusting settings Briefly displays the battery life indi cator network connection type data server status and PDD PVD Numbers amp Decimal Set number values or selects menu Set number values or selects menu items items Stop N A Stops delivery pump remains on Gar Starts delivery N A Bimet Pols lt Begins priming after confirmation Displays the programmed bolus programming or confirmation BEGIN DELIVERY screen Indicator What it means CX Alarm The Alarm indicators yellow or red are on whenever the pump is in an alarm condi tion The specif
56. Operator s Manual Software Version V1 1 This manual and its contents are valid for use with software version V1 1 Medfusion Model 4000 pump Operator s Manual Technical Assistance The issue date of this manual is included on the back cover If your manual is a year or more old contact Smiths Medical to see if a newer manual is available If you have comments or questions concerning the operation of the Medfusion Syringe Infusion Pump Model 4000 Medfusion Model 4000 pump please call the appropriate number given below When call ing please specify your pump s software version This information is located on the start up screen Our staff at Smiths Medical in the USA is available to help clinicians 24 hours a day with the programming and operation of the Medfusion Model 4000 pump Smiths Medical ASD Inc 1265 Grey Fox Road St Paul MN 55112 USA 1 800 258 5361 USA 1 214 618 0218 www smiths medical com A printed copy of this manual is available upon request Table of Contents Important Safety Information 1 WALTINGS eccrine iniri sies 1 CAUTIONS assinet erines aeai aa aI EE ia R EE 4 DYNO aee E E 5 Introduction l dications TOF Us siasnsnens nanana 6 CORE ATMCICAIRONG 55 ssscis ses scsatsevaloasaanasesenssenetacesaniepheomesmaeanen 7 About the pump 8 Features and COntrOlSsssnnsssess i 8 Keypad CLOSE UD siiri nissai steek 9 Network Connections 11 Ethernet State cmaresrnenee n AS 11 Wireless S
57. Steps 3 through 5 are the bolus program ming screens If Autoprompt is Enabled in PharmGuard Toolbox 2 they are part of the nor mal infusion programming workflow 3 Ifthe initial infusion is programmed in one of the body weight modes e g Dose Kg Min the bolus dose may be programmed in the parameters of that dose mode e g Mg Kg or in Total Dose e g Mg Use the number keys to set the desired bolus dose for this infusion or to set the dose volume in mL if applicable for the infusion Volume is limited by the maximum fill volume of the current syringe size and minimum volume is 1 600 the syringe size When the dose setting or bolus volume is correct press Enter 62 A bolus may be programmed during the initial infu sion setup at the BEGIN INFUSION screen or during an infusion without stopping medication delivery If Bolus Autoprompt is set to Enable in PharmGuard Toolbox 2 when initially programming a continuous infusion the bolus programming screens steps 3 5 below are part of the drug program setup Pressing Disable at the bolus entry screen will disable the bolus feature for the duration of the infusion Disable turns Bolus off for the duration of the infusion Clear deletes an entry Backspace erases a character Medfusion Model 4000 pump Operator s Manual 4 Confirm that the bolus dose settings and total bolus dose are correct If incorrect press No and the pump r
58. Syringes PSS Series 2 see the product literature pro vided with that product Please see the tables on page 131 for information regarding the lowest recommended rates for each syringe size used on the pump The table below is provided for convenience Should changes to the listed syringes occur the values shown here may be superceded see the Instructions for Use provided with the Medfusion Standard Syringes M Size Min Rate Max Rate Minimum volume Minimum recommended rate Manufacturer to infuse FlowSentry FlowSentry disabled enabled 0 0016 0 033 B D Bocian Dickinson 0 01 29 por om f oos 0033 3 o ooo5 0 17 o os a ome _ 483 622 944 29 105 o fon 0 0333 p30 fot Monoject Covidien 0 0016 a Cs oor w Oo f e oo n oo ooo f a os as o o tt f se o oos po 8st 7z oos o f o o a o a Terumo ismumos BAe R a ee s oo a oo o os ss oos Co f a fa oa Co f oa f a o o Con no o 131 Medfusion Model 4000 pump Operator s Manual Wikre G Size Min Rate Max Rate Minimum volume Minimum recommended rate Manufacturer to infuse O om m A r OO e O e BB Perfusor B Braun J S o i oos i7 os BB Omnifix B Braun O fo o To ee ae FlowSentry is not available with 1 mL and Terumo syringes Syringe Size Minimum Recommended Bolus Volume
59. When ready press Enter At the BEGIN INFUSION screen all values are set and the pump pauses the pump may be configured with additional confirmation screens requiring you to confirm all settings twice before beginning the infusion Prior to connecting to the patient press lt lt to initiate the priming sequence page 59 Medfusion Model 4000 pump Operator s Manual Below are the steps for programming an Intermittent Volume Time infusion Select INTERMITTENT VOLUME TIME from the selection menu or choose a drug program that uses the intermittent volume time mode infusion type Choose the syringe model and size and load the syringe as instructed on page 34 55 Medfusion Model 4000 pump Operator s Manual 56 6 Confirm the settings and start the infusion or use the three menu keys shown at right to modify the settings WARNING Confirm All Settings Before starting any delivery always confirm the accuracy of all infusion values to the original order Programming the pump at a delivery rate other than that pre scribed will cause inappropriate delivery which can result in serious injury or death 7 When all delivery settings are confirmed as correct press lt to begin infusion Main Menu returns to the Main Menu Options allows selection from a list of variables e g standby etc Clear TVD clears total volume delivered Recall last settings The Medfusion Model 4000
60. al slack Failure to prime correctly can delay infusion delivery and cause Total Volume Delivered to read higher than what is actually delivered to the patient The size should now appear in the display Note If the syringe is incorrectly loaded guide ar rows appear on screen to identify the problem Arrow pointing down means check syringe barrel clamp Arrow pointing left means check syringe plunger holders Arrow pointing up t means check syringe flange clip 36 Medfusion Model 4000 pump Operator s Manual Note Some syringes may have similar outer dimen sions despite being different sizes for example BD 1mL Luer Lok and 3mL syringes or even different models In these cases the pump will display op tions requiring you to select the correct syringe size actually in use Always verify that the syringe model shown is what you are actually using 9 Make sure the pump correctly recognizes the syringe size and the syringe model is correct If not verify that the model and size are available on the pump contact the person within the facility responsible for customizing the pump for more information if necessary WARNING Only use the Medfusion Standard Syringes supplied with PharmGuard Toolbox 2 and included in the Medfusion Standard Configuration or the models and sizes available as part of the PharmGuard Supported Syringes PSS Series 2 and a
61. an IV pole using the poleclamp Failure to verify the stability could cause the object to tip with the possibility of causing damage to the pump and other equip ment If the poleclamp is not adequately tightened it could cause the pump to fall e NEVER use organic solvents e g acetone quarternary ammonia compounds strong acids or bases to clean any portion of the pump as these compounds may damage the pump e The pump is spray resistant from the top and sides but not water proof NEVER spray clean ing or other fluids directly into openings on the bottom of the pump as pump damage may occur e The pump is not certified waterproof Never im merse the pump in water or other fluids as this can render the pump inoperable e NEVER use light oil sprays e g WD40 to clean or lubricate pump These oils contain chemicals that can damage the plastic of the pump No user added lubrication is necessary e NEVER sterilize the pump in a steam autoclave or gas sterilizer Using autoclave or gas sterilization can seriously damage the pump and will void the warranty Symbols The following is a list of symbols which may appear on the pump or on its labeling or accessories as well as certain technical terms along with an explanation of what they mean sw A v 109 K R 2 RJ oO ae a 5 SOs IPX3 Serial number Caution Type CF equipment protection from elec tric s
62. are confirmed as correct press lt to begin infusion 47 Medfusion Model 4000 pump Operator s Manual Volume weight infusions The following volume weight modes may be available on a pump mL kg min and mL kg hr Volume weight infusions rate calculations allow pro gramming by e Patient s weight e Volume of drug per kilogram of weight e Volume limit KVO loading dose or bolus dose may also be programmed these options are only available if they have been enabled in the custom program using PharmGuard Toolbox 2 Use the number keys to set the patient s weight in kilograms Weight is limited to the indicated range Press Enter to accept the patient weight setting The pump may be customized with an additional patient weight body surface area confirmation screen Re enter the patient weight then press Enter to accept the setting At the VOLUME KILOGRAM screen press the number keys to set the volume per weight setting Range limits are determined by the installed syringe size patient weight and or the custom setup in the Configuration When the setting is correct press Enter to accept it If desired and if they are enabled program a Bolus Dose Loading Dose or Volume Limit see Options page 61 At the BEGIN INFUSION screen all values are set and the pump pauses the pump may be configured with additional confirmation screens requiring you to confirm all settings twice before beginning the inf
63. areesmbennnns Vol me V UME sireci arsi neniaro ak sst EAE Ss Intermittent volume THIS ssssssriissirssiissisisisr orisii Recall last settihgSssuprsssriniei Priming the syste nenerisseinanianasaes Options Bolus dosne aceon arr E T Bol progra MMi essssissscusscstsienscnrisinansdennnniions TONS livet eia e A ETE Continuing an interrupted bolus dose Bolus dose rate TEAUCHOM o5sssicadnuresinsrscisivovinsesiedesiananats Loading dOS6S secncndiadndieahnciadnnadconmeniieiaal Setup loading CONG is core rtealeanerrersdadsaiansausecemeencelrarnaias Delivering a loading dose assssisisseseasaderanirnouamaanaces Continuing an interrupted loading dose Loading dose tate TedUCHON sian cinnrindncnseaniaes Volume limit a sscusttousessnis sttedepretedsinwonmemetishapestinusaenopautiaunss Setting volume liMit oreren n nsaan Keep Vein Open KVO Tates Programming KVO Late sssccssiscsssessisssdeessevssissssvescavesesonses PRN ccc se cent a E bing Programming StANO DY ssisiesnyscasisinsesarnctestabaenaseioctennsiasieus Delayed Start sian REE T Programming delayed start sssssssssseesesssrersssseressrreeesreee Periodic callback alarini sreinaene e sees Programming periodic callback alarm eee Override aiid toggle features zon ennag Change to Dose Change to Volume ou eee Override occlusion limit serieesssrorancsnnriiis Override alarm loudness sisssssissiissiisisiessras Dasable enable PlOWSCMUYy sitctuwstinecastcsndisecsimnenerasiai
64. arger post occlusion bolus at higher occlusion limit settings delivery inaccuracies or other potential hazards Bolus Volume Delivering a bolus volume less then the recommended bolus volume for the syringe used may result in delivery inaccuracies Use an infusion set with the smallest diameter tubing available that does not result in excessive back pressure at the desired flow rate Consider prim ing loading bolus and flush rates when selecting an infusion set Larger size syringes at occlusion setting HIGH may produce a post occlusion bolus larger than 0 3 mL due to excessive syringe plunger tip compli ance When using Quick libraries preset values are automatically inserted without pausing to verify each setting The BEGIN INFUSION screen displays immediately after selecting confirming the drug program Verify the infusion parameters before starting the delivery Certain data fields may not be programmed e g patient weight and require data entry before the infusion will proceed If a system failure alarm occurs and cannot be cleared by powering the pump down then back up the pump cannot be used Remove it from use and send it to a trained biomedical technician for service Electric Shock hazard The only means of remov ing AC power is to disconnect the AC power cord e While the AC power cord is attached to the pump and plugged into an AC outlet live mains voltage is present inside the pump Ensure that the
65. ary entry Press lt to begin the preset infusion after verifying infusion settings and using the Prime feature Some data fields may be blank and require data entry to proceed Medfusion Model 4000 pump Operator s Manual 1 To use Quick Library programs from the SELECT screen use the number keys to select a drug program For example if 1 at right is selected the pump loads the stored settings for PROPOFOL 10 MG ML infusion and pauses at the BEGIN INFUSION screen All the infusion settings display on the BEGIN INFUSION screen You have the option to change the default settings for weight and dose using the soft keys displayed All settings should be confirmed to ensure they are correct Always check the infusion settings accuracy You are responsible for ensuring the safety of any infusion the pump is programmed to deliver Use the Prime feature then press lt to begin the infusion Medfusion Model 4000 pump Operator s Manual PharmGuard Safety Software Dose Protocol Protection PharmGuard Medication Safety Software provides programmable Hard and Soft upper and lower limits for infusion parameters Refer to the PharmGuard software limits in the Technical Specifications section of this manual page 133 for a list of all parameters that may be protected with PharmGuard software limits Soft limits Soft limits are the normal limits and show on screen as High and Low Soft limits
66. ase 117 Medical Electrical Equipment Safety eee 117 Electromagnetic Comp atin ty i isssssitssavasenansessedvesinss 117 Miscellaneous Standards cjssisinnssiaswtasaissecsaioecemniss 119 Compliance tsi aissiscsassncasssniovsnnvsssvenssvaupsusnionsvseavisnns 120 IEEE 802 11 b g Radio for Auxiliary COMMUNICATION sss scsccssssessscesesseseecsastosssovensnvecesnsesevse s 123 Technical specifications sssini 124 Specifications asessorin ioii siriiai rosas ros inaari s iiair 124 Safety Features 128 Safety Features and Fault Detection 128 Hardware Safety Features ccssccosscssccstenssosesctscsecsesseesias 128 Software Safety FeatUr sS sis eccssssstsisssncsocsavedeostasesatdetscosecetans 128 Hardware related Software Safety Features 128 Program Memory Check FLASH memory POST OP BGIN D vsisisssscasssncnerssessievitntsnenasertarenisnenaes 128 RAM Memory Check RAM BGND cscs 128 Motor Circuit Check pump motor phase A or B POST and Motor rate error during operation 128 Keyboard Encoder Check Control key POST OF BOND sissncaaciasiarnsinnndvmecseinets 128 Data Handling Software Safety Features 0 0 0 128 Data Stored in EEPROM Critical data POST or EEPROM timeout or Primary Secondary criticaldata corrupte dssmnresessecanisainas 128 Data Used in Calculations Critical data failure 128 Timer Data Registers Time base BGND time of day clock POST time of day clock timeout 129 Additional Technical Infor
67. at very low rates below Minimum Recommended Rate for the syringe may cause improper pump oper ation delayed occlusion sensing larger post occlusion bolus at higher occlusion limit settings delivery inac curacies or other potential hazards Bolus Volume Delivering a bolus volume less then the recommended bolus volume for the syringe used may result in deliv ery inaccuracies Use an infusion set with the smallest diameter tubing available that does not result in exces sive back pressure at the desired flow rate Consider priming loading bolus and flush rates when selecting an infusion set If accuracy is of prime concern use only syringes that meet the 2 requirement of the ISO 7886 2 Standard Friction and compliance of the syringe plunger tip affect delivery startup and flow continuity The bigger the syringe the greater the friction and compliance the slower the startup Use a smaller syringe when running at a lower rate The tables on page 131 show the recommend minimum delivery rates for the standard syringes included with PharmGuard Toolbox 2 by syringe size Similar in formation is provided in the documentation supplied with PharmGuard Supported Syringes PSS Series 2 When programming flow rates a limited priority alarm will be activated with an advisory message on 24 the screen if a rate that falls outside those recom mended is entered Note e FlowSentry is not available for all syri
68. ays use the smallest syringe for volume of fluid b ing delivered inana a 24 Bolus Vol m snsnsinisisinionininnnnasennuara 25 Use appropriate internal diameter tubing 25 Programming an Infusion 26 Turn the pump 00 cscs diaisadahdnan dn dassendesase 26 Turning the UNIS OIE visessaiisranteseosennseeonarrndshancssvinrcsarcens 27 Selecting a Delivery Mode and Programming an USON fasten e a e taetdidytutuius 28 General Infusion Programming Procedure 29 Selecting an TRIS BOR eilenn inane 30 Select a Profile Custom Configuration s es 31 Selecta CAC GORY reisisseinenis inisi Select Drug PEOGT AUD sy cnsinsescssscuniasemseceteatarimeosniopeanes Select a Delivery Mode Medfusion Standard ADO UP ATION Vo sscessinsttsoienaiaroinsecdiirmnetniyanaiend Loading a syringe and syringe model setup Unloading the Syringe psicaiescastsinevicensedinnvencsaear sven Programming SIONS oy cccaisscoccutaiiveanvoieavnicedswenciaoine candace Continuous mode PANE os passcatescssnssdiariviessarasctsoesatasinye Doses Minand ae Tt sscosscstsscsescsesesanseutcaisoecausteasstes DOSE DAY ce sistevestsvessntssessstiesss seh RENE Dose Time eisiesissesicsitienissichipiniieudecvidatestestees Body weight surface area infusion deliveries Volume Weis it ITU StS ses sascsscscescestsaeseasc cesecoetsnastives Dose kg time dose m time co ssiascvscaseansiarnrsnnceacoaans Vol me weight ti sss scasssnasactaaasesdesceccomseno
69. ber keys to select the delivery time then press Enter INFUSION COMPLETE 1 nL WEIGHT TIME QG 83 68 TBI 1 nL TIME REMAINING H HA HA RATE 24 LHR MAIN MENU OPTIONS CLEAR TUD BEGIN FLUSH SETUP SELECT SYRINGE MODEL B D MONOJECT TERUMO aS SS ESS ESS LOAD SYRINGE PRESS ENTER WHEN READY m H i i EEE Eee FLUSH VOLUME TO INFUSE PRESS ENTER TO CONTINUE HIGH a LOW 4 085 as ML ee CEAR BACKSPACE ENTER CONFIRM SAME RATE M EAN FLUSH TIME PRESS ENTER TO CONTINUE HIGH 00 16 00 LOW 90 02 00 H BBE HR MIN SEC CEAR BACKSPACE ENTER Medfusion Model 4000 pump Operator s Manual To begin flush delivery press Confirm OR e Press Chg Vol to return to the FLUSH VOLUME screen and change the volume OR e Press Chg Time to return to the FLUSH TIME screen and change the time OR e Press Main Menu or the Quick Library to skip the flush delivery and return to the MAIN menu Note If no keys are pressed for 30 seconds the User Callback alarm will sound 9 When Confirm is pressed the flush infusion begins delivering with FLUSHING and the library name alternately appearing To cancel the flush press Cancel If flush delivery is cancelled or should an alarm interrupt flush delivery you will have the option of restarting it by pressing Flush or if finished press Main Menu or the Quick Library to exit When the flush infusion has been delivered delivery s
70. cable public low voltage power supply network that sup plies buildings used for domestic purposes IEC 61000 3 2 Voltage fluctuations Not Applicable Flicker emissions IEC 61000 3 3 Compliance using 1 AC power cord length of 2 4 m 8 feet 2 Rechargeable lithium ion battery pack 3 Ethernet cable of less than 3 m 9 75 feet Exceeding this length could result in increased susceptibility to external electromagnetic interfer ence WARNING The pump should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the user should verify normal operation of the pump in the configuration in which it is to be used 120 Medfusion Model 4000 pump Operator s Manual Guidance and Manufacturer s Declaration Electromagnetic Immunity The Medfusion Syringe Infusion Pump Model 4000 is intended for use in the electromagnetic environment specified below The customer or the user of the Medfusion Syringe Infusion Pump Model 4000 should assure that it is used in such an environment Immunity test IEC 60601 Compliance level Electromagnetic environment Test level guidance Electrostatic 6 kV contact 8 kV contact Floors should be wood concrete or ceramic tile If floors are covered with n 8 kV air 15 KV air synthetic material the relative humidity should be at least 30 IEC 61000 4 2 Electrical fast 2 kV for power 2 kV for power Mai
71. ccur in the vicinity of equip ment marked with the following symbol en NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from struc tures objects and people a The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 to 40 70 MHz gt The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz are intended to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas For this reason an additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in these frequency ranges Fieldstrengths from fixed transmitters suchas base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an elec tromagnetic site survey should be considered Ifthe measured field strength in the location in which the Medfusion Syringe Infusion Pump Model 4000 is used exceeds the applicable RF compliance level above the Medfusion
72. ction is cleared you may resume the loading dose if desired See the previous page for instructions 71 Medfusion Model 4000 pump Operator s Manual Volume limit A Volume Limit is an Option available for continuous delivery modes On reaching the preset volume limit the pump stops or changes to KVO if a keep vein open rate has been programmed Volume limit is based on the amount of programmed volume that is delivered Enable Disable Volume Limit If Volume Limit is not currently available as a dosing option it can be enabled through custom pump configuration using PharmGuard Toolbox 2 Setting volume limit A volume limit can be set either before starting an infusion or by pausing the pump during an infusion Volume limit is found in the OPTIONS menu which you access from the BEGIN INFUSION screen 1 With the pump stopped press Options 2 Use the number key to select VOLUME LIMIT 3 Use the number keys to set the volume limit then press Enter Note Volume is limited to 500 mL regardless of syringe size in use as some infusions may require multiple syringes Disable turns Volume Limit off CLEAR deletes an entry Backspace erases a character 72 Medfusion Model 4000 pump Operator s Manual 4 The volume limit setting now appears on the display Program Volume Delivered PVD will appear on the screen directly above the V LimIT If this is a new infus
73. cturer s proprietary confidential information No rights are granted under this license or otherwise to decompile pro duce humanly readable copies of reverse engineer modify or create any derivative works based upon the Licensed Computer Program 3 All other terms and conditions of this Limited Warranty shall apply to the Licensed Computer Program The Manufacturer disclaims responsibility for the suitabil ity of the Pump for any particular medical treatment or for any medical complications resulting from the use of the Pump The Manufacturer shall not be responsible for any incidental damages or consequential damages to property loss of profits or loss of use caused by any defect or malfunction of the Pump This warranty gives the Original Purchaser specific legal rights and the Original Purchaser may have other legal rights which may vary from state to state Index A AC power connection port 9 111 Alarms amp alerts 99 Troubleshooting 103 Update s Available Notification 110 Battery 111 Battery Alarms 107 guidelines 112 Onscreen power gauge 112 Body weight surface area infusions 46 Bolus dosing 62 Bolus rate reduction 66 106 Continuing restarting a bolus dose 65 C Changing rate 94 during delivery 94 when paused 95 Cleaning the pump 141 Communication 123 140 Concentration and dosing units 133 Configuration 6 12 134 Configuration profile 30 Continuing a bolus dose 65 Continuing a loading dose 70
74. d Disabled Defines whether dates are separated by a slash yyyy mm dd or a dash yyyy mm dd Defines whether decimal points in numbers are represented by a comma or a period Defines if the pump will prompt a user for their User ID when overriding a Drug Program infusion property You can select from two values Enabled or Disabled Defines if the pump will prompt a user to program a flush infusion following completion of an infusion You can select from two values Enabled or disabled Defines whether a user will be allowed to set an infusion time for a flush infu sion You can select from two values Enabled or disabled Defines the maximum volume allowed by the pump during a flush infusion Maximum flush volume is a numeric value from the minimum volume for the syringe to the fill volume of the syringe Defines if the FlowSentry Rapid Occlusion Detection feature is enabled You can select from two values Enabled or Disabled Defines the sensitivity of the FlowSentry algorithm during normal infusion You can select from four values Low least sensitive Normal High or Very High most sensitive Defines the sensitivity of the FlowSentry algorithm during infusion startup You can select from four values Low least sensitive Normal High or Very High most sensitive Defines the click loudness level when pressing pump keys You can select from five levels Off Level 2 Level 3 Level 4 or Level 5 Level 5
75. d minimum volume is 1 600 of the selected syringe size When the Volume setting is correct press Enter Note Volume is limited to 500 mL regardless of syringe size in use as some infusions may require multiple syringes 2 Press the number keys to set delivery time Time is always limited by maximum and minimum rates for selected syringe size and or the custom setup in the Configuration When the delivery time is correct press Enter At the BEGIN INFUSION screen all values are set and the pump pauses the pump may be configured with additional confirmation screens requiring you to confirm all settings twice before beginning the infusion Prior to connecting to the patient press lt lt to initiate the priming sequence page 59 Confirm the settings and start the infusion or use the three menu keys to modify the settings WARNING Confirm All Settings Before starting any delivery always confirm the accuracy of all infusion values to the original order Programming the pump at a delivery rate other than that pre scribed will cause inappropriate delivery which can result in serious injury or death 6 When all delivery settings are confirmed as correct press lt to begin infusion 54 ing or bolus dose cannot be set in this mode To program Volume Time choose it at the selection menu or choose a drug program that uses the vol ume time mode infusion type Choose the syringe model and size a
76. de by pressing its number If the desired mode is not displayed press More to display additional delivery modes if present The pump requires confirmation of manual mode selection Press Yes to confirm the selection or press No to return to the SELECT screen After a delivery mode selection is made the pump will prompt you to select the syringe model and size before programming the selected mode see page 34 Specific information for programming the vari ous delivery types follows the instructions for the syringe 33 Medfusion Model 4000 pump Operator s Manual Loading a syringe and syringe model setup Once a Drug Program or manual delivery mode has been chosen specify the syringe model and size and load the syringe Pumps can be customized to allow for use of a wide variety of syringe brands and sizes or can limit to as few as a single syringe brand If a pump has been customized to a single syringe brand none of the following screens will appear Syringe setup and loading is a multi step process based on your daily practice of infusing patients with medications or other fluids Use your facility s standard protocol for preparing an infusion WARNING Only use the Medfusion Standard Syringes supplied with PharmGuard Toolbox 2 and included in the Medfusion Standard Configuration or the models and sizes available as part of the PharmGuard Supported Syringes PSS Series 2 and always confirm
77. dium Syringe Plunger Not in Place High Press The syringe is not loaded correctly or the sensor has failed Make sure the syringe plunger head is properly inserted Proceed with the infusion if possible If the alarm recurs remove the pump from ser vice for repair by a trained biomedical service technician 106 Medfusion Model 4000 pump Operator s Manual Alarm Message Priority Remedy Syringe Volume Near High Press The pump has calculated that the volume of medication in the Empty syringe is nearly empty The Syringe Empty Alarm will activate when the syringe is empty Make preparations to install a new syringe if neces sary The time until the syringe is empty can be estimated by estimating the volume remaining in the syringe and dividing by the delivery rate User Call Back Medium The pump was left idle on a user input screen Either e Finish the programming steps e Return to the SELECT THE PROFILE screen where no alarms sound e Turn off the pump Syringe Near Empty alarm priority is configurable separately for each profile using PharmGuard Toolbox 2 System Failure and Advisory Alarms Battery Alarms Alarm Message Priority Remedy System Advisory Medium The internal battery is not working The pump may be used on AC Battery Communication power on a conditional basis As soon as possible remove pump from Timeout service for repa
78. e Kg Hr Intermit Volume Time Dose M Time Dose Kg Min mL Hr Dose m2 Day mL Kg Hr Other mode Dose m2 Hr mL Kg Min Recall Last Settings Send Configuration Types of Delivery Modes Possible These are the types of infusion modes possible Some are manual in that they can be used in Drug Programs or can be menu items on their own while others can only be used in the creation of Drug Programs such as Dose Kg Time and Dose M Time Flush feature may be used in some modes Possible Options Bolus Dose The Customization oo Loading Dose P ro cess Override Alarm Loudness Override Occlusion Limit Periodic Callback Alarm Standby Toggle Empty Tone Toggle FlowSentry Toggle Near Empty Tone Toggle PVD PDD Volume Limit Not all options are available in all delivery modes or Drug Programs Medfusion Model 4000 pump Operator s Manual General Programming The Medfusion Model 4000 pump has a variety of delivery modes that are customizable by the user The actual modes available on a given pump and their lo cation on a given screen depend on the custom setup performed All customization is accomplished using the PharmGuard Toolbox 2 software including which syringes and features are available on the pump as well as hard and soft limits on values see below and page 19 for discussion about hard and soft limits The modes and programming steps described in this chapter and the steps given fo
79. e Loading Dose e Standby e Volume Limit e Disable Enable FlowSentry These options are available when the pump is running an infusion e Bolus Dose e Override Alarm Loudness e Periodic Callback Alarm e Disable Enable Volume Empty Tone e Disable Enable Near Empty Tone e Change to Dose Change to Volume e Disable Enable FlowSentry Medfusion Model 4000 pump Operator s Manual Note Customization settings in individual drug pro grams take priority over profile settings as to which options are available For instance while Bolus Dose and Loading Dose may be available as options in a given profile individual drug programs within that profile may have these options disabled and you will therefore not be able to set them when using those specific drug programs 61 Medfusion Model 4000 pump Operator s Manual Bolus dosing A Bolus dose is a separate delivery that pauses the main infusion delivers the bolus often at a different higher rate then returns to the main infusion when complete It is an optional parameter of continuous delivery modes which allows a bolus volume or dose to be delivered over a specified time Bolus dose may also be configured to be automatically prompted or included in the programming steps of a drug program Bolus programming If programming a bolus at the BEGIN INFUSION screen or during an infusion 1 Press Options 2 Use the number keys to choose BoLus DOsE
80. e red alarm indicator will be turned on and the pumping mechanism will be disabled Some watchdog failures for example one that may occur rarely when powering down follow ing a Configuration update may be cleared by cycling power on the pump Software Safety Features Hardware related Software Safety Features Program Memory Check FLASH memory POST or BGND At power up and at regular intervals thereafter the program memory is tested by calculating a Cyclic Redundancy Code CRC on the program and then comparing it with the CRC stored with the program If the stored and calculated CRCs do not match the software will display a system fault screen turn on a continuous audible alarm and stop all drug delivery RAM Memory Check RAM BGND During operation the random access memory is checked A series of bit patterns is written to and read from the RAM If the read data is different from the written data the software will display a system fault screen turn on a continuous alarm and stop all drug delivery Motor Circuit Check pump motor phase A or B POST and Motor rate error during operation At power up the pump performs power on self test POST checks of the motor Motor POST checks in clude the ability to drive current to the motor Motor 128 Drive Phase A B POST the ability for the watchdog to stop the motor Motor Drive off POST Periodically during pump operations the software checks motor operation
81. e with the PharmGuard Server will receive the Configuration Depending on the settings and features chosen in cus tomization certain features may or may not be avail able when programming any specific pump Each user is responsible to determine which features are present on the pump they are using and to program them ac cordingly For this reason the following warning is included throughout the steps for programming and delivering fluids throughout this manual WARNING Confirm All Settings Before starting any delivery always confirm the accuracy of all infusion values to the original order Programming the pump at a delivery rate other than that prescribed will cause inappropriate delivery which can result in serious injury or death Medfusion Model 4000 pump Operator s Manual Medfusion 4000 Infusion Pump Medfusion Standard Configuration includes manual delivery modes and a variety of syringes No Drug Programs Medfusion Model 4000 Pump or Options are available in the Standard Configuration With Custom Configuration PharmGuard Toolbox V2 Create a custom Configuration settings and Drug Programs validate Configuration then send to pump using PharmGuard Toolbox or PharmGuard Server see the product literature supplied with these products for more information Dose Day Dose m2 Min mL Kg Time Dose Hour Dose Min Volume Over Time Dose Kg Day Dose Time Dose Kg Time Dos
82. ed Disable enable near empty alarm tone eee Disable enable vol empty alarm tone eee Infusion Delivery Starting amp stopping infusion delivery eee Start delivery from Pause svacseisisesacaorsediesssserecsisvrenstsauiives Starting delivery from standby or delayed start Stopping delivery ciacs cscstescinssessavtasazerssvasnoseaontensoucheeses Continuing interrupted Celiver ycaisasissassasaadensysnassases Flush feature scannen aima Volume Only msi oeras enue sissisr ids N aSa Continuing an interrupted flush infusion WYO NMS AEN Ume sorses E EnA Medfusion Model 4000 pump Operators Manual Medfusion Model 4000 pump Operator s Manual Time to CCNA SIO assosscssasscss ssesessepschasiasoasetievensecsastvetteteeaecaes 92 Occlusion trend graph during delivery uu eee 92 FlowSentry rapid occlusion detection 0 0 0 92 Post occlusion bolus reduction siscsscscvscrivenessasstexinisesanss 93 Making changes during delivery siiisicecccviscsssssssisesssonsenusies 94 Changing delivery Taless onea 94 Changing rate during delivery oo cesses 94 Changing the rate when paused scccsssccesasscsasteconsstesans 95 Total volume program volume dose delivered 96 Displaying Program Volume Delivered PVD Program Dose Delivered PDD seess 96 Clearing total volume program volume or program dose delivered 97 Keypad TOC sorasasoorionariariapi ii aen nE 98 Alarms amp remedi
83. edaves 145 Limited Warranty 146 Index 147 Important Safety Information WARNING Read this entire manual before us ing the Medfusion Syringe Infusion Pump Model 4000 Medfusion Model 4000 pump Failure to follow the instructions and important information contained in this manual or improper inadequate troubleshooting can lead to death or serious injury Warnings cautions and other important safety infor mation can be found in this section and throughout the manual they are contained within lines above and below in the main part of the manual See the Alarms and Remedies section for information on troubleshooting pump alarms The term WARNING is used in this manual to indi cate a hazard that has the potential to cause injury or death to a patient or user The term CAUTION is used to indicate a hazard that has the potential to cause damage to the product or other property Warnings e To avoid risk of explosion never use pump in presence of flammable anesthetics oxygen en riched atmospheres or explosive gases e Due to risk of explosion never use this pump inside a hyperbaric chamber If the patient is placed in a hyperbaric chamber while connected to a pump located outside the chamber delivery accuracy can be affected Due to pressure changes on the IV tubing under delivery can occur during compression and over delivery can occur during decompression e Medical Electrical Equipment needs special pre caution
84. eight twice to confirm the setting a double check You can select from two values Enabled or Disabled Defines if a pump user will be prompted to enter a Standby time during infu sion setup You can select from two values Enabled or Disabled Defines if a pump user will be prompted to enter a Volume Limit during infu sion setup You can select from two values Enabled or Disabled 137 Medfusion Model 4000 pump Operator s Manual Device Setup Features The following items are set on a per pump basis in the Device Setup menu All of these features are optional and while they do not directly affect infusion program ming they can affect alarms and reporting Preventative maintenance date activates Time Zone Daylight Saving Defines the date when the pump s preventative maintenance required alarm Defines the time zone where the pump is located Defines if a pump will automatically switch to Daylight Saving Time on the ap propriate date If selected you must specify when Daylight Saving begins and ends what time the clocks change and by how much Flow Delivery Graphs In this device as with all syringe infusion pumps the motion of the pumping mechanism and variations in individual disposables both the syringe and infusion set cause short term fluctuations in the rate accuracy The curves on the following page show typical perfor mance of the pump system in two ways 1 A flow versus time graph dur
85. ensor failures resulting in alarms Medfusion Model 4000 pump Operator s Manual 4 Lift upward on the Syringe Barrel Clamp and turn it so it is out of the way 5 Squeeze the Plunger Release Lever on the syringe plunger driver and pull gently to extend it all the way outward WARNING Verify that the plunger holders secure ly capture the syringe plunger Make sure to capture the syringe barrel and flange Failure to properly secure the syringe could result in uncontrolled fluid flow to the patient which could result in serious injury or death 6 Load the syringe onto the pump as illustrated making sure the flange of the syringe barrel is pressed or rolled into the Flange Clip 35 Medfusion Model 4000 pump Operator s Manual 7 Squeeze the Plunger Release Lever on the syringe plunger driver and push it toward the syringe plunger once it is flush with the syringe plunger release the lever Be sure both holders close around the syringe plunger 8 Turn and lower the Barrel Clamp onto the barrel of the syringe WARNINGS e Verify that the plunger holders securely capture the syringe plunger Make sure to capture the sy ringe barrel and flange Failure to properly secure the syringe could result in uncontrolled fluid flow to the patient which could result in serious injury or death e Always use the Prime function on the pump when loading a new syringe in order to remove any me chanic
86. equirements The Medfusion Model 4000 pump includes a low power RF transmitter for non critical communica tion The RF band of transmission is 2412 MHz to 2462 MHz The bandwidth of the signal is 20MHz The modulation is OFDM and CCK The maximum output power at the RF connector is 0 032 watts 123 Medfusion Model 4000 pump Operator s Manual Technical specifications Specifications Below are the technical specifications of the Medfusion Model 4000 pump Testing was performed using the syringes listed in the table on page 130 and the following Medfusion Administration Sets 1 Model 536040 for low flow rates and 2 Model MX448HL60 for high flow rates Minimum increment of 0 01 mL hr resolution Size pump only 10 5 wide x 6 2 high x 5 7 deep 27cm x 16cm x 14 5cm Weight Approximately 4 54 lbs 2 04 kg Classification Type CF protection from electric shock Moisture protection IPX3 sprayproof Pump Alarms Syringe empty syringe near empty syringe not loaded properly incorrect syringe size infusion complete KVO battery low damaged not working incorrect calculation value out of range occlusion fluid restricted rate reduced pressure increasing pump stopped system fault system advisory set time date maintenance recommended data corrupted For a complete list of alarms see the General system alarms and alerts table starting on page 103 Time to occ
87. es The Medfusion Model 4000 pump imports and exports data to assist in history data management The pump communicates with the PharmGuard Server using Wireless and Ethernet interfaces With its wired or wireless Ethernet connection bi directional com munication of Configuration and infusion data is pos sible to and from the Medfusion Model 4000 pump via your institution s network Pump Configurations and firmware can be updated and infusion settings and events history downloaded in combination with the PharmGuard Toolbox 2 software application and the PharmGuard Server The pump also has the FlowSentry rapid occlusion detection feature which is a comprehensive array of pressure related safety features including rapid alarm response and reduced false alarms Pressure trending is shown in the pump display allowing earlier oppor tunities for intervention as well as a post occlusion bolus reduction feature Indications for use The Medfusion Model 4000 Syringe Infusion Pump is indicated for the following uses e Inthe administration of fluids requiring precisely controlled infusion rates including blood or blood products lipids drugs antibiotics enteral solu tions and other therapeutic fluids e By the following delivery routes arterial epidural intravenous intrathecal subcutaneous and en teral e By the following delivery modes continuous volume time mass body weight intermittent and bol
88. es Standard libraries are organized on a per Profile basis Each Profile allows up to eight library Categories with up to 36 Drug Programs each for a total of 288 en tries per profile One Quick Library per Profile for rapid setup Accessories may not be available in all areas contact customer service for availability Rotating Poleclamp catalog number 3000RPC PharmGuard Toolbox 2 Version 2 1 Software catalog number 22 4075 0201 51 Medfusion Standard Configuration catalog number 67 2460 0001 51 Medfusion Standard Syringes catalog number 67 2459 0100 51 PharmGuard Supported Syringes PSS Series 2 various contact Smiths Medical for details For replacement parts including power cords and replacement battery packs see the Medfusion Model 4000 Series Technical Service Manual catalog number 67 2452 51 127 Medfusion Model 4000 pump Operator s Manual Safety Features Safety Features and Fault Detection Hardware Safety Features A watchdog circuit made up of a separate micro controller with a dedicated timer alarm speaker and power supply monitors the main microprocessor and associated electronics The purpose of this circuit is to detect failures of the system including power electronics and software and generate an alarm if one is detected If a failure is detected a watchdog or SYSTEM FAILURE alarm will be generated through the dedicated speaker th
89. es 99 Alaris alerts YPES nnas ii 99 Re displaying an alarm Message 100 User Callback Blatt 4 anid cenirsndecapetantnamaraes 101 Syringe Empty Alari Process ssssinicssesesasssessssssecinnsovenvesenss 101 Syringe Near Empty alarm assaissssansieiunsarnens 101 Syringe Volume Near Empty alarm uu 101 Syringe Empty alaf iiisceecinsbaiaananeneies 102 System Advisory Maintenance is Recommended 102 System Faltes enesis Aa 102 General system alarms amp alerts sia cisssitusssssnastsssiussvussnsedsescuen 103 System Failure and Advisory Alarms 107 Battery Alaris sscssnssssiconcovasnssansesnestessvacesscnyscintonsvsunvsssens 107 System Fail te Alarms seserian 108 System Advisory Alar MSninassnannnaisuii 108 Update s Available Notification ssssssssesssssssssssresssress 110 Battery and AC power operation 111 On screen display of internal battery power level GaSe scsiccissessssacspscosanastarsesecoeas 112 Battery guidelines sosise ssir 112 Poleclamp assembly amp use 113 Rotating detachable poleclamp standard 113 Assembling the rotating detachable poleclamp 114 Assembling the stationary poleclamp ee 115 EMC information for the Medfusion Model 4000 PULP E E eat eats 116 Use OE cables stotecsscnenyiastenersctansirisaeerdtescartinepmotoraectanss 116 Stacked equipment sisisi nn 116 Technical specifications amp other information 117 Pump development standards cia cascexssaitd cnseoveeenondeds
90. ess than the KVO rate and triggers an alarm KVO delivery automatically stops when the pump calculates the syringe is empty or if was pressed When the pump automatically stops keep vein open infusion it sounds a syringe empty alarm Stop KVO Infusion Stop a KVO infusion at any time by pressing m Silence KVO Alarm Silence the alarm by pressing 75 Medfusion Model 4000 pump Operator s Manual Standby Standby is an Option that allows the pump to re main at the BEGIN INFUSION screen without the User Callback alarm sounding for the Standby period e The pump does not automatically start an infu sion at the end of the standby e Instead the pump triggers an alarm at the end of the standby period Programming standby 1 When the pump is paused at the BEGIN INFUSION screen press Options Use the number keys to choose STANDBY Set the Standby time in hours amp minutes The maximum Standby setting is 24 hours The default standby time is 1 00 Hr When the Standby time is correct press Enter to accept the standby setting and go to the BEGIN INFUSION screen The standby timer then appears in the upper right corner on screen counting down alternately with PREss lt 4 gt To BEGIN INFUSION and the Drug Program name The User Callback alarm is disabled for this interval Standby continues until the timer has counted to zero Standby can be discontinued at any time by pre
91. eturns to the ENTER Botus Doss screen If correct press Yes Note that the bolus dose may be entered in dose kg or Total Dose for weight based modes depending on pump customization The confirmation screen highlights in reverse the value that the pump calculates Use the number keys to set bolus delivery time in minutes and seconds The default value for bolus delivery rate is set in custom configuration Maximum amp minimum time is calculated from the maximum amp minimum rate for the syringe size currently in use and or the custom setup in the Configuration If using a manual delivery mode and the Bolus Time feature has been disabled the pump will default to the maximum bolus rate When the bolus time is correct press Enter Using PharmGuard Toolbox 2 it is possible to restrict bolus time to minutes only If that is the case the screen will look like this It is also possible to specify an absolute time limit using PharmGuard Toolbox 2 in which case you will not be able to change it Note If the bolus is being programmed while an infusion is delivering pressing Enter following time entry will cause the BEGIN BOLUS DELIVERY screen to be displayed See Bolus Delivery starting at item 2 in the section that follows for instructions on delivering the bolus 63 Medfusion Model 4000 pump Operator s Manual Bolus delivery I Press lt lt if necessary PRIME BOLUS 2 The BEGIN BoLus DELIV
92. gher than what is actually de livered to the patient Periodically check the fluid pathway and all con nections including the catheter administration set connection for leaks Leaks in the system may cause fluid loss resulting in under delivery as well as allowing an opening for contamination Always turn off fluid flow to patient in tubing via clamp or stopcock before loading or unloading a syringe Uncontrolled fluid flow can occur when infusion set is not clamped or turned off resulting in inappropriate delivery rate NEVER prime any syringe while connected to a patient infusion site as this may cause over infu sion To avoid air embolism always purge all air from syringe and infusion lines before connecting to the patient Once the syringe and tubing system is connected to the patient raising the system above the patient even briefly can cause significant bolusing due to changes in hydrostatic pressure Lowering the system below the patient even briefly can cause significant interruptions in flow due to changes in hydrostatic pressure This could cause improper pump operation resulting in inaccurate fluid deliv ery Place the pump as close to the patient s infu sion site as possible Use the smallest syringe size necessary to deliver the fluid or medication Using a large syringe at very low rates below Minimum Recommended Rate for the syringe may cause improper pump operation delayed occlusion sensing l
93. hange the loading dose settings e If enabled in PharmGuard Toolbox 2 and if the loading dose settings have been programmed in body weight the key labeled Chg In mL will allow the dose to be changed in mL directly if enabled Note If no keys are pressed for 30 seconds the User Callback alarm will sound 4 If Yes was pressed the LOADING DOSE DELIVERY screen appears and the infusion begins with DELIVERING and the library name alternately appearing The pump delivers the loading dose then auto matically switches to the normal delivery rate CANCEL stops the loading dose and returns to the and screen The loading dose volume delivered is OFER A VE TNE EGTER automatically added to the Total Volume Delivered TVD as well as the Programmed Volume Delivered PVD or Programmed Dose Delivered PDD for that infusion 69 Medfusion Model 4000 pump Operator s Manual Continuing an interrupted loading dose Should a High Priority alarm occur during load ing dose delivery or if Gf or Cancel are pressed the dose will stop You can then either continue the dose from where it left off or cancel the dose 1 If necessary press O to silence the alarm Troubleshoot the alarm condition 2 Press lt 3 To continue the loading dose from where it left off delivering only what was remaining press Yes Press No to cancel the remainder of the loading dose and begin the main infusion 70
94. harge When the BATTERY Low mes charge level briefly appears on the battery shaped the battery sage displays plug the pump into a power outlet for recharging The battery indicator remains on continuously when charging If the pump IS plugged into an out let and fails to charge the battery or the pump has been stored for longer than two months with Wh infusi Ib hi out charging contact Service amp en running an infusion on internal battery this Repair for information on how to battery shaped gauge also appears briefly in the up test and or service the battery per right corner of the display at the start of delivery gauge in the bottom left corner of the display When you can The internal battery is intended run on battery to allow infusions of medications and fluids when an external pow er outlet is not conveniently avail able or when the patient is being moved vt l When you When the battery becomes fully Briefly display this battery shaped gauge at a pie cannot run on depleted all infusion stops and while the pump is infusing on battery by pressing battery a BATTERY DEPLETED alarm begins sounding For a fully de pleted battery plug in the AC power cord turn the pump off to clear the alarm and then turn the pump back on Leave the pump plugged in for at least 8 hours to completely recharge the battery e See GENERAL SYSTEM ALARMS AND ALERTS table
95. he actual name assigned to the Quick Library in the Configuration Quick Library is only an example Select a Drug Program 5 Select a Drug Program by pressing its number Note the number of pages in the category is displayed along with the current page in this example 1 8 If the desired drug program is not displayed and provided the category contains more drug programs press Next or if you know the page number of the drug program you want press Page then use the number key for the page Once past page 1 of the category press Prev to move back a page 32 Medfusion Model 4000 pump Operator s Manual The pump requires a confirmation for drug pro gram selections press Yes to confirm the selection or press No to return to the SELECT screen If manual modes are available in the custom Configuration and selected for an infusion the pump prompts for a confirmation as well Press Yes to confirm the selection or press No to return to the Select screen After a drug program selection is made the pump will prompt you to select the syringe model and size before programming the selected mode see page 34 Specific information for programming the vari ous delivery types follows the instructions for the syringe Select a Delivery Mode Medfusion Standard Configuration 1 Ifthe pump does not have a custom configuration the Medfusion Standard Configuration menu displays Select a delivery mo
96. he desired loading dose for this infusion or to set the dose volume in mL if applicable for the infusion Volume is limited by the maximum fill volume of the current syringe size and minimum volume is 1 600 the syringe size When the loading dose setting or volume is correct press Enter Medfusion Model 4000 pump Operator s Manual A loading dose may be programmed at the BEGIN INFUSION screen by pressing Options If Loading Dose Autoprompt is set to Enable in PharmGuard Toolbox 2 when initially programming a continu ous infusion the loading dose programming screens steps 3 5 below are part of the drug program setup Pressing Disable at the loading dose entry screen will disable the feature for the duration of the infusion Disable turns Bolus off for the duration of the infusion Clear deletes an entry Backspace erases a character 67 Medfusion Model 4000 pump Operator s Manual 4 Confirm that the loading dose settings and total loading dose are correct If incorrect press No and the pump returns to the ENTER LoapING Doss screen If correct press Yes Note that the bolus dose may be entered in dose kg or Total Dose for weight based modes depending on pump customization The confirmation screen highlights in reverse the value that the pump calculates Use the number keys to set delivery time in minutes amp seconds The default value for loading i e bolus delivery rate is set in cus
97. hock Class II Equipment in which protection against electric shock relies on double or reinforced insulation instead of basic insula tion Accessible metal components of pump enclosure use this higher level of insulation instead of safety grounding Date of manufacture CAUTION Federal USA law restricts this device to sale by or on the order of a physi cian Catalog number Latex free Do not reuse Use by UL Mark for Canada and the United States Indicates the product was manufactured in accordance with the requirements of UL Underwriter s Laboratory Temperature limitation Humidity limitation Atmospheric pressure limitation E Wired Connection D Device Server Connection W Wireless connection D Device Server Connection Operating voltage range for alternating cur rent i e AC or mains power source Equipment that is ingress protected from fluid spraying at a vertical angle from above and from angles to 60 on either side of vertical Medfusion Model 4000 pump Operator s Manual gt Non ionizing radiation A MR Magnetic Resonance Conditional Australian c tick mark Indicates that the product complies with the applicable stan dard and establishes a traceable link be tween the equipment and the manufacturer importer or their agent responsible for com pliance and for placing it on the Australian or New Zealand market A Pins of connectors and other areas identi AtaS fied with this ESD Warning
98. horized to use the infusion pump can use programs from the available libraries Medfusion Model 4000 pump Operator s Manual Types of programmable Library Categories There are two types of library categories in the Medfusion Model 4000 pumps What it does Library Category Type Standard Standard library categories contain pro grams with parameters that are applied when programming an infusion These libraries require you to step through and review each setting This allows modifying standard settings while stepping through preset values Quick A quick category contains drug programs with the presets necessary for program ming an infusion However they do not pause at each level for you to enter the settings Instead the entire set of values is pro grammed at one step including syringe model and size The BEGIN INFUSION screen where all infusion values are shown displays at once At that point you confirm all the settings are correct then press to begin delivery WARNINGS Confirm All Settings Before starting any delivery always confirm the accuracy of all infusion values to the original order Programming the pump at a de livery rate other than that prescribed will cause inap propriate delivery which can result in serious injury or death When using Quick libraries preset values are au tomatically inserted without pausing to verify each setting The BEGIN INFUSION screen displays
99. iate the priming sequence page 59 52 The pump calculates the correct flow rate in mL hr to achieve the required drug dose To program a volume weight time infusion at the selection menu choose ML KG TIME or choose a drug program that uses the volume weight time mode infusion type Choose the syringe model and size and load the syringe as in structed on page 34 Medfusion Model 4000 pump Operator s Manual 6 Confirm the settings and start the infusion or use the menu keys shown at right to modify the settings WARNING Confirm All Settings Before starting any delivery always confirm the accuracy of all Main Menu returns to the Main Menu infusion values to the original order Programming Options allows selection from a list of variables e g z bolus volume limit etc the pump at j delivery raie other than that pre Clear TVD clears total volume delivered scribed will cause inappropriate delivery which can result in serious injury or death 7 When all delivery settings are confirmed as correct press lt to begin infusion 53 Medfusion Model 4000 pump Operator s Manual Volume time The volume over time rate calculation allows pro gramming by e Dose Volume e Delivery Time The pump calculates the correct flow rate by dividing the volume by the delivery time Volume limit load Press the number keys to program the volume to infuse Volume is limited to 500 mL an
100. ic details of each alarm are covered in the Alarm section later in this manual AC Line The AC Line indicator green is on whenever the pump is connected to mains line power It is off when the pump is not connected to an active AC line Battery The Battery indicator green blinks on amp off whenever the pump is operating on inter nal battery power and remains on when battery is charging CEOD ock The Lock indicator indicates the pump has been locked into its current operational mode While this indicator is lit the keypad is locked and no changes can be made to settings Attempting to stop or change an infusion while locked will result in an alarm and an informational message EE infusing The Infusing indicators are 3 green lights which illuminate in sequence right to left when the pump is infusing During intermittent volume over time delivery mode a single Infusing indicator lights during the time between infusions When the pump is off or stopped the Infusing indicator is not lit A Communicating The Communicating indicator blue is on whenever the pump is communicating with fe the PharmGuard Server using wireless or wired interface There is no audible tone associated with communications During normal network operations the light may peri odically turn on and off The Communicating indicator has no affect on clinical opera tions of the pump Network Connections The pump can be con
101. idation and then approved via your facility s ap propriate review Only after this process is completed should a Configuration be made available to pumps for patient use A defined process for assuring that the new update is installed on all pumps in a timely man ner should be developed Press to turn the pump off To install the update press Enter To exit the screen without installing the update either press again or wait 60 seconds for the pump to turn off automatically without installing the update The Learning progress is then shown on the pump s display DO NOT press or any other key until the update finishes When the process is complete the pump automatically turns off In rare cases the pump will complete the update and then at 0 percent remaining a watchdog system failure will oc cur Turning the pump off then back on should clear this condition and make the pump ready for use Validate the update is correctly installed when the pump is next turned on on the pump s startup screen the version number matches that shown in PharmGuard Toolbox 2 and the Configuration CRC matches the one displayed on the Teach Progress screen in PharmGuard Toolbox 2 if unsure what the version number and CRC should be contact your PharmGuard Toolbox 2 Administrator or follow your valida tion protocol 110 Note If a pump is operating on battery power and the battery has 10 or less rema
102. ight side of the keypad are used In many cases once a value is entered you will need to press a softkey to Enter or save the value or to open the menu Some menus are very large and there will be more items to choose from than can fit on a single dis play screen In those cases one of the softkeys will be More indicating there are more options available and More can be pressed to view them On those sorts of menus once the end of the choices is reached the More key becomes Beginning indicating Beginning can be pressed to go back to the first page of the menu If a mistake is made in programming or a menu opened accidentally press Cc to return to a previ ous screen or menu 22 OOO OOO OOO SOO Legend In this manual menu information that appears on screen is shown in bold and small capitals for in stance SELECT THE PROFILE Text associated with softkeys is shown as bold for instance Enter The Workflow Process The basic workflow for programming and delivering an infusion is shown in the diagram on the following page The infusion may consist of several distinct deliver ies possibly including a loading dose main infusion one or more boluses during the main infusion as well as a flush or KVO infusion once the main infusion is complete It is possible that all of these parts are programmed in the initial infusion setup sequence or they may also be added at a later time af
103. in background Motor back ground checks include the stopping of the motor when an infusion stops and the motor supply voltage test If a motor POST or background check fails the pump will display a system fault screen turn on a continu ous two tone audible alarm flash the backlight and stop all drug delivery If the Motor shaft fails to complete the first shaft rotation Motor Not Running or a subsequent shaft rotation Motor Rate Error with the expected timing the pump will display a high priority alarm turn on a continuous two tone audible alarm flash the backlight and stop all drug delivery When the pump is powered on with a depleted battery and no AC power this alarm may sound due to the low battery state Recharge the battery turn the pump on turn the pump off then turn the pump on to clear the condition Keyboard Encoder Check Control key POST or BGND Every time the software receives data from the key board encoder it is checked If the data is not a valid key press the software will disregard the key press Data Handling Software Safety Features Data Stored in EEPROM Critical data POST or EEPROM timeout or Primary Secondary critical data corrupted Before use data associated with delivery and stored in EEPROM is tested by calculating a CRC on the data and then comparing it with the CRC stored with the data If the EEPROM timeout or EEPROM Primary and Secondary stored and calculated CRCs do not match
104. ing the stabilization period start up curves 2 The accuracy of fluid delivery of particular time periods or observation windows is measured trumpet curves The start up curve displays flow rate continuously from the start of the infusion The curve visually represents flow rate uniformity Trumpet curves are derived from the second hour of this data Tests were performed per the IEC 60601 2 24 standard Over long observation windows short term fluctua tions have minimal effect on accuracy as represented by the flat part of the curve As the observation window is reduced short term fluctuations have an increasing effect as represented by the mouth of the trumpet Being aware of system accuracy over various observation windows may be of interest when certain drugs are being administered Short term fluctuations in rate accuracy may have clinical impact depending on the half life of the drug being infused therefore both the trumpet curve and drug half life should be taken into account 138 The data was created using a Medfusion pump and Becton Dickinson B D WWD 30 mL syringe The 1 mL hr data was created using the Medfusion 536040 Extension set and 18G needle The 5 mL hr data was created using the Medfusion MX448HL60 Extension set and 18G needle Start up curves over stabilization period Minimum rate 1 mL hr Intermediate rate 5 mL hr Medfusion Model 4000 pump Operator s Manual 2
105. ini mum bolus volumes for the syringe used may result in delivery inaccuracies Minimum Recommended Bolus Volume Syringe Size 30 35 mL lmL 50 mL l mL 60 mL l mL Medfusion Model 4000 pump Operator s Manual Use appropriate internal diameter tubing For the most consistently precise control of all fluids and medications it is recommended to use appropri ate internal diameter tubing as well as to minimize residual volumes between syringe and patient by reducing a Tubing internal diameter generally for rates under 5 mL hr small internal diameter tubing is recommended for rates 5 mL hr or above tubing with a larger internal diameter should be used to reduce occlusion alarms b Tubing length c Size of in line filters d Number of stopcocks This makes the infusion setup less variable or compli ant which in turn reduces the start time for fluid to reach the patient and reduces time required for de tecting an occlusion and maintains delivery accuracy Use only the standard syringes specified on the table on page 130 and supplied with PharmGuard Toolbox 2 or supplied with the PharmGuard Supported Syringes PSS Series 2 available from Smiths Medical Smiths Medical also provides a variety of infusion sets that can be used with the pump See www smiths medical com for information regarding infusion sets available from Smiths Medical or contact your sales representative
106. ining charge the Update Notification will not activate This is because with less than 10 charge it is possible that the battery will be depleted before the update can be completed Pump Software Version as Configuration Version and CRC numbers Medfusion Model 4000 pump Operator s Manual Battery and AC power operation The infusion pump is typically operated by AC mains power The pump contains a rechargeable battery that is con tinually charged as long as the pump is connected to AC power see page 125 for battery life specification If the AC is disconnected while the pump is turned on the pump automatically begins drawing power from the internal battery Attaching the power cord 1 Thread the power cord connector through the cord retainer and connect the AC power cord to the connector port on the pump 2 Insert the screws into the cord retainer and tighten them to attach the cord retainer to the pump to prevent accidentally unplugging the pump WARNING Shock Hazard The only means of removing AC power is to disconnect the AC power cord While the AC power cord is attached to the pump and plugged into an AC outlet live mains voltage is present inside the pump 111 Medfusion Model 4000 pump Operator s Manual On screen display of internal Battery guidelines battery power level gauge Power amp Battery Limits Whenever the pump is turned on the internal battery When to c
107. interval programmed The Periodic Callback Alarm can be discontinued at any time by changing the Periodic Callback Alarm time to zero 80 Medfusion Model 4000 pump Operator s Manual Override and toggle features When the pump is paused at the BEGIN INFUSION screen or in some cases while infusing pressing Options gives you access to several override and tog gle options that will affect the current infusion only These Options will return to the default selection whenever the pump is turned off or whenever the program is returned to the MAIN menu prior to be ginning the next infusion Change to Dose Change to Volume When delivering a drug program or infusion containing a concentration must be a continu ous style infusion you may want to view either the volume delivered PVD or the dose delivered PDD The toggle PVD PDD option may be used at the BEGIN INFUSION screen or during an infu rie lai ae f ale Delivered indicates Volume is sion without stopping medication delivery currently selected 1 With the pump at the BEGIN INFUSION screen or during medication delivery press Options Use the number keys to choose CHANGE TO DOSE or CHANGE TO VoLUME only one or the other will be shown depending on the current setting You may have to press More to see this option PDD Program Dose Delivered indicates Dose is currently selected PVD will change to PDD or vice versa depe
108. ion prior to connecting to the patient press lt lt to initiate the priming sequence page 59 WARNING Confirm All Settings Before starting any delivery always confirm the accuracy of all infusion values to the original order Programming the pump at a delivery rate other than that pre scribed will cause inappropriate delivery which can result in serious injury or death 6 Press lt to begin infusion The infusion will automatically stop when it reaches the preset volume limit 73 Medfusion Model 4000 pump Operator s Manual Keep Vein Open KVO rate The Keep Vein Open KVO rate is an Option available for continuous delivery modes The keep vein open feature is intended for use when delivering a series of infusions to a patient and the de livery site must remain patent between the end of one infusion and the beginning of the next e A volume limit must be programmed for KVO to work After a volume limit is reached a low rate KVO is set to maintain patency of the infusion site e The range of rates available appears on the ENTER KVO RATE screen KVO rates are calcu lated by syringe size and its minimum flow rate e The programmed KVO rate must be less than the normal delivery rate and greater than or equal to minimum flow rate for the syringe Once the volume limit has been reached the pump will Programming KVO rate 1 With the pump stopped press Options Use the number keys to choose KVO
109. ion in the custom Configuration using PharmGuard Toolbox 2 How do you know if FlowSentry has been acti vated e During startup and during the stabilization pe riod following a rate change a pound sign will appear to the left of the pressure trend graph The presence of the indicates that FlowSentry is ac tive and that the delivery pressure is stabilizing Note FlowSentry is disabled at rates greater than roughly of the syringe size per hour See the table at Medfusion Model 4000 pump Operator s Manual FlowSentry maximum infusion rate Syringe Size right for more information 60 mL 20 mL hr 50 mL 20 mL hr 35 mL 12 mL hr 30 mL 10 mL hr 20 mL 6 6 mL hr 12 mL 3 3 mL hr e Once the delivery pressure has reached a stable 10 mL 3 3 mL hr level the sign will be replaced by a horizontal ar smi 1 65 mL hr iiia 5mL 1 65 mL hr 3 mL 1 mL hr e Ifthere is an increase in the delivery pressure the horizontal arrow will be replaced by a vertical ar row 1 In this way you can easily see a that FlowSentry is activated and b whether the delivery pressure is stabilizing steady or increasing In the event that the FlowSentry has not been activated there will be no or arrow signs to the left of the pressure trend graph FlowSentry is automatically disabled when the deliv ery rate for a syringe size is exceeded as indicated in the following table
110. ir by a trained biomedical technician System Advisory Medium The internal battery is not working The pump may be used on AC Battery Not Working power on a conditional basis As soon as possible remove pump from service for repair by a trained biomedical technician System Failure System Press to turn the pump off The battery is completely drained Plug in Depleipu Batiery Fault the AC power cord then press to turn the pump on Until the bat tery is allowed to recharge the pump can only be used if connected to AC power System Advisory Medium Initial Indicates battery is low and needs charging soon or the pump or Low Low Battery will not be able to continue delivery Press D If possible plug in power cord and run pump on AC mains while recharging the battery As an additional reminder for each 1 drop in capacity after the initial Low Battery alarm the Low priority Low Battery alarm will sound If the pump is not plugged in the amber alert LED will blink at the same rate as the battery indicator LED until the SYSTEM FAILURE BATTERY DEPLETED alarm occurs as a visual reminder that the battery is low 107 Medfusion Model 4000 pump Operator s Manual System Failure Alarms Alarm Message Priority Remedy System Failure System Either a key on the keypad has been pressed for longer than 7 seconds Control Key Switch BGND Fault or the keypad needs to be replaced fluid delivery stops
111. ive may talk you through to a solution if possible Component parts such as the internal battery can be ordered from Smiths Medical Service and Repair Note If outside the USA contact your local dis tributor for service assistance Medfusion Model 4000 pump Operator s Manual 143 Medfusion Model 4000 pump Operator s Manual Returning a pump to the USA for repair When the service representative cannot resolve an issue over the phone then it becomes necessary to return the infusion pump for service 1 Ifthe problem cannot be resolved through the telephone assistance of the Service Department obtain a Return Authorization RA number by calling Customer Service at 1 800 258 5361 USA Customer Service hours of operation are Monday through Friday 7 00AM to 5 30PM CST Clean and decontaminate the pump and accessories prior to returning items to Smiths Medical This is required before shipment according to United States Occupational Safety amp Health Administration OSHA regulations Package the infusion pump carefully for shipment Smiths Medical will not accept returns for service without the assigned RA number clearly printed on the shipping package Mark the RA number clearly on the outside of the shipping package used to return the pump Ship the carefully packaged infusion pump to Smiths Medical ASD Inc 1265 Grey Fox Road St Paul MN 55112 1 800 258 5361 USA www siniths medica
112. ize of the syringe being used and may also be limited by any custom configuration settings To begin flush delivery press Confirm OR e Press Chg Vol to return to the FLUSH VOLUME screen and change the volume OR e Press Main Menu or the Quick Library to skip the flush delivery and return to the MAIN menu 88 This feature is only available if enabled for intermit tent timed infusions for example Dose kg Time Volume Time mL Kg Time etc and is not available for continuous infusions Depending on the pump s custom configuration a volume limit may have been set the drug program using PharmGuard Toolbox 2 Note If no keys are pressed for 30 seconds the User Callback alarm will sound 7 When Confirm is pressed the flush infusion begins delivering with FLUSHING and the library name alternately appearing The flush is calculated to deliver at the same rate as the previous infusion To cancel or stop the delivery press E If flush delivery is cancelled stopped or should an alarm interrupt flush delivery you will have the option of restarting it see below When the flush infusion has been delivered delivery stops and the pump alarms Press O to silence the alarm then press Main Menu Continuing an interrupted flush infusion Should a High Priority alarm occur during flush infusion delivery or if Ce is pressed to interrupt a flush infusion delivery will stop You can then ei
113. l mEq or Units Use the number keys to select the medication concentration units The actual units available on a pump depends on the custom setup Press Enter to accept the medication concentration units Use the number keys to set medication concentration Concentration is limited to 4 digits Press Clear to clear an entry Press Backspace to erase a character Press the Enter key to accept the setting Use the number keys to set the delivery units The actual units available on a pump depends on the custom setup If only one delivery unit is available for the concentration units selected this screen will not appear Press Enter to accept the delivery units Use the number keys to set dose Range limits for dose are determined by syringe size and or the custom setup in the Configuration The high and low dose limits display on screen When the dose is correct press Enter The time setting screen appears Press the number keys to set the time in hours and minutes then press Enter At the BEGIN INFUSION screen all values are set and the pump pauses the pump may be configured with additional confirmation screens requiring you to confirm all settings twice before beginning the infusion 44 Medfusion Model 4000 pump Operator s Manual 7 Confirm the settings and start the infusion or use the three menu keys shown at right to modify the settings Prior to connecting to the patient press lt lt to i
114. l ASD Inc the Manufacturer warrants to the Original Purchaser that the Medfusion Syringe Infusion Pump Model 4000 the Pump not including accessories shall be free from defects in materials and workmanship under normal use if used in accordance with this Operator s Manual for a period of one 1 year from the actual date of sale to the Original Purchaser THERE ARE NO OTHER WARRANTIES This warranty does not cover normal wear and tear and mainte nance items and specifically excludes batteries administration sets extension sets or any other accessory items or equipment used with the Pump Subject to the conditions of and upon compliance with this Limited Warranty the Manufacturer will repair or replace at its option without charge except for a minimal charge for postage and handling any Pump not including accessories which is de fective if a claim is made during such one year period The following conditions procedures and limitations apply to the Manufacturer s obligation under this warranty A Parties Covered by this Warranty This warranty extends only to the Original Purchaser of the Pump This warranty does not extend to subsequent purchasers The Original Purchaser may be a patient medical personnel a hospital or institution which purchases the Pump for treatment of patients The Original Purchaser should retain the invoice or sales receipt as proof as to the actual date of purchase B Warranty Pe
115. l com Note Unless accessory items such as the poleclamp AC power cord etc are specifically part of the problem encountered remove all accessory items from the pump before returning it to Smiths Medical Medfusion Model 4000 pump Operator s Manual Collect Separately WARNING Collect Separately There are potential health hazards associated with improper disposal of batteries electronics and contaminated used in fusion sets and syringes Dispose of used batteries infusion sets syringes and other used accessories or a pump that has reached the end of its useful life in an environmentally safe manner and according to any regulations that may apply This product contains electrical and electronic com ponents including batteries that may contain materi als which if disposed of with general waste could be damaging to the environment In accordance with Directive 2002 96 EC Waste Electrical and Electronic Equipment residents of the European Union must follow specific disposal or recy cling instructions for this product Contact your local distributor or visit the following web site for specific instructions http www smiths medical com recycle index html Non European Union residents must dispose of or re cycle this product including batteries in accordance with the local laws or regulations that apply 145 Medfusion Model 4000 pump Operator s Manual Limited Warranty Smiths Medica
116. land Rub Tester ASTM F2503 08 Standard Practice for Marking Medical devices and Other Items for Safety in the Magnetic Resonance Environment ISO 3744 1994 Acoustics Determination of Sound Power Levels ISO 14971 2007 Medical Devices Application of Risk Management to Medical Devices UL746C 2004 Polymeric Materials Use in Electrical Equipment Evaluations 119 Medfusion Model 4000 pump Operator s Manual Guidance and Manufacturer s Declaration Electromagnetic Emissions The Medfusion Syringe Infusion Pump Model 4000 is intended for use in the electromagnetic environment specified below The customer or the user of the Medfusion Syringe Infusion Pump Model 4000 should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF Emissions Group 1 The Medfusion Syringe Infusion Pump Model 4000 may be configured to use RF energy as a wireless communication method to a network Therefore when using the wireless communication method the user should evaluate the Medfusion Model 4000 pump in the environment of its intend ed use to ensure that the RF energy output does not interfere with the operation of other devices CISPR 11 RF emissions Class A The Medfusion Syringe Infusion Pump Model 4000 is suitable for use in all establishments other CISPR 11 a __ _ ______ than domestic and those directly connected to the Harmonic emissions Not Appli
117. le CAUTION NEVER use sharp objects to depress key pad keys on the pump This may damage the pump by rendering keypad keys inoperable Only the Medfusion Standard Syringes supplied with PharmGuard Toolbox 2 and included in the Medfusion Standard Configuration or the addi tional syringe models and sizes available as part of the PharmGuard Supported Syringes PSS Series 2 see page 21 may be used on the pump Ensure all medications or fluids are compatible with the syringe catheters tubing and fittings used in the infusion setup Always ensure fluids are compatible with each other when infusing more than one fluid or medi cation through the same infusion site If connect ing more than one pump to the same infusion site use one way checkvalves to prevent pumps from interfering with each other Verify that the pumps will operate together without alarming Medfusion Model 4000 pump Operator s Manual Contraindications WARNING ECMO use Do not use on the inlet side of Extracorporeal Membrane Oxygenation ECMO systems where the negative pressure is greater than negative 100mm Hg as the high negative pressures can result in uncontrolled fluid flow Medfusion Model 4000 pump Operator s Manual About the pump Features and Controls Following are several illustrations showing the various controls connectors and features of the Medfusion Model 4000 pump Display all pump operating and status i
118. ll return the viewing screen backlight to bright and silence the audible alarm for the programmed alarm silence period During a medium priority alarm condi tion all keys except a are locked You must silence the alarm by pressing a before any other action can be taken If the front panel controls are locked when a medium priority alarm occurs the pump controls do not unlock 99 Medfusion Model 4000 pump Operator s Manual Type Definition and Remedy Low priority A low priority alarm indicates any condition not requiring immediate operator interven tion Low priority alarms are announced with a continuous yellow indicator a viewing screen backlight that oscillates between bright and dim and a non repeating audible signal During a low priority alarm condition all keys except O are locked You must silence the alarm by pressing before any other action can be taken If the front panel controls are locked when a low priority alarm occurs the pump controls do not unlock Limit priority A limit priority alarm provides user feedback related to interaction with the pump Note The audio part of Limit priority alert is tied to Key Click loudness which is set in PharmGuard Toolbox 2 If key click loudness is set to Off there will be no audible tone accompanying Limit priority alerts visual alerts will still appear in the display The vol ume will otherwise sound at the loudness level selected for key click
119. lusion alarm typical values Very High 50 psi testing performed using BD 1 mL syringe High and Very Low testing performed using BD 20 mL syringe Flow Rate Occlusion Setting Max time to Max time to occlusion steady occlusion start up state hr min sec hr min sec 00 00 38 00 07 15 00 26 58 00 22 25 00 07 16 00 06 39 00 00 13 00 00 36 00 05 35 00 04 33 00 01 55 00 03 40 Variable dependent on infusion variables and syringe in use Typical values obtained when testing a pump using a BD 20mL syringe at Intermediate 5 mL hr rate Bolus after occlusion at minimum selectable Occlusion alarm setting Very Low 0 0454 mL 1 mL hr minimum 5 mL hr intermediate Bolus volume at occlusion release typical values Bolus after occlusion at maximum selectable Occlusion alarm setting High 0 0815 mL WARNING Larger size syringes at occlusion setting HIGH may produce a post occlusion bolus larger than 0 3 mL due to excessive syringe plunger tip compliance Power source Internal battery Rechargeable lithium ion AC power 100 240 VAC 50 60 Hz 42VA Safety Class II Type CF with Functional Earth conductor 124 Medfusion Model 4000 pump Operator s Manual Battery Life 400 charge cycle counts minimum Battery longevity 10 hours typical at 5 0 mL hr with 60 mL syringe from fully charged battery Operating conditio
120. lways confirm that the syringe model and size displayed on the pump matches the model and size loaded into the pump Use of unapproved syringes may cause improper pump operation resulting in inaccurate fluid delivery or occlusion sensing or other potential hazards 10 Thread the tubing through the three Tubing Holders on the top left side of the pump WARNING Periodically check the fluid pathway and all connections including the catheter admin istration set connection for leaks Leaks in the sys tem may cause fluid loss resulting in under delivery as well as allowing an opening for contamination 11 Press Confirm to confirm the syringe information The pump will now automatically display the pro gramming screens for the delivery mode chosen Since there are many modes to choose from in which a wide variety of functions within that mode may or may not have been enabled what follows is an explanation of the programming steps required for each possible delivery mode with all functions enabled 37 Medfusion Model 4000 pump Operator s Manual Unloading the syringe WARNING Turn off fluid flow Always turn off fluid flow to patient in tubing via clamp or stopcock before loading or unloading a syringe Uncontrolled fluid flow can occur when infusion set is not clamped or turned off resulting in inappropriate delivery rate and may cause serious injury and or death Unload a syringe exactly the opposite way
121. ly Smiths Medical supplied service replacement parts including the battery pack Unauthorized modification and or the use of unauthorized ser vice replacement parts will also void the Limited Warranty This device contains an RF transmitter which may interfere with aircraft systems Before using any Medfusion Model 4000 pump users must be thoroughly familiar with the con tents of the operator s manual including all warn ings cautions and instructions for use This syringe infusion pump is intended for use only under the direction of trained medical pro fessionals Do not use on the inlet side of Extracorporeal Membrane Oxygenation ECMO systems where the negative pressure is greater than negative 100mm Hg as the high negative pressures can result in uncontrolled fluid flow The user should ensure that the performance of fered by the pump is fit for the intended use and that the pump is not used in any way or for any purpose other than its intended purpose This pump is not to be used in any intra articular space infusion The pump must be positioned in an MR environ ment such that it is secured to a non moveable ob ject and the magnetic fringe field does not exceed Medfusion Model 4000 pump Operator s Manual 150 gauss Exposing the Medfusion Model 4000 pump to magnetic fields that exceed 150 gauss presents a risk of becoming a projectile hazard and can lead to possible patient injury or death Irreversible da
122. mage to the pump can also occur rendering it inoperable Confirm All Settings Before starting any delivery always confirm the accuracy of all infusion values to the original order Programming the pump at a delivery rate other than that prescribed will cause inappropriate delivery Always read manufacturer precautions and guide lines for medications fluids syringes and admin istration sets used with this pump Medications or fluids may interact with the plastic components of the infusion syringe and sets Only use the Medfusion Standard Syringes sup plied with PharmGuard Toolbox 2 and included in the Medfusion Standard Configuration or the models and sizes available as part of the PharmGuard Supported Syringes PSS Series 2 and always confirm that the syringe model and size displayed on the pump matches the model and size loaded into the pump Use of unapproved syringes may cause improper pump operation resulting in inaccurate fluid delivery or occlusion sensing or other potential hazards Verify that the plunger holders securely capture the syringe plunger Make sure to capture the sy ringe barrel and flange Failure to properly secure the syringe could result in uncontrolled fluid flow to the patient Always use the PRIME function on the pump when loading a new syringe in order to remove any mechanical slack Failure to prime correctly can delay infusion delivery and cause Total Volume Delivered to read hi
123. mation 130 Medfusion Standard Syringes iseceicscsssesscssisesasssasrspesocases 130 PharmGuard Supported Syringes PSS Series 2 130 Flow rate amp minimum volume by manufacturer Besize Standard Syringes sissncdesssdivrscasesieniisarss 131 Concentration and dosing units sicisacnandsnnauseine 133 PharmGuard software TIS nuesnsiiecscan 133 Configuration Optio Sesoni 134 General OpPHONS iiien Ee nar e A E aE 134 Progra OptOms esiin aaivee teveviays 136 Auto Prompt OPH ONS sccccsescsesvessviecssssssessonessveerddeesee 137 Device Setup Features oi c cccsccsesssscicssesscsssseteasssesosssesesnss 138 Flow Delivery Grappa isississsviasssanssedssueossnosseavesboveassscavivanse 138 Start up curves over stabilization period 139 Trumpet curves over T2 period sssssecresuriiss 139 COMMUNICATIONS sssscasssssssssssessessssssssessasessssscassssesessaseasese saves 140 Magnetic Resonance Imaging MRI Information 140 MRI Related Testy ss sceisscossuissisievenssaivh tondaivarnciiutaies 140 Image DistOrtiON scsscccsseessscassssssnvcsssessosesssssvsessssessvseies 140 Cleaning atid Cat Gs sscisisscarannencanancnnimnraamnnayseins 141 Maintenance amp S rviCe cssssscccssssssesesessesessssssesisesessssesevensee 142 Periodic MaMeNdOCe cisions demote 142 Using Smiths Medical USA service assistance 143 Returning a pump to the USA for repair 144 Collect Separately siasssisisavsaeiussscnseisaninessancsscisihasveuscab
124. mits they are reverse highlighted Overridden limits in reverse When a soft limit is overridden as described in Soft Limits above the overridden values are displayed in reverse highlight Invalid infusion parameter combination The pump has several types of limits physical limits those imposed by the syringe size in use and drug program limits When the PharmGuard software limits and the pump physical limits cannot be reconciled the alarm INVALID INFUSION PARAMETER COMBINATION or CALCULATED RATE OUT OF RANGE is displayed At this point the only possible corrective action is to silence the alarm look at the prompt to determine which values were to be entered press one or more times and attempt to re enter valid values An example of an invalid infusion parameter combination is one where the pump physical maximum is lower than the software minimum or vice versa Whenever a CALCULATED RATE OUT OF RANGE or in cer tain cases of an INVALID INFUSION PARAMETER COMBINATION alarm it is possible that the drug program created in PharmGuard Toolbox 2 software is such that no valid entry is possible in which case you will need to document the issue and request an update for custom Configuration It may be useful to check calculations using a calcula tor and formula to help identify issues with invalid in fusion parameters If a pump has recurring issue with invalid infusion parameters contact
125. n a pump depends on the custom setup Press Enter to accept the medication concentration units Use the number keys to set medication concentration Concentration is limited to 4 digits Press Clear to clear an entry Press Backspace to erase a character Press the Enter key to accept the setting Use the number keys to set the delivery units The actual units available on a pump depends on the custom setup If only one delivery unit is available for the concentration units selected this screen will not appear Press Enter to accept the delivery units Use the number keys to set dose rate Range limits for dose rate are determined by syringe size and or the custom setup in the Configuration The high and low rate limits display on screen When the dose is correct press Enter At the BEGIN INFUSION screen all values are set and the pump pauses the pump may be configured with additional confirmation screens requiring you to confirm all settings twice before beginning the infusion Confirm the settings and start the infusion or use the four menu keys shown at right to modify the settings e Volume limit KVO loading dose or bolus dose may also be programmed these options are only available if they have been enabled in the profile or specified in the Drug Program using PharmGuard Toolbox 2 At the selection menu choose DosE Day or choose a drug program that uses the infusion type Choose the syringe model and size
126. ncoding matrix e Increase the acquisition Field of View e Increase the slice thickness e Increase the number of averages Medfusion Model 4000 pump Operator s Manual Cleaning and care Below are common methods and cautions relating to cleaning and caring for the infusion pump WARNING Power Source To avoid electric shock before cleaning always switch electrically operated equipment off and disconnect from AC power source CAUTIONS e Avoid Using Solvents NEVER use organic sol vents e g acetone quarternary ammonia com pounds strong acids or bases to clean any portion of the pump e Spray Resistant The pump is spray resistant from the top and sides but not water proof NEVER spray cleaning or other fluids directly into openings on the bottom of the pump e Not Waterproof The pump is not certified water proof Never immerse the pump in water or other fluids e Avoid Oil Sprays NEVER use light oil sprays e g WD40 to clean or lubricate pump These oils contain chemicals that can damage the plastic of the pump No user added lubrication is necessary e Never Autoclave NEVER sterilize the pump in a steam autoclave or gas Using autoclave or gas sterilization can seriously damage the infusion pump and void the warranty 1 Follow your institution s guidelines for cleaning and disinfecting of devices The pump can be safely cleaned with the following agents Common bleach 10 solu
127. nd how and why to discharge one s body to earth or to bond oneself by means of a wrist strap to earth prior to making a connection Use of cables WARNINGS e Use of cables other than as listed below may result in increased EMC emissions or decreased immunity of the pump e Use of the listed cables with equipment other than those specified may result in increased EMC emis sions or decreased immunity of the equipment or system It is recommended that when connecting the pump to a network using an Ethernet cable the net work equipment should conform to EN IEC 60950 e The pump should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the user should verify normal operation of the pump in the configuration in which it is to be used 116 This pump has been tested for EMC with the follow ing cables e Smiths Medical 21 2145 01 AC power cord e Ethernet unshielded less than 3 meter Stacked equipment WARNING The pump should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the user should verify normal operation of the pump in the configuration in which it is to be used Medical Electrical Equipment needs special precau tions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual Portable and mobile RF communication equipment can affect Medical Electrical E
128. nd load the syringe as instructed on page 34 Main Menu returns to the Main Menu Options allows selection from a list of variables e g standby etc Clear TVD clears total volume delivered Intermittent volume time This Intermittent Volume Time Mode allows speci fication of a delivery volume for a specific delivery time after which the delivery stops for a programmed interval then the pattern recycles In other words the pump delivers for a set period pauses a set period then infuses for a set period and so on e The delivery stop interval equals Time Between Starts minus Delivery Time e The pattern repeats at Time Between Starts interval Use the number keys to set the volume Volume is limited to 500 mL and minimum volume is 1 600 of syringe size When the volume is correct press Enter Note Volume is limited to 500 mL regardless of syringe size in use as some infusions may require multiple syringes 2 Use the number keys to set the delivery time Maximum and minimum times are calculated for the syringe in use and or the custom setup in the Configuration When ready press Enter Use the number keys to set the time between starts value Maximum and minimum times are calculated for the delivery time entered minimum time must be at least one minute longer than the delivery time the pump will not accept delivery times equal to or less than the delivery time
129. nding on the current setting See page 96 for more information on PVD PDD 81 Medfusion Model 4000 pump Operator s Manual Override occlusion limit The pump s programmed default occlusion setting can be overridden This allows setting a higher or lower occlusion limit for a specific infusion Note When a 1mL syringe is entered into the programming the occlusion pressure setting is fixed at very high 50psi meaning you do not have the option of changing it 1 Set the delivery mode parameters When the pump is paused at the BEGIN INFUSION screen press Options Use the number keys to choose OVERRIDE Occu LimiT You may have to press More to see this option The highlight shows the pump s current default setting Use the number keys to choose the occlusion setting you want to use then press Enter see the table on page 92 for more information about occlusion settings 82 Override alarm loudness Occasionally it may be necessary to change the loudness of the audible alarm For instance if the infusion is taking place in an area with a lot of am bient room noise the loudest alarm setting may be wanted The alarm loudness can be set from Level 1 quietest to Level 5 loudest however it cannot be disabled or completely silenced 1 With the pump running or stopped press Options 2 Use the number keys to choose OVERRIDE ALARM LOUDNESS You may have to press More to see this option
130. nected to the PharmGuard Server and or to the PharmGuard Toolbox 2 Software When the pump is connected to the net work there are two connectivity states Wireless and Ethernet Ethernet wired connection When the pump is con nected to Ethernet it automatically defaults to com municating over Ethernet Wireless When an Ethernet connection is not pres ent and the Wireless Interface is enabled the pump communicates via Wireless The blue Communicating light li is on whenever the pump is communicating with the PharmGuard Server using wireless or wired interface Note To set up a network configuration see the pro cedure provided in the Medfusion Model 4000 Net work Settings Manual Network Configuration the instructions provided with the PharmGuard Server and work with your IT personnel as needed Ethernet State The pump displays the ED icon when the pump is connected to the PharmGuard Server using the Ethernet connection First an F icon is displayed when the Ethernet connection is established then an ED icon when the connection to the PharmGuard Server is also established Wireless State The pump displays the icon WD when the pump is connected to PharmGuard Server using a Wireless connection First a W icon is displayed when the Wireless connection is established then a WD icon when the connection to the PharmGuard Server is also established
131. nforma tion appears on the display The lower portion of the display corresponds with the 4 softkeys their function changes depending on the pump programming being accomplished on the key pad Tubing Holders Thread infusion set tubing be tween holders to prevent kinking at syringe tip Carrying Handle Syringe Barrel Clamp The clamp holds the syringe barrel securely in place Syringe Barrel Flange Clip When loading a sy ringe slide the syringe flange into the clip Syringe Plunger Holders Holds the syringe plung er securely in place Syringe Plunger Driver Once loaded and delivery is started the driver pushes the plunger forward at a controlled precise rate to deliver fluid m Syringe Plunger Release Lever Squeeze the release lever to allow placement of the syringe plunger onto the holder during loading or to remove it during unloading Keypad See Keypad closeup next page for iden tification of the individual keypad keys and what they are used for Medfusion Model 4000 pump Operator s Manual 10 AC Power Connection Port Plug the AC power cord into connection port to allow pump to op erate on AC mains power Ethernet Port Plug an Ethernet network cable into the port to receive and send Configurations and data 12 Optional Poleclamp Mount If desired attach the optional poleclamp here 13 Pump Base Bottom Keypad closeup PRIME BOLUS G e mm B w O
132. ng the syringe plunger Always use the Prime feature when loading a new syringe If the alarm persists remove the pump from service for repair by a trained biomedical service technician Certain syringe models and sizes may cause the barrel clamp sensor to have difficulty in verifying the clamp is in position When this alarm oc curs press QA verify that the barrel clamp is indeed in place then press Confirm OR When the pump was powered up the syringe barrel clamp was lifted up and resting on the pump handle When the syringe model is selected this alarm occurs Press QA press Confirm and continue loading the syringe Ensure that the syringe barrel clamp is properly positioned on the syringe barrel Check Syringe Flange Sensor High Sensor is active when a syringe is not loaded correctly Check the sy ringe flange holder Ensure the syringe barrel clamp flange holder and plunger holders are properly engaged and the flange holder pulls back to the side of the case If holder does not operate correctly or the alarm per sists immediately remove the pump from service for repair by a trained biomedical service technician 103 Medfusion Model 4000 pump Operator s Manual Alarm Message Priority Remedy Check Syringe Plunger High Sensor is active when syringe is not loaded correctly Check the syringe Sensor plunger holders Ensure the syringe barrel clamp flange holder and plu
133. nge sizes or types Check the documentation that came with the Medfusion Standard Syringes Series 2 supplied with PharmGuard Toolbox 2 and or PSS Series 2 for information on the availability of FlowSentry e If a rate below that shown on the tables on page 131 or in the documentation supplied with the PharmGuard Supported Syringes PSS Series 2 is entered the Rate Below Recommended Min for Syringe Size alarm will occur see page 105 for a full explanation of the alarm The absolute minimum rate allowed by the pump with a given syringe is listed in the tables found on page 131 and included in the literature supplied with the PharmGuard Supported Syringes PSS Series 2 e High viscosity fluids may cause false occlusion alarms at lower occlusion alarm settings particularly with higher rates of delivery When infusing higher viscosity fluids adjust the occlusion alarm setting to minimize false occlusion alarms Bolus Volume The recommended minimum bolus volume is 1 0 mL or 10 percent of the syringe volume of the syringe used which ever is less In other words for a 1 0 mL syringe regardless of the actual volume of medica tion contained the minimum recommended bolus volume is 0 1 mL For a 60 mL syringe the recom mended minimum bolus volume regardless of the ac tual volume of medication contained the minimum recommended bolus volume is 1 0 mL Bolus volumes delivered that are less then the recommended m
134. nger holders are properly engaged and the holders move freely If they do not operate correctly or if the alarm persists immediately remove the pump from service for repair by a trained biomedical service technician Data Does Not Match Limit In cases where confirmation of entered data is required the confirma Previous Entry tion value did not match the originally programmed value Re enter the correct value Force Sensor Bgnd Test High A self test was performed on the force sensor and the test failed due to a sensor malfunction OR the Syringe Plunger Driver was being moved during the pump startup process or if the Syringe Plunger Driver re ceives a hard bump during the pump startup process Press QA Press to turn the pump off Immediately remove the pump from service for repair by a trained biomedical service technician Infusion Complete High The programmed infusion based upon the values entered in the pump has been delivered Press a Either begin a new infusion return to the SELECT THE PROFILE screen where no alarms sound or turn off the pump Input Out of Range Limit The time value entered is greater than the maximum allowed for the Greater Than Max Minutes minutes or seconds Please try a lower value Seconds Input Out of Range Limit The value entered is greater than the maximum allowed for the item Greater Than Max Value Please try a lower value Input Out of Range Less Limit The value entered is less
135. nitiate the priming sequence page 59 3 yee Main Menu returns to the Main Menu If desired Loading Dose or Volume Limit Options allows selection from a list of variables e g bolus see Options page 61 volume limit etc Clear Totals clears total volume delivered and PVD or WARNING Confirm All Settings Before starting PDD any delivery always confirm the accuracy of all infusion values to the original order Programming the pump at a delivery rate other than that pre scribed will cause inappropriate delivery which can result in serious injury or death 10 When all delivery settings are confirmed as correct press lt to begin infusion 45 Medfusion Model 4000 pump Operator s Manual Body weight surface area infusion deliveries The following Body weight surface area based infu sion delivery modes may be available on a pump dose kg min dose m min dose kg hr dose m hr dose kg day dose m day The body weight surface area rate calculation allows programming by e Drug concentration units i e g mL mg mL mceg mL mMol mL mEq mL or Units mL e Drug concentration e Drug delivery units i e g mg mcg ng mMol mEq or Units e Patient s weight Body surface area e Dose Press the number keys to set the medication concentration units The actual units available on a pump depends on the custom setup Press Enter to accept the medication concentration uni
136. not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz NOTE 3 An additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas NOTE 4 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people IEEE 802 11 b g Radio for Auxiliary Communication The Medfusion Model 4000 pump intentionally receives RF electromagnetic energy for non critical communication The RF band of reception is 2412 MHz to 2462 MHz The bandwidth of the signal is 20Mhz Note The pump may be interfered with by other equipment even if that other equipment complies with CISPR EMISSION r
137. ns Temperature 5 to 40 C 40 to 104 F Infusion Back Pressure Storage transportation conditions Delivery Accuracy KOUA s A 20 to 95 non condensing PUNA A 70 kPa to 106 kPa 10 2 psia to 15 4 psia 100 mmHg to 300 mmHg 20 to 50 C 4 to 122 F Temperature Cae A 20 to 95 non condensing 70 kPa to 106 kPa 10 2 psia to 15 4 psia Nominal 2 syringe accuracy for infusion back pressures of 100 mmHg to 300 mmHg At low infusion rates the system accuracy may not be achieved for short periods During the total infusion time the accuracy averages out see accuracy curves page 138 Overall flow rate accuracy is equal to pump accuracy combined with syringe tolerances For syringes specified to meet the ISO 7886 2 standard syringe accuracy may be expected to meet the 2 requirement Ambient Pressure WARNING Ensure that the 2 accuracy specification is taken into account when programming the pump and or filling a syringe If accuracy is of prime concern use only syringes that meet the 2 requirement of the ISO 7886 2 Standard Failure to do so may result in medication in the syringe becoming depleted sooner than expected If the pump is being used to deliver critical or life sustaining medication the interruption in the delivery of medication could result in patient injury or death Bolus Accuracy This data taken with BD 20 mL syringe
138. ns power quality should be that of a Tansieniburst supply lines supply lines typical commercial or hospital environ IEC 61000 4 4 1 kV for input output lines 1 kV for input output lines ment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environ ment Voltage dips short inter lt 5 Ur lt 5 UT Mains power quality should be that of ruptions and voltage ih Hes on Aes a typical commercial or hospital envi variations on power sup ee eae ead ae ronment If the user of the Medfusion ply input lines for 0 5 cycle for 0 5 cycle Syringe Infusion Pump Model 4000 requires continued operation during o power mains interruptions it is recom IEC 61000 4 11 40 Ur 40 Ur mended that the Medfusion Syringe 60 dip in Ur 60 dip in Ur Infusion Pump Model 4000 be powered for 5 cycles foi Beales from an uninterruptible power supply 70 Ur 70 Ur 30 dip in Ur 30 dip in Ur for 25 cycles for 25 cycles lt 5 UT lt 5 UT gt 95 dip in Ur gt 95 dip in Ur for 5 sec for 5 sec Power frequency 3 A m 400 A m and Power frequency magnetic fields should 50 60 Hz 3 A m be at levels characteristic ofa typical i location in a typical commercial or hos Magnetic field pital environment IEC 61000 4 8 Note Ur is the AC mains voltage prior t
139. numeric value in the range 1 to 2 minutes Alarm Silence Time Alarm Style Defines the tone style a pump will use when sounding an alarm You can select 134 Auto Lock Time Bolus Change in mL Bolus Time Feature Bolus Total Dose Date Separator Decimal Separator Enter User ID on Override Flush Flush Time Maximum Flush Volume FlowSentry FlowSentry Sensitivity FlowSentry Startup Sensitivity Key Click key click loudness Maximum Body Surface Area Maximum Bolus Rate Medfusion Model 4000 pump Operator s Manual from three styles Medfusion Defined International Standard and Medfusion Multi tone Defines the number of seconds the pump will wait before automatically locking the pump s interface Auto Lock Time is a numeric value in the range 0 to 999 seconds Setting this value to zero will disable the Auto Lock feature Defines if a pump user can change a Bolus Dose or Loading Dose in mL You can select from two values Enabled or Disabled Defines if a pump user will have to enter a time when setting a Bolus Dose using a manual delivery mode Due to a conflict between library and profile options bolus time is always enabled inside of library programs You can select from two values Enabled or Disabled Defines if a pump user will be allowed to enter a Bolus Dose or Loading Dose as a Total Dose rather than the standard dose kg in weight based modes Select from two values Enabled an
140. o application of the test level 121 Medfusion Model 4000 pump Operator s Manual Guidance and manufacturer s declaration electromagnetic immunity The Medfusion Syringe Infusion Pump Model 4000 is intended for use in the electromagnetic environment specified below The customer or the user of the Medfusion Syringe Infusion Pump Model 4000 should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the Medfusion Syringe Infusion Pump Model 4000 including cables than the recom mended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 10V d 0 35 JP IEC 61000 4 6 150 kHz to 80 MHz outside ISM bands 10 Vrms 10V d 1 2 VP 150 kHz to 80 MHz in ISM bands Radiated RF 10 V m 10 V m d 1 2 P 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz d 23 JP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the rec ommended separation distance in metres m b Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range 4 Interference may o
141. o clear the Total Volume delivered Press Yes to clear total volume delivered only Or press No to exit without clearing The program volume or dose delivered is cleared automatically whenever the pump s delivery mode is changed The Total Volume Delivered is only cleared when the softkey is pressed i e Clear Totals key Recovering TVD TDD Information The Total volume delivered display can be restored after turn ing the pump off by using the Recall Settings selec tion from the Main menu If TVD has been cleared then only the quantity infused since clearing will be stored in memory It may be good practice to make note of TVD before clearing it 97 Medfusion Model 4000 pump Operator s Manual Keypad lock The keypad can be locked during delivery The lock feature is provided to make the delivery settings tam per resistant Once the keypad is locked a setting cannot be modi fied until the keypad is unlocked The Medfusion Model 4000 pump offers a programmable unlock code option set through custom configuration Any high priority alarm automatically unlocks the front panel 1 Press Lock to lock the front panel controls PRIME BOLUS The Lock indicator on the front panel lights Ifany front panel keys other than Unlock are pressed a PUMP IS LOCKED message appears on screen Press the Unlock menu key to unlock the front panel If an Unlock Passcode has been set you will be prompted
142. o distur bance characteristics Limits and methods of measurement AS NZS 3200 1 2 2005 Australian New Zealand Standard Medical electrical equipment Part 1 2 General requirements for safety Collateral standard Electromagnetic compatibility Requirements and tests Parent Standard CISPR 11 2003 Industrial scientific and medical ISM radio frequency equipment electromagnetic disturbance characteristics limits and methods of measurement Amendment 1 2004 Amendment 2 2006 ASTM F2052 06 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment IEEE 802 11 2007 IEEE Standard for Information technology Telecommunications and informa tion exchange between systems Local and metropolitan area networks Specific requirements Part 11 Wireless LAN Medium Access Control MAC and Physical Layer PHY Specifications ETSI EN 300 328 2006 V1 7 1 Electromagnetic compatibility and Radio spectrum Matters ERM Wideband Transmission systems Data transmission equipment operating in the 2 4 GHz ISM band and using spread spectrum modulation techniques Part 2 Harmonized EN covering essential requirements under article 3 2 of the R amp TTE Directive ETSI EN 301 489 1 V1 8 1 Electromagnetic compatibility and Radio spectrum Matters ERM 2008 ElectroMagnetic Compatibility EMC standard for radio equipment and services Part 1 Common technical req
143. o volume limit set Program a volume limit then set a KVO rate Syringe Does Not Match Entry Limit The drug program indicates a specific syringe and the syringe in use is different Verify the correct drug program and syringe are being used Syringe Empty High Press a The syringe is now empty Either e Prepare and load another syringe e Return to the SELECT THE PROFILE screen where no alarms sound e Turn off the pump Syringe Empty Stop High Press D The pump has either calculated based on the syringe model in use that the syringe should be at it s forward most travel point or the pump s Syringe Plunger Driver has moved as far forward as is possible Either e Prepare and load another syringe e Return to the SELECT THE PROFILE screen where no alarms sound e Turn off the pump Syringe Flange Not in Place High Press a The syringe is not loaded correctly or the sensor has failed Make sure the syringe flange is properly inserted into the flange clip Proceed with the infusion if possible If the alarm recurs remove the pump from service for repair by a trained biomedical service technician Syringe Near Empty Medium or Low The pump is indicating the syringe will soon be empty The Near Empty Time interval ranges from 1 240 minutes This time interval may be set via the Near Empty Time in PharmGuard Toolbox 2 as well as the alarm priority Low or Me
144. oLus Doss OR e Press lt 4 Tocontinue the bolus from where it left off delivering only what was remaining press Yes Press No to exit the bolus screen cancel bolus delivery and return to the main infusion 65 Medfusion Model 4000 pump Operator s Manual 66 Bolus dose rate reduction The increased delivery rate of a bolus dose may trigger an occlusion alarm depending on the occlusion limit settings in the pump and the re sistance in the line If this occurs the bolus rate is automatically reduced to 70 The bolus rate is reduced by increasing the bolus time over the bolus volume The bolus rate continues to be reduced until resistance is below the set occlusion limit There could be a variety of reasons for this to occur including but not limited to the occlusion limit in use fluid medication viscosity tubing size the patient s infusion site setup etc 1 Press O to silence the alarm Bolus delivery continues at the reduced rate The pump continues to monitor the infusion and may reduce the rate multiple times However the first alarm is the only one that produces an audible tone If the first alarm is silenced additional rate reductions will not cause an audible tone to sound however the amber yellow LED and the alarm message will display and can be cleared by pressing a If the bolus rate reduces below the infusion rate or the bolus time increases past the maximum bolus time the
145. ons Repair or replacement of the Pump or any component part thereof is the EXCLUSIVE remedy offered by the Manufacturer The following exclusions and limita tions shall apply 146 1 No agent representative or employee of the Manufacturer has authority to bind the Manufacturer to any representation or warranty expressed or implied 2 THERE IS NO WARRANTY OF MERCHANTABILITY OR FITNESS OR USE OF THE PUMP FOR ANY PARTICU LAR PURPOSE 3 The Pump can only be used under the supervision of medi cal personnel whose skill and judgment determine the suitabil ity of the Pump for any particular medical treatment 4 All recommendations information and descriptive litera ture supplied by the Manufacturer or its agents are believed to be accurate and reliable but do not constitute warranties E Computer Program License 1 The Pump is intended to be used in conjunction with a par ticular Licensed Computer Program supplied by Manufacturer and use of any other program or unauthorized modification of a Licensed Computer Program shall void Manufacturer s war ranty as set forth above 2 The Original Purchaser and any users authorized by the Original Purchaser are hereby granted a nonexclusive non transferable license to use the Licensed Computer Program only in conjunction with the single Pump supplied by Manufacturer The Licensed Computer Program is supplied only in machine readable object code form and is based upon Manufa
146. ontrols do unlock Note System faults may result in subsequent faults being logged in the pump s Alarm History however only the initial fault is displayed on the pump due to the fact that the only method for ending the alarm is to turn the pump off High priority A high priority alarm is initiated by any condition that halts an ongoing infusion High priority alarms are signaled with a flashing red indicator a viewing screen backlight that oscillates between bright and dim and a repeating audible signal Press O to return the viewing screen backlight to bright and silence the audible alarm for the programmed alarm silence period During a high priority alarm condition all keys except O are locked You must silence the alarm by pressing O before any other action can be taken If the front panel controls are locked when a high priority alarm occurs the pump controls do unlock A high priority alarm that stops delivery during a loading dose or bolus will not return to the BEGIN DELIVERY screen until the alarm is silenced this allows you to record the portion of the loading dose bolus volume delivered prior to the alarm sounding Medium priority A medium priority alarm indicates any condition requiring intervention but does not halt infusion Medium priority alarms are signaled with a flashing yellow indicator a viewing screen backlight that oscillates between bright and dim and a repeating audible signal Pressing a wi
147. osage of medication or fluids to a patient choose the syringe model and size and load the syringe as instructed on page 34 s Medfusion Model 4000 pump Operator s Manual WARNING Confirm All Settings Before starting any delivery always confirm the accuracy of all infusion values to the original order Programming the pump at a delivery rate other than that pre scribed will cause inappropriate delivery which can result in serious injury or death 4 When all delivery settings are confirmed as correct press lt to begin infusion Be sure all pump settings are correct before starting infusion TVD and PVD PDD Retention The pump also re tains TVD and PVD or PDD from the last infusion If these values are not wanted you must manually clear them before beginning a new infusion 58 Priming the system Priming is one of the functions of the Prime Bolus key lt lt Always prime a new syringe after loading it onto the pump and before connecting the tubing to the patient This removes the mechanical slack in the pump and syringe and significantly reduces start up time The priming sequence is extremely important to assure the accuracy of the delivery and reduce the start up time The priming sequence is performed after the infusion is programmed and before the de livery is started The message at the top of the BEGIN INFUSION screen will alternate between PRESS lt 4 gt To BEGIN INFUSION
148. p The range is 0 to 6 hours Defines if a pump user will be able to enter a Keep Vein Open KVO rate This value cannot be set or changed while an infusion is running Defines if a pump user will be able to enter a Loading Dose during infusion setup Defines if a pump user will be able to change the loudness level of a pump s alarm during an infusion Override Occlusion Limit Periodic Callback Alarm Standby Toggle Vol Empty Tone Toggle FlowSentry Toggle Near Empty Tone Toggle PVD PDD Volume Limit Auto Prompt Options Medfusion Model 4000 pump Operator s Manual Defines if a pump user will be able to override the profile default setting of the pressure at which the pump will consider the line occluded for the current infusion Defines if a pump user will be able to enter a Periodic Callback Alarm time dur ing infusion setup The range is 0 to 8 hours Defines if a pump user will be able to enter a Standby time during infusion setup The range is 0 to 24 hours Defines if a pump user will be able to disable the Syringe Vol Empty Alarm Tone for the current infusion The user callback alarm will still be activated after the defined Alarm Silence Time Defines if a pump user will be able to disable the FlowSentry Rapid Occlusion Detection feature for the current infusion Defines if a pump user will be able to disable the Syringe Near Empty Alarm Tone for the current infusion Displayed on the pum
149. p options menu as Change to Dose or Change to Volume Defines if a pump user will be able to change the profile default set ting to display the delivered Program Dose or the delivered Program Volume Defines if a pump user will be able to enter a Volume Limit during infusion setup This value cannot be set or changed while an infusion is running The range is 0 to 500 mL Auto Prompt Options are optional settings that the user will be prompted to enter for all infusions initiated in the defined profile The default for all Auto Prompt Options is Disabled Bolus Dose Confirm Settings Enter User ID to Program Prompt to Prime Re enter Weight Standby Volume Limit Defines if a pump user will be prompted to enter a Bolus Dose during infusion setup You can select from two values Enabled or Disabled Defines if a pump user will be prompted to Confirm Infusion Settings when setting up an infusion Once the infusion settings are made if Confirm Settings is enabled the user will be required to re confirm the settings You can select from two values Enabled or Disabled Defines if a pump user will be prompted to enter their User ID when setting up an infusion You can select from two values Enabled or Disabled Defines if a pump user will be prompted to Prime as a last step in setting up an infusion You can select from two values Enabled or Disabled Defines if a pump user will be prompted to re enter a patients w
150. poleclamp Failure to verify the stabil ity could cause the object to tip with the possibility of causing damage to the pump and other equipment If the poleclamp is not adequately tightened it could cause the pump to fall 113 Medfusion Model 4000 pump Operator s Manual Assembling the rotating detachable poleclamp 1 Unpack the pump and poleclamp assembly from the shipping container Slide the rotating poleclamp onto the poleclamp anchor at the rear of the pump until the retainer lock button audibly clicks into place Pull the round lock button at the top of the clamp assembly up and rotate the clamp to fit either a vertical or horizontal pole To remove the pump from the poleclamp pull the release lever toward the pump and slide the pump off the poleclamp 114 Medfusion Model 4000 pump Operator s Manual Assembling the stationary poleclamp A Phillips head screwdriver is required to assemble the poleclamp 1 Unpack the poleclamp assembly from the shipping container The T bracket attaches the poleclamp to the pump When you receive the poleclamp assembly it is configured for use with a vertical pole If you wish to change this assembly for use with a horizontal pole e g bed rail reconfigure the T bracket using the following steps e Remove the 4 pan head screws and their lock washers from the rear of the poleclamp Align the T bracket for horizon
151. programming via PharmGuard Toolbox 2 Once configured on the PharmGuard Toolbox 2 taught to a Medfusion Model 4000 pump and once a drug has been selected from the library entries on the pump may be required for the following e Drug selection only e Drug concentration NOTE If preset limits were programmed in PharmGuard Toolbox 2 this option will be available If a preset value was programmed in PharmGuard Toolbox 2 the concentration limits are not needed Press the number keys to set medication concentration Concentration is limited to 4 digits Press Clear to clear an entry Press Backspace to erase a character Press Enter to accept the setting Press the number keys to set the patient s weight in kilograms or surface area in square meters Weight surface area are limited to the indicated range Press Enter to accept the patient weight surface area setting The pump may be customized with an additional patient weight body surface area confirmation screen If so re enter the patient weight body surface area then press Enter to accept the setting At the Doss screen press the number keys to set the dose Dose limits displayed are dependant on custom settings and installed syringe size When the setting is correct press Enter to accept the dose The pump calculates the correct flow rate in mL hr to achieve the required drug dose The time setting screen appears Press the number keys to set the time
152. pump will recall the set tings used to run the last infusion Note If a pump has a custom configuration cre ated using PharmGuard Toolbox 2 and taught to the pump the Recall last settings feature is available only in those profiles it has been included in To use the feature you must first enter the profile for the previous infusion Any Options used in the infusion disable bolus dose adjust alarm volume occlusion setting etc return to the default settings and must be reprogrammed 1 Select RECALL LAST SETTINGS from the selection menu If it isn t shown press the More key and search for it In this example press the number 4 When selected press Enter to confirm the syringe type and size if the syringe has been replaced After the syringe has been confirmed the CONTINUE SAME INFUSION screen appears Prior to connecting to the patient press lt lt to initiate the priming sequence page 59 If No is pressed the pump returns to the MAIN menu to select a different Drug Program or Manual delivery mode If Yes is pressed the pump pauses at the BEGIN INFUSION screen and PVD is not cleared After reviewing these previously used settings the pump pauses To clear the TVD and PVD or PDD press Clear Totals For volume limited infusions only the remaining volume specified will be delivered Medfusion Model 4000 pump Operator s Manual Reuse the same delivery settings to repeat an identi cal d
153. quipment Medfusion Model 4000 pump Operator s Manual Technical specifications amp other information Pump development standards Medical Electrical Equipment Safety Reference Year Title IEC 60601 1 1988 Medical Electrical Equipment Part 1 General Requirements for Safety Amendment 1 1991 Amendment 2 1995 IEC 60601 1 4 2000 Medical electrical equipment Part 1 4 General requirements for safety Collateral standard Programmable electrical medical systems IEC 60601 1 6 2006 Medical electrical equipment Part 1 6 General requirements for safety collateral standard usability IEC 60601 2 24 1998 Medical Electrical Equipment Part 2 Particular requirements for safety of infusion pumps and controllers IEC 62304 2006 Medical device software Software life cycle processes IEC 62366 2007 Medical Devices Application of usability engineering to medical devices EN 60601 1 1990 Medical Electrical Equipment Part 1 General Requirements for Safety EN 60601 1 4 1996 Medical electrical equipment Part 1 4 General requirements for safety Collateral standard Programmable electrical medical systems Amendment 1 1999 EN 60601 1 6 2007 Medical electrical equipment Part 1 6 General requirements for safety collateral standard usability EN 60601 2 24 1998 Medical Electrical Equipment Part 2 Particular requirements for safety of infusion pumps and controllers EN 475 1995 Medical Devices Elect
154. r an empty syringe can be a multi step process on the Medfusion Model 4000 pump The Syringe Near Empty alarm and Syringe Volume Near Empty alarms are both calculated by the pump based on infusion volume and time and are designed to indicate the syringe is nearing empty so there is time to prepare for another syringe if needed The Syringe Empty and Syringe Empty Stop alarms are the final alarms in the process stopping fluid delivery when the syringe is empty The Syringe Near Empty alarm time is calculated based on the flow rate and syringe volume to occur at the set amount of time before the Syringe Volume Near Empty alarm The Syringe Volume Near Empty alarm occurs at a syringe position near the end of the syringe travel Due to variation in syringe dimensions the pump will continue to infuse for a variable amount of time until the syringe plunger reaches the end of the syringe and the Syringe Empty alarm sounds Medfusion Model 4000 pump Operator s Manual stopping the infusion The Syringe Near Empty alarm time may be set and is useful in allowing preparation time for the next syringe on continuous infusions This alarm indi cates the time remaining to the Syringe Volume Near Empty alarm The Syringe Volume Near Empty alarm provides indication that the syringe is nearly empty The re maining time to the Syringe Empty alarm is variable depending on
155. r programming them are based on general setup parameters Which of the features and functions are available on a specific pump and how the screens associated with them appear depends entirely on how the pump was customized If the functions and screens on a pump look different than those shown here it is due to this customization It is possible that a pump is customized so that an in fusion cannot be programmed without first entering a user ID or so that certain profiles cannot be accessed without first entering a passcode If that is the case you will be prompted to enter an ID or a passcode when attempting to program an infusion WARNING Always read manufacturer precautions and guidelines for medications fluids syringes and administration sets used with this pump Medications or fluids may interact with the plastic components of the infusion syringe and sets This interaction may result in serious injury or death Exceeding limits The pump has two types of programmed infusion limits Hard limits and Soft limits o Hard Limits Values that cannot be exceeded under any conditions Hard limits show up as Max and Min on the pump If you try to exceed a hard limit a screen similar to the following figure dis plays The pump then prompts you to enter a new value e Soft Limits The normal range Soft Limits show up as High and Low on the pump They are the normal upper and lower limits You can enter a value
156. re for this infusion 1 With the pump running or stopped press Options 2 Use the number keys to choose DISABLE NEAR EMPTY TONE or ENABLE NEAR Empty TONE only one of the above will be displayed depending on whether the Near Empty Alarm feature is currently active or not You may have to press More to see this option 84 Medfusion Model 4000 pump Operator s Manual Disable enable vol empty alarm tone The pump may be configured to have an alarm sound to indicate when the volume of medication in a syringe is near empty The calculation for when the alarm sounds is based on the syringe size used and the volume initially programmed Use this option to enable or disable this feature for this infu sion 1 With the pump running or stopped press Options 2 Use the number keys to choose DISABLE EMPTY TONE or ENABLE EMPTY TONE only one of the above will be displayed depending on whether the Empty Alarm feature is currently active or not You may have to press More to see this option 85 Medfusion Model 4000 pump Operator s Manual Infusion Delivery Sta rting amp stopping infusion WARNING Confirm All Settings Before starting any delive ry delivery always confirm the accuracy of all infusion values to the original order Programming the pump An infusion delivery can be started at any time after at a delivery rate other than that prescribed will cause a delivery mode has been set up An
157. release lever 8 35 36 System Advisory 107 System Failures 102 108 T Technical specifications 124 Concentration and dosing units 133 Flow delivery graphs trumpet curves 138 Options 136 PharmGuard limits 133 Total Volume Delivered 96 Clearing 97 Trumpet curves flow delivery graphs 138 Tubing holders 8 37 Turning the pump off 27 U Unloading a syringe 38 Unlocking the keypad 98 Update s Available 110 User Callback alarm 101 V Vol Empty alarm tone disable enable 85 Volume time ml hr infusions 54 WwW watchdog 128 Wireless State 11 Workflow Process 23 Smiths Medical ASD Inc St Paul MN 55112 USA 1 800 258 5361 USA 1 214 618 0218 www smiths medical com race Rx Smiths Medical International Ltd TN25 4BF UK ONLY 0473 Tel 44 0 1233 722100 Smiths Medical Australasia Pty Ltd 61 Brandl Street Eight Mile Plains QLD 4113 Australia 61 0 7 3340 1300 Medfusion PharmGuard FlowSentry and the Medfusion and Smiths Medical design marks are trademarks of Smiths Medical The symbol indicates the trademark is registered in the U S Patent and Trademark Office and certain other countries All other names and marks are trademarks tradenames or service marks of their respective owners This product includes software developed by the OpenSSL Project for use in the OpenSSL Toolkit http www openssl org This product includes cryptographic software written by Erc Young eay cryptsoft com
158. rformance Procedure Notice of the claimed de fect must be made in writing or by telephone to the Manufacturer as follows Customer Service Department Smiths Medical ASD Inc 1265 Grey Fox Road St Paul MN 55112 USA 1 800 258 5361 USA or Smiths Medical International Ltd 1500 Eureka Park Lower Pemberton Ashford Kent TN25 4BF UK 44 0 1233 722100 Notice to the Manufacturer must include date of purchase model and serial number and a description of the claimed defect in sufficient detail to allow the Manufacturer to determine and fa cilitate any repairs which may be necessary AUTHORIZATION MUST BE OBTAINED PRIOR TO RETURNING THE PUMP If authorized the Pump must be properly and carefully packaged and returned to the Manufacturer postage prepaid Any loss or damage during shipment is at the risk of the sender C Conditions of Warranty The warranty is void if the Pump has been 1 repaired by someone other than the Manufacturer or its authorized agent 2 altered so that its stability or reliability is affected which includes use of service replacement parts not sup plied by Smiths Medical or its authorized agents including the battery pack 3 misused or 4 damaged by negligence or acci dent Misuse includes but is not limited to use not in compliance with the Operator s Manual or use with non approved accessories Removal or damage to the Pump s serial number will invalidate this warranty D Limitations and Exclusi
159. rically generated alarm signals UL 60601 1 2006 Medical Electrical Equipment Part 1 General Requirements for Safety US Deviations to IEC 60601 1 CAN CSA C22 2 No Medical Electrical Equipment Part 1 General Requirements for Safety November 601 1 M90 2003 1990 Canadian Deviations to IEC 60601 1 Update No 2 November 2003 AS NZS 3200 1 0 1998 Australian New Zealand Standard Medical electrical equipment Part 1 0 General requirements for safety Parent Standard Australian Deviations to IEC 60601 1 AS NZS 3200 2 24 Medical Electrical Equipment Part 2 24 Particular requirements for safety 1999 Infusion pumps and controllers Electromagnetic Compatibility Reference Year Title 47 CFR Part 15 247 FCC Rules and regulations 47 CFR part 15 247 Class B Class B RSS 210 Issue 7 June Low power Licence exempt Radiocommunication Devices All Frequency Bands 2007 Category I Equipment Canada EN 60601 1 2 2007 Medical electrical equipment Part 1 2 General requirements for safety Collateral standard Electromagnetic compatibility Requirements and tests EN 61000 4 2 2009 Electromagnetic Compatibility EMC Part 4 Testing and measurement techniques Section 2 Electrostatic Discharge immunity test Basic EMC Publication 117 Medfusion Model 4000 pump Operator s Manual Reference Year Title EN 61000 4 3 2006 Electromagnetic Compatibility EMC Part 4 Testing and measurement techniques Sec
160. ringe therefore the infusion continues Press If you do not wish to deliver any remaining fluid or if the syringe is empty press and unload the syringe Either prepare and load another sy ringe return to the SELECT THE PROFILE screen where no alarms sound or turn the pump off The pump continues delivery and continues until no fluid remains in the syringe As soon as the syringe plunger reaches the end of the syringe it halts delivery and displays the Syringe Empty message on screen Press The pump has stopped delivery and is at the BEGIN INFUSION screen Either prepare and load another syringe return to the SELECT THE PROFILE screen where no alarms sound or turn the pump off Syringe Empty alarm The SYRINGE EMPTY alarm is a high priority alarm advising the syringe is empty The Empty alarm stops delivery immediately Press a to clear the alarm tone amp message Unload the syringe If the infusion is complete either turn the pump off or prepare for another infusion If the infu sion is not complete prepare and load another syringe and e return to the SELECT THE PROFILE screen where no alarms sound or turn off the pump OR e if the mode in use was a continuous infu sion the screen displays CONTINUE SAME INFUSION with choices of Continue or Restart Continue or restart the infusion or turn the pump off 102 Monoject 1 3 12 and 35 mL Because of
161. rned to the MAIN menu and can be cleared by pressing Clear Totals This display totals the boluses loading dose and normal delivery vol umes e Priming volume Which should never be deliv ered to the patient does not accumulate on this display e Program volume or dose delivered Appears on screen while the pump is paused and during DELIVERY for the first three seconds and briefly by pressing cS e Program Dose Delivered Only available when concentration has been programmed e Toggle from PVD to PDD Available through OPTIONS menu provided this option has been enabled for use See page 81 for instructions on using this option 96 Medfusion Model 4000 pump Operator s Manual Clearing total volume program volume or program dose delivered Use the following steps to clear the total volume and program volume or dose and reset the counter to zero With the pump paused press if necessary 1 Press Clear Totals 2 Confirmation is required to clear totals delivered Press Yes to clear total volume delivered and program volume or dose de livered Or press No to exit without clear ing The program volume or dose delivered is cleared automatically whenever the pump s delivery mode is changed The Total Volume Delivered is only cleared when the softkey is pressed i e Clear Totals key With the pump delivering 1 From any run screen press Clear TVD 2 Confirmation is required t
162. rupted for any reason 1 Ifthere is an active alarm first silence it 2 To continue the infusion press Yes Press No to cancel the remainder of the infusion and return to the MAIN menu Medfusion Model 4000 pump Operator s Manual PRIME BOLUS K PRIME BOLUS K 87 Medfusion Model 4000 pump Operator s Manual Flush feature Some medications and infusions may require flush ing the line to remove any residual medication or infusate Using PharmGuard Toolbox 2 this feature can be enabled for certain profiles facilitating the pump to automatically prompt flushing the tubing when an infusion is complete The pump may prompt to set a delivery time for the flush or only to specify a volume depending on how the feature is enabled Volume only 1 When the programmed infusion is complete or the SYRINGE EMPTY alarm activates and the pump alarms press The BEGIN FLUSH SETUP screen appears If you do not want to start the flush at this point press No the pump will return to the BEGIN INFUSION screen If you do want to begin the flush setup press Yes Remove the syringe at the end of the infusion when prompted and replace with the flush syringe Press the number key to select the syringe model Load the syringe onto the pump verify the correct size is shown then press Enter Use the number keys to enter the desired amount of flushing infusate then press Enter Volume is limited by the s
163. s Level 2 quietest Level 3 Level 4 or Level 5 loudest A limit priority alarm sounds a three tone non repeating audible signal and displays an advisory message on screen for 3 seconds If the front panel controls are locked when a low priority alarm occurs the pump controls do not unlock Re displaying an alarm message Whenever an alarm is silenced the alarm message remains on the screen for approximately 3 seconds This message can be re displayed for an additional 3 seconds by pressing D 100 User Callback alarm The User Callback alarm is a Medium priority alarm that serves as a reminder to finish what you started Once you begin programming any infusion delivery the pump expects you to continue until setup is com plete If the pump is paused too long 30 seconds after a profile is selected or on a data entry screen the pump initiates this alarm There are several basic resolutions Press ANY key to silence the alarm for another 30 seconds Go to the BEGIN INFUSION screen There the alarm silence interval is one to two minutes depending on the configuration Use the Standby option to prevent the User Callback alarm while paused at the BEGIN INFUSION screen Press lt to begin the infusion Cancel the infusion and return to the SELECT THE PROFILE screen where no alarms sound Press amp hold and turn the pump off Syringe Empty Alarm Process Sensing fo
164. s dosing 62 Delayed start 78 87 Disable enable near empty alarm tone 84 Disable enable rapid occlusion detection 84 Disable enable vol empty alarm tone 85 KVO Keep Vein Open 74 Loading dose 67 Delivering a loading dose 69 Override alarm loudness 83 Override occlusion limit 82 Perioodic callback alarm 79 Standby 76 Override alarm loudness 83 Override occlusion limit 82 P Periodic callback alarm 79 PharmGuard Safety Software 6 15 19 31 133 PharmGuard Server 11 Poleclamp 113 rotating detachable poleclamp Assembling 114 Stationary poleclamp Assembling 115 Post occlusion bolus reduction 93 Prime function 36 57 Program Dose Delivered PDD 96 Clearing 97 Displaying 96 Program Volume Delivered PVD 96 Clearing 97 Displaying 96 Q Quick libraries 15 R Rapid occlusion detection disable enable 84 Rate reduction 66 71 106 Recall last settings 57 Restarting a bolus dose 65 Restarting a loading dose 70 148 Self tests 26 Service 142 Soft limits 14 19 133 Software Safety Features 128 Data Handling Software Safety Features 128 Hardware related Software Safety Features 128 Standard libraries 15 Using 16 Standby 76 87 Starting an infusion 86 from pause 86 from standby delayed start 87 Stopping an infusion 87 Stopping delivery 87 Symbols 5 Syringe barrel clamp 8 35 36 Syringe barrel flange clip 8 35 Syringe manufacturer type 39 Syringe plunger driver 8 36 Syringe plunger holders 8 Syringe plunger
165. s regarding EMC and needs to be installed and put into service according to the EMC infor mation provided e Portable and mobile Radio Frequency RF com munications equipment can affect medical electri cal equipment e This equipment has been tested and found to comply with the limits for a Class A digital device pursuant to part 15 of the FCC rules These lim its are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the operator s manual may cause Medfusion Model 4000 pump Operator s Manual harmful interference to radio communications Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interfer ence at his own expense This equipment system is intended for use by healthcare professionals only The equipment sys tem may cause radio interference or may disrupt the operation of nearby equipment It may be necessary to take mitigation measures such as re orienting or relocating the Medfusion Model 4000 pump or shield the location The unauthorized modification of this product may constitute a safety hazard which could lead to patient injury or death as well as the potential for property damage including the risk of fire Use on
166. se m Hr Concentration Hard and Soft User Defined Dose m Min m Configurable User Defined Dose m Day Dose rate Hard and Soft User Defined Options Parameter Limit Type Limit range Loading dose Dose Hard and Soft User Defined Time Hard and Soft User Defined Bolus dose Dose Hard and Soft User Defined Time Hard and Soft User Defined KVO Rate Hard User Defined Volume Hard MAX Max bolus rate Rate Hard User Defined Configuration options A pump s Alarm Setup Auto Prompts Limits Occlusion Detection settings and many miscellaneous properties can be customized within the PharmGuard Toolbox 2 software These properties define the limits imposed by a pump and the general operational behavior of a pump The following is a list of user configurable settings that are available Each of these settings is customizable for each profile that is defined General Options General Options are optional settings that affect all infusions initiated in the defined profile Defines if 1 mL syringe support is enabled You can select from two values Enabled or Disabled Defines the loudness level of a pump s alarm You can select from five levels Level 1 Level 2 Level 3 Level 4 or Level 5 Level 1 is the softest Level 5 the loudest The alarm cannot be disabled or completely silenced ImL Syringe Support Alarm Loudness Defines the number of minutes until the User Callback alarm will sound Alarm Silence Time is a
167. section contains a table of the general system alarms listed alphabetically which may be encoun tered while operating the Medfusion Model 4000 pump This table identifies the alarm by message and type and provides a definition and possible remedies WARNING If a system failure alarm occurs and can not be cleared by powering the pump down then back up the pump cannot be used Remove it from use and Medfusion Model 4000 pump Operator s Manual send it to a trained biomedical technician for service Alarm Message Calculated Rate Out of Range Priority High Remedy Based on the values entered the pump has calculated a rate that is not valid and cannot be delivered based on physical limits such as syringe parameters Press D Verify that all infusion parameters have been entered correctly If the invalid combination is part of a Drug Program contact your PharmGuard Toolbox 2 Administrator who will have to review and correct the problem Check Clutch Plunger Lever Check Syringe Barrel Clamp High Medium The pump has sensed that the plunger driver is not moving correctly This may be caused by a variety of issues such as the Prime function was not used before starting delivery leaving slack in the drive system the plunger levers are moved the clutch is not properly engaged or there is a problem with the pump hardware Press and check the plunger lever and ensure the lever moves freely and is capturi
168. should test the pump at least yearly to ensure continued safe opera tion e This testing should be performed at least yearly or whenever the pump has been damaged or dropped e The occlusion and other sensors must be checked yearly e Refer to the Technical Service Manual for specific details The PharmGuard Toolbox 2 User s Manual provided with the PharmGuard Toolbox 2 software provides information on customizing the settings and features of the pump which in turn affect the use and opera tion of the pump on a daily basis The Medfusion Model 4000 Series Technical Service Manual part number 67 2452 51 provides technical information on this pump including e Functional Descriptions e Calibration e Theory of Operation e Service Parts e Diagnosis and Testing Contact Smiths Medical for availability Including replacement battery packs and power cords Using Smiths Medical USA service assistance Use the following steps to make use of Smiths Medical USA service assistance 1 Contact the Smiths Medical Service Department USA at one of the following telephone numbers Toll free in the U S 1 800 258 5361 Outside the U S 1 214 618 0218 When calling any of these numbers please have the following ready Model name number of pump Pump serial number Purchase date if pump is within warranty period Description of problem in as much detail as possible The service representat
169. sider the line occluded You can select from four limits Very Low Approx 4 psi 206 9 mmHg Low Approx 8 psi 413 7 mmHg Normal Approx 12 psi 620 6 mmHg and High Approx 16 psi 827 4 mmHg For 1 mL syringes the occlusion limit is fixed at Very High Approx 50 psi and cannot be changed Defines the passcode that must be entered to access a profile when program ming an infusion Profile Passcodes can be any numeric code in the range of 1000 to 9999 To disable a Profile Passcode simply delete the contents of this property Defines if the pump will display the delivered Program Dose or the delivered Program Volume You can select from two values Volume or Dose Defines the passcode that must be entered at a pump to unlock its interface Unlock Passcodes can be any numeric code in the range 0 to 9999 To disable the Unlock Passcode simply delete the contents of this property Program Options are optional settings that affect the current infusion initiated in the defined profile While individual options can be enabled for a profile they can also be disabled in individual drug programs within that profile Settings in drug programs take priority over those of the profile Bolus Dose Delayed Start KVO Loading Dose Override Alarm Loudness 136 Defines if a pump user will be able to enter a Bolus Dose during infusion setup Defines if a pump user will be able to enter a Delayed Start time during infu sion setu
170. ssing lt when Main Menu is pressed to return to the main menu or by setting standby to zero If this is a new infusion prior to connecting to the patient press lt lt to initiate the priming sequence page 59 76 Enable Disable Standby The Standby option can be enabled disabled through custom configuration us ing PharmGuard Toolbox 2 Medfusion Model 4000 pump Operator s Manual 6 When the counter reaches zero the pump sounds an alarm reminding you to begin the infusion WARNING Confirm All Settings Before starting any delivery always confirm the accuracy of all infusion values to the original order Programming the pump at a delivery rate other than that pre scribed will cause inappropriate delivery which can result in serious injury or death IZ Medfusion Model 4000 pump Operator s Manual Delayed start Delayed Start is an Option that allows the pump to remain at the BEGIN INFUSION screen without the User Callback alarm sounding for the specified period then automatically starts the infusion at the end of the Delayed Start period Programming delayed start 1 When the pump is paused at the BEGIN INFUSION screen press Options 2 Use the number keys to choose DELAYED START Set the Delayed Start time in hours amp minutes The maximum delayed start setting is 6 hours The default delayed start time is 1 00 Hr When Delayed Start is correct press Enter to
171. structed on page 34 6 Confirm the settings and start the infusion or use the four menu keys shown at right to modify the settings Prior to connecting to the patient press lt lt to initiate the priming sequence page 59 If desired program a Bolus Dose Loading Dose or Volume Limit see Options page 61 WARNING Confirm All Settings Before starting any delivery always confirm the accuracy of all infusion values to the original order Programming the pump at a delivery rate other than that pre scribed will cause inappropriate delivery which can result in serious injury or death 9 When all delivery settings are confirmed as correct press lt to begin infusion Medfusion Model 4000 pump Operator s Manual Main Menu returns to the Main Menu Chg Dose allows modifying the set dosage without starting from scratch Options allows selection from a list of variables e g bolus volume limit etc Clear Totals clears total volume delivered and PVD or PDD 41 Medfusion Model 4000 pump Operator s Manual Dose Day The Dose Day mode may be available on a pump Program Dose Day by setting 42 Drug concentration units i e g mL mg mL mceg mL mMol mL mEq mL or Units mL Drug concentration Drug delivery units e g g mg mcg ng mMol mEq or Units Dose rate Use the number keys to select the medication concentration units The actual units available o
172. syringe dimensional variation Syringe Near Empty alarm The SYRINGE NEAR Empty alarm is a Medium or Low priority alarm that occurs indicating that the syringe will reach empty in the Near Empty Time interval The Near Empty Time interval ranges from 1 240 minutes This time interval may be set via the Near Empty Time PharmGuard Toolbox 2 setting as well as the alarm priority Low or Medium Note If the Near Empty Time is greater than or equal to the infusion time the SYRINGE NEAR EMPTY alarm will sound as soon as the infusion is started The pump sounds the respective priority alarm tone displays the near empty alarm message on screen but does not stop delivery Pressing a when this alarm is active silences the alarm The Syringe Near Empty alarm occurs only once if the infusion is allowed to continue until it stops due to an End of Infusion Syringe Empty or some other alarm Press O to clear the alarm message Confirm how long before the infusion ends If necessary prepare a new syringe to load onto the pump and then start a new infusion Syringe Volume Near Empty alarm The Syringe Volume Near Empty alarm is a Medium priority alarm indicating that the syringe has reached the syringe position Volume Empty Due to syringe 101 Medfusion Model 4000 pump Operator s Manual variation there may still be a residual volume of medi cation in the sy
173. t Clovidien 3 6 12 20 35 and 60 mL Luer lock 1mL Tuberculin Terumo Terumo 3 5 10 20 30 and 60mL Luer Lock Medical 1mL Tuberculin BB Omnifix B Braun 5 10 20 and 50 mL Luer Lock BB Perfusor B Braun 20 and 50 mL Luer Lock The critical volume maximum which could be infused in the event of a single point failure is 1 100th of the syringe size by volume PharmGuard Supported Syringes PSS Series 2 In order to offer customers a wide range of available sy ringe manufacturers and sizes Smiths Medical has avail able PharmGuard Supported Syringes PSS Series 2 in addition to the Medfusion Standard Syringes Refer to www smiths medical com or call Customer Service for more information about available PharmGuard Supported Syringes PSS Series 2 The PharmGuard Supported Syringes PSS Series 2 can only be imported into the PharmGuard Toolbox 2 These additional syringe models can be sent to a pump as available syringes for the downloadable Configurations Information regarding syringe flow rate and minimum volume for these syringes can be found in the product literature supplied with the PSS Series 2 130 Medfusion Model 4000 pump Operator s Manual Flow rate amp minimum volume by manufacturer amp size Standard syringes For flow rate and minimum volume information regard ing syringes available in the PharmGuard Supported
174. tal mounting see previous page Install the 4 washers and pan head screws to mount the L bracket to the clamp Tighten them to at least 10 in lb 1 1 Nm torque Use the small flathead screws and star lock washers to attach the poleclamp to the bottom of the pump Tighten them to at least 10 in lb 1 1 Nm torque 115 Medfusion Model 4000 pump Operator s Manual EMC information for the Medfusion Model 4000 pump Electromagnetic Compliance EMC precautions are necessary when dealing with the Medfusion Model 4000 pumps Accessible pins of connectors identified with the ESD warning symbol near them should not be touched with the fingers or hand held tool unless proper precautionary measures are followed These measures include 1 Discharging one s body to earth or to a large metal object 2 Bonding oneself by means of an ESD wrist strap to earth It is recommended that all staff including clinical and biomedical staff receive training in the meaning of the ESD warning symbol and on the above precautionary measures This training should also include an introduction to the physics of electrostatic discharge the volt age levels that can occur in normal practice and the damage that can be done to electronic components if they are touched by an operator who is electrostati cally charged Further an explanation should be given of the methods to prevent build up of electrostatic charge a
175. tate ip ucsesscavessesscais n anria ER 11 Connected to Toolb kssnir a 11 Network Configuration sesssissrcsn esns 11 Attaching the Pump to the Network cscs 11 Network stats sieniin a E S 11 Pump Customization and General Programming 12 Custom Co figurati iisiss nanni 12 General Programming a ississssscsassnvsessvenvssandonsescraurscosssnsnisunias 14 Exceeding TMS iicssistsitiearsceiern a EE 14 How pump settings and limits are prioritized 14 User defined pump Configurations 00 0 15 What are Co OMSL ONASE ss sscasesasiinnssanscscvansdniauessedbsnsion 15 When are Drug Programs used s sseesessererserereeeeree 15 Who can use these Drug Programs uss is 15 Types of programmable Library Categories 15 Using a Custom Configuration sss eessssssrsssesssssteerseserreseee 16 Using Q ick LIDrATiESsnn pnie n a 17 PharmGuard Safety Software Dose Protocol PrOLCCUIOM ssssissscisisssssscssstsescsasssssesese sosssssssevssesesnsessssesess 19 RS ONS iiss E A RE 19 Hard MitSssesecarmanenmenananre moaia 19 Adjusted limits im EVES Eariri 20 Overridden limits in reverse sseeesesessesrersrerreesres 20 Invalid infusion parameter combination 20 PharmGuard Supported Syringes PSS Series 2 21 Navigating the pump MENUS vi sisacissasisedsceenressnsnensosanessencics 22 The Workflow PrOCESS ssisissississsassiesssiieisaiesrt osise 22 Guidelines for enhanced pump performance 24 Alw
176. ter the initial setup but before pressing J to start the infusion or in some cases after the infusion is started Because the pump has multiple customizable fea tures actual Drug Programs and manual infusion may have other delivery options and confirmation screens included that are not shown in the diagram These additional options and screens are dependent on the custom Configuration created in PharmGuard Toolbox 2 Medfusion Model 4000 pump Operator s Manual Program Options Deliver Start gij v __ Change conem Rate Dose Syringe Continue NO Continue YES l l l i Loading l Dose __ Program Options l l l l KEY Power Off Required Workflow a Function Dependent Required The Workflow Process 23 Medfusion Model 4000 pump Operator s Manual Guidelines for enhanced pump performance The following are guidelines for enhanced syringe pump performance Review occlusion time and flow delivery graphs starting on page 92 Use appropri ate syringe size tubing and inline devices for expedit ing delivery of medication or fluid Certain factors enhance syringe pump performance where perfor mance is defined as a Time to Detect Occlusion b Continuity of Flow c Startup Time Always use the smallest syringe for volume of fluid being delivered WARNING Use the smallest syringe size necessary to deliver the fluid or medication Using a large syringe
177. the startup process and manipulating the pump dur ing this process may cause it to detect false sensor failures resulting in alarms 26 Medfusion Model 4000 pump Operator s Manual Turning the pump off The pump can be turned off at any time in any deliv ery mode while the pump is running Note If there are any alarms sounding you must first silence the alarm by pressing O before the pump can be turned off With the pump infusing 1 Press and hold PRIME BOLUS eo om X E mF o OS The PREss POWER AGAIN TO SHUTDOWN screen appears Infusion has not stopped at this point If is not pressed again power off is cancelled after 6 minutes 2 Press and hold again to turn the pump off To cancel press Continue or cS Infusion stops when the pump is turned off With the pump stopped 1 Press and hold The pump turns off Note If there are any Configuration or software updates waiting to be installed in the pump the UPDATE S AVAILABLE message is displayed when you attempt to turn the pump off See page 110 27 Medfusion Model 4000 pump Operator s Manual Selecting a Delivery Mode and Programming an infusion Due to the customization capabilities of the Medfusion Model 4000 pump the screen shown once power up is complete depends entirely on what if any customization was performed Typically a Custom Configuration will have been cre ated using PharmG
178. then the drug program category GEN PEDs A D opens Custom drug programs are displayed on the Drug Program screen To use a drug program use the number keys to select the desired drug program see page 32 for a full explanation of this screen For example if entry 2 is selected the preset infusion parameters for ABELCET 2 MG ML is chosen You are next prompted to load a syringe then confirm amp accept each level of settings by pressing Enter Some data fields may require data input prior to proceeding e g Patient Weight WARNING Confirm All Settings Before starting any delivery always confirm the accuracy of all infusion values to the original order Programming the pump at a delivery rate other than that pre scribed will cause inappropriate delivery which can result in serious injury or death 5 When all settings are confirmed the Begin Infusion screen is displayed Use the Prime feature then press lt to begin the infusion Using Quick Libraries Smiths Medical ships the infusion pump with Medfusion Standard Configuration that does not include a Quick Library The profiles categories and custom drug programs available on a pump depend on the configuration set up by the person responsible for custom configura tion Quick Libraries is an option that can be set up in custom configuration This option designates a cat egory in a profile as a Quick Library A profile with quick library
179. tion 3 Radiated radio frequency electromagnetic fields immunity test Basic EMC Publication EN 61000 4 4 2004 Electromagnetic Compatibility EMC Part 4 Testing and measurement techniques Section 4 Electrical fast transients bursts immunity test Basic EMC Publication EN 61000 4 5 2006 Electromagnetic Compatibility EMC Part 4 Testing and measurement techniques Section 5 Surge immunity test Basic EMC Publication EN 61000 4 6 2007 Electromagnetic Compatibility EMC Part 4 Testing and measurement techniques Section 6 Immunity to conducted disturbances induced by radio frequency fields Basic EMC Publication EN 61000 4 8 1993 Electromagnetic Compatibility EMC Part 4 Testing and measurement techniques Section 8 Power frequency magnetic field immunity test Amendement 2001 EN 61000 4 11 2004 Electromagnetic compatibility EMC Part 4 Testing and measuring techniques Section 11 Voltage dips short interruptions and voltage variations immunity tests EN 45502 1 1997 Active implantable medical devices Part 1 General requirements for safety mark ing and information to be provided by the manufacturer Section 27 1 only EN 45502 2 1 2003 Active implantable medical devices Part 2 1 Particular requirements for active implantable medical devices intended to treat bradyarrhythmia cardiac pacemak ers Section 27 8 only EN 55011 2007 Industrial scientific and medical ISM radio frequency equipment Radi
180. tion diluted with water Mild detergent mixed with water Isopropyl alcohol 70 solution For best results clean by spraying cleanser directly onto a soft cloth and then wiping surfaces dry 141 Medfusion Model 4000 pump Operator s Manual Maintenance amp service This chapter includes information relating to both standard maintenance and service WARNINGS e Pump Maintenance To avoid electric shock only trained biomedical service personnel may service this pump Service personnel should disconnect the AC power cord before servicing the pump e Shock Hazard The only means of removing AC power is to disconnect the AC power cord While the AC power cord is attached to the pump and plugged into an AC outlet live main voltage is present within the pump e Manufacturer Recommended Maintenance Always maintain this pump following manufac turer recommended instructions in the Service Manual Improperly maintained pumps may cause either under infusion or over infusion to patient e Never Open the Pump Case To avoid electric shock users should never open the pump case or battery compartment for any reason Service personnel should always disconnect the AC power cord before servicing the pump e Dropped or Damaged Pumps Never use a dropped or obviously damaged pump Withdraw it from service until a trained biomedical technician can test it 142 Periodic maintenance Trained biomedical service personnel
181. to supply the passcode before the front panel will unlock 98 Medfusion Model 4000 pump Operator s Manual Alarms amp remedies The Medfusion Model 4000 pump has numerous alarms built into it These are triggered by situations as a means of warning or advising you something is not functioning within normal parameters Pump alarms are logged into the pump s Alarm History viewable in the BIOMED menu and may be included in various reports via PharmGuard Toolbox 2 and or the PharmGuard Server Alarms alerts types Below is a table of the alarms and alerts generated by the pump including definitions and remedies Type Definition and Remedy System Fault priority A System Fault alarm is initiated when one of the system fault conditions occur Fluid delivery stops System Fault alarms are signaled with a flashing red indicator repeating audible signal and a viewing screen backlight that oscillates between bright and dim the pump will return to the MAIN menu and show the BlomED menu as the only choice Press O to silence the audible alarm then press to turn the pump off There is no other method for ending a System Fault alarm If the alarm persists when the pump is turned back on or if the MAIN menu shows only the BIOMED menu the pump must be removed from service for inspection and repair by a trained biomedical technician If the front panel controls are locked when a System Fault alarm occurs the pump c
182. tom configuration Maximum amp minimum time is calculated from the maximum amp minimum rate for the syringe size currently in use or maximum and minimum can be set using PharmGuard Toolbox 2 Using PharmGuard Toolbox 2 it is possible to restrict loading time to minutes only If that is the case the screen will look like this Using PharmGuard Toolbox 2 it is also possible to expand loading time to up to 12 hours If that is the case the screen will look like this After the loading dose is set and accepted the pump pauses The Loading Dose setting now appears on the BEGIN INFUSION screen If this is a new infusion prior to connecting to the patient press lt lt to initiate the priming sequence page 59 WARNING Confirm All Settings Before starting any delivery always confirm the accuracy of all infusion values to the original order Programming the pump at a delivery rate other than that pre scribed will cause inappropriate delivery which can result in serious injury or death 68 Medfusion Model 4000 pump Operator s Manual Delivering a loading dose PRIME BOLUS 1 When ready press lt Q o 2 The BEGIN LOADING Dost screen appears Depending on which mode the pump is delivering in the screen is slightly different To begin delivering the loading dose press Yes OR e Press No to skip the loading dose and return to the NORMAL DELIVERY Screen OR e Press Chg Dose to c
183. tops and the pump alarms Press O to silence the alarm then press Main Menu 91 Medfusion Model 4000 pump Operator s Manual Time to occlusion The time for the pump to detect an occlusion is af fected by three factors 1 Occlusion Pressure Setting High H Normal N Low L or Very Low VL 2 Flow Rate Setting 3 Syringe amp Tubing Compliance i e softness of syringe plunger tip or tubing Reference the Specifications section of this manual page 124 for typical time to occlusions values See guidelines for pump performance on time to occlu sion At lower rates smaller syringes have shorter occlusion times which is why the smallest available syringe for the volume to be delivered should always be used Occlusion trend graph during delivery The pump automatically monitors occlusion or syringe backpressure during any infusion This trend appears in a bar graph on the right side of the display during delivery The letter at the top of the graph indicates the configured occlusion alarm level Relative Pressure Meaning VH Very High fixed for 50 psi 345 kPa 1 mL syringes H High 16 psi 110 kPa N Normal 12 psi 83 kPa L Low 8 psi 55 kPa VL Very Low 4 psi 28 kPa The pressure graph is scaled between 0 psi at the bot tom and the Occlusion setting pressure at the top The occlusion limit can be set from Very Low to High for syringes with a volume greater
184. ts Press the number keys to set medication concentration Concentration is limited to 4 digits Press Clear to clear an entry Press Backspace to erase a character Press Enter to accept the setting Use the number keys to set the delivery units The actual units available on a pump depends on the custom setup If only one delivery unit is available for the concentration units selected this screen will not appear Press Enter to accept the delivery units Press the number keys to set the patient s weight in kilograms or surface area in square meters Weight surface area are limited to the indicated range which may have been customized Press Enter to accept the patient weight surface area setting 46 e Volume limit KVO loading dose or bolus dose may also be programmed these options are only available if they have been enabled in the custom program using PharmGuard Toolbox 2 The pump calculates the correct flow rate in mL hr to achieve the required drug dose To program a body weight surface area infusion at the selection menu choose either DosE KG MIN DOSE M2 M1n DosE KG HR DOSE M HR or DosE KG Day DosE M Day or choose a drug program that uses the body weight surface area mode infusion type Choose the syringe model and size and load the syringe as in structed on page 34 Medfusion Model 4000 pump Operator s Manual The pump may be customized with an additional patient weight body s
185. tting in the Configuration If you cannot clear the occlusion alarm there may be a problem with the pump that requires repair by a trained biomedical technician Outside Range Limit Silence Alarm to Continue Medium The entered rate is outside of the Drug Program soft limits Press O to continue You may then choose to override the range limit or change the value entered Periodic Callback Silence Alarm to Continue Pressure Increasing Check Infusion Line Medium Medium Press User programmed callback alarm no remedy required Press FlowSentry detects increasing pressure in the infusion line Check infusion line for blockage for example check the infusion set for closed stopcocks clamps check the tubing for kinks verify the patency of the tubing and the IV site etc Clear or remedy any discovered occlu sion If occlusion is not cleared the Occlusion alarm will result Profile Does Not Match Last Settings Profile Limit The user attempted to use the Recall Last Settings feature Recall Last Settings only works if the pump is in the same profile under which the previous infusion was programmed Pump is Locked Limit The keypad has been locked to prevent changes during infusion The alarm is initiated by pressing any key except Unlock Press Unlock to make changes to delivery settings Rate Below Recommended Min for Syringe Size Limit Reminds you that the
186. uard Toolbox 2 and have been sent to the pump If a Configuration with Profiles was sent to the pump the pump will stop at the SELECT THE PROFILE MAIN menu If no Custom Configuration was sent to the pump the pump will stop at the Medfusion Standard Configuration MAIN menu If the Custom Configuration sent to the pump consists of only one profile containing a Quick library the pump stops at the Quick library menu The graphic on the following page shows the general steps required to program and start an infusion Specific instruction for programming the various settings delivery modes and options follows 28 Medfusion Model 4000 pump Operator s Manual General Infusion Programming Procedure Load desired syringe may also be done when it comes up in the programming process Custom Configuration Medfusion Standard Configuration Select a Profile Select a Category or manual delivery mode Select a Drug Program Select a manual delivery mode Select a Syringe Model Size an If not done previously load desired syringe Verify model and size Program required infusion parameters as they appear in programming process If desired and if available program desired Options Prime infusion set and pump Start infusion Medfusion Model 4000 pump Operator s Manual Selecting an Infusion Following are the steps for selecting an infusion type for programming an infusion The
187. uirements ETSI EN 301 489 17 V1 2 1 ElectroMagnetic Compatibility and Radio Spectrum Matters ERM 2002 ElectroMagnetic Compatibility EMC Standard for Radio Equipment and Services Part 17 Specific Conditions for 2 4 GHz Wideband Transmission Systems and 5 GHz High Performance RLAN Equipment 118 Medfusion Model 4000 pump Operator s Manual Miscellaneous Standards Reference Year Title IEC 60320 1 2007 Appliance couplers for household and similar general purposes Part 1 General requirements IEC 60320 1 2001 Amendment 1 2007 IEC 60529 2001 Degrees of Protection Provided by Enclosures IP Code IEC 60878 2003 Graphical Symbols for electrical equipment in medical practice EN 980 2008 Graphical Symbols for Use in the Labeling of Medical Devices EN 1041 2008 Information Supplied by the Manufacturer with Medical Devices EN ISO 10993 1 2003 Biological Evaluation of Medical Devices Part 1 Evaluation and Testing ASTM D999 08 Method for Vibration Testing of Shipping Containers ASTM D4169 08 Performance Testing of Shipping Containers and Systems ASTM D4332 01 2006 Conditioning Containers Packages or Packaging Components for Testing ASTM D4728 06 Standard Test Method for Random Vibration Testing of Shipping Container ASTM F2097 08 Standard Guide for Design and Evaluation of Primary Packaging for Medical Products ASTM 5264 98 2004 Standard Practice for Abrasion Resistance of Printed Materials by the Suther
188. urface area confirmation screen If so re enter the patient weight body surface area then press Enter to accept the setting At the Dose RATE screen press the number keys to set the dose Range limits are determined by installed syringe size and or the custom setup in the Configuration When the setting is correct press Enter to accept the dose If desired and if they are enabled program a Bolus Dose Loading Dose or Volume Limit see Options page 61 At the BEGIN INFUSION screen all values are set and the pump pauses the pump may be configured with additional confirmation screens requiring you to confirm all settings twice before beginning the infusion Prior to connecting to the patient press lt lt to initiate the priming sequence page 59 Confirm the settings and start the infusion or use the four menu keys shown at right to modify the settings WARNING Confirm All Settings Before starting Mala Menu returnsto the Man Meu any delivery always confirm the accuracy of all Chg Dose allows modifying the set dosage without infusion values to the original order Programming starting from scratch the pump at a delivery rate other than that pre Options allows selection from a list of variables e g bolus volume limit etc scribed will cause inappropriate delivery which can Clear Totals clears total volume delivered and PVD or result in serious injury or death PDD 10 When all delivery settings
189. us e Incritical care anesthesia neonatal and pediatric applications or other healthcare settings where the use of the syringe infusion pump can be moni tored or supervised by a clinician e Inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1 5 Tesla WARNINGS Before using any Medfusion Model 4000 pump users must be thoroughly familiar with the contents of this Operators Manual including all warnings cau tions and instructions for use e The user should ensure that the performance offered by the pump is fit for the intended use and that the pump is not used in any way or for any purpose other than its intended purpose e This pump is not to be used in any intra articular space infusion e This syringe infusion pump is intended for use only under the direction of trained medical professionals o If the pump is used to deliver life sustaining medi cations an additional pump must be available for situations where an interruption in infusion could be dangerous e The pump must be positioned in an MR environ ment such that it is secured to a non moveable object and the magnetic fringe field does not exceed 150 gauss Exposing the Medfusion Model 4000 pump to magnetic fields that exceed 150 gauss presents a risk of becoming a projectile hazard and can lead to possible patient injury or death Irreversible damage to the pump can also occur rendering it inoperab
190. usion Prior to connecting to the patient press lt lt to initiate the priming sequence page 59 48 The pump calculates the correct flow rate in mL hr to achieve the required drug dose To program a vol ume weight infusion at the selection menu choose either ML KG MIN or ML KG Hr or choose a drug program that uses the volume weight mode infusion type Choose the syringe model and size and load the syringe as instructed on page 34 6 Confirm the settings and start the infusion or use the four menu keys shown at right to modify the settings WARNING Confirm All Settings Before starting any delivery always confirm the accuracy of all infusion values to the original order Programming the pump at a delivery rate other than that pre scribed will cause inappropriate delivery which can result in serious injury or death 7 When all delivery settings are confirmed as correct press lt to begin infusion Medfusion Model 4000 pump Operator s Manual Main Menu returns to the Main Menu Chg Dose allows modifying the set dosage without starting from scratch Options allows selection from a list of variables e g bolus volume limit etc Clear Totals clears total volume delivered and PVD or PDD 49 Medfusion Model 4000 pump Operator s Manual Dose kg time dose m2 time The body weight surface area infusion delivery mode will only be available on your pump through custom
191. varia tions in syringe manufacturing the Monoject 1 3 12 and 35 mL syringes may in some cases not fully empty Here the empty alarm sounds with some fluid left in the syringe System Advisory Maintenance is Recommended If your organization has set up a preventive mainte nance policy for the Medfusion Model 4000 pump and programmed a preventive maintenance reminder in the BIOMED menu a special alert is added When it is time for a preventive maintenance inspection each time the pump is turned on SYSTEM ADVISORY MAINTENANCE IS RECOMMENDED appears at the top of the MAIN MENU Press O to silence the audible alarm and send to pump for maintenance as soon as practical This alert will recur each time the pump is powered up until a trained biomedical service techni cian has reset it System Failures System Failure alarms may indicate a problem with pump hardware or software Occasionally turning the pump off then back on will clear the fault see the pages that follow for specific information If the alarm persists when the pump is turned back on the pump must be removed from use and checked by a trained biomedical service technician If the pump experiences certain system faults a screen requiring entry of a Biomed Passcode will appear If this screen appears immediately remove pump from service for inspection repair by a trained biomedical service technician General system alarms amp alerts This
192. wn here Press any number key to select the desired profile If a mistake is made press to return to the SELECT THE PROFILE screen If the desired profile is not displayed press More to display the next page of profiles Either a Selecta profile by pressing its number and continue the programming process OR b Press Beginning to return to the first page of the SELECT THE PROFILE screen If required enter the profile passcode then press Enter 3 Medfusion Model 4000 pump Operator s Manual Select a Category 4 Once inside a profile select a category by pressing its number If a category cannot be found press CHG Profile to return to the SELECT THE PROFILE menu Each Profile can have a maximum of 8 Categories with up to 36 Drug Programs each resulting in a maximum of 288 entries per Profile The actual number of drug programs is dependent on the content of each drug program and on the amount of available pump memory Quick Library a Ifthe Profile selected includes a Quick Library the Quick Library s drug program selection screen displays Select a drug program by pressing its number If Quick Library drug programs are not desired press Main Menu to exit the Quick library and display the category choices for further drug program selections Item 4 above applies to Quick Library as well The far left softkey can be pressed to access the Quick Library The key will reflect t

Medfusion® Model 4000 pumpOperator`s Manual

Contents

Download Pdf Manuals

Related Search

Related Contents

Medfusion&reg; Model 4000 pumpOperator`s Manual

Contents

Download Pdf Manuals

Related Search

Related Contents

Medfusion® Model 4000 pumpOperator`s Manual