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Sigma Spectrum Operators Manual

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1. REVIEW PROGRAM Press to display the setup screen when pump is stopped SILENCE Press to quiet the audio alarm for 2 minutes Additionally any key can be pressed for silence TAPER DOWN Press to enable a cyclic TPN program to taper down automatically TITRATE Press to change the flow rate and VTBI volume to be infused without stopping the pump 31 Manual 41018 6 05 6 2 4 Revision C Activating a Drug Library on a Pump with a Wireless Module Activating a Drug Library is the process of replacing the current Drug Library or deploying a new Drug Library The pump will receive a new Drug Library any time the pump is on and at the drug library check interval specified in the Drug Library When a new Drug Library is received it is placed in a queued position in the pump While the new Drug Library is queued the current Drug Library remains the active Drug Library When all infu sions are cleared and the pump is returned to the Care Area screen the queued Drug Library is auto matically made active While a Drug Library is queued a DIL icon will appear in the upper right hand corner of the pump screen To see or activate the new queued library that is available from the run screen 1 Press the OPTIONS soft key 2 Use the arrow buttons to select VIEW INFORMATION and press OK The Library Information screen displays the current active Drug Library information and the queued new drug library that is ready to
2. Figure 20 Type Drug s First Two Letters NOTE D is obtained by pressing the 2 key one time and the O is obtained by pressing the 5 key three times similar to phone texting S IE Manual 41018 6 05 6 2 4 Revision C e Use the arrow keys to cursor to the desired drug and press OK See Figure 21 Cursor to the desired Cursor to the desired drug and press OK drug and press OK DOBUTamine DOBUTamine DOPamine DOPamine Figure 21 Select Drug Screen 4 Cursor to the correct drug concentration if more than one is offered and press OK See Figure 22 Cursor to the desired Cursor to the desired concentration and concentration and press OK press OK DOBUTamine DOBUTamine Cursor to the desired concentration and press OK DOBUTamine 500mg 250mL CONFIRM CONC 250mg 250mL Figure 22 Select Concentration Screen Once a concentration is selected a dialog box appears prompting confirmation of the selected drug concentration Press YES to continue or NO to reselect Note that the confir mation dialog box appears only when you select from a list of concentrations or if you are entering a concentration manually to a drug that has been assigned a variable concentra tion in the Drug Library 34 Programming the Pump Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 5 Use the arrow buttons to indicate whether you are setting up the primary or secondary bag and press
3. e NO Apply clamp to primary line above upper Y injection site and press OK to confirm primary is clamped Are drops falling in the SECONDARY drip chamber and not in the PRIMARY PRI Figure 42 Secondary Check Flow at Run The two bag icon denotes the secondary is running See Figure 43 Figure 43 Secondary Icon Manual 41018 6 05 6 2 4 Revision C 10 If primary line is clamped the secondary infuses until completion and the rate will decrease to a KVO keep vein open rate with alarm See Figure 44 11 Press STOP 12 Select Infusion E Press the SECONDARY soft key to return to the secondary setup See Figure 45 This allows reprogramming of the last secondary infusion or with a new drug Wi Press the begin PRIMARY soft key to return to the primary infusion See Figure 45 Then remove clamp from primary and press OK to begin primary infusion General Care Select the desired SECONDARY SECONDARY infusion COMPLETE DARY 4 jm SECONDARY setup or begin 1 New Drug pileta dp PRIMARY infusion 1 mL hr KVO 3 EJ Press STOP silence SECONDARY begin PRIMARY cancel Figure 44 Secondary Completion Figure 45 Select Infusion Figure 46 Select Desired Secondary KVO Alarm Infusion Screen 13 Confirm flow from primary drip chamber YES NO M YES Primary infuses as programmed B NO Close clamp on secondary line Press OK to confirm secondary line is clamped 14 Upon completion of t
4. Is this a new patient Press yes to clear current program Figure 12 New Patient Screen Load the primed IV set Select your Care Area Select drug or fluid Type first 2 letters of drug name 3 4 5 6 Select and confirm a Concentration if more than one is displayed 7 Select Delivery Bag if required 8 Enter and press OK to confirm all required values on the Setup Screen 9 Confirm that all clamps and vents are in the proper position 10 Press RUN STOP to start the infusion 11 Check and confirm proper flow 23 Manual 41018 6 05 6 2 4 Revision C Starting a New Infusion using the BASIC Mode For use only when drug is not in the Drug Library Press the ON OFF button to turn the pump on If the previous setup needs to be erased press YES soft key when prompted New Patient see New Patient prompt above Load the primed IV set Select Care Area Select drug or fluid Enter B A prompts to BASIC Selection Select Delivery Bag Select a Dose Mode default is mL hr Enter and press OK to confirm all required values on the Setup Screen Confirm that all clamps and vents are in the proper position Press RUN STOP to start the infusion Check and confirm proper flow Secondary Infusions SO Geo co Ov da che UO qoo rt e e om pec ue 24 Stop the pump if it is running Lower the primary bag at least 20 below the secondary bag Open secondary roller
5. Operator s Manual 35700BAX amp 35700ABHB Gen 2 Operating System Pump Operating Software v6 05 For Use with MDL Editor v6 2 4 spectrum i f ay 1 eo00 ON serue ox RUN OFF STOP BASIC ABG DEF GHI LoL wv 2 3 JKD MNO POR JU 5 6 STU vw YZ La 87 9 EXIen p wv me 711 Park Avenue Medina New York 14103 v 800 356 3454 f 585 798 3909 www sigmapumps com Manual 41018 6 05 6 2 4 Revision C Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 2011 Copyright SIGMA LLC 711 Park Avenue Medina New York 14103 v 800 356 3454 f 585 798 3909 www sigmapumps com es sigmaspectrum Manual 41018 6 05 6 2 4 Revision C Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 TABLE OF CONTENTS Introduction and Safety isis esu akuk sade woe n RC RC RH ee 1 Intended Device Use 2 ise sod p IL Ped Pe x bec e b RRRREARME HP ESPERE 1 Related Documents sa acu deg Rea qoe Pot EISE Ae Rank ES e be Ran Os 1 Regulatory Information 2 eek rp RR RR E Ad en PR ERROR RUE a wes 1 Contacting SIGMA Technical Support s s s sasaaa aaeeea 1 Conventions PRETI 2 Summary of Warnings and Cautions 0 00 0 ee 2 System Components ias dachcta Wa Rib ardd Ea x a ri ERR a RUE RO d 10 Spectrum Pump lllustrations 422 bus RE etx FERRE RR Rech drea eae 11 Hardware Labels uua aum mee 1e ERI EP bed he ADR ES RES S A Rn PST
6. 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 Y Site 1 ea with luer lock adapter lever lock cannula 76 2C6419s Solution Set Interlink Y Site 1 ea with luer lock adapter DUO VENT spike 92 2C8401s Solution Set Clearlink Y Site 1 ea with male luer lock 76 2C8419s Solution Set Clearlink Y Site 1 ea with male luer lock adapter DUO VENT spike 92 2C6519s CONTINU FLO Solution Set Interlink Y Site 2 ea with luer lock adapter backcheck valve 89 2C6537s CONTINU FLO Solution Set Interlink Y Site 3 ea with luer lock adapter backcheck valve 110 2C8515s CONTINU FLO Solution Set Clearlink Y Site 1 ea with male luer lock backcheck valve 106 2C8519s CONTINU FLO Solution Set Clearlink Y Site 2 ea with male luer lock backcheck valve 112 2C8537s CONTINU FLO Solution Set Clearlink Y Site 3 ea with male luer lock backcheck valve 110 3C0062s CONTINU FLO Solution Set Interlink Y Site 4 ea with 4 way large bore stopcock extension set backckeck valve 123 Primary Set Minidrip 60 drops mL 2C6402s Solution Set Interlink Y Site 1 ea with luer lock adapter lever lock cannula 76 2C6424s Solution Set Interlink Y Site 2 ea with luer lock adapter 93 2C8402s Solution Set Clearlink Y Site 1 ea with male luer lock 76 2C6520s CONTINU FLO Solution Set Interlink Y Site 2 ea w
7. 53 sigmaspectrum Manual 41018 6 05 6 2 4 Revision C To titrate VTBI without stopping the pump 1 Atthe RUN screen press the TITRATE soft key See Figure 58 2 At the titration screen press the VTBI soft key See Figure 59 3 Enter new value and press OK See Figure 60 DOBUTamine mcg kg min EJ titrate review options Figure 58 Run Screen 54 DOBUTamine 500 mg 250 mL Dose mcg kg min 204 soft limits i Rate mL hr mL hr retum Figure 59 Titrate Screen DOBUTamine 500 mg 250 mL VTBI mL retum Figure 60 Titrate VI BI Screen Programming the Pump Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 Delayed Run 1 If Delayed Run is enabled per drug in the Drug Library the start of any programmed infu sion can may be delayed by up to 12 hours On the infusion set up screen enter any value between one minute and twelve hours 00 01 to 12 00 hr min for the delay run parameter and press OK 2 Once a delay time is entered the infusion programming is complete and the set is loaded press the RUN key to begin the infusion delay timer 3 The delay running screen appears with the remaining delay time shown in a flashing for mat 4 When the delay time period expires the pump begins delivery of the programmed infusion Check Flow will display Stopping Canceling the Delay Timer While the delay is running it may be stopped or c
8. TMOL 108 APPENDIX G Icons Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 APPENDIX H SPECTRUM DEFAULT SETTINGS Factory Settings for Pump Software Once a user changes these defaults they will remain at the most current setting Some settings can be controlled by the Drug Library as indicated below These settings are hard defaults that cannot be changed by the clinician programming the pump unless noted otherwise below Table 1 User Options Alarm Settings Original Factor ABD NONE Feature 8 y User Options Controlled by the Default Drug Library Audio Volume Medium Low Medium High Yes Drug Level Configuration Audio Tone Long Long Short No Standby Delay Infinite Infinite Specified No Time frame Bag Near Empty Off On Off Yes Drug Level Alert Configuration Downstream Medium Low Medium High Yes Care Area Pressure Limit Level Configuration Downstream Pressure Limit can be set in the Drug Library by Care Area The user still retains the ability to change this setting at the pump level but the pump will default back to the Drug Library setting 109 Manual 41018 6 05 6 2 4 Revision C BASIC Configurations Table 2 User Options Display Settings SETUP Options Feature Original Factory Default MEC vy RUN Screen Options Audio Level Indicator Off No Rate mL hr On No Dose rate On No mL VTBI Off No Time h
9. hr mg min mg kg min mg kg day mcg hr mg kg hr mcg min mcg kg min mcg kg day ng min ng kg min Units hr Units kg hr Units min Units kg min mUnits min mUnits kg hr mUnits kg min mEq hr mEq kg hr mmol hr mmol kg hr 111
10. 1 If Secondary Callback is enabled as optional per drug in the Drug Library a dialog box shall be displayed at the completion of programming a secondary infusion that asks if the clinician would like to be called back at the completion of the secondary infusion See Fig ure 47 General Care CeFAZolin 1 grams 50 mL Secondary Primary Rate muhr SECONDARY CALLBACK yes Figure 47 Secondary Callback Dialog Box Manual 41018 6 05 6 2 4 Revision C BM If YES is pressed a callback icon will be displayed on the RUN screen alternating with the VTBI bag icon during the secondary infusion to indicate that the callback feature is active See Figure 48 General Care General Care CeFAZolin CeFAZolin 100 100 mL hr a ey review options titrate review options titrate Figure 48 Alternating Run Screens with Secondary Callback Enabled B If NO is pressed the callback icon will not be displayed and the pump will automatically transition to the primary infusion upon completion of the secondary infusion Master Drug Library Editor allows Secondary Callback configuration as REQUIRED OPTIONAL or NEVER B If REQUIRED the pump will not offer the clinician the Callback dialog box and the pump will drop to the KVO Rate at the completion of the secondary infusion and sound an audio alarm to call the clinician back B If OPTIONAL the clinician will be presented with the Callback dialog box up
11. 120 VAC gt 95 96 dip in 120 VAC for 5 sec Supply power quality should be that of a typical commercial or hospital environ ment If the user of the Spectrum requires continued operation during power interruption it is recommended that the Spectrum be powered from an uninterrupted power supply or the inter nal battery be fully charged to provide unit power as specified in this opera tor s manual Power frequency 50 60 Hz magnetic field IEC 61000 4 8 400 A m 400 A m 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 APPENDIX E Electromagnetic Compatibility Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 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 Manual 41018 6 05 6 2 4 Revision C 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
12. 30 0 20 096 L o 10 0 ih o b ul 0 096 zL 10 0 20 0 30 0 40 0 4 50 0 Observation Window min Typical of minimum rate last Hr Trumpet NOTE For Hospira calibration the last hour is the 72nd hour For Baxter calibration the last hour is the 96th hour 94 APPENDIX B Flow Rate Accuracy Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 APPENDIX C BOLUS ACCURACY The SIGMA Spectrum IV Pump may have an 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 mini mum 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
13. 5 6 120 20794 48 Lo man Set Yellow Key Slide Clamp with inline backcheck valve 3 CLAVE Y sites amp OL gt 6 20795 48 LS Primary Set Yellow Key Slide Clamp with inline backcheck valve 3 CLAVE Y sites amp OL 5 120 w Extension 20803 48 LS Primary Set Yellow Key Slide Clamp CLAVE Y site amp OL 100 20815 48 LS Primary Set Yellow Key Slide Clamp with inline backckeck valve 3 PP Y Sites amp OL 5 110 Primary Set Micro 60 Drops mL 11411 78 LS Mlcrodrip Primary Piggyback Set w backckeck valve 2 PP Y Sites amp OL 6 7 100 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 gt 80 11962 78 LS Microdrip Piggyback Set with inline backcheck valve 2 CLAVE Y sites amp OL 100 12058 78 Microdrip Set with yellow striped tubing CAIR Clamp amp OL 112 12426 48 LS Microdrip Piggyback Set with inline backcheck valve 3 CLAVE Y sites amp OL 7 100 73 Manual 41018 6 05 6 2 4 Revision C 7a 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 5 100 Primary Filter Set Micro 60 Drops mL 20801 48 LS Primary Microdrip Filter Set with backcheck valve Yellow Key Slide Clamp 2 CLAVE Y Sites amp OL 2 5 100 Primary Filter Set Macro 15 Drops mL
14. Pole Clamp enables the pump to be offset on left or right side of the single standard IV pole diam eters ranging from 0 75 to 1 25 E The clamp can also be clamped to hospital bed side rail diameters ranging from 0 75 to 1 25 B Mount the clamp on the IV pole by rotating the triangular knob clockwise The cylindrical protru sion on the triangular knob helps to rotate the knob faster E The pump mounted on the adaptor can be rotated clockwise or counterclockwise in 90 increments by pressing the lever located on the arm E The pump can be offset by the length of the arm by rotating the arm in clockwise or counterclock wise in 90 increments by pressing the lever located on the body of the clamp E Make sure the pump is in vertical orientation with the key hole at the top of the pump while in oper ation Bb Refer to the cleaning section of this manual for compatible cleaners E Refer to the installation manual P N 41092 on how to install the clamp on the pump E The weight of the clamp is less than 1 2 lbs E The dimension of the clamp is less than 7 0 long X 2 5 high X 4 5 wide CAUTION Always operate the pump in vertical direction with the key hole at the top of the pump 79 es sigmaspectrum Manual 41018 6 05 6 2 4 Revision C APPENDIX A SPECIFICATIONS Master Drug Library MDL Editor PC based pharmacy edited and controlled customized in house list of all IV drugs and manuals
15. along with their safe delivery parameters Care Area enables E same name same concentration drugs to have different dose rate limits E pump configurations for maximum rate VTBI patient weight and occlusion level Each drug entry includes at a minimum 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 pri mary or secondary IV container and pump screen color Drug Library Transfer Transfer via a wireless network connection to a pump using a Wireless Battery Module Transfer from the PC directly to a pump via IrDA Standard Gravity IV Sets Standard gravity IV sets from Baxter or Hospira Standards 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 IrLAP and IrDA Serial Infrared Link Management Protocol v1 1 IrLMP IrDA Tiny TP v1 1 Wireless 802 11b 802 11b g EIA RS 232 levels for Asynchronous Transmit Receive only RS232 APPENDIX A Specifications Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 Specification Description AC Power AC Power Adaptor low profile covers only one outlet Medical Grade EN60601 1 2 m Input
16. below The customer or user of the Spectrum should assure that it is used in such an environment Immunity test IEC 60601 test Compli Electromagnetic environment guidance level ance level 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 RF 3 Vrms 3 Vrms d 1 2 P IEC 61000 4 6 150 kHz to 80 MHz in ISM bands a 10 Vrms 10 Vrms d 1 2 P 150 kHz to 80 MHz in ISM bands 2 Radiated RF 10 vim 10 V m d 1 2 P 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz d 2 3 P 800 MHz to 2 5 GHz I Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m 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 Modules SIGMA Part Number 35083 and 35162 W 100 APPENDIX E Electromagnetic Compatibility Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 Note 1 At 80 MHz and 800 MHz the highe
17. left of the pumping mechanism with door opened 6 Load the primed IV set tubing into the tubing channel E Load the tubing from the top to bottom of the tubing channel B Make sure the tubing is taut E Push the tubing into loading point 2 and then loading points 3 and 4 The tubing is properly loaded when the screen displays three green bars and check marks Preparing the Pump and IV Sets Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 7 Confirm no drops are falling in the drip chamber Close the door by pressing the upper and lower corners near the door hooks 9 Open the slide clamp by pulling it straight up and out of the keyhole while holding the tub ing around it down to provide strain relief 10 Open the roller clamp and confirm no flow 11 Confirm proper vent position if applicable Unloading an IV Set 1 Close the roller clamp 2 Push the slide clamp into the keyhole until the door opens Pull the tubing out from the bottom of the pump towards the top NOTE Be sure to 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 NOTE When changing IV sets or containers always keep the roller clamp fully closed except when following standard gravity set priming procedures Preparing the Pump for a Secondary Infusion
18. 100VAC 240VAC 50 60 Hz 200 mA m Output P N 35727 9VDC 1200 mA short circuit protected m Output P N 35714 9VDC 800 mA short circuit protected m cord length 3 0 m 9 75 feet Use only SIGMA part number 35727 or 35714 The SIGMA Spectrum Infusion Pump is classified according to Medical Electrical Equipment standards as m Class II Equipment m Type BF Applied Part m Continuous Operation AC Power Adaptor Approximate Weight 10 oz Alarm Volume Variable three levels high medium and low Alarms and Alerts W Air In Line dual beam ultrasonic detector alarms for large bubbles but allows smaller bubbles to pass Detects air bubbles gt 1 125pL Hospira 140pL Baxter will alarm if gt 1 mL of air in 15 min lt 5OpL bubbles are omitted in the summation of the 1 mL up to 1 5mL at 60 F m 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 m Very Low Battery 15 minutes of battery power remain m Due for inspection Preventative Maintenance and or Network Certification Anti Free Flow System Set based utilizing IV set slide clamp 81 Manual 41018 6 05 6 2 4 Revision C Specification Description Battery Power and Capacity Standard Battery m Lithium Ion 1800 mA h 7 4 VDC nominal SIGMA Part Number 35724 m Capacity 8hrs at 125 mL hr a
19. 2 4 10 The run screen appears indicating that the infusion is running See Figure 27 Are all clamps DOBUTamine open Is tubing not kinked Are drops flowing re drops flowing g mcg kg min review options titrate Figure 26 Check Flow at Run Figure 27 Run Screen Programming the Pump Using the BASIC Mode 1 Press the ON OFF button to turn the pump on 2 If the previous setup needs to be erased press YES soft key when prompted New Patient See Figure 28 New Patient Is this a new patient Press yes to clear current program Figure 28 New Patient Screen 37 Manual 41018 6 05 6 2 4 Revision C 3 Use the arrow keys to select the Care Area nursing area and press OK See Figure 29 Using A select the Care Area and push OK Care Areas Anesthesia Labor and Delivery Oncology Figure 29 Select Care Area 4 Using the keypad type the letters BA select BASIC and press OK See Figure 30 Type the first two letters Cursor to the desired Cursor to the desired of the drug name or drug and press OK drug and press OK type the first letter and press OK BASIC Drug Name Basiliximab Basiliximab Figure 30 Select BASIC at Drug Selection Screen 38 Programming the Pump Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 5 Use the arrow buttons to indicate whether you are setting up the primary or secondary bag an
20. Blood sets with both clamps closed above the blood filter will cause upstream occlusion conditions that may not be detected by the pump See the Specification Section for Downstream Occlusion times and bolus release information 6 Introduction and Safety Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 intended to be used in this manner Strong magnetic fields those beyond VVARNING The Spectrum Pump is not designed to be MRI compatible nor is it CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION 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 The Power Adaptor with Protector is compatible with the cleaners mentioned in this Operators manual For the methods of cleaning and compatible cleaners that can be used on the AC Power Adaptor with Protector See Cleaning and Storage on page 67 Use Keypad Lock to Avoid Tampering Close the clamp on the secondary line or remove the secondary container administration to prevent the secondary medication from flowing when the Primary mode is intended Use Stable IV Poles Mount pumps on IV poles that securely hold the pump Service Personnel Must be Trained by SIGMA Servicing Spectrum Pumps is restricted to qualified SIGMA trained service personnel who
21. Drug Events 2 BASIC Mode Drug library limits DERS do not exist when using BASIC mode BASIC mode allows you to manually specify a dose mode rate volume time or other parameters for the infusion BASIC mode does possess Gen 2 systems Check Flow at Run Secondary Error Prevention and Single Step Titration Infusion Programming Modes The following infusion programming modes are available with the Spectrum Pump using this operat ing software 1 Continuous Infusion IV drug or fluid therapy prescribed as a continuous dose rate The IV therapy continues to infuse until no longer required and is often titrated to achieve optimal physiologic response B Primary Mode E Secondary Mode B Multistep Mode 2 Cyclic Mode IV drug or fluid therapy that requires a volume rate mL hr ramp up to a main mL hr rate for a prescribed period of time and then tapers the rate down until total infusion time has completed Manual 41018 6 05 6 2 4 Revision C Keys Used to Program and Operate the Pump Hard Keys Description BASIC BASIC is an infusion mode not utilizing DERS This key directs user to BASIC instructions ALPHANUMERICAL Programming screens enable numbers and drug selection screen enable letters Press alpha numeric keys once twice or three times to select corresponding letters or numbers OK Press to confirm entries and advance cursors ON OFF Press to turn the pump on or off RUN STOP Press to
22. OK See Figure 23 DOBUTamine Primary Bag Using V select Primary or Secondary Bag and press OK Figure 23 Bag Selection Screen NOTE The bag selection prompt does not appear if the selected drug has been specifically assigned in the Drug Library as Primary no secondary Secondary only Primary only multi step 6 Enter all required values on the Setup Screen See Figure 24 7 Review the parameters of the drug as displayed on the programmed Setup Screen See Fig ure 25 DOBUTamine 500mg 250mL 500mg 250mL Primary Bag Primary Bag Weight kg Weight kg 70 Dose mcg kg min Dose mcg kg min 5 Rate mL hr Rate mL hr 10 5 VTBI mL VTBI mL 250 Time hr min Time hr min 24 21 Volume given mL clear program Volume given mt dear program Figure 24 Primary Setup Screen Figure 25 Programmed Setup Screen Manual 41018 Revision C NOTE NOTE 6 05 6 2 4 If Weight Confirmation is enabled set up in the Drug Library the pump will require that the patient weight parameter is re entered into the pump Both entered values must match to confirm patient weight You will receive a dialog box if you exceed the dose rate limits defined in the Drug Library for the drug E Soft dose rate or mL hr limits may be exceeded by pressing OK followed by pressing the YES soft key to accept or the NO soft key to decline the dose rate displayed in the dia log box B Hard dose or
23. REVIEW soft key to view infusion information and clear volume given mL Stopped B Press REVIEW PROGRAM soft key to display setup screen and change any value B Press PROGRAM SECNDRY soft key to program a secondary infusion Manual 41018 6 05 6 2 4 Revision C Setting up a Secondary Infusion 1 Make sure you have prepared the pump for a secondary infusion using the steps in Pre paring the Pump for a Secondary Infusion section beginning on page 27 2 Follow the steps for programming the primary bag infusion as described in either Pro gramming the Pump Using the Dose Error Reduction System section beginning on page 33 or Programming the Pump Using the BASIC Mode section beginning on page 37 3 When you have finished programming the pump for the primary infusion and before you run the infusion press PROGRAM SECNDRY soft key to begin programming the second ary bag See Figure 34 General Care Normal Saline 0 9 Primary Bag Rate mL hr VTBI mt Time hr min Volume given mL hold secndry Figure 34 Program Secondary after Primary Setup 4 If pump is already running press STOP See Figure 35 followed by REVIEW PROGRAM soft key See Figure 36 then PROGRAM SECNDRY as displayed on pump setup screen soft key See Figure 37 General Care General Care General Care Normal Saline 0 9 Normal Saline 0 9 Normal Saline 0 9 Primary Bag Pu m p Rate muhr 2 2 Stopped VTBI mL Time hr min Volu
24. Set non DEHP except pump segment with connections slide clamp on pump segment 6 110 Y Type Blood Set 10 drops mL 11994 48 Y Type Blood Set 170 micron blood filter chamber amp OL 105 12450 48 LS HEMA Y Type Blood Set 1 CLAVE Y Site w 210 micron blood filter chamber amp Secure Lock3 9 100 20796 48 LS Y Type Blood Set Yellow Key Slide Clamp 1 CLAVE Y Site w 170 micron filter amp OL 5 9 110 20805 48 LS Y Type Blood Set Yellow Key Slide Clamp 1 CLAVE Y Site w 210 micron filter amp OL 5 9 100 20806 48 LS Y Type Blood Set Yellow Key Slide Clamp 1 CLAVE Y Site w 170 micron filter amp OL gt 9 100 Compatible IV Sets Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 All sets use roller clamps referenced to as CAIR clamp All sets except the Blood sets use convert ible pins LS LifeShield amp OL Option Lok PP Prepierced CAIRG CLAVE Option Lok LifeShield Microdrip amp SoluSet are all registered names trademarks associated with Hospira Abbott Laboratories Compatible Hospira IV Sets WARNINGS The numbers reference the description listing table WARNING j 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 Doin
25. With MDL Editor v6 2 4 COMPATIBLE IV SETS SIGMA Nitroglycerin Lipid Sets Connect IV containers to catheters Set description Cat No 99021 Pump Calibration Length 99 overall Hospira 15 PVC pumping section DEHP free vented drip chamber 60 drops mL Polyethylene lined tubing Priming Volume 20mL Luer Lock y m 1 lt coat m Figure 69 Nitroglycerin Lipid Set SIGMA Y Type Blood Sets Connect Blood and Saline Bags to catheters Set description Cat No 99031 Pump Calibration Length 104 overall Hospira 15 PVC pumping section 200 Micron blood filter Lower Y injection site Priming Volume 42mL Luer Lock NOTE IV Sets are Latex Free 7 Zap RA D umi Figure 70 Y Type Blood Set Manual 41018 6 05 6 2 4 Revision C Compatible Baxter IV Sets The following is a partial listing of the Baxter IV Sets compatible with the SIGMA Model Spectrum Pumps that have been calibrated for Baxter S I V set tubing For a full listing of compatible sets refer to DOC 11182 on the SIGMA website www sigmapumps com NOTE Administration sets with non DEHP tubing in the pumping section are not intended for use with the Spectrum pump and are not included in the compatible set list 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
26. and after IV set unloading This can cause dangerous uncontrolled free flow to occur During IV container changes always close the set s roller clamp When the set is in the pump and the door is closed the slide clamp can safely be opened If gravity flow is to be used the pump door will be open or the set will be outside the pump Verify gravity flow is maintained at the intended rate whenever the pump door is open and when the set is outside of the pump A fluid bolus will occur maximum of 0 1 mL when the slide clamp is removed and the administration set is loaded Disposal To dispose of this device or the associated administration sets adhere to local state federal and or other governing regulations Use the Specified Manufacturer s IV Set Type This label is located on the top of the pump and indicates the specific type of IV tubing that the pump has been calibrated for The use of other manufacturer s brands or type tubing could produce pump inaccuracies that could be unsafe for patients Introduction and Safety Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 VVARNING Upstream Occlusion Alarm Suspension feature should not be used when delivering critical drugs where the risk of flow stoppage due to an undetected upstream occlusion outweighs that of flow interruption due to nuisance alarms where no upstream occlusion is present WARNING Upstream Occlusion Alarm Suspension feature should not be used for dr
27. be activated See Figure 17 3 Press the EXIT soft key to return to the run screen 4 Stop the pump and clear the infusion program to make the queued Drug Library active See Figure 18 NOTE Once a Drug Library is queued the user cannot prevent the queued library from being activated LIBRARY INFO UPDATE DRUG LIB Active Drug Library Name ExLibrary1 Date Modified 01 15 2010 Version 1 Format 13 New drug library activated COMPLETE Queued Drug Library Name ExLibrary2 Date Modified 02 05 2011 Version 2 Format 13 Clear infusion s to activate queued drug library Name ExLibrary2 Date Modified 02 05 2011 Version 2 PRESS OK Figure 17 Library Information Figure 18 Library Update 32 Programming the Pump Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 Programming the Pump Using the Dose Error Reduction System 1 Press the ON OFF key to turn the pump on 2 Use the arrow keys to select the Care Area nursing area and press OK See Figure 19 Using V select the Care Area and push OK Care Areas Anesthesia Labor and Delivery Oncology Figure 19 Select Care Area 3 Select the drug from the Drug Library Using the keypad type the drug s first two letters and press OK All drugs beginning with those two letters will appear See Figure 20 Type the first two letters of the drug name or type the first letter and press OK Drug Name
28. contain ers E With secondary rates above 300mL hr look for and clamp off primary line siphoning 56 Pump Operation Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 Placing the Pump in STANDBY Hold You can place the pump in a standby state to prevent the occurrence of the Inactivity Alarm see Alarms section beginning on page 59 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 1 Load the set and complete the infusion setup Once setup has been completed and the highlight is on the Volume Given mL value a dis play appears stating that the pump may either be started or it may be placed in standby mode 2 To place the pump in standby press the HOLD soft key See Figure 62 General Care Normal Saline 0 9 Primary Bag Rate mL hr VTBI mt Time hr min Volume given mL program secndry Figure 62 HOLD Soft Key B When standby is activated the IN STANDBY popup message See Figure 63 is displayed in a flashing format NOTE If the standby period is set to infinite the time value in the display will be replaced with a dashed line Figure 63 IN STANDY Popup Message 3 While in standby press RUN at any time to begin the infusion Pressing any other key or opening the pump door cancels standby mode
29. 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 Always wear gloves when cleaning a pump Alcohols are flammable and should not be used for Battery cleaning disinfection Alcohols should only be used in well ventilated spaces Manual 41018 6 05 6 2 4 Revision C CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION When cleaning the battery pack care should be taken to prevent shorting of the pack s exposed terminals 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 cell
30. fully into the keyhole Observe the Direction of Flow diagram left of the pumping mechanism with door opened Load tubing tautly from top to bottom in loading points 1 2 3 and 4 following the red green prompts E Close the door with thumb pressure over both door hooks which is at the top of the door and the bottom of the door E Open the slide clamp by pulling it straight up and out of the keyhole while holding the tub ing around it down to provide strain relief Use the Dose Error Reduction System DERS B DERS protects against human errors that could cause Adverse Drug Events E BASIC mode can not detect many of the human errors that DERS can BASIC mode does possess some Gen 2 features such as Check Flow at Run Secondary Error Prevention and Single Step Titration Confirm Safe Accurate Pump Operation E Confirm at startup and periodically thereafter drops are falling in the drip chamber at the expected rate IV or Container vents are properly functioning tubing clamps are in the proper positions and tubing is free from kinks or signs of collapse outside the pump Do not drop the AC Power Adaptor M The AC Power Adaptor has a built in power supply and is an electronic device It is not sim ply a plug and it will break if repeatedly dropped E Keep the power cord plugged in whenever the pump is not in use Follow secondary procedures E Use a secondary hanger fully extended to drop primary containers below secondary
31. mL hr limits cannot be exceeded Re enter rates within hard limits E Single Step Titration Rate advisory dose or mL hr rate entered is increased or decreased by a set in the Drug Library above or below the current rate Press YES to accept or NO to decline the change displayed in the dialog box In BASIC mode the rate advisory is set for an increase of 101 and a decrease of 51 and cannot be changed The rate advisory is set for an increase of 500 and a decrease of 99 if the selected Care Area name contains Anesthesia or OR and cannot be changed After you have OK d each of the parameters select one of the following actions E To start the infusion make sure the slide clamp and roller clamp is open and press RUN Bb To put the pump in standby mode press HOLD E To set up a secondary infusion enabled using the MDL Editor press PROGRAM SECNDRY For instructions on setting up a secondary infusion refer to Setting up a Secondary Infusion section beginning on page 40 If you press RUN the infusion will start The next display will be the Check Flow at Run error prevention system Check the flow and confirm all clamps are open there are no kinks or collapses in the tubing outside of the pump drops are flowing and vents are func tioning If everything is flowing properly press the YES soft key See Figure 26 Programming the Pump Pump Operating Software v6 05 For Use With MDL Editor v6
32. may reduce the flow rate causing a deviation in accuracy by 9 Negative back pres sure of 100 mmHg may increase flow rate causing a deviation in accuracy of 7 Hospira and 3 Baxter IV Sets Flow Profile The SIGMA Spectrum Infusion pump has the following start up flow rate accuracy curve shape asso ciated 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 infu sion pumps and controllers CAUTION Accuracy Refer to 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 and respond appropriately to all primary and secondary check flow prompts Small bore catheters or needles may cause excessive back pressure at high flow rates Size the catheters according to expected flow rate and fluid viscosity 1 REFERENCE AAMI ID26 1998 SUB CLAUSE 50 102 2 LIQUID CONTAINER MUST BE VENTED OR A COLLAPSIBLE BAG 86 APPENDIX B Flo
33. start or stop the infusion SETUP Press to access drug selection screen Soft Keys The top row of keys on the keypad are non labeled keys with various functions depending on what is displayed above them Description ARROWS Press to advance cursors and or select alternate choices BACK Press to go back to the previous screen BOLUS Press to access the Bolus setup CLEAR Press to erase the highlighted entry CLEAR PROGRAM Press to selectively clear primary mode secondary mode or both CLR STEP Press to clear one step of Multi Step Programming Mode EDIT Press to change the flush volume on the flush setup screen HOLD Press to place the pump in standby mode Programming the Pump Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 Soft Keys The top row of keys on the keypad are non labeled keys with various functions depending on what is displayed above them Description MULIT STEP Press to access the Multi Step Programming Mode OPTIONS Press to select additional pump features related to alarm settings display settings or information view PROGRAM SECONDARY Press to set up a secondary infusion RESET Press to restart the multi step and cyclic TPN programs to the beginning of the program REVIEW Press to view the setup screen without stopping the pump REVIEW PRIMARY REVIEW SECONDARY Press to view values in the setup screen
34. 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 vol ume is 300 mL the maximum flow rate is obtained with a bolus time of 18 01 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 300 mL 5 may be expected Where as using a minimum bolus volume 0 5 mL and delivering the volume in a short amount of time 1 minute the mean value of 0 5 mL 16 may be expected Manual 41018 6 05 6 2 4 Revision C APPENDIX D DOWNSTREAM OCCLU SION Time to Occlusion The maximum time for activation of the downstream occlusion alarm at the minimum flow rate of 0 5 mL hr is 1 hour at the minimum occlusion threshold setting It is 3 hours at the maximum occlu sion alarm threshold setting The maximum time for activation of the downstream occlusion alarm at the intermediate flow rate of 25 mL hr is 50 seconds at the minimum occlusion threshold setting It is three minutes at the max imum occlusion alarm threshold setting Bolus Volume The maximum bolus volume generated as a result of operation at 25 mL hr and reaching the mini mum downstream occlusion alarm threshold is 0 25 mL The maximum bolus volume generated as a result of operation at 25 mL hr and reaching the maxi mum downstream occlusion alarm threshold is 0 8 mL CAUTION Specificat
35. three levels LOW MEDIUM and HIGH E Audio Volume may be preset in the Master Drug Library Editor The default setting is Use Pump Setting Use Pump Setting is adjustable at the pump E Audio Tone set the type of alarm tone that sounds Short or Long Bb Standby hr min Set the length of time to keep the pump in Standby or Hold after setup of the infusion has completed Settings are from 00 01 to 99 59 hr min Setting the value to 00 00 or Infinite results in an infinite Hold period B Near Empty alert When enabled a Near Empty alert is displayed when 30 minutes or less of infusion remains If the initially programmed infusion is less than 30 minutes the alert shall not be generated regardless of the setting 17 Manual 41018 6 05 6 2 4 Revision C E Near Empty alert has three settable options in the Master Drug Library Editor ON OFF or Use Pump Setting The default setting is Use Pump Setting Use Pump Set ting is adjustable at the pump B Downstream Pressure Limit The Downstream Pressure limit has three levels LOW 6 psi 4 psi MEDIUM 13 psi 6 psi and HIGH 19 psi 9 psi Bb The default Pressure Limit may be preset for a Care Area in the Master Drug Library Editor The default setting is Use Pump Setting Use Pump Setting is adjustable at the pump NOTE This icon shall be displayed next to any configuration item in the options menu User pL or Biomed whose setting has been ass
36. upstream air upstream occlusion or downstream alarms and influence flow rate accuracy 4 Burettes with closed vents or shutoff valves will cause upstream occlusions that may not be detected by the infusion pump Rigid unvented containers used with unvented sets or vented sets with vent closed will cause upstream occlusions that may not be detected by the infusion pump 5 Ball Valve operation may not be detected as an alarm condition when using the SIGMA Spectrum Pump 6 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 7 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 8 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 WARNING Use the Specified Manufacturer s IV Set Type This label is located on the top of the pump and indicates the specific type of IV tubing that the pump has been calibrated for The use of other manufacturer s brands or type tubing could produce pump inacc
37. 107 General CONS C saes 108 vil C Ir Manual 41018 6 05 6 2 4 Revision C APPENDIX H SPECTRUM DEFAULT SETTINGS 109 Factory Settings for Pump Software 0 cece eee 109 BASIC Configurations uaaa aaae 110 VIII Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 INTRODUCTION AND SAFETY Intended Device Use The Spectrum and Spectrum with Master Drug Library is intended to be used for the controlled administration of intravenous fluids These fluids may include pharmaceutical drugs blood blood products and mixtures of required patient therapy The intended routes of administration consist of the following clinically acceptable routes intravenous arterial subcutaneous intrathecal epidural or irrigation of fluid space The Spectrum is intended to be used in conjunction with legally mar keted intravenous administration sets and medications provided by the user The Spectrum and Spectrum with Master Drug Library are suitable for many user facility applica tions such as but not limited to hospitals outpatient care areas home care and ambulatory care services The Spectrum and Spectrum with Master Drug Library are intended to reduce operator interaction through guided programming thereby helping to reduce errors associated with complex device pro gramming Parameter programming requires trained health care professional confirmation of li
38. 11538 68 LS Primary Piggyback Set 0 2 micron filter PP backcheck valve PP Y site amp OL 3 go 11963 68 LS Primary Piggyback Set with inline backcheck valve 2 CLAVE Y sites 0 2 Micron High Pressure Filter amp OL 9 100 12573 48 LS Primary Set 0 2 micron filter specific pumping section 1 CLAVE Y Site amp OLS 9 7 110 20780 48 LS Primary Set 0 2 micron filter with backcheck valve Yellow Key Slide Clamp 2 CLAVE Y Sites amp OL 5 100 150 mL Burette Set Macro 15 Drops mL 12907 65 LS Burette Set backcheck valve 2 PP Y Sites 1 CLAVE Port amp OL 7 8 106 5 20797 48 LS Burette Set Yellow Key Slide Clamp 3 CLAVE Ports amp OL 5 6 120 20798 01 LS Burette Set Yellow Key Slide Clamp 4 CLAVE Ports amp OL 5 167 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 7 100 11964 02 LS Filter SoluSet 150 x 60 slide clamp 1 CLAVE Y Site amp OL 8 77 12341 01 LS Microdrip SoluSet 150 x 60 capped port 1 CLAVE Y Site amp OL 77 20804 01 D Microdrip Burette Set Yellow Key Slide Clamp Filter Valve Capped port 1 CLAVE Y Site amp OL 145 7 410 Primary Nitroglycerin Set Macro 15 Drops mL 11993 78 Nitroglycerin Primary Pump Set not for gravity administration specific pumping section with slide clamp 6 110 Fat Emulsion Set Macro 15 Drops mL 12060 58 Fat Emulsion
39. 4 After pressing RUN confirm check flow NOTE To place a pump in standby after an infusion has started Press STOP REVIEW soft key followed by the HOLD soft key Manual 41018 6 05 6 2 4 Revision C Operating the Keypad Lock The keypad can be locked in two ways B Manually by entering the keypad lock code B Automatically by activating the Auto Keypad Lock feature in the Drug Library CAUTION Use Keypad Lock to Avoid Tampering Manually locking the keypad To lock the keypad enter the code 429 K E Y NOTE 429 is the default keypad lock code Refer to the Library Configurations section in the MDL User Manual P N 41020 to change the keypad lock code Keypad lock code is set hospital wide in the Drug Library and may be 1 to 4 digits 1 9 only zero can not be used This code is entered when the pump is in the run mode to prevent unauthorized activation of specific key entries A popup message appears briefly indicating the keypad has been locked If locked press ing any key will also result in this popup message being displayed The Key lock icon is shown on the top left corner of the screen amp 3 When the keypad is locked you can press the REVIEW soft key to view infusion setup data How ever no values can be changed and therefore navigation from value to value is not allowed when the keypad is locked The keypad allows certain alarm conditions to be silenced and cleared while in the
40. ESET soft key from the program stopped screen Clearing the entire multi step program To clear the entire program press the CLEAR PROGRAM soft key and answer YES to the confirma tion screen Clearing an individual step To clear the setup data from any individual step 1 Make sure the pump is stopped 2 Press the REVIEW soft key 3 Use the arrow soft keys to move the highlight to the desired step in the step bar 4 Press the CLR STEP soft key NOTE Clearing a step does not delete that step unless it is the last step in the program Cyclic TPN Mode The Cyclic TPN Mode is selected in the Drug Library It is designed to deliver TPN in an automatic ramp up main rate and taper down program The infusion schedule is calculated with the rates and volumes for 10 ramp steps up occupying 10 of the total infusion time 10 taper down steps occu pying another 10 and the main rate accounting for the remaining 80 of the infusion time To program Cyclic TPN 1 Press the ON OFF key to turn the pump on Use the arrow keys to select the Care Area and press OK Select Cyclic TPN from the Drug Library 2 3 4 Enter the program VTBI and press OK 5 Enter the program time and press OK 6 View display screen with main rate VTBI prog time ramp up time main step time taper down time and volume given mL M Press RUN to start infusion 8 Check the flow and confirm all clamps are open there are no kinks in tubing and drops ar
41. If the infusion is to include both a primary and secondary bag and IV set set up the bags and IV using the following instructions 1 Prepare primary and secondary bags and IV sets 2 Usea primary set with an upper Y injection site and backcheck valve NOTE Failure to prime remove all air bubbles from backcheck valves in primary sets may cause the valve to malfunction resulting in secondary fluid flow back up into the primary container Connect the secondary set to the primary set s upper Y injection site 4 Using a drop hook lower the primary bag approximately 20 below the secondary bag to provide the secondary bag with a gravity advantage This causes the primary set s back check valve to close which allows secondary flow 5 Confirm proper vent position if applicable 27 Manual 41018 6 05 6 2 4 Revision C PROGRAMMING THE PUMP Gen 2 Error Prevention consists of four error prevention systems 1 Dose Error Reduction System DERS 2 Check Flow At Run doesn t apply to Anesthesia and OR Care Areas E The screen See Figure 13 prompts the clinician at the start of the infusion to ensure that there are no closed clamps or kinks in the tubing that might prevent flow 3 Secondary Error Prevention doesn t apply to Anesthesia and OR Care Areas E During secondary setup a popup See Figure 14 prompts the clinician to verify the sec ondary VTBI Volume To Be Infused equals the secondary bag volume E The screen See Figu
42. 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 not stopped the keypad will automatically relock upon return to the run screen Automatically locking the keypad In the MDL you can set the keypad to lock automatically by activating the Auto Keypad Lock fea ture by Care Area Keypad will be automatically locked 60 seconds after the run key is pressed Passcode must be entered on the keypad to unlock Always guard the keypad lock code from unauthorized view or access Uncontrolled access by a patient or family member may cause injury to the patient For more information about this feature refer to the Care Area Configurations section in the MDL User Manual P N 41020 58 Pump Operation Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 ALARIVIS The Spectrum Pump will display alarms when specific conditions exist Depending on the priority these alarms can be an audible tone and or an alarm message is displayed on the pump screen The message states the reason for the alarm and contains prompts for clearing the alarm NOTE The following alarms will utilize the drug audio alarm setting entered in the MDL Editor when the drug is selected at the pump Inactivity Air in line Air Accumulation Upstream Occlusion Downstream Occlusion Slide Clamp Closed KVO Bag Near Empty See Figure 64 General Care Normal Sa
43. Manual 41018 6 05 6 2 4 Revision C Trumpet Curve Last Hour Set Rate 25 mL hr 15 096 10 0 5 0 z 9 LL o 0 0 r a o 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 W LI s 5 0 10 0 15 0 Observation Window min Typical of intermediate rate last Hr Trumpet Graph NOTE For Hospira calibration the last hour is the 72nd hour For Baxter calibration the last hour is the 96th hour 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 clini cal 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 inter mediate rate 25 mL hr for the SIGMA Spectrum NOTE The SIGMA Spectrum is best classified as a Volumetric In
44. N SET CLEARLINK Y SITE 1EA WITH LUER LOCK ADAPTER 8 112 NITROGLYCERIN SET 10 DROP mL 1C8043s VENTED NITROGLYCERIN SET WITH LUER LOCK ADAPTER 12 PVC PUMPING SEGMENT 6 133 NITROGLYCERIN SET 60 DROP mL 2C7551s VENTED NITROGLYCERIN SET INTERLINK Y SITE 1 EA WITH LUER LOCK ADAPTER 12 PVC PUMPING SEGMENT 106 2C8851s Vented Nitroglycerin Set Clearlink Y Site 1ea with luer lock adapter 11 PVC pumping segment 105 Buretrol Clearlink CONTINU FLOW and Interlink are all registered names trademarks associ ated with Baxter International Inc 71 Manual 41018 6 05 6 2 4 Revision C Compatible Baxter IV Sets WARNINGS The numbers reference the description listing table WARNING 1 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 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 or upstream occlusion alarms Flow rates above 300 mL hr may cause fluid to be siphoned from the primary container during piggyback operation Failure to prime remove all air bubbles from backcheck valves in primary sets may cause the valve to malfunction resulting in secondary fluid flow back up into the primary container 3 Partially occluded filters can cause nuisance
45. Observing the drip chamber to verify that there is no flow from your fluid container when the pump is stopped Confirming the drip rate approximates the pump s flow rate during RUN operation Confirming pump settings are as intended Confirming correct patient route dose rate dose mode time and drug concentration With IV therapy vital signs and IV access sites are monitored per facility s standard practice of care The Spectrum Gen 2 Operating System is not intended to replace clinician patient observation When using the pump periodic patient monitoring must be performed to ensure that the infusion is proceeding as intended The pump was not designed nor is it intended to detect infiltrations or extravasations Never operate the Spectrum unless all of the above safe operations are being practiced Operational Overview Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 WARNING 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 is recommended in the Specifications section of this manual Using a dropped damaged dirty or wet pump Pressurizing IV bags Positioning IV containers more than 3 feet above o
46. PE aa a 844528 60 Preventing Nuisance Alarms suaaaa anaana 64 Managing Bolus before Occlusion Downstream Release 64 Battery Warning Levels 0 000 eee eee 64 Cleaning and Storage cases kakacwewikawsoa ddan ee ieee eR Ro ewe dae 67 Compatible Cleaners n cicbceniGeeadeleadteege akboe sateedeR dep px ee s 67 Cleaning the PUMP 2 ios e RR RR dee es eee baba wee ka eae eKaaes 68 Compatible IV SetS 54a Ver ache daiwa ds Bes ee Cee aed eke 69 SIGMA Nitroglycerin Lipid Sets llli 69 SIGMA Y Type Blood Sets ad rh dE ek dre eh o bed e Ra Ree a ees 69 Compatible Baxter IV SiS i23 eese bep ue 9 RRSCRE RF Reg pA ODE FE add 70 Compatible Baxter IV Sets WARNINGS sssseeeee eese 72 Compatible Hospira IV Sets 4 2 32e ER ERR ERR ERE ERE Re e Bhs ERE ae 73 Compatible Hospira IV Sets WARNINGS eee ee eee 75 Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 ACCOSSONGS sii diane ace ceo go ed Kuba RA OR CR ACh a CK ic ew cd d 77 Tandem Gal Bl 2 261 aan 9e E oed penad arani e dud Kobe d E Red d quide 77 Lu nig T st tease ate ae Aye Coane Bs ae a a aE aed 78 AC Power Adaptor Protector s coris auaa rREXS RR RE EXE Ee EERARE temas 78 Double Rotating Pole Clamp Assembly 00000 c eee eee eee 79 APPENDIX A Specifications 2 000 c eee eee eee 80 Master Drug Library MDL Editor 0 20 00 c eee 80 Drug Library Transfe
47. ancelled E To stop the delay press the STOP key The display updates to DELAY STOPPED and the delay timer is paused and no longer flashes E To cancel the delay press the CANCEL soft key The remaining delay time is cleared and the display updates to PUMP STOPPED Changing the Delay Timer The remaining delay time value may be changed by pressing STOP 1 Press REVIEW PROGRAM soft key to display the setup screen 2 Move the cursor to the delay value and enter the new desired delay time and press OK NOTE The new delay time is immediately applied The delay time value may not be cleared while the delay is running Weight Confirmation The Weight Confirmation screen See Figure 61 set up in the Drug Library requires the patient weight parameter to be re entered to confirm correct entry If values do not match Values Differ popup message will appear Press OK and enter accurate value DOBUTamine 500 mg 250 mL Weight kg dde Confirm Weight kg 120 Figure 61 Weight Confirmation Manual 41018 6 05 6 2 4 Revision C PUMP OPERATION Operating Tips Follow all prompts on the pump screen E The Operator must press OK to confirm all entries and changes E Follow all prompts on screen to clear alarms Be sure to load sets properly Wb Start with a fresh section of tubing loaded in the pump make sure there is enough tubing for patient movement E To open the pump door insert the gravity IV set s slide clamp
48. and press OK after each entry Bb To avoid infusing residual amounts of the secondary container at primary flow rates be sure to properly set the secondary VTBI value Secondary VTBI should equal secondary bag volume NOTE A watermark indicator See Figure 41 is displayed behind the parameter data to help distinguish the secondary 2 setup screen from the primary 1 setup screen This watermark does not appear on primary only infusions General Care CeFAZolin 1 grams 50 mL Secondary Bag Using V select Primary or Secondary Bag and press OK dear program Figure 40 Secondary Bag Selection General Care CeFAZolin 1 grams 50 ml Secondary Primary Rate munr VTBI mL Time hr min Volume given mL review EE primary clear Figure 41 Secondary Infusion Setup Screen Programming the Pump Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 8 Press RUN to begin the secondary infusion 9 Confirm the flow from the secondary drip chamber YES NO See Figure 42 E YES Secondary infuses as programmed until completion with automatic transition to primary unless Secondary Callback is ON E NO Hang secondary bag above primary bag confirm secondary clamp is open and flow from the secondary container then press the YES or NO soft key YES Secondary infuses as programmed until completion with automatic transition to primary unless Secondary Callback is ON
49. ators manual For the methods of cleaning and compatible cleaners that can be used on the AC Power Adaptor with Protector see Cleaning and Storage section beginning on page 67 Connecting the Power Adaptor To engage the Power Adaptor 1 Align the arrow on the Power Adaptor cord with the arrow on the connector identified as the external Power Adaptor connection on the back of the SIGMA Spectrum Pump 2 Insert the Power Adaptor module into the appropriate powered outlet receptacle The green LED on the Power Adaptor is on when the adaptor is plugged into a powered wall outlet See Figure 11 A plug symbol appears in the top left corner on the Spectrum Pump display if the Power Adaptor is working properly when the pump is in operation See Figure 10 qE Figure 10 External Power Symbol 15 Manual 41018 6 05 6 2 4 Revision C Removing the Power Adaptor NOTE Improper removal may damage the AC Power Adaptor To remove the AC Power Adaptor grasp the handle of the Protector and pull it back from the receptacle in a straight direction See Figure 11 m A C Power Adapter P N 35714 m A C Power Adaptor P N 35727 Figure 11 Pull the adaptor straight out Do not pull the adaptor at an angle This could bend the prongs Do not pull the cord to unplug the adaptor from the receptacle Improper twisting or pulling of the connector or cord may damage the power supply Charging the Battery When the SIGMA Spectrum is c
50. ay from other equipment such as hand held transmitters cellular phones and electrosurgical equipment that may generate strong radio frequency interference RFI Refer to the EMC Immunity Section Separation Distance in this manual for recommended minimum distance Guidance and manufacturer s declaration electromagnetic emissions The SIGMA Model Spectrum Infusion pump is intended for use in the electromagnetic environment speci fied below The customer or user of the Spectrum should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 1 The Spectrum uses RF energy only for its internal CISPR 11 function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The Spectrum is suitable for use in all establish CISPR 11 ments including domestic establishments and those directly connected to the public low voltage Harmonic emissions Class A power supply network that supplies buildings used IEC 61000 3 2 for domestic purposes Voltage fluctuations flicker emissions Complies IEC 61000 3 3 97 Manual 41018 6 05 6 2 4 Revision C Immunity ESD transient burst voltage disparity magnetic Guidance and manufacturer s declaration electromagnetic immunity The SIGMA Model Spectrum Infusion pump is intended for use in the el
51. clamp Press the REVIEW PROGRAM soft key Press the PROGRAM SECONDARY soft key Select drug or fluid for the secondary infusion type first 2 letters of drug name Select and confirm Concentration if more than one is displayed Press OK to select confirm the secondary delivery bag Enter and press OK to confirm all required values on the setup screen Confirm that all clamps and vents are in the proper position Press RUN STOP to begin secondary infusion Check the flow and confirm drops are falling in secondary drip chamber and no drops fall ing in the primary drip chamber Operational Overview Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 PREPARING THE PUIVIP AND IV SETS VVARNING Use the Specified Manufacturer s IV Set Type This label is located on the top of the pump and indicates the specific type of IV tubing that the pump has been calibrated for The use of other manufacturer s brands or type tubing could produce pump inaccuracies that could be unsafe for patients VVARNING The following can cause flow rate inaccuracies and must be avoided Non vented IV sets with rigid non vented containers or vents on sets or burettes left in the closed position when they should be open 1 Mount the pump on an IV pole 2 Plug the pump s AC Adapter into a powered outlet receptacle if available NOTE Itis recommended that the Spectrum Pump s AC Adapter be plugged into a powered outlet receptacle whene
52. d e The rate advisory is set for an increase of 50096 and a decrease of 99 if the selected Care Area name contains Anesthesia or OR and cannot be changed To titrate dose without stopping the pump 1 Press the TITRATE soft key See Figure 53 2 Dose is displayed Observe the displayed soft dose limits See Figure 54 DOBUTamine MCN Dose mcg kg min 204 soft limits 1y mcg kg min Rate mL hr review options titrate retum mL hr Figure 53 Run Screen Figure 54 Titrate Screen 52 Programming the Pump Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 3 Enter a new dose See Figure 55 DOBUTamine 500 mg 250 mL Dose mcg kg min 204 soft limits 1y Rate mL hr Figure 55 Titrate Screen with New Dose To titrate rate mL hr without stopping the pump 1 At the run screen press TITRATE soft key See Figure 56 2 At the titrate screen press mL hr soft key See Figure 57 DOBUTamine 500 mg 250 mL Dose mcg kg min 204 soft limits 1y DOBUTamine Rate mL hr mL hr mcg kg min EJ review options titrate Figure 56 Run Screen Figure 57 Titrate Screen retum Observe the displayed mL hr soft limits 4 Enter a new mL hr flow rate S Press OK If soft limits are exceeded press YES to accept new value or NO to return to prior value Values exceeding the hard limits set in the Drug Library will not be accepted by the pump
53. d press OK See Figure 31 6 Select mL hr See Figure 32 or use arrow softkeys to scroll through dose rates and press OK See Figure 33 BASIC MODE BASIC MODE BASIC MODE BASIC Primary Bag BASIC BASIC Primary Bag Using V select Mode P Modelu 1 C TET R Primary or Secondary VTBI mL 0 VTBI m 0 Bag aid press OK Time hrmin 00 00 Time he min 00 00 Volume given mi Volume given mL 0 dear program Figure 33 Arrow Soft Keys used to scroll through Dose Rates multi step dear program Figure 31 BASIC Mode Bag Figure 32 Select Dose Rate Selection 7 Ifa dose rate is chosen enter drug amount and diluent mL values Enter the dose or flow rate value and press OK 9 Enter the VTBI Volume To Be Infused in mL and press OK 10 Confirm the computed infusion time 11 Confirm the Volume Given mL value or press CLEAR to erase it NOTE VTBI counts down to zero while volume given counts from zero up 12 Press RUN to begin the infusion 13 Check and confirm proper flow E Press YES if drops are flowing all clamps are open and there are no kinks in the tubing E Press NO if no drops are flowing Open all clamps and check for kinks in the tubing Confirm all infusion parameters are as intended Bb Press TITRATE soft key to change dose rate mL hr or VTBI 14 Review or reprogram the primary infusion as needed Running E Press the
54. d press OK after each entry 3 Press RUN to start bolus delivery 4 To cancel the Bolus during infusion the user can press the CANCEL soft key NOTE At the completion of the Bolus transition to the Primary Infusion rate is automatic Multi Step Programming The Multi Step Programming Mode allows the pump to be programmed with up to 10 individual infusion rate steps using either the Dose Error Reduction System or BASIC Programming Opera tions Primary infusions are eligible for use in the Multi Step Programming Mode if selected as Pri mary Only Multi Step or Primary or Secondary bag selection in the Drug Library 1 Press the ON OFF key to turn the pump on 2 If the prior setup needs to be erased press YES soft key 3 Use the arrow keys to select the Care Area and press OK 4 If the drug is to be delivered using the Drug Library select the drug as described in Pro gramming the Pump Using the Dose Error Reduction System section beginning on page 33 5 If the drug is to be delivered using the BASIC mode Type the letters BA select BASIC and press OK 6 At the bag selection screen select the primary or secondary bag select Primary Bag and then press the MULT STEP soft key to enter the Multi Step Programming Mode NOTE The Multi Step Program Mode is not available for the primary bag when a secondary program exists in memory NOTE If the selected drug has been configured in the Drug Library as a Primary Onl
55. e flowing If everything is flowing properly press the YES soft key 9 Observe mL remaining value and green INFUSING icon 10 Press REVIEW soft key to display program status 11 To begin early taper down press TAPER DOWN soft key 12 Are you sure you want to begin the taper down dialogue box displays on screen Con firm by pressing the YES soft key 51 Manual 41018 6 05 6 2 4 Revision C 13 When pump is stopped RESET soft key allows user to start the program from the begin ning 14 At completion the pump infuses at KVO Press STOP to automatically reset the program from the beginning NOTE Once the TPN program starts delivery no changes to the infusion parameters can be made Titrating You will receive a dialog box if the dose rate limits defined in the Drug Library for the drug are exceeded E Soft dose rate or mL hr limits may be exceeded by pressing OK followed by pressing the YES soft key to accept or the NO soft key to decline the dose rate displayed in the dia log box E Hard dose or mL hr limits cannot be exceeded Re enter rates within hard limits E Single Step Titration Rate advisory dose or mL hr rate entered is increased or decreased by a set in the Drug Library above or below the current rate Press YES to accept or NO to decline the change displayed in the dialog box In BASIC mode the rate advisory is set for an increase of 101 and a decrease of 51 and cannot be change
56. e clamp 5 8 H x 4 2 W x 2 5 D m WithIV pole clamp 5 8 Hx 6 4 W x 4 7 D With Wireless Battery Module m Without IV pole clamp 6 3 H x 4 2 W x 2 5 D m With IV pole clamp 6 3 Hx 6 4 W x 4 7 D Pumping Mechanism Linear peristaltic 83 Manual 41018 6 05 6 2 4 Revision C Specification Description Storage Temperature With Standard Battery m Storage temperature 4 to 120 F 20 to 49 C 10 to 90 relative humidity non condensing With Wireless Battery Module m Storage temperature 4 to 120 F 20 to 49 C 10 to 90 relative humidity non condensing Timekeeping Real Time Clock battery backed 10 year life NOTE Clock is set to GMT Total Drug Delivered 0 1 to 9999 mL with 0 1 mL increments from 0 1 to 99 9 mL and 1 0 mL increments from 100 to 9999 mL Volumetric Accuracy Accuracy is based on volume collected over one hour using compatible Baxter and Hospira Standard IV Sets BAXTER HOSPIRA 0 5 1 9 mL hr 0 1mL hr 0 1mL hr 2 0 800 mL hr 5 5 801 999 mL hr 5 10 Specified accuracy is maintained on Baxter Standard IV Sets for up to 96 hours maximum 12 liters and on Hospira Standard IV Sets for up to 72 hours maximum 9 liters Weight With Standard Battery m Without IV pole clamp 25 5 oz 1 0 oz m With IV pole clamp 33 5 oz 1 0 oz With Wireless Battery Module m Without IV pole clamp 26 5 oz 1 0 oz m Wit
57. ector may not detect partially occluded tubing Always check to ensure the IV set s clamp is not closed above the Spectrum Pump and respond appropriately to all primary and secondary check flow prompts Small bore catheters or needles may cause excessive back pressure at high flow rates Size the catheters according to expected flow rate and fluid viscosity Single Fault Conditions A bolus of approximately 0 1 mL may be generated as a result of a single fault condition This equipment is not suitable for use in the presence of a Flammable Anesthetic Mixture with Air or with Oxygen or Nitrous Oxide NOTE This statement applies to oxygen enriched environments such as oxygen tents It is not meant to apply to patients on breathing tubes Refer to IEC 60601 2 24 Operational Overview Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 Starting a New Infusion Using the Dose Error Reduction System DERS 1 Press the ON OFF button to turn the pump on 2 If the previous setup needs to be erased press YES soft key when prompted New Patient NOTE New Patient Prompt When the pump is turned on and programmed infusion data exists in memory a screen is displayed asking the operator if the intended use for the pump is for a New Patient Answering YES to this prompt clears the existing infusion data answering NO retains the data and allows the operator to resume the infusion See Figure 12 New Patient
58. ectromagnetic environment specified below The customer or user of the Spectrum should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic dis charge ESD IEC 61000 4 2 8 kV contact t 15 kV air 2 kV contact t 15 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 See Note 1 Electrical fast tran 2 kV for power 2 kV for power Supply power quality should be that of a sient burst supply lines supply lines typical commercial or hospital environ ment IEC 61000 4 4 1 kV for input Not applicable output lines Surge t1 kV differential t1 kV differential Supply power quality should be that of a mode mode typical commercial or hospital environ IEC 61000 4 5 ment t2 kV common mode Not applicable Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 96 120 VAC 95 96 dip in 120 VAC or 0 5 cycle 40 120 VAC 60 96 dip in 120 VAC for 5 cycles 70 96 120 VAC 30 dip in 120 VAC for 25 cycles 5 96 120 VAC 95 96 dip in 120 VAC for 5 sec lt 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
59. ectrum should be cleaned and disinfected for each patient use according to facility protocol CAUTION 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 Always wear gloves when cleaning a pump Alcohols are flamable and should not be used for Battery cleaning disinfection Alcohols should only be used in well ventilated spaces When cleaning the battery pack care should be taken to prevent shorting of the pack s exposed terminals Compatible Cleaners For a complete list of compatible cleaning materials refer to DOC 11318 on the SIGMA website www sigmapumps com B 10 solution of bleach and water Up to 9096 Isopropyl alcohol Caltech Industries Dispatch Steris TBQ and Steris Germicidal Surface Wipes Product Number 1608 GS Steris Coverage TB plus Disinfectant Cleaner Metrex Cavicide and Cavi Wipes Ecolab Inc EnVerros SaniMaster 4 Professional Disposables International Inc Sani Cloth Bleach Wipe and Super Sani cloth Micro Scientific Opti Cide wipe and spray liquid Sklar Disinfectant Cleaner DisCide Ultra Disinfecting Towelettes 3M HB Quat Disinfectant Cleaner Medline Micro Kill Wipes JohnsonDiversey O
60. ess RUN to advance small bubbles past the air detector Each press of RUN advances approximately 0 1mL Use a syringe to aspirate air from the lower Y injection site or re prime the set AIR LIMIT EXCEEDED The pump will alarm when greater than approximately 1mL of accumulated air has been detected in 15 min AUDIO The audio alarm may be silenced for 2 minutes by pressing any key Audio level alarm is set in the Drug Library Audio level alarm settings include use pump setting low medium and high BATTERY MISSING Battery not detected Confirm that the Battery is properly installed and securely latched into the pump DEPLETED BATTERY The Battery is fully depleted and unable to power the pump To recharge the Battery and continue the infusion plug the pump s AC Power Adaptor into an AC outlet Confirm that the adaptor s Power Cord Connector is attached to the pump DOOR NOT FULLY CLOSED SET OUTSIDE CHANNEL The pump s door has not closed and latched correctly Close the roller clamp below the pump Then open the door by inserting the slide clamp into the keyhole Re load the IV set following the on screen prompts Once the IV set has been loaded properly close the pump s door ensuring both door latches shut securely Alarms Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 Alarm Action DOOR OPEN Slide clamp is inserted into the keyhole and opens the door while the se
61. et may cause the valve to malfunction resulting in secondary fluid flow back up into the primary container 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 Rigid unvented containers used with unvented sets or vented sets with vent closed will cause upstream occlusions that may not be detected by the infusion pump Yellow Key Slide Clamp sets are only compatible with Spectrum software versions 4 02 06 or higher and are 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 IV 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
62. fusion 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 APPENDIX B Flow Rate Accuracy Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 Startup Graph First Two Hours Set Rate 5 mL hr 1 00 0 90 4 0 80 0 70 0 60 0 50 0 40 0 30 Flow Rate mL hr Gi 0 20 Time min Typical of minimum rate start up flow rate 91 es sigmaspectrum Manual 41018 6 05 6 2 4 Revision C Trumpet Curve 2nd Hour Set Rate 5 mL hr 50 096 40 0 30 0 20 0 10 0 0 0 T T T T T T T T 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 10 0 Error of Flow 20 0 30 0 40 0 50 0 Observation Window min Typical of minimum rate 2nd Hr Trumpet Graph ge APPENDIX B Flow Rate Accuracy Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 Flow Rate Graph Last Hour Set Rate 5 mL hr 0 90 0 80 l l 0 70 o A A 0 60 d E 0504 o c 0 40 z 2 iL 030 0 20 0 10 0 00 0 10 20 30 40 50 60 0 10 Time min Typical of minimum rate last Hr Flow Accuracy 93 es sigmaspectrum Manual 41018 6 05 6 2 4 Revision C Trumpet Curve Last Hour Set Rate 5 mL hr 50 096 40 096
63. g 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 see Secondary Infusion Failure to prime remove all air bubbles from backcheck valves in primary sets may cause the valve to malfunction resulting in secondary fluid flow back up into the primary container 3 Partially occluded filters can cause nuisance upstream air upstream occlusion or downstream alarms and influence flow rate accuracy 4 Burettes with closed vents or shutoff valves will cause upstream occlusions that may not be detected by the infusion pump Rigid unvented containers used with unvented sets or vented sets with vent closed will cause upstream occlusions that may not be detected by the infusion pump 5 Yellow Key Slide Clamp sets are only compatible with Spectrum software versions 4 02 06 or higher Keyed for correct direction of flow 6 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 7 Some IV 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 o
64. h IV pole clamp 34 5 oz 1 0 oz aa APPENDIX A Specifications Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 Specification Description Wireless Network Interface Wireless Battery Module 802 11b SIGMA Part Number 35083 W Standard IEEE 802 11b m Transmit power 16 dBm typical Wireless Battery Module 802 11b g SIGMA Part Number 35162 m Standard IEEE 802 11b g m Transmit Power 12 dBm typical Wireless Security WEP Wired Equivalent Privacy m Encryption 64 128 bit RC4 WPA WPA2 802 111 m Encryption TKIP CCMP AES WPA PSK 802 1X authentication LEAP WEP only PEAP MSCHAPv2 EAP TLS Manual 41018 6 05 6 2 4 Revision C APPENDIX B FLOW RATE ACCURACY Effect of Fluid Container Height 2 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 devi ations in the nominal specification for device flow rate accuracy The nominal head height used for the flow rate specification is 24 61 cm Effect of Back Pressure Positive back pressure can influence the flow rate accuracy of the infusion Back pressure equivalent to 300 mmHg
65. he secondary infusion and once the transition is made to the primary infusion a one bag icon shall replace the two bag icon on the run screen NOTE Upon completion of the secondary infusion the clamp on the secondary set should be closed to prevent any remaining fluid in the secondary bag from being delivered at the primary delivery rate 44 Programming the Pump Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 Clearing the Secondary Mode While Returning to the Primary Infusion Press STOP Press CLEAR PROGRAM soft key Press PROGRAM SECNDRY soft key Press YES soft key M dec p opus cs Close the clamp on the secondary line above the upper Y injection site or remove secondary container and tubing CAUTION Close the clamp on the secondary line or remove the secondary container administration to prevent the secondary medication from flowing when the Primary mode is intended Press OK to continue The primary review screen appears Press RUN to start the primary infusion SOS es DW ON Check for flow and confirm that all clamps are open there are no kinks in tubing and drops are flowing If everything is flowing properly press the YES soft key Secondary Callback Assigned to a Secondary Drug in the Drug Library Secondary Callback is a feature that causes the pump to drop to the KVO Rate 1 mL hr at the com pletion of the secondary infusion and sound an audio alarm to call the clinician back
66. heads 12 Battery Compatibility wci see ione cen o a aede acr OR RON D e nate 13 Setting Up the Pump iue coe a m eR eo eR m RR i e 14 Unpack the PUMP esce ke RePEc RSENESS RETRFGER EEG UR FREE EOL CREER NE 14 AC Power Adaptor s ness xwiegexeduscxetrixU Rae xeedq ea epit MERE 15 Cleaning the Power Adaptor sssaaa uaaa aaea 15 Connecting the Power Adaptor illillslseeeelsl e 15 Removing the Power Adaptor 0 00 0 eh 16 Charging ihe Battery 2 ados aee S arr oe os wah eeGhbe swabs oague er nadie 16 Configuring User Options oia sh RR ERR RR REA ES RARE KRERF RR 17 User Options xxn vont Rc on een pha RR oe ha a aede Re V Wade a 17 The User Options menu has three categories 000 llle 17 Operational Overview eseeeeeeeeeee 20 Starting a New Infusion Using the Dose Error Reduction System DERS 23 Starting a New Infusion using the BASIC Mode 2000 eee eee 24 Secondary Infusions 2 22 2 keen dass n e RR CR RR ROUX KORR E Ra DAS 24 Preparing the Pump and IV Sets Lleessseees 25 Loading an IV Set isse xo se Rak d RR EXER RE rece Gia Sed Se enee XR 26 Unloading an IV Set aseo iu rA EX RR Era Ge eas Meee deus RR 27 Preparing the Pump for a Secondary Infusion 00 000 eee 27 Programming the Pump leeeeeeerenn 28 Infusion Programming Modes 1a qp eene EXE RE RUERSR ORDRE HERR ree poena 29 Keys Used to Program and Operate the P
67. idental 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 Manual 41018 6 05 6 2 4 Revision C WARNING Follow Neonatal and Pediatric Precautions Use 60 drop 1mL IV sets Configure the pump with appropriate flow rate VI BI Volume To Be Infused patient weight and occlusion alarm limits using CONFIGURATIONS Options mode Prior to connecting to patient prime IV set then close roller clamp load IV set open slide clamp and roller clamp if equipped to avoid possible bolus 2 mL that would result around a door opening set loading event Ifthe pump door is opened with an IV set connected to a patient 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 0 085 mL bolus in the syringe and unclamp the set below the Y site Do Not Allow Uncontrolled Gravity Flow When loading a primed IV set ensure before pump manipulation that the roller clamp below the pump is in the closed position 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
68. ification Description Flow Rate 0 5 to 999 mL hr with 0 1 mL hr increments from 0 5 to 99 9 mL hr and 1 0 mL hr increments from 100 to 999 mL hr Infusion Modes Primary and Secondary Multi Step and Cyclic TPN KVO At the completion of a primary infusion the pump will infuse at the KVO rate configured per drug in the Drug Library or the current infusion rate whichever is lower The default KVO rate is set at 1 mL hr but may be configured to between 0 5 50 mL hr At the completion of a secondary infusion program the pump will run at a fixed KVO rate of 1 mL hr Logging Memory m AC Power Adaptor low m 24 hr memory of all set up screens except for multi step and cyclic modes that are maintained permanently W Separate pump history log and drug event log m 10 000 event capacity Once the maximum number of log entries is reached the data for each new event replaces the data for the oldest event the data for oldest event is lost Maximum Pump Pressure 28 PSI Occlusion Pressure Adjustable High 19 9 PSI Medium 13 6 PSI and Low 6 4 PSI Operational Conditions With Standard Battery m Operating temperature 60 to 90 F 15 6 to 32 2 C 20 to 90 relative humidity non condensing With Wireless Battery Module m Operating temperature 60 to 80 F 15 6 to 26 7 C 20 to 90 relative humidity non condensing Overall Size Pump With Standard Battery m Without IV pol
69. igned in the Master Drug Library Editor to the currently selected drug 2 Display Settings E Run Screen Options Each of the items in this list may be turned ON or OFF If enabled they are included in the alternating screens that are displayed while the pump is running Bb Audio level indicator shows L M or H as selected in Audio Volume B Rate mL hr shows the mL hr infusion rate of the current delivery E Dose rate shows the dose rate of the current delivery B mL VIBI shows the remaining Volume To Be Infused in mL Bb Time hr min shows the time remaining in the current infusion in hr min format B Display Adjust Bb Backlight Level The display backlight level may be adjusted from 1 to 10 with 10 being the highest or turned OFF The backlight consumes approximately 400 mW when set to maximum brightness therefore battery life is maximized when the back light is set to OFF 3 View Information B Pump Information The pump information screen has the following read only information that either the user clinician or Bio Medical Engineer may find useful B SW Version E Serial number The serial number assigned by SIGMA for tracking and device history E Tube type the name of the IV tube set manufacturer that the device is calibrated for use with B Wireless Module E From the Pump information screen press the sw info soft key to display the Software Ver sion screen which show the versions of the individual s
70. ion Prompts for Primary and Sec ondary Infusions VERY LOW BATTERY Less than 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 F Low Very Low Battery Tutorial section beginning on page 103 63 Manual 41018 6 05 6 2 4 Revision C Preventing Nuisance Alarms Check the following items to prevent nuisance alarms Remove all air from IV sets While priming invert and tap air from all Y sites and back check valves Do not administer extremely cold or hot solutions Warm solutions to room temperature before use to help prevent nuisance upstream occlusion or air in line alarms caused by out gassing of micro bubbles Effervescent foamy or frothy solutions can result in nuisance upstream occlusion alarms 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 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 in pump s AC Power Adaptor 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 IV set pulsation Managing Bol
71. ionals can operate Spectrum Gen 2 Operating software Confirm safe accurate pump operation at start and periodically thereafter by Ensuring that IV sets or container vents are properly functioning that tubing clamps are in the proper positions and that tubing is free from kinks or signs of collapse outside the pump Observing the drip chamber to verify that there is no flow from your fluid container when the pump is stopped Confirming the drip rate approximates the pump s flow rate during RUN operation Confirming pump settings are as intended Confirming correct patient route dose rate dose mode time and drug concentration With IV therapy vital signs and IV access sites are monitored per facility s standard practice of care The Spectrum Gen 2 Operating System is not intended to replace clinician patient observation When using the pump periodic patient monitoring must be performed to ensure that the infusion is proceeding as intended Introduction and Safety Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 The pump was not designed nor is it intended to detect infiltrations or extravasations Never operate the Spectrum unless all of the above safe operations are being practiced WARNING 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 mate
72. ions for Downstream Occlusion detection times and bolus volume after release of occlusion are based on specific test conditions The analytical related conditions are A 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 25 The 48 test administration set contained one y site no filters or other components Testing was at the nominal room temperature 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 APPENDIX D Downstream Occlusion Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 APPENDIX E ELECTROIVIAGNETIC COMPATIBILITY Emissions may result in increased Emissions or decreased Immunity of this medical device VVARNING The use of accessories or cables other than those specified by SIGMA CAUTION 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 aw
73. ith luer lock adapter backcheck valve 89 2C6546s CONTINU FLO SOLUTION SET INTERLINK Y SITE 3 EA WITH LUER LOCK ADAPTER BACK CHECK VALVE 7 106 70 Compatible IV Sets Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 2C8546s CONTINU FLO SOLUTION SET CLEARLINK Y SITE 3 EA WITH MALE LUER LOCK BACKCHECK VALVE 2 7 106 PRIMARY FILTER SET MACRO 10 DROPS mL 2C6571s CONTINU FLO SOLUTION SET 0 22 MICRON FILTER INTERLINK Y SITE 2 EA WITH LUER LOCK ADAPTER BACKCHECK VALVE 105 2C8571s CONTINU FLO SOLUTION SET 0 22 MICRON FILTER CLEARLINK Y SITE 2 EA WITH LUER LOCK ADAPTER BACKCHECK VALVE 3 105 PRIMARY FILTER SET MINIDRIP 60 DROPS mL 2C6572s CONTINU FLO SOLUTION SET 0 22 MICRON FILTER INTERLINK Y SITE 2 EA WITH LUER LOCK ADAPTER BACKCHECK VALVE 3 105 BURETROL MINIDRIP 60 DROPS mL 2C7519s 150 ML BURETTE INTERLINK Y SITE 2 EA WITH LUER LOCK ADAPTER BALL VALVE DRIP CHAMBER 5 117 2C7562s 150 ML BURETTE INTERLINK Y SITE 3 EA WITH VALVELESS BURETTE 115 2C7564s 150 ML BURETTE INTERLINK Y SITE 2 EA WITH DRIP CHAMBER FILTER VALVE MALE LUER LOCK ADAPTER 7 105 2C8819s 150 ML BURETTE CLEARLINK Y SITE 2 EA WITH LUER LOCK ADAPTER BALL VALVE DRIP CHAMBER 5 117 Y TYPE BLOOD SET 10 DROPS mL 2C6750Hs BLOOD SOLUTION SET INTERLINK Y SITE 1 EA WITH LUER LOCK ADAPTER 170 TO 260 MICRON FILTERS 115 2C8750s BLOOD SOLUTIO
74. le the tower Events are not sent to the net TU work host Red background 5 Searching for the network and host The will toggle to the left and Pu 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 net a work host Green background Network disabled 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 new Drug Library has been received the information and is ready for DIL activation This icon can appear within any of the icon listed above The figure below shows the key lock and power icon upper left and the network connection wire less icon upper right ea KD Alert Bar Setup and Run screens Figure 71 Icon Displays 107 Manual 41018 6 05 6 2 4 Revision C General Icons The following icons are displayed on various screens in the Spectrum 8 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 item in the options menu User or Biomed whose setting has been assigned in the Master Drug Library Editor to the currently selected drug
75. left side of the tubing channel 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 IEC 60417 5140 12 System Components Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 BATTERY COMPATIBILITY There are three battery types 1 P N 35724 Standard Battery 2 P N 35083 802 11b Wireless Battery Module 3 P N 35162 802 11b g Wireless Battery Module The Standard Battery P N 35724 and 802 11b Wireless Battery Module P N 35083 are compati ble with all SIGMA Spectrum Pumps The 802 11b g Wireless Battery Module P N 35162 is only compatible with wireless G compatible pumps Wireless G compatible pumps are identified by the letter G preceding the serial number on the pump See Figure 7 Pumps that do NOT have a letter G preceding the serial number are not compatible with the 802 11b g Wireless Battery Module P N 35162 See Figure 8 Figure 8 Serial Number for Pump NOT Compatible with the 802 11b g Wireless Battery Module P N 35162 13 Om Manual Revision C 41018 6 05 6 2 4 SETTING UP THE PUMP 14 Unpack the Pump The SIGMA Spectrum is packaged to provide protection during transportation and storage When you unpack the pump
76. line 0 9 IN AIR LIMIT nm eee EXCEEDED Upstream occlusion may exist INACTIVITY ALARM Check for kinks and Push any key to silence Check for kinks and closed clamps above dosed damps above the pump the pump To advance air for aspiration Aspirate air from lower from lower Y site Y site or reprime set Press OK then RUN Press OK then RUN program sechdry silence silence UPSTREAM DOWNSTREAM BAG NEAR OCCLUSION OCCLUSION Eliminate closed o l d clamp kinked tube pen clamps an or clotted filter or tube kinks above catheter to E M PTY pump then restart pump press RUN PUMP IS RUNNING 30 minutes remain silence silence Press OK to confirm Figure 64 Example Alarms Messages Manual 41018 6 05 6 2 4 Revision C Silencing an Alarm To silence the audio tone for an alarm press the SILENCE soft key or any key on the keypad This silences the alarm tone for 2 minutes If the alarm has not been cleared after 2 minutes the alarm tone will resume Clearing an Alarm To clear an alarm follow all of the prompts and instructions in the alarm message The alarm clears after you have corrected the alarm condition and followed all of the prompts Alarm Messages Alarm AIR IN LINE Action Check for kinks in tubing or closed clamps above the pump that may result in an upstream occlusion Evaluate tubing for presence of air Press OK and then pr
77. log allows the user to suspend the alarm for the currently programmed infusion The alarm will automatically be enabled when The STOP key is pressed 2 The Door is opened 3 The Infusion Transitions from Secondary to Primary 4 Any alarm condition that stops the pump and the pump is turned OFF and then back ON WARNING Upstream Occlusion Alarm Suspension feature should not be used when delivering critical drugs where the risk of flow stoppage due to undetected upstream occlusions outweighs that of flow interruption due to nuisance upstream occlusion alarms WARNING Upstream Occlusion Alarm Suspension feature should not be used for drugs delivered in RIGID containers since the flow restrictions caused by lack of proper container venting may be difficult to recognize when troubleshooting an alarm condition ea Alarms Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 Alarm UPSTREAM OCCLUSION ALARM SUSPENSION Continued Action NOTE Upstream Occlusion Suspension feature is enabled by default in the Drug Library for BASIC mode WARNING Upstream Occlusion Alarm Suspension feature should only be used after the operator visually observes positive line flow Suspend all Suspend all Upstream Occlusion Upstream Occlusion alarms for remainder alarms for remainder of this infusion of Secondary infusion STOP key will re enable alarm STOP key will re enable alarm Figure 65 Upstream Suspens
78. lose the set s roller clamp When the set is in the pump and the door is closed the slide clamp can safely be opened If gravity flow is to be used the pump door will be open or the set will be outside the pump Verify gravity flow is maintained at the intended rate whenever the pump door is open and when the set is outside of the pump WARNING When the set s slide clamp is removed from the pump s keyhole a fluid bolus will occur maximum of 0 1 mL in the IV set if the administration set is loaded in the pump CAUTION Accuracy Refer to trumpet curves for flow rate accuracy as a function of short infusion durations See APPENDIX B Flow Rate Accuracy beginning on page 86 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 and respond appropriately to all primary and secondary check flow prompts Small bore catheters or needles may cause excessive back pressure at high flow rates Size the catheters according to expected flow rate and fluid viscosity 1 Power on the pump 2 Position the slide clamp approximately 18 below the drip chamber and or approximately 6 to 8 below the upper Y injection site 3 Position the roller clamp on the IV tubing comfortably below the pump 4 Insert the slide clamp into the keyhole loading point 1 and press down until the door opens 5 Observe the Direction of Flow diagram
79. mL may be generated as a result of a single fault condition Introduction and Safety Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 CAUTION Only use the AC power adaptor specified for this equipment Using other power adaptors may cause personal injury or damage to equipment CAUTION This equipment is not suitable for use in the presence of a Flammable Anesthetic Mixture with Air or with Oxygen or Nitrous Oxide NOTE This statement applies to oxygen enriched environments such as oxygen tents It is not meant to apply to patients on breathing tubes Refer to IEC 60601 2 24 Manual 41018 6 05 6 2 4 Revision C SYSTEM COIVIPONENTS The SIGMA Spectrum with Gen 2 Operating Software is comprised of the following components Master Drug Library MDL Editor A software tool intended to be used by pharmacists to list all medications that would be delivered via the Spectrum Pump along with associated care areas and infusion parameters for each drug entry SIGMA Spectrum Infusion Pump The pump and the interface for programming the pump E Gen 2 Error Prevention Systems E Dose Error Reduction System DERS Bb Check Flow At Run Wi Secondary Error Prevention E Single Step Titration Standard Gravity IV Sets Compatible IV sets with slide clamp used for the door opening with slide clamp required for door opening RUN Cae Je oe Jes BASIC ABC DEF GHI 0 2 V JKL MNO PQR F
80. me given mL review clear program review options titrate s program sechdry Figure 35 Run Screen Figure 36 Infusion Stopped Figure 37 Setup Screen 40 Programming the Pump Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 5 If the drug is to be delivered using the Dose Error Reduction System select the drug from the Drug Library NOTE The drug must be pharmacy hospital approved for delivery as a secondary line E Using the keypad type the drug s first two letters and press OK All drugs beginning with those two letters will appear See Figure 38 General Care Type the first two letters of the drug name or type the first letter and press OK Drug Name General Care Type the first two letters of the drug name or type the first letter and press OK Drug Name dear program review Figure 38 Secondary Drug Entry E Use the arrow keys to scroll to the desired drug and press OK See Figure 39 General Care General Care Cursor to the desired Cursor to the desired SECONDARY drug and press OK CeFAZolin CeFAZolin Figure 39 Secondary Drug Selection S IE n Manual 41018 6 05 6 2 4 Revision C ae Press OK to select secondary bag or use the arrow soft keys to change to primary bag See Figure 40 Confirm the values on the setup screen E Confirm the drug and concentrations are correct if selected E Enter all required data
81. mits and drug therapy to physician s directive The SIGMA Spectrum and SIGMA Spectrum with Master Drug Library have not been tested or approved for use in motor vehicles or aircraft Related Documents The following documents also pertain to the SIGMA Spectrum with Gen 2 Operating System M Service Manual P N 41019 B MDL User Manual P N 41020 Regulatory Information Conforms to UL STD 60601 1 Certified to CAN CSA STD C22 2 NO 601 1 M90 Contacting SIGMA Technical Support Contact SIGMA LLC for all service information at Telephone 1 800 356 3454 E mail techsupport sigmapumps com Manual 41018 6 05 6 2 4 Revision C Conventions WARNING Indicates a potentially hazardous situation which if not avoided could result in death or serious injury CAUTION Indicates a potentially hazardous situation which if not avoided may result in minor or moderate personal injury or property damage This word is used to also alert against unsafe practices Summary of 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 Confirm Safe Operation at Start and Thereafter Only trained health care profess
82. n the display B View History Log select this option to view the entire history log on the pump screen E View System Error Log select this option to view only the system errors recorded in the history log E View Drug Error Log select this option to view only the events associated with pro gramming an infusion including any drug limits that may have been exceeded during setup B Dump History Log select this option to send the entire history log out of the pump via the IrDA port refer to the Logging section of the SIGMA Spectrum Service Manual P N 41019 19 Manual 41018 6 05 6 2 4 Revision C OPERATIONAL OVERVIEW The following sections provide a high level overview of how to setup program and operate the Spectrum Pump For detailed instructions refer to these sections Preparing the Pump and IV Sets section beginning on page 25 Programming the Pump section beginning on page 28 Weight Confirmation section beginning on page 55 Alarms section beginning on page 59 WARNING Confirm Safe Operation at Start and Thereafter Only trained health care professionals can operate Spectrum Gen 2 Operating software Confirm safe accurate pump operation at start and periodically thereafter by Ensuring that IV sets or container vents are properly functioning that tubing clamps are in the proper positions and that tubing is free from kinks or signs of collapse outside the pump
83. oftware components that are installed B SW Version B Sharp B PIC 18 Setting Up the Pump Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 B CPLD B SmartBatt Charger build B Network Module E Library Information The library information screen identifies the name of the Active Drug Library in pump memory as well as the Name Date Modified Version Number Format Indicators Drugs Care Areas Advisories B Show Clinical Advisory If the current infusion has a clinical advisory associated with it selecting this option will display the advisory If the current infusion does not have a clinical advisory associated with it this option is not selectable and appears in grey text in the dis play E Infusion Information The infusion information screen identifies the infusion specific pri mary and secondary bag parameters that are not otherwise displayed on the setup screen The information includes the following information for each bag if programmed audio level near empty alert status primary only pressure setting KVO rate primary only and primary siphoning alert or secondary complete alert status secondary only B History Log Selecting this option provides access to the event log Available options for viewing the log are listed below NOTE Access to this option is provided only when the pump is not running delivering If the pump is running this option is not selectable and appears in grey text i
84. on comple tion of programming the secondary infusion Press OPTIONS to change callback status dur ing secondary infusion B If NEVER the pump will automatically transition to the primary infusion upon completion of the secondary infusion 46 Programming the Pump Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 When secondary infusion completes pump stops KVO rate If Callback is enabled an alarm occurs See Figure 49 1 Press STOP 2 Return to SECONDARY SETUP or begin to PRIMARY INFUSION displays See Figure 50 General Care SECONDARY COMPLETE NDARY s SECONDARY setup Infusing at pid begin j 1 mL hr KVO PRIMARY infusion Press STOP eT silence SECONDARY begin PRIMARY Figure 49 Secondary Completion Screen Figure 50 Select Infusion Screen 47 Manual 41018 6 05 6 2 4 Revision C Programming a Loading Dose A loading dose is an initial higher dose of a medication or fluid delivered once at the start of an infu sion When programming an infusion using DERS you can select a loading dose 1 Be 4 9v m 48 A loading dose can be enabled using Drug Library and infuses at the beginning of an infu sion A loading dose amount time and limits can be assigned to drugs in the Drug Library A loading dose icon syringe is displayed next to the Primary or Secondary Bag line on a completed setup screen See Figure 51 P Figure 51 Loading Dose Icon After all Primary Inf
85. onnected to the AC Power Adaptor and the adaptor is plugged into a powered outlet receptacle 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 Refer to APPENDIX G Icons section beginning on page 105 for a listing of the symbols used and their description 16 Setting Up the Pump Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 Configuring User Options The Spectrum Pump has two sets of configuration options E User options E Biomed options VVARNING 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 NOTE For a description of the Biomed options refer to the SIGMA Spectrum Service Manual User Options To access the User Options menu From the Care Area selection screen 1 Press the OPTIONS soft key 2 Select User Options from the menu and press OK From the RUN or STOPPED screen 1 Press the OPTIONS soft key The User Options menu has three categories E Alarm Settings W Display Settings B View Information 1 Alarm Settings E Audio Speaker actuated audio alarm E Audio Volume The audio volume of the pump has
86. pectrum 4 Over the frequency range 150 kHz to 80 MHz field strength should be less than 3 V m 101 Manual 41018 6 05 6 2 4 Revision C Immunity Separation Distances Recommended separation distance between portable and mobile RF communications equipment and the Spectrum The SIGMA Model Spectrum is intended for use in an electromagnetic environment in which the RD dis turbances are controlled The customer or user of the Spectrum can help prevent electromagnetic inter ference 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 Ww 150 kHz to 80 MHz 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz outside ISM in ISM bands bands d 2 3 P d 1 2 P d 1 2 P d 1 2 P 0 01 0 12 0 12 0 12 23 0 1 0 38 0 38 0 38 73 1 1 2 1 2 1 2 2 3 10 3 8 3 8 3 8 7 3 100 12 12 12 23 For transmitters rated at maximum output power not listed above the recommended separation distance din meters m can 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 trans mitter manufacturer NOTE 1 A
87. pening expands to 1 5 C clamp knob comes off if semi permanent attachment of carrier is desired CAUTION Use Stable IV Poles Mount pumps on IV poles that securely hold the pump 77 Accessories Manual 41018 6 05 6 2 4 Revision C Multi Pole Cat No 55088 1 Holds 5 pumps Adjustable height stainless steel pole 7 hook top UL CSA six outlet power strip for multi pole plug 4 in 1 cord from IV pole to wall outlet Heavy duty 6 leg base with 3 soft rubber casters J A Patient support ring attached to rear of plate w CAUTION 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 lt 1 liter 1000 cc AC Power Adaptor Protector SIGMA Part Number P N 45742 E Snaps on the adaptor side of AC Power Adaptor P N 35714 B Handle on the Protector helps for easy insertion and removal of adaptor power supply from receptacle Bb Protects adaptor from damage CAUTION 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 78 Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 Double Rotating Pole Clamp Assembly SIGMA Part Number P N 35743 E The double rotating feature of Double Rotating
88. peration and clamp detection Other slide clamps associated with the set need to be observed and controlled by the user oo 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 75 Manual 41018 6 05 6 2 4 Revision C 76 WARNING 9 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 Use the Specified Manufacturer s IV Set Type This label is located on the top of the pump and indicates the specific type of IV tubing that the pump has been calibrated for The use of other manufacturer s brands or type tubing could produce pump inaccuracies that could be unsafe for patients Compatible IV Sets Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 ACCESSORIES Tandem Carrier Cat No 55092NS B Holds 2 Spectrum Pumps Stainless upright tubes and aluminum plate a E C clamp jaw opening expands to 1 5 C clamp knob comes off if semi permanent attachment of carrier is desired 3 Pump Carriers Cat No 55093 m B Holds 3 pumps WB Stainless upright tubes and aluminum plate B UL CSA four outlet power strip for multi pole plug in 1 cord from IV pole to wall outlet C clamp jaw o
89. r 1 foot below the pump Non vented IV sets with rigid non vented containers or vents on sets or burettes left in the closed position Using Microdrip or Minidrip chambers for flow rate settings greater than 200 mL hr Doing so may influence flow rate accuracy and cause nuisance air or upstream occlusion alarms Exceeding 500 mL hr flow rate settings when using sets with backcheck valves Doing so may influence flow rate accuracy or cause nuisance upstream air or upstream occlusion alarms Flow rates above 300mL hr may cause fluid to be siphoned from the primary container during piggyback operation see Secondary Infusion WARNING Follow Epidural Precautions Epidural administration of drugs other than those indicated for epidural use can result 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 WARNING Follow Neonatal and Pediatric Precautions Use 60 drop 1mL IV sets Configure the pump with appropriate flow rate VTBI Volume To Be Infused patient weight and occlusion alarm limits using CONFIGURATIONS Options mode Prior to connecting to pa
90. r 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 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 5 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 it is 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 the oretically 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 S
91. r min Off No setting N A in Cyclic TPN Mode Display Adjust 10 highest level No A BASIC infusion provides for NON DERS based infusion programming Drug Library Limits DERS do not exist when using BASIC mode BASIC allows the user to manu ally specify a mL hr rate dose mode dose rate and volume to be infused among other parameters It does possess the Gen 2 features Check Flow at Run Secondary Error Prevention and Single Step Titration Rate Change of 101 CAUTION The use of BASIC programming should be restricted and actively monitored by a hospital s QA Risk Pharmacy and Nursing departments 110 APPENDIX H SPECTRUM DEFAULT SETTINGS Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 Table 3 BASIC Fixed Settings BASIC Configuration Settings Fixed Settings Allow Bolus Yes Allowing Loading Dose No Delayed Run Not Available KVO Rate 1 mL hr Secondary Callback Not Available Single Step Rate Change 101 Table 4 BASIC Settings Configurable in the Drug Library BASIC Configuration Settings Default Settings Temporary Upstream Occlusion Alarm Suspension Feature Enabled See Upstream Suspension Prompts for Primary and Secondary Infusions on page 63 Table 5 Dose Modes Available in BASIC Mode BASIC Configuration Settings Default Settings Any Infusion while in BASIC Mode mL hr mL kg min mL kg hr g hr mg hr mg kg
92. r ss2ccnei0c2daseneedieus ac ipedeseaascaneeadads ed 80 Standard Gravity IV Sets 42 2 990 tae RES RR eb beth qiie aE ee eS 80 StandaldS a d Gu ode d eed Da das dd Adr eodd e od R3 woe d Ode equae 80 APPENDIX B Flow Rate Accuracy eeeeeeeeeeeeeeeeee 86 Effect of Fluid Container Height 0 000 eee 86 Effect or Back Pressure 2c c22 c 2655ee5cei RRORRRRGHRRGRH CREARE C RES ACER 86 FIOW PION ger wee te bee GEER eee ae ede ee ae ewe ee ee 86 APPENDIX C Bolus Accuracy lees 95 APPENDIX D Downstream Occlusion Lueesss 96 Titre 6 OODOGIISIOIT 2a docks Eden 0 h9 cedex RPRRERTERERReRERE ST a8 5e ES 96 BOWS VOlUITiB sup TREE PRREESCERDERERRESEQRSPUERRERRG P SER aded p 96 APPENDIX E Electromagnetic Compatibility 97 EMISSIONS uv vx qa ERE RUER RR EWEEESNNEREUNEPlaSEPRI SS ee ERES qp 97 Immunity ESD transient burst voltage disparity magnetic 98 Immunity Conducted and Radiated 0 0c eee eee 100 Immunity Separation Distances 000 c eee eee 102 APPENDIX F Low Very Low Battery Tutorial 103 Low Battery Tutorial 232 239 wa RR EKE ose ECCE ERRCEEAS de RC E XGA 103 Very Low Battery Tutorial z uus usu x RR RR x XE HRS RR Rs 104 APPENDIX G IconS 4 inca ctaedeurt ce ER pli aane x mcr NRPRUR wenn 105 Power ICONS REP 105 Wireless ICONS 2 222 404 525 c8deaee Res teede de Geeeredetouh 3d Gerd ses
93. ration 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 pump operation and clamp detection Other slide clamps associated with the set need to be observed and controlled by the user Manual 41018 6 05 6 2 4 Revision C 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 WARNING Hospira IV Sets 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 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 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 Failure to prime remove all air bubbles from a backcheck valve in a primary s
94. re 15 prompts the clinician to verify drops are falling in the sec ondary drip chamber and not in the primary Critical Care un Vancomycin Are drops falling in the 1000 mogisomt SECONDARY drip Secondary Primary chamber and not in the PRIMARY Are all clamps open Is tubing not kinked Rate muhr VTBI mL Seconc a yev Are drops flowing dear program Figure 13 Check Flow at Run Figure 14 Secondary Bag Volume Figure 15 Secondary Check Flow Confirmation 4 Single Step Titration set at 500 in Anesthesia and OR Care Areas Bb Each facility s Drug Library can be programmed with limits for the percent rate change that is considered safe for each single titration step E A rate advisory See Figure 16 will alert the clinician if the dose or mL hr rate has been programmed to exceed the facility s pre configured limit RATE ADVISORY Figure 16 Single Step Titration Rate Alert es Programming the Pump Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 The SIGMA Spectrum Pump provides two main options for controlling infusions 1 Dose Error Reduction System DERS This system uses predetermined dosing information stored in the pump s Drug Library using the Master Drug Library Editor to control the dose rate volume time and other infusion parameters for specific drugs This system pro tects against programming errors that could cause Adverse
95. re 66 LOW BATTERY Plug into wall outlet yd Push OK to dismiss for 5 minutes PUMP IS RUNNING Figure 66 Low Battery Alarm If the pump is not plugged in or the alarm is not acknowledged after 2 minutes the alarm volume increases and the troubleshooting tutorial automatically begins When the Low Battery warning initiates a minimum of 30 minutes of runtime remains Very Low Battery If the battery level drops below the low battery level the message changes to Very Low Battery and begins to flash The back light also dims to reduce battery usage See Figure 67 VERY LOW BATTERY Plug into wall outlet N 7 N Is power cord plugged into wall outlet PUMP IS RUNNING Figure 67 Very Low Battery Alarm The troubleshooting tutorial starts automatically When the Very Low Battery warning initiates a minimum of 15 minutes of runtime remains Manual 41018 6 05 6 2 4 Revision C Battery Depleted If the battery level drops below the Very Low Battery level the message changes to Battery Depleted See Figure 68 BATTERY DEPLETED PUMP wit NOT RUN Change battery or plug in AC cord and restart pump Figure 68 Battery Depleted Alarm The pump will stop running If the pump is not plugged in within 3 minutes the pump will shut itself off 66 Alarms Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 CLEANING AND STORAGE The SIGMA Sp
96. remove the Spectrum from the protective anti static bag remove the protect ing foam end caps and discard the desiccant package A battery tab isolates 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 To remove the battery tab pull the tab away from the Battery Pack mounting cavity See Figure 9 Figure 9 Battery Tab 1 Save all packaging materials except for the desiccant package for reuse This is advised in the event product repair or warranty replacement is necessary 2 Fully charge the battery prior to use 3 For battery charge specifications see Battery Power and Capacity section beginning on page 82 Setting Up the Pump Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 AC Power Adaptor CAUTION Only use the power adaptor specified for this equipment Using other power adaptors may cause personal injury or damage to equipment When plugged into a powered wall outlet the AC Power Adaptor charges the pump s battery The AC Power Adaptor uses a locking cord connection to prevent inadvertent disconnection NOTE Avoid dropping AC Power Adaptors on the floor Drops will cause them to malfunction As with all electronic devices drops should always be prevented Cleaning the Power Adaptor CAUTION The Power Adaptor with Protector is compatible with the cleaners mentioned in this Oper
97. rials Operating temperatures outside of 60 90 F for Standard Battery and 60 80 F for Wireless Battery Module Using IV sets longer than is recommended in the Specifications section of this manual Using a dropped damaged dirty or wet pump Pressurizing IV bags Positioning IV containers more than 3 feet above or 1 foot below the pump Non vented IV sets with rigid non vented containers or vents on sets or burettes left in the closed position when they should be open Using Microdrip or Minidrip chambers for flow rate settings greater than 200 mL hr Doing so may influence flow rate accuracy and cause nuisance air or upstream occlusion alarms Exceeding 500 mL hr flow rate settings when using sets with backcheck valves Doing so may influence flow rate accuracy or cause nuisance upstream air or upstream occlusion alarms Flow rates above 300mL hr may cause fluid to be siphoned from the primary container during piggyback operation see Secondary Infusion WARNING Upstream occlusions caused by improperly vented glass bottles or burettes may not be detected because of the very slow building vacuums resulting from these situations WARNING Follow Epidural Precautions Epidural administration of drugs other than those indicated for epidural use can result in serious patient injury When administering epidural analgesics use only catheters specifically labeled for epidural analgesia drug delivery To help prevent acc
98. ry is 75 charged Battery is 100 charged SRRB D Battery is installed and the AC adaptor is connected Alternates with one of the battery levels above on pumps with Wireless Battery Module Battery is depleted or missing red battery AC adaptor is connected with no battery installed Alternates with the battery missing icon above B 105 Manual 41018 6 05 6 2 4 Revision C Sleep Mode Power Icons Battery Charging Charge Complete Install Battery 106 The AC adaptor is connected and the Wireless Battery Module is being charged Battery segments bars indicate battery charge level black battery white background Standard Battery is being charged black battery white background Wireless Battery Module is fully charged white battery green background Battery Error An error code number may also be displayed Refer to the Service Manual for a description of the error code red battery AC power is supplied and battery pack is not 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 APPENDIX G Icons Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 Wireless Icons These icons are only visible when Wireless Battery Module is installed They appear in the upper right corner of the pump Initializing The dot will circ
99. sly programmed primary rate SLIDE CLAMP CLOSED Open slide clamp and press 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 pressing the ON key If neither procedure clears the fault return the pump for service UPSTREAM OCCLUSION Eliminate the occlusion or flow restriction by checking for an upstream above pump closed clamp kinked or collapsed IV tubing outside the pump closed burette valve and malfunctioning or closed IV set or burette air vent Press RUN to start infusion Verify patency by confirming drop rate is consistent with programmed rate 61 Manual 41018 6 05 6 2 4 Revision C Alarm Action UPSTREAM OCCLUSION A drug or fluid that produces micro bubbles in solution can ALARM SUSPENSION cause nuisance upstream occlusion alarms This is most likely associated with certain drugs identified as effervescent and also with cold fluids that are warming during infusion A drug configuration in the Drug Library allows the clinician to temporarily suspend the upstream occlusion alarm on the pump if the clinician considers the alarm to be a nuisance The suspension prompt appears after two consecutive upstream occlusion alarms and a positive confirmation on the check flow display screen See Figure 65 This dia
100. t 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 756 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 NOTE 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 and in the frequency range 80 MHz to 2 5 GHz to decrease the likelihood that mobile portable communications equipment could cause inter ference if it is inadvertently brought into patient areas NOTE 4 The guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people radiation nor is it intended to be used in this manner Exposure to radiation of this type may cause the device to operate improperly WARNING The Spectrum Pump is not designed to be exposed to linear accelerator Do not expose the SIGMA Spectrum to linear accelerator radiation Doing so may cause injury to the patient and or damage to the equipment 102 APPENDIX E Electromagnetic Compatibility Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 APPENDIX F LOW VERY LOW BAT TERY TUTORIAL The Low Battery and Very Low Battery Tutorials provide step by step confirmation that the external power supply is connected to the wall o
101. t is loaded Close the roller clamp Follow display prompts DOWNSTREAM Eliminate a closed clamp kinked tubing positional catheter OCCLUSION clotted catheter clogged IV filter or other sources of occlusion below the pump DOWNSTREAM PRESSURE The downstream pressure limit differs from Care Area default LIMIT RESET SETTING set in the Drug Library Select YES to reset or NO to keep the current setting INACTIVITY ALARM The pump has been inactive for 2 minutes and no action has been taken Follow the on screen prompts and resume or restart the pump by pressing RUN IN STOP SLIDE CLAMP CLOSED Open slide clamp and press RUN or unload set LOW BATTERY The low battery alarm threshold has been reached Plug the AC Power Adaptor into the pump and into the AC source outlet as soon as possible to recharge the Battery PRIMARY INFUSION COMPLETE The Primary Infusion Volume To Be Infused VTBI has counted down to zero The pump is running at a Keep Vein Open rate KVO rate or the actual infusion rate whichever is lower The Drug Library default KVO rate is set at 1mL hr in the Drug Library SECONDARY INFUSION COMPLETE The Secondary VTBI has counted down to zero A secondary infusion with Secondary Callback enabled will run at the pump s default KVO rate of 1mL hr If Secondary Callback is disabled when Secondary VTBI has counted down to zero the pump will automatically transition back to the previou
102. t the highest backlight settings m 12 hr recharge time m Charging occurs if AC Power Adaptor is plugged in whether pump is ON or OFF Wireless Battery Module 802 11b m Lithium Ion 1800 mA h 7 4 VDC nominal SIGMA Part Number 35083 m Capacity 4 hrs at 125 mL hr at the highest backlight settings m 16 hr recharge time m Charging occurs if AC Power Adaptor is plugged in whether pump is ON or OFF Wireless Battery Module 802 11b g m Lithium Ion 1800 mA h 7 4 VDC nominal SIGMA Part Number 35162 W Capacity 4 hrs at 125 mL hr at the highest backlight settings m 16 hr recharge time m Charging occurs if AC Power Adaptor is plugged in whether pump is ON or OFF Display Color 16 out of a palette of 262 144 possible colors HRTFT 240 X 270 LED Front Lit 0 2235 mm X 0 2235 mm dot pitch Dose Modes mL hr mL kg min mL kg hr g hr mg hr mg kg hr mg min mg kg min mg kg day mcg hr mg kg hr mcg min mcg kg min mcg kg day ng min ng kg min Units hr Units kg hr Units min Units kg min mUnits min mUnits kg hr mUnits kg min mEg hr mEq kg hr mmol hr mmol kg hr External Interfaces IrDA SIR Encoding Protocol Supports IrOBEX Additional Asynchronous Serial Port expansion bus available at battery terminals Software upgrades may be performed through external RS 232 ae APPENDIX A Specifications Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 Spec
103. tient prime IV set then close roller clamp load IV set open slide clamp and roller clamp if equipped to avoid 21 Manual 41018 6 05 6 2 4 Revision C CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION possible bolus 2 mL that would result around a door opening set loading event If the pump door is opened with an IV set connected to a patient 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 0 085 mL bolus in the syringe and unclamp the set below the Y site Confirm Audio Operation When pressing 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 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 Follow Physicians 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 health care practitioner Accuracy Refer to trumpet curves for flow rate accuracy as a function of short infusion durations See APPENDIX B Flow Rate Accuracy beginning on page 86 The upstream occlusion det
104. ugs delivered in RIGID containers since the flow restriction caused by lack of proper container venting may be difficult to recognize when troubleshooting an alarm condition VVARNING Upstream Occlusion Alarm Suspension feature should only be used after the operator visually observes positive line flow VVARNING Baxter IV Sets Minidrip sets 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 AN AN AN N 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 or upstream occlusion alarms Flow rates above 300 mL hr may cause fluid to be siphoned from the primary container during piggyback operation Failure to prime remove all air bubbles from a backcheck valve in a primary set may cause the valve to malfunction resulting in secondary fluid flow back up into the primary container 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 Rigid unvented containers used with unvented sets or vented sets with vent closed will cause upstream occlusions that may not be detected by the infusion pump Ball Valve ope
105. ular phones and electrosurgical equipment that may generate strong radio frequency interference RFI Refer to the EMC Immunity Section Separation Distance in this manual for recommended minimum distance Confirm Audio Operation When pressing 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 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 Electric Shock Hazard Refer servicing to qualified service personnel at your institution or return to SIGMA Accuracy Refer to trumpet curves for flow rate accuracy as a function of short infusion durations See APPENDIX B Flow Rate Accuracy on page 86 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 and respond appropriately to all primary and secondary check flow prompts Small bore catheters or needles may cause excessive back pressure at high flow rates Size the catheters according to expected flow rate and fluid viscosity Follow Physicians 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 health care practitioner Single Fault Conditions A maximum bolus of 0 1
106. ump 20000 eee eaes 30 Activating a Drug Library on a Pump with a Wireless Module 32 C Ir Manual 41018 6 05 6 2 4 Revision C Programming the Pump Using the Dose Error Reduction System 33 Programming the Pump Using the BASIC Mode 0000 cee eaee 37 Setting up a Secondary Infusion 0 0 ccc eee 40 Clearing the Secondary Mode While Returning to the Primary Infusion 45 Secondary Callback Assigned to a Secondary Drug in the Drug Library 45 Programming a Loading Dose 4i Exe RREE E RRRESTERAEASMARER Sees a Red 48 Programming a Bolus 2 2532 5 e REFERRE SIR EIU eT PSP S ed 49 Multi Step Programming css d e exa RR REERRREREXERUREEFERRRRXSRREER ES 49 Cyclic TPN MOOSB axes E Rud IRECA ERESDA FEN RP EAE ade ERE Hes xus 51 TWANG 2s rrr e ver ERE EIAS Ee Ed mem ed ecce sire iid qan dr eq icis 52 Delayed Ufo sured zeEaepPEEPRRESEPRORERNECEQDOCUPRENTAPS ESPERE S 55 Weight Confirmation 2 c 50 2 xem ARRERERA REC RUGG eg hh basse ae ee peas 55 Pump Operation cin nee yp Haa 68 mine far sama RT me 56 Operating IpS f 242s tees due desea ERR SERRA RA HR bee neietecasaaceeees 56 Placing the Pump in STANDBY Hold 220542545444 644 4 93640403084 57 Operating the Keypad Lock 2 ccc0 visteesiseereeev sees VOR eee bee ewe 58 Ci ee ee ee er ere ee eae 59 Silencing an Alarm PP 60 Clearing an Alarm ss di anaana aana 60 Alarm Messages ouo pGd ee RE rei ttes aaea RE
107. uracies that could be unsafe for patients 7a Compatible IV Sets Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 Compatible Hospira IV Sets The following is a partial listing of the Hospira IV sets compatible with the SIGMA Spectrum Pumps that have been calibrated for use with Hospira nominal size 0 100 LD Series IV set tubing Please consult DOC 11181 for a full listing of compatible sets 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 EN cS No Brief Description Primary Set Macro 15 Drops mL 11309 58 LS Primary Piggyback Set PP backckeck valve 2 PP Y Sites amp OL 9 7 106 11540 58 LS Primary Piggyback Set PP backcheck valve PP Y site amp OL2 80 11545 58 LS Primary Set PP Y site amp OL 78 11679 65 LS Primary Piggyback Set with inline backcheck valve 2 PP Y sites and OL 100 11960 68 LS Convertible Pin I V Set CLAVE Y site and OL 100 11961 68 LS Primary Piggyback Set with inline backcheck valve 2 CLAVE Y sites amp OL 100 11965 68 LS Primary Piggyback Set inline backcheck valve 3 CLAVE Y sites and OL 7 100 12574 48 LS Primary Set Convertible Pin amp OL 100 20778 48 LS Primary Set with backcheck valve Yellow Key Slide Clamp 2 CLAVE Y Sites amp OL 5 100 20793 48 LS Primary Set Yellow Key Slide Clamp with inline backcheck valve 3 CLAVE Y sites 0 2 micron filter amp OL2 3
108. us before Occlusion Downstream Release Managing unintended small bolus releases when clearing downstream occlusions When a downstream occlusion alarm occurs pressure and a small volume of 0 98 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 Battery Warning Levels The pump provides three warning levels as the battery capacity decreases while operating on battery power These levels are Low Battery Very Low Battery Battery Depleted There is ample time between the alarms for the pump to be plugged into main power The trouble shooting tutorial also automatically pops up on the pump screen to guide the user through the pro cess See APPENDIX F Low Very Low Battery Tutorial section beginning on page 103 If the pump is not plugged in the battery continues to slowly discharge even if the pump is turned off 64 Alarms Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 Low Battery When the battery is low the pump sounds a triple beep audio alarm every 5 seconds Press OK to temporarily suspend this alarm While suspended the Low Battery status will be indicated in the alert bar and a tone will be generated once every five minutes to remind the operator of the Low Bat tery status See Figu
109. usion values are entered a Loading Dose dialog box displays Do you want to deliver a Loading Dose from the PRIMARY or SECONDARY bag YES NO See Figure 52 General Care Insulin 100 mg 100 mL Primary Bag Pn Dose mg hr 10 Loading Dose Figure 52 Loading Dose Dialog Box If you select YES the loading dose setup screen displays Enter all required data and press OK after each entry Press RUN to start the delivery of the Loading Dose Check for flow and confirm that all clamps are open there are no kinks in tubing and drops are flowing If everything is flowing properly press the YES soft key To cancel the Loading Dose during infusion the user can press the CANCEL soft key NOTE At the completion of the loading dose transition to the Primary Infusion rate is automatic Programming the Pump Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 Programming a Bolus A Bolus is a higher dose of medication or fluid and can be delivered throughout the infusion E Can always be delivered in BASIC mode and is optional in DERS if configured in the Drug Library E Amount time and limits can be assigned to drugs in the Drug Library by using the Master Drug Library Editor E Can be programmed while the pump is stopped or while infusing To program a Bolus while the pump is stopped or infusing 1 Press the BOLUS soft key The bolus setup screen appears 2 Enter all required data an
110. utlet the power light is illuminated and the power cord is properly connected to the Spectrum LOW BATTERY Plug into wall outlet T Is power cord plugged into wall outlet a LOW BATTERY Low Battery Tutorial T Iswall plug light on v LOW LOW BATTERY BATTERY Faulty power supply T T Is cord pushed firmly SEND PUMP into back of pump FOR REPAIR 7 N Push OK to continue LOW BATTERY Faulty power jack T SEND PUMP FOR REPAIR Push OK to continue 103 Manual 41018 6 05 6 2 4 Revision C Very Low Battery Tutorial VERY LOW d y BATTERY Eii When the Very Low Battery Alarm activates the following ug into wall outlet tutorial appears Is power cord plugged into wall outlet VERY LOW BATTERY C Is wall plug light on Y VERY LOW VERY LOW BATTERY BATTERY Faulty power supply 1 Is cord pushed firmly 5 SEND PUMP into back of pump yi FOR REPAIR Push OK to continue VERY LOW BATTERY Faulty power jack SEND PUMP FOR REPAIR Push OK to continue 104 APPENDIX F Low Very Low Battery Tutorial Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 APPENDIX G ICONS Power Icons These icons are visible in the upper left corner of the pump display Battery is low or very low red battery Battery is 2596 charged Battery is 5096 charged Batte
111. v wv amp B stu wwx yz v ww amp Figure 1 SIGMA Spectrum Pump Figure 2 Standard gravity IV set 10 System Components Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 Spectrum Pump Illustrations READ OPERATOR S A MANUAL BEFORE REV A USING DEVICE Figure 4 Back View With Standard Battery P N 35724 gt A Ny WIRELESS BATTERY MODULE WIRELESS BATTERY MODULE a IEEE 802 116 IEEE 802 11b g CONTAINS TRANSMITTER CONTAINS TRANSMITTER MODULE tt MODULE Fcc b Mco 50M879 FCC D MCOSOM1 538 READ OPERATOR S MANUAL BEFORE REV A USING DEVICE 6 spectrum E g SIGMA P N 35162 AX reo operator s manuat BEFORE USING DEVICE vase N ZEN SIGMA International Inc Medina NY 14103 1 800 356 3454 Figure 5 Back View With 802 11b Wireless Bat Figure 6 Back View With 802 11b g Wireless tery Module P N 35083 Battery Module P N 35162 SD ctomecrecerum 7 Manual 41018 6 05 6 2 4 Revision C Hardware Labeling The following is a description of the labels and symbols that appear on the Spectrum Pump Attention consult ACCOMPANYING DOCUMENTS ISO 7010 W001 CLASS II EQUIPMENT IEC 60417 5172 TYPE BF APPLIED PART IEC 60417 5333 Direct current IEC 60417 5031 Recyclable dispose of properly ISO 7000 1135 This is a representation of the Direction of Flow not to scale This label is located on the
112. ver possible 3 Select a compatible IV set See Compatible IV Sets beginning on page 69 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 NOTE Pumped on tubing should not be re loaded into the pumping channel to avoid nuisance alarms and to maintain flow rate accuracy 4 Prepare IV fluid containers and prime IV sets E Fill drip chambers approximately halfway E Use standard gravity IV set priming technique to purge air from sets and all Y injection sites E Close the roller clamp 12 below the upper Y injection site B Allowing IV solutions to warm to room temperature before use will reduce nuisance air in line alarms Manual 41018 6 05 6 2 4 Revision C Loading an IV Set WARNING Do Not Allow Uncontrolled Gravity Flow When loading a primed IV set ensure before pump manipulation that the roller clamp below the pump is in the closed position 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 This can cause dangerous uncontrolled free flow to occur During IV container changes always c
113. w Rate Accuracy Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 Startup Graph First Two Hours Set Rate 25 mL hr 50 00 4 45 00 40 00 35 00 30 00 25 00 4 20 00 Flow Rate mL hr Qi 15 00 10 00 5 00 0 00 0 10 30 40 50 60 70 80 90 100 110 120 5 00 Time min The percent variation of mean flow rate accuracy over a specific observation period may be quanti fied 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 spe cific measurement interval is provided 87 es sigmaspectrum Manual 41018 6 05 6 2 4 Revision C Trumpet Curve 2nd Hour Set Rate 25 mL hr 15 096 10 096 5 0 0 0 T 1 37 3 gt or a a T T T r 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 5 0 f Error of Flow 10 0 15 0 Observation Window min 88 APPENDIX B Flow Rate Accuracy Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 Flow Rate Graph Last Hour Set Rate 25 mL hr 50 00 45 00 40 00 35 00 30 00 j 20 00 Flow Rate mL hr Qi 15 00 10 00 5 00 0 00 0 10 20 30 40 50 60 5 00 Time min Typical of intermediate rate last Hr Flow Accuracy es sigmaspectrum
114. xivir TB Wipes 67 Manual 41018 6 05 6 2 4 Revision C Cleaning the Pump Do not use rigid cleaning instruments or spray solutions directly on the pump and its accessories To clean the pump 1 Turn the pump off and unplug the AC power adaptor from the power source 2 Place the pump in an upright position 3 Apply the compatible cleaning agent with a dampened cloth per the manufacturers instruc tions using appropriate dilution ratio NOTE Disinfectants should remain on the pump s surface in an even but not dripping film for the recommended contact time for the compatible cleaning agents 4 Open the pump s door using a standard IV set s slide clamp 5 Clean the speaker vent power adaptor connector door release keyhole and pumping channel areas with soft swabs 6 Apply solutions sparingly to the swabs and wipe down the necessary areas NOTE 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 7 Dispose of all cleaning materials including the slide clamp as required per facility proto col biohazard policy WARNING Disposal To dispose of this device or the associated administration sets adhere to local state federal and or other governing regulations 68 Cleaning and Storage Pump Operating Software v6 05 For Use
115. y Multi step infusion bag selection will be bypassed and the Multi Step Program Mode setup screen will be displayed 49 Manual 41018 6 05 6 2 4 Revision C 10 11 12 NOTE Multi Step Program Mode is not available as a secondary infusion In the Multi Step Programming Mode continue with the setup as described in the BASIC or DERS programming sections A 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 tabbed white highlight When the setup of an individual step has been completed press OK to advance and pro gram the next step When the 10th step has been programmed the program schedule is complete and no more steps may be programmed NOTE 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 step in the program Any parameter data missing within the program shall be identified in a popup message when the user starts the pump View the setup data for any programmed step 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 NOTE A one second delay exists from the time a step is selected and when its setup data is displa
116. yed to allow rapid scrolling along the step bar E If the infusion is stopped you can change any setup data by pressing REVIEW and nav igating to that step and pressing OK to move to the values that must be changed B Ifthe pump is running you can view any programmed step by pressing the REVIEW soft key however no values can be changed with the exception of the Volume Given value which can be cleared by pressing the CLEAR soft key Press RUN to start the program The run screen appears as described in the mL hr or Dose Error Reduction System sections with the addition of a program step indicator This indicator displays the current program step as Step x of y where x is the current step being delivered and y is the total number of programmed steps Pump will automatically advance to programmed steps while infusing Check the flow and confirm all clamps are open there are no kinks in tubing and drops are flowing If everything is flowing properly press the YES soft key When the program completes press the STOP key The program schedule automatically resets itself and may be restarted without entering re entering any setup data NOTE Always verify current program parameters for each step prior to starting a new infusion Programming the Pump Pump Operating Software v6 05 For Use With MDL Editor v6 2 4 The program will be retained indefinitely during power off cycles until reset To reset the program press the R

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