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Sigma Spectrum Infusion Pump User Manual

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1. en ce 61 Appendix 63 REMOVE FROM THE SHIPPING BOX The SIGMA Spectrum has been packaged to provide protection during transportation and storage Remove the Spectrum from the protective anti static bag and remove the protecting foam end caps Discard the desiccant package The battery tab has been provided to isolate the battery voltage from the pump during transport and distribution Remove the battery insulating tab prior to charging the pump s battery or operating the pump This is accomplished by pulling the tab straight out from the Battery Pack mounting cavity Pull the battery tab straight out from the Battery Pack cavity gt t is suggested that all packaging materials be saved for reuse This is advised in the event product repair or warranty replacement is necessary gt It is strongly recommended that the pump s battery be fully charged 12 hour minimum before depending on the battery as a source of pump power KEY OPERATING TIPS 1 FOLLOW ALL PROMPTS 2 LOAD SETS PROPERLY To open the pump door push the gravity IV set s slide clamp fully into the keyhole Load tubing tautly from top to bottom in loading points 1 2 3 and 4 following the red green prompts Push the door closed in the two door hook areas Open the slide clamp by pulling it straight up while holding the tubing around it down 3 USE THE DRUG ERROR PREVENTION SYS
2. Lasik hub due pU SC dw d SG tuu 13 TOWEFAGSDIOE sito 14 Set Loading UMOAGING a a 14 Drug Error Prevention 15 I20Sebxale ueste eu axi usc tnu Qin ace 15 Basic mL hr Programming uos euin teil us texas Oa dus uoto pe CU E 15 CONIC 5 I ala ENS 16 Reviewing Reprogramming a Depleted Secondary 17 Manual Programming Mode eene nennen nennen nnne nns 17 Rede Eon toa RHEINE RE 18 mice RP ae NER Kn 18 Keypad EK 18 PUMP Standby 19 BI clo ko M c T P 19 PB RI 21 MI etcetera E IM MMC I M MU A 21 Adios piti Mt aum EE LUE ME 21 I3epleted iia ES e AA A E P metes qu utu des cU DUUM a d DL I E LU ES RUE 21 Door Not Fully Closed Set Outside 21 Door Delect E MA M MM 21 PO WISTS AO CCIIS RR HH 21 elsi OO TOTEM 21 WAG CRY OF MAUI QR EUR Or 21 DSO SCs yas aac asus TOO 21 In Stop Open Slide Clamp Airain rnanan esu eae eina oua cu erat es
3. LOW LOW BATTERY BATTERY Faulty power supply NN Is cord pushed firmly D SEND PUMP into back of pump FOR REPAIR Push OK to continue LOW Faulty power jack SEND PUMP FOR REPAIR Push OK to continue 57 VERY LOW BATTERY Plug into wall outlet into wall outlet Is power cord plugged VERY LOW BATIERY ls wall plug light on EE If the Very Low Battery alarm is shown the following troubleshooting tutorial shall begin The tutorial is designed to provide step by step confirmation that the external power supply is connected to the wall outlet that its power light is illuminated and that the power cord is properly connected to the Spectrum If external power is detected at any point during this tutorial the Pump plugged in screen shall be shown before returning to the RUN screens VERY LOW BATIERY Is cord pushed firmly into back of pump VERY LOW BATTERY Faulty power supply SEND PUMP FOR REPAIR Push OK to continue VERY LOW BATTERY Faulty power jack SEND PUMP FOR REPAIR Push OK to continue 58 59 Appendix C Power 5 These icons are visible in the upper left corner of the pump display Battery is 2595 charged Battery is 50 charged Battery is 75 charged
4. 123 Primary Set Minidrip 60 drops mL 2C6402s Solution Set Interlink 1 ea with luer lock adapter lever lock cannula 76 2C6424s Solution Set Interlink 2 ea with luer lock adapter 93 2C8402s Solution Set Clearlink 1 ea with male luer lock 76 2C6520s CONTINU FLO Solution Set Interlink 2 ea with luer lock adapter backcheck valve 89 2C6546s CONTINU FLO Solution Set Interlink 3 ea with luer lock adapter backcheck valve 106 2C8546s CONTINU FLO Solution Set Clearlink 3 ea with male luer lock backcheck valve 106 Primary Filter Set Macro 10 drops mL 2C6571s 2C8571s CONTINU FLO Solution Set 0 22 micron filter Interlink 2 ea with luer lock adapter backcheck valve 105 CONTINU FLO Solution Set 0 22 micron filter Clearlink 2 ea with luer lock adapter backcheck valve 105 Primary Filter Set Minidrip 60 drops mL 2C6572s CONTINU FLO Solution Set 0 22 micron filter Interlink 2 ea with luer lock adapter backcheck valve 105 Buretrol Minidrip 60 drops mL 2C7519s 150 mL Burette Interlink 2 ea with luer lock adapter Ball Valve Drip Chamber 117 2C7562s 150 mL Burette Interlink 3 ea with valveless Burette 115 2C7564s 150 mL Burette Interlink 2 ea with drip chamber filter valve male luer lock adapter 105 2C8819s 150 mL Burette Clearlink 2 ea with luer lock adapter Ball Valve Drip Chamber 117 Y Type Blood
5. Battery is 10095 charged Battery is installed and the AC adaptor is connected Alternates between one of the battery levels above Battery is depleted Red battery Wireless Battery Module Icons Battery Wireless Battery Module is being charged Battery segments bars animate from left to right Black battery White background Charging Charge Wireless Battery Module is fully charged White battery Green background Complete Battery Error This will alternate with a battery code number Refer to the Service Manual for a description of the error code Red battery Install AC power is supplied and battery pack is not B attery installed Black battery Initial pump screen when AC power is supplied and the pump is powered off Battery charger is determining the current status of the installed battery Black battery 60 Appendix C Wireless icons These icons are only visible when Wireless Battery Module is installed and in the upper right corner of the pump Initializing The dot will circle the tower Events are not sent to the network host Red background Searching for the network and host The will toggle to the left and right of the tower while searching Events will be sent to the network upon connection to the network host Yellow background Connected to host Signals will radiate outward Events are sent to the network host Green background Network disable
6. Downstream Release MANAGING UNINTENDED SMALL BOLUS RELEASES WHEN CLEARING DOWNSTREAM OCCLUSIONS When a downstream occlusion alarm occurs pressure and a small volume of 0 8 mL of fluid the bolus builds up between the pump and the point of occlusion When it might be harmful to infuse the bolus into the patient simultaneously withdraw 0 9 mL of fluid from the lower Y site of the IV set and eliminate the source of the occlusion 23 WARNINGS AND CAUTIONS Operation is Limited to Trained and Tested Operators SIGMA Spectrum operation is strictly limited to trained operators whose competency in safe Spectrum operation and in safe IV therapy practices has been tested and proven Pump owners have sole responsibility for operator training and testing even when SIGMA personnel assist in training processes WAUA Confirm Safe Operation at Start and Thereafter Confirm safe accurate pump operation at start and periodically thereafter by Confirming there is no drip chamber flow when the pump is stopped Confirming the drop rate approximates the pump s flow rate during RUN operation Confirming pump settings are as intended Confirming correct patient route dose time and drug concentration Regularly observing that the patient s vital signs and IV site are in good condition Note that infiltrations can not be detected by IV pumps They must be detected by clinicians and minimized The Spectrum is not a substitute fo
7. Set 10 drops mL 2C6750Hs 2C8750s Blood Solution Set Interlink 1 ea with luer lock adapter 170 to 260 micron filter 115 Blood Solution Set Clearlink with luer lock adapter 8 112 Nitroglycerin Set 60 drop mL 2 75515 2C8851s Vented Nitroglycerin Set Interlink 1 ea with luer lock adapter 12 PVC pumping segment 106 Vented Nitroglycerin Set Clearlink 1ea with luer lock adapter 11 PVC pumping segment 105 Buretrol Clearlink CONTINU FLOW and Interlink are all registered names trademarks associated with Baxter International Inc 35 Compatible Baxter IV Sets WARNINGS numbers with reference to description listing WARNING Minidrip chambers should not be used for flow rate settings greater than 200 mL hr Doing so may influence flow rate accuracy and cause nuisance upstream air or upstream occlusion alarms When using sets with back check valves flow rate settings should not exceed 500 mL hr Doing so may influence flow rate accuracy or cause nuisance upstream air or upstream occlusion alarms Flow rates above 300 mL hr may cause fluid to be siphoned from the primary container during piggyback operation Partially occluded filters can cause nuisance upstream air upstream occlusion or downstream alarms and influence flow rate accuracy Burettes with closed vents or shutoff valves will cause upstream occlusions that may not be detected by the infusion pump Ball Valve operation
8. administration specific pumping section with slide clamp 110 Fat Emulsion Set Macro 15 Drops mL 12060 58 Fat Emulsion Set non DEHP except pump segment with connections slide clamp on pump segment 110 Y Type Blood Set 10 drops mL 12450 48 LS Y Type Blood Set 1 CLAVE Y Site w 210 micron blood filter chamber amp Secure Lock 100 20796 48 LS Y Type Blood Set Yellow Key Slide Clamp 1 CLAVE Y sites w 170 micron filter amp OL 110 20805 48 LS Y Type Blood Set Yellow Key Slide Clamp 1 CLAVE Y Site w 210 micron filter amp OL 100 20806 48 LS Y Type Blood Set Yellow Key Slide Clamp 1 CLAVE Y Site w 170 micron filter amp OL 100 All sets use roller clamps referenced to as CAIRO clamp All sets except the Blood sets use convertible pins LS LifeShield amp OL Option Lok PP Prepierced CAIR CLAVE Option Lok LifeShield Microdrip amp SoluSet are all registered names trademarks associated with Hospira Abbott Laboratories Compatible Hospira IV Sets WARNINGS numbers with reference to description listing WARNING 1 Microdrip chambers should not be used for flow rate settings greater than 200 mL hr Doing so may influence flow rate accuracy and cause nuisance air or upstream occlusion alarms 2 When using sets with backcheck valves flow rate settings should not exceed 500 mL hr Doing so may influence flow rate accuracy or cause nuisance upstream air
9. assure a full charge 29 SERVICING ee Electric shock hazard There are no user serviceable parts Do not remove the case Refer servicing to SIGMA trained and qualified service personnel Refer to the Service Manual for inspection and maintenance procedures To Return Pumps to SIGMA Phone 1 800 356 3454 for a repair authorization RA number A P O number for non warranty repairs is also required Ship pumps to SIGMA 711 Park Avenue Medina NY 14103 Include a problem description contact person phone number and return address Label the shipping box with the RA number Return pumps in original boxes with original inserts to prevent damage during shipment Required Maintenance and Frequency Maintenance consists of routine cleaning and annual performance evaluations as described in the service manual Pumps suspected of being damaged must be tested for proper performance before being returned to patient use This includes pumps that have been physically damaged dropped or those that have fluid intrusion 30 ACCESSORIES Tandem Carrier Cat No 55092NS 3 Pump Carriers Cat No 55093 Holds 3 pumps Stainless up right tubes and aluminum plate UL CSA four outlet power strip for multi pole plug in 1 cord from IV pole to wall outlet C Clamp jaw opening expands to 1 5 C Clamp knob comes off if semi permanent attachment of carrier is desired 31 2 Hold
10. floors are covered with synthetic material the relative humidity should be at least 30 See Note 1 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the Spectrum requires continued operation during power mains interruption it is recommended that the Spectrum be powered from an uninterruptible power supply or the internal battery be fully charged to provide unit power as specified in this operator s manual Power frequency magnetic fields should be at levels characteristic of a typical commercial or hospital environment Note1 For levels 2 3 amp 4 a clearable alarm will occur with interruption of flow WARNING The Spectrum pump is not designed to be MRI compatible nor is it intended to be used in this manner Strong magnetic fields those beyond the level tested may cause the device to operate improperly Do not expose the SIGMA Spectrum to strong magnetic fields such as is common with MRI equipment Doing so may cause injury to the patient and or damage to the equipment 52 Immunity Conducted and Radiated Guidance and manufacturer s declaration electromagnetic immunity The SIGMA Model Spectrum Infusion pump is intended for use in the electromagnetic environment specified bel
11. may not be detected as an alarm condition when using the SIGMA Spectrum Pump Rigid polyethylene lined tubing as is often used in nitroglycerine sets may produce as much as 10 PSI downstream occlusion pressure above the lower limit of the SIGMA Spectrum pump specification Some Sets contain two or more slide clamps Only the slide clamp on the pumping section or on the section with the main roller clamp should be used for pumping operation and clamp detection Other slide clamps associated with the set need to be observed and controlled by the user Blood sets with both clamps closed above the blood filter will cause upstream occlusions conditions that may not be detected by the pump See the Specification Section for Downstream Occlusion times and bolus release information 36 LIMITED WARRANTY SIGMA warrants to the original purchaser the SIGMA Spectrum Infusion Pump hereinafter to be free from defects in material and workmanship under normal use and service for one year from the date of shipment SIGMA s obligation under this limited warranty shall be limited to repair or replacement of pumps which upon SIGMA s examination are found defective in material or workmanship under normal use and service within one year from the date of purchase by the original purchaser The repair or replacement of any pump under this limited warranty shall not extend the term of this limited warranty beyond the original term as set forth in t
12. optional bolus mode of operation This feature allows the user to perform a BOLUS SETUP action To utilize this feature the pump must be programmed with either a specific rate or a specific amount to be delivered in a certain amount of time If the pump is currently operating in mL hr delivery mode the bolus rate value is entered in mL hr and the volume is entered in milliliter mL If the pump is operating in a non mL hr delivery mode for example mcg kg min the bolus amount would be entered in mcg kg however the ML HR soft key may be pressed in the setup screen to enter the bolus information in mL hr format In either mode the time is entered in minutes and seconds min sec Limits are placed on the minimum and maximum amount of time for the bolus delivery The limit constraints are contained within the software of the Spectrum pump and are necessary to control the maximum or minimum flow rate of the bolus infusion The accuracy of the bolus volume is dependent on the resultant flow rate that is obtained from the calculation of volume to be delivered in the time requested For example if the maximum bolus volume is 300 mL the maximum flow rate is obtained with a bolus time of 18 02 min sec or a flow rate of approximately 999 mL hr Using this maximum bolus volume and delivering the volume in the shortest amount of time the mean value of 302 mL x 5 may be expected Whereas using a minimum bolus volume 5 mL and delivering the volume in
13. positional catheter clotted catheter clogged IV filter or other sources of occlusion below the pump and the pump will restart automatically Infusion Complete The VTBI volume to be infused has counted down to zero and has been delivered The pump is running at a rate of 1 0mL hr KVO rate keep vein open or the actual infusion rate whichever is lower Push STOP to halt the KVO rate and return to the Setup Screen Select a new VTBI value and push RUN Inactive Alarm The pump has been inactive for 2 minutes and no action has been taken Follow the prompted action and resume or restart the pump by pushing Run In Stop Load Set Load the IV set and push RUN In Stop Open Slide Clamp Open the slide clamp remove it from the keyhole and push RUN In Stop Push Run Push RUN to begin the infusion 21 Low Battery Less than 30 minutes of battery power remains Plug the AC Power Adaptor into the pump and into the AC source outlet as soon as possible to recharge the battery Full charging requires 12 hours for Standard Battery and 16 hours for Wireless Battery Module Very Low Battery Less than 75 of the low battery capacity remains The AC Power Adaptor should be plugged in immediately The tutorial to check the AC Power Adaptor will automatically begin see Appendix B for details Battery Missing Battery not detected Check to make sure it is fully latched Shut Door Shut the pump
14. setup data may be changed by navigating to that step and pressing OK to move to the values that must be changed It the pump is running any programmed step may be viewed by pressing the REVIEW soft key but no values may be changed with the exception of the Volume Given value which may be cleared by pressing the CLEAR soft key Push RUN to start the program e screens appear as described in mL hr or Dose Error Prevention programming sections with the addition of a program step indicator shown in the Step x of y format where x is the current step being delivered and y is the total number of programmed steps e When the program completes the STOP key is pressed the program schedule automatically resets Note Always verify current program parameters for each step prior to starting a new infusion itself and may be restarted without entering reentering any setup data The program will be retained indefinitely during power off cycles until reset To reset the program push the RESET soft key from the PROGRAM STOPPED screen To clear the entire program press the CLR ALL soft key and answer YES to the confirmation screen To clear the setup data from any individual step the pump must be stopped Move the highlight to the desired step in the step bar and press the CLR STEP soft key Note that clearing a step does not delete that step unless it is the last step in the program Titrating Totitrate flow rates without st
15. with inline backcheck valve 2 CLAVE Y sites amp OL 100 LS Primary Set Convertible Pin amp OL 100 LS Primary Set with backcheck valve Yellow Key Slide Clamp 2 CLAVE Y Sites amp OL 100 LS Primary Set Yellow Key Slide Clamp with inline backcheck valve 3 CLAVE Y sites 0 2 micron filter amp OL 120 LS Primary Set Yellow Key Slide Clamp with inline backcheck valve CLAVE Y sites amp OL 5 120 LS Primary Set Yellow Key Slide Clamp with inline backcheck valve 3 CLAVE Y sites amp OL 120 w Extension LS Primary Set Yellow Key Slide Clamp CLAVE Y site amp OL 100 LS Primary Set Yellow Key Slide Clamp with inline backckeck valve 3 PP Y Sites amp OL 110 Primary Set Micro 60 Drops mL 33 11411 78 15 Primary Piggyback Set w backckeck valve 2 PP Y Sites amp 1 5 100 11539 78 LS Microdrip Primary Set PP Y site amp OL 70 11550 78 LS Microdrip Primary Piggyback Set PP backcheck valve PP Y site Set OL 80 11962 78 15 Microdrip Piggyback Set with inline backcheck valve 2 CLAVE Y sites amp 100 Inches 12058 78 Microdrip Set with yellow striped tubing CAIR Clamp amp OL 112 12453 48 LS Microdrip Primary Set 1 CLAVE Y site amp OL 100 20779 48 LS Microdrip Primary Set with backcheck valve Yellow Key Slide Clamp 2 CLAVE Y Sites amp OL 100 Primary Filter Set Micro 60 Drops mL 20801 48 L
16. 0 25 00 20 00 Flow Rate mL hr Gi 15 00 10 00 5 00 15 0 10 0 5 0 Error of Flow 5 0 10 0 15 0 Start up Graph First Two Hours Set Rate 25 mL hr i Jl JA LLL TITAN AMI 0 0 The percent variation of mean flow rate accuracy over a specific observation period may be quantified with the use of a trumpet graph Using the rationale for development of a statistical trumpet graph as defined in IEC 60601 2 24 a presentation of the SIGMA Spectrum mean flow over a specific measurement interval is provided Trumpet Curve 2nd Hour Set Rate 25mL Hr Overall percentage error A 22 096 5 6 7 8 9 40 11 4 5 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 2 13 14 1 Ep min Observation Window min 45 96 Error of Flow 50 00 45 00 Flow rate Graph Last Hour Set Rate 25 mL hr 40 00 35 00 Flow Rate mL hr Gi ce e 2 e 15 00 10 00 5 00 0 00 5 00 15 096 10 096 5 0 0 0 5 0 10 0 15 0 Time min Typical of intermediate rate last Hr Flow Accuracy Trumpet Curve Last Hour Set Rate 25mL Hr 3N4 5 6 7 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Overall pe
17. ENT The power adaptor is used to charge the pump s battery The power adaptor uses a locking cord connection to prevent inadvertent disconnection To engage the power adaptor align the arrow of the power adaptor cord with the arrow on the connector identified as the external power adaptor connection on the back of the SIGMA opectrum pump Insert the power adaptor module into the appropriate wall power outlet The Spectrum will display a plug symbol if the power adaptor is working properly when the pump is in operation The green led on the power adaptor should be on when the adaptor is plugged into a powered wall outlet NOTE IMPROPER REMOVAL MAY DAMAGE THE POWER E ADAPTOR Remove the power adaptor cord connection from the SIGMA Spectrum by pulling back the external power adaptor s shell This will unlock the connection and removal is accomplished by simply pulling on the connector with the shell retracted away from the back of the pump Improper twisting or pulling of the connector or cable may damage the power supply NOTE Repeated drops of power adaptors on floors will cause them to malfunction As with all electronic devices drops should always be prevented Set Loading Unloading THE PUMP WILL INDEX WHEN THE SET S SLIDE CLAMP IS REMOVED FROM THE PUMP S KEYHOLE THIS WILL PROPEL FLUID MAXIMUM OF 1ML IN THE IV SET IN THE DIRECTION OF FLOW AND POSSIBLY TO THE PATIENT THIS WILL OCCUR IF THE ADMINISTRATION SET IS LOADED IN THE PU
18. EW pulls up the set up screen without stopping the pump Pre Pump Programming MOUNT THE PUMP to an IV pole Plug the pump into wall outlet if available 13 IV SETS select only IV sets made by the manufacturer listed on top of the pump IV sets must be of standard stiffness and diameter Performance can not be achieved using stiff large or small diameter tubing Contact SIGMA for compatible standard IV set lists and for special SIGMA blood nitroglycerin and lipid sets PUMPED ON TUBING should not be re loaded into the pumping channel to avoid nuisance alarms and to maintain flow rate accuracy NOTE Flow Rate accuracy Will be maintained if the set has been pumped on for no more than 72 hours for Hospira and 96 hours for Baxter IV sets at rate settings not greater than 125 mL hr or for total volumes of not more than 9 liters Hospira or 12 liters Baxter PREPARE IV CONTAINERS AND PRIME IV SETS by positioning roller clamps below the pump positioning slide clamp near the keyhole at the top of the pump inverting bags that need to be mixed rather than shaking them warming IV solutions to room temperature before use drip chambers approximately halfway and using standard gravity IV set priming technique to purge air from sets and all Y sites AC Power Adaptor USE ONLY THE POWER ADAPTOR SPECIFIED FOR THIS EQUIPMENT USE OF OTHER POWER ADAPTORS MAY CAUSE PERSONAL INJURY OR DAMAGE TO EQUIPM
19. IP CCMP encryption 802 1 x EAP authentication e LEAP WEP only PEAP TTLS e GTC MD5 OTP PAP CHAP MSCHAP MSCHAPc2 TTLS MSCHAPv2 Pre shared key mode PSK Environmental Limits With Standard Battery e Operating temperature 60 to 90 F 15 6 to 32 2 C 20 to 90 relative humidity non condensing e Storage temperature 4 to 120 F 20 to 49 C 10 to 90 relative humidity non condensing With Wireless Battery Module 41 Display Operating temperature 60 to 80 F 15 6 to 26 7 C 20 to 90 relative humidity non condensing Storage temperature 4 to 120 F 20 to 49 C 10 to 90 relative humidity non condensing Full color HRTFT 240 x 270 LED front lit 0 2235 mm by 0 2235 mm dot pitch Alarms and Alerts Timekeeping Air In Line dual beam ultrasonic detector alarms for large bubbles but allows smaller bubbles to pass Detects air bubbles gt 1 125 Hospira 140uL Baxter will alarm if gt 1 mL of air in 15 min lt 50pL bubbles are omitted in the summation of the 1 mL up to 1 5mL at 60 F Audio speaker actuated audio alarm low medium and high levels selected through the configurations screen Battery Missing pump does not detect battery attached Depleted Battery pump stops running alarms for 3 minutes Dose Rate Limit Exceeded the pump will run with a soft dose rate exceeded after a double confirmation it will not run with a hard dose rate exceeded rates must be reset withi
20. MP AND A PATIENT IS CONNECTED TO THE ADMINISTRATION SET OPEN THE PUMP DOOR by inserting the slide clamp into the keyhole loading point 41 and pressing down until the door opens LOAD IV SET TUBING INTO THE TUBING CHANNEL Loading must be from the top to bottom of the tubing channel and the tubing should be taught Load the tubing into loading point 2 and then loading points 3 and 4 CLOSE THE DOOR by pressing the upper and lower corners near the door hooks areas 14 OPEN THE SLIDE AND ROLLER CLAMP UNLOAD SETS push the slide clamp in the keyhole until the door opens and pull tubing out from the bottom of the pump towards the top PREVENT FREE FLOW whenever the pump door is open and when the set is out of the pump This is accomplished by having the set s slide clamp or roller clamp fully closed or by partially opening the roller clamp to achieve gravity flow WHEN CHANGING IV SETS OR CONTAINERS always keep the set s slide clamp or roller clamp fully closed except when following standard gravity set priming procedures Drug Error Prevention Programming Turn the pump Select the care area nursing area Push OK Type the drug s first two letters all drugs beginning with those two letters will appear Push OK Scroll to the desired drug Push OK Select the correct drug concentration if more than one is offered Push OK If the Concentration Confirmation option is enabled a
21. PECT TO ANY CLAIM OF THE PURCHASER ARISING OR RESULTING DIRECTLY OR INDIRECTLY FROM THE USE OF THE PUMP IN NO EVENT SHALL SIGMA BE LIABLE HEREUNDER FOR AN AMOUNT THAT EXCEEDS THE PURCHASE PRICE OF THE PUMP NO PERSON FIRM OR CORPORATION IS AUTHORIZED TO ASSUME FOR SIGMA ANY LIABILITY IN CONNECTION WITH THE SALE OF THE PUMP 38 Appendix A APPENDIX A SPECIFICATIONS Pump Options e Through the use of a Drug Library the pump enhances safety by providing each drug s concentration choices dose rate mode starting dose rate and dose rate limits preventing wrong dose rate e Prevents the cause of adverse drug events while additionally alerting operators to pumps improperly running drugs in non drug error prevention modes mL hr modes e operator manually selects the care area drug name and concentration and set up screen then displays the required entries for infusion start up e When necessary the drug error prevention system can be bypassed and manually selected mL hr dose mode and ramp taper modes can be accessed With Optional Wireless Battery Module standard battery is replaced by a Wireless Battery Module This option will be capable of receiving a new drug library and sending pump status information via the wireless network connection Master Drug Library MDL e based pharmacy edited and controlled customized in house list of all IV and epidural drugs along with their safe delivery parame
22. RF communications equipment and the Spectrum The SIGMA Model Spectrum is intended for use in an electromagnetic environment in which the RD disturbances are controlled The customer or user of the Spectrum can help prevent electromagnetic interference by maintaining a minimum distance between the portable and mobile RF communications equipment transmitters and the Spectrum as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter output power of m transmitter 150 kHz to 80 MHz 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz W outside ISM in ISM bands bands For transmitters rated at maximum output power not listed above the recommended separation distance d in meters m be determined using the equation applicable to the frequency of the transmitter where power P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At80 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 6 756 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 3 An additional factor of 10 3 is used in calculating the recommended separation distance for the transmitters in the ISM frequency band between 150 kHz and 80 MHz an
23. S Primary Microdrip Filter Set with backcheck valve Yellow Key Slide Clamp 2 CLAVE Y Sites amp OL gt gt 100 Primary Filter Set Macro 15 Drops mL 11538 68 LS Primary Piggyback Set 0 2 micron filter PP backcheck valve PP Y site 8 OL 80 11963 68 LS Primary Piggyback Set with inline backcheck valve 2 CLAVE Y sites 0 2 Micron High Pressure Filter amp OL 100 12573 48 LS Primary Set 0 2 micron filter specific pumping section 1 CLAVE Y Site amp OE 440 20780 48 LS Primary Set 0 2 micron filter with backcheck valve Yellow Key Slide Clamp 2 CLAVE Y Sites amp OL 100 150 mL Burette Set Macro 15 Drops mL 12907 65 LS Burette Set backcheck valve 2 PP Y Sites 1 CLAVE Port amp OL 106 5 20797 48 LS Burette Set Yellow Key Slide Clamp 3 CLAVE Ports 8 120 20798 01 LS Burette Set Yellow Key Slide Clamp 4 CLAVE Ports amp OL 167 w Extension 150 mL Burette Set Micro 60 Drop mL 11398 20 LS Microdrip Filter SoluSet 150 x 60 PP site on burette capped port PP Y Site amp OL 100 11964 02 LS Filter SoluSet 150 x 60 slide clamp 1 CLAVE Y Site amp OL 9 77 12341 01 LS Microdrip SoluSet 150 x 60 capped port 1 CLAVE Y Site amp OL 77 20804 01 15 Microdrip Burette Set Yellow Key Slide Clamp Filter Valve Capped port 1 CLAVE Y Site amp OL 449 Primary Nitroglycerin Set Macro 15 Drops mL 11993 78 Nitroglycerin Primary Pump Set not for gravity
24. TEM DEP mode protects against human errors that could cause Adverse Drug Events BASIC mode can not detect human errors 4 DO NOT DROP THE POWER SUPPLY The power supply is an electronic device It is not simply a plug and it will break if repeatedly dropped 5 FOLLOW SECONDARY PROCEDURES Use SIGMA metal hooks to drop primary containers below secondary containers With secondary rates above 300 mL hr look for and clamp off primary line siphoning BACKGROUND INFORMATION Intended Device Use The SIGMA Spectrum is a multifunctional intravenous and epidural drug error prevention DEP smart infusion pump It is intended for infusion applications in hospitals outpatient care areas and homecare services System Components SIGMA Spectrum Pump Standard gravity IV sets with slide clamp DN HUN ETUPI GHI 1 1 3 EL POR 4 5 amp Fig 1 Fig 2 1 Master Drug Library MDL The MDL is a software tool used by pharmacy to list every IV and epidural drug found in the pharmacy s formulary along with associated care areas and infusion parameters for each drug entry 2 MDL Transfer Accomplished by e Transfer from a wireless network connection to a pump using a wireless battery module e Transfer from the PC to a mobile PDA and then transfer by infrared from the PDA to a pump 3 SIGMA Spectrum Infusion Pump Fig 1 4 Standard Gravity IV Sets containing a slide clamp used for d
25. TICULAR PURPOSE ANY AFFIRMATION OF FACT OR PROMISE MADE BY SIGMA SHALL NOT BE DEEMED TO CREATE AN EXPRESS WARRANTY THAT THE PUMP SHALL CONFORM TO THE AFFIRMATION OR PROMISE ANY DESCRIPTION OF THE PUMP IS FOR THE SOLE PURPOSE OF IDENTIFYING IT AND SHALL NOT BE DEEMED TO CREATE AN EXPRESS WARRANTY THAT THE PUMP SHALL CONFORM TO SUCH DESCRIPTION ANY SAMPLE OR MODEL IS FOR ILLUSTRATIVE PURPOSES ONLY AND SHALL NOT BE DEEMED TO CREATE AN EXPRESS WARRANTY THAT THE PUMP SHALL CONFORM TO THE SAMPLE OR MODEL AND NO AFFIRMATION PROMISE DESCRIPTION SAMPLE OR MODEL SHALL BE DEEMED TO BE PART OF THE PURCHASE OF THE PUMP PURCHASER EXPRESSLY ACKNOWLEDGES THAT THIS LIMITED WARRANTY CONSTITUTES PURCHASER S SOLE AND EXCLUSIVE REMEDY WITH RESPECT TO ANY CLAIM OF PURCHASER ARISING OR RESULTING DIRECTLY OR INDIRECTLY FROM THE USE OF THE PUMP IN NO EVENT SHALL SIGMA BE LIABLE HEREUNDER FOR AN AMOUNT WHICH EXCEEDS THE PURCHASE PRICE OF THE PUMP LESS A 150 USAGE FEE FOR EACH MONTH THE PURCHASER HAS HAD POSSESSION OF THE PUMP NO PERSON FIRM OR CORPORATION IS AUTHORIZED TO ASSUME FOR SIGMA ANY LIABILITY IN CONNECTION WITH THE SALE OF THE PUMP 37 SIGMA SPECTRUM BATTERY PACK LIMITED WARRANTY SIGMA International warrants to the original purchaser the SPECTRUM Infusion Pump Battery Pack hereinafter Battery to be free from defects in material and workmanship under normal use and service for one year from the date of purchase SIGMA s obligation under this li
26. a Sea caria ute 21 IS top es Pus de Us eed ien oae dotes tenta sare lect ou top 21 22 LOW Balen y 22 Banery MISSING score P 22 Mem 22 Slide Clamp Closed iet etie ocean tta dede 22 SV SUS MI EMO dads eid ante aah shuren Sales ieu Most te ten Lo iA a pua le ei 22 m m UE 22 Dome 23 Prevent Nuisance cT 23 Managing Bolus before Occlusion Downstream 23 WARNINGS AND CAUTIONS diiiiuco S Sire orae ud 24 CLEANING AND STORAGE isipin saanane aaa Aaaa CE atta nud Cea ean ucc cR eee 28 jedem E 28 Battery DISDOS LEE 29 stare m Lm 29 Battery Removal and 29 viride Cen Tree 30 PUMPS 30 Required Maintenance and Frequency 30 ACCESSORIES ERES 31 SIGMA IV SEIS Lei cL dm b E 33 COMPATIBLE IV SETS vea Va EVE Y E 33 Compatible Hospira IV Sets WARNINGS 34 Compatible Baxter IV Se
27. a reasonably shortest amount of time 1 minute the mean value of 52 mL 16 may be expected DOWNSTREAM OCCLUSION Time to Occlusion The maximum time for activation of the downstream occlusion alarm at the minimum flow rate of omL hr is 1 hour at the minimum occlusion threshold setting It is hours at the maximum occlusion alarm threshold setting The maximum time for activation of the downstream occlusion alarm at the intermediate flow rate of 25mL hr is 50 seconds at the minimum occlusion threshold setting It is three minutes at the maximum occlusion alarm threshold setting Bolus Volume The maximum bolus volume generated as a result of operation at 25 mL hr and reaching the minimum downstream occlusion alarm threshold is 0 25mL The maximum bolus volume generated as a result of operation at 25 mL hr and reaching the maximum downstream occlusion alarm threshold is 0 8mL Caution Specifications for Downstream Occlusion detection times and bolus volume after release of occlusion are based on specific test conditions The analytical related conditions are e distance of 48 from the point of the downstream occlusion to the SIGMA Spectrum s Downstream Occlusion sensor approximately the distance from the IV administration set s exit from the pumping channel to the point of occlusion The 48 test administration set contained one no filters or other components e Testing was at the nominal room temperat
28. ary Bag or in Primary Bag when a secondary program exists in memory With Manual Program Mode entered setup again continues as described in the Basic or Dose Error Prevention programming sections step indicator bar is located at the top of the screen The bar shows which steps within the program have parameter data a small white highlight and which step is currently being viewed a full white highlight Once setup of an individual step has been completed press OK to advance and program the next step When the 10 step has been programmed the program schedule is complete and no more steps may be programmed Only one step is necessary to start a program however it must be the first and only programmed step The pump may not be started if setup data is missing from any 17 step in the program Any parameter data missing within the program shall be identified in a popup message when a program attempts to be started The setup data for any programmed step may be viewed by moving the highlight using the up ARROW soft key to the step indicator bar located at the top of the setup screen and then using the left and right ARROW soft keys to move from step to step e Note that a one second delay exists from the time a step is selected and when its setup data is displayed This delay is to allow rapid scrolling along the step bar without updating the screen contents repeatedly and unnecessarily e If the pump is stopped any
29. as Do not immerse any part of this device or allow cleaning fluids to seep inside the pump Do not use phenol based cleaners disinfectants Phenols degrade plastics and membrane switches Phenols are intended for cleaning of hard non porous surfaces such as sinks counter tops and stainless steel Do notuse abrasive cleaners Storing Connect the AC power adaptor to the pump and supply source power to charge the pump s battery during storage This will insure a fully charged battery for subsequent use Do not store or transport pumps in ways that might result in physical damage For extended periods of storage remove the battery and repackage the pump in the 28 original shipping container Storage at elevated temperatures will diminish battery life Do not store in temperatures above 120 or below 4 F and humidity should not exceed 90 RH non condensing Battery Disposal The SIGMA Spectrum contains a Lithium lon rechargeable standard LAY battery pack Wireless Battery Module It should not be disposed of in trash in fire lt is recyclable product and should be disposed of properly Return to SIGMA for disposal if an authorized disposal center cannot be found Do not short circuit the battery terminals Do not disassemble or modify Battery Charging When the SIGMA Spectrum is connected to the AC Power Adaptor and the adaptor is plugged into a powered outlet receptacle main
30. cation Section for Downstream Occlusion times and bolus release information 34 DOC 11182 Rev C SIGMA Compatible Baxter IV Sets SIGMA Spectrum pumps that have been calibrated for Baxter S I V set tubing All sets must include a Blue Slide Clamp on the section of the set to be placed into the Spectrum pump No Brief Description Primary Set Macro 10 drops mL 1C8109s Solution Set Male luer lock 101 1C8160s Solution Set Male luer lock 69 1C8296s Solution Set Male luer lock 125 2C6401s Solution Set Interlink 1 ea with luer lock adapter lever lock cannula 76 2C6419s Solution Set Interlink 1 ea with luer lock adapter DUO VENT spike 92 2C8401s Solution Set Clearlink 1 ea with male luer lock 76 2C8419s Solution Set Clearlink 1 with male luer lock adapter DUO VENT spike 92 2C6519s CONTINU FLO Solution Set Interlink 2 ea with luer lock adapter backcheck valve 89 2C6537s CONTINU FLO Solution Set Interlink 3 ea with luer lock adapter backcheck valve 110 2C8515s CONTINU FLO Solution Set Clearlink 1 ea with male luer lock backcheck valve 106 2C8519s CONTINU FLO Solution Set Clearlink 2 ea with male luer lock backcheck valve 112 2C8537s CONTINU FLO Solution Set Clearlink 3 ea with male luer lock backcheck valve 110 3C0062s CONTINU FLO Solution Set Interlink 4 ea with 4 way large bore stopcock extension set backckeck valve
31. d 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 4 The guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people WARNING The Spectrum pump is not designed to be exposed to linear accelerator radiation nor is it intended to be used in this manner Exposure to radiation of this type may cause the device to operate improperly Do not expose the SIGMA Spectrum to linear accelerator radiation Doing so may cause injury to the patient and or damage to the equipment Appendix B Appendix B Low Very Low Battery Tutorial LOW BATTERY Plug into wall outlet n Push OK to dismiss for 5 minutes PUMP ISRUNNING VERY LOW BATTERY Plug into wall outlet N 4 4 N Is power cord plugged into wall outlet PUMP ISRUNNING Pump plugged in The triple beep audio alarm shall repeat every 5 seconds Pressing OK shall temporarily suspend this alarm and return to RUN only when the battery level is high enough to indicate that the battery is not near the Dead Battery level which causes the pump to stop In this situation the only action that can be allowed is to get the AC applied If connecting external power does not pr
32. d or Wireless battery removed Events are not sent to the network host Gray background Network module error Events are not sent to the network host inverting Red and White background A different drug library is available to download to the pump This icon can appear alongside any of the icon listed above See below on how to activate this new drug library DL Figure 1 below shows the key lock and battery icon upper left and the network connection upper right icon tg setup and Run screens Figure 1 Icon displays Activating a Drug Library The pump must be on and in the idle state not running for the new drug library to be loaded automatically to the pump The pump screen will display the status bar as the library is being installed A confirmation screen will be displayed when the download is complete See figure 3 Press OK 61 If the Pul is running The 44 image may appear in the upper right corner next to one of the wireless icons indicating that a drug library is now available To see the new library that is available from the run screen Press the options soft key Arrow to select View Information and press OK Arrow to Library Information and press OK The Library Information screen will display the current active drug library information and the queued new drug library that is ready to be activated See figure 2 Press the exit soft key to return to the
33. dialog shall appear prompting confirmation of the selected drug concentration Press yes to continue or no to reselect Note that the confirmation dialog will appear only when selecting from a list of concentrations or if entering a concentration manually to a drug that has been assigned a variable concentration in the Master Drug Library MDL When the setup screen appears e Confirm the drug and concentration is correct e Select primary or secondary bag and push e Enter required data Push OK after each entry The bag selection prompt shall not be offered if the selected drug has been specifically assigned to either the primary or secondary bag in the MDL Push RUN to begin the infusion Confirm that all infusion parameters are as intended Dose Rate Limits SOFT DOSE RATE LIMITS may be exceeded by pushing OK twice once to enter the value and again to accept the limit warning thereby providing a double confirmation HARD DOSE LIMITS can not be exceeded Reset rates within HARD limits to start the pump Basic mL hr Programming Turn the pump Push BASIC 15 Ifthe prior setup needs to be erased push CLEAR ALL When the BASIC screen is displayed Select primary or secondary bag Push OK Select mL hr or use ARROW soft keys to scroll through dose rates Push OK Enter the flow rate value Push OK Enter the VTBI Volume To Be Infused in mL Push OK Confirm the computed i
34. door and either push RUN to start the infusion or push OFF Power will not turn off with the door open Slide Clamp Closed Open slide clamp and push run or reload the set System Error An internal fault has been detected Some faults can be cleared by either cycling power off then on or by turning the power off disconnecting the battery reconnecting it several seconds later and pushing the ON key If neither procedure clears the fault return the pump for service Upstream Occlusion Eliminate the occlusion by checking for an upstream closed clamp kinked tube or closed burette valve and push the RUN key 22 TIPS Prevent Nuisance Alarms The following steps will help to prevent nuisance alarms Remowve all air from IV sets and Y sites Warm solutions to room temperature before use Invert do not shake IV bags that need to be mixed Fill drip chambers half way Do not load pumped on IV set tubing in the pumping channel or in the air and occlusion detector areas Follow prompts and HELP screens Use only compatible IV sets as labeled and identified on the SIGMA pump Keep the tubing channel clean and dry Avoid empty IV containers by properly setting VTBI values Plug pump s AC power adaptor in to maintain battery charge Using the Low Downstream pressure setting at flow rate setting above 500 mL Hr may cause Downstream nuisance alarms that are created by I V set pulsation Managing Bolus before Occlusion
35. e ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 756 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 The ISM compliance level in the ISM frequency band between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz are intended to decrease the likelihood that mobile portable communications equipment could cause interference if itis inadvertently brought into patient areas For this reason an additional factor of 3K is used in calculating the recommended separation distance for transmitters in these frequency ranges Field strength from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radio 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 Spectrum is used exceeds the applicable RF compliance level above the Spectrum should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Spectrum Over the frequency range 150 kHz to 80 MHz field strength should be less than V m 53 Immunity Separation Distances Recommended separation distance between portable and mobile
36. ert the user that altering any part of the scanner or pump may cause light levels to exceed Class 1 limits Under normal conditions this is not an issue eZ Ue Use Sound IV Poles Do not mount pumps on IV poles that allow pump cases to impact floors if poles tip over Service Personnel Must be Trained at SIGMA Servicing Spectrum pumps is restricted to qualified SIGMA trained service personnel who employ SIGMA authorized parts and procedures Use of other parts and servicing procedures Is prohibited Perform Preventative Maintenance Annually Pumps should be tested for proper performance annually and also whenever damage from drops fluid intrusion and other causes is suspected See SIGMA Spectrum Service Manual for complete information Do Not Improperly Clean Pumps During cleaning do not allow fluid to seep inside pump especially through front panel door latch holes or back case speaker holes or severe damage may occur Wipe on minimal amounts of cleaning fluids never spray them Use only SIGMA specified compatible cleaning fluids Do not autoclave or ETO sterilize pumps Be Cautious Near RF Sources The Spectrum pump meets the electromagnetic compatibility EMC requirements as specified in the International Electrotechnical Commission s IEC 60601 1 2 2001 09 standard for emissions and immunity It is good practice to keep the pump separated away from other equipment such as hand held transmitters ce
37. f the list the D RUN soft key shall appear replacing the DOWN ARROW soft key Pressing the D RUN soft key shall cause the Delay time value parameter line to appear on the setup screen Enter any value between one minute and twelve hours 00 01 12 00 hr min and press OK e Note leaving the Delay time value clear and pressing OK or navigating away from it via an ARROW soft key will cause the parameter line to be removed from the display for the duration of the currently programmed 19 infusion The D RUN softkey must be pressed again to display the delay time parameter Once a delay time is entered the infusion program completed and the set is loaded the RUN key may be pressed to begin the infusion delay timer The screen shall update to a DELAY RUNNING display with the remaining delay time shown in a flashing format While the delay is running it may be stopped by pressing the STOP key display updates to DELAY STOPPED and the delay timer is paused and no longer flashes or it may be cancelled by pressing the CANCEL soft key remaining delay time is cleared and the display updates to PUMP STOPPED The remaining delay time value may be changed while the delay is running or stopped From the setup screen press REVIEW if the delay is running move the cursor to the Delay value and enter the new desired delay time and press OK The new delay time shall be immediately observed e Note the Delay time value may not be cleared w
38. hile the delay is running When the delay time period expires the pump shall begin delivery of the programmed infusion 20 ALARMS Air in Line Push OK and then push RUN to advance small bubbles past the air detector Each push of RUN advances approximately 0 1 mL Use a syringe to aspirate air from the lower Y site or re prime the set Audio be silenced for 2 minutes by depressing any key Low medium and high volume levels may be selected in the CONFIG screen Depleted Battery The battery is fully depleted and unable to run the pump To continue the infusion and recharge the battery by plugging the pump s AC power adaptor into an AC outlet Confirm that the adaptor s power cord connector is attached to the pump Full charging requires a minimum of 8 hours for the Standard Battery and 12 hours for the Wireless Battery Module Door Not Fully Closed Set Outside Channel pump s door has not closed and latched correctly Ensure the slide clamp is closed open the door using the slide clamp and re load the IV set Close the pump s door ensuring both door latches shut securely Door Open The slide clamp has been closed and inserted in the keyhole when the pump was running The pump is stopped Close the door open the slide clamp remove it from the keyhole and push RUN to restart the infusion OR open the door and unload the IV set Downstream Occlusion Eliminate a closed clamp kinked tube
39. his paragraph All repairs qualifying under this limited warranty must be performed by SIGMA qualified and trained service personnel In the event that any pump is found to be defective during the aforesaid warranty period the purchaser shall notify SIGMA in writing of any claimed defect within thirty days after such claimed defect is discovered The pump claimed to be defective must then be promptly delivered to SIGMA or its designated representative for inspection and repair or replacement if necessary Pumps returned to SIGMA must be properly packaged and sent to SIGMA with postage and handling prepaid Severe pump damage may result if SIGMA shipping cartons and inserts are not used Shipping cartons and inserts are available from SIGMA This limited warranty shall not apply to defective conditions or damage caused in whole or in part by negligence fluid spills dropped pumps misuse abuse improper installation improper cleaning alteration or damage resulting from improper shipment to SIGMA If after inspection SIGMA is unable to identify a problem SIGMA reserves the right to invoice purchaser for such inspection THIS LIMITED WARRANTY IS THE SOLE AND ENTIRE WARRANTY PERTAINING TO THE PUMP AND IS IN LIEU OF AND EXCLUDES ALL OTHER WARRANTIES OF ANY NATURE WHATSOEVER WHETHER EXPRESS IMPLIED OR ARISING BY OPERATION OF LAW TRADE USAGE OR COURSE OF DEALING INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PAR
40. ians Orders Federal USA law restricts this device to sale or use by on the order of or under the supervision of a physician or other licensed healthcare practitioner Single Fault Conditions The maximum downstream occlusion time due to a single fault condition in seconds may be determined by dividing 2448 by the flow rate in mL hr In the event of a downstream occlusion detector failure the secondary detection method will limit the pressure developed by the pump to 10 PSI above nominal setting and generate an audible and visual alarm A bolus of approximately 0 5 mL may be generated as a result of a single fault condition Air volume equivalent to 15 seconds of delivery may be delivered to the patient in the event of a single fault condition The amount of undetected air in mL is dependent on flow rate setting divided by 360 This air may not reach the patient depending on tubing length from the pump to the patient One inch of tubing is approximately equivalent to 120mL of fluid 27 CLEANING AND STORAGE The SIGMA Spectrum is portable and it should be cleaned and disinfected for each patient use according to facility protocol Compatible cleaners include 1 10 solution of bleach and water Up to 90 Isopropyl alcohol Caltech Industries Dispatch 2 3 4 Steris TBQ and Steris Germicidal Surface Wipes Product Number 1608 GS 5 Metrex Cavicide and Cavi Wipes V 6 May be others Contact SIGMA for additional informa
41. ing with Wireless Battery Module Back View With Standard Battery Back View With Wireless Battery Module 12 SETUP AND OPERATION Keys SOFT KEYS the top row of keys on the keypad are non labeled keys with various functions depending on what is displayed above them ARROWS advance cursors and select alternate choices HELP selects photo instructions for things such as door opening set loading confirms entries and advances cursors SETUP starts programming LETTERS are selected by pushing corresponding numerical keys once twice or three times quickly BASIC allows selection of mL hr setup bypassing the Drug Error Prevention system From BASIC dose rate modes and ramp taper modes may also be selected CLEAR erases the highlighted entry CLR ALL erases the entire pump set up screen SILENCE quiets the audio alarm for 2 minutes Additionally any key can be pushed for silence HOLD places the pump in standby mode ON OFF turns the pump on or off RUN STOP starts and stops the infusion OPTIONS allow the user to select additional pump features BACK allows the user to go back RESET resets Manual Programming Mode to Step 1 RAMP allows access to the Manual Programming Mode CLR STEP clears one step of Manual Programming Mode TITRATE allows flow rate changes without stopping the pump BOLUS allows Bolus Setup without stopping the pump REVI
42. irst Two Hours Set Rate 5mL Hr 1 00 0 90 0 80 0 70 0 60 0 50 0 40 Flow Rate mL hr Gi 0 30 0 20 0 10 0 00 0 10 Time min Typical of minimum rate start up flow rate 47 96 Error of Flow Flow Rate mL hr Gi 50 096 40 0 30 0 20 0 10 0 0 0 10 0 20 0 30 0 40 0 50 0 1 00 0 90 0 80 0 70 0 60 0 50 0 40 0 30 0 20 0 10 0 10 Trumpet Curve 2nd Hour Set Rate 5 mL Hr Overall percentage error A 10 1 2 23 24 25 26 27 28 29 30 31 10 11 12 13 14 15 16 17 18 19 20 21 2 Observation Window min Typical of minimum rate 2 Hr Trumpet Graph Flow Rate Graph Last Hour Set Rate 5mL Hr Time min Typical of minimum rate last Hr Flow Accuracy 48 96 Error of Flow 50 0 40 0 30 0 20 096 10 0 0 0 10 0 20 0 30 0 40 0 50 0 Note For Hospira calibration the last hour is the 72 hour Trumpet Curve Last Hour Set Rate 5 mL Hr Overall percentage error A 3 6 Observation Window min Typical of minimum rate last Hr Trumpet For Baxter calibration the last hour is the 96 hour 49 BOLUS ACCURACY The SIGMA Spectrum IV Pump may have an
43. iuid Container ds Fabulas 44 Effect of BACK Pressure acuit ten ete dae 44 EHecCLO Terpetalllte castae fedet e eene ins Roe Anota gods saa 44 POW A HOTS ads che ends eb Ec uias ace sla E Det deleted E E S UENIT De LS SELL TIUS EE EDS 44 BOLUS ACCURACY wt tua vu ded uu dvd eges uo vega 50 DOWNSTREAM OCCLUSION 50 x 50 BOUS VOMO TERNI 50 ELECTROMAGNETIC COMPATIBILITY nnn 51 FNS SIONS nren bue folc M A E ICE Irae hol techie Ee M Rs PD NE ELLE 51 Immunity ESD transient burst voltage disparity magnetic 52 Immunity Conducted and Radiated cccccceccccecceceeceeceeeeeeeeeeseecesseeeesseeeeseeeeseeessaes 53 Immunity Separation Distances cccccceccccseececeeeeceeeeeceeeeeceeseeeessueeesaeeeesaeeeseeeeeanes 54 Appendix B Low Very Low Battery Tutorial 56 Appendix C ICONS heo uti du su 60 Appendix Wireless ICONS sisua
44. llular phones and electrosurgical equipment that may generate strong radio frequency interference RFI Reference the EMC Immunity Section Separation Distance in this manual for recommended minimum distance Confirm Audio Operation When pushing the ON key and all other keys confirm that an audio beep is heard If sound cannot be heard discontinue use of the pump and return to SIGMA for service Battery Retaining Fastener The battery retaining fastener screw can be used for both standard battery and Wireless Battery Module to avoid accidental battery disconnection and unexpected loss of power to the pump Dae Confirm Display Operation Regularly observe the pump s display Discontinue use of the pump and return to SIGMA for service if display abnormalities are observed Dae Electric Shock Hazard There are no user serviceable parts Do not open the case Refer servicing to qualified service personnel at your institution or return to SIGMA Accuracy Reference trumpet curves for flow rate accuracy as a function of short infusion durations The upstream occlusion detector may not detect partially occluded tubing Always check to ensure the IV set s clamp is not closed above the Spectrum pump Small 26 CAUTION CAUTION bore catheters or needles may cause excessive backpressure at elevated flow rates Please size the catheters according to expected flow rate and fluid viscosity Follow Physic
45. mited warranty shall be replacement of Batteries which upon SIGMA s examination are found defective in material or workmanship under normal use and service within one year from the date of purchase by the original purchaser The replacement of any Battery under this limited warranty shall not extend the term of this limited warranty beyond the original term as set forth in this paragraph During the aforesaid warranty period a Battery shall be capable of accepting a full charge as indicated by a full charge icon and maintaining the specified battery capacity as outlined in section 1 5 It is normal for battery capacity to decrease over the life of the battery Beyond the aforesaid warranty period batteries may exhibit a normal decrease in capacity depending upon age and usage f batteries exhibit decreased capacity they may need to be replaced Replacement batteries purchased separately from SIGMA International will be subject to the aforesaid one year warranty In the event that any Battery is found to be defective during the aforesaid warranty period the purchaser shall notify SIGMA in writing of any claimed defect within thirty days after such claimed defect is discovered The Battery claimed to be defective must then be promptly delivered to SIGMA or its designated representative for inspection and replacement if necessary Batteries returned to SIGMA must be properly packaged and sent to SIGMA with postage and handling prepaid Thi
46. mp has been calibrated to The use of CAUTION us ooo 0 E other manufacturers brands or type tubing may produce pump SETS CALL 1 4 inaccuracies that may be unsafe for patients Ze Use Key lock to Avoid Tampering CAUTION To lock the keypad after the pump starts running enter the number 429 The display will indicate KEYPAD LOCKED The keypad is now locked A lock symbol will replace the display message To unlock the keypad re enter 429 During KEYLOCK parameters can be read but not changed and the pump can not be stopped or turned off Follow Neonatal and Pediatric Precautions Use 60 drops 1 mL IV sets Configure the pump with appropriate flow rate VTBI patient weight and occlusion alarm limits using CONFIGURATIONS mode Prior to connecting to patient prime set load set open slide and roller clamp if equipped to avoid possible bolus 2mL that would result around door opening set loading event If the pump door is opened with an IV set connected to a patient and bolusing at door closing must be avoided before closing the door clamp the set below the lower Y site connect a syringe to the lower Y site close the door open the slide clamp collect a 0 085mL bolus in the syringe and unclamp set below the Y site 25 eZ Ue Use of controls adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure This caution is to al
47. n hard limits Downstream Occlusion automatic restart occurs after the downstream occlusion is cleared Actuation can be set to Low 6 4 PSI Medium 13 6 PSI or High 19 9 PSI Inactivity actuates after the pump has been inactive for 2 minutes Infusion Complete occurs when the reaches zero at which time a KVO rate begins The previous running rate or 1 mL hr whichever is lower In Stop Load Set In Stop Open Slide Clamp In Stop Push Run Low Battery 30 minutes of battery power remain Shut Door Slide Clamp Closed Pump Stopped System Error Upstream Occlusion Very Low Battery 15 minutes of battery power remain Real Time Clock battery backed 10 year life Logging Memory AC Power 24 hr memory of all set up screens except for ramp taper modes that are maintained permanently Separate pump and drug library history logs minimum of 96 hours each under extensive logging intensive operating conditions AC Power Adaptor low profile covers only one outlet Medical Grade EN60601 1 2 Input 100V AC 240V AC 50 60Hz 200mA Output 9V DC 800mA short circuit protected cord length 3 0 m 9 75 feet Use only SIGMA part number 05079 or equivalent The SIGMA Spectrum Infusion Pump is classified according to Medical Electrical Equipment standards as e Class 1 Equipment e BF Applied Part e Continuous Operation 42 External Interfaces Standards RS 232 RTX and CTS only IrDA SIR E
48. ncoding Protocol Supports IrOBEX Additional Asynchronous Serial Port expansion bus available at battery terminals Software upgrades may be performed through external RS 232 or IrDA ports IEC60601 1 including collateral standards Third Party Notified Body Testing Reference Electromagnetic Compatibility Tables IrDA Serial Infrared Physical Layer Link Specification v1 4 IrPHY IrDA Serial Infrared Link Access Protocol v1 1 and IrDA Serial Infrared Link Management Protocol v1 1 IrLMP IrDA Tiny TP v1 1 Wireless 802 11b EIA RS 232 levels for Asynchronous Transmit Receive only RS232 43 FLOW ACCURACY Effect of Fluid Container Height The performance of the infusion pump will be influenced by the forces of gravity on the fluid being administered to the patient When a fluid container is positioned above or below the patient s administration site pressure forces associated with the fluid s head height distance measured from the center of the pumping mechanism to the top of the fluid in the source container will cause deviations in the nominal specification for device flow rate accuracy The nominal head height used for the flow rate specification is 24 61 cm A deviation of as much as 4 may occur if the fluid in the source container is located to a head height of 20 50 cm Effect of Back Pressure Positive back pressure can influence the flow rate accuracy of the infusion Back pressure eq
49. ners to catheters Set Description Cat No 99021 99022 Length 99 overall 15 PVC pumping section DEHP free vented drip chamber 60 drops mL Polyethylene lined tubing Priming Volume 20mL Luer Lock Pump Calibration Hospira Baxter Y Type Blood Sets Connect Blood and Saline Bags to catheters Set Description Cat No 99031 99032 NOTE Pump Calibration Hospira Baxter Length 104 overall 15 PVC pumping section 200 Micron blood filter Lower Y injection site Priming Volume 42mL IV Sets are Latex Free Luer Lock COMPATIBLE IV SETS DOC 11181 Rev B SIGMA Compatible Hospira IV Sets SIGMA Spectrum pumps that have been calibrated for use with Hospira nominal size 0 100 I D Series I V set tubing Sets must include a Green Slide Clamp or a Yellow Keyed Slide Clamp on the section of the set to be placed into the Spectrum pump No Brief Description Primary Set Macro 15 Drops mL 11309 58 11540 58 11545 58 11679 65 11960 68 11961 68 12574 48 20778 48 20793 48 20794 48 20795 48 20803 48 20815 48 LS Primary Piggyback Set PP backckeck valve 2 PP Y Sites amp 106 LS Primary Piggyback Set PP backcheck valve PP Y site 8 OL 80 LS Primary Set PP Y site amp OL 78 LS Primary Piggyback Set with inline backcheck valve 2 PP Y sites and OL 100 LS Convertible Pin I V Set CLAVE Y site and OL 100 LS Primary Piggyback Set
50. nfusion time Confirm the Volume Given mL value or push CLEAR to erase it Note VTBI counts down to zero while VOLUME GIVEN counts from zero up Push RUN to begin the infusion Secondary Infusion Prepare primary and secondary bags and IV sets see Secondary Infusions under HELP for photo instructions e Use a primary set with an upper Y site and back check valve e Connect the secondary set to the primary set s upper Y site e Using the metal extension hook supplied by SIGMA lower the primary bag approximately 20 inches below the secondary bag to provide the secondary bag with a gravity advantage This causes the primary sets back check valve to close which ensures secondary flow When the secondary bag empties the primary back check valve opens and primary fluid begins to flow Program the pump for the primary bag as described above Then push SETUP to begin programming the secondary bag f a drug is to be delivered in the secondary program drug must be pharmacy hospital approved for delivery as a secondary line enter the drug name by typing the drug s first two letters Scroll to the desired drug Push OK Otherwise push BASIC and use the soft key A V to change the bag to Secondary Press OK and select mL hr or dose rate mode When the setup screen appears e Confirm the drug and concentrations are correct if selected e Select secondary bag using the soft arrow keys waterma
51. oduce the plug icon shown below or if the alarm is not acknowledged after 2 minutes the alarm volume shall increment up and the troubleshooting tutorial Shown on the next page shall automatically begin The help soft key may be pressed to start the tutorial immediately When the battery level drops very close to the Dead Battery level the LOW message updates to VERY LOW and begins to flash in the display The backlight also dims to the low setting to reduce battery usage and extend the operating life of the battery At this point the help tutorial is also started automatically Once external power has been applied the plug icon is displayed for two seconds as positive feedback before returning to normal RUN screens 56 LOW If the Low Battery alarm is left unacknowledged for 2 minutes or if the help softkey is pressed the following troubleshooting tutorial BA ERY shall begin Plug into wall outlet The tutorial is designed to provide step by step confirmation that the external power supply is connected to the wall outlet that its power light is illuminated and that the power cord is properly connected to the Spectrum Is power cord plugged dd into wall outlet If external power is detected at any point during this tutorial the Pump plugged in screen shown on the previous page shall be shown before returning to the RUN screens BATTERY ls wall plug light on m
52. oor opening Fig 2 Cautions and Warnings For other essential conditions of use general warnings and operator preparation see SETUP AND OPERATION ALARMS and CAUTIONS and WARNINGS section in this manual SYMBOLS qira ae Attention consult ACCOMPANYING DOCUMENTS CLASS 1 EQUIPMENT TYPE BF APPLIED PART Direct current ON only for part of the EQUIPMENT OFF only for part of the EQUIPMENT Note to completely disconnect the equipment from the external power unplug the AC Power Adaptor from the mains receptacle Recyclable dispose of properly These symbols are on the Battery Pack and are used to identify polarity of the battery This is for reference only This is a representation of the Direction of Flow label not to scale This label appears behind the door of the pump It is intended to assist the user in determining the direction of fluid flow from the medication container to the patient The fluid direction is controlled by the pumping mechanism when the door is closed and the pump is in the infusion mode running Non ionizing electromagnetic radiation 7 ILLUSTRATIONS Front View Door Open spectrum PUSH TUBING IN JUST BELOW 3 2072 13 2909 73414 21 ON RUN SETUP Ay STOP BASIC ABC DEF GHI 1 2 3 JKL MNO PQR 4 5 6 stu vwx vz Front View Pump Running with Standard Battery Front View Pump Runn
53. opping the pump not available in Program Modes e Push TITRATE e Observing the displayed hard and soft rate limits enter a new flow rate e Push either RUN or Patency Checks To confirm the IV line is not blocked e Push STOP e Open the door e Slowly open the slide or roller clamp to check for gravity flow If gravity flow can not be achieved a clamp is closed the tubing is kinked the catheter is blocked or a filter may be clogged Keypad Lock Operation To lock the keypad the caregiver should enter the code 429 E Y This code is entered when the pump is in the run mode to prevent unauthorized activation of 18 CAUTION specific key entries A popup message shall be displayed briefly indicating the keypad has been locked The Key lock icon is shown on the top left corner of the screen The REVIEW soft key may be pressed to allow review of the infusion setup data No values may be changed and therefore navigation from value to value is not allowed when the keypad is locked The keypad will allow certain alarm conditions to be silenced and cleared while in the Keypad Lock mode The code must be re entered to unlock the Keypad If the keypad is unlocked while reviewing the setup data and the pump is running as long as the pump is not stopped the keypad will automatically relock upon return to the RUN screen Always guard the keypad lock code from unauthorized view or access Uncontrolled acces
54. or upstream occlusion alarms Flow rates above 300 mL hr may cause fluid to be siphoned from the primary container during piggyback operation see Secondary Infusion Partially occluded filters can cause nuisance upstream air upstream occlusion or downstream alarms and influence flow rate accuracy Burettes with closed vents or shutoff valves will cause upstream occlusions that may not be detected by the infusion pump Yellow Key Slide Clamp sets are only compatible with Spectrum Software of 4 02 06 or higher Keyed for correct direction of flow Sets having a length that is greater than 48 inches from the exit of the pump to the patient connection end may have an increased downstream occlusion pressure time to occlusion and bolus at occlusion release For rates of less than 100 mL hr the pump should be set to the LOW downstream pressure setting Some Sets contain two or more slide clamps Only the slide clamp on the pumping section or on the section with the main roller clamp should be used for pumping operation and clamp detection Other slide clamps associated with the set need to be observed and controlled by the user This set is configured with a roller clamp above the set slide clamp When loading it into the Spectrum pump ensure proper set orientation with slide clamp located above the pump Blood sets with both clamps closed above the blood filter will cause upstream occlusions conditions that may not be detected by the pump See the Specifi
55. ow The customer or user of the Spectrum should assure that it is used in such an environment Immunity test IEC 60601 test level saa er Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the Spectrum including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted 3 Vrms 4 2 61000 4 6 150 kHz to 80 MHz in ISM bands 10 Vrms 10 Vrms 150 kHz to 80 MHz in ISM bands Radiated RF 10 V m 1 2 NP 80 MHz to 800 MHz 61000 4 3 80 MHz to 2 5 GHz d 2 3VP 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 dis the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of the equipment marked with the following symbol This excludes the Wireless Battery Module SIGMA Part Number 35083 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 Th
56. r regular patient observation Never operate the Spectrum unless all of the above safe operations are being practiced Prevent Inaccuracy The following can cause flow rate inaccuracies and must be avoided Incompatible brand IV sets and compatible brand IV sets with unusually large or small diameters or unusually stiff materials Operating temperatures outside of 60 90 F for Standard Battery and 60 80 F for Wireless Battery Module Using IV sets longer than 72 hours for Hospira or 96 hours for Baxter Using dropped damaged dirty or wet pump Pressurizing IV bags Positioning IV containers more than 3 feet above or 1 foot below the pump Note Upstream occlusion detection is only effective for occlusions present immediately after the start of the pump s run operation Upstream occlusions caused by non vented IV sets used with non vented glass bottles or closed burette air vents cannot be detected because of the very slow building vacuums resulting from these situations WAAI This equipment is not suitable for use in the presence of a Flammable Anesthetic Mixture with Air or with Oxygen or Nitrous Oxide This statement is a requirement of the IEC 60601 2 24 standard It applies to oxygen enriched environments such as oxygen tents It is not meant to apply to patients on breathing tubes 24 Wwe Follow Epidural Precautions Epidural administration of drugs other than those indicated for epidural use can res
57. rcentage error A 3 8 Observation Window min Typical of intermediate rate last Hr Trumpet Graph Note For Hospira calibration the last hour is the 72 hour For Baxter calibration the last hour is the 96 hour 46 It is important for the clinician to understand the pharmacological influence of specific drugs based on concentrations and patient response when used in conjunction with the SIGMA Spectrum Pumping mechanisms produce fluctuation in fluid flow by design based on the specific mechanism type peristaltic piston rotary etc electronic control system and other factors related to the administration set s characteristics Specific flow profiles are helpful in determining the correct clinical application for the infusion pump Data is presented as requested by the applicable standards and represents the typical flow rate function of the Spectrum pump for short and long term operation To help with the visualization of the flow inconsistencies that are typical of most infusion pumps the start up graphs and trumpet curves are extended to include the minimum rate 5mL hr and intermediate rate 25 mL Hr for the SIGMA Spectrum NOTE The SIGMA Spectrum is best classified as a Volumetric Infusion Pump as defined by the applicable standards Reference IEC 60601 2 24 and AAMI ID26 1998 Medical electrical equipment Part 2 Particular requirements for safety of infusion pumps and controllers Start up Graph F
58. rk indicator will be displayed beneath the parameter data to help distinguish the Secondary 2 setup screen from the Primary 1 setup screen Note that this watermark shall not appear on Primary only infusions e Enter all required data Push OK after each entry avoid infusing residual amounts of the secondary container at primary flow rates be sure to properly set the secondary VTBI value Push RUN to begin the secondary infusion Scrolling run screens and or a two bag icon denote the secondary is running e Open the secondary roller clamp when prompted Push OK again to confirm accomplishment of that step and begin delivery e f the secondary rate is above 300 mL hr a dialog box appears prompting observation of the primary drip chamber 16 f drops are seen the primary line should be clamped closed Press yes in this dialog box if a clamp is being applied to the primary line Upon completion of the secondary infusion the pump will enter a KVO state and it will ask for the removal of the clamp from the primary line Push OK once the clamp has been removed to clear the alert and begin the primary delivery e Press no in the dialog if drops are not observed in the primary drip chamber e Upon completion of the secondary infusion transition to the primary infusion shall be automatic and one icon shall replace the two bag icon on the RUN Screen e Note Upon comple
59. run screen Stop the pump and clear the infusion program to load the new drug library that is available LIBRARY INFO UPDATE DRUG LIB Active Drug Library Name RefLibraryv4 Date Modified 12 12 05 Version D Format 4 New drug library activated Name i Date Modified RefLibraryV4 1 Date Modified 1 30 06 Version 1 Version 1 Format Clear infusion s to activate d drug lib queued drug library PRESS OK Figure 2 Library Information Figure 3 Library Update 62 Appendix C General Icons The following icons are displayed on various screens in the Spectrum TMEL The keypad lock icon is shown in the upper left corner above the power icon of the display whenever the lock code has been entered to enable the keypad lock feature This icon shall be displayed next to any configuration option menu item User or Biomed whose setting has been assigned in the Master Drug Library to the currently selected drug The word option will be displayed to the right of this image on any option that is an MDL settable option and a drug has not yet been selected 63
60. s the pump s standard battery pack or Wireless Battery Module will be charged to full capacity It is not necessary to turn the pump on Charging will take approximately 8 hours for Standard Battery and 12 hours for the Wireless Battery Module to fully charge a depleted battery Refer to Appendix C for a listing of the symbols used and their description Battery Removal and Replacement Should removal of the battery become necessary for any reason the following procedure may be used 1 2 Turn unit OFF if ON Disconnect the AC Power Adaptor and lay the SIGMA Model Spectrum Pump on its front Use a protective surface such as plastic foam to prevent damage to the keypad window Remove the screw located in the upper right hand corner of the SIGMA opectrum Battery if equipped Depress the release mechanism found in the top center portion of the battery and pull away from the back of the unit Install the battery by placing the battery insulation tab over the terminals and then gently sliding the battery down the back of the case and inserting the bottom of the battery into the pocket then pivoting it into the latch Make sure the latch is engaged to retain the battery Remove the battery insulating tab prior to charging the pump s battery or operating the pump Install the retaining screw if equipped Plug the AC power adaptor into an outlet and charge for 8 hours for Standard Battery and 12 hours for the Wireless Battery Module to
61. s 2 Spectrum pumps Stainless up right tubes and aluminum plate C Clamp jaw opening expands to 1 5 Vie ee C Clamp knob comes off if semi permanent attachment of carrier is desired Single Pole Cat No 86681 Adjustable height stainless steel pole Revolving 4 hook top Stable 5 leg base with 2 casters Support wheel for patient convenience Single Pole Cat No 55096 Adjustable height stainless steel pole Revolving 4 hook top Stable 5 leg base with 3 casters i KLE 24 A T j Ss VAN 7 SES m T NJ d lee 7 2 CAUTION Multi Pole Cat No 55088 1 Holds 5 pumps Adjustable height stainless steel pole f hook top UL CSA six outlet power strip for multi pole plug in 1 cord from IV pole to wall outlet Heavy duty 6 leg base with 3 soft rubber casters Patient support ring attached to rear of plate Always route IV set tubing and AC Power Adaptor cabling to prevent patient hazard or entanglement Identify the individual IV set lines when multiple pumps and routes of administration are practiced Securely mount IV pumps to pole by turning the mounting knob clockwise To maintain IV pole stability never exceed 210 cm 83 from floor to IV pole top and limit bag volume at this extended height to 1 liter 1000 cc SIGMA IV SETS Nitroglycerin Lipid Sets Connect IV contai
62. s by a patient or family member may possibly cause injury to the patient Pump Standby Hold Mode The pump may be placed in a standby state to prevent the occurrence of the Inactivity Alarm see ALARMS for the period of time specified in the User Settings Alarm Settings menu option The default setting is to provide an infinite period of time however this value may be changed from one minute up to 99 hours and 59 minutes For Standby Mode to be available the set must be loaded and the infusion setup must be complete Once setup has been completed and the highlight is on the Volume Given mL value a display will appear stating that the pump may either be started or it may be placed in standby mode To place the pump in standby press the HOLD soft key When standby is activated the indicated message will be displayed in a flashing format Note that if the delay period is set to infinite the time value in the display will be replaced with a dashed line While in standby the user may press RUN at any time to begin the infusion Pressing any other key or opening the pump door will cancel standby mode Pump Standby may also be used when the pump is stopped in a non alarm condition Press the REVIEW soft key and then press the HOLD soft key from the SETUP screen Delayed Start The start of any programmed infusion may be delayed by up to 12 hours During infusion setup move the highlight to the Volume Given mL value at the bottom o
63. s limited warranty shall not apply to defective conditions or damage caused in whole or in part by negligence fluid spills dropped Pumps or Batteries misuse abuse improper installation improper cleaning alteration or damage caused by improper shipment to SIGMA If after inspection SIGMA is unable to identify a problem SIGMA reserves the right to invoice the purchaser for such inspection THIS LIMITED WARRANTY IS THE SOLE AND ENTIRE WARRANTY PERTAINING TO THE PUMP AND IS IN LIEU OF AND EXCLUDES ALL OTHER WARRANTIES OF ANY NATURE WHATSOEVER WHETHER EXPRESS IMPLIED OR ARISING BY OPERATION OF LAW TRADE USAGE OR COURSE OF DEALING INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE ANY AFFIRMATION OF FACT OR PROMISE MADE BY SIGMA SHALL NOT BE DEEMED TO CREATE AN EXPRESS WARRANTY THAT THE PUMP SHALL CONFORM TO THE AFFIRMATION OR PROMISE ANY DESCRIPTION OF THE PUMP IS FOR THE SOLE PURPOSE OF IDENTIFYING IT AND SHALL NOT BE DEEMED TO CREATE AN EXPRESS WARRANTY THAT THE PUMP SHALL CONFORM TO SUCH DESCRIPTION ANY SAMPLE OR MODEL IS FOR ILLUSTRATIVE PURPOSES ONLY AND SHALL NOT BE DEEMED TO CREATE AN EXPRESS WARRANTY THAT THE PUMP SHALL CONFORM TO SUCH SAMPLE OR MODEL AND NO AFFIRMATION PROMISE DESCRIPTION SAMPLE OR MODEL SHALL BE DEEMED TO BE PART OF THE PURCHASE OF THE PUMP THE PURCHASER EXPRESSLY ACKNOWLEDGES THAT THIS LIMITED WARRANTY CONSTITUTES THE PURCHASERS SOLE AND EXCLUSIVE REMEDY WITH RES
64. sigmaspectrum Operator s manual Revision Date 5 15 08 SIGMA International SIGMA P N 41018 Rev X 711 Park Avenue Medina New York 14103 v 800 356 3454 f 585 798 3909 www sigmapumps com CONTENTS REMOVE FROM THE SHIPPING 4 KEY OPERATING TIPS tuendo n vdeD 5 BACKGROUND 6 Intended Device USE 6 System COMPONEN Sasra a ata i a ibt Meo t te isa a uet Lt Una Io M UE 6 Cautions and Warnings REED INE 6 jd o Rl 7 ILLUSTRATION S ER ER 8 PROM VIEW DoOr ODO sede 8 Front View Pump Running with Standard 9 Front View Pump Running with Wireless Battery 10 Back View With Standard Battery esssssssssesssssseeeeennen nennen 11 Back View With Wireless Battery 12 SETUP AND OPERATION 5 5 cerae ce eso 13 E ho tus Sendai eck CP Sole 13 PresP rnp Programitfiltid
65. ters e Upto 1000 drugs and 32 care areas e area enable 1 same name same concentration drugs to have different dose rate limits 2 pump configurations for maximum rate VTBI patient weight and occlusion level e Each drug entry includes the care area drug name concentration dose rate mode bolus mode starting dose rate soft able to be exceeded and hard not able to be exceeded an optional setting dose rate and bolus limits volume to be infused VTBI primary or secondary IV container and pump screen color Drug Library Transfer Accomplished by e Transfer from a wireless network connection to a pump using a wireless battery module e Transfer from the PC to a mobile PDA and then transfer by infrared from the PDA to a pump Infusion Modes e Large and small volume parenterals LVP Standard Gravity IV Sets e Uses standard gravity IV sets from Hospira and Baxter Size and Weight otandard Battery e Without IV pole clamp 5 8 Hx 4 2 W x 2 5 D weight 25 oz 1 0 oz e With IV pole clamp 5 8 Hx 6 4 W x 4 7 D weight 33 5 oz 1 0 oz Wireless Battery Module Dimension e Without IV pole clamp 6 3 Hx 4 2 W x 2 5 D e With IV pole clamp 6 3 Hx 6 4 W x 4 7 D Weight e Wireless Battery Module s 0 75 lbs 40 Battery otandard Battery e Lithium lon 1800 mA h 7 2V nominal SIGMA Part Number 35702 e Pump operating time on battery power is at least 8 hours at 125ml hr wi
66. th the backlight on new battery e 12hr recharge time e Charging occurs if AC Power Adaptor is plugged in whether pump is ON or OFF Wireless Battery Module e Lithium lon 1800 mA h 7 2V nominal SIGMA Part Number 35083 e Capacity 4 hrs 500 mL at 125 mL hr at the highest backlight settings e 12hr recharge time e Charging occurs if AC Power Adaptor is plugged in whether pump is ON or OFF Pump Characteristics and Flow Rate Accuracy e Linear peristaltic mechanism e 0 5 999 mL hr flow range in 0 1 mL hr increments from 0 5 to 99 9 mL hr and 1 mL hr increments thereafter e Volumetric accuracy based on volume collected over one hour using standard Hospira Baxter 5 from 2 800 mL hr gt 800 mL hr 10 for Hospira 5 from 2 999 mL hr for Baxter 0 5 1 9 mL hr x0 1mL Total volume up to 9 liters Hospira or 12 liters Baxter e KVO keep vein open rate of either 1 mL hr or the actual rate whichever is lower at infusion complete alarm e maximum pump pressure 36 PSI which can never be obtained with operational occlusion alarm limits Wireless Network Interface Standard IEEE 802 11b Frequency 2 4 GHz Data rate Up to 11 Mbps with automatic fallback Modulation CCK 11 5 Mbps DQPSK 2 MBPS DBPSK 1 Mbps Transmit power 16 dBm typical Receiver sensitivity 82 dBm 11 Mbps Wireless Security e WEP Wired Equivalent Privacy 64 128 bit encryption RC4 e WPA WPA2 802 11i 128 bit TK
67. tion To clean the pump turn it off and unplug the AC power adaptor from the power source Place the pump in an upright position keyhole release upward Apply the compatible cleaning agent with a dampened cloth per the manufacturers instructions using appropriate dilution ratio Disinfectants should remain on the pump s surface in an even but not dripping film for the compatible cleaning agents recommended contact time Open the pump s door using a standard IV set s slide clamp Clean the speaker vent power adaptor connector door release Keyhole and pumping channel areas with soft swabs Apply solutions sparingly to the swabs and wipe down the necessary areas Do not use rigid cleaning instruments or spray solutions directly on the pump For severe solution spills it is recommended that the Standard Battery Wireless Battery Module be removed The Battery Pack cavity area of the pump may be cleaned by wiping down those regions with a dampened cloth as described previously Dispose of all cleaning materials including the slide clamp as required per facility protocol biohazard policy CAUTION Alcohols are flammable and should not be used for Standard Battery Wireless Battery Module cleaning disinfection Always use alcohols in a well ventilated area When cleaning the Standard Battery Wireless Battery Module care should be taken to prevent shorting of the pack s exposed terminals Do not sterilize this device by autoclaving or ETO g
68. tion of the secondary infusion the clamp on the secondary set should be closed to prevent any remaining fluid in the secondary bag being delivered at the primary delivery rate Reviewing Reprogramming a Depleted Secondary Infusion a secondary infusion has completed its setup parameters may be reviewed pressing the review softkey moving the cursor to the bag selection parameter and pressing either arrow softkey to select Secondary Pressing OK while viewing Secondary with pump in stop will repopulate secondary bag setup parameters from the Drug Library e Note Secondary bag setup parameters will not repopulate prior to completion of previous secondary infusion Manual Programming Mode The Manual Programming Mode allows the pump to be programmed with up to 10 individual infusion steps using either the Drug Error Prevention or Basic Programming Operations Drugs are eligible for use in the Manual Programming Mode provided that the selected drug has not been specifically assigned to either the primary or secondary bag as identified in the pump s Master Drug Library Initial programming is similar to the descriptions for Basic or Dose Error Prevention SETUP modes At the primary bag selection of the programming the RAMP soft key will be displayed allowing access into the Manual Program Mode Press RAMP to enter Manual Program Mode e Note that Manual Program Mode is not available in Second
69. ts WARNINGS 36 APPENDIX A SPECIFICATIONS 40 PUMP ODUOMS ee alee ence eee 40 Master Drug Library WIDE soient utate atr adit eds east tpe sad uuu Rd rd oec 40 Drug Library Transiter A vut emu asta 40 Deb veu ids abi e vadit Vds oue UI 40 Standard XSravity usu isaac ee suus tea dde 40 Size and VV epe 40 PUL MY Mr EE 41 Pump Characteristics and Flow Rate Accuracy 41 Wireless Network Interface ccccccccccccecccccccccccececenecececececececucacacacucecececutetecscueacecececeeas 41 VVIRCIESS T EL 41 EnvirenmentealEImilbs oec onte e pun dibus cede laetos 41 Bel pM rc 42 E A zT TTD TTE 42 iBniz i i jelrlepec rrr 42 Memory br Toc 42 42 External 43 43 LOW RATE AGCUBAQGY Esca Ta vezvrx cues cux cos evve eus su 44 Effector F
70. uivalent to 300 mmHg may reduce the flow rate causing a deviation in accuracy by 9 Negative back pressure of 100 mmHg may increase flow rate causing a deviation in accuracy of 7 Hospira and 3 Baxter IV Sets Notes Reference AAMI ID26 1998 Sub clause 50 102 Note Liquid container must be vented or a collapsible bag Effect of Temperature Nominal temperature range for pump calibration and accuracy testing is 72 2 F The SIGMA Spectrum has been designed with temperature compensation that opposes the influence of cold and hot temperature extremes This design is currently validated to control deviation in flow rate accuracy within 10 at 60 F and 7 at 90 F temperature limits for Hospira IV Sets and 5 from 60 F to 90 F for Baxter IV Sets Flow Profile The SIGMA Spectrum Infusion pump has the following start up flow rate accuracy curve shape associated with stability through time These graphs represent the variation in flow rate that is recorded from the time the infusion is started to the end of a two hour period The graph is intended to give a picture of the general stability with time of the infusion The graph is commonly called a start up curve The techniques and methods of test and generation of this graph are as detailed in IEC 60601 2 24 Medical electrical equipment Part 2 24 Particular requirements for the safety of infusion pumps and controllers 44 50 00 45 00 40 00 35 00 30 0
71. ult in serious patient injury When administering epidural analgesics use only catheters specifically labeled for epidural analgesia drug delivery To help prevent accidental infusion of non epidural drugs DO NOT USE epidural administration sets that contain injection sites Label the administration container and IV set EPIDURAL USE ONLY Clearly identify infusion pumps used for epidural administration Use KEYLOCK Do Not Allow Uncontrolled Gravity Flow To open the pump door the IV set s slide clamp must first be closed thus providing set based anti free flow protection Do not open the slide clamp when the door is open or during and after IV set unloading or dangerous uncontrolled free flow can occur During IV container changes always close the set s slide or roller clamp When the set is in the pump and the door is closed the slide clamp can be left open If gravity flow is to be used the pump door will be open or the set will be outside the pump and you will need to be sure gravity flow is maintained at the intended rate whenever the pump door is open and when the set is outside of the pump Disposal To dispose of this device the associated administration sets adhere to local state federal and or other governing regulation Ze Use the Specified Manufacturer s IV Set g This label is located on the top of the pump and indicates the specific type of IV tubing that the pu
72. ure 72 F 2 F Time to Downstream Occlusion and Bolus Volume release will generally increase under the following conditions longer distances to the occlusion point additional fluid volumetric area from filters or other components within the IV set length and hotter room temperatures 50 ELECTROMAGNETIC COMPATIBILITY Emissions Ue The use of accessories or cables other than those specified by SIGMA may result in increased Emissions or decreased Immunity of this medical device Guidance and manufacturer s declaration electromagnetic emissions The SIGMA Model Spectrum Infusion pump is intended for use in the electromagnetic environment specified below The customer or user of the Spectrum should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance Group 1 The Spectrum uses RF energy only for its internal RF emissions function Therefore its RF emissions are very low CISPR 11 and are not likely to cause any interference in nearby electronic equipment RF emissions Class B mE CISPR 11 The Spectrum is suitable for use in all Gi establishments including domestic establishments Harmonic emissions dep and those directly connected to the public low IEC 61000 3 2 voltage power supply network that supplies buildings used for domestic purposes Voltage fluctuations flicker emissions Complies IEC 61000 3 3 51 Immunity ESD transient b
73. urst voltage disparity magnetic Guidance and manufacturer s declaration electromagnetic immunity The SIGMA Model Spectrum Infusion pump is intended for use in the electromagnetic environment specified below The customer or user of the Spectrum should assure that it is used in such an environment Immunity test IEC 60601 Compliance level Electromagnetic environment test level guidance Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 8 kV contact 15 air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 120 gt 95 96 dip in 120 VAC or 0 5 cycle 40 9o 120 VAC 60 96 dip in 120 VAC for 5 cycles 70 95 120 VAC 30 dip in 120 VAC for 25 cycles 5 120 VAC gt 95 dip in 120 VAC for 5 sec 2 kV contact 15 air 2 kV for power supply lines Not applicable 1 kV differential mode Not applicable 5 120 VAC gt 95 dip in 120 VAC or 0 5 cycle 40 120 VAC 60 dip in 120 VAC for 5 cycles 70 120 VAC 30 dip in 120 VAC for 25 cycles lt 5 120 gt 95 dip in 120 VAC for 5 sec Floors should be wood concrete or ceramic tile If

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