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Abbott GemStar™ Pump - Frank`s Hospital Workshop

1. 30 0 A 20 0 4 gt 10 0 4 R 3 0 0 i S m z y 3 10 0 3 20 0 4 Hu 30 0 0 5 10 15 20 25 30 Observation Interval minutes e Max Min v Mean 130 Abbott GemStar Manual 430 600095 002 Rev 8 02 Abbott GemStar Pump Specifications FLOW RATE 25 mL 0 mm Hg Delivery Head Start Up 50 0 45 0 40 0 5 35 04 _ 30 04 B 25 01 MA NAF gt 4 20 04 E 1504 g 10 04 g 5 0 5 04 10 0 0 10 20 30 40 50 60 70 80 90 100 110 120 Time minutes Actual Rate Programmed Rate PERCENT ERROR 25 mL 0 mm Hg Delivery Head Start Up 15 0 10 0 Bb 50 B de 1 t x 0 0 E i S L 50 m 3 10 0 H 15 0 0 5 10 15 20 25 30 Observation Interval minutes Max Min v Mean Abbott GemStar Manual 430 600095 002 Rev 8 02 131 Abbott GemStar Pump Specifications FLOW RATE 25 mL 0 mm Hg Delivery Head 96 Hour wt o Rate mL hr N 0 10 20 30 40 50 Time minutes Actual Rate Programmed Rate PERCENT ERROR 25 mL 0 mm Hg Delivery Head 96 Hour 15 0 10 0 5 0 gt L P L 0 0 5 0 10 0 Flow Rate Variability 15 0 0 5 10 15 20 25 30 Observation In
2. FLOW RATE 25 mL 0 mm Hg Delivery Head 20 in H20 Filling Head Start Up 50 0 45 0 40 0 35 0 30 0 E 25 0 20 0 E 15 0 o 10 0 y 5 0 0 0 5 0 10 0 0 10 20 30 40 50 60 70 80 90 100 110 120 Time minutes Actual Rate Programmed Rate PERCENT ERROR 25 mL 0 mm Hg Delivery Head 20 in H20 Filling Head Start Up 15 0 10 0 p 5 0 4 Tea E o E 0 0 x f I 7 r gt g 5 0 4 3 a 3 10 0 Hu 15 0 0 5 10 15 20 25 30 Observation Interval minutes Max Min y Mean Abbott GemStar Manual 430 600095 002 Rev 8 02 135 Notes 136 Abbott GemStar Manual 430 600095 002 Rev 8 02 Warranty The Abbott GemStar Pump has been carefully manufactured using high quality components It is warranted to be free from defects in material and workmanship for a period of one year from the date of purchase under normal use and service The warranty on the optional battery pack and other accessories is limited to 90 days On return to Abbott Laboratories the pump will be repaired or replaced within the terms of this warranty Material returned to Abbott Laboratories must be properly packaged and sent freight prepaid This warranty shall not apply ifthe pump has been repaired by anyone other than Abbott Laboratories qualified service personnel or altered in any way which in Abbott Laboratories judgment affects its stability or reliability or ifthe serial
3. GEMSTAR System Operating Manual For use with the Abbott GemStar Pump List 13000 36 a ABBOTT LABORATORIES NORTH CHICAGO IL 60064 USA EAN 430 600095 002 Rev 8 02 Abbott GemStar Pump System Operating Manual For use with the Abbott GemStar Pump List 13000 36 PLEASE Read this entire manual before using the Abbott GemStar Pump This manual is designed for use by healthcare professionals caregivers and patients For consultation and technical support contact your local Abbott Laboratories sales office This manual is designed for use with Abbott GemStar Pumps used in the United Kingdom Australia and other English speaking countries Abbott GemStar Manual 430 600095 002 Rev 8 02 Change History Part Number Description of Change Pages Changed 430 600095 001 Original Release N A Rev 3 00 430 600095 002 Second Release N A Rev 8 02 ii Abbott GemStar Manual 430 600095 002 Rev 8 02 Contents Introduction 1 Abbott GemStar Pump Layout o o e 2 Abbott GemStar Pump Components 2 22 arr ra vr kn 4 ThEraplesra v s rabatt ete SES AE AA GE 2 Sire 5 Abbott GemStar Pump Features o 2 0 6 Menu System 2 sje va ha BG e A ba ER aw E 7 Operating Modes 4 sats al en Ge OR Oe KA ee Ee ee REG 8 Abbott GemStar Pump Set sees ses rss ss ss over 8 Indications for USE io a eB oe ed be ee a 9 Contraindications for Use 2 0
4. PRINT 9 Tip PROGRAM REVIEW is also accessed by SPEEDVEROTOCOL VIEW displays selecting Review Resume from the Change Menu or at power on if a program is stored in the pump s memory and the pump has been powered off for 5 or more minutes 70 EW PROGRAM from the Options Menu PROGRAM RE REVIEW PROGRAM HISTORIES KEYPAD LOCK PUMP SETTINGS o I NT fF W DY NEXT DOSE Abbott GemStar Manual 430 600095 002 Rev 8 02 Options Menu Histories EVIEW PROGRAM Select HISTORIES from the Options Menu Select the number key that corresponds to the desired function EYPAD LOCK K PUMP SETTINGS Complete the appropriate steps for the selected SET CLOCK function PRINT SPEED PROTOCOL N EXT DOSE Select this item from the To do this function Display includes Histories Menu Current date and time Date and time the program was cleared a new container was selected or a speed protocol was recalled History event log of the latest 400 events HISTORY Display history event log of the latest 400 events Time and date when shift was cleared Volume infused in the shift Any relevant program specific information SHIFT TOTALS Display or clear shift totals Amount infused e VIBI Any relevant program specific information VOLUME TOTALS Display volume totals CONFIGURATION Display pump configuration Dependent upon pump configuration
5. 1 0 mL hr Clear History Event Log and Bolus History PMLEGIS SHIRT CLEARED Select CLEAR HISTORY from the Histories Menu END OF EVENT LOG CLEARING HISTORY displays for 3 4 seconds before the Sample History Event Log pump exits OPTIONS 9 Tip Press BACK UP to exit OPTIONS immediately Display Bolus History Select BOLUS HISTORY from the Histories Menu Press BACK UP when done to exit OPTIONS TIME IS 09 15 AM FRI 11 JUN 99 G Vv Note Bolus History is only available if the current ry y program has a bolus programmed or had a bolus programmed at one time The Bolus History is maintained An ne NR in hourly increments for the latest 48 hours SKENET SANN BOL AMT XXXX X mL The Bolus History is cleared when a new program is XX XXM TO XX XXM entered a Speed Protocol is recalled or the History is cleared Operation Test This function allows the testing of various pump operations to ensure the Abbott GemStar Pump is working properly Refer to the Operation Test section for instructions 72 Abbott GemStar Manual 430 600095 002 Rev 8 02 Options Menu Keypad Lock REVIEW PROGRAM Select KEYPAD LOCK from the Options Menu HISTORIES Select the desired lock level KEYPAD LOCK The following lock levels listed from lowest to highest 4 PUMP SETTINGS restrictions are available 5 SET CLOCK 6 PRINT LE 7 SPEED PROTOCOL Lock Level Abbreviation 8
6. Abbott GemStar 13078 01 Connects the Abbott GemStar Pump to a compatible serial printer or computer to download the event history program or speed protocol information Connecting the Bolus Cord List 13027 01 Connect the bolus cord to the port labeled Bolus on the bottom of the pump 110 Abbott GemStar Manual 430 600095 002 Rev 8 02 Optional System Components Recharging the Battery Pack List 13073 01 The Abbott GemStar Battery Pack may be recharged using the Abbott GemStar AC Mains Adaptor List 13026 01 USA or 13072 01 Universal CAUTION ALWAYS connect to a grounded AC mains outlet when using AC mains adaptor USE ONLY AC mains adaptors specifically labeled for use with the Abbott GemStar Pump to charge the battery pack During charging the battery pack is warm If the battery pack becomes hot to the touch IMMEDIATELY unplug AC mains power and contact Abbott Customer Support The battery pack light illuminates yellow while the battery pack is charging When the battery pack is fully charged the light illuminates green a Note Refer to the instructions included with the Abbott GemStar Battery Pack for more information Plug the pin connector of the AC mains adaptor List 13026 01 USA or 13072 01 Universal into the port on the bottom of the battery pack Plug the AC mains adaptor into a standard wall outlet Leave the pack connected to the AC mains adaptor for at least 8 hours
7. General Infusion Sets 13268 GemStar Primary Piggyback Pump Set LifeShield Secure Lock Convertible Piercing Pin Macrobore Tubing Pressure Activated Anti Siphon Valve Latex Free 110 in 279 cm Pain Management Sets 13261 GemStar Pump Set Secure Lock Non Vented Microbore Tubing Yellow Striped Split Set with Integral Pressure Activated Anti Siphon Valve on Extension Set Latex Free 110 in 279 cm 13262 GemStar Pump Set with PCA Extension Secure Lock Non Vented Microbore Tubing Split Set with Integral Pressure Activated Anti Siphon Valve on Extension Set Latex Free 110 in 279 cm 13047 GemStar Pump Set with PCA Extension Secure Lock Non Vented with PCA Injector and Female Luer Lock Adapter Microbore Tubing Split Set with Integral Pressure Activated Anti Siphon Valve Latex Free 96 in 244 cm 122 Abbott GemStar Manual 430 600095 002 Rev 8 02 Abbott GemStar Pump Specifications Physical Dimensions Weight The Abbott GemStar Pump is composed of latex free components only Height 5 5 in 14 0 cm Width 3 8 in 9 7 cm Depth 2 0 in 5 1 cm Approximately 17 0z 482 grams excluding batteries Transport and Storage Environment Ambient Temperatures Relative Humidity Atmospheric Pressure Store in cool and dry environment 4 to 140 F 20 to 60 C 10 to 90 0 10 000 ft 0 3 000 m equivalent pressu
8. USE ONLY the AC mains adaptor specifically labeled for use with the Abbott GemStar Pump to charge the battery pack The Abbott GemStar AC Mains Adaptor is for use with the Abbott GemStar Pump or Abbott GemStar Battery Pack only DO NOT use the Abbott GemStar AC mains adaptor with other products During charging the battery pack is warm If the battery pack becomes hot to the touch IMMEDIATELY unplug the AC mains adaptor and contact Abbott Customer Support Please comply with local disposal and recycling regulations as appropriate for disposable batteries rechargeable battery packs medical electronic components and pump sets Abbott GemStar Manual 430 600095 002 Rev 8 02 13 Notes 14 Abbott GemStar Manual 430 600095 002 Rev 8 02 System Setup The minimum elements required for using the Abbott GemStar Pump are Abbott GemStar Pump Appropriate power source Appropriate Abbott GemStar Pump Set Appropriate fluid container Patient access device Air eliminating filters and extension sets may be added to the line as required by the therapy Ga Vv Note Contact an Abbott Laboratories Representative for more information on selecting the appropriate pump set configuration Setup Overview Select an appropriate power source Prime the pump set Load the cassette into the pump Select the appropriate optional system components such as a bolus cord as required EN CI GY E Selecting a Power
9. a Note If the pump is already in a single lock state the Lock Sequence Number must be entered before a second lock level can be applied Refer to Adding a Second Lock Level for more information Select the desired lock level For THERAPY NEW CONTAINER and FULL Lock go to step 5 For RATE CHANGE Lock set the minimum and maximum programmable ranges for the continuous delivery rate and bolus dose in a Pain Management program 9 Tip Press GW to toggle between the MIN and max values MIN flashes on the display Enter the minimum value MAX flashes on the display Enter the maximum value Press YES ENTER when done Repeat step 4 for bolus dose if available in the current program Enter the lock sequence number Asterisks display as the numbers are entered e For THERAPY Lock enter 0 0 0 3 1 For UNLOCKED FULL NEW CONTAINER and RATE CHANGE lock levels enter 1 3 0 0 0 a Note Default lock sequence numbers are shown Abbott GemStar Manual 430 600095 002 Rev 8 02 85 Clinician Instructions Adding a Second Lock Level Complete steps 1 and 2 for Locking the Pump Note When the pump is in a single lock state the pump displays ENTER LOCK SEQUENCE NUMBER For example ifthe pump is currently under THERAPY LOCK for Pain Management and the clinician wants to add RATE CHANGE as a second lock level the pump will request the Lock Sequence Number before RATE CHANGE lock can
10. Abbott GemStar Manual 430 600095 002 Rev 8 02 Clinician Instructions a Note If NO is pressed the pump returns to the STOP mode When START is pressed DELIVER LOADING DOSE NOW displays again Press YES ENTER to deliver the loading dose Infusion resumes automatically when the loading dose is complete Press NO to cancel the loading dose and resume infusion e Press YES ENTER to deliver the loading dose After the loading dose is complete press START to resume infusion Press NO to return to the STOP mode Press START to resume infusion Display Shift Totals Press OPTIONS and select HISTORIES Select SHIFT TOTALS from the Histories Menu The shift totals display Use the CN and W to scroll the display When done the pump END OF displays CLEAR TOTALS YES OR NO SHIFT TOTALS CLEAR TOTALS Press YES ENTER to clear the shift totals or press YES OR NO NO to exit OPTIONS without clearing the shift totals 9 Tip Press HELP to display shift totals when the pump is not in PROGRAMMING mode or an alarm condition Abbott GemStar Manual 430 600095 002 Rev 8 02 87 Notes 88 Abbott GemStar Manual 430 600095 002 Rev 8 02 Troubleshooting This section contains information on audible and visual alarms that may occur with the Abbott GemStar Pump CAUTION Ifthe pump does not perform as stated in this manual stop using it IMMEDIATELY Fo
11. CLEAR HISTORY Clear history event log and bolus CLEARING HISTORY history displays for 3 to 4 seconds BOLUS HISTORY Display bolus history in hourly increments for the last 48 hours Bolus History is available only when a bolus is programmed or has been programmed during the last 48 hours OPERATION TEST Perform user assisted Operation Display messages guide the Test user through each section of the test Current date and time Number of boluses delivered Number of bolus demands Amount delivered through bolus delivery Abbott GemStar Manual 430 600095 002 Rev 8 02 71 Options Menu Display History Shift Totals Volume Totals and VERSION N NNN Configuration S N XXXXXXXX TIME IS 09 00 AM I Note Some menu items may not be available depending on the FRI 11 JUN 99 configuration of the pump Select the number key that corresponds to the desired SEN NA function 08 15AM 11 JUN Press BACK UP when done to exit OPTIONS HISTORY CLEARED 11 00PM 10 JUN a Note For Shift Totals only the pump displays CLEAR EVENT LOG TOTALS YES OR NO Press YES ENTER to clear the PM11 18 SET ON shift totals or press NO to exit OPTIONS without AIR SENSITIVITY clearing the shift totals PM11 18 SET CONT in SIZE 100 mL 9 Tip Press and hold or W to scroll through the M ey arene history displays faster
12. Changing a Variable Time Program 22202 66 Variable Time Programming Worksheet 0 67 Options Menu 69 OVEIVISW o a a a O AA 69 Tips for Using the Options Menu mosse reses e o 69 Review Program 2 2 aa rss rss kn nt 70 HiStori suu giao P a ds ka s yee r Sonia 71 Keypad Lock se coo e ea ee A ee SS 73 Change Pump Settings 22 2 2000200004 75 Set ClOCK 2 3 er a E ee ae Heke at SE Soe we Basi eee a 77 iv Abbott GemStar Manual 430 600095 002 Rev 8 02 RART erara 2 ho ad A A A A a hoe AG 77 Speed Protocol caca rt GEK Gr a Sey ete 78 NEXEDOSE codi a A oh a SUG a A ae ek a 79 Connecting to the Data Port sosse se e e 80 Clinician Instructions 85 Clinician Locking Sequence Instructions 85 Program and Deliver a Clinician Activated Loading Dose 86 Display Shift Totals 0 a e e aa 87 Troubleshooting 89 Alarm Messages ee kne 89 Alert Messages ee o aa eri e I e 94 Other Display Messages sees rer rs sr ss ss ss 97 Maintenance 99 Pump Storage xs as o ml de nb a Be rk GEA Boe EG 99 Cleaning and Disinfecting sosse ere e e e 99 A l ae d A RN al E ce 101 Operation Test 103 Equipment Required 0 00000 eee eee 103 TeSUSe tup es oes Se Es A fig Se ALS EEA EG G 103 Performing the Operation Test some esse css 104 Print
13. PRINT BOLUS Hx Print the current program shift and volume totals and the bolus history Hx for the latest 48 hours when the current program has a bolus programmed or had a bolus programmed at one time STOP PRINT Cancel the print function This function is only available if you have selected one of the print functions above Speed Protocol Select SPEED PROTOCOL from the Options Menu Select the number key that corresponds to the desired protocol function Follow the display prompts Refer to the appropriate Speed Protocol functions for more information Select this item from the Speed Protocol Menu REVIEW PROGRAM HISTORIES KEYPAD LOCK PUMP SETTINGS SET CLOCK PRINT E N SAO 0 BB ON FF PEED PROTOCOL EXT DOSE To do this function ASSIGN Store a program in pump memory for later use REVIEW RECALL Review assigned protocols from the RUN or STOP mode Recall an assigned protocol from the STOP mode DELETE Delete protocols from pump memory 78 Abbott GemStar Manual 430 600095 002 Rev 8 02 Assign Options Menu Select ASSIGN from the Speed Protocol menu Select 1 9 to assign to the new protocol If the selected speed protocol is already assigned REPLACE PROTOCOL ASSIGNMENT displays e Press YES ENTER to replace the protocol The new speed protocol displays and the pump exits OPTIONS Press NO to keep t
14. YES ENTER to confirm Power off the pump and install two fresh disposable AA batteries to ensure backup power source NO INTERNAL BATT NO POWER LOSS ALARM AVAILABLE ENTER TO CONFIRM No disposable batteries or dead disposable batteries and external power Press YES ENTER to confirm Power off the pump and install two fresh disposable AA batteries to ensure backup power source SING BATTERIE TER TO CONFIRM Disposable batteries only Press YES ENTER to confirm If an external power source is in use ensure the connections are secure USING EXT BATT PO CONFIRM Docking station battery or battery pack and disposable batteries Press YES ENTER to confirm If an AC mains adaptor is in use ensure the connections are secure Accessing the Programming Menu After powering on the pump determines if a program is currently stored in its memory Respond to the display message as described in the following table 30 Abbott GemStar Manual 430 600095 002 Rev 8 02 Basic Operation Display Message Condition User Response No message the pump Pump memory is clear To enter a new program displays the Select a therapy from the Programming Menu Programming Menu and enter a new program Refer to the appropriate therapy section for instructions CURRENT THERAPY A program is currently To continue
15. ak programmed e e e Silence an Alarm Select a New Container Purge Change a Program Under Rate Change Lock only the delivery rate or bolus dose volume can be changed and must be within the preset values Review Recall Speed Protocol Under Therapy Lock the recalled protocol must be the same type that was programmed when the pump was locked Assign or Delete Speed Protocol Set Air Sensitivity Distal Occlusion Level Sound Level and Clock Clear Shift Totals Program and Deliver a Loading Dose Outside of Programming Mode Enter a New Program Under Therapy Lock the new program must be of the same type that was programmed when the pump was locked Piggybacking Rate Titration Operation Test Clear History Select Another Therapy 74 Abbott GemStar Manual 430 600095 002 Rev 8 02 Options Menu Change Pump Settings DI EVIEW PROGRAM ISTORIES EYPAD LOCK 1 Select PUMP SETTINGS from the Options Menu N T Select the number key that corresponds to the desired pump setting Follow the display prompts Refer to the appropriate steps of the desired pump setting for more information SET CLOCK PRINT SPEED PROTOCOL NEXT DOSE Select this item from To do this function Comments the Pump Settings Menu AIR SENSOR Change the air sensor The air alarm sounds when the pump detects sensitivity an
16. 061 y 0 5 4 E 044 o I 0 1 4 AH WAL A oo AI gb 0 1 0 10 20 30 40 50 60 70 80 90 100 110 Time minutes Actual Rate Programmed Rate PERCENT ERROR 0 1 mL 0 mm Hg Delivery Head Start Up 200 0 150 0 3 a ES S 100 0 gt i 3 50 0 S 3 o fr ya 00 gt o Le 3 gt 50 0 RRA 3 p 100 0 E 150 0 Hu 200 0 0 5 10 15 20 25 30 Observation Interval minutes Max Min lt Mean 128 Abbott GemStar Manual 430 600095 002 Rev 8 02 Abbott GemStar Pump Specifications FLOW RATE 1 mL 0 mm Hg Delivery Head Start Up 2 0 1 8 1 6 1 4 1 2 LS 1 0 BEG de L L Y D j L A LN Pd og i ri i E 06 vu 0 4 3 02 0 0 0 2 0 4 0 10 20 30 40 50 60 70 80 90 100 110 120 Time minutes Actual Rate Programmed Rate PERCENT ERROR 1 mL 0 mm Hg Delivery Head Start Up 30 0 20 0 4 10 0 0 0 se se se aa t 2 z 10 0 20 0 30 0 0 5 10 15 20 25 30 Observation Interval minutes Max m Min v Mean Abbott GemStar Manual 430 600095 002 Rev 8 02 129 Abbott GemStar Pump Specifications FLOW RATE 1 mL 0 mm Hg Delivery Head Hour 96 Rate mL hr 0 10 20 30 40 50 Time minutes Actual Rate Programmed Rate PERCENT ERROR 1 mL 0 mm Hg Delivery Head Hour 96
17. 8 02 Basic Operation Quick Start To start a therapy Determine the program settings Refer to the appropriate therapy section for a worksheet that may be copied to record the program settings Set up the pump and prime the cassette Refer to the System Setup section Power on the pump and access the Programming Menu Refer to Powering On the Pump in this section Select the therapy type and follow the display prompts to enter the program Refer to the appropriate therapy section for detailed instructions Press START to begin delivery Tip To enter a new program when the pump is already powered on 1 Press STOP to place the pump in STOP mode 2 press CHANGE to access the Change Menu and 3 select NEW PROGRAM The current program clears and the pump displays the Programming Menu Operating Tips Many of the pump s functions advance to the next step automatically when the display prompt is answered Use the number keys to enter requested values then press YES ENTER to advance to the next step The following keys are useful during programming HELP During programming and alarm conditions press HELP to display information about the current condition Otherwise press HELP to display shift totals Press the up or down arrow to scroll through long display messages A Y Press the up arrow to insert a decimal point in a numeric value CHANGE If you enter an incorrect nu
18. Abbott GemStar Primary Piggyback Pump Set with a proximal Y site backcheck valve and a secondary piggyback set with an extension hook The secondary container must be higher than the primary container Refer to the instructions included with the piggyback pump set for more information WARNING When using the pump for secondary delivery piggybacking ensure the fluids being administered are chemically and physically compatible The piggyback rate and piggyback VTBI display until the secondary container has been delivered Then the primary delivery resumes automatically Note Piggyback infusion amount is NOT added to the primary programmed infusion amount 60 Abbott GemStar Manual 430 600095 002 Rev 8 02 Continuous Preparing for Secondary Delivery Piggybacking Ensure a primary piggyback pump set with a proximal Y site backcheck valve is in place Use the extension hook from the secondary pump set to suspend the primary container from the I V pole Prepare the secondary pump set according to the instructions included with the set Attach a needle or blunt cannula if appropriate and prime the secondary pump set Suspend the secondary container from the 1 V pole a Note When using a secondary container of 500 mL or greater ensure the bottom of the secondary container is at least 7 inches 17 8 cm above the fluid level in the primary container Use additional extension hooks if neces
19. Auto KVO When the programmed VTBI has completed delivery Auto KVO delivery begins automatically and the empty container alarm sounds Note Auto KVO delivers even while the empty container alarm sounds Press SILENCE to quiet the alarm for 2 minutes If the mL hr Only rate is greater than or equal to 1 mL hr the Auto KVO delivers at 1 mL hr If the mL hr Only rate is less than 1 mL hr the Auto KVO delivers at the same rate Rate Titration a To titrate the rate while the pump is infusing In the RUN mode press the numeric keys corresponding to the new rate The rate flashes on the display Press YES ENTER For example if the current rate is 100 mL hr press 5 0 YES ENTER to change the rate to 50 mL hr Note You have approximately five seconds after pressing a key to press another numeric key the decimal key or YES ENTER If no key is pressed within five seconds the rate does not change and the delivery continues as programmed NEW RATE displays with the new value e Press YES ENTER within 10 seconds to accept the change and begin delivery at the new rate Press NO to continue delivery at the programmed rate Piggybacking a Piggybacking with the Abbott GemStar Pump requires the use of an Abbott GemStar Primary Piggyback Pump Set with a proximal Y site backcheck valve and a secondary piggyback set with an extension hook The secondary container must be higher than the primary co
20. KVO mL 9999 mL max Air Sensitivity Q On Alarms at approx 0 5 mL of air N A Q 2m1 Alarms at approx 2 mL of air Q off No alarm Maximum VTBI is 9600 mL minus any taper amount Programmable ranges for taper down are 1 minute to 3 hours OR 2 times the remaining volume divided by the continuous delivery rate whichever is less Abbott GemStar Manual 430 600095 002 Rev 8 02 57 Notes 58 Abbott GemStar Manual 430 600095 002 Rev 8 02 Continuous Therapy Features and Specifications This therapy allows programming of a continuous delivery Programming ranges are listed in the programming worksheet included in this section If a number outside of the acceptable program range is entered an error message displays the minimum or maximum value allowed Optional KVO Keep Vein Open may be set during programming The rate can be titrated while the pump is infusing An optional secondary container can be piggybacked on the primary container during regular delivery using an Abbott GemStar Piggyback Pump Set Refer to Piggybacking in this section for more information Continuous Programming EY GY EN a Select CONTINUOUS from the Programming Menu Select the unit of measure and concentration as required Enter the rate Enter the VTBI Enter the KVO rate if desired KVO runs after the programmed VTBI until the total container is infused If no KVO is desired press YES ENTER while the va
21. Press HELP to display the allowed values 2 Change the program values THIS OPTION NOT AVAILABLE WHILE PROGRAMMING THE PUMP User has attempted to access a function that is not available from the first programming display Abbott GemStar Manual 430 600095 002 Rev 8 02 1 Press YES ENTER to return to the first programming display 2 Complete programming 3 Access desired function 97 Notes 98 Abbott GemStar Manual 430 600095 002 Rev 8 02 Maintenance Pump Storage Store the Abbott GemStar Pump in a cool dry place Remove the disposable batteries and the battery pack before storing the pump Program and event history are protected in the software memory for at least one year when power is removed from the pump Cleaning and Disinfecting Establish a routine schedule for cleaning the pump to keep the case exterior cassette pocket and tubing channel free of contamination CAUTION To avoid mechanical or electronic damage do not immerse pump in any fluids or cleaning solutions Some cleaning and sanitizing compounds may slowly degrade components made from some plastic materials Do not use compounds containing combinations of isopropyl alcohol and dimethyl benzyl ammonium chloride Do not sterilize by heat steam ETO or radiation Apply disinfectants to the outside surface of the pump only Do not use abrasive cleaners or materials on the pump
22. STOP mode 9 Tip If you enter an incorrect numeric value during programming press CHANGE BEFORE pressing YES ENTER to reset the value to zero Then enter the correct value Abbott GemStar Manual 430 600095 002 Rev 8 02 31 Basic Operation Starting a New Container Ga Note The NEW CONTAINER function is not available when the pump is in FULL Lock Refer to the Options Menu section for more information on locking the keypad To repeat the current program with a new container From the STOP mode press CHANGE to access the Change Menu Select NEW CONTAINER from the Change Menu NEW CONTAINER displays for several seconds and the amount infused clears from the pump s memory MA Review the program Press START to begin delivery EN mM 32 Abbott GemStar Manual 430 600095 002 Rev 8 02 Weight Dosed Therapy Features and Specifications This therapy allows programming of delivery rate as a function of body weight Programming ranges are listed in the programming worksheet included in this section If a number outside of the acceptable program range is entered an error message displays the minimum or maximum value allowed The air sensitivity in a Weight Dosed program is automatically set to ON This setting may be changed through the Options Menu after programming is complete Refer to Air Sensitivity in the Options Menu section for more information The pump automatically d
23. Sensor Select the desired setting A DISTAL OCCLUSION MAKE XXXXX DEFAULT displays Select i YES ENTER or NO HIGH 2 MEDIUM e If NO is selected the distal occlusion setting is 3 LOW temporarily in effect until a new program is entered or the pump has been off for more than 24 hours If YES ENTER is selected the distal occlusion setting is permanent until the setting is changed again Sound Level When the Sound Level function is accessed the pump sounds intermittent beeps at the current sound level ata T The blocks on the top line of the display indicate the USE AW TO ADJUST current sound level Use to increase the sound e SOUND COPE level Use W to decrease the sound level ENTER MBEN DONE 9 Tip Press CHANGE to restore the sound level to the default setting Press YES ENTER when done 76 Abbott GemStar Manual 430 600095 002 Rev 8 02 Options Menu Set Clock Select SET CLOCK from the Options Menu REVIEW PROGRAM HISTORIES KEYPAD LOCK PUMP SETTINGS Select 12 Hour or 24 Hour format 24 Hour format is shown in example Ss W N PR ME Use the arrow keys to set the weekday and month PRINT Use the number keys to enter the current day year 7 SPEED PROTOCOL and time NEXT DOSE EN MU a Note When entering the time in 12 Hour format use Y to toggle between AM and PM SET CLOCK TYPE
24. air bubble of approximately 0 5 mL when ON or at approximately 2 mL when 2 mL is selected The air alarm does not sound if OFF is selected The air alarm may also be set during programming if the current therapy allows it Removing power has no effect on the air alarm setting OCCL SENSOR Change the distal occlusion Default Setting High sensor sensitivity The pump alarms when distal pressure is greater than the selected occlusion sensor limit SOUND LEVEL Adjust the audible alarm Default Setting Maximum level Abbott GemStar Manual 430 600095 002 Rev 8 02 75 Options Menu Air Sensitivity WARNING To reduce the risk of infusing air use an air eliminating filter when the air sensitivity is set to OFF The current air sensitivity flashes on the display ON AIR SENSITIVITY Select the desired Air Sensitivity level 1 ON If OFF is selected AIR ELIMINATING FILTER IS 2 2 mL RECOMMENDED displays 3 OFF e If ON Or 2 mLis selected CHANGE AIR ALARM FROM XXXX TO XXXX displays CHANGE AIR ALARM Select YES ENTER or NO FROM XXXX If NO is selected the air sensitivity does not ner change the current air alarm status displays and YES OR NO the pump exits OPTIONS If YES ENTER is selected the new setting is accepted the air alarm status displays for approximately 3 seconds before the pump exits OPTIONS Occlusion
25. enter the total in mL when programming a concentration press KA to move to the mL line Enter the mL value when mL flashes on the display E Select the air sensitivity E Review the program WARNING If the cassette is removed from the pump ALWAYS disconnect the pump set from the patient and purge the line before restarting therapy Bolus Delivery Bolus doses and delivery limits are set during programming The default bolus dose delivery rate in a pain management protocol is 125 mL hr A bolus cord is available for patient bolus requests refer to Connecting the Bolus Cord in the Optional System Components section for more information 38 Abbott GemStar Manual 430 600095 002 Rev 8 02 Pain Management Delivering a Bolus Dose From the RUN mode press either the bolus button on the top of the pump or the button on the end of the bolus cord to begin bolus dose delivery BOLUS DELIVERY flashes on the display and the amount infused accrues as the delivery progresses When the bolus dose is complete the following will occur The bolus request and delivery amount are recorded to the event and bolus history logs Delivered boluses are added to the total bolus amount in the program amounts The bolus lockout time is reset if applicable and subsequent bolus requests are ignored until the lockout time has elapsed Programmed infusion continues a Note ALL bolus requests are rec
26. flap D on the upper left side of the case to secure the tubing on the outside of the case Ensure the tubing exits the side of the case near the zipper tab when the zipper is closed E 6l Place the case around the waist Snap the buckle together to secure Adjust the belt for a snug comfortable fit Abbott GemStar Manual 430 600095 002 Rev 8 02 115 Optional System Components Carrying Case 500 mL List 13079 01 or 1000 mL List 13980 01 These soft sided carrying cases may be worn around the waist or over the shoulder They are designed to hold the Abbott GemStar Pump and up to a 500 mL List 13079 01 or a 1000 mL List 13980 01 flexible fluid bag Place the pump on the inside front window A Ensure the keypad is facing the window Secure the pump with the large side straps B and C Then secure the top D and bottom E straps Place the fluid bag on the backside of the compartment F 116 Abbott GemStar Manual 430 600095 002 Rev 8 02 Optional System Components Secure the bag with flaps G and H Secure the bag spike with strap I Ensure that the fluid flow is not restricted Use a figure 8 pattern to wrap the tubing Secure the tubing to the inside of the case with tabs J and K Ensure the tubing is not kinked SF EIDES Zip the case closed Ensure the tubing exits through one of the sides near the zipper tab when the case is closed Place the case around the wai
27. in this section If a number outside of the acceptable program range is entered an error message displays the minimum or maximum value allowed Optional KVO Keep Vein Open may be set during programming The pump may be disconnected from the patient between dose deliveries A call back alarm can be set to alert the patient or caregiver to reconnect the pump before the next scheduled delivery begins The pump must remain powered on for the call back alarm to function Intermittent Programming Select INTERMITTENT from the Programming Menu Enter the dose amount LL E Enter the infusion time for each dose For example press 2 0 if each dose is to deliver for 20 minutes EN Enter the frequency of dose deliveries For example press 2 0 0 to start a dose every two hours Enter the total number of doses in the container UT To determine the number of doses in the container divide the volume in the container by the dose amount 6l Enter the KVO rate KVO delivers before a delayed start time between doses and after the last dose until the total container is infused If no KVO is desired press YES ENTER while the value displayed is zero Enter the container size The pump automatically calculates the minimum container size required to deliver the number of programmed doses and KVO between doses a Note If KVO is desired before a delayed start you must increase the container siz
28. number has been altered effaced or removed THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES EXPRESS OR IMPLIED Abbott GemStar Manual 430 600095 002 Rev 8 02 137 Notes 138 Abbott GemStar Manual 430 600095 002 Rev 8 02 WARNING Federal USA law restricts this device to sale by or on the order of a physician or other licensed practitioner WARNING Possible explosion hazard exists if used in the presence of flammable anesthetics CE UL2601 1 SP NRTL C 22 2 No 601 1 Type BF IPX1 bbott Laboratories Abbott Laboratories Authorized Representative Abbott Logistics B V PO Box 365 8000 AJ Zwolle Netherlands CSA is a registered trademark of the Canadian Standards Association The use of NRTL C adjacent to the CSA mark indicates that the product has been certified by CSA to U S and Canadian standards CSA has been accredited by the U S Occupational Safety and Health Administration OSHA as a Nationally Recognized Test Laboratory NRTL Equipment providing a degree of protection higher than that for Type B equipment against electrical shock particularly regarding allowable leakage currents and having an F Type applied part Protected against dripping water Attention Consult accompanying documents Abbott GemStar and Luer Lock are trademarks of Abbott Laboratories Inc CAIR and LifeShield are registered trademarks of A Inc Super Edisonite is a reg
29. only bolus only or continuous with bolus delivery Programming ranges are listed in the programming worksheet included in this section If a number outside of the acceptable program range is entered an error message displays the minimum or maximum value allowed In Continuous Bolus protocols you may zero either the continuous rate or the bolus when entering or changing a program The continuous rate and bolus volume cannot be zero at the same time The default bolus delivery rate is 125 mL hr A loading dose may be set during programming which can be delivered after programming and priming are complete The loading dose rate is 125 mL hr Ga Note The use of a lockbox is recommended with pain management protocols Refer to Using the Abbott GemStar Lockboxes on page 106 for instructions on using a lockbox with the Abbott GemStar Pump Pain Management Programming Y O EN mI Select PAIN MANAGEMENT from the Programming Menu Select the delivery mode Note If you select Continuous Bolus you can change the continuous delivery rate or bolus amount to zero through the CHANGE menu without reprogramming the pump Select the unit of measure and concentration as required Set the continuous delivery rate Note The pump only delivers in increments of 0 1 mL Values entered in a Pain Management therapy may be rounded to the nearest 0 1 mL For example at a concentration of 15 mg mL a rate of 5 mg ro
30. response when The pump has been powered on with only disposable batteries as a power source or The pump has switched to internal power disposable batteries due to a loss of external power or a reduction in external power below acceptable levels When powering on the pump Press YES ENTER to confirm disposable batteries are the only power source When switching from AC mains Press SILENCE to clear the alarm Abbott GemStar Manual 430 600095 002 Rev 8 02 93 Troubleshooting Is the Cause Alarm Display Message _ pump Alarm Condition Remedy infusing Y Yes A Audible alarm N No V Visual alarm USING EXT BATT Y Vv This is a normal response When powering on the when pump The pump has been Press YES ENTER to powered on with confirm external battery external batteries as a power source power source or When switching from AC The pump has switched mains to external battery Press SILENCE to power due to a loss of clear the alarm AC mains or The pump has switched to external battery power while running on internal batteries Alert Messages Is the pump Cause Alert Display Message infusing Alarm RA Remedy Y Yes A Audible alarm N No V Visual alarm ALMOST EMPTY Y A V Delivery will complete Press SILENCE to in 30 minutes or less quiet the alarm for 10 For bolus only minutes program deliver
31. the Taper Up and Taper Down times if applicable Note Time is entered in hours minutes For one hour press 1 0 0 not 6 0 Enter the total time to infuse Enter the KVO rate If no KVO is desired press YES ENTER while the value displayed is zero Note KVO runs after Taper Down until the total container is infused Enter the container size VIBI KVO Note If KVO is programmed you must increase the container size to accommodate the desired KVO volume Select the air sensitivity Review the program WARNING If the cassette is removed from the pump ALWAYS disconnect the pump set from the patient and purge the line before restarting therapy Abbott GemStar Manual 430 600095 002 Rev 8 02 55 Total Parenteral Nutrition TPN Changing a TPN Program G Vv Note You cannot change a program when the pump is in FULL or NEW CONTAINER Lock Can be changed before Can be changed at any time Cannot be changed START is pressed e VTBI KVO rate Delivery mode Taper times Increase container size only Total TPN time Air sensitivity To change a program From the STOP mode press CHANGE and select 4 CHANGE PROGRAM As each program parameter displays make the desired changes or press YES ENTER to accept the current setting Review the program Press START to begin delivery TPN Auto Taper Down Auto Taper Down is only available if a Taper Down time was ente
32. the current program type of therapy stored in pump memory Press YES ENTER USE CURRENT Note A program review is required if the pump YES OR NO has been powered off for 5 or more minutes To reset the current program Press YES ENTER Press CHANGE to access the Change Menu Refer to Starting a New Container on the following page Note If the pump has been powered off for 5 or more minutes the Change Menu displays automatically To enter a new program Press NO CLEARING PROGRAM displays Select a therapy from the Programming Menu and enter a new program Refer to the appropriate therapy section for instructions Programming the Pump The pump s menu system provides step by step guidance through the programming process Refer to the appropriate therapy section for more information on programming the pump Select the desired therapy from the Programming Menu Enter the requested parameters as prompted Refer to the appropriate therapy section for a programming worksheet a Note Program parameters can be changed at any time until the Program Review is complete Press BACK UP to return to previous program displays and make changes as desired Changing some parameters may require new entries for subsequent program displays Review the program if required Press YES ENTER when done SAVING PROGRAM displays and the program is stored in the pump s memory then the pump enters the
33. to completely recharge the pack Abbott GemStar Manual 430 600095 002 Rev 8 02 111 Optional System Components Using the Abbott GemStar Lockboxes The Abbott GemStar Lockbox is an enclosure that can be locked with a key to secure the pump and a flexible container or syringe When the pump is secured in the lockbox the user has access to the AC mains connector data and bolus ports keypad and bolus button 60 mL Lockbox List 13071 01 Open the lockbox A Flip the top door up B Align the pump with the lockbox C Slide the pump down into the lockbox until fully seated Flip the top door down Connect the pump set to the syringe and prime Place the syringe inside the lockbox D Insert the cassette into the pump E KO EA ES fel KN EN es E NN Ensure the tubing will not be pinched when closing the lockbox Close and lock the lockbox Remove the key 112 Abbott GemStar Manual 430 600095 002 Rev 8 02 Optional System Components 250 mL Lockbox List 13024 01 Open the lockbox A Flip the top door up B Align the pump with the lockbox C Slide the pump down into the lockbox until fully seated Flip the top door down Connect the pump set to the bag and prime EN EI 0 FS CM GY E Place the flexible container inside the lockbox with the administrative por
34. 0 0 0 rss o 10 Warnings and Cautions seeders knr ee eee 10 System Setup 15 Setup Overview ee 15 Selecting a Power Source 2 2 a arva krakk 15 Priming an Abbott GemStar Pump Set 18 Loading the Cassette 0 nrk nrk kan 26 Releasing the Cassette ee se ses ss ss sons 21 Basic Operation 29 Quick S bana RN A Pee a a EE eee 29 Operating TIPS s a cas aa AE REG AG es da 29 Powering On the Pump 2 2 00 e 30 Accessing the Programming Menu o e soo 30 Programming the Pump e 31 Starting a New Container 2 e e e 32 Weight Dosed 33 Therapy Features and Specifications 33 Weight Dosed Programming o ses ss ses eee sa 33 AUTO KVO a o Bt ts ct tut oe Slat ti tee LLO e 34 Rate Titration 26 4 2 Secor er e a SN ERE s 34 Changing a Weight Dosed Program o o 005 35 Weight Dosed Programming Worksheet 36 Pain Management 37 Therapy Features and Specifications 37 Pain Management Programming o e e sot 37 Bolus Delivery lt os co aa da a 38 Loading Dose Delivery o o e 40 Changing a Pain Management Progam 41 Pain Management Programming Worksheet 42 Abbott GemStar Manual 430 600095 002 Rev 8 02 iii A mL hr Only 43 Therapy F
35. 0 1 1000 mg mL Q Concentration mcg mL 1 1000 mcg mL Q mL Rate 0 1 9999 mg hr 1 999900 mcg hr 0 1 1000 mL hr VTBI 0 1 99999 mg Volume To Be Infused 1 9999000 mcg 0 1 9999 mL KVO L No KVO Rate 0 0 Keep Vein Open CQ Yes KVO Rate 0 1 5 0 mL hr Container Size 0 1 99999 mg VTBI KVO 1 9999000 mcg 0 1 9999 mL Air Sensitivity Ron Alarms at approx 0 5 mL of air N A Q 2mL Alarms at approx 2 mL of air Q Off No alarm 64 Abbott GemStar Manual 430 600095 002 Rev 8 02 Variable Time Therapy Features and Specifications This therapy allows programming of multiple doses at specified times Programming ranges are listed in the programming worksheet included in this section If a number outside of the acceptable program range is entered an error message displays the minimum or maximum value allowed Optional KVO Keep Vein Open may be set during programming The default bolus delivery rate is 400 mL hr Variable Time Programming a a EN MES CM GY EN Bu Select VARIABLE TIME from the Programming Menu Select the phase type Press 1 for Percentages 2 for Rates or 3 for Doses Select the unit of delivery Change the displayed time if necessary Enter the optional base rate with start and stop time If programming in Rates or Doses go to step 7 If programming in Percentages set the daily amount Enter the phase information f
36. 02 Rev 8 02 95 Troubleshooting Alert Display Message OS Alarm et Remedy Y Yes A Audible alarm N No V Visual alarm END OF INFUSION N A V The pump has If no KVO is selected The pump delivers Laat ae em 1 Press SILENCE to KVO if selected prog P quiet the alarm for 2 minutes 2 Press STOP to place the pump in the STOP mode and clear the alarm If KVO is selected 1 The pump sounds 5 beeps approximately every 15 minutes 2 Press STOP to place the pump in STOP mode and clear the alarm FLASHING DISPLAY N A V A Non programming Follow the instructions on Line four of the Callback has occurred the display to clear the because the pump has alarm display flashes been waiting for more than three minutes for a keypress ona non programming input or a confirmation display PROGRAMMING N A V Programming has not 1 Press any key to clear INCOMPLETE been completed and no the alarm Keys have been pressed 2 Complete the program within three minutes entries START N A V A Stop Mode Callback 1 Press SILENCE to START flashes on the display Other parts of the display are not affected 96 has occurred because the programmed pump has remained in the STOP mode for more than three minutes quiet the alarm for 3 minutes 2 Follow the instructions on the display to clear the alarm Abbott GemStar Manual 430 600095 002 Rev 8 0
37. 095 002 Rev 8 02 19 System Setup Push down on the flow stop to ensure the cassette is in the closed position Insert the cassette into the cassette pocket Refer to Loading the Cassette on page 26 CAUTION When priming is complete ensure no fluid flows at the distal end of the pump set If flow is observed DO NOT use the pump set Connect the pump set to the patient access device Priming Pump Sets WITHOUT a Drip Chamber Using the PURGE Key WARNING Failure to use the anti siphon valve may result in unrestricted flow a 20 Push down on the flow stop to ensure the cassette is in the closed position Hold the flexible fluid container with the administration port pointed toward the ceiling and insert the piercing i pin Insert the cassette into the cassette pocket Refer to Loading the Cassette on page 26 Press PURGE PRIME THE SET displays Press YES ENTER While holding the flexible fluid container with the administration port pointing toward the ceiling press and hold PURGE Note Purge rate is 250 mL hr The pump purges for up to 2 minutes each time you press and hold PURGE Continue using the PURGE key until fluid fills the tubing Ensure all air is removed from the container cassette and tubing CAUTION When priming is complete ensure no fluid flows at the distal end of the pump set If flow is obser
38. 1 SELECT 12 HOUR Press YES ENTER to confirm er SURO E28 HOU 9 Tip To view the clock from the RUN or STOP mode press YES ENTER then immediately press and HOLD 1 The clock displays until 1 is released TIME IS 20 35 MON 26 JUL 99 ENTER TO CONFIRM Print REVIEW PROGRAM HISTORIES KEYPAD LOCK PUMP SETTINGS SET CLOCK WARNING Disconnect the pump from the patient BEFORE connecting the pump to a printer or computer a ON BF a Note Ensure the printer is connected to the pump BEFORE selecting a print function Refer to Connecting to a Printer in this section for more information SPEED PROTOCOL NEXT DOSE Select PRINT from the Options Menu Select the number key that corresponds to the desired print function When the print transmission is complete the pump exits OPTIONS Abbott GemStar Manual 430 600095 002 Rev 8 02 77 Options Menu Select this item from the Print Menu To do this function PRINT HISTORY Print the current program shift and volume totals and history event log up to the most recent 400 events since the history was last cleared PRINT PROGRAM Print the current program PRINT PROTOCOL Print a specified speed protocol or a complete list of all speed protocols If a protocol is not assigned NOT ASSIGNED prints next to that protocol number
39. 2 Troubleshooting Other Display Messages Other Display Message Cause Condition Remedy KEYPAD LOCKED User has attempted to perform a Unlock the keypad to function that has been locked out access the desired function NOT ALLOWED DURING INFUSION PRESS STOP TO HALT DELIVERY User has attempted to perform a function that is not available in RUN mode Press STOP to access the desired function Press YES ENTER to return to the RUN mode display ROUNDING The pump sounds four quick beeps and displays the rounded number The pump has rounded a number that was entered during programming Press YES ENTER to accept the rounded value and continue to the next step DOSE IN PROGRESS NEW CONTAINER NOT ALLOWED User has attempted to access NEW CONTAINER function when it is not allowed Press STOP to stop delivery then access NEW CONTAINER through the Change Menu CANNOT CHANGE CLOCK WHILE TIME BASED DELIVERY IS IN PROGRESS User has attempted to change the clock during a time based delivery 1 Press STOP 2 Clear the program through the Change Menu 3 Change the clock through the Options Menu 4 Reprogram the pump PROGRAM EXCEEDS AX CONTAINER SIZE CHANGE PROGRAM VALUES The VTBI KVO volume resulted in a container size greater than the allowed value 1
40. Connect the pump to power failure due to one AC mains adaptor of the following rechargeable battery Batteries have been pack OR replace both removed while the disposable batteries pump was on battery with fresh AA batteries source 2 Power on the pump External power has Review the program if failed or has been required disconnected and no 3 Press START to begin batteries are installed delivery Pump has been powered on with insufficient power source 92 Abbott GemStar Manual 430 600095 002 Rev 8 02 Troubleshooting Alarm Display Message Is the pump infusing Alarm Cause Condition Remedy Y Yes N No A Audible alarm V Visual alarm PROX OCCLUSION The pump has detected sustained negative pressure on its proximal side 1 Press SILENCE to quiet the alarm for 1 minute 2 Press STOP to place the pump in the stop mode 3 Check for sources of proximal occlusion gt Kinked tubing above pump gt Blockage in the bag and in the spike gt Empty bag gt High torque syringe gt Other obstructions 4 Ifthe problem persists clamp the distal line and reinstall the cassette Refer to Loading the Cassette in the System Setup section If the alarm still persists power off the pump Clamp the distal line then power on the pump 5 Press START to begin delivery USING BATTERIES This is a normal
41. NEXT DOSE Therapy Lock T Rate Change Lock R 1 THERAPY LOCK New Container Lock N 2 RATE CHANGE Full Lock F 3 NEW CONTAINER 4 FULL LOCK The Abbott GemStar Pump allows two lock levels to be applied at the same time Therapy Lock may be used with either Full Lock New Container Lock or Rate Change Lock When two lock levels are applied if a function is available under one lock level but not the other the more stringent restrictions apply When the pump is locked under a particular level a small lock symbol MM appears next to the applied lock level as shown above When the pump is in RUN or STOP mode the lock symbol appears in the lower left corner of the display and the lock level abbreviation appears in the lower right corner The table on the following page lists the functions available for each lock level Refer to Clinician Instructions on page 85 for detailed instructions Abbott GemStar Manual 430 600095 002 Rev 8 02 73 Options Menu Abbott GemStar Keypad Lock Level Functions U Unlock T Therapy Lock R Rate Change Lock N New Container Lock F Full Lock Function is Available Function R N F Comments Lock Unlock Keypad e e e Rate Change Lock is available only if the current program is Pain Management Power Pump On or Off ke Start or Stop Infusion Se le Access Display Help Print and Program elele Review Functions Deliver a Bolus 21218
42. ONS Select HISTORIES from the Options Menu Select OPERATION TEST from the Histories Menu Follow the instructions on the display The pump provides step by step guidance through each section of the test Abbott GemStar Manual 430 600095 002 Rev 8 02 103 Operation Test Performing the Operation Test 9 Tip The checklist at the end of this section may be copied to record test results Case Inspection Visually inspect the case and keypad for damage Check the case for missing screws or labels Enter the results Ifthe pump is free of damage and all the screws and labels are in place press YES ENTER If damage is found on the case or keypad or any screws or labels are missing press NO Cassette Pocket and Latch Inspection BY EN CI CI EN KN Visually inspect the cassette pocket and the sensors A Verify that they are free of dirt and residue Verify that the four cassette latches B are present Verify that they open and close when the cassette release button is pressed Verify that the plunger seal C and sensor seals D are present and intact Verify that the plunger E is not scraped or damaged Verify that the sensor pins F are not damaged Install the cassette Verify that the cassette fits smoothly and securely Enter the results Ifthe cassette pocket area and latches are free of damage and ALL of the above steps are verified press YES ENTER e If damage is found
43. OPTIONS e Provides access to these menu items from the STOP or RUN mode 1 Review Program 5 Set Clock 2 Histories 6 Print 3 Keypad Lock 7 Speed Protocol 4 Pump Settings 8 Next Dose Scrolls through display messages UP arrow enters a decimal point in numeric entries Responds YES to display questions Accepts entries and advances to the next step 2 NO Responds NO to display questions 3 HELP Provides context sensitive information during programming steps and alarm conditions Otherwise displays Shift Totals 4 PURGE e Clears an AIR IN LINE alarm Primes an Abbott GemStar Pump Set Not all menu items are available with all modes Refer to the appropriate section for more information Abbott GemStar Manual 430 600095 002 Rev 8 02 3 Introduction Bolus Button Pole Clamp Track Cassette Release Button Power Connector Data Port Connector Bolus Connector Tubing Channel Cassette Pocket Battery Pack Connector Battery Compartment Abbott GemStar Pump Components Press this button to initiate a bolus delivery if available in the current program Top View Use to connect to an optional pole clamp Push down on this button to release the cassette from the pump Use to connect AC mains adaptor to the pump Use to connect a printer or computer to the pump Use to connect a bolus cord to the pump Align pump set tubing in
44. Setup Priming Pump Sets WITH a Drip Chamber Using the PURGE Key ALWAYS set the Air Sensitivity to either ON or 2mL when WARNING Failure to use the anti siphon valve may result in unrestricted flow using vented drip chambers UT Y O CY EN OM Push down on the flow stop is in the open priming position Close the CAIRQ roller clamp to ensure the cassette Insert the piercing pin into the container Suspend the container on an 1 V Pole Squeeze the drip chamber until filled halfway Open the CAIRO roller clamp Insert the cassette into the cassette pocket Refer to Loading the Cassette on page 26 Press PURGE PRIME THE S ET displays Press YES ENTER Press and hold PURGE Note Purge rate is 250 mL hr The pump purges for up to 2 minutes each time you press and hold PURGE Continue using the PURGE key until fluid fills the tubing Ensure all air is removed from the container cassette and tubing CAUTION When priming is complete ensure no fluid flows at the distal end of the pump set If flow is observed DO NOT use the pump set Connect the pump set to the patient access device Abbott GemStar Manual 430 600095 002 Rev 8 02 S stem Setup Priming Pump Sets with Extensions WARNING Failure to use the anti siphon valve may result in unrestricted flow Push do
45. Source The Abbott GemStar Pump may be powered by one or more of the following Abbott GemStar AC Mains Adaptor Abbott GemStar Battery Pack Two disposable AA batteries Abbott GemStar Manual 430 600095 002 Rev 8 02 15 System Setup CAUTION To ensure proper pump operation ALWAYS replace BOTH batteries with fresh disposable AA batteries when a change is required Use of rechargeable batteries in the battery compartment is NOT recommended Installing disposable batteries is recommended regardless of the power source used to provide continuing operation if the external power source fails Installing Disposable Batteries Flip up the tab of the battery door A on the bottom of the pump While holding onto the tab turn the battery door counterclockwise B until it is released from the battery compartment Pull the door free C and remove any existing batteries Install two fresh disposable AA batteries into the battery compartment Ensure the negative and positive battery terminals are inserted according to the diagram at right Return the battery door to the battery compartment D Turn the battery door clockwise E Ensure the battery door is secured under the slot Snap the tab down to lock the battery door in place F 16 Abbott GemStar Manual 430 600095 002 Rev 8 02 System Setup Connecting the Rechargeable Battery Pack To connect the battery pack Align the connectors on
46. Using abrasive cleaners or cleaning solutions not recommended by Abbott Laboratories may result in product damage To avoid pump damage cleaning solutions should be used only as directed in the table on the following page The disinfecting properties of cleaning solutions vary consult the manufacturer for specific information Never use sharp objects such as pens pencils fingernails paper clips needles etc to clean the pump Abbott GemStar Manual 430 600095 002 Rev 8 02 99 Maintenance Recommended Cleaning Solutions The pump is not adversely affected by the recommended cleaning solutions in the table below Ga Note NOT all cleaning solutions are disinfectants Check product labeling Cleaning Solution Manufacturer Preparation Super Edisonite S M Edison Per manufacturer s recommendation Chemical Co Vesphene II se Calgon Vestal Per manufacturer s recommendation Laboratories Manu Klenz Calgon Vestal Per manufacturer s recommendation Laboratories Formula C Diversey Corp Per manufacturer s recommendation Household bleach Various Per healthcare facility procedures DO NOT exceed one part bleach in ten parts water Cleaning the Pump Case Power off the pump LN Disconnect the pump from AC mains power 05 Clean the exposed surfaces of the pump with a soft lint free cloth dampened with the appropriate cleaning solution Wipe the solution from the pump surface with a w
47. all times Failure to observe a warning message is potentially life threatening CAUTION A CAUTION usually appears in front of a procedure or statement It contains information that could prevent irreversible product damage or hardware failure Neglecting to pay attention to a caution could result in serious patient or user injury Note A NOTE provides information to help clarify a procedure or statement Tip A TIP emphasizes a procedure or statement that makes the pump easier to use Abbott GemStar Manual 430 600095 002 Rev 8 02 1 Introduction Abbott GemStar Pump Layout BO08600600809 0000 O 2 Abbott GemStar Manual 430 600095 002 Rev 8 02 Introduction 1 DISPLAY Four line display indicates the pump s status 2 SILENCE Temporarily silences alarm 3 STOP Stops infusion 4 START Starts infusion 5 POWER INDICATOR Indicates the pump is powered by AC mains when lit continuously Indicates the pump is powered by external batteries when flashing 6 O Powers the pump on or off 7 BACK UP Provides access to previous steps during programming Exits Help Change and Options menus 8 CHANGE Provides access to these menu items from the STOP or RUN mode 1 Review Resume 4 Change Program 2 New Container 5 Piggybacking 3 New Program Corrects an entry during a programming step 9
48. ater moistened lint free cloth Pi ES Use a dry lint free cloth to dry the pump after cleaning 100 Abbott GemStar Manual 430 600095 002 Rev 8 02 Maintenance Cleaning the Cassette Pocket and Tubing Channel The area containing the ultrasonic sensors located in the cassette pocket should be cleaned on a regular basis CAUTION Use care not to damage the silicone seals around the sensor bodies Remove the cassette if installed Use a cotton swab moistened with an approved cleaning solution to clean the sensor faces A tubing channel B plunger tip C and sensor pins D Dry the sensor faces and tubing channel and ensure that the sensor faces are free of detergent film and or debris Repair The Abbott GemStar Pump has no user serviceable components with the exception of disposable batteries Ifthe display clock stops working contact Abbott Laboratories Customer Support to arrange for lithium battery replacement Homecare Customers Call your healthcare professional or homecare company regarding any required service or repairs DO NOT attempt to repair the pump for any reason The Abbott GemStar Pump is covered by a manufacturer s warranty for one year after purchase During this time opening the pump case for any reason voids this warranty Refer to the Warranty section for details Refer all service to Abbott certified technicians only An Abbott GemStar Techn
49. backing Ga x Note To distinguish the piggyback delivery from the primary delivery PLGGYBACK displays and the piggyback VTBI counts down to completion For example a piggyback rate of 250 mL hr with a remaining VTBI of 218 5 mL will display as shown 9 Tip Prepare and set up containers BEFORE programming the pump for piggyback delivery Enter the dose amount for the secondary container Enter the infusion time for the secondary container AS GY E Press YES ENTER to begin piggyback delivery a RATE VTBI PIGGYBACK 250 0 mL hr 218 5 mL gt gt gt gt p gt Press CHANGE and select 5 PIGGYBACKING from the Change Menu Open the slide clamp or CAIR roller clamp on the tubing of the secondary set Note Primary flow stops until the secondary VTBI is delivered then primary flow automatically resumes Any remaining secondary fluid will be delivered at the primary rate The maximum piggyback rate is 300 mL hr For secondary rates above 300 mL hr flow may occur from the primary container Changing a Piggyback Delivery Press CHANGE to reset the dose amount to zero Set the infusion time for the secondary container Press YES ENTER to begin piggyback delivery SS GY E a amount is changed the pump begins a new VTBI countdown Canceling a Piggyback Delivery Enter the new piggyback dose amount and press YES ENTER Press CHANGE and select 5 PIGGYBACKING from the Change M
50. be added Enter the Lock Sequence Number Complete steps 4 and 5 for Locking the Pump Note When two lock levels are applied ifa function is available under one lock level but not the other the more stringent restrictions apply Unlocking the Pump Select the locked level from the Keypad Lock Menu Enter the lock sequence number for that level Note If the pump is locked under two levels each level must be unlocked separately Unlocking one level has no effect on the other level For example if both THERAPY and RATE CHANGE lock levels are applied the clinician must unlock both the RATE CHANGE and THERAPY locks The pump displays the current lock levels Press YES ENTER to return to the mode the pump was in when the Options Menu was selected Program and Deliver a Clinician Activated Loading Dose This feature is available only when the keypad is UNLOCKED or when THERAPY is the only lock level The loading dose rate is 125 mL hr EY GY CN a 86 From the STOP mode press YES ENTER immediately followed by 0 PROGRAM A LOADING DOSE displays Press YES ENTER to continue Enter the loading dose Press YES ENTER when done DELIVER THE LOADING DOSE NOW displays Note If YES ENTER is pressed infusion DOES NOT begin automatically when the clinician activated loading dose is complete Press START to resume infusion after the loading dose is complete
51. c or not stable under infusion conditions should not be used with this system Warnings and Cautions The following is a list of warnings and cautions that should be heeded when operating the Abbott GemStar Pump Elsewhere in this manual warnings and cautions that are relevant to the procedure being discussed are repeated Pay attention to all alert messages General Cautions Federal USA law restricts this device to sale by or on the order of a physician or other licensed practitioner Manual references to specific values are approximate only unless indicated otherwise Air in line sensitivity values are approximate only Disconnect the pump from the patient BEFORE connecting the pump to a computer or printer For those patients who are likely to be adversely affected by unintended operations and failures including interrupted medication or fluid delivery from the device close supervision and provision for immediate corrective action should be provided 10 Abbott GemStar Manual 430 600095 002 Rev 8 02 Introduction Regarding Drugs Used Pump Sets and Containers USE ONLY Abbott GemStar Pump Sets with the Abbott GemStar Pump Use of unauthorized sets may result in injury to the patient or damage to the pump NEVER use drugs that are incompatible with silicone rubber or PVC plastic To reduce the loss of potency for drugs known to be absorbed by PVC plastic and silicone begin infusion as soon as practica
52. e and visual alarms when Refer to the Troubleshooting Alarms attention is required section Audible Keypad Sounds a single beep when any key is Refer to Abbott GemStar Pump Response pressed If an invalid key is pressed the Layout in this section for keypad pump sounds a flutter tone information Keypad Lock Restricts access to various options Four lock Refer to the Options Menu and levels are available Clinician Instructions sections New Container Repeats the current program without Refer to the Basic Operation reprogramming the pump section e Piggybacking Allows delivery from a secondary container Refer to the appropriate therapy during a Continuous or mL hr Only program section Power on Performs a self test each time the pump is Refer to the Basic Operation Self test powered on section Operation Test Performs user assisted tests to verify the pump is functioning properly Refer to the Operation Test section Program Maintains a history event log with a date Refer to the Options Menu History and time stamp of each event for each section program Review the history on the display or download it to a printer or computer Speed Protocols Stores up to nine frequently used programs Refer to the Options Menu in the pump s memory for quick access section 6 Abbott GemStar Manual 430 600095 002 Rev 8 02 Menu System Introduction The Abbott GemStar Pum
53. e between doses Start Time Q Start immediately after programming Q Start time Specify AM or PM if not 24 hour clock 12 00 AM 11 59 PM or 00 00 23 59 The pump automatically calculates the minimum container size required to deliver the number of programmed doses and KVO between doses If KVO is desired before a delayed start you must increase the container size to accommodate the desired KVO volume 54 Abbott GemStar Manual 430 600095 002 Rev 8 02 Total Parenteral Nutrition TPN Therapy Features and Specifications This therapy allows programming of Total Parenteral Nutrition TPN protocols Programming ranges are listed in the programming worksheet included in this section If a number outside of the acceptable program range is entered an error message displays the minimum or maximum value allowed Taper Up and Taper Down may be programmed to gradually increase and decrease the rate of delivery at the beginning and end of a therapy If Taper Down is selected during programming the pump allows auto tapering if the continuous delivery is stopped before the programmed volume has completed delivery Optional KVO Keep Vein Open may be set during programming TPN Programming a a a EN MY EA Fol ill Select TPN from the Programming Menu Select the TPN delivery mode Enter the total VTBI Volume To Be Infused Maximum VTBI is 9600 mL minus any taper amount Enter
54. e display prompts for the selected function Refer to the appropriate Options Menu function description in this section for more information Ga Note Menu selections may vary depending on the configuration of the pump Some Options Menu functions are not available in all modes REVIEW PROGRAM HISTORIES KEYPAD LOCK PUMP SETTINGS SET CLOCK PRINT SPEED PROTOCOL EXT DOSE 0 JJ Dn USS WY PR Tips for Using the Options Menu The following keys are helpful when using the Options Menu 1 8 Press the corresponding number key to select a menu function YES ENTER Press YES ENTER to accept changes or to continue when done viewing a display A Y Press the up or down arrow to scroll through long display messages BACK UP Press BACK UP to return to a previous display or to exit OPTIONS Tip A menu item does not have to be on the display to be selected For example only items 1 through 4 display when the Options Menu is first accessed To select the Print Menu without scrolling the display press 6 Note When the pump exits OPTIONS the display returns to the mode the pump was in when the Options Menu was accessed Abbott GemStar Manual 430 600095 002 Rev 8 02 69 Options Menu Select this item from the Options Menu To do this function Comments 400 events shift or volume totals bolus history if available or current configuration settings Clea
55. e pump advances to the next test Ifthe test is failed clean the sensors and press IZ to rerun the test or press YES ENTER to confirm failure Note Clean the sensor pins before repeating the proximal occlusion test Refer to the Maintenance section for instructions 106 Abbott GemStar Manual 430 600095 002 Rev 8 02 Operation Test Air in line Test The air in line alarm should occur within approximately 1 minute to pass this test Release the clamp Remove the proximal end of the pump set from the reservoir Press PI Press START The test result displays Press PF Ifthe test is passed the pump advances to the next test EN MM GY E If the test is failed clean the sensors and press AQ to rerun the test or press YES ENTER to confirm failure Ga Note Clean the sensor faces before repeating the air in line test Refer to the Maintenance section for instructions Printing Test Results KKEKKKKKKKKKKKKKKKKKKKKKKKAKKKKKKKKKKKK KKK ABBOTT GemStar When the test is complete the OPERATION TEST pump displays an option to RESULTS print the test results If desired ee ee OK ORK eee ee ee K k k k KOKK KK KK KK KK follow the steps below to print the test results An example of PUMP SERIAL NUMBER XXXXXXXXX the printed test results is shown 10 45AM 4 JUL 99 KN a VERSION n n n Note For maximum battery life the pump should be operated on 1 Case Inspection PASS AC mains whe
56. e to accommodate the desired KVO volume E Select the air sensitivity Abbott GemStar Manual 430 600095 002 Rev 8 02 49 Intermittent a E SET CALL BACK ALARM FOR NEXT DOSE displays The pump may be disconnected from the patient between dose deliveries The call back alarm can be set to alert the patient or caregiver to reconnect the pump before the next scheduled delivery begins At the set time before each dose the alarm sounds START flashes on the display and the alarm LED flashes Press SILENCE to silence the alarm for three minutes Then reconnect the pump to the patient For example press 1 0 to set the alarm to sound 10 minutes before the start of the next scheduled delivery When programming the call back alarm be sure to allow enough time for the patient or caregiver to reconnect the pump to the patient and to press START BEFORE the scheduled dose start time Press YES ENTER to set the call back alarm e Press NO if you do not want to set the call back alarm Note The call back alarm works only when the pump is powered on AND in the STOP mode DO NOT power off the pump while it is disconnected from the patient if you have set the call back alarm Y Confirm the displayed time is correct Press OPTIONS to change the clock if required Bl The current time and START NOW displays e Press YES ENTER to begin delivery when the pump enters the RUN mode Press NO to set a de
57. eatures and Specifications s ooo 43 mL hr Only Programming aaa a 43 AUOKVO Elia e A a e prii ee ee 43 Rate Titration Zu de a B AE de E Sed fed al EOE GS ew eae 44 Piggybackingi s ond a gr eee SM et ee ee Ee ee AE dn a 44 Changing a mL hr Only Program 2 2 ee e o 47 mL hr Only Programming Worksheet 48 Intermittent 49 Therapy Features and Specifications sosse ss 49 Intermittent Programming e 49 Intermittent Delivery Interruptions ooo a a 51 Changing an Intermittent Program Lava va vr rv a 53 Intermittent Programming Worksheet 25 54 Total Parenteral Nutrition TPN 55 Therapy Features and Specifications 55 TPN Programming 2 vara ee ere ee 55 Changing a TPN Program sees ere akan 56 TPN Auto Taper DOWN akan nn 56 TPN Programming Worksheet 2 2 rav vrak rakk 57 Continuous 59 Therapy Features and Specifications 59 Continuous Programming 0 kr ee tee 59 Rate Titration oa a ce de ae Sed ea dd 60 PiggybackinG sf lt a cos is alae es e e ae ees 60 Changing a Continuous Progam o e o o 63 Continuous Programming Worksheet 0 64 Variable Time 65 Therapy Features and Specifications 65 Variable Time Programming ooa 0022 eee 65 Variable Time Delivery Interruptions 2 66
58. ed route the tubing through the loops on the bottom of the carrying case Ensure the tubing is not kinked N Adjust the shoulder straps and waist belt for a snug comfortable fit Tip When not using the waist belt secure it under the large flap on the back of the case 118 Abbott GemStar Manual 430 600095 002 Rev 8 02 Optional System Components Using the Abbott GemStar Docking Station List 13075 01 Connecting the Pump Mount the docking station to the I V pole and tighten the knob Align the connectors on the bottom of the pump with the connectors on the docking station Slide the pump into the docking station until it snaps into place A Connect the docking station to AC mains power The docking station light illuminates yellow while the docking station is charging When the docking station is fully charged the light illuminates green Connecting the Bolus Cord and Printer Cable WARNING Disconnect the pump from the patient BEFORE connecting the pump to a printer or computer Plug the bolus cord B into the bolus port on the rear right side ofthe docking station G POS Plug the printer cable C into the printer port on the rear a right side ofthe docking station o E Abbott GemStar Manual 430 600095 002 Rev 8 02 119 Optional System Components Disconnecting the Pump To remove the pump press the release b
59. elivers KVO Keep Vein Open after the programmed VTBI Volume To Be Infused has completed The rate can be titrated while the pump is infusing WARNING ALWAYS set the Air Sensitivity to either ON or 2mL when using vented drip chambers Weight Dosed Programming a EN rol Select WEIGHT DOSED from the Programming Menu Select the unit of measure Enter the patient weight if required Note Total concentration is ALWAYS entered as mg in mL even if mcg is the selected unit of measure Enter the concentration as mg in mL Tip Use SW to toggle between mL and mg Enter the value in mg when mg flashes on the display Enter the value in mL when mL flashes on the display Press YES ENTER to confirm Enter the rate The pump automatically displays the mL hr equivalent even when another unit of measure is selected Enter the VTBI Review the program Abbott GemStar Manual 430 600095 002 Rev 8 02 33 Weight Dosed WARNING If the cassette is removed from the pump ALWAYS disconnect the pump set from the patient and purge the line before restarting therapy Auto KVO When the programmed VTBI has completed delivery Auto KVO delivery begins automatically and the empty container alarm sounds Ga x Note Auto KVO delivers even while the empty container alarm sounds Press SILENCE to quiet the alarm for 2 minutes If the weight dosed rate is greater tha
60. entages 0 1 100 O Rates 0 1 400 mL hr 0 1 9600 mL U Doses Unit of Measure Q Concentration mg mL 0 1 1000 mg mL Q Concentration mcg mL 1 1000 mcg mL Q mL Current Time Confirm or correct current time 12 00 AM 11 59 PM or 00 00 23 59 Base Rate U No O Yes Start time 12 00 AM 11 59 PM or 00 00 23 59 Stop time 0 1 400 mL hr Rate Total Daily Amount for All Phases required only when programming in percentages SEE ATTACHED WORKSHEET Bolus Dose 0 1 mL 25 0 mL 0 1 mg 2500 mg 1 mcg 25000 mcg Bolus Lockout minutes 5 999 min KVO I No KVO Rate 0 0 Keep Vein Open O Yes KVO Rate 0 0 5 0 mL hr Container Size 0 1 99999 mg Total Daily Amount X Number of Days 1 9999000 mcg of Therapy 0 1 9999 mL Air Sensitivity O On Alarms at approx 0 5 mL of air N A Q 2m1 Alarms at approx 2 mL of air Q Off No alarm Sum of all phases must equal 100 when programmed in percentages Abbott GemStar Manual 430 600095 002 Rev 8 02 67 Variable Time Start Time Stop Time Percentage Note The sum of all phases must equal 100 when programmed in percentages 68 Abbott GemStar Manual 430 600095 002 Rev 8 02 Options Menu Overview Press OPTIONS from the RUN or STOP mode Select the number key that corresponds to the desired function Follow th
61. enu Note You must know the amount that has already been delivered When the piggyback dose Press CHANGE and select 5 PIGGYBACKING from the Change Menu Press CHANGE to reset the dose amount to zero Press YES ENTER to cancel piggyback delivery 46 Abbott GemStar Manual 430 600095 002 Rev 8 02 mL hr Only Changing a mL hr Only Program Y Note You cannot change a program when the pump is in FULL or NEW CONTAINER Lock Can be changed at any time Delivery rate Container size Piggybacking To change a program From the STOP mode press CHANGE and select 4 CHANGE PROGRAM As each program parameter displays make the desired changes or press YES ENTER to accept the current setting Press START to begin delivery a Note A program review is not required and is only available through the Change or Options Menu Abbott GemStar Manual 430 600095 002 Rev 8 02 47 mL hr Only Abbott GemStar mL hr Only Programming Worksheet GIVE Parameter Selections and or Values to be Programmable Ranges Entered Therapy mL hr Only N A Rate 0 1 1000 mL hr VTBI Volume To Be Infused 0 1 9999 mL 48 Abbott GemStar Manual 430 600095 002 Rev 8 02 Intermittent a Therapy Features and Specifications This therapy allows programming of multiple doses at regular intervals Programming ranges are listed in the programming worksheet included
62. ette is removed from the pump ALWAYS disconnect the pump set from the patient and purge the line before restarting therapy Regarding Air In Line and Infusion To reduce the risk of infusing air use an air eliminating filter when the air sensitivity is set to OFF ALWAYS remove all air from the cassette tubing and injection site prior to connecting to the patient ALWAYS disconnect the pump set from the patient prior to priming or purging ALWAYS set the Air Sensitivity to either ON or 2mL when using vented drip chambers Abbott GemStar Manual 430 600095 002 Rev 8 02 11 Introduction Regarding Pump Operation If the pump does not perform as stated in this manual remove the pump from service IMMEDIATELY ALWAYS connect to a grounded AC mains power source when using AC mains power If the quality of the grounding source is in doubt operate the pump only with batteries USE ONLY the AC mains adaptors specifically labeled for use with the Abbott GemStar Pump Installing disposable batteries is recommended regardless of the power source used to provide continuing operation if the external power source fails ALWAYS replace BOTH batteries with new batteries when a change is required The use of rechargeable batteries in the battery compartment is NOT recommended ALWAYS avoid sources of high intensity electromagnetic radiation e g radio transmitters MRI scanners microwave ovens X ray machines and CAT scanner
63. gram Refer to Accessing the Programming Menu in the Basic Operation section for more information CHECK CASSETTE X N A V The cassette is improperly 1 Press SILENCE to installed or not installed quiet the alarm for 1 X indicates where to look minute for the cause of the alarm 2 Press STOP to place A Air Sensor the pump in the STOP D Distal mode P Proximal 3 Reinstall the cassette 4 Press START to begin delivery CALL N A V The pump has detected a 1 Write down the codes 1 800 XXX XXXX condition that may require and telephone number service 2 Power offthe pump If CODE NN MMM TTT the pump does not power off disconnect external power and remove the batteries 3 Call the telephone number shown on the display message Cause Condition Remedy 90 Abbott GemStar Manual 430 600095 002 Rev 8 02 Troubleshooting sustained distal pressure over the user selected limit To avoid a bolus infusion after an occlusion refer to page 126 Is the Cause Alarm Display Message _ pump Alarm REO Remedy infusing Y Yes A Audible alarm N No V Visual alarm DIST OCCLUSION N A V The pump has detected Press SILENCE to quiet the alarm for 1 minute Press STOP to place the pump in the stop mode Check for sources of distal occlusion gt Kinked tubing below the pump gt Clamped pa
64. he existing protocol and exit OPTIONS Review Recall SS Oo CN Delete Select REVIEW RECALL from the Speed Protocol menu Select the desired protocol to review recall Review the program Press YES ENTER Ifin the STOP mode select 1 to recall the protocol or select 2 to review another protocol e Ifin the RUN mode the pump exits OPTIONS Select DELE H E from the Speed Protocol Menu Select the desired protocol to delete Press YES ENTER to confirm deletion or NO to exit OPTIONS without deleting Next Dose This function is only available when the current therapy Tr REVIEW PROGRAM is Intermittent and the pump is not delivering a dose 2 HISTORIES 3 KEYPAD LOCK To set the time for the next dose pe SETTINGS Select NEXT DOSE from the Options Menu 5 SET CLOCK Use the number keys to enter the start time for the 6 PRINT next dose Press YES ENTER when done to 7 SPEED PROTOCOL 8 accept the change and exit OPTIONS NEXT DOSE Tip Use amp W to toggle between AM and PM Abbott GemStar Manual 430 600095 002 Rev 8 02 79 Options Menu Connecting to the Data Port The Data Port may be used to connect the Abbott GemStar Pump to a Seiko DPU 414 or compatible serial printer to print the Operation Test results or the files available from the Print Menu Using communication software included with most computer operating systems or available from
65. he secondary container Press YES ENTER to begin piggyback delivery SS GY E a Note You must know the amount that has already been delivered When the piggyback dose amount is changed the pump begins a new VTBI countdown Canceling a Piggyback Delivery Press CHANGE and select 5 PIGGYBACKING from the Change Menu Press CHANGE to reset the dose amount to zero Press YES ENTER to cancel piggyback delivery 62 Abbott GemStar Manual 430 600095 002 Rev 8 02 Continuous A Changing a Continuous Program Ga Note You cannot change a program when the pump is in FULL or NEW CONTAINER Lock Can be changed at any time Cannot be changed Delivery rate Container size Unit of measure e VTBI Air sensitivity Concentration KVO rate Piggybacking To change a program From the STOP mode press CHANGE and select 4 CHANGE PROGRAM As each program parameter displays make the desired changes or press YES ENTER to accept the current setting MA Review the program Press START to begin delivery EN mM Abbott GemStar Manual 430 600095 002 Rev 8 02 63 Continuous A TM i Abbott GemStar Continuous Programming Worksheet GIVE Parameter Selections and or Values to be Programmable Ranges Entered Therapy Continuous N A Unit of Measure L Concentration mg mL
66. ical Field Service Manual is available to Abbott certified technicians Abbott GemStar Manual 430 600095 002 Rev 8 02 101 Notes 102 Abbott GemStar Manual 430 600095 002 Rev 8 02 Operation Test N This test is designed to ensure your Abbott GemStar Pump is operating properly Abbott Laboratories recommends performing this test a minimum of once every 12 months Refer to facility requirements to determine additional testing needs The test can be performed when the pump is in the STOP mode and requires approximately 15 minutes to complete Each section of the test must be run in sequence The pump automatically sets the delivery rate when required during the Operation Test Note This test is only available when the pump is UNLOCKED WARNING Disconnect the pump from the patient BEFORE performing the Operation Test Equipment Required gt Abbott GemStar Pump Two Abbott GemStar Microbore Pump Sets without a filter Reservoir with at least 50 mL of water 20 mL or larger graduated cylinder graduated in 0 1 mL Two fresh disposable AA batteries Appropriate Abbott GemStar AC Mains Adaptor or other Abbott approved external power source Test Setup Note The pump clears any program and shift totals stored in pump memory before starting the Operation Test DOES MA A E Connect the external power source and install two fresh disposable AA batteries Power on the pump Press OPTI
67. id flows at the distal end of the pump set If flow is observed DO NOT use the pump set If extension set has a Y extension prime it if needed Connect the pump set to the patient access device Abbott GemStar Manual 430 600095 002 Rev 8 02 25 System Setup Loading the Cassette Align the cassette as shown Insert the cassette into the cassette pocket Push the cassette into the pocket until it is firmly seated When properly installed the cassette cannot be removed from the pocket unless the cassette release button is pushed CAUTION Ensure the cassette is properly installed Align the tubing in the tubing channel CAUTION Before connecting to the patient access device ensure no fluid flows at the distal end of the pump set while the pump is in the STOP mode If flow is observed DO NOT use the pump set Connect the pump set to the patient access device 26 Abbott GemStar Manual 430 600095 002 Rev 8 02 System Setup Releasing the Cassette Close the slide clamp or CAIR roller clamp on the distal line A Push down on the cassette release button on the top of the pump Remove the cassette a Note When the cassette is released from the pump the cassette flow stop automatically reverts to the closed position preventing free flow Abbott GemStar Manual 430 600095 002 Rev 8 02 27 Notes 28 Abbott GemStar Manual 430 600095 002 Rev
68. ing Test Results sosse esse 000002 eee eee 107 Operation Test Checklist soo rr rr rr rr rr rr 108 Optional System Components 109 Connecting the Bolus Cord 2 aa vrak krakk kr 110 Recharging the Battery Pack 2 aar rv vr vnr kran 111 Using the Abbott GemStar Lockboxes 2 2 0 a 112 Using the Abbott Carrying Cases sosse ess ss 114 Using the Abbott GemStar Docking Station 119 Pump Sets 121 Abbott GemStar Pump Specifications 123 Occlusion Information sees sees o e ss ss ss sea 126 Warranty 137 IEC Symbols inside back cover Abbott GemStar Manual 430 600095 002 Rev 8 02 Notes vi Abbott GemStar Manual 430 600095 002 Rev 8 02 Introduction The Abbott GemStar Pump is a small and lightweight single channel infusion device that can be powered by AC mains adaptor rechargeable battery pack two disposable AA batteries or the Abbott GemStar Docking Station The Abbott GemStar Pump is designed for use in the home in the hospital or anywhere electronic infusion is required When powered by batteries the Abbott GemStar Pump is ideal for ambulatory patients The following conventions are used throughout this manual Convention Use Example ALL CAPS Keys Press YES ENTER to continue ALL CAPS Display messages The pump displays END OF INFUSION WARNING A WARNING message contains special safety emphasis and must be observed at
69. ions on entering a program For menu item 2 refer to Starting a New Container in the Basic Operation section for instructions For menu items 3 4 and 5 refer to the appropriate therapy section for instructions Refer to the Options Menu section for instructions Abbott GemStar Manual 430 600095 002 Rev 8 02 Introduction nee Operating Modes The Abbott GemStar Pump has four operating modes Help Mode The pump enters the HELP mode when HELP is pressed while programming or during an alarm condition The HELP mode displays additional information Programming Mode The pump enters the PROGRAMMING mode after the pump is powered on or when CHANGE is pressed Run Mode After START is pressed the pump enters the RUN mode even during periods of non delivery Stop Mode When programming is complete the pump enters the STOP mode until START is pressed to begin the programmed therapy When the programmed therapy is complete and during certain alarm conditions the pump automatically enters the STOP mode Press STOP to enter the STOP mode at any time Abbott GemStar Pump Set The Abbott GemStar Pump must be operated with an Abbott GemStar Pump Set which is a sterile single use disposable STERILE 2 pump set Fluid path and areas beneath undisturbed protective set covers are sterile and nonpyrogenic in the intact unit package Contact an Abbott Labo
70. istered trademark of S M Edison Chemical Company Seiko is a registered trademark of Seiko Instruments Inc Vesphene II se and Manu Klenz are registered trademarks of Calgon Vestal Laboratories Formula C is a trademark of Diversey Corporation Teflon is a registered trademark of DuPont Velcro is a registered trademark of Velcro Industries B V This document and the subject matter disclosed herein are proprietary information Abbott Laboratories retains all the exclusive rights of dissemination reproduction manufacture and sale Any party using this documentation accepts it in confidence and agrees not to duplicate it in whole or in part nor disclose it to others without the written consent of Copyright O 2002 Abbott Laboratories Inc All Rights Reserved Printed in USA Abbott Laboratories North Chicago Illinois 60064 USA Abbott GemStar Manual 430 600095 002 Rev 8 02
71. ivered by continuous bolus or continuous with bolus For epidural use the administration of drugs is restricted to those anesthetic and analgesic drugs approved for continuous epidural administration e g Chloroprocaine Hydrochloride USP Lidocaine Hydrochloride USP and Morphine Sulfate Injection USP Preservative Free Abbott GemStar Manual 430 600095 002 Rev 8 02 9 Introduction WARNING Delayed respiratory depression following continuous epidural administration of preservative free morphine sulfate has been reported For epidural administration the following is recommended Nylon or Teflon catheter Pump sets without Y sites Stickers for the tubing indicating ongoing administration a Note Facilities practicing epidural anesthesia analgesia must be staffed and equipped to manage cardio pulmonary resuscitation Supplies should include oxygen naloxone and other appropriate resuscitative drugs and equipment Continuous monitoring e g oximetry is recommended for the patient during epidural administration as well as frequent patient observation for side effects for up to 24 hours following completion of drug administration by the epidural route Contraindications for Use The Abbott GemStar Pump should not be operated by persons who do not have the mental and physical capability or the emotional stability to properly operate this pump Drugs not compatible with silicone rubber or PVC plasti
72. l after priming the pump set Use of high flow rates during infusion will minimize drug absorption DO NOT use medications which are unstable under infusion conditions ALWAYS use connections with Luer Lock fittings Use aseptic technique with all fluid path connections Remove the protective coverings as assembly progresses ALWAYS close the slide clamps before removing the cassette from the pump Ensure the cassette is properly installed before using the pump Arrange tubing cords and cables to minimize the risk of patient strangulation or entanglement When using the pump for secondary delivery piggybacking ensure the fluids being administered are chemically and physically compatible NEVER use vented fluid containers e g glass or rigid plastic unless suspended from a pole Stop infusion if signs or symptoms of infiltration occur In vitro studies have shown that infusing older units of additive solution packed red blood cells or frozen deglycerolized red blood cells at rates greater than 200 mL hr may produce some level of hemolysis that may be considered clinically unacceptable Failure to use the anti siphon valve may result in unrestricted flow When infusing short half life drugs i e those dosed with units of mcg kg min at very low rates 0 8 mL hr or less the rate may be too slow for that drug Consider using a lower drug concentration with these drugs so a pump rate above 0 8 mL hr can be used If the cass
73. l fluid path connections Remove protective coverings as assembly progresses Ga x Note Refer to the appropriate instructions included with the pump set for more information False occlusion alarms and fluid delivery inconsistencies may occur when pumping viscous fluids in microbore tubing at rates greater than 500 mL hr Opening the Pump Set Open the Abbott GemStar Pump Set package and remove the contents Ga Vv Note Packaging may differ from the diagram shown Remove the protective covers from the fluid container administration port and the pump set 18 Abbott GemStar Manual 430 600095 002 Rev 8 02 System Setup Priming Pump Sets WITHOUT a Drip Chamber WARNING Failure to use the anti siphon valve may result in unrestricted flow Push down on the flow stop 0 to ensure the cassette is in the open priming position Hold the flexible fluid container with the administration port pointed toward the ceiling and insert the piercing pin Open the slide clamp Invert the cassette approximately 45 While holding the inverted cassette squeeze or roll the flexible fluid container to eliminate air from the container cassette and tubing 6l If necessary tap the cassette to eliminate any remaining air bubbles Return the cassette to the upright position Continue priming until fluid fills the tubing Abbott GemStar Manual 430 600
74. layed start time SET START TIME displays Enter the desired start time and press YES ENTER when done Review the program WARNING If the cassette is removed from the pump ALWAYS disconnect the pump set from the patient and purge the line before restarting therapy Tip To use a delayed start without specifying a start time 1 Press YES ENTER 2 Complete the program review 3 Power off the pump 4 When the pump is powered on again complete the program review then press START to begin delivery 50 Abbott GemStar Manual 430 600095 002 Rev 8 02 Intermittent Intermittent Delivery Interruptions Missed Start Time Ifthe programmed start time is missed it can be changed through the Options Menu Refer to Next Dose in the Options Menu section more information Ifthe pump remains in the STOP mode and the first dose is missed press START to begin delivery immediately and all subsequent doses will be shifted Ifthe pump is programmed with a delayed start time and is then powered off before START is pressed the pump will skip to the NEXT occurrence of the programmed start time For example the current time is 10 00 PM The user sets the delayed start time for 10 30 PM and then powers off the pump The user does not power on the pump until 10 40 PM which is 10 minutes AFTER the scheduled start time The pump does not begin delivery until 10 30 PM the FOLLOWING day Dose Interru
75. livery rate in milliliters mL only Programming ranges are listed in the programming worksheet included in this section If a number outside of the acceptable program range is entered an error message displays the minimum or maximum value allowed The air sensitivity is automatically set to ON This setting may be changed through the Options Menu after programming is complete Refer to Air Sensitivity in the Options Menu section for more information The pump automatically delivers KVO Keep Vein Open after the programmed VTBI Volume To Be Infused is complete The rate can be titrated while the pump is infusing An optional secondary container can be piggybacked on the primary container during regular delivery using an Abbott GemStar Piggyback Pump Set Refer to Piggybacking in this section for more information A program review is not required and is only available through the Change or Options Menu WARNING ALWAYS set the Air Sensitivity to either ON or 2mL when using vented drip chambers mL hr Only Programming Select mL hr Only from the Programming Menu Enter the rate Enter the VTBI Ga Note A program review is not required for mL hr Only programs WARNING If the cassette is removed from the pump ALWAYS disconnect the pump set from the patient and purge the line before restarting therapy Abbott GemStar Manual 430 600095 002 Rev 8 02 43 mL hr Only
76. local sources these files can also be transferred to a computer WARNING Disconnect the pump from the patient BEFORE connecting the pump to a printer or computer Equipment Needed Connect to Printer Connect to Computer Abbott GemStar Pump Abbott Serial Printer Cable List 13078 01 Seiko DPU 414 or Compatible Serial Printer Serial DB9 Female to Female Gender Changer Null Modem Computer Available from local sources Configuration Settings Refer to the printer or computer documentation for information on configuration settings The printer or computer must be configured as follows to use the Data Port Baud Rate 2400 Data Bits 8 Stop Bits 1 Parity None Carriage Return Line Feed CR LF Flow Control None When using the Seiko DPU 414 printer the switch settings MUST be configured to work with the Abbott GemStar Pump 80 Abbott GemStar Manual 430 600095 002 Rev 8 02 Options Menu To configure the switch settings on the Seiko DPU 414 Slide the POWER switch to ON while pressing the ONLINE button After the list of the current settings starts printing out release the ONLINE button Set the switches according to the table below Push ONLINE button to continue setting switches Press ONLINE to set switch ON Press FEED to set switch OFF Continue setting switches until Dip SW setting complete is printed Switch Settings for Seiko DPU 414 Pri
77. lue displayed is zero Enter the container size VIBI KVO VTBI is the default value on the CONTAINER display Note If KVO is programmed you must increase the container size to accommodate the KVO delivery In order to enter the total in mL when programming a concentration press VW to move to the mL line and enter the mL size Select the air sensitivity Review the program WARNING If the cassette is removed from the pump ALWAYS disconnect the pump set from the patient and purge the line before restarting therapy Abbott GemStar Manual 430 600095 002 Rev 8 02 59 Continuous AAPP os Rate Titration a To titrate the rate while the pump is infusing In the RUN mode press the numeric keys corresponding to the new rate The rate flashes on the display Press YES ENTER For example if the current rate is 100 mL hr press 5 0 YES ENTER to change the rate to 50 mL hr Note You have approximately five seconds after pressing a key to press another numeric key the decimal key or YES ENTER If no key is pressed within five seconds the rate does not change and the delivery continues as programmed NEW RATE displays with the new value e Press YES ENTER within 10 seconds to accept the change and begin delivery at the new rate Press NO to continue delivery at the programmed rate Piggybacking a Piggybacking with the Abbott GemStar Pump requires the use of an
78. meric value during programming press CHANGE before pressing YES ENTER to reset the value to zero BACK UP Press BACK UP to return to a previous display to exit OPTIONS or to exit the HELP mode Note To power off the pump press and HOLD O until the display clears Abbott GemStar Manual 430 600095 002 Rev 8 02 29 Basic Operation Powering On the Pump CAUTION If the self test does not display or if beeps do not sound at power on contact Abbott Customer Support before using the pump Press ID to power on the pump The pump completes a self test and displays the currently set time No response is required If the set time is not correct refer to Setting the Clock in the Options Menu section a GEMSTAR 7 UNIT SELF TEST TIME IS 10 00 AM FRI 1 JAN 99 Note The self test takes approximately 30 seconds to complete If the pump is locked lock symbols appear at the beginning and end of the second line UNIT SELF TEST f The pump evaluates the available power source s Respond to the display message as described in the following table Display Message No message displays Power Source s AC power and disposable batteries User Response No response required the pump advances to the next step LOW BATTERIE ER TO CONFIRM AC power and low voltage disposable batteries or low voltage disposable batteries only Press
79. mp detects distal pressure greater than 26 psi 179 kPa 14 psi 96 kPa Alarms when pump detects proximal pressure less than or equal to 4 psi 28 kPa 124 Abbott GemStar Manual 430 600095 002 Rev 8 02 Abbott GemStar Pump Specifications Piggyback Rate 0 1 to 300 mL per hour Pump Self Tests and Safety Features Self test performed when the power switch is activated Diagnostic routine including motor speed and air detection monitoring is repeated continuously while the pump is powered on Error and alarm conditions are indicated by both audible and visual alarms delivery in progress is stopped if appropriate refer to the Troubleshooting section Abbott GemStar Manual 430 600095 002 Rev 8 02 125 Abbott GemStar Pump Specifications Occlusion Information 8 g 126 Avoiding Bolus Infusion After Occlusion Press STOP Close the distal clamp A Press the cassette release button to remove the cassette from the pump Press down on C to open the flow stop Wait 10 seconds Press down on to close the flow stop Load the cassette into the pump Open the distal clamp Review the program Press START to start the pump A Abbott GemStar Manual 430 600095 002 Rev 8 02 Abbott GemStar Pump Specifications Stored Occlusion Volume Delivery Rate of Pressure Limit Stored Volume Time to Occlude 25 mL hr at in mL in seconds Pressu
80. n connected to a 2 Cassette Pocket amp Latch PASS printer or computer 3 Power Check PASS Connect the serial printer 1 FEN PARSE cable List 13078 01 to the e Display NISSE pump Refer to Connecting 6 LED Test PASS to a Printer in the Options 7 Volume Accuracy Test PASS Menu section for more 8 Distal Occlusion Test PASS information 9 Proximal Occlusion Test PASS Press YES ENTER to print My SER ae the test results KKK KKK KKK KKK KKK KKK KKK KKK KK KKK KKEKKKKKK KA VERIFIED BY KKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKK KKK After the results have been transmitted to the printer KKEKKKKKKKKKKKKKKKKKKKKKKKAKKKKKKKKKKKK KKK or if NO is pressed the END OF pump automatically OPERATION TEST proceeds to the Main RESULTS KkKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKK Programming Menu 1234567890123456789012345678901234567890 Abbott GemStar Manual 430 600095 002 Rev 8 02 107 Operation Test Abbott GemStar Operation Test Checklist Case Inspection O D Cassette Pocket and Latch Inspection Power Check Keypad Check Display Test LED Test Volume Accuracy Test Distal Occlusion Test Proximal Occlusion Test Air in line Test Printed Test Results COO OJO O ae E O O DO COL OO U b Serial Number Verified By 108 Abbott GemStar Manual 430 600095 002 Rev 8 02 Optional System Components All Abbott GemStar Optional S
81. n or equal to 1 mL hr the Auto KVO delivers at 1 mL hr If the weight dosed rate is less than 1 mL hr the Auto KVO delivers at the same rate Rate Titration To titrate the rate while the pump is infusing In the RUN mode press the numeric keys corresponding to the new rate The rate flashes on the display Press YES ENTER For example if the current rate is 4 0 mg kg hr press 5 YES ENTER to change the rate to 5 0 mg kg hr Press VW to enter the rate in mL When using units other than mL the pump automatically adjusts the mL hr value You have approximately five seconds after pressing a key to press another numeric key the decimal key or YES ENTER If no key is pressed within five seconds the rate does not change and the delivery continues as programmed NEW RATE displays with the new value e Press YES ENTER within 10 seconds to accept the change and begin delivery at the new rate Press NO to continue delivery at the programmed rate 34 Abbott GemStar Manual 430 600095 002 Rev 8 02 Weight Dosed Changing a Weight Dosed Program Vv Note You cannot change a program when the pump is in FULL or NEW CONTAINER Lock Can be changed at any time Cannot be changed Delivery rate Unit of measure VTBI Concentration amount of drug Patient weight To change a program From the STOP mode press CHANGE and select 4 CHANGE PROGRAM ME As each program parameter displa
82. ntainer Refer to the instructions included with the piggyback pump set for more information WARNING When using the pump for secondary delivery piggybacking ensure the fluids being administered are chemically and physically compatible The piggyback rate and piggyback VTBI display until the secondary container has been delivered Then the primary delivery resumes automatically Note Piggyback infusion amount is NOT added to the primary programmed infusion amount 44 Abbott GemStar Manual 430 600095 002 Rev 8 02 mL hr Only Preparing for Secondary Delivery Piggybacking Ensure a primary piggyback pump set with a proximal Y site backcheck valve is in place Use the extension hook from the secondary pump set to suspend the primary container from the I V pole Prepare the secondary pump set according to the instructions included with the set Attach a needle or blunt cannula if appropriate and prime the secondary pump set Suspend the secondary container from the 1 V pole a Note When using a secondary container of 500 mL or greater ensure the bottom of the secondary container is at least 7 inches 17 8 cm above the fluid level in the primary container Use additional extension hooks if necessary 6l Connect the secondary pump set to the proximal Y site or proximal port Abbott GemStar Manual 430 600095 002 Rev 8 02 45 mL hr Only Programming a Secondary Delivery Piggy
83. nter Function Setting Button to Press Input Method Serial Off FEED Printing Speed High On ONLINE Auto Loading On On ONLINE CR function CR and LF On ONLINE DIP SW setting command Enabled On ONLINE Printing density 100 Printing density 100 ONLINE Printing density 100 ONLINE Print Mode 40 columns ONLINE User defined char On ONLINE Ordinary Characters On ONLINE Zero Font No slash ONLINE Character Set American ONLINE Character Set American ONLINE Character Set American ONLINE Character Set American Data bit length 8 bits ONLINE Parity No parity ONLINE Parity condition Odd ONLINE Flow control H S busy ONLINE Baud rate 2400 bps ONLINE Baud rate 2400 bps Baud rate 2400 bps Baud rate 2400 bps ONLINE Abbott GemStar Manual 430 600095 002 Rev 8 02 81 Options Menu Connecting to the Seiko Printer WARNING Disconnect the pump from the patient BEFORE connecting the pump to a printer or computer CAUTION Do not connect the Abbott GemStar AC Mains Adaptor to a printer Ga x Note For maximum battery life the pump should be operated on AC mains when connected to a printer or computer KN EN MU Connect the serial printer cable to the printer and to the data port on the bottom of the pump Ensure the printer is ONLINE and ready to receive data Refer to printer documentation for more informati
84. oduct damage may occur if proper care is not exercised during unpacking installation and use Should the pump inadvertently be subjected to mishandling check connections and programmed data to confirm no damage has occurred Refer to the Operation Test section for further information ALWAYS fully close the battery door when using disposable batteries ALWAYS avoid dropping or hitting the pump If the pump is dropped or hit ALWAYS verify programmed data NEVER use sharp objects e g fingernails pens pencils or other probes to program or clean the pump Use care not to damage the silicone seals around the sensor bodies in the cassette pocket Abbott GemStar Manual 430 600095 002 Rev 8 02 Introduction To avoid mechanical or electronic damage NEVER submerge pump in water or other fluids and avoid fluid spills If pump becomes wet dry it immediately with a dry lint free cloth Check connections and programmed data Some cleaning and sanitizing compounds may slowly degrade components made from some plastic materials DO NOT use compounds containing combinations of isopropyl alcohol and dimethyl benzyl ammonium chloride DO NOT sterilize by heat steam ethylene oxide ETO or radiation Apply disinfectants to the outside surface of the pump only DO NOT use abrasive cleaners or materials on the pump Using abrasive cleaners or cleaning solutions not recommended by Abbott Laboratories may result in product damage
85. on Ensure paper is loaded in the printer Select the desired print function from the pump menu 82 Abbott GemStar Manual 430 600095 002 Rev 8 02 Options Menu Connecting to a Computer WARNING Disconnect the pump from the patient BEFORE connecting the pump to a printer or computer Note For maximum battery life the pump should be operated on AC mains when connected to a printer or computer Ul DV MI ES Connect the serial printer cable to the null modem A Connect the null modem to the serial gender changer B Connect the serial gender changer to the serial port of the computer C Connect the serial printer cable to the data port D on the bottom of the pump Configure the communications software on the computer Refer to Configuration Settings on page 80 9 Tip After the data transfer is complete the file may be viewed or printed using any text editor Abbott GemStar Manual 430 600095 002 Rev 8 02 83 Notes 84 Abbott GemStar Manual 430 600095 002 Rev 8 02 Clinician Instructions The instructions in this section apply to special features available to clinicians If desired remove this section from the manual to prevent unauthorized access to these features Clinician Locking Sequence Instructions Locking the Pump To lock the pump from the RUN or STOP mode Press OPTIONS to display the Options Menu Select KEYPAD LOCK from the Options Menu
86. or ANY of the above steps cannot be verified press NO 104 Abbott GemStar Manual 430 600095 002 Rev 8 02 Operation Test Power Check The display indicates that an external power source and batteries are connected Press w LN Remove both disposable batteries and press PF The display indicates that only external power is connected Press PF Install both disposable batteries Disconnect the external power source and press PF EN MU The display indicates that only batteries are connected and displays the test results Press W If the pump fails reconnect the external power source and press CN to rerun the test or press YES ENTER to confirm failure Keypad Test Press each key including the Bolus Button Press YES ENTER last Enter the results If each key makes an audible tone press YES ENTER e If any key does not make an audible tone press NO Display Test Press YES ENTER when prompted The display fills with solid boxes for approximately 10 seconds To view the solid boxes for another 10 seconds after the display times out press A Enter the results If the display fills with solid boxes press YES ENTER e If the display does not fill with solid boxes press NO LED Test Verify that both the Power green and Alarm red LEDs illuminate Refer to the Abbott GemStar Pump Layout in the Introduction section for the location of the LEDs En
87. or each phase Up to 24 phases can be programmed Note Ifprogramming in percentages the total daily amount of all phases programmed must equal 100 Enter the optional bolus dose and its lockout Enter the optional KVO Enter the container size The pump calculates the minimum container size required to deliver the phases base rate and KVO for one day or in a 24 hour period If delivering the protocol for more than one day multiply this amount by the number of days of therapy Note You must increase the container size to accommodate bolus deliveries Select the air sensitivity Review the program WARNING If the cassette is removed from the pump ALWAYS disconnect the pump set from the patient and purge the line before restarting therapy Abbott GemStar Manual 430 600095 002 Rev 8 02 65 Variable Time Note With variable time programming the pump keeps track of where it is in the program each minute of the entire 24 hour period For example if Phase 1 is missed and the pump is placed in RUN mode in the middle of Phase 2 it starts delivery according to the program parameters from the middle of Phase 2 Variable Time Delivery Interruptions If a phase is interrupted and the pump is placed in the RUN mode Before the end of the phase The phase runs to its scheduled stop time After the end of the phase but before the beginning of the next start time The next phase begins deli
88. orded to the Event and Bolus History logs If the bolus delivery does not start it may be locked out by one of the following conditions Bolus lockout period Loading dose delivery in progress Bolus dose delivery in progress Bolus per hour limit 1 hour or 4 hour dose limit Bolus Dose Interruptions Bolus deliveries may be interrupted by pressing STOP or by an alarm condition When START is pressed again COMPLETE BOLUS NOW displays Refer to the following table for the appropriate response To do this Press this key Bolus lockout time is set to Deliver the remaining bolus amount YES ENTER The time of delivery completion Clear the undelivered bolus amount NO The time the bolus was interrupted Abbott GemStar Manual 430 600095 002 Rev 8 02 39 Pain Management Loading Dose Delivery A loading dose is set during programming and can be delivered after programming and priming are complete Ga Note Loading dose amounts are not included in a 1 hour or 4 hour limit Delivering a Loading Dose After priming and programming are complete press START DELIVER THE LOADING DOSE NOW displays Press YES ENTER to begin delivery When the loading dose is complete the following will occur Programmed infusion begins automatically The dose amount is recorded to the history log The bolus lockout time is reset if applicable and subsequent bol
89. p uses a menu system that provides step by step guidance through all of the pump s functions Refer to the following table for a list of functions within each menu Use the keypad to select menu items answer display prompts and enter numeric values as required Note Menu items may vary depending on the pump s configuration 9 Tip A menu item does not have to be on the display to be selected Programming Menu Select NEW PROGRAM from the Change Menu to access the Programming Menu Refer to the Basic Operation section for more information on accessing the Programming Menu WEIGHT DOSED PAIN MANAGEMENT ML HR ONLY INTERMITTENT TPN CONTINUOUS VARIABLE TIME YANO BP WN FP REVIEW RESUME NEW CONTAINER NEW PROGRAM CHANGE PROGRAM PIGGYBACKING Oe WNP REVIEW PROGRAM HISTORIES KEYPAD LOCK PUMP SETTINGS SET CLOCK PRINT SPEED PROTOCOL NEXT DOSE OANnNO fF WYN FP Press the number key corresponding to the therapy type to be programmed For example press 2 to select Pain Management Press CHANGE to access the Change Menu Change Menu Press the number key corresponding to the desired Change Menu function Note Piggybacking is only available in mL hr Only and Continuous therapies Press OPTIONS to access the Options Menu Options Menu Press the number key corresponding to the desired Option Menu function Refer to the appropriate therapy section for instruct
90. ptions To understand how interruptions are resolved compare the normal Intermittent delivery diagram below for a 1 hour dose every four hours to the interruption diagrams shown in the examples Dose Delivered Ifan Intermittent dose is interrupted and the pump is placed in the RUN mode during the on or off cycle of the current dose the dose continues delivery from the point where it was interrupted and all subsequent doses are shifted Abbott GemStar Manual 430 600095 002 Rev 8 02 51 Intermittent For example in the following diagram an intermittent dose was started at 2 00 The dose was interrupted during the current dose cycle and was started again before the end of the current dose cycle Dose Delivered Dose Interrupted d Ifan Intermittent dose is interrupted and the pump is placed in the RUN mode after the off cycle of the current dose the next dose begins delivery and all subsequent doses are shifted if necessary For example in the following diagram an intermittent dose was stared at 2 00 It was interrupted during the current delivery cycle at 2 30 but was not started again until after the current delivery cycle at 6 45 Dose Delivered Dose Interrupted d When the dose is complete the start time for the Next Dose displays To change the start time refer to the Options Menu section Any missed Intermittent doses except the first dose are added to the end of the deliver
91. r consultation and technical support contact your local Abbott Laboratories sales office 9 Tip Press HELP for additional information during programming and alarm conditions Alarm Messages Is the Pump automatically enters STOP mode E Cause Alarm Display Message _ pump Alarm Condition Remedy infusing Y Yes A Audible alarm N No V Visual alarm AIR IN LINE N A V The specified volume of air 1 Press SILENCE to has been detected in the line distal to the cassette while infusing quiet the alarm for 1 minute Press STOP to clear the alarm Disconnect the patient from the pump set Press and hold PURGE Note Purge rate is 250 mL hr The pump purges for up to 2 minutes each time you press and hold PURGE Reconnect the pump set to the patient access device Press START to begin delivery Abbott GemStar Manual 430 600095 002 Rev 8 02 89 Troubleshooting Is the Alarm Display Message pump Alarm infusing Y Yes A Audible alarm N No V Visual alarm CHANGE BATTERIES N A V The pump has entered the 1 Replace both disposable STOP mode due to batteries with fresh AA battery voltage below batteries and press acceptable levels GO to restart the pump OR temporarily connect the pump to the AC mains adaptor and the pump will automatically restart Replace both batteries as soon as possible 2 After power on resume the current pro
92. r the history Access the Operation Test REVIEW PROGRAM Display the current program N A settings HISTORIES Display the history for the latest N A KEYPAD LOCK Access the locking and unlocking functions to prevent unauthorized alteration of the infusion protocol The lock levels allow the clinician to restrict access to various levels of pump operation When the pump is locked under a particular level a small lock symbol displays by the name of the applied lock level on the Keypad Lock Menu PUMP SETTINGS Change the air sensor occlusion sensor and sound level settings N A history if available current program settings and speed protocols SET CLOCK Set the clock The clock can be displayed in 12 hour or 24 hour format PRINT Print the history event log bolus Files may be downloaded to a printer or personal computer SPEED PROTOCOLS Assign review recall and delete the stored protocols Allows up to 9 speed protocols to be saved in pump memory Removing power has no effect on the Speed Protocol settings NEXT DOSE Change the start time of the next dose when an interruption has caused a missed dose in an intermittent program NEXT DOSE appears on the menu only when the pump is in an intermittent program and changing the next dose is allowed Review Program Select RE VI Press YES ENTER or BACK UP when done to exit OPTIONS SET CLOCK
93. ratories Representative for more information on selecting the appropriate pump set configuration Additional disposable components such as air eliminating filters and extension sets may be added to the line as required by the therapy To use an Abbott GemStar Pump Set follow the instructions included with the set 8 Abbott Gemstar Manual 430 600095 002 Rev 8 02 Introduction The basic components of the Abbott GemStar Pump Set are shown below Piercing Pin Proximal End Cassette Distal End Tubing Slide Clamp Flow Stop Secure Lock 2 3 4 5 6 7 8 9 Anti Siphon Valve Indications for Use a Physicians or certified licensed healthcare professionals should always oversee infusions Pump users should be under the supervision of a healthcare professional and should be instructed in using and troubleshooting the pump Instruction should emphasize preventing intravenous 1 V related complications including appropriate precautions to prevent accidental infusion of air The pump is suitable for intravenous arterial subcutaneous short term epidural infusion and parenteral administration of general I V fluids medications nutritional fluids and blood blood products The epidural route is recommended to provide anesthesia or administer analgesia for periods up to 96 hours Note Epidural administration of anesthetics is recommended in the continuous mode only Epidural administration of analgesics may be del
94. re Operating Environment Ambient Temperatures 41 to 104 F 5 to 40 C Power Sources AC Mains Battery Battery Pack Wall mount AC mains adaptor 6 ft 1 8 m cord molded plug Input 110 VAC Output 3 0 VDC Tabletop AC mains adaptor molded plug Input 100 240 VAC Output 3 0 VDC Two disposable AA batteries Rechargeable using Abbott GemStar AC Mains Adaptor Power Capacity Using two fresh disposable AA batteries or a charged battery pack at room temperature the pump is capable of delivering approximately 96 hours at rates below 5 mL hr 48 hours at rates at or above 5 mL hr but below 25 mL hr 24 hours at rates at or above 25 mL hr but below 125 mL hr 3000 mL at a rate of 125 mL hr or higher Pump Mechanism Volumetric Piston Driven Memory Protection Current program and 400 event history log protected by internal lithium battery backed memory for at least one year after power is removed Operating Controls One 23 key keypad bolus data port and AC mains jacks bolus button Abbott GemStar Manual 430 600095 002 Rev 8 02 123 Abbott GemStar Pump Specifications External Power LED Green LED marked with plug icon illuminates continuously when pump is connected to AC mains Green LED flashes when pump is connected to external batteries Alarm LED Red LED marked with alarm icon illuminates during alarm conditions Audible Alarm The audible ala
95. re Setting Macro Micro Macro Micro Macro Micro Low Medium 14 psig 13 psig High 7 psig 7 psig 48 3 kPa 48 3 kPa 96 5 kPa 89 6 kPa 32 psig 30 psig 220 6 kPa 206 8 kPa Delivery Rate Accuracy a The following trumpet curves represent the typical flow rate deviations both positive and negative from the set flow rate under test conditions defined by International Electrotechnical Commission IEC Standards for infusion pumps Using these curves the medical professional may determine if the device can be expected to perform in a manner suitable for the drug or fluid to be infused The typical accuracy for this device is 5 of the set rate for most conditions after a period of normalization It is recommended that the medical professional refer to the following curves when making decisions regarding drug and fluid administration The maximum over infusion which may occur from a single fault condition is 2 78 mL The sets used in this testing are comparable to Abbott GemStar Pump Set List 13273 Note False occlusion alarms and fluid delivery inconsistencies may occur when pumping viscous fluids in microbore tubing at rates greater than 500 mL hr Abbott GemStar Manual 430 600095 002 Rev 8 02 127 Abbott GemStar Pump Specifications FLOW RATE 0 1 mL 0 mm Hg Delivery Head Start Up 11 1 0 4 0 9 E 074
96. red during programming Auto Taper Down may be activated when the continuous delivery portion of a TPN with Taper Down protocol is stopped Auto Taper Down is not available while the pump is in an alarm condition Press STOP during TPN delivery DO YOU WANT AUTO TAPERING displays Press NO to return to the STOP mode and then if desired press START to resume therapy e Press YES ENTER to set Auto Taper Down Enter the Auto Taper Down time The maximum Auto Taper Down time is three hours OR two times the remaining volume divided by the continuous delivery rate whichever is less a Note Time is entered in hours minutes For one hour press 1 0 0 not 6 0 Press YES ENTER to return to the RUN mode then press START to begin Auto Taper Down 56 Abbott GemStar Manual 430 600095 002 Rev 8 02 Total Parenteral Nutrition TPN Abbott GemStar TPN Programming Worksheet GIVE Parameters Selections and or Values to be Programmable Ranges Entered Therapy TPN N A Delivery Mode U Continuous N A Q Continuous Taper Down Q Continuous Taper Up Q Continuous Taper Up and Down VTBI Volume To Be Infused mL 1 9600 mL Taper Up O No O Yes hrs min 1 min 3 hrs Taper Down Q No O Yes hrs min 1 min 3 hrs Total Time to Infuse hrs min 1 min 24 hrs KVO L No KVO Rate 0 0 Keep Vein Open O Yes KVO Rate 1 0 5 0 mL hr Container Size VTBI
97. rm is user adjustable from the maximum volume down to silent The alarm automatically reverts to the maximum volume if the user does not respond within one minute Display Backlit four line by sixteen character alphanumeric graphics display Backlight on AC Backlight on Batteries Continuous Continuous during programming program review and history display otherwise activated by keypress or alarm not activated by bolus request Real Time Clock Accuracy of 1 minute per month or better Print Function Port amp Interface Printers RS 232 serial interface port minimum baud rate of 2400 isolated circuit Seiko DPU 414 or compatible serial printer System Accuracy 10 for rates of 0 1 to less than 5 mL hr 5 for rates of 5 to 1000 mL hr Air Sensitivity ON 2 mL OFF Pump alarms at approximately 0 5 mL of air Alarms for any bubble greater than 500 microliters with a tolerance of 200 microliters Pump alarms at approximately 2 mL of air Alarms when pump detects 2 0 1 0 0 2 mL of air in 6 mL of total volume delivered Alarm is not activated Recommend using air eliminating filter when Air Sensitivity is set to OFF Occlusion Sensitivity Distal Occlusion Low Medium High Proximal Occlusion Alarms when pump detects distal pressure greater than 7 psi 48 kPa 5 psi 34 kPa Alarms when pump detects distal pressure greater than 12 psi 83 kPa 8 psi 55 kPa Alarms when pu
98. s Use of radio frequency emitting devices such as cellular telephones 2 way radios and Electrical Surgical Devices ESU in close proximity to this device may affect its operation Possible explosion hazard exists if the pump is used in the presence of flammable anesthetics NEVER use the pump in the presence of flammable or explosive vapors Non hazardous low level electrical potentials are commonly observed when fluids are administered using infusion devices These potentials are well within accepted safety standards but may create artifacts on voltage sensing equipment such as ECG EMG and EEG machines These artifacts vary at a rate that is associated with the infusion rate Ifthe monitoring machine is not operating correctly or has loose or defective connections to its sensing electrodes these artifacts may be accentuated so as to simulate actual physiological signals To determine if the abnormality in the monitoring equipment is caused by the infusion device instead of some other source in the environment set the infusion device so that it is temporarily not delivering fluid Disappearance of the abnormality indicates that it was probably caused by electronic noise generated by the infusion device Proper setup and maintenance of the monitoring equipment should eliminate the artifact Refer to the appropriate monitoring system documentation for setup and maintenance instructions Regarding Handling and Maintenance 12 Pr
99. s or press YES ENTER to accept the current setting Review the program Press START to begin delivery ES mM Abbott GemStar Manual 430 600095 002 Rev 8 02 41 Pain Management Bolus Only Continuous Bolus Abbott GemStar Pain Management Programming Worksheet GIVE Parameters Selections and or Values to be Programmable Ranges Entered Therapy Pain Management N A Delivery Mode U Continuous N A Unit of Measure U Concentration mg mL 0 1 100 mg mL 1 1000 mcg mL U Concentration mcg mL Q mL Continuous Rate 0 1 2500 mg hr 1 25000 mcg hr 0 1 25 0 mL hr Loading Dose O No 0 1 2500 mg Oy A a 1 25000 mcg F ee 0 1 25 0 mL Bolus Dose 0 2500 mg 0 25000 mcg 0 25 0 mL Bolus Lockout minutes 5 999 min Optional Dose Limit U 4 hour limit Amount 4X rate 400 mL 40000 mg 400000 mcg QI 1 hour limit Amount Rate 100 mL 10000 mg 100000 mcg U boluses hour Number No dose limit 1 12 For continuous plus bolus delivery Note For Bolus Only the 1 or 4 hour limit m inimum is 1 bolus dose Container Size 0 1 99999 mg 1 9999000 mcg 0 1 9999 mL Air Sensitivity QU On Alarms at approx 0 5 mL of air N A Q 2 mL Alarms at approx 2 mL of air Q Off No alarm 42 Abbott GemStar Manual 430 600095 002 Rev 8 02 mL hr Only Therapy Features and Specifications This therapy allows quick programming of de
100. sary 6l Connect the secondary pump set to the proximal Y site or proximal luer port Abbott GemStar Manual 430 600095 002 Rev 8 02 61 Continuous I Programming a Secondary Delivery Piggybacking A Note To distinguish the piggyback delivery from the primary PIGGYBACK delivery PIGGYBACK displays and the piggyback VTBI counts RATE 250 0 mL hr down to completion For example a piggyback rate of 250 VTBI 218 5 mL mL hr with a remaining VTBI of 218 5 mL will display as gt gt gt shown 9 Tip Prepare and set up containers BEFORE programming the pump for piggyback delivery Press CHANGE and select 5 PIGGYBACKING from the Change Menu Enter the dose amount for the secondary container Enter the infusion time for the secondary container Open the slide clamp or CAIRO roller clamp on the tubing of the secondary set Press YES ENTER to begin piggyback delivery AS GY E a Note Primary flow stops until the secondary VTBI is delivered then primary flow automatically resumes Any remaining secondary fluid will be delivered at the primary rate The maximum piggyback rate is 300 mL hr For secondary rates above 300 mL hr flow may occur from the primary container Changing a Piggyback Delivery Press CHANGE and select 5 PIGGYBACKING from the Change Menu Press CHANGE to reset the dose amount to zero Enter the new piggyback dose amount and press YES ENTER Set the infusion time for t
101. sing the Abbott GemStar Pole Clamp available separately Abbott Carrying 13594 01 Soft sided carrying case can be worn around the waist to hold the Case 250 mL Abbott GemStar Pump and up to a 250 mL flexible container Abbott Carrying 13079 01 Soft sided carrying case can be worn around the waist or over the Case 500 mL shoulder to hold the Abbott GemStar Pump and up to a 500 mL flexible container Abbott Carrying 13980 01 Soft sided carrying case can be worn around the waist or over the Case 1000 mL shoulder to hold the Abbott GemStar Pump and up to a 1000 mL flexible container Abbott Carrying 13593 01 Soft sided carrying case can be worn around the waist or as a backpack to hold a 3 liter or smaller flexible container and the Abbott GemStar Pump with batteries or battery pack Includes List 13590 01 Abbott GemStar Manual 430 600095 002 Rev 8 02 109 Optional System Components Product Description List Serial Printer Cable Abbott 3 Liter Carrier 13590 01 Interior support for the Abbott Carrying Case 3 Liter Abbott GemStar 13075 01 Plugs into a 100 240 VAC Volt mains supply to power the Abbott Docking Station GemStar Pump while mounted on an I V pole During periods of 100 240 Volts transport an internal rechargeable battery pack powers the pump for up to 16 hours at a rate of 125 mL hr or less When the AC mains supply is attached the internal batteries are recharged in 4 to 6 hours
102. st with the front window facing away from the body Snap the buckle together to secure Adjust the belt for a snug comfortable fit Carrying Case 3 Liter List 13593 01 This soft sided carrying case may be worn around the waist or as a backpack It is designed to hold the Abbott GemStar Pump with batteries or a battery pack and up toa 3 liter flexible fluid bag a Note This carrying case includes an interior support Abbott 3 Liter Carrier List 13590 01 that may be removed from the case and used separately Unzip the carrying case and release all Velcro straps and flaps Place the fluid bag on the carrying case as shown A Hook top strap B through the hole in the top of the fluid bag and secure Fold small flaps C and D over the bag as shown and secure Secure straps E and F across the length of the fluid bag and over the small flaps Secure the spike connection with strap G Fold large flaps H and I over as shown and secure CA GT EI CT ES KC SY E Place the pump with the keypad facing upward inside the pocket J on the flap The pump s display should be visible through the opening on the front of the pocket Abbott GemStar Manual 430 600095 002 Rev 8 02 117 Optional System Components Secure the pump with straps K and L Secure the tubing with strap M Place the secured pump N inside the large zipper case or other carrying case Zip the large case closed HARAR If desir
103. t down D Hang the bag on the hook inside the lockbox E Insert the cassette into the pump F Bu Ensure the tubing will not be pinched when closing the lockbox Close and lock the lockbox Remove the key Removing the Lockbox Remove the lockbox from the pole Unlock the lockbox Open the lockbox and flip the top door up AS GY E Press the cassette release button to remove the cassette n E NM Lift the pump out of the lockbox e a Abbott GemStar Manual 430 600095 002 Rev 8 02 113 Optional System Components Using the Abbott Carrying Cases Ensure the administration set is fully primed and the cassette is properly loaded before placing the pump in the carrying case Refer to the System Setup section for more information Carrying Case 250 mL List 13594 01 This soft sided carrying case may be worn around the waist It is designed to hold the Abbott GemStar Pump and up to a 250 mL flexible fluid bag Place the fluid bag in the zippered compartment A on the backside of the case Ensure the bag spike is positioned so that the fluid flow is not restricted Place the pump inside the front compartment B of the case 114 Abbott GemStar Manual 430 600095 002 Rev 8 02 Optional System Components Secure the tubing to the inside of the pack with the Velcro tabs C Ensure the tubing is not kinked Use the large Velcro
104. ter the results If both LEDs illuminate press YES ENTER e If either of the LEDs does not illuminate press NO Abbott GemStar Manual 430 600095 002 Rev 8 02 105 Operation Test a Volume Accuracy Test The pump should deliver between 19 0 to 21 0 mL within approximately 3 minutes to pass this test Load a primed pump set into the pump Press P Place the proximal end in the reservoir of water Press P Place the distal end in a 20 mL graduated cylinder Press V Press START Enter the results Ifthe pump delivers between 19 0 to 21 0 mL press YES ENTER Ifthe pump does not deliver between 19 0 to 21 0 mL press NO Pi ES ma GY EN Distal Occlusion Test The occlusion should occur within approximately 30 seconds to pass this test Clamp the pump set 10 to 12 inches 25 4 to 30 5 cm below the cassette Press START The test result displays Release the clamp and press P Ifthe test is passed the pump advances to the next test Ifthe test is failed clean the sensors and press CN to rerun the test or press YES ENTER to confirm failure Note Clean the sensor pins before repeating the distal occlusion test Refer to the Maintenance section for instructions Proximal Occlusion Test The occlusion should occur within approximately 30 seconds to pass this test Clamp the pump set above the cassette Press START The test result displays Press P Ifthe test is passed th
105. terval minutes Max Min v Mean 132 Abbott GemStar Manual 430 600095 002 Rev 8 02 Abbott GemStar Pump Specifications FLOW RATE 25 mL 100 mm Hg Delivery Head Start Up Rate mL hr 0 10 20 30 40 50 60 70 80 90 100 110 120 Time minutes Actual Rate Programmed Rate PERCENT ERROR 25 mL 100 mm Hg Delivery Head Start Up 15 0 E 10 0 B 50 z 5 r r r k 1 gt 0 0 E 2 aia g PE 50 Oo E 10 0 15 0 0 5 10 15 20 25 30 Observation Interval minutes Max HH Min v Mean Abbott GemStar Manual 430 600095 002 Rev 8 02 133 Abbott GemStar Pump Specifications FLOW RATE 25 mL 100 mm Hg Delivery Head Start Up Rate mL hr 0 5 10 15 20 25 30 0 10 20 30 40 50 60 70 80 90 100 110 120 Time minutes Actual Rate Programmed Rate PERCENT ERROR 25 mL 100 mm Hg Delivery Head Start Up 15 0 _ 10 0 E 5 0 y iti 5 0 0 gt gt gt gt gt gt gt gt gt gt gt g 2 5 0 E 10 0 15 0 Observation Interval minutes Max H Min v Mean 134 Abbott GemStar Manual 430 600095 002 Rev 8 02 Abbott GemStar Pump Specifications
106. the top of the battery pack A with the connectors on the bottom of the pump B Snap the battery pack into place To release the battery pack Press the release button C on the battery pack Remove the battery pack from the pump Connecting the Abbott GemStar AC Mains Adaptor Connect the cord of the AC mains adaptor to the connector labeled 3VDC on the bottom of the pump Plug the AC mains adaptor into a standard wall outlet CAUTION ALWAYS connect to a grounded AC mains power source when using the AC mains adaptor USE ONLY AC mains adaptors specifically labeled for use with the Abbott GemStar Pump Abbott GemStar Manual 430 600095 002 Rev 8 02 17 System Setup Priming an Abbott GemStar Pump Set The Abbott GemStar Pump Set must be primed to eliminate air from the cassette and tubing before loading into the pump WARNING ALWAYS remove air from the cassette tubing and injection site prior to connecting to the patient ALWAYS disconnect the pump set from the patient prior to priming or purging Arrange tubing cords and cables to minimize the risk of patient strangulation or entanglement Failure to use the anti siphon valve may result in unrestricted flow CAUTION USE ONLY Abbott GemStar Pump Sets with the Abbott GemStar Pump Use of unauthorized sets may result in injury to the patient or damage to the pump To prevent contamination use aseptic technique with al
107. this channel Load the cassette into this pocket Use to connect the Abbott GemStar Rechargeable Battery Pack to the pump Install two fresh disposable AA batteries in this compartment for battery power Abbott GemStar Manual 430 600095 002 Rev 8 02 Introduction Therapies Seven types of therapy are available for delivery of medications and fluids The following table lists available features and possible applications of each therapy A A A fo Therapy Possible Applications 3 x g 8 58 5 g o 3 SEl a 9 RO 2 as 8 9 A A Weight Dosed Critical care pediatrics E j Pain Management Administration of analgesics or anesthetics for patient controlled pain management PCA mL hr Only Simple rate programming 7 j Intermittent Interval based therapies such as antibiotics TPN Total Parenteral Nutrition fluid delivery Continuous Delivery of mg mcg or mL hr with a selectable KVO Keep Vein Open option Variable Time Chronotherapy s Legend Available Note Menu items may vary depending on the pump s configuration 5 Abbott GemStar Manual 430 600095 002 Rev 8 02 Introduction Abbott GemStar Pump Features e Adjustable Adjusts the distal occlusion pressure limits Refer to the Options Menu Settings air sensor sensitivity real time clock and section audible alarm volume Alerts and Signals audibl
108. tient access device gt Clogged LV filter gt Other obstructions If the problem persists remove and reinstall the cassette Refer to Loading the Cassette in the System Setup section Press START to begin delivery Abbott GemStar Manual 430 600095 002 Rev 8 02 91 Troubleshooting ihe Cause Alarm Display Message _ pump Alarm REO Remedy infusing Y Yes A Audible alarm N No V Visual alarm LOW BATTERIES Y A V The pump has detected 1 Press SILENCE to battery voltage below quiet the alarm for 15 acceptable levels and the minutes batteries are the primary 2 Press STOP to place power source the pump in the STOP Note The pump allows the mode user to clear the LOW 3 Connect the pump to BATTERIES audible and AC mains adaptor visual alarm Ifthe condition rechargeable battery has not been corrected after pack OR replace both 15 minutes the audible and disposable batteries visual alarms resume with fresh AA batteries a 4 Press START to begin Ifthe pump is infusing and a delivery LOW BATTERIES alarm occurs the pump continues for approximately 30 minutes before it can no longer deliver due to insufficient power If an external power source is used the rate is changed or the pump is powered on after a LOW BATTERIES alarm and those same batteries are still in the pump this interval may be different POWER LOSS N A V The pump has detected a 1
109. unds to 4 5 mg 5 mg 333 mL 4 5 mg 3 mL When a value is rounded the pump sounds four quick beeps ROUNDING displays for a few seconds and then the rounded value displays Press YES ENTER to accept the rounded value and continue to the next step Program a loading dose as required Abbott GemStar Manual 430 600095 002 Rev 8 02 37 Pain Management 6l Program a bolus dose with lockout time and dose limit as required Regarding a 1 Hour or 4 Hour Dose Limit The hour dose limit is the maximum volume continuous plus bolus or bolus only amount that may be delivered over the selected period When the programmed dose limit is reached the continuous delivery stops and a new bolus is not allowed As the oldest delivery amounts age out of the Hour Dose Limit record the pump accepts bolus requests or resumes continuous delivery if programmed a Note If a 1 hour or 4 hour dose limit is programmed a bolus in progress does not stop until the individual bolus volume has been delivered Therefore a bolus delivery initiated before the programmed dose limit is reached may exceed the dose limit at the completion of the bolus Loading doses are not included in the hour dose limit volume and a dose limit in effect does not prevent the delivery of a loading dose If programmed in units of mcg or mg the line displaying the units flashes Enter the container size in proper unit measure or see the note below a Note In order to
110. us requests are ignored until the lockout time has elapsed Loading Dose Interruptions Loading dose deliveries may be interrupted by pressing STOP or by an alarm condition When the interruption is resolved press START COMPLETE THE LOADING DOSE displays Refer to the following table for the appropriate response To do this Press this key Deliver the remaining loading dose amount YES ENTER Clear the undelivered loading dose amount NO 40 Abbott GemStar Manual 430 600095 002 Rev 8 02 Pain Management Changing a Pain Management Program 4 Note You cannot change a program when the pump is in or Lock hange a prog hen the pump is in FULL or NEW CONTAINER Lock With a RATE CHANGE Lock the continuous delivery rate and bolus amount can be changed within the set ranges Can be changed at any time Cannot be changed Delivery rate Container size Delivery mode Bolus Air sensitivity Unit of measure Bolus lockout Dose limit amount Concentration Dose limit type a Note Although the delivery mode cannot be changed if a Continuous Bolus therapy is programmed the continuous rate or bolus amount can be changed to zero This function may be restricted by the minimum values set with a RATE CHANGE Lock To change a program From the STOP mode press CHANGE and select 4 CHANGE PROGRAM ME As each program parameter displays make the desired change
111. utton D on the top of the docking station and slide the pump out 120 Abbott GemStar Manual 430 600095 002 Rev 8 02 Pump Sets The Abbott GemStar Pump Sets listed in the table on the following page are available for use with the Abbott GemStar Pump Contact an Abbott Laboratories Representative for appropriate pump set configurations Ga Note All Abbott GemStar Pump Sets are composed of latex free components only CAUTION USE ONLY Abbott GemStar Pump Sets with the Abbott GemStar Pump Use of unauthorized sets STERILE 2 may result in injury to the patient or damage to the pump Fluid path and areas beneath undisturbed protective set covers are sterile and nonpyrogenic in the intact unit package Ga Note The disposable pump sets should be changed per the Centers for Disease Control CDC guidelines or health care provider policy Discard after use Abbott GemStar Manual 430 600095 002 Rev 8 02 121 Pump Sets The following sets are a representation of the GemStar TM Pump Sets currently available to the market LIST DESCRIPTION NO Ambulatory Sets 13271 GemStar Pump Set LifeShield Secure Lock Pre Pierced Y Site Non Vented Orange Polyethylene Lined Light Resistant Microbore Tubing Pressure Activated Anti Siphon Valve Latex Free 96 in 244 cm _ 13273 GemStar Pump Set Secure Lock Non Vented Microbore Tubing Pressure Activated Anti Siphon Valve Latex Free 96 in 244 cm
112. ved DO NOT use the pump set Connect the pump set to the patient access device Abbott GemStar Manual 430 600095 002 Rev 8 02 System Setup Priming Pump Sets WITH a Drip Chamber WARNING Failure to use the anti siphon valve may result in unrestricted flow ALWAYS set the Air Sensitivity to either ON or 2mL when using vented drip chambers Push down on the flow stop 05 to ensure the cassette is in the open priming position Close the CAIRQ roller clamp Insert the piercing pin into the container Suspend the container on an I V Pole Squeeze the drip chamber until filled halfway Invert the cassette approximately 45 6l Open the CAIR roller clamp Abbott GemStar Manual 430 600095 002 Rev 8 02 21 System Setup If necessary tap the cassette to eliminate any remaining air bubbles E Return the cassette to the upright position Continue priming until fluid fills the tubing E Push down on the flow stop to ensure the cassette is in the closed position Insert the cassette into the cassette pocket Refer to Loading the Cassette on page 26 CAUTION When priming is complete ensure no fluid flows at the distal end of the pump set If flow is observed DO NOT use the pump set Connect the pump set to the patient access device 22 Abbott GemStar Manual 430 600095 002 Rev 8 02 System
113. very at the scheduled start time All applicable Base Rate or KVO delivery infuses while waiting for the start of the next phase In the middle of a phase and the phase start was missed because of a program interruption or a missed program start The pump immediately begins delivery of the current phase at its current time based point Changing a Variable Time Program a Note You cannot change a program when the pump is in FULL or NEW CONTAINER Lock Can be changed at any time KVO rate Container size Air sensitivity Bolus Base rate Can ONLY be changed before START is pressed Current time Daily amount Phase parameters Cannot be changed Unit of measure Concentration Phase type To change a program From the STOP mode press CHANGE and select 4 CHANGE PROGRAM As each program parameter displays make the desired changes or press YES ENTER to accept the current setting Review the program Press START to begin delivery Note The container size cannot be made smaller than the daily total of phases base rate and KVO combined or the current amount delivered whichever is greater 66 Abbott GemStar Manual 430 600095 002 Rev 8 02 Abbott GemStar Variable Time Variable Time Programming Worksheet GIVE Parameter Selections and or Values to be Programmable Entered Ranges Select Phase Type Q Perc
114. wn on the flow stop Co to ensure the cassette is in the open priming position Hold the flexible fluid container with the administration port pointed toward the ceiling and insert the piercing pin Open the slide clamp Invert the cassette approximately 45 While holding the inverted cassette squeeze or roll the flexible fluid container to eliminate air from the container cassette and tubing 6l If necessary tap the cassette to eliminate any remaining air bubbles Return the cassette to the upright position Continue priming until fluid fills the tubing 24 Abbott GemStar Manual 430 600095 002 Rev 8 02 System Setup E Push down on the flow stop to ensure the cassette is in the closed position E Insert the cassette into the cassette pocket Refer to Loading the Cassette on page 26 Note Extension set with anti siphon valve must be attached before patient use Connect the extension set to the pump set refer to the instructions that come with the pump set Press PURGE PRIME THE SET displays Press YES ENTER Press and hold PURGE x Note Purge rate is 250 mL hr The pump purges for up to 2 minutes each time you press and hold PURGE Continue using the PURGE key until fluid fills the tubing Ensure all air is removed from the container cassette and tubing CAUTION When priming is complete ensure no flu
115. y schedule 52 Abbott GemStar Manual 430 600095 002 Rev 8 02 Intermittent Changing an Intermittent Program Ga Note You cannot change a program when the pump is in FULL or NEW CONTAINER Lock Can be changed at Can be changed if no dose is Cannot be changed after any time in progress START is pressed Dose parameters Next dose start time Current time KVO rate Container size Air sensitivity Call back alarm To change a program From the STOP mode press CHANGE and select 4 CHANGE PROGRAM MA As each program parameter displays make the desired changes or press YES ENTER to accept the current setting Review the program Press START to begin delivery EN FO Abbott GemStar Manual 430 600095 002 Rev 8 02 53 Intermittent _ Abbott GemStar Intermittent Programming Worksheet GIVE Parameters Selections and or Values to be Entered Programmable Ranges Therapy Intermittent N A Dose Amount 0 1 9600 mL Infusion Time Per Dose hrs min 1 min 24 hrs Dose Frequency Infusion time per dose 1 min hrs min to 96 hrs Number of Doses Per Container 1 999 KVO L No KvVO Rate 0 0 Keep Vein Open O Yes KVO Rate 0 1 5 0 mL hr Container Size 0 1 9999 mL Air Sensitivity Q On Alarms at approx 0 5 mL of air N A Q 2mL Alarms at approx 2 mL of air Q Off No alarm Call Back Alarm O No Q Yes ae Alarm hrs min before start 1 min tim
116. y will Note This alert is onl complete during the available with Pain y next bolus delivery Management protocols 94 Abbott GemStar Manual 430 600095 002 Rev 8 02 Troubleshooting infuse unless Auto mL hr Only or Weight Dosed programs The pump does not KVO is delivering in a delivered the programmed container size or the pump has delivered the VTBI programmed AND Auto KVO is delivering gt Is the pump Cause Alert Display Message infusing Alarm Condition Remedy Y Yes A Audible alarm N No V Visual alarm CHECK PRINTER Y AIV The printer has not Press SILENCE to responded to quiet the alarm for 2 commands from the minutes pump Ensure the printer is The printer is not properly connected to properly connected the pump by checking to the pump the following gt Printer is powered on and in ONLINE mode gt Cable is plugged in to both the pump and the printer gt Cable part number and printer settings are correct If the problem continues select STOP PRINT from the Print Menu to cancel all print jobs EMPTY CONTAINER N A V The pump has Press SILENCE to quiet the alarm for 2 minutes Press STOP to place the pump in the STOP mode and clear the alarm Use the NEW CONTAINER function to repeat the current program Refer to Starting a New Container in the Basic Operation section Abbott GemStar Manual 430 600095 0
117. ys make the desired changes or press YES ENTER to accept the current setting Review the program Press START to begin delivery PS MU Abbott GemStar Manual 430 600095 002 Rev 8 02 35 Weight Dosed Abbott GemStar Weight Dosed Programming Worksheet GIVE Parameter Selections and or Values to be Entered Programmable Ranges Therapy Weight Dosed N A Unit of Measure Q mcg kg min Q mcg kg hr Q mcg min O mg kg min O mg kg hr Q mg min Q mL hr N A Patient Weight When programming in kg min or kg hr 2 0 200 0 kg Concentration 2 entries are required Use W to toggle For all units of measure EXCEPT mL hr mg 0 1 9999000 mg mL 0 1 9999 mL Rate see below VTBI Volume To Be Infused 0 1 9999 mL Programmable Ranges for Rate 0 1 8333 mg kg min 0 1 500000 mg kg hr 0 1 16666 mg min 0 01 166666 mcg kg min 0 01 9999999 mcg kg hr 0 01 166666 mcg min 0 1 1000 mL hr CAUTION When infusing short half life drugs i e those dosed with units of mcg kg min at very low rates 0 8 mL hr or less the rate may be too slow for that drug Consider using a lower drug concentration with these drugs so a pump rate above 0 8 mL hr can be used 36 Abbott GemStar Manual 430 600095 002 Rev 8 02 Pain Management Therapy Features and Specifications This therapy allows programming of a continuous
118. ystem Components are composed of latex free components only Product Description List Description Case 3 Liter Abbott GemStar 13026 01 Wall mount adaptor plugs into a 110 VAC mains supply to power AC Mains Adaptor the Abbott GemStar 6 ft 1 8 m cord 110 Volts USA Abbott GemStar 13072 01 Tabletop adaptor plugs into a 100 240 VAC mains supply to power AC Mains Adaptor the Abbott GemStar 100 240 Volts Universal Abbott GemStar 13027 01 Allows bolus requests to be made up to 6 feet 1 8 m from the Bolus Cord pump Abbott GemStar 13076 01 Attaches the Abbott GemStar Pump to an I V pole The clamp is Pole Clamp mounted to the track on the back of the pump Press the release button to remove the pump Abbott GemStar 13073 01 The rechargeable nickel metal hydride batteries power the Abbott Battery Pack GemStar Pump during periods of transport or when use of AC power is not desirable The battery pack is recharged using an Abbott GemStar AC Mains Adaptor Abbott GemStar PCA 13071 01 Locks the Abbott GemStar Pump and a 60 mL Abbott PCA syringe in Syringe Lockbox a plastic enclosure The lockbox can be attached to an I V pole using 60 mL the Abbott GemStar Pole Clamp available separately Abbott GemStar 13024 01 Locks the Abbott GemStar Pump and up to a 250 mL flexible I V Lockbox 250 mL container in a plastic enclosure The lockbox can be attached to an LV pole u

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