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MRidium OPERATION MANUAL

1. 4 7 7 Radio Channel menu Press the Channel soft key to highlight the desired channel Both Remote and Pump must be set to the same channel 4 17 UR ME 06 11 55 Radio Channel MENU gt KVO Rate gt 3Channel 1 gt Occlusion Limit gt Channel 2 gt Lock Keys gt Channel 3 gt gt Channel 4 KH Set Comm Channel gt Channel 5 gt NEXT MENU gt Channel 6 Next Menu Options Radio Channel Menu Figure 4 10 Set Comm Channel Displays 4 7 8 Exiting the Special Features Menu To exit the Special Features Menu press the MENU or CANCEL control key The pump will return to the Primary Pump Setup screen where setup of the Primary Pump may be performed 4 8 Air Bubble Detection and Reset The pump has an air bubble detector that will detect air bubbles that are greater than 100 uL which pass in front of it When this happens the infusion will stop and the pump will alarm Once the condition has been corrected the infusion cycle must be manually restarted 4 9 Data Retention The pump program settings and option selections are retained in non volatile memory If the pump has been turned off for longer than one 1 hour delivery settings are cleared The History Log data which stores a comprehensive range of the pumps operational information is retained indefinitely on a FIFO First In First Out basis The History Log holds approximately 3 000 to 5 000 entries and alarms It can be downloaded from the Pump into a comput
2. Immediately respond to a Close Door alarm due to imminent lapse in infusion therapy Immediately respond to the Check Door alarm as this indicates possible Free Flow of IV Fluids Dropping or a severe shock to the pump could result in damage and resultant pump inaccuracy Refer the pump to qualified service personnel for proper checkout if either of these conditions occur Do not place the pump into use if it fails any of the Power On Self Tests Always verify flow rate VTBI Volume to be Infused and or dose drug entries before starting infusion When opening the door always check that the free flow preventer black slide clamp is fully pulled outward to the shut off position If questionable Pump operation is observed or if a System Failure occurs 1 e an unexplained continuous audible alarm with no displayed values discontinue use of the Pump and refer it to qualified service personnel Although unlikely failure of certain rugged mechanical components such as the free flow prevention mechanism could cause fluid delivery limited to the contents of the fluid container The maximum volume that may be infused under a single fault condition is 0 1 mL Single fault failure of any electronic or motor control component would result in less than 0 3 mL of unexpected fluid delivery A small amount of fluid is expelled from the set less than 0 05 mL under worse case conditions when the mechanical drive advances to Index
3. STEP3 SLIDE THE TOP WEIGHT ON THE POST AND REST IT ON BASE ASSEMBLY STEP4 ATTACH THE BOTTOM WEIGHT TO THE TOP WEIGHT USING 5X FLAT HEAD SCREWS P E Frisia DEER Abies Z PRIVATE AND CONFIDENTIAL o DISCRFION IRADIMED CUSTOMER MANUAL STEP 3 amp 4 DRAWN 8 FO pate MAR 19 210 DRAWING NO CHECKED M DATE 100319 F01 THIS PRINT IS PROPERTY OF AMICO ACCESSORIES AND IS LOANED IN CONFIDENCE SUBJECT TO RETURN Far WO UPON REQUEST AND WITH THE UNDERSTANDING THAT NO COPIES ARE TO BE MADE WITHOUT THE CONSENT OF AMICO ACCESSORIES ALL RIGHTS TO DESIGN OR INVENTION ARE RESERVED Y 9 H 9 NOTE TIGHTEN THE BOLT UNTIL THE STICKER DISSAPEARS UNDER THE WEIGHT LARGE WASHER BOLT STEP5 SECURE THE POST ASSEMBLY TO THE WEIGHT ASSEMBLY USING THE LARGE AND SMALL WASHER AND THE BOLT IN THE SEQUENCE SHOWN IN THE ASSEMBLY l SMALL WASHER TOP POST ASSEMBLY BOITOM ASSEMBLY im mi i A Ze me STEP5 SLIDE THE TOP POST ASSEMBLY p ONTO THE CONNECTOR OF THE BOTTOM ASSEMBLY AND LOCK THE PIECES TOGETHER USING THE HOLE PLUNGER MECHANISM NOTE PUSH THE PLUNGER PIN WITH vir E ur E a Kai r zr EB ire Tre une E qe ATTE ILL Erbe cr dn iis A TOOL PLUNGER PIN _ ES ENSURE TIP OF PLUNGER E IS PROTRUDING FROM E THE POST E 85 Fulton Way Richmond HL Ondare LAE 2N4 CANADA Tal 205 743 777B AMIC Fox 905 763 8587
4. DESCRIFRON IRADIMED CUSTOMER MANUAL THIS PRINT IS PROPERTY OF AMICO ACCESSORIES AND IS LOANED IN CONFIDENCE SUBJECT TO RETURN FART NO UPON REQUEST AND WITH THE UNDERSTANDING THAT NO COPIES ARE TO BE MADE WITHOUT THE CONSENT OF AMICO ACCESSORIES SCALE NIS DRAWK Ar FO part MAR 9 210 Date DRAWING HO 100319 FOl CHECKED ET ALL RIGHTS TO DESIGN OR INVENTION ARE RESERVED NOTES
5. performance is observed additional measures may be necessary such as re orienting or relocating the MRidium 3850 System d Over the frequency range 150 kHz to 80 MHz field strengths should be less than V 1 V m MRIdium 3850 System Table 205 Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM for LIFE SUPPORTING EQUIPMENT and SYSTEMS Recommended separation distances between portable and mobile RF communications equipment and the MRidium 3350 System The MRidium 3850 System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the MRidium 3850 System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the MRidium 3850 System as recommended below according to the maximum output power of the communications equipment Rated Separation distance according to frequency of transmitter maximum m output power 150 kHz to 80 MHz 150 kHz to 80 MHz in 80 MHz to 800 MHz 800 MHz to 2 5 GHz of transmitter outside ISM bands ISM bands W d 1 17VP d 1 2VP d 1 2VP d 2 33VP For transmitters rated at a maximum output power 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 pow
6. 1 10 PSI 6 9 to 68 8 kPa Occlusion is detected by building of pressure in the I V Line downstream of the pump NOTE If the alarm recurs without apparent cause the Occlusion Pressure Limit may be set too low Readjust Occlusion Pressure Limit accordingly Ensure that occlusion pressures chosen are clinically appropriate Perform the following to adjust the Occlusion Pressure Limit a Press the MENU control key b Press the OCCLUSION LIMIT soft key Use the up and down arrow control keys to adjust limit between 1 10 PSI 6 9 to 68 8 kPa d Press ENTER 4 16 e Press the CANCEL control key to return to the main programming screen NOTE Dual Channel Operation The KVO Rate and the Occlusion Limit apply to both Channel A and Channel B 4 7 5 Lock Keys This feature allows the user to prevent an accidental key activation The Lock Key option will not be displayed unless it has been enabled in the Service Mode Perform the following to activate Key Lock Press the MENU control key Press the LOCK KEYS soft key Verify all keys are locked except Menu a fo go p If any other key is pressed a tone will occur to denote that key 1s locked Perform the following to deactivate Key Lock a Press the MENU control key b Press the UNLOCK KEYS soft key C Verify all keys are now unlocked This feature 1s reserved for service personnel to enable contact Service Biomedical department for activation details of this activat
7. 3 to 2474 5 MHz Irad med Default Avoids 802 11 bands 1 and 2 France 2400 to 2450 MHz with Radio programming selection Service Selectable Number of Channels 85 U S Channels Note A limited frequency mode is available for France Service Selectable A 3 0 to 80 RH non condensing 0 to 95 RH non condensing Primary Volume To Be Infused VTBI Range Occlusion Detection Mechanism Two separate upstream amp downstream semiconductor force sensors Occlusion Pressure Measurement Range 1 to 10 PSI 6 9 to 68 8 kPa with 0 2 PSI resolution Occlusion Pressure Measurement Accuracy lt 2 PSI 13 8 kPa or within 10 of setting whichever is greater Occlusion Detection no flow Time typically lt 30 sec dependent on selected Flow Rate 55 min max mL Hr Occluded I V Line bolus volume 25 mL Hr to 10 0 7 mL max PSI occlusion Air in Line Detection Method Ultrasonic bubble detector Air in Line Detector Threshold s gt 100 uL Liquid Source height limits 100 to 50 cm relative to pump center A 4 Larmor Frequencies 8 4 through 128 MHz Magnetic Field Limit Same as Pump 10 000 Gauss 1 Tesla magnetic field line Minimal ferrous material used inside unit non magnetic ultrasonic motor used inside SideCar Unit 3855 REMOTE DISPLAY CONTROL UNIT 0 to 80 RH non condensing 0 to 95 RH non condensing Power Consumption lt 19 Volt Amperes 120 VAC nominal lt 100 VA maximum during 113
8. 4 35 00 4 46 00 4 57 00 5 08 00 5 19 00 5 30 00 5 41 00 5 52 00 6 03 00 6 14 00 e e e e 3 2 56 00 3 07 00 min sec Figure G 8 Flow Error Flow Error AAMI ID 26 1998 50 102 Data Set Standard Trumpet Curve over T 1 Period 25 mL hr 9 11 13 15 17 19 21 23 25 27 29 31 33 35 Observation Window min Figure G 9 AAMI ID 26 1998 50 102 Data Set Standard Trumpet Curve over T 2 Period 25 mL hr 11 13 15 17 19 21 23 25 27 29 31 33 35 Observation Window min Figure G 10 G 7 Flow Rate ml hr Volume delivered ml AAMI ID 26 1998 50 102 Data Set Flow Rate at TO 999 mL hr 1100 1080 rec oo f rappel pe 1020 ol Hm ANA TL Hm A xo Hap E IT TARA o uU PY NT Val p SA SS RE pp 960 ee A E 3 ll E S E Oo C Y a a WE VE wep WE all A DE el INN WEE c H VEO LO o LO O Q LO ce LO O LO e LO ce ui c LO CH LO O Q c a Inno i IN we ee 2 i 60 El E we ee a A GRO Ge FS MARO M4 O ET po o e eA CO E pa El GJ g qis e q q q a CN e Time Hours Min Figure G 11 AAMI ID 26 1998 50 102 Data Set Volume Delivery 999 mL hr 3000 ho A ql e ce c e e 1500 1000 Figure G 12 Flow Error Flow Error AAMI ID 26 1998 50 102 Data Set Standard Trumpet Curve over T 1 Period 999 mL hr g 11 13 15 17 19 21 23 25 27 29 31 33 35 Observation
9. 4 8 C Press the RATE or VTBI soft key and set the new parameter s using the up and down arrow control keys d Press Enter to accept the new values and return to Secondary display or press the CANCEL soft key to return to the secondary run screen 4 4 0 Stopping a Secondary Infusion and Returning to the Primary Infusion Perform the following to stop a secondary infusion and return to the primary infusion a Press the START STOP Channel control key b Observe that Cancel A or B is displayed as a soft key option e Press Cancel A or B soft key e The pump is on hold and the light is not on d The Primary infusion programming screen will display s To stop flow from the secondary container the clamp on the secondary set must be closed or the set disconnected from the upper injection port e Press START STOP to restart at primary settings 4 4 7 Dual Channel Operation When both channel A and B are running the options for viewing and changing the primary settings when a secondary infusion is running move to the Menu To view or change the primary settings a Select MENU Key b Press Primary A or Primary B Soft Key Verify that Primary A Rate 1s highlighted Use UP or DOWN arrow keys to change if necessary d Press VTBI Soft Key Use UP or DOWN arrow keys to change if necessary Press ENTER to save changes and return o run screen e Press CANCEL to return to split running screen without making changes Lc
10. COUNTERWEIGHT AL ALY 5 KC 11 02 LE CASTER MRI 3 00 LC S HOOK POLYQUI JISC POLYQUIP TREE LABEL MR IV POLE MODEL LOT RAQOO2X1A IRADIMED1 25 DIAM RS POST 32 5 TAP 10 3 5 1 0028 H 2 00 OST S ST 0028 LCI SPLIT SS ST 0028 32 18 X 2 00 LG HHCS 9 ST 0022 2 LO FHSCS SS ST 0015 10 LC FHS 51 0012 40 10 L ATCH ITE QTY I a E H H be Title Histol H 2 1119 Assembly Instruction Rev C 010308 Installation Guide lradimed 1119 MRI Pump Roll Stand Kit The purpose of this guide is to 1 Describe assembly of Roll Stand Post and Base page H 3 2 Describe attachment of IV Bag Hooks to IV Pole page H 3 3 Describe assembly of IV Poles page H 4 General Precautions Federal law in the USA restricts this device to sale by or on the order of a physician For safe operation use only Iradimed Corporation recommended MRI compatible or MRI safe accessories Always secure the IV Pole wheel locks after positioning within the MRI Magnet Room Product damage may occur unless proper care is exercised during unpacking and installation Use only GCX Corporation recommended assemblies and parts Any replacement component must be non magnetic for safe operation Refer all service to Iradimed Corporation or GCX Corporation Authorized Service Representatives A m
11. Channel B SideCar Perform the following to attach the Channel B SideCar a b e Turn 3850 Pump OFF Remove SideCar port protector cap on rear of 3850 Pump Do not discard protector cap Position the Channel B SideCar See Figure 4 5 next to the left side of MRidium 3850 Pump Slide the Channel B SideCar connection port onto the pump press together and tighten two 2 thumb screws on the rear Tighten upper and lower screws a little at a time until secure Do not overtighten the thumbscrews Turn ON pump and verify start up checkout refer to section 4 2 4 6 2 Detaching the Channel B SideCar Perform the following to detach the Channel B S deCar a b Turn 3850 Pump OFF Slide the Channel B SideCar backward to disconnect from main pump after loosening upper and lower thumb screws Re attach SideCar port protector cap on rear of 3850 pump 4 11 4 7 Special Features Menu There are additional features that are accessed by pressing the MENU control key Pressing the MENU control key brings up the Special Feature Setup Menu to provide the operator with the ability to set the Dose Rate Calculation adjust the Alarm Volume set the KVO Rate and adjust the Occlusion Limit Depending on optional accessories 1 e Remote or Channel B user may also lock keyboard set communication channel for Remote Display program Bolus or change view primary infusion from this screen 4H ME 06 11 55 IR ME 06 11 55 MENU
12. Charge LED EZ Latch Door Figure 1 1 Front of Pump 1 1 2 Pump Drive Mechanism See Figure 1 2 for location of the major components of the infusion system pump drive mechanism IV Set Upper Snap in Port Inlet Pressure Sensor Linear Peristaltic Pump Drive Mechanism Outlet Pressure Sensor IV Set Lower Snap in Port with Free Flow Detector Switch Bubble Detector x Figure 1 2 Pump Drive Door Open a Upper and Lower I V Set Snap In Port Provides for a secure mounting of the I V set for infusion b Linear Peristaltic Pump Drive Mechanism Provides for the positive movement of fluids through the infusion line C Bubble Detector Provides for the detection of air bubbles in the infusion line Free Flow Detector Switch Located internally in the pump s lower snap in port the IV Set Free Flow Detector Switch detects when IV set is properly installed and functioning e Inlet and Outlet Pressure Sensors Provide infusion line pressure measurements for pressure monitoring and alarms NOTE After attachment of the 3851 Sidecar module Refer to Section 4 6 the operation of Channel B Sidecar M pump drive mechanism is identical to the main pump drive The only difference 1s that the Channel B door opens to the left side which is opposite that of the main pump door 1 3 1 1 3 Back of the Pump See Figure 1 3 Figure 1 4 for the location of the major components on the back of the p
13. E 06 11 55 am EE 06 11 55 Primary A Bolus A 222 gt Rate 1 0 ze 191 0 E gt VTBI 2 VI Split Screen Display Separate Screen Display Figure 4 4 Bolus Setup Displays 4 9 4 5 Bolus Delivery The Bolus feature is used to deliver a bolus The operator enters this feature by selecting the Bolus option in the menu on the setup screen or the running screen 4 5 1 Bolus Setup and Start The Bolus option may be programmed at the start of an infusion or added to an infusion in progress Perform the following to program a Bolus Dose for infusion NOTE The VTBI of the Bolus cannot exceed the VTBI of the Primary infusion a b J IS LA a b C d Bolus A Soft Key If the Channel B SideCar Option is installed and Channel A channel is running pressing this soft key will allow Bolus A selection Bolus B Soft Key If the Channel B SideCar Option is installed and Channel B channel is running pressing this soft key will allow Bolus B selection Press BOLUS soft key from either the Primary programming running screen or menu e If from the primary programming screen the screen will split for Bolus information See Figure 4 4 e If from the primary running screen a separate Bolus display will appear See Figure 4 4 e When both channels are running the Bolus option is accessed from the Menu The screen will display Bolus for the channel chosen Observe that the Rate 1s highlighted Use the up
14. Fluid leakage out the air inlet can occur Since this set is vented fluid will flow without movement of the syringe plunger If the patient s access device requires needle access add a 17 Gauge or larger needle to the 1057 set s luer outlet before attaching to the access device 3 2 4 LV Extension Set 1058 Priming Refer to instructions accompanying the set Perform the following to prime I V Extension Set 1058 a Ensure hospital pump set tubing is clamped closed Remove pre existing infusion set from its non MRI hospital pump Ensure flow 1s stopped clamped closed before removal Remove 1058 Extension set from package close both the roller clamp and FLOW PREVENTER and remove blue tubing protector from silicone rubber pumping segment Attach inlet luer fitting clear cap to the pre existing infusion set at its distal end Open roller set clamp to prime the set Ensure FLOW PREVENTER is open To remove air from the injection port invert and tap while fluid 1s passing through the port f Close FLOW PREVENTER pinch clamp by pulling the black slide clamp outward g Grasp FLOW PREVENTER slide clamp and load pump segment into MRidium pump h Attach distal luer outlet blue cap to pre existing infusion set s injection port nearest the patient s vascular access device 1 Open set roller clamp and begin infusion 3 3 LV Set Insertion and Removal For insertion instructions see subparagraph 3 3 1 and for removal instruct
15. Iradimed Corporation Customer Service for prompt assistance in resolving shipping problems The following is a list of items shipped with Remote Display Charger e MRidium 3855 Remote Display Charger e Spare Battery Pack Optional e 1129 Installation Guide e Hospital Grade Power Cord e 2 4 GHz Antenna e LB2025 Channel ID Marker Sheet 2 4 Unpacking 3851 Channel B SideCar Remove the Channel B SideCar from it s shipping carton and examine for visible damage that may have occurred during shipping Check the materials carefully against the packing list and purchase request Save all the packing materials invoice and bill of lading as these may be required to process a claim against the carrier if there is damage from shipment Contact Iradimed Corporation Customer Service for prompt assistance in resolving shipping problems The following is a list of items shipped with Channel B SideCar e MRidium 3851 Channel B SideCar e One 1 Sample I V Set Provided for initial Clinical Engineering testing 2 1 e 1130 Installation Guide 2 5 Preparing the Pump for Use Once the pump has been unpacked perform the following to prepare the pump for use 2 5 1 Installing Battery Slide the removable battery pack into the rectangular open slot on the rear of the MRidium M 3850 The battery pack will lock into place a Battery Initial Charging The battery should be allowed to charge for nine 9 hours prior to placing the pump in
16. MENU gt Dose Rate Calc A gt KVO Rate gt Dose Rate Calc B gt Occlusion Limit gt Alarm Volume gt Lock Keys gt gt gt gt Set Comm Channel gt NEXT MENU gt NEXT MENU Figure 4 6 Special Feature Setup Menu SEMEL 03 18 57 Tul Mt 03 18 57 Dose Rate A Dose Rate A Primary Primary Drug ZDose 0 28 vmcoikoaimin Dose 0 28 mcg kg min Conc 1 00 mg 1 mL gt Conc 1 00 mg 1 mL gt Weight 60 0 kg gt Weight 60 0 kg gt Rate 1 0 mL hr gt Rate 1 0 mL hr gt VTBI 0 0 mL gt VTBI 0 0 mL Ready to Ready to Start Start Dose Rate Display Dose Rate Display w Drug Library Software Release 362 Post Release 362 and earlier and above Figure 4 7 Dose Rate Calculation Menu 4 12 4 7 1 Dose Rate Calculation The MRidium 3850 infusion pump automatically calculates a Rate based on a Dose amount Weight and Concentration of medication The correct rate and dose is then automatically transferred to the main programming screen for Dose Rate calculations and Drug Library included in software releases later than Release 362 see chart below and Default Values Table in Appendix A on page A 3 Dose Rate Calculator w Drug Library Only available in software releases later than Software Release 362 Dose Rate Calculator can be used for Primary Secondary or Bolus infusions A Drug Library Dose Rate Calculator Default Values Table 1 Drug Default provided in Appendix A on page A 3 E WARNING Selection of any
17. Volume Infused VI Range 0 1 to 9999 mL 0 mL Keep Vein Open KVO Rate Range adjustable 1 to 5 mL hr None always retains last setting 500 mL hr Bolus Rate Range 1 0 to 99 9 mL hr in 0 1 mL hr increments 100 TO 999 mL hr in 1 mL hr increments Bolus To Be Infused Range 0 1 to 999 mL max value Primary 0 mL VTBI Setting Occlusion Pressure Limit Range 1 to 10 PSI in 0 1 PSI increments None always retains last 6 8 to 68 9 kPa setting Dose Programming Patient Weight 0 1 to 160 Kg in 0 1 Kg increments 15 PED Range 60 ADULT Dose Programming Drug 0 01 to 99 9 mg mL Varies dependent on selected Concentration Range Drug Dose Programming 1 to 999 mL 1 mL CONC Diluent Range Dose Programming Dose in mg Kg 0 01 to 9999 mg Varies dependent on selected min Range Drug Dose Programming Volume to Be 0 1 to 999 mL O mL Infused Dose Programming 1 to 999 min Varies dependent on selected Time Range Drug Alarm Sound Volume gt 65 dBA at 1 meter Settings Minimum None always retains last to Maximum Graphical Display setting Drug Library Option Allow selection of 1 to 5 drugs used in Default value is on Drug Dose Rate Calculator When OFF only library choices are available one drug Drug is available A 7 LV ADMINISTRATION SETS General Specifications IV Set Materials used Integral Free Flow Protection Air Trapping Feature Access Device Connection Access Device Connection needleless
18. When the device is programmed and delivering in the secondary mode only fluid from the secondary container 1s being delivered to the patient as the primary infusion is temporarily stopped Delivery from the primary container resumes when the fluid level in the secondary line equilibrates with or s even with the fluid level in the primary container There are key elements in setting up and delivering a secondary infusion e Head height differential To prevent sympathetic flow flow from the primary container the secondary container must be at least 9 5 inches 24 cm higher than the primary container e The clamp on the secondary set must be opened If the clamp is not opened the fluid will be delivered from the primary container WARNING The secondary VTBI settings require consideration of such variables as factory overfill medication additions etc Underestimating the volume will cause the remaining Secondary solution to be infused at the Primary rate overestimating will result in the Primary solution being infused at the secondary rate Multiple doses from a single container are not possible 4 6 4 4 1 Priming a Secondary Administration Set Any secondary set can be used with the MRidium 1000 Series I V Set The secondary set must be primed prior to beginning the secondary infusion The secondary set may be primed in one of two ways 1 Forward Priming Gravity prime using the secondary fluid or 2 Back Priming Primi
19. Window min Figure G 13 AAMI ID 26 1998 50 102 Data Set Standard Trumpet Curve over T 2 Period 999 mL hr 11 13 15 17 19 21 23 25 al 29 31 33 Observation Window min Figure G 14 G 9 APPENDIX H 1119 LV POLE ASSEMBLIES AND PARTS DESCRIPTIONS General Precautions Federal law in the USA restricts this device to sale by or on the order of a physician For safe operation use only Iradimed Corporation recommended MRI compatible or MRI safe accessories Always secure the IV Pole wheel locks after positioning within the MRI Magnet Room Product damage may occur unless proper care is exercised during unpacking and installation Use only recommended assemblies and parts Any replacement component must be non magnetic for safe operation Refer all service to Iradimed Corporation or Authorized Service Representatives A maximum number of two 2 pumps can be safely used on any one 1 IV pole mounted no more than 54 inches 137cm from the floor NOTE There are several 1119 I V Pole configurations When using the following assembly instructions please match the appropriate instructions to your specific 1119 I V Pole Routine Maintenance Periodically check all mounting hardware Tighten as necessary for optimal operation Cleaning the Mounting Assembly 1 The mounting assembly may be cleaned with most mild non abrasive solutions commonly used in the hospital environment e g dilute
20. and down arrow control keys to enter Bolus rate the rate defaults to 500 Press the VTBI soft key Use up and down arrow control keys to enter Bolus VTBI value Press Enter to accept this starts the Bolus if programmed while the pump 1s running If pump was not running press the START STOP Channel control key to begin Bolus infusion Upon completion of the Bolus infusion an audible alert sounds and the primary infusion rate resumes with the VTBI counting down Stopping Bolus Rate Dose Perform the following to stop a Bolus Dose infusion Press START STOP Channel control key Press Cancel A or B soft key Observe that the Push Start A or B prompt is displayed Press the START STOP Channel control key to resume the Primary infusion parameters 4 5 3 Restoring Bolus Dose A Bolus Dose can be restored after it is complete Perform the following to restore a Bolus Dose a b Press BOLUS soft key from running screen or Menu Verify dosing parameters and press Enter control key The Bolus begins immediately NOTE Confirm the primary mode parameters are correct before accessing the Bolus Dose option Bolus VTBI must be less than the primary VTBI 4 10 Figure 4 5 Attaching Channel B SideCar 4 6 Channel B 3851 LV Pump SideCar A second channel may be added to the MRidium M pump Perform substep 4 6 1 to add the Channel B SideCar and substep 4 6 2 to remove the Channel B SideCar 4 6 1 Attaching the
21. conforme ai requisiti essenziali ed agli altri principi sanciti dalla Direttiva 1999 5 CE i iek rta atbilst Direkt vas 1999 5 EK b tiskaj m pras b m un citiem ar to saistitajiem noteikumiem D 7 Maltese MT Dan l apparat huwa konformi mal htigiet essenzjali u l provedimenti l ohra Malti rilevanti tad Direttiva 1999 5 KE Norwegian NO Dette utstyret er i samsvar med de grunnleggende krav og andre relevante j Norsk bestemmelser EU direktiv 1999 5 EC Polish PL Urzadzenie jest zgodne z og lnymi wymaganiami oraz szczeg lnymi Polski warunkami okre lonymi Dyrektywa UE 1999 5 WE Portuguese PT Este equipamento est em conformidade com os requisitos essenciais e Portugu s outras provisos relevantes da Directiva 1999 5 CE Applicable Standards The following standards were applied during the assessment of the product against the requirements of the Directive 1999 5 EC Radio EN 300 328 e EMC EN 60601 1 2 e Safety EN 60601 1 1 and EN 60601 2 24 CE Marking For the 2 4 GHz wireless products such as the MRidium 3850 System using the 3850R MRI Infusion Pump with 2 4 GHz FHSS Transceiver and 3855 Remote Display Controller with the 2 4 GHz FHSS Transceiver the following CE mark and class 2 identifier are added to the equipment National Restrictions In the majority of the EU and other European countries the 2 4 GHz band has been made available for the use of ISM Industrial Scien
22. drug from the Dose Rate Calculator DO utamine Library will replace all user set values to the default values 4 Adenosine o described in the Default Values Table in Appendix A 5 Dexmedetomidine Verify all selections prior to beginning the infusion B Dosing Units 1 Original Dose Units mg kg min mg kg hr mcg kg min mcg kg hr 2 Volume over Time Dose Units 3 Non Weight Based Dose Units mcg kg 0 00 9999 mg hr mg min mg kg 0 00 9999 mcg hr mcg min Time Field 1 999 min No Weight Entry Messages are developed to indicate 1f calculated values exceed the Rate or VTBI specifications Und under range or Ovr over range denote settings outside the established units Rate 1 0 to 99 9 100 to 999 mL hr VTBI 0 1 to 999 mL NOTE In Pediatric Mode the Dexmedetomidine unit values are fixed at Dose mcg kg hr and CONC mcg These unit values can only be modified in the Adult Mode NOTE Drug Library can be enabled disabled from the Service Mode This feature should only be set by qualified service personnel as described in the 1125 Service manual NOTE Selecting a different drug name in the Drug Library changes the previous concentration and dose rate values to the default values appropriate for the selected drug The choice of drug names and default values cannot be modified by the user The Dose Rate Calculation feature is used to calculate the volumetric rate for a either Channel A or B and is accessed through the menu Th
23. each time the pump latch 1s opened and closed with a set loaded If potent drugs are being used take appropriate action to guard against overmedication of the patient Always set the occlusion pressure alarm limit at the minimum level required for the prescribed fluid therapy Whenever closing the Pump Door check to make sure that nothing interferes with the pumping mechanism During a running infusion each interruption and re start of the infusion can add approximately 0 05 mL of delivered fluid to the indicated Volume Infused Vill Pump Related Precautions Continued There are dangerous voltages present on internal components that may cause severe shock or death upon contact Never open the pump casing it s power supply or the Remote Charger when connected to Mains power Disconnect from AC power and remove battery pack prior to servicing or cleaning Do not operate the pump on patients with the battery removed pump will stop and not alarm during AC power loss without battery installed Use of a properly maintained and charged battery will allow proper operation Do not touch battery connector pins and patient simultaneously If the Low Battery alarm sounds connect the pump with its power supply to AC power immediately Replace blown fuses on the 1120 Pump MRI power supply or Remote Display Charger with fuses of the same type and rating only or a fire hazard could exist Never use sharp objects paper clips needles e
24. from Appliance Inlet on the rear of the Unit Alternate Voltage Export For power cord plug types see local country distributor Unit shipped in USA with US 3 pin power NEMA plug 3850 EQUIPMENT CLASSIFICATION Classification according to IEC 60601 1 According to the type of protection against Class I equipment and internally powered electrical shock According to the degree of protection against Type CF defibrillator proof equipment electrical shock According to the type of protection against Ordinary Equipment Complies with Section 44 4 of the Infusion harmful ingress of water Pump standard IEC 60601 2 24 According to the methods of sterilization or Non sterilizable Use of liquid surface disinfects only disinfection According to the mode of operation Continuous operation Equipment not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide About the Pump The MRidium 3850 Infusion System incorporates a unique ultrasonic motor providing the non magnetic motor power driving the MRidium 3850 pumping unit This allows the MRidium 3850 to be constructed with minimal magnetic material and safely operable in high magnetic fields Features include e Non magnetic ultrasonic drive motor e Special aluminium RF noise shielding enclosure The pump is equipped with a unique battery display that provides the clinician continuous monitoring of battery capaci
25. listed chemicals or processes as a means for controlling infection Consult your hospital s infection control officer or epidemiologist To clean or sterilize mounted instruments or accessory equipment refer to the specific instructions delivered with those products H 6 Configuration 2 1119 LV POLE ASSEMBLIES AND PARTS DESCRIPTIONS NOTE The following tools are required for the assembly of this IV Pole Small Screws 1 8 HEX Big Screws 3 16 HEX Bolthead 1 2 Wrench H 7 4x IV HOOKS 3x Screws SWIVEL DISK V BOTTOM POST TOP POST STEP2 SCREW THE HOOKS INTO THE SWIVEL PIECE SECURE THE SWIVEL TO THE TOP POST USING THE 3x FLAT HEAD SCREWS PROVIDED NOTE THAT THE TRI HOLE PATTERN IS ASSYMETRICAL AND THEREBY ONLY ONE CORRECT HOLE ALIGNEMENT CONFIGURATION IS POSSIBBLE BUSHING ROLLASTAND BASE ASSEMBLY A dlecesscricxs Richmond il On I f EMICO onse Tum MM UA DESCRIFTICN IRADIMED CUSTOMER MANUAL STEP 1 amp 2 SCALE NES nRAWN EY FO cate MARIS S210 CHECKED at DATE THIS PRINT IS PROPERTY OF AMICO ACCESSORIES AND IS LOANED IN CONFIDENCE SUBJECT TO RETURN FarTRO UPON REQUEST AND WITH THE UNDERSTANDING THAT NO COPIES ARE TO BE MADE WITHOUT THE CONSENT OF AMICO ACCESSORIES STEP1 ASSEMBLE THE BOTTOM POST BUSHING ASSEMBLY ONTO THE ROLLSTAND BASE DRAWING NO 100319 F01 ALL RIGHTS TO DESIGN OR INVENTION ARE RESERVED _ 8 H TOP WEIGHT
26. lite inem Bcc eye eene 1 1 IE Fooro mte PUEDO uo icons rotores ici acota 1 2 Llc AMA E ene Orreene ee 1 3 MEA ASS E EA EA T 1 4 LIS TIO MELPOWOFOSUDDEE nee a Edu w acu 1 6 1 1 5 Front of the Remote Display Charger esses 1 7 1 1 5 Backor the Remote DREI ensure 1 8 L2 onu A A e IP E o o o A 1 9 L amp L a BS m 1 9 e RE 1 11 LXI Tniormational E 1 11 1 3 2 Infusion Parameter Setup DISplay nee aaa 1 12 PA A O E E PO A 1 12 RAT EE 1 12 E Ge O EE 1 12 US Spell Feste Senp WEN rer 1 12 le NRO EN 1 12 1 5 a Ann 1 13 1 6 Mamtenance and Operator Vera comisaria criada 1 13 1 7 ea o AAA eee ere 1 13 2 0 o RERO 2 1 24 us MAMMA a EE T E TE 2 1 B A PP ut beca dum ue FR I Catus un sdon den 2 1 2 3 Unpacking Remote Lusplavit DITE au ea Deg 2 1 25 Unpacking 3531 Channel Ben nein 2 1 2 Propano he Pump TOO 2 2 Ei Me E ee 2 2 22 4E 00 AP A 2 2 24 Operational Checkout of the PODIf einen 2 2 2 8 P E ERR Em 2 2 2 9 Remote Disploy OA nee 2 2 2 9 1 Charging Battery with the Remote een 2 3 EE a a NOCET 2 3 O I O0 0 gi o0 REESE 2 3 30 I V Set Preparation for LB ios urne etia iii 3 3 1 o RC E E T TT 3 1 A56 X DR PRU EE 3 2 dech 4 0 4 1 4 2 4 3 4 4 4 5 4 6 4 7 4 8 4 9 5 0 3221 LN Administration Set 1056 Prime 3 2 Bi NR RE 3 2 3 2 3 LV Syringe Adapter Set 1037 TE 3 3 Jat LV Extension Set 1053 Pine 3 3 LV Set Insertion a
27. observation windows not continuous data versus operating time Over long observation windows short term fluctuations have little effect on accuracy as represented by the flat part of the curve Variations in system accuracy and start up characteristics over various observation windows can be of interest when certain drugs are being delivered Trumpet curves are all derived from the second hour of the data collection period FLOW CHARACTERISTICS UNDER VARYING DELIVERY CONDITIONS Effects of Pressure Variations Under conditions of 300 mmHg pressure the MRidium 3850 Infusion System exhibits a long term accuracy offset of approximately 1 0 from mean values Under conditions of 100 mmHg pressure the MRidium 3850 Infusion System exhibits a long term accuracy offset of approximately 3 0 from mean values No significant change in short term variations result under these pressure conditions G 1 Effects of Negative Solution Container Heights With a negative head height of 0 5 meters the MRidium 3850 Infusion System exhibits a long term accuracy offset of approximately 2 0 from mean values No significant change in short term variations result under negative head height conditions Effects of Rate No significant change in short term variations result with rates of 1 0 ml hr or above NOTE Tests were conducted in accordance with IEC 6060 1 2 24 Particular requirements for safety of infusion pumps and controllers and
28. peristaltic pump e Dual channel pump offers the same features while providing two independent infusion pumps in one instrument e The Remote Display Charger Unit allows for remote ability to control the Pump with a total of two channels from outside the MR Scanner The system is designed for use in the following patient care areas e MRI 0 2 to 3T systems e MRI Recovery e Pump operable and safe in up to 1 Tesla 10 000 Gauss magnetic field EMI Statement This equipment generates uses and can radiate radio frequency energy and 1f not installed and used in accordance with the instructions may cause harmful interference to other devices in the vicinity However there 1s no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to other devices which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures 1 Reorient or relocate the receiving device 2 Increase the separation between the equipment 3 Connect the equipment into an outlet on a circuit different from that which the other devices s are connected 4 Consult the manufacture or field service technician for help Mains Disconnection Method 3850 Pump Disconnect power cord 1121 from Appliance Inlet on the side of the MRI power supply unit 1120 3855 Remote Charger Unit Disconnect power cord 1128
29. personnel 6 9 Battery Care and Maintenance 6 9 1 Introduction Over discharge over charge and over current short circuit are all conditions detected by the internal smart power gauge of the battery These conditions all result in the battery shutdown battery will not deliver power until placed into charge Over discharge can cause cells to outgas during subsequent charge cycles Severe outgassing can result 1n the battery pack swelling Replace any battery pack with visible signs of deformation or swelling 6 9 2 1133 Battery Pack Maintenance Checkout Procedure The 1133 Battery Pack should be inspected anytime the pack is removed or at least every 90 days for the following l Battery Pack communicates with the Pump This indicated by the Battery Icon being shown on the display of the Pump or Remote Display Refer to Section 1 3 1 of this manual for Battery Icon description 2 The Battery Pack holds sufficient operating charge capacity This 1s indicated by allowing the Pump to operate on battery power for the recommended minimum time 3 Battery Pack Gas Gauge indicator functions These functions can be confirmed by performing the checks defined in Sections 6 5 and 6 6 above 4 Physical Inspection of the Battery Pack case Remove the Battery Pack from the Pump or Remote Display and inspect for physical damage or signs of mechanical shock cracked casing or swollen case 5 Physical Inspection of the Battery Pack cell
30. port IV Set Injection Site Sealing IV Set Maximum Pressure Withstand IV Set Maximum Pull Force Withstand IV Set Operating Temperature Range IV Set Storage Temperature Range IV Set Storage Shelf Life IV Set Infusion Use Life Recommended Fluid Container Height above Pump 1055 Bypass Set Primary Set Length Set Inner Diameter Set Outer Diameter Priming Volume 1056 Standard Set Primary Set Length Set Inner Diameter Set Outer Diameter Priming Volume 1057 Syringe Set Primary Set Length Set Inner Diameter Set Outer Diameter Priming Volume 1058 Extension Set Primary Set Length Set Inner Diameter Set Outer Diameter Priming Volume A PVC Tubing No Latex or DEHP Custom flow preventer incorporated into each set Fluid free flow can t occur without mechanically opening the flow preventer Air Trapping Y sites used Male Luer Lock fitting provided for connection to O O D a 7 U O 3 lt es All sets include self sealing injection sites gt 14 PSI gt 15 Nt 3 3 Ibs per ISO 8536 4 5 to 40 C 40 TO 52 C years hours O to 60 cm 0 to 23 6 inches 5 inch 215 cm 0 108 inch 2 7 mm 0 152 inch 3 9 mm 2 mL max 118 inch 300 cm 0 108 inch 2 7 mm 0 152 inch 3 9 mm 8 mL max 5 inch 215 cm 0 050 inch 1 3 mm 0 092 inch 2 3 mm mL max 72 inch 185 cm 0 108 inch 2 7 mm 0 152 inch 3 9 mm O mL max 8 APPENDIX B REPAIR All repairs on products under w
31. primary administration set or back prime as above C Open the clamps on both the primary and secondary administration sets d When the fluid level in the secondary line equilibrates with the fluid level in the primary container flow from the primary fluid container resumes Non magnetic hanger o NEL MUI MSS gt Rate 1 0 Minimum head gt VTBI Q height differential of 10 inches 25 cm v 0 0 SecA mL gt VTBI 0 mL gt Channel B Figure 4 3 Secondary Infusion Set up and Programming Screen 4 7 NOTE The Channel B option will only appear when an optional second pump channel is installed 4 4 3 Programming a Secondary Infusion Perform the following to program a secondary infusion a Press the SECONDARY soft key b Observe that the programming screen splits to display Secondary Rate and VTBI with the Rate value highlighted See Figure 4 3 Enter the desired flow rate using the up and down arrow control keys Press Enter or VTBI soft key Observe that the VTBI value is highlighted Enter the desired volume to be infused using the up and down arrow control keys Observe that the Ready to Start prompt 1s displayed Press the START STOP Channel control key Observe that the secondary Rate and VTBI 1s displayed on the main display screen ge op pn ke o e The green infusion running indicator light flashes e Confirm flow from the secondary fluid container by observing the drip cha
32. reviewing this setup screen Review and verify the new infusion parameter s before starting the infusion SECTION 6 BATTERY OPERATION 6 0 Battery Operation 6 1 Introduction The 3850 system includes a smart Battery Pack that self monitors its performance and status and communicates this information to the Pump This allows the Pump to monitor the battery parameters in order to maximize the life of the battery reduce battery related costs and minimize Pump Battery down time NOTE The Battery Pack is sealed such that the batteries can t be replaced If the Battery Pack fails or becomes unusable do not attempt to replace the internal batteries Replace the Battery Pack Contact Iradimed Corporation for disposal 6 2 Inserting the Battery Pack Perform the following to insert the Battery Pack into the pump or Remote Display Charger a Grasp the Battery Pack firmly b Slide the Pack into the battery compartment on the rear of the Unit Push in firmly until the pack snaps into place The Battery Pack can be inserted when the Unit is either turned On or Off C After the Unit is turned On verify that the Battery Icon on the Main Display has the X removed and the Icon s filled or filling during the charge cycle Figure 6 1 Battery Installation 6 3 Charging the Battery Pack After insertion of the Battery Pack attach the Power Adapter to the Pump and the AC power source The battery will charge automatically whene
33. s battery Use only Iradimed model 1133 Battery Pack CAUTION Battery pack is slightly magnetic Use caution when removing from pump near strong magnetic fields Handle Battery Compartment Pole Clamp Optional Secondary Pump Drive Electrical Connector Memory Port Audible speaker UO Port Power 2 4 GHz Input Antenna Connector 3850R only Figure 1 4 Back of Pump Original Version 1 5 1 1 4 1120 MRI Power Supply See Figure 1 5 for information on the pump s MRI Power Power Supply WARNING AC Adapter is magnetic Keep outside the 1 000 Gauss line or at least 10 feet 3 meter from the MRI magnet Secure with velcro straps provided to the floor NEVER velcro or secure the AC Adapter directly to the pump or I V Pole MRidium MRI Power Supply WARNING KEEP OUTSIDE OF 1000 GAUSS 100mT MAGNETIC FIELD LINE OR MORE THAN 10 FT 3 M ROM MRI MAGNET SSI INO A Ce Se Iradimed Corporation IW AMT Made in USA LB2007 C Figure 1 5 Model 1120 MRI Power Supply 1 6 1 1 5 Front of the Remote Display Charger See Figure 1 6 for the location of the major components on the front of the 3855 Remote Display Charger a Antenna Provides 2 4 GHz bidirectional communication to MRidium 3850 MRI Infusion Pump b Main Display Provides a visual display of all the parameters and features of the pump C Run Alarm Lamp Provides a visual display of the pumps operating condition d
34. tubing above injection port Contraindicated for most blunt cannula systems For unattended medication delivery only luer locking Secondary sets and syringes should be attached to the valve e Flush injection ports in accordance with hospital policy after or between small volume injections lipids blood or blood product infusions blood withdrawals incompatible medications e FREE FLOW PREVENTER is OPEN when half moon shaped clamp is pressed INWARD To CLOSE PULL the slide clamp OUTWARD e Dispose of used set in accordance with applicable regulations and hospital policy e Follow appropriate pump directions for use 3 2 LV Set Priming There are four I V Sets available for use with this pump Priming of Administration Set 1056 is discussed in subparagraph 3 2 1 priming of ByPass Set 1055 is discussed in subparagraph 3 2 2 priming of Syringe Adapter Set 1057 s discussed in subparagraph 3 2 3 and priming of Extension Set 1058 1s discussed in subparagraph 3 2 4 Always use aseptic technique 3 2 1 LV Administration Set 1056 Priming Refer to instructions accompanying the set Perform the following to prime I V Administration Set 1056 a Remove from package close roller clamp and remove blue tubing protector from silicone rubber pumping segment b Insert administration set spike into prepared fluid container following accepted hospital procedure and hang fluid container approximately 15 inches above MRidium 3850 Pump
35. when the pump door 1s shut and will also close automatically to prevent fluid flow when the pump door is open WARNING To prevent free flow verify Free Flow Preventer is in the closed position slide clamp pulled out When properly loaded in the pump the Free Flow Preventer in the infusion set automatically prevents free flow when the pump door is opened It can also be manually operated for user set up convenience The CHECK DOOR alarm indicates Free Flow Preventer is in the open flowing position with the pump door not fully closed Immediately check for proper IV set installation Free Flow Preventer position and pump door closure b Operation of the Roller and Slide Clamps Either the Roller Clamp See Figure 3 2a or the Slide Clamp See Figure 3 2b s the manual way used to stop the flow of the fluid through the infusion set Close the Roller Clamp by moving the roller to pinch the tubing closed or close the Slide Clamp by moving the clamp to pinch the tubing closed e m Y a Figure 3 2 Roller and Slide Clamps 3 1 Precautions The following precautions apply to the use of these I V Sets e Always use aseptic technique when handling any I V Set e The fluid path is sterile and nonpyrogenic discard if packaging is not intact or if protector caps are missing or loose 3 1 Replace Set according to accepted hospital policies or every six 6 hours maximum For I V push medication occlude
36. 3 Guidance and manufacturer s declaration electromagnetic immunity for LIFE SUPPORTING EQUIPMENT and SYSTEMS Guidance and manufacturer s declaration electromagnetic immunity The MRidium 3850 System is intended for use in the electromagnetic environment customer or the user of the MRidium 3850 System should assure that it is used in such an environment Immunity test IEC 60601 test Compliance level Electromagnetic environment guidance level Portable and mobile RF communications equipment should be used no closer to any part ofthe MRidium 3850 System including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms d 1 17VP 150 kHz to 80 MHz outside ISM bands IEC 61000 4 6 10 Vrms d 1 20VP 150 kHz to 80 MHz outside ISM bands Radiated RF 10 Vrms d 1 20JP 80 MHz to 800 MHz 80 MHZ to 2 5 GHz IEC 61000 4 3 d 2 33JP 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 recommended separation distance in meters m b Field strengths from fixed RF transmitters as determined by an electromagnetic site survey c should be less than the compliance level in each frequency range d Interference may occur in the vicinity of equipment marked with the following symbol IEC 60417 No 417 1EC5140 S
37. 3 Battery Pack charging Spare Battery Charging Bay For 1133 Rechargeable Lithium Polymer Pack 14 8 v at 6 0 Ah MRI Magnet Compatibility None specified 3855 Remote Unit is NOT intended for use inside the Magnet Room A 5 Dose Rate Calculator Default Values Drug Name Label Adult Te ee ee C ONE CO Drug Come imime img ime imgin imimL Amgime imgim m 60 eog sog 15g tg 15g Rate 43mm 43mm 49m Timi imi 270 mLthr Time na na m m m m EEE e Ba A Pa E SR ER DE p ee EES Dobutamine ose E ma a a D DEE ers Dose e e I m imas SE EE EE e Lm p UE _ S Cem Rate _ Time T Dose 7 Conc W Rate _ Time fer Dexmedetomidine D IBS 3 SIS D at Warning Default values are provided for initial setup only Verify all selections prior to beginning the infusion A 6 USER SETTING DEFAULTS Characteristic Specification Range Initial Start Up Factory Default Value Primary Flow Rate Range 0 to 100 mL 1 0 to 99 9 mL hr in 0 1 mL hr increments 1 mL hr hr Primary Flow Rate Range gt 100 mL hr 100 to 999 mL hr in 1 mL hr increments 1 mL hr 1 mL hr Secondary Flow Rate Range O to 100 1 0 to 99 9 mL hr in 0 1 mL hr mL hr increments 100 to 999 mL hr in 1 mL increments Primary Volume To Be Infused VTBI 0 1 to 999 mL 0 mL Range Secondary Volume To Be Infused 0 1 to 999 mL 0 mL VTBI Range Total
38. 7 9 11 13 15 17 19 21 23 25 2 29 31 33 35 Observation Window min Figure G 4 G 4 Flow Error Flow Error AAMI ID 26 1998 50 102 Data Set Standard Trumpet Curve over T 1 Period 1 mL hr Observation Window min Figure G 5 AAMI ID 26 1998 50 102 Data Set Standard Trumpet Curve over T 2 Period 1 mL hr Observation Window min Figure G 6 G 5 Flow Rate ml hr Volume delivered ml AAMI ID 26 1998 50 102 Data Set Ir EI 28 0 i vet It CO 270 CHUL HUEL EEE EEE EEE i op ee ALLE EE EO EET E WOU il DEE EEE NEE en AI II a55 LUU A A A UELI O AI A AA 245 A A A 240 GEOTRUST A A A A a TR UI 25 A M a rr TII Flow Rate at T 0 25 mL hr 30 0 2 E 29 0 SE MA sier ck Ve HLLLLLLELL eld H UIDI SERIE E EL KUNSCH E UM N uu 2E CERE 5 5 EA 1 E A C II GE _ OOOO emt EN 20 0 oo O t Y o cg Q Time Hours Min 0 00 0 05 0 10 0 15 0 20 0 25 0 30 0 35 0 40 0 45 0 50 1 10 1 15 1 20 1 25 1 30 1 35 1 40 1 45 1 50 1 55 2 00 Figure G 7 AAMI ID 26 1998 50 102 Data Set Volume Delivery 25 mL hr zb zb A sesch N w EE Hh a 8 23 E xc NM t e On C CO ce X2 CY EN GC En GC Em CC o S o o 0 00 00 0 11 00 0 22 00 0 33 00 0 44 00 0 55 00 50 00 2 01 00 2 12 00 2 23 00 2 34 00 2 45 00 3 18 00 3 29 00 3 40 00 3 51 00 4 02 00 4 13 00 4 24 00
39. AAMI ID26 1998 Medical electrical equipment Part 2 Particular requirements for the safety of infusion pumps and controllers MRidium 1056 Infusion Sets were used during this testing Occlusion Pressure Tests NOTE 2 PSI 13 8 kPa 10 PSI 68 8 kPa Occlusion Pressure Test Conditions Occlusion Pressure Test Results Occlusion Detection Time Pressure 8 minutes 2 PSI setting 55 00 minutes 10 PSI limit at 2 PSI Flow Rate at 1 mL hr setting Occlusion Detection Time Pressure 8 minutes 2 PSI setting 108 seconds 1 48 minutes limit at 10 PSI Flow Rate at 25 mL hr at 10 PSI setting max pressure reached was 10 2 PSI Occlusion Detection Time Pressure 26 seconds 10 PSI setting max pressure reached limit at 10 PSI Flow Rate at 100 mL was 10 1 PSI hr Occlusion Detection Time Pressure 8 seconds 10 PSI setting max pressure reached was limit at 10 PSI Flow Rate at 500 mL 9 9 PSI hr Occlusion Detection Time Pressure 8 seconds 10 PSI setting max pressure reached was limit at 10 PSI Flow Rate at 999 mL 10 8 PSI hr Post Occlusion Pressure Alarm Measured value was lt 0 7 mL after bolus release Occlusion Relief Bolus Volume Delivered Pressure limit at 2 PSI Flow Rate at 25 mL hr Post Occlusion Pressure Alarm Measured value was 0 7 mL after bolus release Occlusion Relief Bolus Volume Delivered Pressure limit at 10 PSI Flow Rate at 25 mL hr Battery Operating Time Flow Rate at gt 12 Ho
40. ART STOP key to restart infusion Re enter patient s infusion settings If message recurs refer the pump to qualified service personnel for repair Plug Pump into AC Mains Power Press ON key and choose Same Patient to resume infusion MESSAGE TYPE CAUSE RESOLUTION BAD BATTERY Alert Battery fault has occurred Remove from use Contact qualified service personnel Inlet Occluded A or B Alarm Flow has been obstructed between fluid container and Pump Load Set A or B Prompt Pump needs to verify operation establish pressure baseline and perform motor test Pressure Error A or B Prompt Excessive variation in pressure due to motion flow from other Pumps or blood pressure prevents accurate setting of pressure baseline History Checksum Error VTBI KVO Audible Only No Alert Communicat on between pump Communication and Remote Display has been Remote Display interrupted unit only Unload Set Prompt Pump needs to reset air in line detector U Prompt Under Range of Rate or VTBI established settings nd Ovr Prompt Over Range of Rate or VTBI established settings 5 3 Check administration set for probable cause kinked tubing clogged filter etc Press Start Stop for appropriate channel to restart infusion Open Pump Door until message disappears Close Door to resume infusion Always turn Pump on prior to loading set Press ENTER Value
41. Access softkey for Bolus Setup Display Bolus Bol us Bolus Setup Display Access softkey for channels RALIS Channel B Access softkey for Channel B Active Softkeys MRidium 3850 Primary Setup Screen Remote Charger Primary Setup Screen Active Softkeys arrow only appears beside arrow only appears beside options with active softkeys options with active softkeys Figure 1 9 Setup Display Screens 1 3 1 Informational Display The Informational Display is located at the top of the display screen This portion of the display provides the operator with operational information such as the battery status AC power status and the current time Provides a visual indication of the charge level of the Pump main battery When full the battery is charged fully The level drops in increments of 25 on both the Pump and Remote as the battery discharges If the symbol has an X through it no battery is installed Provides a visual indication of connection with Remote Display and receive level as indicated by vertical bars Only displayed when internal radio has linked with Remote Display Current channel is displayed to the right of the bars 1 6 No bars indicates no communication Provides a visual indication of the spare battery charge level in the Remote Display unit Informational Display When full the battery is charged fully Level shows increments of 25 as the battery 1s charged if symbol has an X through it no battery is in
42. Battery Charger Compartment Located at the top rear of the Remote allows charging of an 1133 Pump Battery when battery is installed and Remote is connected to AC Mains outlet as indicated by AC Power Battery Charge LED located below the power On Off keys 6 Main Control Keypad Provides control of the various features of the pump f Soft keys Provides a way to adjust the configuration of the pump g AC Power Battery Charge LED Provides indication that AC power is applied Green or Charging a spare battery Amber h Memory Port Located underneath the front panel provides for field update of system software Use only AM01 Software Card idium M id INFUSION SYSTEM e EE 12 03 30 genre baa Run Alarm Antenna a e y TE pu EC m Ode mM e 00 MW Battery Charger Main Display A Compartment Screen Ken on rear of Remote Soft Keys Ka B Channel B Main Control Power ON Switch Keypads Power OFF Switch AC Power Battery Charge LED Memory Port Figure 1 6 Front of 3855 Remote Display Charger 1 7 1 1 6 Back of the Remote Display Charger See Figure 1 7 for the location of the major components on the back of the 3855 Remote Display Charger a b 000 Audible Speaker Provides the audible sounds for alarms and alerts 2 4 GHz Antenna Connector Used to connect 2 4 GHz Antenna for wireless communication with the 3850 MR IV pump Power Input Provides for connection t
43. C Squeeze drip chamber to fill approximately 1 2 full e Open vent cap if glass fluid container d To prime tubing and clear air from injection sites slowly open roller clamp allowing fluid to fill tubing e Invert and tap injection sites to clear any air bubbles f Close roller clamp and Free Flow Preventer by sliding pinch clamp outward WARNING Inlet Occlusion indication may not be reliable when used with bypassed I V sets that incorporate a check valve 3 2 2 LV ByPass Set 1055 Priming Refer to instructions accompanying the set Perform the following to prime I V ByPass Set 1055 a Ensure hospital pump set tubing is clamped closed Remove set from hospital pump b Remove ByPass set from package close roller clamp and remove blue tubing protector from silicone rubber pumping segment Attach clear covered Luer Lock connector to upper injection site on hospital set Open roller clamp on ByPass set allow fluid to fill tubing Tap injection sites to clear any air bubbles Close roller clamp close Free Flow Preventer pinch clamp by sliding it outward C mo ao Attach blue capped Luer lock connector to lower injection site on hospital set 3 2 3 2 3 LV Syringe Adapter Set 1057 Priming Refer to instructions accompanying the set Perform the following to prime I V Administration Set 1057 NOTE Do not puncture or add medication through air inlet See Figure 3 3f a b Remove from package close sl
44. ESERVED BY IRADIMED CORPORATION C 1 APPENDIX D MANUFACTURERS TECHNICAL DECLARATION EMC Information Tables as required by EN 60601 1 2 2000 Clause 6 In accordance with EN 60601 1 2 2000 Medical Electrical Equipment Part 1 2 General requirements for safety Collateral standard Electromagnetic Compatibility Requirements and tests l Medical Electrical Equipment needs special precautions regard ng EMC and needs to be installed and put into service according to the EMC information provided in the Accompanying Documents the following tables 2 Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment 3 The equipment or system should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary the equipment or system should be observed to verify normal operation n the configuration in which it s used The following tables as required in EN 60601 1 2 2000 provide information regarding the Electromagnetic Compatibility EMC of this product and its accessories Table 201 Guidance and manufacturer s declaration electromagnetic emissions for all EQUIPMENT and SYSTEMS Guidance and manufacturer s declaration electromagnetic emissions The MRidium 3850 System is intended for use in the electromagnetic environment specified below The customer or the user of the MRidium 3850 System should assure that it is used in such an
45. Hooks 2 Upper IV Pole H 4 1119 Assembly Instruction Rev C 010308 Attaching Upper IV Pole to Lower Pole 1 Screw Upper Pole clockwise CW onto Lower Pole Tighten as much as possible by hand 2 Using the 3 32 hex wrench provided tighten the set screw in the Upper Pole Screw Upper Pole P CW onto Lower Pole Tighten Set Screw 1119 Assembly Instruction Rev C 010308 Routine Maintenance Periodically check all mounting hardware Tighten as necessary for optimal operation Cleaning the Mounting Assembly 1 The mounting assembly may be cleaned with most mild non abrasive solutions commonly used in the hospital environment e g diluted bleach ammonia or alcohol solutions The surface finish will be permanently damaged by strong chemicals and solvents such as acetone and trichloroethylene Do not use steel wool or other abrasive material to clean the mounting assembly Damage caused by the use of unapproved substances or processes will not be covered by warranty We recommended that you test any cleaning solution on a small area of the mounting assembly that is not visible to verify compatibility Never submerge the roll stand or allow liquids to enter the mounting assemblies Wipe any cleaning agents off the mounting assembly immediately using a water dampened cloth Dry all mounting assemblies thoroughly after cleaning CAUTION GCX makes no claims regarding the efficacy of the
46. I Xadimed CORPORATION ADVANCED TECHNOLOGIES IN MR FLUID MANAGEMENT MRidium MRI INFUSION SYSTEM DPERATION MANUAL T e w u Ser Se ee rom TA me WR kx n rr M lt idium MERI INFUSION SYSTEM t 12 03 30 Primary amp 22 gt Rate EI hr EN UL Ld nL UI 0 0 nL gt Secondary gt Bolus gt Channel B START STOP CHANNEL Zu START STOP CHANNEL a BREED MRidiumTM 3850 Infusion System Operation Manual Part Number 1124 Release 7C 10 2011 PER ECN 000372 2005 2011 Radimed Corporation IRad med Corporation 7457 Aloma Ave Suite 201 Winter Park Florida 32792 U S A Tel 407 677 8022 Fax 407 677 5037 e mail customerservice iradimed com le C US 0413 MEDICAL EQUIPMENT UL 60601 1 Intertek 319 888 European Authorized Representative Medical Device Consultancy 7 Pinewood Drive Ashley Heath Market Drayton Shropshire UK TF9 4PA www medicaldeviceconsultancy co uk I lt adimed CO RP ANITA sf CONTENTS Paragraph Page ano EEN V Equipment Classification nnne nnne nnne nnne nnns V PN Tg AO PM vi Warnings Precautions cocccccncocooonccnnnnnnonononononnnnnnnnnnnnnnonocnnnnnnnnonnnnnannnnnnnnnnnnnnnos Vil Daer icd EE xii iio AA o eo A EE xii sad Ult xili IN Sne EE 1 1 1 1
47. Nazionali e rispetta il Piano Nazionale di ripartizione delle frequenze in Italia Se non viene installato all interno del proprio fondo l utilizzo di prodotti Wireless LAN richiede una Autorizzazione Generale Consultare http www comunicazioni it it per maggiori dettagli Latvia m db usage of the 2 4 GHz band requires an D form the Electronic Communications Office Please check http www esd lv for more information Antennas The 2 4 GHz wireless ISM Industrial Scientific and Medical communication products described in this document have dedicated antennas which should not be removed or replaced with any antenna that is not supplied directly from Iradimed Corporation or its representatives Operating Frequency The operating frequency is pre set at the factory during manufacturing Mind setting of the operating frequency can only be done by qualified service personnel with a service D 9 password Instructions are provided in the Service documentation regarding the appropriate choices and settings for specific geographic areas It is important that the operating frequency is correctly configured to meet the local regulations Changing Output Power The output power is pre set to 63 mW at the factory during manufacturing Manual setting of the output power above 100 mW can only be done by qualified service personnel with a service password The only available ouput power choices are Level 1 10 mW Level 2 63 mW factor
48. TART STOP CHANNEL START STOP CHANNEL Lenger B ac Power I lt adimed Figure 1 8 Front Panel Control Keys 1 9 START STOP CHANNEL CANCEL MENU E o i START STOP CHANNEL ech START STOP CHANNEL A Pressing this control key starts or stops the Channel A infusion sequence CANCEL Pressing the control key returns function to the previous menu or display with no action Up Arrow Pressing this control key will increase the value of the currently selected option It is also used for on screen menu navigation Down Arrow Pressing this control key will decrease the value of the currently selected option It is also used for on screen menu navigation MENU Pressing this control key activates the Main Menu Display ENTER Pressing this control key will activate or select a menu choice proceed from one prompt to the next and accept store changes START STOP CHANNEL B If the Channel B option SideCar Pump mechanism is installed pressing this control key starts or stops the Channel B infusion sequence ALARM SILENCE Pressing this control key temporarily silences audible alarms for two 2 minutes and clears alarms that have been resolved 1 Pressing this control key turns the unit on When the unit is on this control key is inactive O Pressing and holding this control key for two 2 seconds turns the unit off Soft Keys The six 6 Soft Keys located to the left of the pump s displ
49. abled in the Service Mode Refer to 1125 Service Manual for additional details on the Service Mode 1 4 User Interface The user communicates with the unit by pressing the appropriate control and or soft key and then using the up or down arrows and enter control keys to set and verify the setting being made 1 5 System Self Test The unit performs a series of power on Self Tests on start up to confirm readiness for use Failure during any of these Self Tests will result in a fault message and inability to use the pump Verify successful completion of self test prior to each use 1 6 Maintenance and Operator Verification Using IVP1056 IV Set Verify Pump and Channel B SideCar operation on a routine basis Maintenance and verification must be performed at least once year Test Flow Accuracy Flow pump output into a graduated cylinder with pump set at 200 mL hr Run pump for 12 minutes and verify volume is 40 mL 5 Test Inlet Occlusion With pump running 200 mL hr close slide clamp on inlet side of pump and verify Inlet Occlusion Alarm Test Patient Occlusion With pump running 200 mL hr close roller clamp on patient side of pump and verify Patient Occlusion Alarm Test Bubble Detector Insert a 100 uL bubble above the Bubble detector Restart pump ensure bubble flows down into detector verify Bubble Detection Alarm Clean pump and inspect for any physical damage 1 7 Cleaning Instructions Clean Pump and Channel B SideCar and i
50. aintenance Extensions purchased after the standard warranty has expired shall require a physical inspection by Iradimed Corporation prior to purchase of any Maintenance Extension An additional service fee may also be required to bring the out of warranty product s within specifications before any maintenance extension can be activated Cost of such inspection and possible repair to the product will be communicated to customer at that time We reserve the right to refuse the sale of Maintenance Extension to any Product Iradimed Corporation warrants any such product subject to a Maintenance Extension agreement shall other than its expendable parts provided that same 1s properly operated under conditions of normal use and that periodic maintenance and service 1s performed be repaired by Iradimed and restored to full operational specification as where applicable at the time of original manufacture Any Maintenance Extension will become null and void if product has been repaired other than by Iradimed Corporation or its authorized representative or if the product has been subject to misuse accident negligence or abuse Should a unit perform outside of Iradimed specifications and cannot be corrected by on site technicians with instruction and support from Iradimed and unit must be returned to Iradimed for repair a loaner unit if available may be provided IRADIMED CORPORATION PRODUCTS CONTAIN PROPRIETARY COPY WRITTEN MATERIAL ALL RIGHTS ARE R
51. are Battery being charged 1 1 1 Front of the Pump See Figure 1 1 for the location of the major components on the front of the pump a Handle Located on the top of the pump the handle provides for easy transportation of the pump from location to another b Main Display Provides a visual display of all the parameters and features of the pump C Run Alarm Lamp Provides a visual display of the pumps operating condition Battery Located behind a door on the back of the pump the battery provides for power in the absence of a hospital grade AC Mains outlet e Pump Area EZ Latch Door Pressing down on this button and lifting this handle unlatches the door protecting the pumping mechanism and infusion line f Main Control Keypad Provides control of the various features of the pump g Soft keys Provides a way to adjust the configuration of the pump h AC Power Battery Charge LED Provides indication that MRI power supply is connected and AC power 1s applied to Charge the pump battery Handle T Busan Run Alarm Lamp MRidium s Main Display 12 03 30 Screen e sch 2 ee 4 Battery Pole Clamp on rear of pump ES m Ola Compartment w 00 n on rear of pump gt Secondary j Ill Bolus a Soft Keys START STOP CHANNEL f a gt Channel B pu Main Control Power ON Switch A E Keypads Power OFF Switch 4 AC Power oaea Pump Area Battery
52. arranty must be performed by Iradimed Corporation personnel or an authorized Irad med Corporation Service and Repair Center Unauthorized repairs will void the warranty If a pump fails to function properly or requires maintenance contact Iradimed Corporation Technical Service at 1 407 677 8022 within the U S 001 407 677 8022 from outside the U S during normal business hours EST or by E mail at techsupport iradimed com Iradimed Corporation Technical Service will advise you of the corrective action required If you are advised to return the pump to Iradimed Corporation for repair please do the following a Obtain a Return Authorization Number This will ensure proper routing and facilitate timely repair of your pump b Clean Pump prior to shipment Do not ship contaminated product to IRad med Corporation for repair C Package the pump with adequate protection If available use the original carton and packing materials in which the pump was shipped from Iradimed Corporation d Include a brief description of the problem as well as the name address and phone number of the person to be contacted for additional information e Include a purchase order with the pump being returned if it 1s out of warranty Iradimed Corporation Technical Services can advise you of your pump s warranty status 1f need be Repairs will be made at Iradimed Corporation s current list price for the replacement part s plus a reasonable labor charge f Sh
53. aximum number of two 2 pumps can be safely used on any one 1 IV pole mounted no more than 54 inches 137cm from the floor Parts Reference The following parts and hardware are included in this installation kit see illustrations for parts hardware not shown Le IV Pole 66 2 piece EJ A NA Base with 10 lb Counterweight M 5 16 18 x 1 Hex Head Cap Screw HHCS 3 EES 5 16 Split Lock Washer WER 1 4 20 x 3 4 Flat Head Socket Cap Screw FHSCS 5 meme EEN s swmmeWem BEE Tools Required 1 2 13mm wrench not provided 5 32 and 3 32 hex wrenches provided H 3 1119 Assembly Instruction Rev C 010308 Assembling the Roll Stand Post to Base 1 Insert Lower IV Pole in Base and lay assembly on its side for access to bottom of Base not shown 2 Using a 1 2 13 mm wrench fasten Post to Base with one 1 5 16 18 x 2 HHCS 5 16 split lock washer and 5 16 flat washer 5 16 Flat Washer 1 5 16 Split Lock Washer 1 5 16 18 x 1 HHCS 1 Attaching IV Bag Hooks to Upper IV Pole 1 Assemble Tree Disc over IV Bag Hooks Installation Note If IV Bag Hooks do not fit easily into Tree Disc slots gently tap Hooks into slots with a rubber mallet 2 Align locator pin top of Pole with slot in Tree Disc Using the 5 32 hex wrench provided fasten assembly to top of Upper IV Pole with one 1 1 4 20 x 3 4 FHSCS 1 as shown below 7 a 11420 x 3 4 FHSCS 1 eo Tree Disc IV Bag
54. ay screen are used to perform variable functions depending on the current state of the device When active there is a small arrow present to the right of the key on the pump s display 1 3 Display The display screen provides the operator with the information and prompts necessary to operate this pump See Figure 1 9 for a description of the Primary display In general the display screen functions as follows e Highlighting As the different settings are scrolled through using the Up or Down arrow control key the selected item will become highlighted to distinguish it from the unselected items e Visual indicating of Soft key status Active Soft keys have a arrow beside them pointing toward the menu item or setting that the Soft key controls When Soft keys are inactive the arrow is not displayed e Split Screen The pump displays different types of information in the same area of the screen no matter what particular display is active Informational Gees am ME 06 11 55 am 1 E 06 11 55 informational _ Primary A____ Be Primary A gt Rate 1 0 gt Rate 1 0 m Primary Infusion Uv Primary Infusion Setup Display VTBI 20 gt VTBI 20 mall Setup Display Value of the Volume Infused vi 0 0 vi 0 0 mL Value of the Volume Infused Access softkey for S gt S da Access softkey for Secondary Infusion ecorn d Secondary Infusion Setup Display econ dary ry Setup Display Access softkey for ND
55. bble stopped occurred Disconnect Set from the patient Purge Air in Line Re prime line and resume Faulty pump hardware infusion Refer to qualified service personnel Occlusion pressure alarm Examine patient infusion site for limit 1s set too low source of occlusion or infiltration Re adjust alarm limits as described in Paragraph 4 7 4 Unit alarms after each infusion start Bubble Detected alarm Examine Set to locate air bubble occurred Disconnect Set from the patient Purge Air in Line Re prime line and resume infusion Clock not properly adjusted to Adjust clock time as described in local time after receipt service manual Pump clock is not Clock battery has become Refer to qualified service personnel correct depleted Summer Winter time change Adjust clock as described in service manual Air is present in the Examine Set to locate air bubble Administration Set Disconnect Set from the patient Purge Air in Line Re prime line and resume infusion Administration Set Roller Open Roller Clamp on Administration clamp is closed Set Infusion stops Administration Set Open pump door remove Set and improperly loaded on pump reload Set following instructions drive Kinked Set causes Occlusion Straighten Set and re start infusion Alarm Patient Access Device is Change Patient Access Device blocked 1057 IV set air vent is not Open the white cap of the 1057 IV set open which prevent
56. change confirmation Verify selection and press ENTER required Open and Close door to reset pressure sensors Press START STOP key to start infusion Pump has reverted to the default examine settings and reenter any needed infusion setting changes Prompt Pump detected a memory or power failure Existing operating program settings Press MENU to parameters have been erased Alert VTBI has counted down to zero Channel is in KVO mode Press the appropriate channel s START STOP to stop infusion then press ENTER and the VTBI Soft Key to reenter the new VTBI Change solution container if necessary If therapy is complete remove tubing from pump to end infusion Reposition Remote Display or Pump to re establish communication Be sure Pump is still ON Interference from another Radio source may cause problem Go to an alternate Comm channel on both Pump and Remote Display Otherwise refer unit to qualified service personnel Open door Remove and replace I V set Close door Always turn Pump ON prior to loading set Reset values to be within parameters Rate 1 0 to 999 mL hr VTBI 0 1 to 9 999 mL Reset values to be within parameters Rate 1 0 to 999 mL hr VTBI 0 1 to 9 999 mL MESSAGE TYPE CAUSE RESOLUTION Possible free flow of I V fluid Prompt Calculated Dose Rate Calculator values are outside allowable range Prompt Selected values are outside allowable range Prompt A selected param
57. charged immediately to prevent battery damage Restart power cycle the pump and select Previous Patient to continue infusion CAUTION If Pump is in storage and not used for more than 30 days the battery pack should be removed 6 8 Battery Power Gauge Located at the top left of the informational display this gauge is in the shape of a battery and provides a visual indication of the charge status of the battery When the gauge 1s full then the battery is fully charged when the gauge is empty then the battery is nearly depleted and the pump may not operate unless connected through the MRI Power Supply pump only to a hospital grade AC outlet When the battery is removed the gauge has an X placed inside it If the Battery Operating time seems short the battery gauge may require re calibration to accomplish this perform the following a Remove pump from clinical use Set up pump to operate on battery power b Operate pump until low power alarm occurs continue to operate until the DEAD BATTERY alarm capacity lt 2 occurs C Reconnect the pump to the 1120 MRI Power Supply or move the fully depleted battery to the Remote Display Charger and allow the pump battery to fully recharge When in the pump recharging can occur during normal use if the pump is connected to its 1120 MRI Power Supply The battery should recharge in less than nine 9 hours d If battery life 1s still short refer to qualified service
58. d bleach ammonia or alcohol solutions 2 The surface finish will be permanently damaged by strong chemicals and solvents such as acetone and trichloroethylene 3 Do not use steel wool or other abrasive material to clean the mounting assembly 4 Damage caused by the use of unapproved substances or processes will not be covered by warranty We recommended that you test any cleaning solution on a small area of the mounting assembly that is not visible to verify compatibility 5 Never submerge the roll stand or allow liquids to enter the mounting assemblies Wipe any cleaning agents off the mounting assembly immediately using a water dampened cloth Dry all mounting assemblies thoroughly after cleaning CAUTION Iradimed Corporation makes no claims regarding the efficacy of the listed chemicals or processes as a means for controlling infection Consult your hospital s infection control officer or epidemiologist To clean or sterilize mounted instruments or accessory equipment refer to the specific instructions delivered with those products H 1 Configuration 1 1119 LV POLE ASSEMBLIES AND PARTS DESCRIPTIONS e TOP OF DISC ITEM H OF LABEL ITE NOTE NOTE ASSEMBLY INSTRUCTION SHEET LUG TAPERED LORS CCX RS BASE CASTING BASE ROLL STAN
59. diameter Range PERFORMANCE CHARACTERISTICS Infusion Pump Performance Infusion Pump Performance O Primary Volume To Be Infused VTBI Range Occlusion Detection Mechanism Two separate upstream amp downstream semiconductor force sensors Occlusion Pressure Measurement Range 1 to 10 PSI 6 9 to 68 8 kPa with 0 2 PSI resolution Occlusion Pressure Measurement Accuracy 2 PSI 13 8 kPa or within 10 of setting whichever is greater Occlusion Detection no flow Time typically 30 sec dependent on selected Flow Rate 55 min max 1 mL Hr Occluded I V Line bolus volume 25 mL Hr to 10 0 7 mL max PSI occlusion Air in Line Detection Method Ultrasonic bubble detector A r n Line Detector Threshold s gt 100 uL Liquid Source height limits 100 to 50 cm relative to pump center Calibration units Calibration units of measure 00300 Calibration units of measure 00300 mL hr mL Volts e PSIG mL Volts amp PSIG Audible Alarm Range at 1 meter Minimum dBA Maximum gt 85 dBA MRI Performance MRI Magnet Compatibility 0 2 to 3 0 Tesla MRI Systems MRI Larmor Frequency Interference No interference at compatible Larmor Frequencies 8 4 through 128 MHz Magnetic Field Limit 10 000 Gauss 1 Tesla magnetic field line Minimal ferrous material used inside Pump 15 grams non magnetic ultrasonic motor used inside Pump A 2 Service Selectable Frequency Range 2431
60. e 3850 Pump or 3855 Remote Display and or cause the Battery Pack plastic case to burst open If this occurs do not use tools that could cause damage to the internal battery cells Refer to the 1125 Service Manual for removal under these conditions Under no circumstances should Battery Packs or the internal cells be incinerated as this can cause an explosion 6 6 APPENDIX A SPECIFICATIONS GENERAL SYSTEM REQUIREMENTS General Features Volumetric Infusion Pump for use in the MRI Pump Dive Mechanism Linear Peristaltic Number of Pump Channels User Event Log Non volatile memory retains each operating step and alarm up to 5000 entries ELECTRICAL CHARACTERISTICS HI LO Line Voltage Requirements 100 to 240 VAC 10 50 60 Hz Power Sources Available Internal battery power with separate AC charger power supply Power Consumption lt 15 Volt Amperes 120 VAC nominal at 125 mL hr lt 100 VA maximum during charging Chassis Ground Impedance to Earth lt 0 1 ohms with power supply Ground MECHANICAL CHARACTERISTICS 6 x 8 x 9 Inches 15 25 x 20 3 x 22 9 cm 10 LBS 4 5 Kg 11 5 LBS 5 2 Kg with Battery Dimensions D x W x H Total Weight Operating Temperature Range 5 to 40 C Storage Temperature Range 40 TO 70 C Operating Relative Humidity Range 0 to 80 RH non condensing Storage Relative Humidity Range 0 to 95 RH non condensing Pole Clamp Mounting Pole Diameter inch to 1 5 inch 25 to 38 mm
61. e example shown in Figure 4 7 is for Channel A However the dose calculation screen used for channel B is the same except for the title and the soft key text that is used to go to Channel A s dose calculation screen Once the dose calculation screen has been successfully completed the dose rate a Ready to Start message will appear in the lower right hand corner of the display This message is used to indicate that the user may press the Start Stop Channel control key for the appropriate channel 4 13 The user is free to change the value of any field at any time When a new infusion rate is entered the dose value will change When a new dose value weight concentration or diluent value is entered the infusion rate changes automatically Perform the following steps to select the Dose Rate Calculator a Press the MENU control key Press the DOSE RATE CALC A or B soft key Dose Rate Calc B message will only be visible if the Sidecar Channel B has been connected Observe that the Dose Rate Calculation Menu See Figure 4 7 will be displayed with the word Primary highlighted with post software release 362 The Dose Value will be highlighted in software release 362 and earlier in this case proceed directly to step 1 Use the up and down arrow keys to select Primary Secondary or Bolus in the post software release 362 version NOTE If the Dose Calculator Drug Library Option is enabled further choices
62. e is adjustable for various clinical environments Ensure the alarm sound level is appropriate for the use environment in the MRI so that it can be heard above the ambient noise level especially during scanning Product damage may occur unless proper care is exercised during unpacking and installation Do not use the pump if it appears damaged in any way The battery should be charged before use Battery may not be fully charged upon receipt Connect pump to AC power for at least nine 9 hours before placing the pump into use Always connect the infusion pump power supply or Remote Display Charger to a properly grounded 3 wire power receptacle If the quality of the earth grounding is in question use battery power for the infusion pump This equipment is not suitable for use in the presence of flammable anesthetic or other gases Do not use this system in the presences of flammable gases Arrange tubing cords and cables to minimize the risk of patient or other equipment entanglement The pump is not intended for high pressure high viscosity radiological contrast agents To avoid patient injury always respond to Pump or Remote Display Charger alarms immediately Never leave the patient with the Pump stopped 1f the infusion has not been completed To Prevent injury avoid placement of any NIBP cuff on the limb receiving the I V therapy The Pump contains materials which must be recycled or disposed of properly For proper disposal method
63. ea The AC Power LED on the bottom left hand side will be amber colored until the battery is fully charged The LED will turn green when battery is fully charged and the spare battery Icon in the Remote Display Charger s informational display area will be full with 4 bars NOTE If communication between Remote and Pump is lost the Remote will sound a low pitched alarm for approximately 10 seconds If communication is not returned after 10 seconds the Remote will sound a ramping high pitch alarm tone and display No Communications 2 10 Language Options The MRidium System is capable of displaying information in languages other than English This feature is service selectable and should only be changed by qualified service personnel as described in the 1125 Service Manual 2 11 Product Structure The MRidium 3850 MRI Infusion system is mainly consisted of the following L A E IC it REN g s E 3851 with 3850R SideCar Pump Tv n See o o 3855 1120 1119 Remote Display Charger Power Supply IV Pole Stand 2 3 2 4 SECTION 3 LV SET PREPARATION FOR USE 3 0 LV Set Preparation for Use dl de Figure 3 1 Free Flow Preventer Free Flow Preventer is shown in the no flow closed position a Operation of the Free Flow Preventer See Figure 3 1 The Free Flow Preventer 1s used to stop the flow of the fluid through the infusion set The Free Flow Preventer will open automatically to allow fluid flow
64. econdary drug remaining in the line the administration set and fluid container When performing a secondary infusion e Secondary solution container must be higher than the primary solution container e The Secondary VTBI Volume to be Infused setting must be equal to the volume in the secondary container This requires consideration of such variables as factory overfill medication additions etc Underestimating the volume will cause the remaining secondary solution to be infused at the primary rate overestimating will result in the primary solution being infused at the secondary rate Multiple doses from a single container are not possible Air bubbles may form distal to the pump as a result of normal out gassing of dissolved air in the fluid This may occur if a chilled solution is being used if the pump is mounted significantly above the patient or with certain fluids known to routinely outgas In these cases an air eliminating filter may be required During a prolonged infusion routinely inspect I V Set access device and patient line assemblies for proper attachment and orientation Variations of head height back pressure selected catheter type or any combination of these may affect rate accuracy Factors that can influence back pressure are I V set configuration I V solution viscosity and I V solution temperature Back pressure may also be affected by catheter type The use of pumping infusion devices ported toget
65. eeeceeeeeeeeaaas F 1 Appendix G Trumpet and start up curves nennen nennen G 1 Appendix H 1119 I V Pole Assemblies and Parts Descriptions H 1 iii Figure 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 1 10 3 1 3 2 3 3 4 2 4 3 4 4 4 5 4 6 4 7 4 8 4 9 4 10 6 1 6 2 Table 5 1 FIGURES Page o AA A ra EU NIBUS E MN DIA UIM UNE 1 2 Pimp Dive Door UP YX 1 3 eseguiti e EN 1 4 Pack or Pomp Oreina NEIERENS EEI 1 5 Model 1120 MRI cocus 6 een tdi 1 6 Front of 3553 Remote Display DIPBBE ee l 7 Back of 3855 Remote Dis plas Baer nenne 1 8 From Pone BR B C nee S 1 9 Seo Dony Ser Eege 1 11 vn sd os qe o aldea EE 1 12 ss a MT 3 ula iie e T n 3 id a i M 3 5 Primary Pomp SEID e uiii Eege 4 3 BIB Taote ion IIIA DRITTE 4 6 Secondary Infusion Set up and Programming Screen 4 7 Dons Senp RE 4 9 ASA ALA E 4 11 specal as o EE 4 12 Dose ale CACAO DIST scada 4 12 Primary Screen with Dose Rate Displayed esee 4 15 Alam een E E nee 4 15 EE BRA AAA IP ori RTT 4 18 ii A A A 6 1 Li AA rio II 6 2 TABLES Page Alarm Alert ano User Prompt Mesa Seege insti iii dias ic 5 2 General Information This document provides the following directions for use e Single channel pump that provides a full range of features in a compact easy to use linear
66. environment Emissions Test Compliance Electromagnetic environment quidance RF emissions Group 1 The MRidium 3850 System must emit electromagnetic energy CISPR 11 in order to perform its intended function remote communications within an specific band for WLAN i e 2 431 to 2 474 GHz Nearby electronic equipment may be affected RF emissions Class B The MRidium 3850 System is suitable for use in all CISPR 11 establishments other than domestic and those directly Harmonic Not applicable connected to the public low voltage power supply network that emissions IEC supplies buildings used for domestic purposes 61000 3 2 Voltage Not applicable fluctuations flicker emissions IEC 61000 3 3 MRIdium 3850 System Table 202 Guidance and manufacturer s declaration electromagnetic immunity for all EQUIPMENT and SYSTEMS Guidance and manufacturer s declaration electromagnetic immunity The MRidium 3850 System is intended for use in the electromagnetic environment customer or the user of the MRidium 3850 System should assure that it is used in such an environment Immunity test IEC 60601 test Compliance level Electromagnetic environment guidance level Electrostatic discharge 6 kV contact 6 kV contact Floors should be wood concrete or ceramic ESD tile If floors are covered with synthetic material IEC 61000 4 2 8 kV air 8 kV air the relative humidity should be at least 30 Electrical fast 2 kV for power 2 kV f
67. er rating of the WE UA 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 D 5 DECLARATION OF CONFORMITY Application of Council Directive s R amp TTE Directive 1999 5 EC Regulation s to which Conformity is Declared R amp TTE Directive 1999 5 EC Standard s to which Conformity is Declared EN 300 328 TEC 60601 1 IEC 60601 1 2 Manufacturer s Name Iradimed Corporation Manufacturer s Address 7457 Aloma Ave Winter Park FL 32792 USA Importer s Name Refer to accompanying Packing Slip Importer s Address Refer to accompanying Packing Slip Type of Equipment MRIdium 3850 Infusion Pump System and accessories Mode
68. er to review This 1s accessed in the Service mode Please see Service Manual 1125 for more details 4 18 SECTION 5 ALARMS 5 0 Alarms 5 1 Introduction 5 2 User Messages There are three 3 types of user messages Alarms Alerts and User Prompts displayed on the pump The following is a description of the user messages a Alarm Major Pump or Channel related problem The infusion stops The RUN ALARM Lamp illuminates RED and flashes The audible alarm tone sounds An alarm message can appear at top of Main Display b Alert Indicates a change in the infusion status The infusion continues to operate The RUN ALARM Lamp illuminates GREEN and flashes The audible tone sounds An alert message can appear at top of Main Display C User Prompt Informational update the infusion status has not changed Generally some steps were not completed or an incorrect key was pressed Prompt message can appear at top of Main Display NOTE When using the Pump with both Channel A and Channel B operating some messages will indicate Channel A or Channel B to identify which channel is affected Always verify the appropriate channel is selected before making any changes If both channels are alarming both RUN ALARM indicators will be flashing RED and the alarm message at the top of the Main Display will alternate both messages See Table 5 1 for a listing of all the messages Alarms Alerts and User Prompts
69. ery pack is damaged this protective circuitry may not prevent battery failure Remove the Battery Pack from use if the Pack becomes damaged or the potential for Battery Pack damage is suspected Do not use a damaged or swollen 1133 Battery Pack Avoid damage to the 1133 Battery Pack by impact dropping overheating or mechanical abuse Never compress drop shock or strike the 1133 Battery Pack Never use objects that could puncture the internal battery cells Any of these actions can cause the battery cells to heat smoke or cause catastrophic battery failure which could result in fire Do not attempt to disassemble the 1133 Battery Pack Damage caused by disassembly or tool use can result in catastrophic battery failure which could result in fire If the 1133 Battery Pack case begins to expand and or swell discontinue battery charging and use immediately and replace the Battery Pack Continued charging will cause further Battery Pack case expansion with possible battery case fracture and potential electrolyte leakage If the 1133 Battery Pack becomes damaged avoid contact with the battery cell electrolyte If the electrolyte contacts the skin or eyes seek medical attention immediately If the 1133 Battery Pack shows sign of the battery case expanding swelling remove the Battery Pack from use and replace it as soon as possible In extreme conditions this swelling can cause the 1133 Battery Pack to become jammed or stuck within th
70. eter that affects a Primary infusion calculated value e g Dose CONC Weight etc has been modified after setting up an infusion Check Door A or B Recheck Settings Press Enter to restart Re enter settings press ENTER to continue Review Primary Review Bolus Prompt A selected parameter that affects a Bolus infusion calculated value e g Dose CONC Weight etc has been modified after setting up an infusion Prompt A selected parameter that affects a Secondary infusion calculated value e g Dose CONC Weight etc has been modified after setting up an infusion 5 4 Be sure door clamp is closed tightly flush with door Open and reclose door or assure Free Flow Preventer is pulled out to stop position Press the ENTER key Previous values are replaced with default values Verify and reenter new settings Press the ENTER key Previous values are replaced with default values Verify and reenter new Settings Select the Dose Rate Calculator Primary Infusion screen Infusion can t be started without reviewing this setup screen Review and verify the new infusion parameter s before starting the infusion Select the Dose Rate Calculator Bolus Infusion screen Infusion can t be started without reviewing this setup screen Review and verify the new infusion parameter s before starting the infusion Select the Dose Rate Calculator Secondary Infusion screen Infusion can t be started without
71. ew Patient only Press the Rate soft key Observe that the rate value is highlighted Adjust the Rate using the up and down arrow control keys if necessary Press Enter to accept value Observe that the VTBI value is highlighted Use the up and down arrow control keys to change the VTBI value if necessary 0 op BO 1 Press the VI soft key twice to clear the volume infused if necessary 4 3 Dual Channel Infusion The MRidium 3850 pump may be configured to perform simultaneous infusions on both Channel A and B if equipped with the optional S deCar 4 3 1 Dual Channel Infusion Setup To perform a dual channel infusion configure both Channel A and Channel B as described in Paragraph 4 2 Push the Start Stop buttons of both channels to begin the infusion Once both infusions are started the display screen splits to display information for both infusion channels Figure 4 2 4 5 dl ME 06 11 55 Primary A gt iawn ete gt Rate 1 D me EH m Channel A Channel B mL Volume Infused lt lt Primary B Volume Infused gt Rate 1 0 me ias oi Channel B gt VTBI 25 mL EN be Dual Channel Infusion Split Screen Figure 4 2 Dual Infusion Display 4 4 Secondary Infusion Configuration The MRidium 3850 pump supports secondary infusions in the form of automatic sequential piggybacking Medications must be compatible to be infused in this manner as they will mix in the tubing below the injection site
72. g 2 2 Unpacking the Pump Remove the pump and all accessories from their shipping carton and examine for visible damage that may have occurred during shipping Check the materials carefully against the packing list and purchase request Save all the packing materials invoice and bill of lading as these may be required to process a claim against the carrier if there s damage from shipment Contact Iradimed Corporation Customer Service for prompt assistance in resolving shipping problems The following is a list of items shipped with the pump e MRidium 3850 MRI IV Pump e MRidium 1124 Operations Manual e MRidium 1125 Service Manual CD e Battery Pack for MRidium 3850 MRI IV Pump e Battery Charger AC Adapter and Interconnect Cable e Hospital Grade Power Cord e One 1 Sample I V Set Provided for initial Clinical Engineering testing e 2 4 GHz Antenna with Remote Option e MRidium 1127 Quick Reference Hang Tags NOTE Customer must order MRI infusion sets separately for use with this product 2 3 Unpacking Remote Display Charger Remove the Remote Display Charger and all accessories from their shipping carton and examine for visible damage that may have occurred during shipping Check the materials carefully against the packing list and purchase request Save all the packing materials invoice and bill of lading as these may be required to process a claim against the carrier if there is damage from shipment Contact
73. her with gravity flow infusion systems into a common IV site primary IV set with secondary IV lines can affect the accuracy of the gravity flow systems and result 1n unintended flow rates from these gravity systems Always ensure the common IV site is acceptable for use under these conditions Reference to specific drugs and default parameters are provided for the user s convenience Always refer to the specific drug product labeling for information concerning appropriate administration techniques and dosages Battery Pack Related Precautions The 1133 Battery Pack contains several lithium polymer cells and an integral safety circuit As these cells age they can expand due to internal gas release which is anticipated for this type of cell However if excessive expansion occurs this can result in the battery case expanding swelling and possibly cause failure of the battery case cells or safety circuit If this 1s observed remove the Battery Pack from use and replace it as soon as possible The 1133 Battery Pack contains protective circuitry to prevent catastrophic battery failure If the Battery pack is damaged this protective circuitry may not prevent battery failure Remove the Battery Pack from use if the Pack becomes damaged or the potential for Battery Pack damage is suspected Do not use a damaged or swollen 1133 Battery Pack Avoid damage to the 1133 Battery Pack by impact dropping overheating or mechanical abuse Never co
74. ide clamp and remove blue tubing protector from silicone rubber pumping segment Remove protective Clear Cap Attach syringe with fluid to vented Syringe Adapter Fitting at top of I V set Follow accepted hospital procedure Ensure Tube Slide Clamp and FLOW PREVENTER are open NOTE When attaching syringe ensure air vent tube is placed inside the syringe fluid path opening before luer locking the syringe E d e Manually push syringe to prime I V Set removing all air bubbles Open air vent cap on Syringe Adapter Fitting See Figure 3 3e Close slide clamp and close FLOW PREVENTER by sliding black pinch clamp outward Grasp FLOW PREVENTER slide clamp and load pump segment into Pump Close Pump Door Ensure syringe with fluid 1s mounted vertically after set 1s loaded and Door is closed Attach distal luer outlet White cap to the port nearest the patient s vascular access device Open set slideclamp and begin infusion CAUTION Do not strike or jar the syringe adapter it has been loaded onto the 1057 Syringe Adapter Set and mounted onto the pump I V set or syringe damage could occur NOTE Small diameter tubing 0 040 inch is used in the 1057 Set Dependent on the desired Flow Rate and fluid viscosity the Pump s Occlusion Pressure Limit may need adjustment to avoid false alarms Pressures may exceed the maximum allowable limit for Flow Rates above 600 mL hr Do NOT depress the syringe plunger during infusion
75. imed Corporation Definitions Channel A The designation for the first infusion channel All pumps contain at least one linear peristaltic pump head for one infusion line Channel B The designation for the second infusion channel The second infusion pump head is optional and some pumps may not contain it KVO Keep Vein Open D Primary Main Infusant for the prescribed I V therapy The infusion settings that are implemented after any secondary infusion sequence is complete Rate Infusion rate 1n mL hr Secondary The first infusion settings to be implemented in an infusion sequence Sometimes referred to as piggyback VI Volume Infused n mL Volume To Be Infused in mL xli Symbols Attention Consult Accompanying Documents Defibrillator Proof Type CF Applied Part Date of Manufacture Indicates that the device conforms to the Medical Device Directive Direct Current Product is Latex free Drops per millimeter specification for I V Set is identified on Drop Symbol Lot or batch code for LN Set will be identified near Lot Symbol Approximate Set priming volume Main Battery Capacity X inside Icon denotes no battery installed AC Power is connected to 100 240 VAC Secondary Infusion Mode Volume to be Infused Caution Federal U S A law restricts this device to sale by or on the order of a physician Maximum rated load is 20 Kg Do not discard Contact recycler for pro
76. in which it is being used 4 1 1 Administration Sets Use only Iradimed Corporation approved MRidium 1000 series infusion sets The use of any other set will cause improper pump operation and will result in inaccurate fluid delivery and risk to the patient Before beginning any infusion cycle verify that the infusion lines are free from kinks and are loaded correctly on the pump Do not reuse any component that is labeled for single use Discard these items immediately after use 4 1 4 1 2 Artifacts It is normal for this pump to produce non hazardous currents when being used for the infusion of electrolytes These currents will vary proportional to the pump s infusion rate Therefore when an ECG monitoring system is not functioning under optimal conditions these currents may appear on the ECG display screen as artifacts and simulate actual ECG readings To determine if the ECG abnormalities are caused by patient condition or the ECG equipment receiving artifact from the pump place the infusion pump on HOLD and observe the ECG signal If the ECG signal becomes normal the ECG monitor requires attention as proper setup of the ECG equipment should remove the pump caused artifact Reference the appropriate ECG monitoring system documentation for instructions on setup and maintenance of the ECG device NOTE Operating parameters Power VTBI etc are retained in memory for one 1 hour unless all power is lost no AC and a depleted bat
77. ing under current operating conditions It is located in the upper portion of the display and is always visible Check the remaining battery capacity when starting an infusion The Battery Gauge updates continuously while infusing a The battery recharges whenever the Pump and its Power Adapter is plugged into an AC power outlet or optionally when the Battery Pack is inserted into the Remote Display Unit b The system includes A green amber light that illuminates when Pump Remote is plugged in to the AC power with the Power Adapter An amber light that illuminates when Pump is charging the battery green indicates charging current termination and the Battery Pack is fully charged Automatic switchover to battery power if Pump is unplugged or in the event of a power failure Note This automatic switchover is not applicable in the Remote Display Unit as it cannot operate on battery power 6 7 Battery Low Indication A Low Battery alert indicating that battery depletion is imminent beginning at least 30 minutes prior to a depleted battery alarm For best results fully charge discharge and recharge the battery before putting the Pump into service Battery run time will be affected by the operating mode rate and back pressure Should the battery smart power gauge detect an over discharge of one or more internal cells the pump will provide a BAD BATTERY alarm condition The pump should be turned off and on and re
78. ion are included in the MRidium M 3850 MRI Infusion Pump Service Manual part number 1125 This option may appear on the second Menu page 4 7 6 NEXT MENU key The NEXT MENU will appear if the Remote Display option or the Channel B SideCar option is installed pressing the NEXT MENU soft key will display additional menu options a Set Comm Channel If the remote control option is installed pressing this soft key will select the Radio Channel selection menu WARNING Upon signal reacquisition between the Pump and the Remote Display always visually confirm that both Pump and Remote displays change with a selection of the MENU key this won t affect the Pump operation if it 1s 1nfusing If using multiple Pumps with the same Remote Display Charger always program each Pump with its unique radio link channel Channels 1 through 6 in the Setup Menu Additionally when changing the Remote Display Charger radio communication channel always re confirm proper communication with the selected Pump This can be done in many ways but the easiest way is to select the MENU key on the Remote Display Charger and visually confirm that the Pump s display matches this change Pressing the CANCEL key on the Remote Display Charger should then return both displays to the original display Doing this at least once before any Pump programming will acknowledge that proper communication has been established between the Remote Display Charger and the selected Pump
79. ions see subparagraph 3 3 2 WARNING DO NOT STRETCH the silicone rubber segment of the I V Set When properly loaded the silicone rubber segment should be taut without slack and centered atop the pump s peristaltic fingers as shown in Figure 3 3 page 3 5 Overstretching or mis positioning of this tubing can result in inaccurate flow and or free flow WARNING Confirm that the I V Set is fully primed prior to inserting the set into the pump 3 3 1 Administration Set Insertion Perform the following to insert the Administration set into the pump See Figure 3 3 a Press the ON Control Key 1 b Open MRidium 3850 Pump door C Install administration set pumping segment by properly positioning the upper tubing retainer see Figure 3 3a and ensure Free Flow Preventer is closed see Figure 3 3b DO NOT STRETCH TUBING d To insert the Free Flow Preventer tilt the Free Flow Preventer top in first see Figure 3 3c and rotate bottom downward to lock into place using Free Flow Preventer s slide clamp Assure tubing above Flow Preventer is located directly down the middle of white PUMP fingers see Figure 3 3g e Run tubing through the Air in Line detector see Figure 3 3d at the bottom of the pump f Close MRidium 3850 Pump door g Open roller clamp or slide clamp depending on IV set type h Verify no flow is flowing through the drip chamber 1055 1056 or 1058 type IV Sets or 1f using 1057 syri
80. ip the pump transportation prepaid to the location specified by your Iradimed Corporation Service Representative with the Return Authorization Number written on the outside of the shipping carton Repairs will be made normally within two 2 weeks and the pump will be returned to you prepaid To ensure full reliability it is recommended that all repairs be made by an Iradimed Corporation Authorized Service and Repair center For repair at your facility a competent individual experienced in the repair of pumps can repair the pump only IF it 1s authorized by Iradimed Corporation Technical Service prior to the repair CAUTION No repair should ever be attempted by anyone not having a complete knowledge of the repair of Iradimed Corporation pumps Only replace damaged parts with components manufactured or sold by Iradimed Corporation Contact the Iradimed Corporation Technical Service and Repair Center for service and technical assistance B 1 APPENDIX C WARRANTY INFORMATION Iradimed Corporation warrants its major products i e pumps remote displays secondary pumps to be free from defects in materials and workmanship for a period of twelve 12 months from the date of original delivery to the buyer or to buyer s order provided that same is properly operated under conditions of normal use and that periodic maintenance and service is performed A ninety 90 day warranty applies to limited life parts e g 1133 MRI Compatible Battery Pac
81. k 1170 Fiberoptic SpO2 sensor and Series 1000 infusion sets A thirty 30 day warranty applies to all parts and accessories not listed above This warranty will become null and void if product has been repaired other than by Iradimed Corporation or its authorized representative or 1f the product has been subject to misuse accident negligence or abuse Iradimed Corporation s sole obligation under this warranty is limited to repairing a product which has been reported to Iradimed Corporation s Technical Service Center during normal business hours and shipped transportation prepaid Iradimed Corporation is not liable for any damages including but not limited to incidental damages consequential damages or special damages This warranty is in lieu of any other warranties guarantees or conditions including merchantability or fitness for a particular purpose The remedies under this warranty are exclusive and Iradimed Corporation neither assumes nor authorizes anyone to assume for it any other obligation in connection with the sale or repair of its products A purchased Maintenance Extension agreement provides for an additional 1 2 or 3 years of authorized repair for major products The maintenance extension period will begin at the end of the standard warranty period and continue until the end of the maintenance extension period purchased The extended maintenance does not apply to equipment which has been subject to abuse or neglect M
82. l No s 3850 Series and 3855 Series Serial No s Refer to accompanying Packing Slip Year of Manufacture Refer to accompanying Packing Slip Certification Method s ___Self certified I the undersigned hereby declare that the equipment specified above conforms to the above Directive s Regulation s and or Standard s Place Winter Park FL Signature Date April 10 2007 Francis Casey Full Name Regulatory Affairs Position Declaration of Conformity with Regard to the EU Directive 1999 5 EC R amp TTE Directive Scope The information in this document is applicable to the MRidium 3850 System using the 3850R MRI Infusion Pump with 2 4 GHz FHSS Transceiver and 3855 Remote Display Controller with the 2 4 GHz FHSS Transceiver and other related products as they come to market The equipment operates in the bands or portions of 2400 to 2483 5 MHz National regulations may require that operations be limited to a portion of the frequency ranges identified above See the National Restrictions section for full details Declaration of Conformity Czech CS Toto zafizeni je v souladu se zakladnimi pozadavky a ostatnimi Cesky odpovidajicimi ustanovenimi sm rnice 1999 5 ES Danish DA Dette udstyr er i overensstemmelse med de v sentlige krav og andre Dansk relevante bestemmelser i Direktiv 1999 5 EF Dutch NL Dit apparaat voldoet aan de essentiele eisen en andere van toepassing Nederlands
83. ld be dropped or severely jarred t should be immediately taken out of service and inspected by a qualified biomedical technician 1 1 Product Description The MRidium 3850 MRI Infusion System is designed for operation in the MRI environment and may be used on the patient near the MRI magnet up to the 1 0 Tesla or 10 000 Gauss Line Operating on battery power when fully charged this system will provide up to 12 hours of operation at an infusion rate of up to 125 mL hr and at least four 4 hours at rates up to 999 mL hr The MRidium Wireless Remote Display allows for remote ability to control the Model 3850 MRidium MRI Infusion Pump with a total of two channels from outside the MR Scanner It utilizes the same user interface as the infusion pumps and will allow adjustment of all pump parameters rates titration volume to be infused starts stops and resetting alarms The large clear display shows all pump information at your desk top from the control room The Wireless remote also acts as a charger for a backup or spare battery pack for the 3850 MRidium MRI Infusion Pump It utilizes a wireless link at 2 4 GHz for easy installation with no image artifacts The 3850R designates a 3850 Pump with the optional 2 4 GHz wireless link for communication with the 3855 Remote Display NOTE The Remote Display Charger only operates on AC Mains Power This unit does not operate on battery power This unit does not sound a Low Battery alarm for the Sp
84. letely Set is not properly mounted in Open pump door and re load Pump won t start pump Administration Set Pump program has not been Enter Pump settings and initiate Pump entered by pressing START STOP for appropriate channel E 1 nn re s de of Set s not Inspect Meere damage or leaks and properly connected replace if necessary Damaged Set is leaking Fluid Leaking from Administration Set Examine Set to locate leak Disconnect Set from the patient Replace and resume infusion Battery not properly charged Plug pump power cord into AC power source until battery is fully charged a won t operate Aged battery won t hold Plug pump power cord into AC power on battery charge source until battery is fully charged If battery won t charge replace battery pack Battery not properly charged Plug pump power cord into AC power source until battery is fully charged Aged battery won t hold Plug pump power cord into AC power charge source until battery is fully charged If battery won t charge replace battery pack and charge again If problem persists refer to qualified service personnel Battery operation 1s too short Battery is hard to Battery cell failure due to Remove replace battery in pump remove from Pump over discharge or individual using appropriate tools as needed cell failure Refer damaged battery to qualified service personnel Occlusion Pressure limits not Adju
85. mber e When the VTBI 0 mL the pump gives an audible alarm and the primary parameters resume and are displayed WARNING The clamp on the secondary set must be opened If the clamp is not opened the fluid will be delivered from the primary container The Secondary VTBI must be equal to the volume in the secondary container Variables such as factory overfill and the amount of medication must be considered when programming the VTBI Underestimating the secondary VTBI will result in the remainder of the secondary solution to be delivered at the primary rate 4 4 4 Viewing Primary Settings during a Secondary Infusion It is possible to view the primary settings while a secondary infusion is in process Perform the following to view the primary settings during a secondary infusion a Press the Adjust Primary soft key b Observe that the primary parameters are now displayed on the central display screen with the secondary infusion continuing without interruption C Press the CANCEL soft key to return to the secondary run screen or wait five 5 seconds for Timeout Return 4 4 5 Changing Primary Settings during a Secondary Infusion It is possible to change the primary settings while a secondary infusion is in process Perform the following to change the primary settings during a secondary infusion a Press the Adjust Primary soft key b Observe that the Primary parameters are displayed with the Rate value highlighted
86. mpress drop shock or strike the 1133 Battery Pack Never use objects that could puncture the internal battery cells Any of these actions can cause the battery cells to heat smoke or cause catastrophic battery failure which could result in fire Do not attempt to disassemble the 1133 Battery Pack Damage caused by disassembly or tool use can result in catastrophic battery failure which could result in fire If the 1133 Battery Pack case begins to expand and or swell discontinue battery charging and use immediately and replace the Battery Pack Continued charging will cause further Battery Pack case expansion with possible battery case fracture and potential electrolyte leakage If the 1133 Battery Pack becomes damaged avoid contact with the battery cell electrolyte If the electrolyte contacts the skin or eyes seek medical attention immediately If the 1133 Battery Pack shows sign of the battery case expanding swelling remove the Battery Pack from use and replace it as soon as possible In extreme conditions this swelling can cause the 1133 Battery Pack to become jammed or stuck within the 3850 Pump or 3855 Remote Display and or cause the Battery Pack plastic case to burst open If this occurs do not use tools that could cause damage to the internal battery cells Refer to the 1125 Service Manual for removal under these conditions Under no circumstances should Battery Packs or the internal cells be incinerated as this can cause a
87. n explosion Xl User Responsibility This product will perform in conformity with the description contained in this users manual and accompanying labels inserts etc when assembled operated maintained and repaired in accordance with the instructions provided This product must be checked and calibrated periodically A malfunctioning product should not be used Parts that are broken missing plainly worn distorted or contaminated should be replaced immediately Should such repair or replacement become necessary refer unit to Iradimed Corporation qualified service personnel This product or any of its parts should not be repaired other than in accordance with written instructions provided by the manufacturer or altered without written approval of Iradimed Corporation The user of the product has the sole responsibility for any malfunction which results from improper use faulty maintenance improper repair damage or alteration by anyone other than Iradimed Corporation or Iradimed Corporation authorized service personnel Using This Manual Read this manual completely before attempting to use the pump Warning Cautions and Notes This manual contains three levels of precautionary information e A Warning alerts the user that there is a possibility of injury or death to a human being e A Caution alerts the user that there is a possibility of damage to equipment e A Note contains essential information deemed especially important by Irad
88. n sets For those not familiar with trumpet curves the 0 line in each Figure represents the set flow for the pump and quantities above this line represent the percentage by which the delivered flow exceeds the set flow rate Quantities below the line represent a flow rate that delivers less than the set flow rate The heavy dark solid line represents the average flow rate error for the entire test interval typically less than 3 The maximum positive and negative mean flow errors are shown at 2 5 11 19 and 31 minute averages and the trumpet curves interpolate the data between these points The longer the time interval is the narrower the error range will be For example an interval of 15 minute will show a narrower error range than an interval of 3 minute This s because at longer observation intervals fluctuations even large ones occurring for only a few minutes represent a comparatively small portion of the data points being analyzed Conversely for a shorter interval any fluctuation will have greater weight Because of this weighting the plotted curve takes on its trumpet shape with the bell of the trumpet widening at the shorter observation periods For further information refer to Health Devices Vol 27 Nos 4 5 April May 1998 As detailed in the product standards listed below trumpet curves are named for their characteristic shape They display discrete accuracy data averaged over particular time periods or
89. nd RBOIowal s eescinescteseeiu aan 3 4 3 3 1 Administration Set Insertion E 3 4 Jad Amm taor A AAA O 3 4 Pump Preparation for Use ooooonncccnnccnoncnononcconnnnnnnnnnnnnnnccnnnnnnnnnononanccnnnnnnnnnnnnnns 4 Su 4 o 4 A rare gt NERO TU A 4 AA X X 4 2 PEE nn e EEE EEE EINEN NEN SEINEN EUM M Stu D EIE 4 2 4 2 1 Programming a Basic Infusion enne 4 3 Gc BOB Bel DEDE PORE een 4 4 4 2 3 Canceling Pausing an UESTRE TT 4 4 4 2 4 KVO Keep Vein Open Infusion Complete cesses 4 4 29 MEE ou DE 4 4 Mer AAA 4 5 4 2 7 Restoring an Infusion following Pump Power Down 4 5 Dual di IMA E Nm 4 5 Di MCI BEC Nini dir PIRE UU TEM 4 5 Secondary Infusion Configuration ocurriera 4 6 4 4 1 Priming a Secondary Administration aert 4 7 242 CUA III E 4 7 4 4 3 Programming a Secondary Infusion oooocccnnnnncnnnnnnnnonnnnnnnnnnnononanononannnnnnnnnnnos 4 8 4 4 4 Viewing Primary Settings during a Secondary Infusion oooooooccnnnnnnnnnnnnnns 4 8 4 4 5 Changing Primary Settings during a Secondary Intusgion 4 8 4 4 6 Stopping a Secondary Infusion and Returning to the Primary Infusion 4 9 DOM ME ww BE E 4 9 A 4 10 dE Pons EAST 4 10 e RINE Bolis Rate RE 4 10 Bi Restornne Bolis bu E 4 10 A gt EE 4 11 4 6 1 Attaching
90. ndicator is flashing 4 3 Verify infusion in running from primary container by observing the drip chamber or air bubbles within the loaded syringe 1057 set only NOTE The Pump needs to be ON prior to loading the I V Set If tubing is installed prior to turning Pump on Load Set or Unload Set messages may appear Remove and replace I V Set to clear Ready to Start prompt will appear 4 2 2 Editing the Infusion Program The clinician has the ability to change or edit titrate the infusion program without having to pause the infusion Perform the following to change or edit the infusion program a Press the RATE or VTBI soft key and set the new parameter s using the up and down arrow control keys b Press ENTER to accept the new value NOTE While the pump is in use all infusion parameters are stored in memory unless the pump has been powered down for more than one 1 hour 4 2 3 Canceling Pausing an Infusion The clinician has the ability to pause an infusion by pressing the START STOP Channel control key for the channel to be cancelled paused once When the START STOP Channel control key has been pressed the pump will display CANCEL INFUSION next to a soft key and the indicator light will go out Every 10 seconds the pump will give a periodic audible tone to remind the operator that the pump 1s still on hold a To cancel the infusion press the soft key next to the CANCEL INFUSION message b To res
91. ned during an infusion Prompt Latch is open prior to starting an infusion Message occurs with an audible beep that repeats every 10 seconds Alarm Pressure in I V line has exceeded Adjustable Pressure Limit due to elevated resistance in delivery path between pump and patient Prompt Dose Complete Audible Only MAX Rate Audible Only Critical Error xxx Close Door A or B Close Door A or B Patient Occluded A or B Settings Lost Message occurs at power up to indicate the existing operating parameters have been erased due to internal battery failure and the system has reverted back to initial default parameter settings DEAD BATTERY Alarm Battery too low to operate Pump 5 2 Evaluate air in set Open Pump Door latch to remove set Remove air per hospital protocol Reinstall set Press START STOP to resume infusion Plug AC Adapter power cord into an AC outlet immediately Make sure Adapter is plugged into the Pump Plug Pump into AC Adapter and or AC Adapter power cord into an AC outlet as soon as possible No action necessary Pump enters KVO Verify and reenter settings Remove from use Contact qualified service personnel Check for proper set installation Close latch Press START STOP to resume infusion Close latch fully downward Check administration set for probable cause kinked tubing closed stopcock high resistance catheter etc Press ST
92. ng the secondary line using the fluid from the primary container the back priming technique minimizes the amount of wasted medication that might occur using the Forward Priming technique NOTE The Back Priming technique may be used for subsequent doses of medication If there is any question on drug incompatibilities consult with the hospital pharmacist before performing the Back Prime technique a Back Priming Technique Perform the following to back prime a secondary administration set using aseptic technique 1 2 3 4 5 Spike secondary medication bag and clamp secondary tubing Attach the secondary set to the upper injection port on the primary administration set Lower the secondary fluid container below the upper injection port on the primary administration set Open the clamp on the secondary set to allow fluid from the primary to back prime into the secondary line When the secondary set is completely primed close the clamp and suspend the secondary container on the I V pole higher than the primary fluid container 4 2 Secondary Infusion Setup Perform the following to setup a secondary infusion a Lower the primary fluid container onto a non magnetic hanger may be enclosed with the secondary administration set Verify hanger is non magnetic prior to use This will allow the pump to pull from the secondary fluid container b Attach the primed secondary set to the upper injection port of the
93. nge set be sure to open vent cap prior to starting pump see Figure 3 3e f 3 3 2 Administration Set Removal Perform the following to remove the Administration set from the pump a Press the START STOP Channel control key on the MRidium 3850 Pump Close roller clamp or slide clamp depending on IV set type E Open the MRidium M 3850 Pump door which automatically closes the Free Flow Preventer d Remove the tubing by grasping the Free Flow Preventer by the Slide Clamp and push down while tipping the top outward 3 4 The tubing will allow gravity flow when the Free Flow Preventer pinch clamp and the roller clamps are in the open position This provides the ability to infuse fluids medications via gravity in an emergency situation WARNING Check Free Flow Preventer black side clamp is fully pulled outward to the shut off position CAUTION Check Free Flow Preventer black side clamp is fully pulled outward shut off any time the chamber door is not fully latched in the closed position Partial closure of the door may open the Free Flow Preventer always close door and fully latch Figure 3 3 IV Set Installation 3 5 3 6 SECTION A PUMP PREPARATION FOR USE 4 0 Pump Preparation for Use 4 1 Quick Setup Perform the following to setup the pump Press the 1 control key to power on the MRidium 3850 Infusion Pump a If displayed select Same Patient to use the last infusion settings o
94. nspect for any physical damage after each use Perform the following to clean the pump Unplug power cord from AC outlet before cleaning Remove Battery Pack from the rear of the Pump Do not spray fluid directly into any connector a oOo g 8 Use a soft cloth dampened with warm water and a mild nonabrasive cleaning solution ek A soft bristled brush may be used to clean narrow areas f Use light pressure when cleaning pressure transducer and air in line detector areas of the pumping channels g Acceptable cleaning solutions include use per manufacturers instructions Soap and Warm water Cidex or other glutaraldehyde based surface disinfectants Quaternary ammonium compounds 10 Bleach Solution 1 part bleach to 9 parts water CAUTION Do not use solvents or aromatic solvent based cleaning agents Damage to plastic parts of the Pump could occur These include solutions containing aromatic solvents naphtha paint thinner etc chlorinated solvents Trichloroethane Methy Ethyl Ketone MEK Toluene etc alcohol or phosphoric acid DO NOT use hard or pointed objects or pressurized sprays to clean any part of the Pump or Channel B S deCar DO NOT steam autoclave EtO sterilize or immerse the Pump or Channel B SideCar SECTION 2 INSTALLATION 2 0 Installation 2 1 Introduction This pump has been designed for the control and fluid management of patients undergoing magnetic resonance imagin
95. nstalled on the left side of the display the user may select and program Channel B n the same manner as Channel A by selecting the Channel B softkey qa WM 06 11 55 gt gt gt mL hr Primary A gt Rate 1 0 gt VTBI 0 mL vi 0 0 mL gt Secondary gt Bolus gt Channel B Figure 4 1 Primary Pump Setup Screen 4 2 1 Programming a Basic Infusion Perform the following to enter the primary Rate and VTBI for infusion a b C 00 En Insert primed MRidium 3850 LV Set into pump and close door Observe that the RATE value is highlighted if not highlighted select using the soft key to the left of Rate Press the up and down arrow control keys to enter the desired flow rate Press ENTER or VTBI soft key to move to the next field Observe that the VTBI value is highlighted Use the up and down arrow control keys to enter the desired volume to be infused Observe that the Ready to Start Prompt is displayed If Ready to Start is not displayed check the I V Set loading and for proper door closure latching NOTE The VTBI is displayed on the main display screen of the MRidium 3850 pump and will count backwards to 0 mL At that time the infusion rate will change to the predetermined KVO rate and the VTBI will display KVO rate h Press the START STOP A or B Channel control key for the proper Channel to begin the infusion Observe that the rate and VTBI are displayed and the green infusing i
96. o hospital grade AC Mains power Fuse Holder Provides replaceable 1A 3AG 250V fuse for the AC Mains power Ground Terminal Used for grounding lug during electrical testing Battery Charger Compartment Located at the top rear of the Remote allows charging of an 1133 Pump Battery when battery is installed and Remote is connected to AC Mains outlet as indicated by AC Power Battery Charge LED located below the power On Off keys Remote Charger is AC powered only and will not run on battery power CAUTION Battery pack is slightly magnetic Use caution when transferring battery pack from pump to Remote Charger near strong magnetic fields 2 4 GHz Ant Battery Charger bu Compartment 2 4 GHz shown with battery Antenna Connector Audible opeaker Ground Terminal Fuse Holder AC Power Input Figure 1 7 Back of 3855 Remote Display Charger 1 8 1 2 Controls The MRidium M 3850 MRI Infusion System is controlled with the use of soft touch control keys These control keys are located on the front panel of both the Pump and Remote Display These control keys provide for turning the Pump and Remote Display ON or OFF starting stopping Channel s A and B infusion sequences accessing and navigating in operational menus review of data and setups and for silencing any active alarms that may occur 1 2 1 Front Panel Control Keys See Figure 1 8 for location of the control keys Mk idium RARI INFUSION SYSTEM StI S
97. ol key to return to the run or programming display screen NOTE The Alarm Volume setting in the MENU option of the Pump and Remote Display Charger only controls the unit being adjusted Adjusting the Alarm Volume setting on the Remote Display will not change the Alarm Volume setting of the Pump 4 75 5 KVO Rate The MRidium 3850 MRI Infusion Pump will default to a preset KVO Keep Vein Open rate when the Primary infusion VTBI counts down to 0 mL This KVO rate may be set to a value between 1 5 mL hr according to your hospitals policy from the Special Feature Setup Menu Perform the following to adjust the KVO Rate a Press the MENU control key b Press the KVO Rate soft key C Press the soft key corresponding to the Channel you wish to change if the optional second channel is not present then only Channel A will be available NOTE Always select the appropriate KVO rate for the prescribed fluid therapy d Use the up and down arrow control keys to adjust limit between 1 5 mL hr e Press ENTER f Press the CANCEL control key to return to the main programming screen NOTE This option may appear on the second Menu page 4 7 4 Occlusion Limits The MRidium 3850 MRI Infusion Pump will display an Inlet Occlusion alarm when there is an occlusion between the infusion bag and the pump Patient Occlusion alarm will display when there is an occlusion between the pump and the patient this alarm has an adjustable pressure limit between
98. operator has the ability to clear the VI for a specific channel or for all attached channels from the setup screen only The VI is displayed on the run and setup screens 4 4 a Clearing Total Volume Infused Perform the following to clear the total Volume Infused from the setup screen 1 Press the VI soft key 2 Observe that displays the message Press VI again to clear display 3 Press the VI soft key again to clear the total volume infused 4 2 6 Pump Shut Down When the pump is powered down it will retain the infusion parameters including volume infused and operational setups for a period of one 1 hour Perform the following to shut down the pump a If an infusion 1s in process press the START STOP Channel control key to place the infusion on hold then press the Cancel Infusion soft key b Press and hold the control key for two 2 seconds an audible tone will sound then the pump will power down 4 2 7 Restoring an Infusion following Pump Power Down Perform the following to restore an infusion after shutting down the pump a Press the ui control key b Observe that Resume Therapy appears after the self check 1f 1t has been less than one 1 hour since shut down The display will prompt for the selection of either New Patient or Same Patient Press the soft key to select the appropriate choice If power has been off for more than one 1 hour the primary setup screen will display N
99. or power supply Mains power quality should be that of a typical transient burst supply lines lines commercial or hospital environment IEC 61000 4 4 1 kV for 1 kV for input output input output lines lines Surge 1 kV differential 1 kV differential mode Mains power quality should be that of a typical mode commercial or hospital environment IEC 61000 4 5 2 kV common 2 kV common mode mode Voltage dips short 5 UT gt 95 lt 5 UT gt 95 dip in Mains power quality should be that of a typical interruptions and voltage dip in UT for 0 5 UT for 0 5 cycle commercial or hospital environment If the user variations on power supply cycle of the MRidium 3850 System requires input lines continued operation during power continued IEC 61000 4 11 40 UT 60 40 UT 60 dip in operation during power mains interruptions it is dip in UT for 5 UT for 5 cycles recommended that the MRidium 3850 System cycles be powered from an uninterruptible power 70 UT 30 70 UT 30 dip in supply or a battery dip in UT for 25 UT for 25 cycles cycles lt 5 UT gt 95 5 UT gt 95 dip in dip in UT for 5 UT for 5 sec sec Power frequency 50 60 3 A m 3 A m Power frequency magnetic fields should be at Hz magnetic field levels characteristic of a typical location in a IEC 61000 4 8 typical commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the test level D 3 Table 20
100. ource of Non lonizing Radiation Symbol 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 structures 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 MHz to 40 70 MHz b 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 likelinood 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 c Field strengths from fixed transmitters such as 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 electromagnetic site survey should be considered If the measured field strength in the location in which the MRidium 3850 System is used exceeds the applicable RF compliance level above the MRidium 3850 System should be observed to verify normal operation If abnormal
101. pect for damage that could compromise sterility If the pouch or Set is damaged discard and use another Set Administration sets should be changed per the Center for Disease Control CDC guidelines or healthcare provider policy Discard after use Design use life of I V sets is six 6 hours maximum Disconnect the I V line from the patient before starting the priming procedure Prepare the primary solution container in accordance with the manufacturer s instructions The use of positive displacement infusion devices ported together with gravity flow infusion systems into a common I V site may impede the flow of the gravity flow system and affect their performance Hospital personnel must ensure that the performance of the common I V site 1s satisfactory under these conditions 1X Set Related Precautions Continued Interconnection with I V sets with small inner diameter may affect pump accuracy at high flow rates Avoid interconnection with small bore diameter I V sets less than 0 050 inch I V tubing if high flow rates are used A kinked or occluded I V line could cause the pump to operate abnormally and affect the accuracy of the infusion Before operating this system verify that the I V line is not kinked or occluded To avoid nuisance alarms confirm that the fluid source is positioned higher than the pump Setting the primary rate greater than the secondary rate will result in a more rapid infusion of any residual s
102. per disposal Spare Battery Capacity X inside Icon denotes no battery installed xii pe29egpIE AJ TI 1 1 STERILE N Li lon 1 0 VI lt gt e gt g Appropriate for use in MR environment MR Conditional Only appropriate for use in MR environment with manufacturer s defined restrictions MR Unsafe Not appropriate for use in MR environment i e inside the MR magnet room Single Use Only Product Serial Number Alternating Current Product does not contain DEHP in the fluid pathway Product Part Number Expiration date for I V set will be identified near hour glass symbol Denotes I V Set was sterilized with Irradiation Contains Lithium Requires proper disposal recycling of this material Power On or On Power Off or Off Volume Infused Input output connection Allows data communication Input Connection Only Output Connection Only Storage Temperature Range 2 4 GHz Radio is communicating EC REP EC Authorized Representative Telecommunications Alert Symbol Class 2 European Union Countries only Radio Frequency transmission source poslFy This product has been certified to ween This product has been certified to o UL60601 1 and applicable Particular UL60601 1 and applicable Particular Standard IEC 60601 2 24 for which the C US Standard IEC 60601 2 24 for which CNOA TS product has been found to comply by mepicaL Equipment the produc
103. per second when communicating with the pump a Turn both Pump and Remote Display Charger on b Press the Menu key on the Remote Display Charger C See NEXT MENU key on page 4 17 Press the NEXT MENU soft key to bring up additional menu options then press the Set Comm Channel soft key d From the Radio Channel menu select the desired Channel 1 through 6 by pressing the soft key next to that channel and verify that Channel is now highlighted e Press the Menu key on the MRidium 3850 MRI IV Pump f See NEXT MENU key on page 4 17 Press the NEXT MENU soft key to bring up additional menu options then press the Set Comm Channel soft key g From the Radio Channel menu select the same Channel that was selected for the Remote by pressing the soft key next to that channel and verify that Channel is now highlighted 2 2 h Apply an ID marker to both the Remote and Pump indicating the Channel selected Do not apply an ID Marker to the Channel B S deCar module as t can be removed to use on another pump 1 Verify communication between Remote and Pump by pressing the Menu key on one and the Cancel key on the other and observing both display match and change simultaneously 2 9 1 Charging Battery with the Remote If a spare battery is to be charged See Figure 1 7 insert battery into the Remote Display Charger s battery bay Verify spare battery Icon 1s visible on the Remote Display Charger s informational display ar
104. r New Patient for new dose information This menu will not be displayed if pump is off for more than one 1 hour b Adjust Rate using the Up and Down arrow keys then press the Im control key C Adjust VTBI using the Up and Down arrow keys then press the Im control key d Open LV Set Compartment door and install primed and de bubbled MRidium M 1000 Series I V Set Take care that the Black Free Flow Preventer tab is pulled outward e Shut the I V Set Compartment door and press the Start Stop control key for the desired pump channel when the Ready to Start message appears f Monitor pump is correctly delivering I V therapy by viewing the green blinking light above the selected channel Check fluid drip rate in the drip chamber WARNING It is the responsibility of hospital personnel to ensure that drugs used in this system are compatible as well as ensuring the performance of each pump as part of the overall infusion Potential hazards include but are not limited to drug interactions inaccurate delivery rates inaccurate pressure alarms and nuisance alarms WARNING The use of positive displacement infusion devices connected together with gravity flow infusion systems into a common I V site may impede the flow of common gravity only systems and affect their performance It is the responsibility of hospital personnel to ensure that the performance of the common I V site is acceptable under the circumstances
105. restricts this device to sale by or on the order of a physician This device is intended for use by trained medical professionals only Refer all service to Iradimed Corporation Authorized Service Representatives The 3850 Pump has been specifically designed for operation inside an MRI Magnet Room and is designed to operate normally in the presence of most frequently encountered electromagnetic interference in the MRI environment Under extreme levels of interference such as in close proximity to an electrosurgical generator cellular telephone or a 2 way radio normal pump operation may be interrupted Avoid use of this pump under these conditions Use only MRI compatible patient access devices e g needles luer ports etc to prevent any possible RF current from reaching the patient s skin The Remote Display Charger is intended for use in the MRI control room Do not operate the 3855 Remote Display Charger inside the MRI Magnet Room For safe operation use only Iradimed Corporation recommended MRI compatible or MRI safe accessories The MRI pump must be mounted securely when used in the MRI scan room Always securely mount the pump using it s integral pole mount clamp or other mechanical fixing means Always secure the 1 V Pole wheel locks after positioning within the MRI Magnet Room Avoid placing the I V Set adjacent to any electrical conductor within the MRI bore which can become heated during MRI scans The Alarm Sound Volum
106. s Remove the Battery Pack from the Pump or Remote Display and confirm that cells inside the Battery Pack are not swelling excessively as noted by viewing internal cells from the edge of the Battery Pack case Swollen cells that are greater than 8 mm thick or cause the Battery Pack s plastic case to bulge indicate a failing battery pack Any failure of any of the above inspection criteria will require discontinuance of use and replacement of the 1133 Battery Pack 6 10 Battery Pack Replacement If the Battery Pack does not operate for the specified time after a full nine 9 hour charge cycle replacement of the Battery Pack 1s recommended 6 4 CAUTION If placed into storage to maintain battery life assure that the battery pack remains charged above 25 one battery segment is visible as indicated by the gas gauge LED display 6 11 Battery Pack Related Precautions The 1133 Battery Pack contains several lithium polymer cells and an integral safety circuit As these cells age they can expand due to internal gas release which is anticipated for this type of cell However if excessive expansion occurs this can result in the battery case expanding swelling and possibly cause failure of the battery case cells or safety circuit If this 1s observed remove the Battery Pack from use and replace it as soon as possible The 1133 Battery Pack contains protective circuitry to prevent catastrophic battery failure If the Batt
107. s contact your local sales representative or distributor Hospital personnel must ensure the compatibility of the drugs as well as the performance of each pump as part of the overall infusion Potential hazards such as drug interactions inaccurate delivery rates inaccurate pressure alarms and nuisance alarms may arise from other incompatibilities Vil Precautions Continued MRI pump uses medical grade silicone rubber and PVC tubing Do not infuse pharmaceuticals or solutions that are incompatible with these materials for example which contain diethylhexylphthalate DEHP Consult the drug labeling to confirm drug compatibility concentration delivery rates and volumes are suitable for concurrent delivery or piggyback delivery secondary followed automatically by primary Simultaneously infusing with more than one pump into one patient line may significantly affect the infusion rate of at least one of the pumps This infusion pump is contraindicated for use on the inlet side of Extra Corporeal Membrane Oxygenation ECMO systems or anywhere the negative pressure is greater than 100 mmHg as the high negative pressure can result in uncontrolled fluid flow Equipment use outside it s specified environmental conditions can affect infusion accuracy Pump Related Precautions This pump is designed to stop fluid flow under alarm conditions Periodic patient monitoring must be performed to ensure the infusion is proceeding as expected
108. s normal air vent to allow air flow into the fluid flow syringe Inlet Occlusion Alarm occurs when using 1057 Syringe Occlusion Pressure Alarm Select a higher Occlusion Pressure IV Set limit is set too low for the Alarm limit to allow normal flow smaller diameter IV tubing Alarm limits may need to be set between 8 and 10 PSI depending on fluid temperature and viscosity Recurring Check The Door Clamp rubber pinis The Door Clamp rubber pin needs Door or Close bent or damaged replacement Refer to qualified service Door messages personnel occur when pump door is closed E 4 Pump is not within range Reposition pump to establish communication Verify pump is within 90 ft 30 m of Remote Display Pump is not operational Verify pump power is on and radio antenna is securely attached to both Pump and Remote Display Pump and Remote Display Verify in the Set Comm Channel menu are not set at the same option that both Pump and Remote channel Display are set to the same comm channel If not change the Remote Display to the Pump s comm channel Remote Display will not communicate Local radio interference Select alternate comm channels for with selected pump prevents communication both Pump and Remote Display However follow the installation procedure Remote Display Installation in Section 2 to avoid the possibility of setting 2 Pumps on the same channel MRI Magnet Room shielding Refer to qualified
109. see italics are available If the drug library option is not available proceed directly to step h The drug name patient weight or drug concentration can t be changed while infusing ao 7 ON C Press Enter Observe that the word Drug is highlighted Use the up and down arrow keys to select choices from the included Drug Library Press ENTER or the DOSE soft key Observe that the Dose value is highlighted Use the up and down arrow keys to set the desired Dose value Press ENTER or the DOSE soft key Observe that the unit is highlighted Use the up and down arrow keys to choose the correct unit ordered mg kg hr mg kg min mcg kg min mcg kg hr mcg kg mg kg mg hr mcg hr mg min mcg min Press ENTER or the CONC soft key Observe that the Conc value is highlighted Use the up and down arrow control keys to enter the concentration of the medication to be infused Press ENTER or the CONC soft key to highlight the Conc units Use the up and down arrow keys to set the Conc units mg mcg Press ENTER or the CONC soft key to highlight the base of the concentration if it 1s greater than 1 mL Use the up and down arrow keys to select this value Press ENTER or the WEIGHT soft key Observe that the Weight value is highlighted NOTE If the patient weight is in pounds divide that value by 2 2 to get weight in kilograms D PP s Use the up and down arrow control keys to enter the patient s weight in kg Press the appropriate Ra
110. service personnel reduces radio signal strength Radio transmission power can be to prevent communication increased within limits by service personnel to accommodate most MRI magnet rooms Contact Iradimed Corporation for additional information E 5 APPENDIX F ACCESSORIES Infusion Sets 1055 50 Bypass Infusion Set carton of 50 1056 50 Infusion Set carton of 50 1057 50 Syringe Adapter Set carton of 50 1058 50 Extension Set carton of 50 1119 MRidium MRI IV Pole Non Magnetic non ferrous I V Pole 1 5 in dia 1120 3850 Pump MRI Power Supply 1121 AC Power Adapter Power Cord 3 ft length medical grade 1125 MRidium Service Manual CD 1122 AC Adapter To Pump Interconnect Cable 10 ft length 1127 Quick Reference Hang Tags 1128 AC Power Cord 3 05 m length medical grade 1133 MRI Compatible Battery Pack 3851 Channel B Pump Drive Assembly Side mount 3855 Remote Display Battery Charger LB2025 Channel ID Marker Sheet AMOI MRidium 3850 Pump System Software Update Card Note The 3850R designates a 3850 Pump with the optional 2 4 GHz wireless link for communication with the 3855 Remote Display APPENDIX G TRUMPET AND START UP CURVES In this Pump as with all infusion systems the actions of the pumping mechanism can cause short term fluctuations in rate accuracy The graphs below Figure G 1 through G 14 show typical performance of the system with its specific infusio
111. st limits to clinically appropriate set properly level en alarm Alarm volume set too low for Adjust alarm volume for the intended l the use environment use environment Faulty alarm speaker Refer to qualified service personnel Continuous audible Faulty pump hardware Refer to qualified service personnel alarm heard Fluid delivery seems Pump not calibrated Refer to qualified service personnel inaccurate Key not pressed firmly Repeat key press pushing in firmly Keys won t function Faulty key panel Refer to qualified service personnel E 2 Pump turned off for longer Train appropriate personnel that than one 1 hour between turning off the pump for more than one uses 1 hour resets pump settings Pump settings are restored to default Pump settings changed Double check key sequence for feature accidentally chosen for correct key sequence Was New Patient chosen History Checksum Error Refer to qualified service personnel internal battery problem Pump memory is damaged or Refer to qualified service personnel internal backup battery is low Memory can only be reset by manufacturer History Log data are lost accidentally Occlusion overpressure inlet Examine Set to locate occlusion occlusion or patient Disconnect Set from the patient to occlusion clear occlusion Re prime line and resume infusion Infusion prematurely Bubble Detected alarm Examine Set to locate air bu
112. stalled mili Provides a visual indication that AC Main Power is connected on the Pump Informational Display 06 1 H 55 Provides the current time in a 24 hour time format 1 3 2 Infusion Parameter Setup Display Below the informational display the Infusion Display provides windows into which the Volume to be Infused VTBI and the Infusion Rate are entered 1 3 3 VI Display The VI Display provides the operator with the Volume Infused for the connected patient 1 3 4 Secondary Pressing this soft key brings up the Secondary Infusion Setup Display to provide the operator with the ability to configure a secondary infusion 1 3 5 Bolus Pressing this soft key brings up the Bolus Setup Display to provide the operator with the ability to configure a Bolus infusion 4i ME 06 11 55 Im o MENU gt Dose Rate Calc A MENU gt KVO Rate gt Dose Rate Calc B gt Occlusion Limit gt Alarm Volume gt Lock Keys gt gt gt gt Set Comm Channel gt NEXT MENU gt NEXT MENU Figure 1 10 Special Features Setup Menu 1 3 6 Special Features Setup Menu Pressing the MENU button brings up the Special Features Setup Menu See Figure 1 10 to provide the operator with the ability to set the Dose Rate Calculation adjust the Alarm Volume set the KVO Rate adjust the Occlusion Limit and Lock Keys and Next Menu if additional options are installed The Lock Key will not be displayed unless it has been en
113. t has been found to comply S Intertek UL 60601 1 by Underwriters Laboratories Inc Intertek 3197888 X1V SECTION 1 INTRODUCTION 1 0 Introduction The MRidium 3850 MRI Infusion System is intended for patients that require medications and or fluids during an MRI scan This pump 1s designed to provide infusion therapy at all stages of the MRI procedure This system is for use by trained medical personnel only and 1s not intended for long term patient care outside of an MRI environment This system provides the following features e Continuous Infusion Dose Rate Calculation Program and Automatic Bolus e Automatic free flow protection for the I V line e Up to two channel fluid delivery each with separate primary secondary programmable rate and VTBI into single or separate IV lines e Rechargeable long life battery Lasts up to 12 hours at 125 mL hr e Status indicator light above door Red for Alarm Green for Infusing e Soft keys to program various functions e Large LCD display screen e Up and Down arrow control keys to change numeric values quickly and easily e Handle for easy portability weighs less than 11 5 pounds e I O port e Optional second channel with the addition of the 3851 SideCar e Optional remote control with the additional 3855 Remote Display Charger e Memory card slot for easy upgrades CAUTION Handle the MRidium 3850 MRI Infusion Pump and additional channels with care If it shou
114. tart the infusion press the START STOP Channel control key for the channel to be restarted 4 2 4 KVO Keep Vein Open Infusion Complete During an infusion the VTBI value will decrease until the VTBI reaches 0 mL When the VTBI is 0 mL the infusion automatically switches to the configured KVO rate or remains at the programmed primary flow rate whichever is less KVO 1s displayed next to the VTBI and the RATE will display either the preselected KVO rate or the current infusion rate again whichever is less A short tone will announce the switch to KVO The KVO rate is configurable from the Special Features Menu which is accessed by pressing the MENU control key and has a rate range from 1 mL hr to 5 mL hr a Resuming an Infusion after KVO Perform the following to resume an infusion after KVO has initiated 1 Press the START STOP Channel control key 2 Replace infusion bag bottle 3 Press the VTBI soft key 4 Observe that the VTBI value is highlighted 5 Use the up and down arrow control keys to enter the new volume 6 Observe that the Ready to Start prompt s displayed 7 Press the START STOP Channel control key to resume infusion at the prior rate 4 2 5 Volume Infused The MRidium 3850 pump tracks the Volume Infused VI when the device is used to deliver fluid to the patient The VI on the device is cumulative with the system calculating the total VI including both the primary and secondary infusions The
115. tc to clean any part of the pump Keep the pump door latch securely closed when the pump is not in use This will avoid door latch damage Do not sterilize the pump or any component by heat steam ethylene oxide ETO or radiation The screen displays the VTBI Volume to be Infused in whole integers above 99 9 Any fraction of a milliliter delivered is not displayed but is retained in memory To avoid damage to the I V Pump and Pole always move the I V Pole separately from the patient trolley to prevent accidental entanglement The pump body is made of aluminum and is non magnetic However when moving the pump within high magnetic fields gt 2000 gauss one might notice Eddy Current effects These are forces generated in the aluminum which resists motion through the intense magnetic field Such effects are normal and present no risk of free magnetic movement of the unit Set Related Precautions Always use aseptic techniques Patient infection could result from mishandled or non sterile assemblies Use only Iradimed Corporation MRidium 1000 Series administration sets The use of other sets will cause improper pump operation resulting in inaccurate fluid delivery MRidium 1000 Series administration sets are only intended to be used with the MRidium Pump All infusion administration sets are supplied sterile and are single use only Do not sterilize or re use Prior to use of any Infusion Set examine the pouch and ins
116. te VTBI or Time 1f displayed soft key Observe that the selected value 1s highlighted Use the up and down arrow control keys to select the value Press ENTER to complete the selection The rate will automatically be calculated and the Ready to Start A or B prompt will appear Verify all entered values before starting infusion 4 14 Press the START STOP Channel control key The Main running screen will display with the correct parameters from the Dose Rate calculation screen with the Dose value displayed between the Rate and VTBI parameters See Figure 4 8 UR 06 11 55 PrimaryA gt gt gt mL hr gt Rate 1 0 Dose 0 35 mcg kg min gt VTBI Q mL v 0 0 gt Bolus gt Channel B Figure 4 8 Primary Screen with Dose Rate Displayed II ME 06 11 55 Alarm Volume Set Volume use to adjust enter to proceed Figure 4 9 Alarm Volume Adjustment Screen 4 15 4 7 2 Alarm Volume The MRidium 3850 MRI Infusion Pump allows the clinician to adjust the audio volume for user alerts and alarms See Figure 4 9 The pump will sound the alarm during adjustment to provide an indication of the current setting of the volume The volume range is on a visual sliding scale Perform the following to adjust the Alarm Volume a Press the MENU control key b Press the ALARM VOLUME soft key C Press the up and down arrow control keys to adjust the volume d Press ENTER e Press the CANCEL contr
117. tery A Settings Lost message at power up indicates existing operating parameters have been erased and the system has reverted back to initial default parameter settings The operator may choose New Patient or Same Patient Same patient will pre set primary pump setup display with the prior Rate and VTBI New patient will clear the Rate VTBI and VI If the Primary Pump Setup screen does not appear as shown in Figure 4 1 t may indicate improper functioning of the display Although the Pump may appear to function properly return it to qualified service personnel for examination and or repair CAUTION Each time the Pump is turned on verify and or set the pressure alarm limit If the pressure alarm limit is not verified the Pump may not be operating with the desired occlusion detection parameter s 4 2 Primary Configuration Pressing the 1 control key powers up the pump Upon power up the pump first runs a Power On Self Test then displays the message Powering On and enters the Primary Pump Setup screen See Figure 4 1 where the Infusion Rate and Volume to be Infused VTBI is set The pump memory will retain the last used settings for up to one 1 hour following power down of the pump Operator has the option of selecting either New Patient or Same Patient If any part of the Power On Self Test fails the pump displays an error message and will not operate If optional Channel B SideCar is i
118. that the pump might display The table is divided into four columns with the first column providing the message which appears on the screen the second identifies the type of message Alarm Alert or User Prompt the third identifies the cause of the message and the fourth contains the suggested action in response to the message 5 3 Responding to an Alarm Perform the following to respond to an alarm a Press the Alarm Silence IRE control key to silence the sound and re set the Alarm Condition monitor b Resolve the alarm condition 1 e clear bubble change battery close door etc Press the Start Stop control key for the appropriate channel to continue the infusion 5 4 Remote Alarms All alarms must be resolved at the pump Alarms are listed in Table 5 1 5 1 Table 5 1 Alarm Alert and User Prompt Messages MESSAGE TYPE CAUSE RESOLUTION Bubble Detected A or B Air detector has detected an air bubble larger than the 100 uL threshold Alarm BATTERY DEPLETED Alert Battery is too low to operate Pump much longer Battery Low Alert Battery has 30 minutes or less of charge remaining Alert A dose delivery has just been completed Message with an audible beep Prompt Calculated rate is outside allowable range An audible beep occurs if key 1s pressed to attempt to move dose out of range Alarm Pump Run Test fails other motor tests hardware or software conflict Alarm Latch was ope
119. the Channel BB 4 11 452 Detachme th Chanel B Sidal geneet 4 11 Special Pa 4 12 AlL Doe R 0 oe 4 13 e AN OE E 4 16 AA NEE 4 16 r We E 4 16 AA E E 4 17 Be AM nn 4 17 Qo E E 4 17 45 Exitine the Special AAA INE ces anna EAN 4 18 Ait Babii breiten isl oie eege 4 18 E eo E EER 4 18 5 1 11 5 1 is A 5 1 OUEMEEU 207 E 5 I 5 3 Repondre T an A AA e II 5 1 5 4 LE EE 5 1 Do EE EES 6 1 6 1 a E 6 1 Me EE Ee 6 1 6 3 Si voll ill road TEE 6 1 04 Kemovint ihe Battery EE 6 2 6 5 ZE EE AMA e O o A 6 2 o MEN 24180 0c i CORR 6 3 6 7 pa LM DU etes medina Nae UNI RI MUN deena MUI MEM SN TUM 6 3 6 8 hoang Poret P 6 4 6 9 Bater de ic udin M 6 4 OMM us o o EE 6 4 6 9 2 1133 Battery Pack Maintenance Checkout Brocedure ceeecceeceeeeeeeeeeeeees 6 4 Bl Baler e A A o DOTT 6 4 Bi Battery Pack Related IN OOO ee ii ori See 6 5 Appendix A Specifications ccccccccccccccccccccceecacaaeeessssssseseeececceceeeeeseeaaaaaaaaesssseesesseeees A Appendix B REO B 1 Appendix C Warranty mmiformaton nennen eese nnne ness nnns C 1 Appendix D Manufacturers Technical Declaration 22er D 1 Appendix E Troubleshootng nennen nennen nennen enses E I Appendix F Accessories ccccssssssseccccecccaeesnssseccceeeeaaeesssseecceeeesaaaassseeeceesessaauaas
120. tific and Medical communication Table 1 provides an overview of the regulatory requirements in general that are applicable for the 2 4 GHz band Later in this section you will find an overview of countries in which additional restrictions or requirements or both are applicable The requirements for any country may evolve Iradimed Corporation recommends that you check with local authorities for the latest status of their national regulations for 2 4 GHz ISM Industrial Scientific and Medical communication Frequency Band 2400 2483 5 MHz Max Power Level EIRP 100 mW Indoor and Outdoor Use Yes The following sections identify countries having additional requirements or restrictions than those listed above France For 2 4 GHz the output power is restricted to 10 mW EIRP when the product is used outdoors in the band 2454 2483 5 MHz There are no restrictions when used in other parts of the 2 4 GHz band For use in France channel selection is limited to 2400 to 2450 MHz Check http Awww arcep fr for more details Italy This product meets the National Radio Interference specifications and the requirements in the National Frequency Allocation Table for Italy Operating wireless equipment requires a general authorization unless it is operated within the boundaries of the owner s property Please check with http comumicazioni it it for more information Questo prodotto conforme alla specifiche di Interfaccia Radio
121. to use The battery charges whenever the pump is connected to a hospital grade power outlet through the AC Power Adapter CAUTION Use only non magnetic I V pole designed for proper safe support of the MRidium 3850 I V pump 2 6 Mounting on I V Pole The Pump should be mounted on an MRI compatible non magnetic I V pole and secured with its ergonomically designed clamp knob The clamping mechanism accommodates pole diameters to 1 5 inches 25 to 38 mm WARNING When using multiple Pumps limit 2 distribute the Pumps to ensure stability 2 7 Operational Checkout of the Pump Power up pump as follows and confirm no failures are displayed during the Power Up Test a Turn on pump b Observe while pump performs power up test C Verify that the pump sounds an audible beep d Observe that the pump displays the initial start up screen 2 5 Pump Storage Plug the Pump into an AC outlet during storage to ensure a fully charged battery when needed The AC indicator light will be green or amber if charging whenever Pump is plugged in to the AC Power Close the door latch es whenever the Pump or Channel B SideCar are not in use 2 9 Remote Display Installation See Paragraph 1 1 6 Connect 2 4 GHz antenna and AC Power Cord to Remote Display Charger Verify MRidium 3850 MRI IV Pump has Remote Radio Option installed And perform the following NOTE Information shown on the remote display is updated at least once
122. ty available This information is displayed when the instrument is turned on The Dual Rate Feature allows the pump to administer both primary and secondary solutions at separate flow rates and volumes Using this feature the clinician can select and start a program for secondary delivery Upon completion of the secondary dose the pump can automatically switch over to a primary rate Both channels of the MRidium M 3850 can be programmed for primary and secondary operation Optional modes are easily accessed with the press of one key The Dose Rate Calculator allows the clinician to calculate a dose rate for continuous infusion given concentration and dosage orders The Bolus Dose feature allows the clinician to set up an initial infusion rate for a specific Bolus volume automatically followed by a maintenance rate from the same container An optional 2 4 GHz wireless link allows communication between the infusion pump and remote display denoted by R in pump model number Qualified service personnel can configure many features of the pump to meet specialized needs Specific pump menu screens may vary depending on software release being used This device is covered under one or more of the following U S Patents 7 267 661 B2 and International Equivalents 7 404 809 B2 and International Equivalents 7 553 295 and International Equivalents Other U S and International patents pending vi Precautions Federal Law in the U S A
123. ump a Handle Provides for easy transportation of the pump from location to another b Optional Secondary Pump Drive Electrical Connector Provides for the addition of a Channel B pump mechanism C I V Pole Clamp Provides a secure mounting of the pump to the I V pole d Audible Speaker Provides the audible sounds for alarms and alerts 2 4 GHz Antenna Connector Used to connect Antenna for Remote Display Charger Option 3850R only f Power Input Provides for connection to the AC Power Adapter to run the pump on hospital grade AC Mains power Connect only model 1120 MRI Power Supply Handle VN N N Y Y Battery N Compartment Optional Secondar L Pimp on i Pole Clamp sal eae Electrical Connector Memory Card Port x oe e sg Audible Speaker e SE a I O Port 9 2 4 GHz A A z Antenna Power Input and Connector 3850R only Figure 1 3 Back of Pump Version 2 Serial Number IR5010778 and above 1 4 g VO Port Provides a connection for retrieving the pump s infusion data from memory Connect only 60601 1 compliant computer for History Log download WARNING Serial I O Port is not PC compatible computer format Pin 8 is connected to the 5 volt supply Refer to the Service Manual for History Log data download instructions h Memory Port Provides for field update of system software Use only A MOT 1 Battery Compartment Provides a safe and secure location for the pump
124. urs at 25mL hr Rate 25mL hr typical G 2 Flow Rate ml hr Volume delivered ml AAMI ID 26 1998 50 102 Data Set Flow Rate at T 0 1 mL hr 2 00 O ES ee N SE A A A JJ Uu 1 50 urb ee ee dua 4 4 4 undb LI 13IH 3 2 RW du Mimi M po UL lip UI JIL WE CDI WAT mo ill WIR IA mori DI ID MIU inis u en A CO AT Ula ae UL UA TN TU UEL EN IL LT C om LUUT NAU OUT III dhak WI HUT aam LIT IO WU III OU HOCH o oo Al LI JI UK UL Tu d o gen 22 E FE d A BEE qd SE BE eee eee oe El N co 0 00 eo 2 2 A A aA A SMS B SZ SF 2 A A m Y YX Y SG 8 5 56 6 d 6 6 6 d O 5 e e e Si e D D e SF i C S d Time Hours Min Figure G 1 AAMI ID 26 1998 50 102 Data Set Volume Delivery 1 mL hr 7 0 6 5 6 0 55 5 0 4 5 4 0 335 3 0 2 5 2 0 1 5 1 0 0 5 0 0 SS SS SKS SKS SS SS KS SS SS KS SS SS SS SS a a ss SS 8 SS 2 CG ge OO aw gg mg cO Gage GG sz 3 5 o OO e ei e C e d SA EM oi oi o oe o o o a a o o a a ap an aD aD aD o o Time hr min sec Figure G 2 AAMI ID 26 1998 50 102 Data Set Standard Trumpet Curve over T 1 Period 1 mL hr Flow Error 1 3 5 7 9 11 Td 15 17 19 21 23 25 27 29 31 33 35 Observation Window min Figure G 3 AAMI ID 26 1998 50 102 Data Set Standard Trumpet Curve over T 2 Period 1 mL hr Flow Error 1 3 5
125. ver the pump is connected to the AC power source as indicated by a visible Amber LED indicator on the Pump front panel The Battery Pack can be inserted when the Pump is either turned On or Off After the Pump is turned On verify that the Battery Icon on the Main Display has the X removed and the Icon is filled or filling during the charge cycle 6 1 6 4 Removing the Battery Pack Press in the Battery Pack latch located on the right side of the installed Pack Grasp the Pack and pull it outward from the Pump s Battery compartment Another new or charged battery Pack can now be placed into the Pump The Battery Pack can be removed when the Pump is either turned On or Off Figure 6 2 Battery Removal 6 5 Testing the Battery Pack The battery level is always evident on the Battery Icon when the Battery Pack is inserted into the Pump and the Pump is On The operating capacity of the Battery Pack can also be tested without the use of the Pump To examine the capacity level depress the small button on the rear of the Battery Pack as indicated on the Battery Pack Label When pressed the Battery Level LED indicators will momentarily show the capacity The indicators can range from five 5 L E D s illuminated for fully charged to one flashing L E D illuminated for fully discharged 6 2 Figure 6 3 Battery Test 6 6 Battery Charge Indicator The Battery Gauge on the Main Display indicates approximate battery capacity remain
126. y default or Level 3 250 mW Instructions are provided in the Service documentation regarding the appropriate choices and settings for Specific geographic areas It is a that the output power 1s correctly configured to meet the local SES Note If you still have questions regarding the compliance of these products or you cannot find the information you are looking for on the Iradimed Corporation website http iradimed com please send an email request to Iradimed Corporation at techsupport iradimed com APPENDIX E TROUBLESHOOTING Unit not turned on Turn on unit by pressing On control key No AC power battery Plug power cord into pump and AC depleted power source or replace battery pack Pump won t turn on with charged battery Blown fuse s Refer to qualified service personnel AC power source has low Switch AC power cord to power voltage receptacle with sufficient voltage Administration Set is not Attach Administration Set to fluid connected to fluid source source Set is not mounted in pump Open pump door and re load Administration Set Administration Set does not Select appropriate MRidium 3850 mount onto pump Administration Set for pump No Fluid Flow Patient line is kinked Straighten kinked line Inspect for damage or leaks and replace if necessary Roller Clamp 1s closed Open Roller or slide clamp Damaged Set or line is Replace damaged Administration Set leaking Reseat door close comp
127. zijnde bepalingen van de Richtlijn 1999 5 EG Estonian ET See seade vastab direktiivi 1999 5 EU olulistele n uetele ja teistele Eesti This equipment is in compliance with the essential requirements and other relevant provisions of Directive 1999 5 EC asjakohastele s tetele English EN German DE Deutsch Greek EL EAAnvikr Finnish Fi Suomi Dieses Ger t entspricht den grundlegenden Anforderungen und den weiteren entsprechenden Vorgaben der Richtlinie 1999 5 EG AUTOS o e omAlapoc eivai COE GUNN PPWON ue TIG OUOIW EIG ATTAITHOEIS KAI GAMES OXETIKES GiaTagelg mo OSnyiag 1999 5 EK T m laite t ytt direktiivin 1999 5 EY olennaiset vaatimukset ja on siin asetettujen muiden laitetta koskevien m r ysten mukainen Cet appareil est conforme aux exigencies essentielles et aux autres dispositions pertinentes de la Directive 1999 5 CE French FR Francais Hungarian HU Margyar Icelandic IS slenska Italian IT Italiano l Latvian LV Latviski Lithuanian LT Sis irenginys tenkina 1999 5 EB Direktyvos esminius reikalavimus ir kitas Lietuvi Sios direktyvos nuostatas Ez a k sz l k teljesiti az alapvet k vetelm nyeket s m s 1999 5 EK ir nyelvben meghat rozott vonatkoz rendelkez seket betta t ki er samkv mt grunnkr fum og rum vi eigandi kv um Tilskipunar 1999 5 EB Questo apparato amp

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