Home

Manual - OSO Home Care

1. 3 Push down on the flow stop G to open priming position the cassette 6 Return the cassette to the upright position Continue priming until fluid fills the tubing Hospira GemStar System Operating Manual 49 Chapter 2 Basic Operation 7 Pushdownon the flow stop to close the cassette e AN F9 v U f X SN E a 8 Connect the extension set to the pump set C J 9 Ensure the slide clamp is open N Z prior to inserting cassette i Note Ensure the tubing is behind the tubing guide at the distal end 9 10 Load the cassette 11 Program the desired therapy 12 Press PURGE CAUTION Ensure all four cassette latches are clearly visible after the cassette is installed Refer to Loading the Cassette on page 35 13 The pump displays PRIME THE SET Press YES ENTER 50 Hospira GemStar System Operating Manual 14 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 N
2. e Responds YES to display questions Accepts entries and goes to the next step Responds NO to display questions 99 Displays information during programming steps and alarm conditions Displays Shift Totals except during programming steps and alarm conditions A 300 oo Clears an AIR IN LINE alarm Primes a GemStar Pump Set 15 9 Li Selects menu items and enters numeric values If two numbers appear before a menu item e g 02 press both number keys to select that item Not all menu items are available with all modes Hospira GemStar System Operating Manual 3 Chapter 1 Introduction GemStar Pump Components Bolus Button Pole Clamp Track Cassette Release Button Power Connector Data Port Connector Bolus Connector Tubing Channel Cassette Pocket LV Tubing Guide Battery Pack Connector Battery Compartment Press this button to start a bolus delivery if available in the current program Use to connect to an optional pole clamp Push down on this button to release the cassette Use to connect the AC mains adaptor Use to connect the GemStar serial cable Use to connect a bolus cord Place the pump set tubing in this channel Load the cassette into this pocket Use to hold the I V tubing Use to connect the GemStar Rechargeable Battery Pack Top View Install two f
3. Hospira GemStar System Operating Manual 149 Notes 150 Hospira GemStar System Operating Manual Chapter 13 Maintenance Pump Storage Store the 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 WARNING DO NOT touch connector ports Refer to caution on page 16 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 NOTt 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 Using abrasive cleaners or cleaning solutions not recommended by Hospira 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 in
4. GEMSTAR Infusion System System Operating Manual For use with the Hospira GemStar Infusion System List 13086 04 List 13087 04 List 13088 04 430 96527 003 A 08 08 Hospira Hospira GemStar Infusion System System Operating Manual For use with the Hospira GemStar Infusion System List 13086 04 List 13087 04 List 13088 04 PLEASE Read this entire manual before using the Hospira GemStar Pump This manual is designed for use by healthcare professionals caregivers and patients The Hospira Technical Support Operations hotline is available 24 hours a day in the USA to provide consultation and technical assistance regarding the Hospira GemStar Pump In the USA Hospira Technical Support Operations 1 800 241 4002 Outside the USA Contact your local Hospira sales office To order additional copies of this manual List 13086 13087 13088 call Hospira Customer Care 1 877 9HOSPIRA 1 877 946 7747 Hospira GemStar System Operating Manual Change History Part Number 430 96527 001 Rev 03 06 430 96527 002 Rev 01 07 430 96527 003 A 08 08 Description of Change Original Issue Second Release Third Release Pages Changed N A All All Hospira GemStar System Operating Manual Contents 1 Introduction 1 GemStar Pump Layout Jk kk kk kk kk kK KI KK KK KK KK KI KK KK KK KK KK KK KK KK e 2 GemStar Pump Components sese nen 4 Iheraples v oisi he eS r gg rrr ie
5. Can be changed before Can be changed at any Cannot be j time changed is pressed e VTBI KVO rate Delivery mode Tapertimes Increase container size Total TPN time only Air sensitivity Note You cannot change a program when the pump is in FULL or CONTAINER Lock To change a program 1 From the STOP mode press CHANGE and select CHANGE PROGRAM 2 As each message displays make the desired changes or press YES ENTER to accept the current setting 3 Review the program Press to begin review 4 Press START to begin infusion Hospira GemStar System Operating Manual 55 9 Chapter 3 Total Parenteral Nutrition TPN Auto Taper Down Auto Taper Down is available only if a Taper Down time was entered 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 56 1 Press STOP during TPN delivery The pump displays DO YOU WANT AUTO TAPERING Press NO to return to the STOP mode Then press START to continue therapy 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 infusion rate whichever is less Note Time is entered in hours minutes 00 00 For one hour thirty minutes press 1 3 0 no
6. To do this function Display the current program settings Comments N A HISTORIES Display the history for the latest 400 events shift or volume totals bolus history if available or current configuration settings Clear the history Display the Operation Test CAUTION Ensure two fresh disposable AA batteries are installed for backup power when using other power sources e g AC mains adaptor docking station battery pack The pump will continue to operate on backup power if the external power source fails Refer to the caution regarding Power Loss on page 14 KEYPAD LOCK Lock and unlock the keypad to prevent unauthorized changes to the program The lock levels allow the clinician to restrict access to various levels of pump operation PUMP SETTINGS Change the air sensor occlusion sensor and sound level settings N A Note This option is not available for List 13088 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 history if available current or personal computer program settings and speed protocols SPEED Assign review recall and delete Allows up to 9 speed protocols to be PROTOCOLS the stored protocols saved in pump memory NEXT DOSE Change the start time of the next NEXT DOSE appears on the m
7. f two numbers appear before a menu item e g 02 press both number keys to select that item 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 so a pump rate above 0 8 mL hr can be used Hospira GemStar System Operators Manual 89 9 Chapter 7 Weight Dosed Programming a Precedex dexmedetomidine hydrochloride injection Delivery If configured and used by your facility you can program a Precedex delivery while programming a Weight Dosed therapy Note Titrate rate loading dose and titrate VTBI are available in Precedex therapy To program a Precedex delivery 1 OS WN 6 Select WEIGHT DOSED from the Programming menu Select MCG KG HR as the unit of measure The pump displays IS THIS A PRECEDEX THERAPY Press YES ENTER Enter patient weight in kg and then press YES ENTER Enter the concentration Enter the unit of measure for the value flashing on the display e Use the AA key to toggle between the values and then press YES ENTER Enter the rate and then press YES ENTER Note Rate is entered in mcg kg hr and then displays in mL hr 7 9 Enter the VTBI in mL and then press YES ENTER The pump displays PROGRAM A LOADING DOSE Press YES ENTER to program a loading dose or NO to review
8. To clear the volume totals END OF 1 Follow the steps for displaying volume totals VOLUME TOTALS CLEAR TOTALS 2 Atthe end of the volume totals the pump displays CLEAR TOTALS YES OR NO e Press YES ENTER to clear the volume totals Press NO to exit OPTIONS without clearing the volume totals YES OR NO A Configuration To display the pump configuration l Press OPTIONS and select HISTORIES 2 Select CONFIGURATION from the Histories Menu 3 Press BACK UP when done to exit OPTIONS Clear History To clear the history event log and bolus history l Press OPTIONS and select HISTORIES 2 Select CLEAR HISTORY from the Histories Menu 3 The pump display CLEARING HISTORY for 3 4 seconds before exiting OPTIONS Tip Press BACK UP to exit OPTIONS immediately 112 Hospira GemStar System Operating Manual 9 Chapter 10 Options Menu Bolus History To display the bolus history l Press OPTIONS and select HISTORIES 2 Select BOLUS HISTORY from the Histories Menu i TIME IS 09 15 AM 3 Press BACK UP when done to exit OPTIONS FRI NOV 10 06 BOL DEL 30 BOL DEM 37 BOL AMT 30 0 mL 06 10A TO 09 14A Sample Bolus History Note Bolus History is only available if the current program has a bolus programmed or had a bolus programmed at one time The Bolus History is maintained in hourly increments for the latest 48 hours The Bolus History is
9. GemStar mL hr Only Programming Worksheet GIVE Parameter Selections and or Values Programmable Ranges to be Entered Therapy mL hr Only N A Rate 0 1 1000 mL hr VTBI Volume To Be Infused 0 1 9999 mL Piggyback Dose Amount 1 7200 mL Piggyback Infusion 1 min or Time dose amount 300 mL hr to 24 hrs min hrs or dose amount 0 1 mL hr 100 Hospira GemStar System Operating Manual Chapter 9 Variable Time Not Applicable to List 13088 Therapy Features and Specifications This therapy allows programming of multiple doses at specified times Optional KVO Keep Vein Open can be set during programming The default bolus delivery rate is 400 mL hr Tip The Programming Worksheet at the end of this chapter lists the minimum and maximum values allowed for this protocol Use copies of the programming worksheet to record program values before programming the pump Variable Time Programming Tips The following table explains how to use the keypad during variable time programming Function Key Function Key 0 9 The DOWN arrow toggles O between units of measure when entering concentrations Scrolls through program review and help messages Selects menu items and enters numeric values AO The UP arrow inserts a decimal Accepts entries or continues when done viewing a display point in a numeric value Displays information during HELP programming and alarm
10. List 13075 03 Chapter 15 Optional System Components Description Plugs into a 100 240 VAC Volt mains supply to power the GemStar Pump while mounted on an I V pole During periods of 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 approximately 6 hours 10 ft 3 m cord GamGiar 44an7a Cannecte the GamSta PBiimn ina GemStar 13078 01 Connects the GemStar Pump to a Serial Cable compatible serial printer or computer to download the event history program or speed protocol information GemStar Connect 13048 01 Allows remote access from a clinician s Clinician Kit computer to a GemStar Pump The Kit includes a modem phone cable serial cable and GemStar Connect software GemStar Connect 13049 01 Use with the GemStar Connect Clinician Kit Patient Kit to allow remote access to a GemStar Pump The Patient Kit includes a modem phone cable and remote pump cable Ace en ND nl Dale bPuemeeav TIKE AA ik a eI ALR DIRT PRA Ghee GemStar Triple Pole 13022 01 Not for use with a lockbox Holds up to three Clamp GemStar devices GemStar Technical 13000 38 Provides advance instructions for Hospira Field Service Manual Certified Technicians GemStar 13000 97 Provides advance instructions for Biomed Configuration Guide technicians
11. WARNING ALWAYS disconnect the pump set from the patient before priming or purging 78 Hospira GemStar System Operating Manual 9 Chapter 6 Continuous Rate Titration To titrate the rate while the pump is infusing 1 Inthe RUN mode press the number keys for the new rate Press YES ENTER For example if the current rate is 50 mL hr press 1 0 0 YES ENTER to change the rate to 100 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 previously programmed 2 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 e Press NO to continue delivery at the previously programmed rate Piggybacking Piggybacking with the GemStar Pump requires a 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 infused are chemically and physically compatible 9 The piggyback rate and piggyback V TBI display until the
12. Bottom li Cap gt 9 Tubing Guide 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 12 Connect the pump set to the patient access device Hospira GemStar System Operating Manual Chapter 2 Basic Operation 43 Chapter 2 Basic Operation Priming Pump Sets WITH a Drip Chamber Using the PURGE Key WARNING Failure to use the pressure activated anti siphon valve may result in unrestricted flow if the cassette is not properly installed in the pump When using a vented set ALWAYS use an air eliminating filter OR set the air sensitivity to either ON or 2 mL KN Note The Purge function is available only if there is a program in the pump 1 Push down on the flow stop to 4 close the cassette 2 Insert the piercing pin into the container Suspend the container 5 on an I V Pole Se T Hi 3 Squeeze the drip chamber until filled halfway Push down on the flow stop to open priming position the cassette Ensure the lower CAIR roller clamp is open prior to inserting cassette 44 Hospira GemStar System Operating Manual 6 Load the cassette CAUTION Ensure all four cassette latches are clearly visible after the cassette is installed Refer to Loading the
13. GemStar System 13981 01 Provides operating instructions for patients Operating Manual and caregivers Hospira GemStar System Operating Manual 167 9 Chapter 15 Optional System Components Connecting the Bolus Cord List 13027 01 Connect the bolus cord to the port labeled Bolus on the bottom of the pump WARNING DO NOT touch connector ports Refer to caution on page 16 WARNING When removing the cord from the bottom of the pump firmly grasp the connector and pull straight out DO NOT twist or bend the cord or connector Using the GemStar Lockboxes The GemStar Lockbox is an enclosure that can be locked with a key to secure the pump and a flexible container or pre filled vial When the pump is secured in the lockbox the user has access to the AC mains data and bolus ports keypad and bolus button Note For the GemStar Universal Lockbox List 12499 01 and GemStar Lockbox with Spring Assist Mechanism SAM List 20706 01 refer to the lockbox for instructions 168 Hospira GemStar System Operating Manual Chapter 15 Optional System Components 30 mL PCA Vial Lockbox List 13077 01 1 Open the lockbox A 8 Load the cassette E 2 Flip the top door up B bi ed E pi nl TY PS M li i CAUTION Ensure all four cassette latches are clearly visible after
14. 250 mL 13024 01 Locks the GemStar Pump and up to a 250 Lockbox not mL flexible I V container in a plastic available enclosure The lockbox can be attached to an for sale I V pole using the GemStar Pole Clamp available separately GemStar 30 mL PCA 13077 01 Locks the GemStar Pump and a 30 mL PCA Vlal Lockbox not vial in a plastic enclosure The lockbox can available be attached to an I V pole using the for sale GemStar Pole Clamp available separately Hospira Carrying 13594 01 Soft sided carrying case can be worn around Case 250 mL the waist to hold the GemStar Pump and up to a 250 mL flexible container Hospira Carrying 13079 01 Soft sided carrying case can be worn around Case 500 mL the waist or over the shoulder to hold the GemStar Pump and up to a 500 mL flexible container Hospira Carrying 13980 01 Soft sided carrying case can be worn around Case 1000 mL the waist or over the shoulder to hold the GemStar Pump and up to a 1000 mL flexible container Hospira Carrying 13593 01 Soft sided carrying case can be worn around Case 3 Liter the waist or as a backpack to hold a 3 liter or smaller flexible container and the GemStar Pump with batteries or battery pack Includes List 13590 01 Hospira 3 Liter Carrier 13590 01 Interior support for the Hospira Carrying Case 3 Liter Hospira GemStar System Operating Manual Product Description GemStar Docking Station Li lon 100 240 Volts
15. 9 Hospira GemStar System Operating Manual Chapter 16 Pump Sets CAUTION USE ONLY GemStar Pump Sets with the GemStar Pump Use of unauthorized sets may result in injury to the patient or damage to the pump Contact a Hospira Representative for appropriate pump set configurations Fluid path and areas beneath undisturbed protective set covers are sterile and nonpyrogenic in the intact unit package STERILE Q The GemStar Pump Sets listed in the table on the following page are available for use with the GemStar Pump Note The disposable pump sets should be changed per the Centers for Disease Control CDC guidelines or health care provider policy Discard after use All GemStar Pump Sets are composed of latex free components only GemStar Pump Sets contain a pressure activated anti siphon valve to reduce the potential for gravity flow at a typical 36 inch head height Some microbore tubing delivery accuracy may be affected when used at extreme operating temperatures lt 10 C gt 35 C relative humidity lt 20 and delivery rates lt 4 9 mL hr gt 350 mL hr Refer to individual set labels for specific instructions and operating conditions The system may underdeliver and the system delivery accuracy may be reduced by as much as 5 when using the following e viscous fluids nonvented syringes e PCA vials except in a lockbox with a spring assist mechanism Delivery accuracy may be impacted when
16. 9999000 mcg 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 Piggyback Dose Amount 1 7200mL Piggyback 1 min or Infusion Time dose amount 300 mL hr to 24 hrs min hrs or dose amount 0 1 mL hr Air Sensitivity may not show in all setting configurations Hospira GemStar System Operating Manual 83 Notes 84 Hospira GemStar System Operating Manual Chapter 7 Weight Dosed Not Applicable to List 13088 Therapy Features and Specifications This therapy allows programming of delivery rate as a function of body weight e The air sensitivity in a Weight Dosed program is automatically set to ON This setting can be changed through the Options Menu after programming is complete Refer to Air Sensitivity in Chapter 10 Options Menu on page 117 The pump automatically delivers KVO Keep Vein Open after the programmed VTBI Volume To Be Infused has completed The rate can be titrated while the pump is infusing e VTBlI can be titrated Tip The Programming Worksheet at the end of this chapter lists the minimum and maximum values allowed for this protocol Use copies of the programming worksheet to record program values before programming the pump WARNING When using a vented drip set ALWAYS use an air eliminating filter or set the air sensitivity to either ON or 2 mL CAUTION When infusing short
17. OPTIONS and select HISTORIES 2 Select HISTORY from the Histories Menu 3 Press or P to scroll the display 4 Press BACK UP when done to exit OPTIONS Shift Totals To display the shift totals l Press OPTIONS and select HISTORIES 2 Select SHIFT TOTALS from the Histories Menu 3 The shift totals display Press or P to scroll the display To clear the shift totals Follow the steps for displaying shift totals At the end of the shift totals the pump displays CLEAR TOTALS YES OR NO e Press YES ENTER to clear the shift totals e Press NO to exit OPTIONS without clearing the shift totals VERSION N NNN S N XXXXXXXX TIME IS 09 00 AM FRI NOV 10 06 NEW CONTAINER 08 15AM NOV 10 HISTORY CLEARED 11 00PM NOV 9 EVENT LOG PM11 18 SET ON AIR SENSITIVITY PM11 18 SET CONT SIZE 100 mL PM11 18 SE RATE 1 0 mL hr PM11 18 SHIFT CLEARED END OF EVENT LOG Sample History Event Log END OF SHIFT TOTALS CLEAR TOTALS YES OR NO A Tip Press HELP to display shift totals when the pump is not in PROGRAMMING mode or an alarm condition Hospira GemStar System Operating Manual 111 Chapter 10 Options Menu Volume Totals To display the volume totals l Press OPTIONS and select HISTORIES 2 Select VOLUME TOTALS from the Histories Menu 3 Press BACK UP when done to exit OPTIONS
18. The first set should be fully primed BEFORE beginning the volume accuracy test Use a second DRY set for the air in line test When the proximal occlusion test is complete remove the WET set from the pump and insert the DRY set Press START to begin the air in line test The WET set can then be placed in the next unit ready for testing 3 Ensure slide clamp is open prior to inserting cassette Volume Accuracy Test The pump should deliver between 19 0 to 21 0 mL within approximately 3 minutes to pass this test Ensure slide clamp is open prior to inserting cassette Load a primed pump set into the pump Press e Place the proximal end in the reservoir of water Press e Place the distal end in a 20 mL graduated cylinder Press Wy Press START OM A UNBE Enter the results e Ifthe pump delivers between 19 0 to 21 0 mL press YES ENTER e Ifthe pump does not deliver between 19 0 to 21 0 mL press NO Hospira GemStar System Operating Manual 159 Chapter 14 Operation Test Distal Occlusion Test The occlusion should occur within approximately 30 seconds to pass this test 1 Clamp the pump set 10 to 12 inches 25 4 to 30 5 cm below the cassette Press START 3 The test result displays Release the clamp and press If the test is passed the pump advances to the next test If the test is failed clean the sensors and press to rerun the test or press YES ENTER to confirm failure Note Clean the
19. 126 1 OU BW N Ensure slide clamp or lower CAIR clamp is open prior to inserting cassette Install a cassette into the pump Connect the GemStar serial cable to the null modem Connect the null modem to the serial gender changer Connect the serial gender changer to the serial port of the computer Connect the GemStar serial cable to the data port on the bottom of the pump Configure the communication software on the computer Refer to Configuration Settings on page 123 Tip After the data transfer is complete use any text editor to view or print the file Hospira GemStar System Operating Manual 9 Chapter 10 Options Menu Transferring Data Using a Computer The GemStar Pump can be connected to a Windows mp h suka The Ioan instructions apply to Computers using Microsoft Windows 95 Windows 98 or Windows NT 4 0 or higher Creating a New Connection Note The following procedure is only needed to create a New Connection the first time the pump is connected to the computer To create a new connection l Follow steps 1 4 in Using an Existing Connection on the following page 2 Ifa message appears asking if a modem is necessary for a connection click NO 3 Enter a name for the new connection e g GemStar Print Files and choose an icon Click OK From the Connect drop down menu select the appropriate COM port Click OK Verify that the following settings are corr
20. 13072 01 Tabletop adaptor plugs into a 100 240 VAC AC Mains Adaptor mains supply to power the GemStar Pump 100 240 Volts Universal GemStar 13027 01 Allows bolus requests to be made up to 6 feet Bolus Cord 1 8 m from the pump Gamenm8 TT l4an7 amp Attaches the Ganaia pimninanlV nae GemStar 13076 01 Attaches the GemStar Pump to an I V pole Pole Clamp The clamp is mounted to the track on the back of the pump Press the release button to remove the pump GemStar Locking 20207 01 GemStar locking pole clamp Pole Clamp GemStar Battery 13073 03 The rechargeable Li lon batteries power the Pack GemStar Pump during periods of transport or Li lon when use of AC power is not desirable The battery pack is recharged using a GemStar AC mains adaptor Hospira GemStar System Operating Manual 165 Chapter 15 Optional System Components Product Description List Description GemStar Universal 12499 01 Locks the GemStar Pump and up to a 250 Lockbox mL flexible I V container or 30 mL PCA vial in a plastic enclosure The lockbox can be attached to an I V pole using the GemStar Pole Clamp available separately GemStar Lockbox 20706 01 Locks the GemStar Pump and a 30 mL PCA with Spring Assist vial in a plastic enclosure The lockbox can be Mechanism SAM attached to an I V pole using the GemStar Pole Clamp available separately GemStar
21. 2 Integral Pressure Activated Anti Siphon Valves and Y Extension with Backcheck Valve Secure Lock Microbore Tubing 97 inch 246 cm General Infusion Sets 13244 Latex Free GemStar HEMA II Y Type Blood Set 210 Micron Filter Lower CLAVE Connector Macrobore Tubing 110 in 279 cm 13267 Latex Free LifeShield GemStar Primary Piggyback Pump Set Secure Lock Convertible Macrobore Tubing Piercing Pin 2 CLAVE Connectors Pre Attached Pressure Activated Anti Siphon Valve Macrobore Tubing 110 in 279 cm 13272 Latex Free LifeShield GemStar 150 x 60 Micro Drip SoluSet Option Lock Convertible Piercing Pin 2 CLAVE Connectors Macrobore Tubing 110 in 279 cm 13274 Latex Free LifeShield GemStar Piggyback Pump Set with 0 2 Micron Filter Secure Lock Convertible Piercing Pin 3 CLAVE Connectors Pre Attached Pre Activated Anti Siphon Valve Macrobore Tubing 110 in 279 cm Hospira GemStar System Operating Manual 181 Notes 182 Hospira GemStar System Operating Manual Chapter 17 GemStar Pump Specifications Physical Dimensions Weight The GemStar only Height 5 7 in 14 5 cm Pump is composed of latex free components Width 3 8 in 9 7 cm Depth 2 0 in 5 1 cm Approximately 18 oz 526 grams excluding batteries Transport and Storage Environment Ambient Temperatures Relative Humidity Atmospheric Pressure Store in cool a
22. 32 STOP key 3 STOP mode 9 taper down 53 54 56 taper up 53 technical assistance 200 Therapies 5 Continuous 77 83 Intermittent 69 75 mL hr Only 93 100 Pain Management 59 66 Precedex 90 Total Parenteral Nutrition TPN 53 57 Variable Time 101 106 Weight Dosed 85 Therapy Lock 114 lock level functions 115 Locking Sequence Instructions 130 unlocking the pump 132 Titrate Rates 5 Titrate VTBI 5 Total Parenteral Nutrition See TPN therapy TPN therapy 5 53 57 Auto Taper Down 56 changing a TPN program 55 features and specifications 53 programmable ranges 57 programming of 54 Programming Worksheet 57 troubleshooting 135 149 alarm messages 136 144 alert messages 145 other display messages 149 Hospira GemStar System Operating Manual U unlocking the pump 132 V Variable Time therapy 5 101 106 changing a Variable Time program 104 delivery interruptions 103 features and specifications 101 programmable ranges 105 programming of 101 Programming Worksheet 105 Volume To Be Infused See VTBI VTBI 78 86 94 piggyback VTBI 79 81 96 98 VTBI Titration 88 96 W warnings and cautions 11 air in line 13 handling and maintenance 16 pump operation 13 Weight Dosed therapy 5 85 Auto KVO 87 changing a Weight Dosed program 88 features and specifications 85 Precedex programming worksheet 91 programmable ranges 89 91 programming of
23. 86 programming worksheet 89 rate titration 64 87 V TBI Titration 88 worksheet Continuous Programming 83 Intermittent Programming 75 mL hr Only Programming 100 Pain Management Programming 66 Precedex Programming 91 TPN Programming 57 Variable Time Programming 105 Weight Dosed Programming 89 Hospira GemStar System Operating Manual Y YES ENTER key 3 31 209 Notes 210 Hospira GemStar System Operating Manual CAUTION Federal USA law restricts this device to sale by or on the order of a physician or other licensed practitioner DANGER Possible explosion hazard exists if used in the presence of flammable anesthetics Authorized Representative Hospira Finisklin Business Park 0050 Sligo Republic of Ireland The C and US indicators adjacent to the CSA Mark signify that the product has been evaluated to the applicable CSA and ANSI UL Standards for use in Canada E amp MCN 160992 and the U S respectively This US indicator includes products eligible to bear the NRTL indicator NRTL i e National Recognized Testing Laboratory is a designation granted by the U S Occupational Safety and Health Administration e US OSHA to laboratories which have been recognized to perform certification to U S Standards Equipment providing an adequate degree of protection against electrical shock and suitable for application to patient Type CF TP X 1 Protected
24. Bah 5 GemStar Pump Features scc kk kk kk KK KK KE KK E KK ga Sta a 6 Menu System i kk kk kK kk KK KK KK KK kK KK kK kK kk kK kk kk kk kk kk kk kk kk kk 7 Operating Modes 0 0 kk kk KK KK KK KK KK KK KK kk kk kk kK kK kk kK kK kk ke 9 Indications for S6 4 cox wa kk kirl yu eee ee 10 Contraindications for Use i kk kk KK KK KK KK KK tee 11 Warnings and Cautions kk kk kK kK KK KK KK KK KK KK KK kK kK kk kK kk kk 11 2 Basic Operation 19 OVSIVIOW o eu Rei et ee m edis p o Ene HH 19 Selecting a Power Source s susua uaaa ees 20 Powering On the PUmp kk kk kk kk kk kk KK KK KK KK rn 27 Accessing the Programming Menu u kk kk KK KK KI eee 29 Programming the Pump lt Jy rrak uA aN Ea EAR k aka kak xw dak d k kK 30 Starting a New Container Ak kk kk kk kK KK KK KK KK KK KK KK KK KK KK KK KK K 32 GemStar PUMP Set ect ais e pee RrRr e LE cept ieee 32 Loading the Cassette i kk kk kK KK kK KK KK KK KK KI KK KK KI ren 35 Releasing the Cassette 0 kk kK kK KK KK KK seh 36 Priming a GemStar PUMP Seb emu Ike tete bei AU 37 3 Total Parenteral Nutrition TPN Not Applicable to List 13088 53 Therapy Features and Specifications kk KK KEK KEK eee 53 TPN Programming 2 gt 4 25y lisse m ja5 Kadri 54 Changing a TPN Program kk kk kk kk KK KK KK KK KK KK KK n 55 TPN Auto Taper Down ssesleee eae 56 TPN Programming Worksheet kk kk kk KK KK KK KIR KK KIR
25. Cassette on page 35 2 Note Ensure the tubing is behind the tubing guide at the distal end Hospira GemStar System Operating Manual 9 Chapter 2 Basic Operation Bottom Cap tL Tubing Guide 7 Program the desired therapy 8 Press PURGE 9 The pump displays PRIME THE SET Press YES ENTER 10 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 11 Connect the pump set to the patient access device 45 9 Chapter 2 Basic Operation Priming Pump Sets Using Pre filled Vials WARNING Failure to use the pressure activated anti siphon valve may result in unrestricted flow if the cassette is not properly installed in the pump A cracked vial might not show evidence of leakage until delivery pressure is applied When using the GemStar Spring Assist Mechanism SAM Lockbox USE ONLY GemStar Pump sets designated for use with the GemStar SAM Lockbox Failure to use designated sets could result in unrestricted flow CAUTION When usi
26. KK KI K KI KOK KK ke 57 4 Pain Management Not Applicable to List 13086 59 Therapy Features and Specifications s an kk kK KK KEK KK KIRR KIK 59 Pain Management Programming kk kk kk kK KK KK KIR KK RIK K KIR K K KIR KI KK 61 Hospira GemStar System Operating Manual iii Contents Bolus Delivety co d Qada sha Sada ku ud er ME RiQU GNEPBE uen ted 62 Loading Dose Delivery sas sae na a ba E k n ura e ne 64 Changing a Pain Management Program Xa KK KK RR RR KK KK KK 65 5 Intermittent Not Applicable to List 13088 69 Therapy Features and Specifications 0 0 KEK KK KK KRE KK 69 Intermittent Programming is s3 lt 4 e ua WA kaml RII It 70 Intermittent Delivery Interruptions lisse BBBBIIR 72 Changing an Intermittent Program lisse 74 Intermittent Programming Worksheet a a kk kk kk KK KK KK KK eene 75 6 Continuous Not Applicable to List 13088 77 Therapy Features and Specifications k kk kk kk kK KEK KRE K 77 Continuous Programming kk kk kk kk kk KK KK KK KK KI KK KK KK KK KK KK KK k 78 Rate Titration cue meh ep be ROOM Va RU ER ERROR EE 79 PIQQYDACKING s 2 crecen d cte eee a Peis Vip MIL Rec ea De DC 79 Changing a Continuous Program 0000 KK KK KK KK KK KK 82 Continuous Programming Worksheet Wu kK KK KK KK KK eee tenes 83 7 Weight Dosed Not Applicable to List 13088 85 Therapy Features and Specification
27. New Container AS 9 Revised step 3 to align with software per REF2800123 Note The NEW CONTAINER function is not available when the pump is in FULL Lock Refer to Chapter 10 Keypad Lock page 114 for more information To repeat the current program with a new container 1 From the STOP mode press CHANGE to display the Change Menu 2 Select NEW CONTAINER from the Change Menu The pump displays NEW CONTAINER for several seconds and clears the amount infused from memory Note In Weight Dosed mL and Pain Management therapies the VTBI can be p es 3 IfProgram Review is desired press OPTIONS then press 1 to begin review 4 Press START to begin delivery GemStar Pump Set 32 The GemStar Pump Set is a sterile single use disposable pump set It is designed for one time use only and should be properly discarded after use Fluid path and areas beneath undisturbed protective set covers are sterile and nonpyrogenic in the intact unit STERILE package Contact a Hospira 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 To use a GemStar Pump Set follow the instructions included with the set Note GemStar Pump Sets contain a pressure activated anti siphon valve to reduce the potential for gravity flow at a typical 36 inch h
28. PRINT 2 Press the number key for the desired print function 3 When printing is complete the pump exits OPTIONS R HISTORIES KEYPAD LOCK P S UMP SETTINGS ET CLOCK oa es WN m 7 8 NEXT DOSE EVIEW PROGRAM SPEED PROTOCOL Select this item from To do this function the Print Menu PRINT HISTORY Print the current program shift and volume totals and history event log 400 events PRINT PROGRAM Print the current program PRINT PROTOCOL Print a specified speed protocol or a complete list of all speed protocols PRINT BOLUS Hx Print the current program shift and volume totals and the bolus history Hx for the latest 48 hours STOP PRINT Cancel printing This function is only available if the pump is printing Hospira GemStar System Operating Manual 119 9 Chapter 10 Options Menu Speed Protocol 1 2 Select this item from the Speed Protocol Menu ASSTGN Press OPTIONS and select SPEED PROTOCOL Press the number key for the desired protocol function Follow the display messages Refer to the instructions for Speed Protocol functions for more information Note Up to nine speed protocols are stored at one time The speed protocols stay in memory even when the pump is powered down until they are deleted To do this function R CO 01 B WN n2
29. Pump has been powered on with insufficient power Source Hospira GemStar System Operating Manual mains adaptor rechargeable battery pack or replace both disposable batteries with fresh AA batteries Power on the pump and resume the current program Refer to Accessing the Program Menu in Section 2 for more information Review the program if required Press START to begin infusion CAUTION Ensure two fresh disposable AA batteries are installed for backup power when using other power sources e g AC mains adaptor docking station battery pack The pump will continue to operate on backup power if the external power source fails Refer to the caution regarding Power Loss on page 14 141 Chapter 12 Troubleshooting detected sustained negative pressure on its proximal side Alarm Display Is the Alarm Cause Remedy Message pump Condition infusing Y Yes A Audible alarm N No V Visual alarm PROX OCCLUSION N A N The pump has 1 Press SILENCE to quiet the alarm for 1 minute 2 Press STOP to place the pump in the stop mode WARNING When a Proximal Occlusion alarm activates DO NOT power off the pump 3 Check for sources of proximal occlusion Kinked tubing above pump Blockage in the container and in the spike Closed clamps above pump Empty container High torque syringe Other obstructions 4 Remove obstructions 5 Press START
30. RR E W 145 Other Display Messages 0 0000 cece eee KK KK KK kK kK kk kk 149 Hospira GemStar System Operating Manual V Contents 13 Maintenance 151 Pump Storage dieere nhe pe ec rex eie I ERA RR 151 Cleaning and Disinfecting kk kk kK kK kK KK KK KK KK KI KK KK ese 151 prac ed 153 14 Operation Test 155 Equipment Required kk kk kk kk kK kK KK KK KIR nh 155 Test Setip sure ors a kana de W s al UP dici eS ea A aE tud Ros NS ce USE 156 Performing the Operation Test 00 000 KK KK KK KK KK KK KK KK KK KI 156 Printing Test Results ius sexe Yil ale em Rum bla a n bac e la RU 161 GemStar HHR HHHH HH n 163 Operation Test Checklist kk kk kK kK KK KK KK KK KK ren 163 15 Optional System Components 165 Connecting the Bolus Cord kk kk kk kk KK KK KK KK KK KK eee 168 Using the GemStar Lockboxes WW kk kk kk KE KK KK KK Ya 168 Using the Hospira Carrying Cases 0 0 00 kK KK KK KK KK KK KK KI KK KK 171 Using the GemStar Docking Station n sisse s esee sss 177 16 Pump Sets 179 17 GemStar Pump Specifications 183 Occlusion Information liiliseeeellee es 186 18 Warranty Technical Assistance 199 A Electrical Potentials 201 Guidance on EMC Compatibility llle 201 Information Regarding Electrostatic Discharge ESD 202 Index 203 IEC Symbols inside back cover vi Hospira GemStar
31. System Operating Manual e 9 Chapter 1 Introduction The GemStar Pump is a small and lightweight single channel infusion device designed for use in the home in the hospital or anywhere electronic infusion is required The GemStar Pump can be powered by AC mains adaptor rechargeable battery pack docking station or two disposable AA alkaline batteries When powered by batteries the GemStar Pump is ideal for ambulatory patients The following conventions are used throughout this manual Convention Use Example ALL CAPS Pump keys Press YES ENTER to continue ALL CAPS Display messages The pump displays ENTER TO CONFIRM WARNING A WARNING message contains special safety information and must be observed at all times Failure to observe a warning message could be life threatening CAUTION A CAUTION contains information that could prevent irreversible product damage or hardware failure Failure to observe a caution could result in serious patient or user injury Note A NOTE contains information or examples to help explain instructions Tip A TIP contains information that makes the pump easier to use Note Examples are provided only to help explain a pump function and may not be clinically relevant Graphics are for illustrative purposes only and may not reflect the actual product Hospira GemStar System Operating Manual Chapter 1 Introduction GemSt
32. affected when used at extreme operating temperatures lt 10 C gt 35 C relative humidity lt 20 and delivery rates 4 9 mL hr gt 350 mL hr Refer to individual set labels for specific instructions and operating conditions Note False occlusion alarms and fluid delivery inconsistencies may occur when 4 pumping viscous fluids in microbore tubing at rates greater than 500 mL hr Trumpet Curves The Trumpet Curve Graphs following the Example show representative maximum and minimum percent flow rate deviation from the programmed rate over time This information was developed in accordance with IEC 60601 2 24 1998 Sub Clause 50 102 Refer to this standard for detailed information How to read a Trumpet Curve Graph Refer to example on the following page The graphs following the Example plot flow rates at 30 second intervals for the first 2 hours and for the 96th hour of delivery The graph plots mean delivery rate error Average of 3 pumps for the 2nd hour and the 96th hour as a straight line The graph also presents maximum and minimum average delivery rate error for this interval plotted by averaging delivery errors over intervals of 2 5 11 19 and 31 minutes Trumpet Curve Example From the Trumpet Curve Graph sample that follows find the 5 minute interval A at the horizontal axis and read the corresponding points B and C on the vertical axis The values are approximately 2 8 and 0 5 This means that
33. 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 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 External Power LED Green LED marked with plug icon lights continuously when pump is connected to AC mains power Green LED flashes when pump is connected to external batteries Alarm LED Red LED marked with alarm icon lights during alarm conditions Audible Alarm The audible alarm is user adjustable from the maximum volume down to silent The alarm cannot be turned off completely The alarm automatically reverts to the maximum volume if the user does not respond within one minute Display Backlight on AC Backlight on Batteries Backlit four line by sixteen character alphanumeric graphics display Continuous Continuous during programming program review and history display otherwise activated by keypress or alarm not activated by bolus request Real Time Clock 184 Accuracy of 5 minutes per month or better at temperatures between 59 F and 95 F 15 C and 35 C Hospira GemStar System Operating Manual Chapter 17 GemStar Pump Specifications Print Function Port amp Interface RS 232 serial interface port data port
34. changed before D is pressed Current time Baserate Daily amount Phase parameters Cannot be changed Unit of measure Concentration Phasetype Note You cannot change a program when the pump is in FULL or CONTAINER Lock Note The clock cannot be changed while a Variable Time Program is in progress If START has already been pressed in a Pain Management program when the SET CLOCK function is selected from Stop Mode the following message shall display from 2 5 seconds during which no keys shall be valid except YES ENTER as a quick escape before returning to the Stop Mode display To change a program 1 From the STOP mode press CHANGE and select CHANGE PROGRAM 2 As each program parameter displays make the desired changes or press YES ENTER to accept the current setting 3 Review the program Press to begin review 4 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 104 Hospira GemStar9 System Operating Manual Chapter 9 Variable Time GemsStar Variable Time Programming Worksheet GIVE Parameter Selections and or Values to be Entered Programmable Ranges Select Phase Type Percentages 0 1 100 Q Rates 0 1 400 mL hr Q Doses 0 1 9600 mL Unit of Measure Q Concentration mg mL 0 1 1000 mg mL Q C
35. cleared when a new program is entered a Speed Protocol is recalled or the History is cleared Operation Test The Operation Test checks several pump functions to ensure the GemStar Pump is working properly Refer to Chapter 14 Operation Test on page 155 for instructions Hospira GemStar System Operating Manual 113 Chapter 10 Options Menu 9 Keypad Lock 114 REVIEW PROGRAM l Press OPTIONS and select KEYPAD LOCK from HISTORIES ihe Options Menu hh 5 e 2 Select the desired lock level e UE 5 SET CLOCK 6 PRINT The following lock levels listed from lowest to highest 7 SPEED PROTOCOL restrictions are available 8 EXT DOSE Lock Level Abbreviation Therapy Lock T Rate Change R ERAPY LOCK Lock E CHANGE Container Lock C TAINER Full Lock F i The GemStar Pump allows two lock levels at the same time Therapy Lock can be used with either Full Lock Container Lock or Rate Change Lock Note Therapy lock is not available for List 13088 When two lock levels are applied if a function is available under one lock level but not the other the more stringent restrictions apply The table on the following page lists the functions available for each lock level When the pump is locked under a particular level a small lock symbol appears next to the applied lock level as shown above When the pump is in RUN or STOP mode the
36. conditions Clears a numeric value resets Co to zero during programming Returns to a previous display BACK UP exits the Options Menu and exits the HELP mode Hospira GemStar9 System Operating Manual 101 9 9 9 Chapter 9 Variable Time Variable Time Programming 1 OU BQ N 8 9 Select VARIABLE TIME from the Programming Menu Select the phase type 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 Then go to step 8 Note If programming in percentages the total daily amount of all phases pro grammed must equal 100 Enter the phase information for each phase Up to 24 phases can be programmed Note When entering time in 12 hour format press or P to toggle between AM and PM Enter the optional bolus dose and its lockout Enter the optional KVO 10 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 Increase the container size to include bolus deliveries 11 Select the air sensitivity if required 102 Hospira GemStar System Operating Manual Chapter
37. lock symbol appears in the lower left corner of the display and the lock level abbreviation appears in the lower right corner Clinicians refer to Chapter 11 Clinician Instructions on page 129 for detailed instructions Hospira GemStar System Operating Manual Chapter 10 Options Menu GemStar Keypad Lock Level Functions U Unlock C Container Lock T Therapy Lock F Full Lock R Rate Change Lock Function is Available Function U T R J CJI F Comments Lock Unlock Keypad e JJ JI JJ II Rate Change Lock is available only if the current program is Pain Management Power Pump On or Off CRI ile fre fe Start or Stop Infusion e JJ jie ile le Access Display Help Print and He IJ JI Program Review Functions Deliver a Bolus e JJ jie ie JI If programmed Silence an Alarm e JJ JI ile Ife Select a New Container MEER CO Purge elle le TI Change a Program e e e 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 jj 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 IE Occlusion Level Sound Level and Clock Clear Shift Totals elle TI Te Progra
38. minimum baud rate of 2400 isolated circuit Printers Seiko DPU 414 or compatible serial printer System Accuracy Continuous 1096 for rates of 0 1 mL to less than 5 mL hr 596 for rates of 5 mL to 1000 mL hr Air Sensitivity ON Pump alarms at approximately 0 5 mL of air Alarms for any bubble greater than 500 microliters with a tolerance of 200 microliters 2 mL 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 OFF Alarm is not activated Recommend using air eliminating filter when Air Sensitivity is set to OFF Occlusion Sensitivity Distal Occlusion Proximal Occlusion Alarms when pump detects distal pressure within a selectable range Low 7 psi 48 kPa 5 psi 34 kPa Medium 12 psi 83 kPa 8 psi 55 kPa High 26 psi 179 kPa 14 psi 96 kPa Alarms when pump detects proximal pressure less than or equal to 4 psi 28 kPa Pump Self Tests and Safety Features Hospira GemStar System Operating Manual 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 Chapter 12 Troubleshooting 185 Chapter 17 GemStar Pump Specifications Occlusion Inform
39. not sound at power on check all power connections and install two fresh disposable AA batteries If the problem continues contact Hospira Technical Support Operations before using the pump Note If a cassette is not properly loaded the pump will sound an alarm after the a power on test is complete 1 Press ON OFF to power on the pump The pump completes a self test and displays the time and date No response is required GEMSTAR 7 UNIT SELF TEST TIME IS 10 00 AM FRI NOV 10 06 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 9 2 The pump checks for available power sources Respond to the display message as shown in the following table Display Message Power Source s User Response No message displays AC power and No response required the pump goes disposable batteries to the next step LOW BATTERIES AC power and weak Press to confirm low voltage ENTER TO Ce disposable batteries Power off the pump and install two or weak disposable fresh disposable AA batteries as a batteries only backup power source NO INTERNAL BATT No disposable Press to confirm NO POWER LOSS batteries or dead ALARM AVAILABLE _ disposable batteries Power off the pump and install two ENTER TO CONFIRM and external power fresh dispo
40. open prior to inserting cassette D Distal Reinstall the cassette P Proximal CAUTION Ensure all Li four cassette latches are clearly visible after the cassette is installed Note Ensure the tubing is behind the tubing guide at the distal end Refer to Loading the Cassette on page 35 Press START to begin infusion Note The pump cannot be powered off during a CHECK CASSETTE alarm except during PROGRAMMING mode CALL N A V The pump has Write down the telephone number and code Power off the pump If the pump does not power off disconnect external power and remove the batteries Call the telephone number shown on the display message 138 Hospira GemStar System Operating Manual Chapter 12 Troubleshooting detected sustained distal pressure over the user selected limit To avoid a bolus infusion after an occlusion complete the following steps 1 Press STOP 2 Close the distal clamp 3 Pressthe cassette release button to remove the cassette from the pump 4 Open the flow stop 5 Wait 10 seconds 6 Close the flow stop 7 Loadthe cassette into the pump 8 Open the distal clamp 9 Review the program 10 Press START to start the pump Alarm Display Is the Alarm Cause Remedy Message pump Condition infusing Y Yes A Audible alarm N No V Visual alarm DIST OCCLUSION N A N The pump has 1 Press SILENCE to quiet the alarm f
41. sensitivity The pump alarms when distal pressure is greater than the selected occlusion sensor limit SOUND LEVEL Adjust the audible Default Setting Maximum alarm level The alarm cannot be turned off completely The alarm automatically reverts to the maximum volume if the user does not respond within one minute Note The current setting flashes on the display 116 Hospira GemStar System Operating Manual 9 Chapter 10 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 1 Press OPTIONS and select AIR SENSITIVITY The current air sensitivity flashes on the display 2 Select the desired Air Sensitivity level Note If OFF is selected the pump displays AIR ELIMINATING FILTER IS RECOMMENDED ENTER TO CONFIRM You must press YES ENTER fo confirm 3 After selecting the desired Air Sensitivity the pump displays CHANGE AIR ALARM FROM XXXX TO XXXX e Press NO to keep the current air sensitivity The current air alarm status displays and the pump exits OPTIONS AIR SENSITIVITY 1 ON 2 2 mL 3 OFF CHANGE AIR ALARM FROM XXXX TO XXXX YES OR NO e Press YES ENTER to accept the new setting The new air alarm status displays and the pump exits OPTIONS Occlusion Sensor 1 Press OPTIONS and select PUMP SETTINGS 2 Select DIS
42. sensor pins before repeating the distal occlusion test Refer to Chapter 13 Maintenance for instructions 9 Proximal Occlusion Test The occlusion should occur within approximately 30 seconds to pass this test l Clamp the pump set above the cassette Press START The test result displays Press Y If the test is passed the pump advances to the next test If the test is failed clean the sensors and press to rerun the test or press YES ENTER to confirm failure Note Clean the sensor pins before repeating the proximal occlusion test Refer to Chapter 13 Maintenance for instructions 160 Hospira GemStar System Operating Manual Chapter 14 Operation Test Air in line Test The air in line alarm should occur within approximately 1 minute to pass this test Ensure slide clamp or lower CAIR clamp is open prior to inserting cassette Release the clamp Remove the proximal end of the pump set from the reservoir Press Y Press START The test result displays Press e Ifthe test is passed the pump advances to the next test O A U N Be e Ifthe test is failed clean the sensors and press D to rerun the test or press YES ENTER to confirm failure Note Clean the sensor faces before repeating the air in line test Refer to Chapter 13 4 Maintenance for instructions Printing Test Results When the test is complete the pump displays an option to print the test results If desired follow the ste
43. service manual concerning operating devices near RF sources Information Regarding Electrostatic Discharge ESD Electrostatic discharge is a transfer of electric charge between bodies of different electrostatic potential in proximity or through direct contact For example an electrostatic discharge might be observed when exiting a car on a very dry day After exiting the car and then touching the car door electrostatic discharge can often be felt and seen Discharging one s body by touching the door with the car key will effectively eliminate these effects Electrostatic discharge can damage electronic equipment At a minimum all staff using the device including clinical biomedical engineering and healthcare staff should read and adhere to the precautionary procedures below Precautionary Procedures One of the most common causes of electrostatic damage to electronic devices is the direct transfer of electrostatic energy from the human body to the electrostatic discharge sensitive electronic equipment DO NOT touch any connectors with fingers or any hand held metal object unless proper precautionary procedures have been followed Methods to prevent build up of electrostatic charge should be employed The use of air conditioning and or humidification conductive floor coverings and non synthetic clothing is recommended during use or servicing of the device Itis recommended that the device be used in areas that have wood concre
44. set connected to the patient Install another cassette in the pump before connecting to a printer or computer Equipment Needed Connect to Printer Connect to Computer GemStar Pump Hospira 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 Hospira GemStar System Operating Manual 9 Chapter 10 Options Menu Configuration Settings Refer to the printer or computer documentation for information on configuration settings Configure the printer or computer 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 2 None Note When using the Seiko DPU 414 printer the switch settings MUST be configured to work with the GemStar amp Pump To configure the switch settings on the Seiko DPU 414 l Press and hold the ONLINE button while sliding the POWER switch to ON 2 When the list of the current settings start printing release the ONLINE button 3 Setthe switches according to the following table Press the ONLINE button to continue setting switches Press ONLINE to set switch ON Press FEED to set switch OFF 4 Continue setting switches until Dip SW setting complete is printed Hospira GemStar System Operating Manual 123 Chapter 10 Options Me
45. the rechargeable battery pack 23 warnings and cautions 14 17 battery pack charge 24 connect 24 release 24 baud rate 185 configuration settings for the Data Port 123 127 switch settings for Seiko printer 124 bolus 5 10 64 bolus button 4 bolus delivery 62 63 bolus dose interruptions 63 clinician instructions 130 131 connecting the bolus cord 168 history 108 occlusion information 186 optional system components 165 203 Index in Pain Management therapy 59 63 print 108 119 in Variable Time therapy 101 104 1 hour or 4 hour dose limit 61 C call back alarm 69 carrying cases using the Hospira carrying cases 171 176 cassette 33 cassette pocket 4 cassette release button 4 cleaning of 151 153 error message 138 inspection of 157 loading 35 loading the cassette 35 releasing the cassette 36 warnings and cautions 13 Change History ii CHANGE key 3 31 Change Menu 8 charging battery pack 24 clinician instructions 129 133 adding a second lock level 131 locking the pump 130 program and deliver a clinician activated loading dose 132 133 unlocking the pump 132 configuration settings data port 123 connect battery pack 24 connect pump 25 connecting the bolus cord 168 connecting the GemStar AC mains adaptor 22 connecting to a computer 126 See also Data Port connecting to the Seiko printer 125 See also Data Port 204 continuous delivery in Pain Management the
46. 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 The pump provides step by step instructions through each section of the test Note This test is available only when the pump is UNLOCKED WARNING Disconnect the pump from the patient BEFORE performing the Operation Test Equipment Required GemStar Pump Two 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 GemStar AC mains adaptor or other Hospira approved external power source Hospira GemStar System Operating Manual 155 Chapter 14 Operation Test Test Setup Note The pump clears any program and shift totals stored in pump memory before 4 starting the Operation Test Connect the external power source and install two fresh disposable AA batteries Power on the pump Press OPTIONS Select HISTORIES from the Options Menu Select OPERATION TEST from the Histories Menu OU A UNBE Follow the instructions on the display Performing the Operation Test 9 Tip The checklist at the end of this section may be copied to record test results Case Inspection l Visually inspect the case and keypad for damage Check the case for missing screws or labels 2 Ent
47. to begin delivery 6 If the problem continues ensure slide clamp or lower CAIR clamp is open Power off the pump Reinstall the cassette Turn on the pump Note Ensure the tubing is behind the tubing guides at the distal end CAUTION Ensure all four cassette latches are clearly visible after the cassette is installed Refer to Loading the Cassette on page 35 142 Hospira GemStar System Operating Manual Chapter 12 Troubleshooting response when Alarm Display Is the Alarm Cause Remedy Message pump Condition infusing Y Yes A Audible alarm N No V Visual alarm USING BATTERIE Y V This is a normal When powering on the pump 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 Press YES ENTER to confirm disposable batteries are the only power source When switching from AC mains power Press SILENCE to clear the alarm CAUTION Ensure two fresh disposable AA batteries are installed for backup power when using other power sources e g AC mains adaptor docking station battery pack The pump will continue to operate on backup power if the external power source fails Refer to the caution regarding Power Loss on page 14 Hospira Gem
48. 1 111 133 135 HELP mode 9 history 6 62 64 108 110 151 display bolus history 113 display clear history 112 print bolus history 108 119 l infusion system layout 22 3 Intermittent therapy 5 69 75 changing an Intermittent therapy 74 Hospira GemStar System Operating Manual changing the start time 108 delivery interruptions 72 73 features and specifications 69 Next Dose function 121 programmable ranges 75 programming of 70 71 Programming Worksheet 75 K Keep Vein Open See KVO Auto KVO KVO 5 in Continuous therapy 77 in Intermittent therapy 69 75 in mL hr Only therapy 95 in TPN therapy 53 in Variable Time therapy 101 in Weight Dosed therapy 85 87 troubleshooting 149 L Li Ion Battery Pack 165 Li Ion Docking Station 167 loading dose 5 61 clinician activated loading dose 132 133 delivery 64 64 65 in Pain Management therapy 59 loading the cassette 35 lock 3 adding a second lock level 131 Full Lock 114 115 keypad lock 6 108 114 keypad lock level functions 115 locking the pump 130 Luer Lock 12 Rate Change Lock 65 114 115 130 131 unlocking the pump 132 lockboxes using the GemStar lockboxes 168 171 locking the pump 130 adding a second lock level 131 205 Index Luer Lock 12 maintenance 151 153 cleaning and disinfecting 151 cleaning the cassette pocket and tubing channel 153 cleaning the pump case 152 recommended cleaning so
49. 5 Enter the rate Note The pump automatically displays the mL hr equivalent even when another unit of measure is selected 6 Enter the VTBI 7 Review the program Press P to begin review 9 86 Hospira GemStar System Operators Manual Chapter 7 Weight Dosed 8 Ifusing the PURGE key to prime the pump set press PURGE now WARNING ALWAYS disconnect the pump set from the patient before priming or purging 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 9 If the weight dosed rate is Auto KVO delivers at Greater than or equal to 1 mL hr 1 mL hr Less than 1 mL hr The weight dosed rate Rate Titration To titrate the rate while the pump is infusing l Inthe RUN mode press the number keys for the new rate Press YES ENTER For example if the current rate is 7 5 mcg kg min press 1 0 YES ENTER to change the rate to 10 mcg kg min 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 previously programmed 9 2 NEW RATE displays with the new value Press YES ENTER within 10 seconds to accep
50. 7 Push down on the flow stop to close the cassette 00 Note Ensure the tubing is behind KS the tubing guide at the distal end 8 Ensure slide clamp is open prior to KA inserting cassette Tuning 9 Load the cassette eu 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 10 Connect the pump set to the patient access device Priming using PURGE is only allowed before START is pressed CAUTION Ensure all four or after one of the following cassette latches are clearly events occur when using Pain visible after the cassette is Management therapy installed Refer to Loading the Complete Review of New Cassette on page 35 Program New Container Air in Line Alarm 38 Hospira GemStar System Operating Manual Chapter 2 Basic Operation Priming Pump Sets WITHOUT a Drip Chamber Using the PURGE Key WARNING Failure to use the pressure activated anti siphon valve may result in unrestricted flow if the cassette is not properly installed in the pump Note The PURGE function is available only if there is a program in the pump 1 Push down on the flow stop to 4 Load the cassette close the cassette 2 Hold the container with th
51. 7 Slowly push down on the injector 10 Ensure slide clamp is open on until fluid flows at the distal end of KVO side prior to inserting the tubing which indicates that all cassette Hospira GemStar System Operating Manual 47 Chapter 2 Basic Operation 11 Load the cassette Bottom ji Tubing Guide CAUTION When priming is complete ensure no fluid flows at the distal end of the pump set DATININ oer ne d ar If flow is observed DO NOT use clearly visible after the the pump set cassette is installed 12 Connect the pump set to the Refer to Loading the patient access device Cassette on page 35 2 Note Ensure the tubing is behind the tubing guide at the distal end 48 Hospira GemStar System Operating Manual Chapter 2 Basic Operation Priming Pump Sets with Extensions WARNING Failure to use the pressure activated anti siphon valve may result in unrestricted flow if the cassette is not properly installed in the pump 1 Push down on the flow stop to 4 Invert the cassette approximately close the cassette 45 2 Hold the container with the 5 administrative port toward the ceiling and insert the piercing pin While holding the rotated cassette squeeze or roll the container to remove air from the container and TI cassette
52. 73 Chapter 15 Optional System Components 8 Place the case around the waist 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 can be worn around the waist or as a backpack It is designed to hold the GemStar Pump with batteries or a battery pack and up to a3 liter flexible fluid bag Note This carrying case includes an interior support Hospira 3 Liter Carrier List 4 13590 01 that may be removed from the case and used separately 174 Hospira GemStar System Operating Manual U AUNE N O 9 Chapter 15 Optional System Components 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 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 Secure the pump with straps K and L 10 Secure the tubing with strap M 11 Place the secured pu
53. 9 Variable Time 12 Review the program Press P to begin review 13 If using the PURGE key to prime the pump set press PURGE now priming or purging WARNING ALWAYS disconnect the pump set from the patient before Note With variable time programming the pump keeps track of where it is in the 4 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 After the end of the phase but before the beginning of the next start time Then The phase runs to its scheduled stop time The next phase begins delivery 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 Hospira GemStar System Operating Manual 103 9 9 9 Chapter 9 Variable Time Changing a Variable Time Program Can be changed at any time KVOrate Container size Air sensitivity Bolus Can ONLY be
54. Actual Rate Programmed Rate PERCENT ERROR 25 mL 0 mm Hg Delivery Head Start Up Flow Rate Variability Observation Interval minutes Max m Min a Mean 194 Hospira GemStar System Operating Manual Chapter 17 GemStar Pump Specifications FLOW RATE 25 mL 0mm Hg Delivery Head 96 Hour Time minutes Actual Rate Programmed Rate PERCENT ERROR 25 mL 0 mm Hg Delivery Head 96 Hour Flow Rate Variability 96 Observation Interval minutes Max Min a Mean Hospira GemStar System Operating Manual 195 Chapter 17 GemStar Pump Specifications FLOW RATE 25 mL 100mm Hg Delivery Head Start Up Rate mL hr Time minutes Actual Rate Programmed Rate PERCENT ERROR 25 mL 100 mm Hg Delivery Head Start Up aves Flow Rate Variability Observation Interval minutes Max m Min 4 Mean 196 Hospira GemStar System Operating Manual Chapter 17 GemStar Pump Specifications FLOW RATE 25 mL 100mm Hg Delivery Head Start Up Rate mL hr Time minutes Actual Rate Programmed Rate PERCENT ERROR 25 mL 100 mm Hg Delivery Head Start Up Flow Rate Variability 96 Observation Interval minutes Max m Min 4 Mean Hospira GemStar System Operating Manual 197 Chapter 17 GemStar Pump Specifications 198 Rate mL hr Flow Rate Variability FLOW RA
55. CC C Ck S kk Kk A kr kx A ko ko ko Ck ck Ck Ck Ck Ck KC CC CCCII CC CC C e M wy W M END OF m OPERATION TEST x d RESULTS m KKEKKEKKKKK KKK KKK CCCII C CCCII C S E I KG x x MK X WW 1234567890123456789012345678901234567890 162 Hospira GemStar System Operating Manual Chapter 14 Operation Test GemStar Operation Test Checklist Case Inspection 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 Serial Number Verified By Hospira GemStar System Operating Manual 163 Notes 164 Hospira GemStar System Operating Manual Chapter 15 Optional System Components All GemStar Optional System Components are composed of latex free components only All GemStar Optional System Components are sold separately Product Description List Description GemStar 13026 01 Wall mount adaptor plugs into a 110 VAC AC Mains Adaptor mains supply to power the GemStar Pump 6 110 Volts USA ft 1 8 m cord GemStar 13026 03 Universal wall mount adaptor plugs into a AC Mains Adaptor 100 240 VAC mains supply to power the 100 240 Volts GemStar Pump 6 ft 1 8 m cord Universal GemStar
56. Function The DOWN arrow toggles between units of measure when entering concentrations Scrolls through program review and help messages Accepts entries or continues when done viewing a display The UP arrow inserts a decimal point in a numeric value HELP Displays information during programming and alarm conditions BACK UP Returns to a previous display exits the Options Menu and exits the HELP mode Clears a numeric value resets to zero during programming Hospira GemStar System Operating Manual 77 9 Chapter 6 Continuous Continuous Programming l Select CONTINUOUS from the Programming Menu Select the unit of measure and concentration as required Enter the rate Enter the VTBI Volume to be Infused 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 value displayed is zero 6 Enter the container size VTBI KVO VTBI is the default value on the CONTAINER display Ui BW N Note If KVO is programmed increase the container size to include the KVO delivery To enter the total in mL when programming a concentration press P to move to the mL line Enter the mL size when mL flashes on the display 7 Select the air sensitivity if required 8 Review the program Press to begin review 9 If using the PURGE key to prime the pump set press PURGE now
57. GRAM l Press OPTIONS and select SET CLOCK 2 HISTORIES 2 Select 12 Hour or 24 Hour format 24 Hour format is 7 ae gant shown in example ZEN CS 3 Use the arrow keys to set the weekday and month 6 PRINT 4 Use the number keys to enter the current day year 7 SPEED PROTOCOL and time 8 NEXT DOSE Note When entering the time in 12 Hour format SET CLOCK TYPE press or to toggle between AM and PM 1 SELECT 12 HO 2 SELECT 24 HO 5 Press YES ENTER to confirm Note The clock cannot be changed while an intermittent TIME IS 20 35 or variable time program is in progress MON JUL 26 06 Tip To view the clock from the RUN or STOP mode ENTER TO CONFIRM press YES ENTER then immediately press and HOLD 1 The clock displays until 1 is released 118 Hospira GemStar System Operating Manual 9 Print Chapter 10 Options Menu WARNING Ensure a cassette is installed in the pump before connecting to a printer or computer If the pump is connected to a patient BEFORE connecting the pump to a computer or printer press STOP close the slide clamp and eject the cassette Leave the pump set connected to the patient Install another cassette in the pump before connecting to a printer or computer Note Ensure the printer is connected to the pump BEFORE selecting a print function Refer to Connecting to the Seiko Printer on page 125 for more information l Press OPTIONS and select
58. Hospira GemStar System Operating Manual 69 9 9 Chapter 5 Intermittent Intermittent Programming 1 2 3 70 Select INTERMITTENT from the Programming Menu Enter the dose amount in mL Enter the infusion time for each dose in hours minutes 00 00 For example press 4 0 if each dose is to deliver for 40 minutes Enter the frequency of dose deliveries For example press 4 0 0 to start a dose every four hours Enter the total number of doses in the container To determine the number of doses in the container divide the volume in the container by the dose amount Enter the KVO rate in mL 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 Note If KVO is desired before a delayed start increase the container size to include the desired KVO volume Select the air sensitivity if required Note DO NOT press YES ENTER after selecting the air sensitivity If YES ENTER is accidentally pressed and a call back alarm is not desired press BACK UP to return to the beginning of step 9 and press NO The pump displays SET CALL BACK ALARM FOR NEXT DOSE e Press NO if you do n
59. I 219 mL Tip Prepare and set up containers BEFORE programming the pump for piggyback delivery Press CHANGE and select PIGGYBACKING from the Change Menu Enter the dose amount for the secondary container Enter the infusion time for the secondary container gt UN H Open the slide clamp or lower CAIR roller clamp on the tubing of the secondary container 5 Press YES ENTER to begin piggyback delivery Note Primary flow stops until the secondary VTBI is delivered then primary flow continues 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 PIGGYBACKING from the Change Menu Press CHANGE to reset the dose amount to zero Enter the new piggyback dose amount and press YES ENTER BR U Ne Set the infusion time for the secondary container 5 Press YES ENTER to begin piggyback delivery 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 Hospira GemStar System Operating Manual 81 9 Chapter 6 Continuous Canceling a Piggyback Delivery 1 Press CHANGE and select PIGGYBACKING from the Change Menu 2 Press CHANGE to reset the dose amount to zero 3 Press YES ENTER to cancel piggyback delivery Alarms Affec
60. K kK KK RR eee eae 102 Variable Time Delivery Interruptions llis 103 Changing a Variable Time Program 0000 kK KK KK KK KK KK KK KK KI 104 GemStar Variable Time Programming Worksheet KAKA 105 10 Options Menu 107 OVEIWVIOW x ule merna a A T decnaaipes dee VELIE ea i riae 107 Tips for Using the Options Menu liliis 107 Review Program gt oe x la Ru EP i AR E eae NEMORE EAE DERE EE 109 Histories cdek rx E ERG Ee CREME XR a ee ba te 109 Keypad Lock 22 resa peu rtm ER Re Ue a al dikek nem e xdg 114 Change Pump Settings kk kk kk kk kK KK KK KK KK eee 116 Set Clock is 4 estate IERI WW D na eee Gd de WA O Y keh aes 118 PUM esistere cete idest Ducato Sd lie bison n fux Bee le Seg to ER Rc 119 Speed Protocol os xus ates erts co eb eg s OR Ru S a ion d 120 Next Dose Not available for List 13088 llle RR KK KK 121 Connecting to the Data Port kk kk kk kk kk kK KK KK KIR KK KI res 122 Transferring Data Using a Computer sasaaa KK KK KK RR RR KK KK KK KK 127 11 Clinician Instructions 129 Clinician Locking Sequence Instructions llli KK EKE 130 Program and Deliver a Clinician Activated Loading Dose 132 Shift Totals and History kk kk kk kK KK KK KK KK KK KK KK KK KK KK eee 133 12 Troubleshooting 135 Alarm Messages aa kina a ne an b VERE er n k n Wi Qd PG a RE GC EDEN 136 Alert Messages steh eMedia erae ae sane GP dened C eda
61. OT use the pump set 15 Connect the pump set to the patient access device Hospira GemStar System Operating Manual Chapter 2 Basic Operation 51 Notes 52 Hospira GemStar System Operating Manual Chapter 3 Total Parenteral Nutrition TPN Therapy Features and Specifications Not Applicable to List 13088 This therapy allows programming of Total Parenteral Nutrition TPN protocols e Taper Up and Taper Down may be programmed to gradually increase and decrease the infusion rate 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 been infused Set an optional KVO Keep Vein Open during programming Tip The Programming Worksheet at the end of this chapter lists the minimum and maximum values allowed for this protocol Use copies of the programming worksheet to record program values before programming the pump TPN Programming Tips The following table explains how to use the keypad during TPN programming Function Selects menu items and enters numeric values 0 9 Function The DOWN arrow toggles between units of measure when entering concentrations Scrolls through program review and help messages Accepts entries or continues when done viewing a display The UP arrow inserts a decimal point in a numeric value Displays info
62. PTIONS without clearing the shift totals e Tip Press HELP to display shift totals when the pump is not in PROGRAMMING mode or an alarm condition Clear History Event Log and Bolus History l Press OPTIONS and select HISTORIES 2 Select CLEAR HISTORY 3 CLEARING HISTORY displays and the pump exits OPTIONS Hospira GemStar System Operating Manual 133 Chapter 11 Clinician Instructions Key Combinations Not on Screens The table below lists special key combinations to access information or activate an activity which is not listed on the screen Screen and or Situation Press Results If a loading dose has been programmed but not delivered displays the DELIVER LOADING DOSE NOW screen YES ENTER 0 Displays the PROGRAM A LOADING DOSE Screen CURRENT DATE YES ENTER 1 Displays the real time clock as long as 1 is held AND TIME down displaying 134 Hospira GemStar System Operating Manual Chapter 12 Troubleshooting This section contains information on audible and visual alarms that may occur with the GemStar Pump CAUTION Ifthe pump does not perform as stated in this manual stop using it IMMEDIATELY For consultation and technical support contact either an authorized Hospira representative or the Hospira Technical Support Operations hotline available 24 hours a day To return the pump for service first contact Hospira Customer Suppo
63. R to accept the number that was entered rounded value and continue to the THE PUMP SOUNDS during programming next step FOUR QUICK BEEPS AND DISPLAYS THE ROUNDED NUMBER DOSE IN PROGRESS User has attempted to 1 Press STOP NEWS CONTATNER access NEW CONTAINER 2 Increase the container size to NOT ALLOWED function when it is not complete the dose 3 Set NEW CONTAINER through the Change Menu allowed INFUSED XXXX X mL Thepump has not delivered Press START to infuse dose NO START DELAY any doses and there is no PRESS START start delay TO INFUSE CANNOT CHANGE User has attempted to 1 Press STOP CLOCK WHILE TIME change the clock during a 2 Clear the program through the BASED DELIVERY time based delivery IS IN PROGRESS Change Menu 3 Change the clock through the Options Menu 4 Reprogram the pump PROGRAM EXCEEDS The VTBI KVO volume 1 Press HELP to display the MAX CONTAINER resulted in a container size allowed values SIZE CHANGE reater than the allowed PROGRAM VALUES ites 2 Change the program values THIS OPTION NOT User has attempted to 1 Press YES ENTER to return AVAILABLE WHILE access a function that is not to the first programming display cac SE THE available from the first 2 Complete programming programming display 3 Access desired function
64. Refer to Loading the Cassette on page 35 Ji d Note Ensure the tubing is in the tubing guide at the distal end Bottom Cap gt Tubing Guide 11 Ensure the tubing will not be pinched when closing the lockbox Hospira GemStar System Operating Manual Chapter 15 Optional System Components 12 Close and lock the lockbox 13 Remove the key Removing the Lockbox Remove the lockbox from the pole Unlock the lockbox Open the lockbox and flip the top door up Press the cassette release button to remove the cassette U AUNE Lift the pump out of the lockbox Using the Hospira 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 Loading the Cassette on page 35 for more information Carrying Case 250 mL List 13594 01 This soft sided carrying case can be worn around the waist It is designed to hold the GemStar Pump and up to a 250 mL flexible fluid bag 1 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 Hospira GemStar System Operating Manual 171 Chapter 15 Optional System Components 2 Placethe pump inside the front compartment B of the case 3 Secure the tubing to the inside of the pack with the Velcro tabs C Ensure the tubing is n
65. Star System Operating Manual 143 Chapter 12 Troubleshooting Alarm Display Is the Alarm Cause Remedy Message pump Condition infusing Y Yes A Audible alarm N No V Visual alarm USING EXT BATT Y V This is a normal When powering on the pump response when Press YES ENTER to The pump has confirm external battery been powered on power source with external sehet n de f Bu UA from AC mains The pump has switched to Press SILENCE to clear the external battery alarm power due to a meu A au CAUTION Ensure two The bump has fresh disposable AA switched to batteries are installed for external battery backup power when power while using other power mierna Daiferies sources e g AC mains adaptor docking station battery pack The pump will continue to operate on backup power if the external power source fails Refer to the caution regarding Power Loss on page 14 144 Hospira GemStar System Operating Manual Alert Messages Chapter 12 Troubleshooting responded to commands from the pump The printer is not properly connected to the pump Alert Display Message Is the Alarm Cause Condition Remedy pump infusing Y Yes A Audible alarm N No V Visual alarm ALMOST EMPTY Y ANN Delivery will complete in Press STOP to clear 30 minutes or less the alarm and put the pump in STOP Mode For bolus only prog
66. TAL OCCLUSION from the Pump Settings Menu 3 Select the desired setting 4 The pump displays MAKE XXXXX DEFAULT Press NO to temporarily change the distal occlusion setting The new setting will be in effect DISTAL OCCLUSION 1 HIGH 2 MEDIUM 3 LOW until a new program is entered or the pump has been off for more than 24 hours Press YES ENTER to permanently change the distal occlusion setting The new setting will remain in effect until the setting is changed again through the Options Menu Hospira GemStar System Operating Manual 117 AS 9 9 Chapter 10 Options Menu Sound Level 1 Press OPTIONS and select PUMP SETTINGS 2 Select SOUND LEVEL from the Pump Settings Menu 3 When the pump displays the Sound Level function it sounds intermittent beeps at the current sound level nnnnnnnn The blocks on the top line of the display indicate the USE AW TO ADJUST current sound level THE SOUND LEVEL ENTER WHEN DONE e Press to increase the sound level e Press P to decrease the sound level Press CHANGE to restore the sound level to the default setting Note The alarm cannot be turned off completely The alarm automatically reverts to the maximum volume if the user does not respond within one minute 4 Press YES ENTER when done Set Clock 1 REVIEW PRO
67. TE 25 mL 0mm Hg Delivery Head 20 in H20 Filling Head Start Up Time minutes Actual Rate Programmed Rate PERCENT ERROR 25 mL 0 mm Hg Delivery Head 20 in H20 Filling Head Start Up Observation Interval minutes Max Min 4 Mean Hospira GemStar System Operating Manual Chapter 18 Warranty Technical Assistance The 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 Hospira the pump will be repaired or replaced within the terms of this warranty Material returned to Hospira must be properly packaged and sent freight prepaid This warranty shall not apply if the pump has been repaired by anyone other than Hospira qualified service personnel or altered in any way which in Hospira s judgment affects its stability or reliability or if the serial number has been altered effaced or removed THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES EXPRESS OR IMPLIED Hospira GemStar System Operating Manual 199 Chapter 18 Warranty Technical Assistance For customer service within the United States contact 1 877 9HOSPIRA 1 877 946 7747 For technical assistance and product return authorization within the United States c
68. Tubing 0 2 micron filter CLAVE Port SL Attached Pressure Activated Anti Siphon Valve Nonvented 96 inch Pain Management Sets 12640 Latex Free GemStar Pump Set Secure Lock Nonvented Piercing Pin And Extension Set with In Line Pressure Activated Anti Siphon Valve Y Extension Check Valve Secure Lock Microbore and Macrobore Tubing 110 Inch 280cm 13045 Latex Free GemStar Pump Set Integral Pressure Activated Anti Siphon Valve Secure Lock Nonvented with PCA injector and female Luer Lock TM Adapter Microbore tubing 96 in 244 cm 13047 Latex Free GemStar Pump Set with PCA Extension Integral Pressure Activated Anti Siphon Valve Secure Lock Nonvented with PCA Injector and Female Luer Lock Adapter Microbore Tubing 96 in 244 cm 13261 Latex Free GemStar Pump Set and Extension Set with Integral Pressure Activated Anti Siphon Valve Secure Lock Nonvented Microbore Tubing Yellow Striped Tubing 110 in 279 cm Hospira GemStar System Operating Manual Chapter 16 Pump Sets List No Description 20635 Latex Free GemStar Pump Set Yellow Striped Tubing Secure Lock Vented piercing Pin 0 2 Micron filter Microbore tubing 110 in Friction fit anti siphon valve 20704 Latex Free GemStar Pump Set with Injector 2 Integral Pressure Activated Anti Siphon Valves Secure Lock Microbore Tubing 99 inch 251 cm 20705 Latex Free GemStar Pump Set with Injector
69. When the alarm sounds press SILENCE to silence the alarm for three minutes Then reconnect the pump to the patient e Tip To use a delayed start without specifying a start time Press YES ENTER Complete the program review Power off the pump e U N R When the pump is powered on again complete the program review then press START to begin delivery Hospira GemStar System Operating Manual 71 Chapter 5 Intermittent Intermittent Delivery Interruptions Missed Start Time If the programmed start time is missed it can be changed through the Options Menu Refer to Next Dose Not available for List 13088 in Chapter 10 Options Menu on page 121 If the pump remains in the STOP mode and the first dose is missed press START to begin delivery immediately and all remaining doses will be shifted If the 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 Note The clock cannot be changed while an Intermittent Program is in progress Dose Interruptions To understand how interruptions are resolved compar
70. against dripping water Attention Consult accompanying documents The GemStar Pump has been assessed and complies with the following standard EN 2 IEC EN 60601 1 2 2001 GemStar LifeShield HEMA and CAIR are registered trademarks of Hospira Inc Luer Lock is trademark of Hospira Inc Seiko Vesphene II se Manu Klenz Formula C Teflon Velcro CLAVE and Microsoft Windows and Windows NT are not trademarks of Hospira This document and the subject matter disclosed herein are proprietary information Hospira 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 Hospira Hospira Inc Lake Forest Illinois 60045 USA Printed in USA Hospira GemStar System Operating Manual
71. al rate Hospira GemStar System Operating Manual Chapter 17 GemStar Pump Specifications FLOW RATE 0 1 mL 0mm Hg Delivery Head Start Up Rate mL hr Time minutes Actual Rate Programmed Rate PERCENT ERROR 0 1 mL 0 mm Hg Delivery Head Start Up 250 0 200 0 150 0 100 0 50 0 0 0 50 0 100 0 150 0 200 0 250 0 Flow Rate Variability Observation Interval minutes Observation Interval minutes Max Min 4 Mean Hospira GemStar System Operating Manual 191 Chapter 17 GemStar Pump Specifications FLOW RATE 1 mL 0mm Hg Delivery Head Start Up Rate mL hr Time minutes Actual Rate Programmed Rate PERCENT ERROR 1 mL 0 mm Hg Delivery Head Start Up Flow Rate Variability Observation Interval minutes Max m Min 4 Mean 192 Hospira GemStar System Operating Manual Chapter 17 GemStar Pump Specifications FLOW RATE 1 mL 0mm Hg Delivery Head Hour 96 Rate mL hr Time minutes Actual Rate Programmed Rate PERCENT ERROR 1 mL 0 mm Hg Delivery Head Hour 96 Flow Rate Variability 96 Observation Interval minutes Max m Min 4 Mean Hospira GemStar System Operating Manual 193 Chapter 17 GemStar Pump Specifications FLOW RATE 25 mL 0mm Hg Delivery Head Start Up Rate mL hr ShooBnBRERBAE O O O O O O O O O O O O Time minutes
72. and is therefore responsible for ensuring that the system complies Hospira GemStar System Operating Manual Chapter 1 Introduction with the requirements of IEC 60601 1 1 If in doubt contact Hospira Technical Support Operations ALWAYS avoid dropping or hitting the pump If the pump is dropped or hit ALWAYS check connections and programmed data NEVER use sharp objects e g fingernails pens pencils or other probes to program or clean the pump e Use care not to damage the silicone seals around the sensor bodies in the cassette pocket To avoid mechanical or electronic damage NEVER submerge pump in water or other fluids and avoid fluid spills If the pump becomes wet dry it immediately with a dry lint free cloth Check connections and programmed data DO NOT touch connector ports Connector ports may be susceptible to Electrostatic Discharge ESD damage 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 i e alcohol wipes 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 Hospira may result in product damage e Please comply with local disposal and recycli
73. ar Pump Layout Shown approximate size 2 Hospira GemStar System Operating Manual Chapter 1 Introduction 9 n TU gt lt Displays the pump s status Silences an alarm This silences an alert for five minutes and an alarm for two minutes Stops infusion Starts infusion oed Lights continuously when the pump is powered by AC mains Flashes when the pump is powered by external batteries e g battery pack Not lit when using disposable AA batteries o TO z 5 Powers the pump on or off To power off the pump press and hold until the display clears Returns to previous steps during programming Exits Help Change and Options menus E O 2 co E P i 8 Displays the following menu items from the STOP or RUN mode New Container Change Program or Titrate VTBI New Program Piggybacking Resets a numeric value to zero Displays the following Options Menu items from the STOP or RUN mode 9 OPTIONS 1 Review Program 4 Pump Settings 7 Speed Protocol 2 Histories 5 Set Clock 8 Next Dose 3 Keypad Lock 6 Print Scrolls through program review and help messages Toggles between AM and PM in time based entries DOWN arrow toggles between units of measure when entering concentrations e Toggles between AM and PM in time based entries UP arrow enters a decimal point in numeric entries Scrolls back by one screen in program review
74. at the rate of 25 mL hr the average maximum flow rate fluctuation for any 5 minute time interval during the 2nd hour of operation was within the limits of 2 8 and 0 5 from the nominal rate The average delivery rate error over the entire 2nd hour was 1 6 D For other time intervals look at other points at the horizontal axis and determine corresponding limits as above Hospira GemStar System Operating Manual 189 9 Chapter 17 GemStar Pump Specifications 190 25 MLHR 0 mm Hg DELVERY HEAD START UP A 15 0 0 Max Positive Error over 5 c 100 Minute Interval 2 8 5 0 y E 0 0 W Max Negative Error over 5 g 50 Minute Interval 0 5 E 10 0 D Average Delivery er Rate Error 1 6 10 0 70 0 5 10 15 20 25 30 Observation Interval minutes A trained professional can use the resulting graphs to select a pump with the appropriate startup and flow characteristics to suit the clinical application Note As an example of how the trumpet curves can be used consider the maximum and minimum deviations at the 5 minute average interval The upper curve provides the maximum expected delivery rate error over a 5 minute interval the lower curve provides the minimum expected delivery rate error over a 5 minute interval An example would be Dopamine administered at 5 mcg kg min At 5 minutes the average drug delivery error would be within the range of 2 8 and 0 5 of the expected nomin
75. ation 186 Avoiding Bolus Infusion After Occlusion 1 2 Press STOP Close the distal slide clamp or lower CAIR roller clamp Press the cassette release button to eject 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 Ensure slide clamp or lower CAIR clamp is open prior to inserting cassette Hospira GemStar System Operating Manual Chapter 17 GemStar Pump Specifications 8 Load the cassette CAUTION Ensure all four cassette latches are clearly visible after the cassette is installed Refer to Loading the Cassette on page 35 gt Note Ensure the tubing is behind the tubing guide at the distal end Bottom Cap Tubing Guide 9 Review the program Press p to begin review 10 Press START to start the pump Hospira GemStar System Operating Manual 187 Chapter 17 GemStar Pump Specifications Stored Occlusion Volume Delivery Rate of 25 Pressure Limit Stored Volume Time to mL hr at in mL Occlude in seconds Pressure Setting Macro Micro Macro Micro Macro Micro Low 7 psig 7 psig 48 3 kPa 48 3 kPa Medium 14 psig 13 psig 96 5 kPa 89 6 kPa High 32 psig 30 psig 220 6 206 8 kPa kPa Delivery Rate Accuracy The following trumpet curves represent the typical flow rate deviations b
76. between the MIN and MAX values e MIN flashes on the display Enter the minimum value e MAX flashes on the display Enter the maximum value Press YES ENTER when done Repeat steps 4 and 5 for a bolus dose if available in the current program Note When two lock levels are applied if a function is available under one lock level but not the other the more stringent restrictions apply Enter the lock sequence number Asterisks display as the numbers are entered For THERAPY Lock enter 0 0 0 3 1 e For UNLOCKED FULL CONTAINER and RATE CHANGE lock levels enter 1 3 E0 0 0 Note Default lock sequence numbers are shown Hospira GemStar System Operating Manual 131 9 9 Chapter 11 Clinician Instructions Unlocking the Pump l Press OPTIONS to display the Options Menu 2 Select KEYPAD LOCK from the Options Menu 3 Select the lock level to be unlocked 4 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 5 The pump displays the current lock levels Press YES ENTER to return to the mode the pump was in when OPTIONS was pressed Program and Deliver a Clinician Activated Loading Dose This feature is available only when the keypad i
77. can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving device Increase the separation between the equipment Connect the equipment to an outlet on a circuit different from that to which the other device 1s connected Consult the manufacturer or field service technician for help The use of portable and mobile RF equipment may have an impact on this and other pieces of medical equipment Prior to using the GemStar Pump and optional system components refer to Appendix A for additional information and precautionary procedures regarding electrical potentials electromagnetic compatibility and electrostatic discharge Regarding Handling and Maintenance Use proper care during unpacking installation and operation of the pump If the pump is inadvertently mishandled check connections and programmed data to ensure there is no damage Refer to Chapter 14 Operation Test for further information Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards e g IEC 60950 for data processing equipment and ICE 60601 1 for medical equipment Furthermore all configurations shall comply with the system standard IEC 60601 1 1 Any person who connects additional equipment to the signal input or output part configures a medical system
78. ce fails Refer to the caution regarding Power Loss on page 14 Hospira GemStar System Operating Manual 147 Chapter 12 Troubleshooting START flashes on the display Other parts of the display are not affected 148 has occurred because the programmed pump has remained in the STOP mode for more than three minutes Alert Display Message Is the Alarm Cause Condition Remedy pump infusing Y Yes A Audible alarm N No V Visual alarm PROGRAMMING N ANN 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 quiet the alarm for 3 minutes 2 Follow the instructions on the display to clear the alarm Hospira GemStar System Operating Manual Chapter 12 Troubleshooting Other Display Messages Other Display Cause Condition Remedy Message KEYPAD LOCKED User has attempted to Unlock the keypad to access the perform a function that has desired function been locked out OT ALLOWED User has attempted to Press STOP to access the DURING INFUSION perform a function that is desired function YE Pun um not available in RUN mode press YES ENTER to return to the RUN mode display ROUNDING The pump has rounded a Press YES ENTE
79. 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 Connect the secondary set to the proximal Y site or proximal luer port Program a secondary delivery Hospira GemStar System Operating Manual Chapter 8 mL hr i H 1 b Pr S N 97 9 9 9 Chapter 8 mL hr 98 Programming a Secondary Delivery Piggybacking Note To distinguish the piggyback delivery from the primary delivery PIGGYBACK 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 VIBI 218 5 mL PIGGYBACK RATE 250 0 mL hr display as 218 5 mL Addad Tip Prepare and set up containers BEFORE programming the pump for piggyback delivery 1 2 3 4 5 Press CHANGE and select 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 lower CAIR roller clamp on the tubing of the secondary set Press YES ENTER to begin piggyback delivery Note Primary flow stops until the secondary VTBI is delivered then primary flow continues Any remaining secondary fluid will be delivered at the primary rate The maximum p
80. ction Refer to the appropriate description in this chapter for more information Note Menu selections may vary depending on the configuration of the pump For example NEXT DOSE is only available when an Intermittent therapy is programmed 9 When the pump exits OPTIONS the pump returns to the mode it was in when OPTIONS was pressed Tips for Using the Options Menu SPEED PROTOCOL NEXT DOSE REVIEW PROGRAM 2 HISTORIES 3 KEYPAD LOCK 4 PUMP SETTINGS 5 SET CLOCK 6 PRINT 7 8 The following keys are helpful when using the Options Menu Function 0 8 Selects menu items and enters numeric values O Function The DOWN arrow toggles between units of measure when entering concentrations Scrolls through program review and help messages Accepts entries or continues when done viewing a display The UP arrow inserts a decimal point in a numeric value Returns to a previous display BACK UP exits the Options Menu and exits the HELP mode Hospira GemStar System Operating Manual 107 Chapter 10 Options Menu Tip A menu item does not have to be on the display to be selected For example only items 1 through 4 are shown when the Options Menu is first displayed To select the Print Menu without scrolling the display press 6 Select this item from the Options Menu REVIEW PROGRAM
81. does not perform as stated in this manual remove the pump from service IMMEDIATELY If the pump does not display the self test or if beeps do not sound at power on check all power connections and install two fresh disposable AA batteries If the problem continues contact Hospira Technical Support Operations before using the pump Ensure a cassette is installed in the pump before connecting to a printer or computer If the pump is connected to a patient BEFORE connecting the pump to a computer or printer press STOP close the slide clamp and eject the cassette Leave the pump set connected to the patient Install another cassette in the pump before connecting to a printer or computer Disconnect the pump from the patient BEFORE performing the Operation Test 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 GemStar Pump USE ONLY the AC mains adaptor specifically labeled for use with the GemStar Pump to charge the battery pack The GemStar AC mains adaptor is for use with the GemStar Pump or GemStar Rechargeable Battery Pack only DO NOT use the GemStar AC mains adaptor with other products During charging the battery pack is warm If the rechargeable battery pack becomes hot to the touch IMMEDIATELY unplug the AC mains adaptor and c
82. duction Alarms attention is required GemStar Pump Layout e Audible Sounds a single beep when any key is Chapter 1 Introduction Keypad pressed If an invalid key is pressed the GemStar Pump Layout Response pump sounds a flutter tone e Keypad Lock Restricts access to various options Four Chapter 10 Options lock levels are available Menu and Chapter 11 Clinician Instructions New Repeats the current program without Chapter 2 Basic Container reprogramming the pump Operation e Piggybacking Allows delivery from a secondary container Chapter 6 Continuous during a Continuous or mL hr Only Not Applicable to List program 13088 and Chapter 8 mL hr Only Not Applicable to List 13088 Power on Performs a self test each time the pump is Chapter 2 Basic Self test powered on Operation e Operation Performs user assisted tests to verify the Chapter 14 Operation Test pump is operating properly Test Program Maintains a history event log with a date Chapter 10 Options History and time stamp of each event for each Menu program Review the history on the display or download it to a printer or computer Speed Stores up to nine frequently used programs Chapter 10 Options Protocols in the pump s memory for quick access Menu Hospira GemStar System Operating Manual 9 Chapter 1 Introduction Menu System The GemStar Pump uses a menu system that provides step by step instructions through all of the pump s functions Refer to t
83. e administration port toward the ceiling and insert the piercing pin CAUTION Ensure all four cassette latches are clearly H visible after the cassette is installed Refer to Loading the Cassette on page 35 2 V 1 1 I ZA a T a ji 3 Ensure slide clamp is open prior to inserting cassette Hospira GemStar System Operating Manual 39 Chapter 2 Basic Operation 9 40 Note Ensure the tubing is behind the tubing guide at the distal end Program desired therapy Press PURGE cue E 3 The pump displays PRIME THE SET Press YES ENTER While holding the container with the administration port 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 observed DO NOT use the pump set Connect the pump set to the patient access device Hospira GemStar System Operating Manual Priming Pump Sets WITH a Drip Chamber Chapter 2 Basic Operation WARNING Failure to use the pressure activated anti siphon valve may result in unrestricted flow if the cas
84. e bolus delivery after an interruption 1 Press START The pump displays COMPL 2 Respond as follows To do this Press this key Deliver the remaining bolus amount ETE BOLUS NOW Bolus lockout time is set to The time of delivery completion Clear the undelivered bolus amount Q The time the bolus was interrupted Hospira GemStar System Operating Manual 63 9 Chapter 4 Pain Management Loading Dose Delivery You can set a loading dose during programming if desired A loading dose can be delivered after programming and priming are complete LOADING DOSI E Now Press YES ENTER e Resets the bolus lockout time if applicable and ignores other bolus requests until Hl E THE LOADING DOSI EB ml Note Loading dose amounts are included in a 1 hour or 4 hour dose limit Delivering a Loading Dose l After priming and programming press START 2 The pump displays DELIVER THE to begin loading dose When the loading dose is complete the pump does the following e Automatically begins programmed infusion e Records the dose amount to the history log the lockout time has elapsed Loading Dose Interruptions Loading dose deliveries can be interrupted by e Pressing STOP e An alarm condition To continue a loading dose 1 Resolve the interruption 2 Press START The pump displays COMPLE 64 Hospira GemStar System Operati
85. e pump To prevent contamination use aseptic technique with all fluid path connections Remove protective coverings as assembly progresses Opening the Pump Set l Openthe GemStar Pump Set package and remove the contents 2 Remove the protective covers from the fluid container administration port and the pump set 34 Hospira GemStar System Operating Manual Chapter 2 Basic Operation Loading the Cassette l Identify the four black cassette latches inside the cassette pocket 2 Ensure slide clamp or lower CAIR clamp is open prior to inserting cassette 4 Insert the cassette into the cassette pocket by pushing firmly along the entire cassette until it is firmly seated 3 Line up the cassette as shown with the flow stop button facing the pump Hospira GemStar System Operating Manual 35 Chapter 2 Basic Operation 5 Verify that all four cassette latches Newel The punica be are securely holding the cassette powered off during a CHECK CASSETTE alarm except during PROGRAMMING mode Refer to Chapter 12 Troubleshooting for information on clearing a CHECK CASSETTE alarm PN E 7 Releasing the Cassette 1 Close the CAIR roller clamp or slide clamp on the distal line CAUTION Ensure the cassette ET is properly installed When g properly installed all
86. e the normal Intermittent delivery diagram below for a 1 hour dose every four hours to the interruption diagrams shown in the examples 72 Dose Delivered i If an 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 Hospira GemStar System Operating Manual Chapter 5 Intermittent point where it was interrupted and all remaining doses are shifted 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 al Dose Interrupted i e 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 All remaining doses are shifted if necessary For example in the following diagram an intermittent dose was started 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 i Dose Interrupted i When the dose is complete the start time for the Next Dose displays To change the start time refer to Chapter 10 Options Menu page 107 Any missed Intermittent doses except the first dose are added to the end of the delivery schedule Hospira GemStar System Operatin
87. ead height Ensure slide clamp or lower CAIR clamp is open prior to inserting cassette False occlusion alarms and fluid delivery inconsistencies may occur when pumping viscous fluids in microbore tubing at rates greater than 500 mL hr The system may underdeliver and the system delivery accuracy may be reduced by as much as 5 when using the following viscous fluids e nonvented syringes e PCA vials except in a lockbox with a spring assist mechanism Hospira GemStar System Operating Manual Chapter 2 Basic Operation A typical GemStar Pump Set is shown below Piercing Pin Tubing Proximal End Slide Clamp Cassette Secure Lock Flow Stop open Ce close Pressure activated Anti Siphon valve Distal End e Hospira GemStar System Operating Manual 33 Chapter 2 Basic Operation WARNING ALWAYS prime the pump set to remove air from the cassette tubing and injection sites 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 pressure activated anti siphon valve may result in unrestricted flow if the cassette is not properly installed in the pump CAUTION USE ONLY GemStar Pump Sets with the GemStar Pump Use of unauthorized sets may result in injury to the patient or damage to th
88. ect Baud Rate 2400 DataBits 8 N Oo uU 5 Stop Bits 1 Parity None Flow Control None 8 Click OK 9 Select the Properties icon 10 Select the Settings tab 11 Select the ASCII setup button 12 Ensure Append line feeds to incoming line ends is checked 13 Click OK in the ASCII setup window 14 Click OK in the Properties window Hospira GemStar System Operating Manual 127 9 Chapter 10 Options Menu 15 From the menu select File Save 16 Exit HyperTerminal Using an Existing Connection To transfer data from the GemStar amp Pump to a computer 1 U BW N N O 9 From the Windows desktop select the Start Menu Select Programs Select Accessories Select HyperTerminal Double click on the icon with the name entered in step 3 Creating a New Connection on page 127 From the menu select Call gt Connect From the menu select Transfer gt Capture Text Type the path and file name where the printout should be saved Ensure the file extension is txt The default path is c windows accessories hyperterminal Note If the file name already exists the new printout will be added to the end of the existing file For example use a patient s name or ID number as the file name Then select that file for all of that patient s printouts Click Start 10 Select the desired print function from the pump Refer to the table of printing functions on page 119 11 Wait for the t
89. ements to 0 11 then to 0 12 Hospira GemStar System Operators Manual 91 Notes 92 Hospira GemStar System Operators Manual Chapter 8 mL hr Only Not Applicable to List 13088 Therapy Features and Specifications This therapy allows quick programming of delivery rate in milliliters mL only The air sensitivity is automatically set to ON This setting can be changed through the Options Menu after programming is complete Refer to Air Sensitivity in Chapter 10 Options Menu on page 117 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 onto the primary container during regular delivery using a GemStar Piggyback Pump Set Refer to Piggybacking in this chapter for more information A program review is not required and is available only through the Options Menu VTBI can be titrated Tip The Programming Worksheet at the end of this chapter lists the minimum and maximum values allowed for this protocol Use copies of the programming worksheet to record program values before programming the pump WARNING When using a vented set ALWAYS use an air eliminating filter or set the air sensitivity to either ON or 2 mL Hospira GemStar System Operating Manual 93 Chapter 8 mL hr mL
90. enu dose when an interruption has caused a missed dose in an intermittent program only when the pump is in an intermittent program and changing the next dose is allowed 108 Hospira GemStar System Operating Manual Chapter 10 Options Menu Review Program l Press OPTIONS and select REVIEW PROGRAM The pump displays PROGRAM REVIEW 2 Press P to begin review 3 Press YES ENTER or BACK UP when done to exit OPTIONS Histories l Press OPTIONS and select HISTORIES 2 Select the number key for the desired function 3 Complete the appropriate steps for the selected function Hospira GemStar System Operating Manual 1 REVIEW PROGRAM 2 3 4 5 6 7 8 HISTORIES KEYPAD LOCK PUMP SETTINGS SET CLOCK PRINT EXT DOSE SPEED PROTOCOL c ON oO e CO PU EYPAD LOCK UMP SETTINGS ET CLOCK RINT Z oU U 0 tg X EXT DOSE EVIEW PROGRAM PEED PROTOCOL 109 Chapter 10 Options Menu Select this item from the Histories Menu HISTORY To do this function Display history event log of the latest 400 events Display includes 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 CAUTION Ensure two fresh dispo
91. er the results Ifthe pump is free of damage and all the screws and labels are in place press YES ENTER e If damage is found on the case or keypad or any screws or labels are missing press NO 156 Hospira GemStar System Operating Manual Chapter 14 Operation Test Cassette Pocket and Latch Inspection 1 N OU 5 UW 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 e 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 or ANY of the above steps cannot be verified press NO Hospira GemStar System Operating Manual 157 Chapter 14 Operation Test 158 Power Check Tip Opening the battery compartment door will disconnect the batteries enough for the pump to recognize external power Then the door can be tightened and testing can continue This can save time when performing multiple tests on a group of pumps l The display indicates that an external power so
92. erapy 57 in Variable Time therapy 105 in Weight Dosed therapy 89 91 Programming Menu 8 accessing 29 programming tips for pump 31 Programming Worksheet Continuous 83 Intermittent 75 mL hr Only 100 Pain Management 66 Precedex 90 TPN 57 Variable Time 105 Weight Dosed 89 proximal end 33 159 proximal occlusion alarm messages 142 occlusion sensitivity 185 test of 160 pump powering on 27 programming 30 programming tips 31 remove 26 pump components 4 pump features 6 pump operation warnings and cautions 13 207 Index pump set 13 17 32 179 180 GemStar Piggyback Pump Set 77 opening 34 pump components 4 See also pump settings pump settings 3 108 air sensitivity 117 change pump settings 116 occlusion sensor 117 sound level 118 pump specifications 183 PURGE key 3 priming pump sets with a drip chamber using the PURGE Key 44 priming pump sets without a drip chamber using the PURGE Key 39 R Rate Change Lock 65 114 130 131 lock level functions 115 locking the pump 130 unlocking the pump 132 rate titration in Continuous therapy 79 in mL hr Only therapy 95 in Weight Dosed therapy 64 87 release battery pack 24 releasing the cassette 36 remove pump 26 RUN mode 9 S shift totals and history 133 SILENCE key 3 specifications pump 183 Speed Protocols 6 108 119 assign review recall delete 120 121 208 START key 3 starting a new container
93. erapy Features and Specifications This therapy allows programming of multiple doses at regular intervals Optional KVO Keep Vein Open can be set during programming The pump can 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 At the set time before each dose the pump produces an audible and visual alarm and flashes START on the display Tip The Programming Worksheet at the end of this chapter lists the minimum and maximum values allowed for this protocol Use copies of the programming worksheet to record program values before programming the pump Intermittent Programming Tips The following table explains how to use the keypad during intermittent programming Function Function 0 9 Selects menu items and The DOWN arrow toggles enters numeric values O between units of measure when entering concentrations Scrolls through program review and help messages Accepts entries or continues The UP arrow inserts a decimal when done viewing a display point in a numeric value Displays information during Returns to a previous display HELP programming and alarm BACK UP exits the Options Menu and conditions exits the HELP mode Clears a numeric value resets Co to zero during programming
94. fails In the event that the internal batteries are removed while the pump is operating the power loss event may not be logged in the history the programmed therapy may not be retained and the alarms audible and visual may not occur ALWAYS avoid sources of high intensity electromagnetic radiation e g radio transmitters MRI scanners microwave ovens X ray machines and CAT scanners 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 e 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 If the 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
95. formation NEVER use sharp objects such as pens pencils fingernails paper clips needles etc to clean the pump Hospira GemStar System Operating Manual 151 Chapter 13 Maintenance Recommended Cleaning Solutions The pump is not adversely affected by the recommended cleaning solutions in the table below Cleaning Solution Manufacturer Preparation Vesphene ll 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 5 25 sodium ten parts water hypochlorite KS Note NOT all cleaning solutions are disinfectants Check product labeling Cleaning the Pump Case 1 Power off the pump 2 Disconnect the pump from AC mains power 3 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 water moistened lint free cloth 5 Usea dry lint free cloth to dry the pump after cleaning 152 Hospira GemStar System Operating Manual Chapter 13 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 t
96. four cassette latches are visibly holding the cassette securely in the cassette pocket 6 Place the tubing in the 2 Push down on the cassette release tubing channel large black button on the top of the pump Note Ensure the tubing is behind the tubing guide at the distal end 3 Remove the cassette Note When the cassette is released from the pump the cassette flow stop automatically closes preventing free flow 36 Hospira GemStar System Operating Manual Priming a GemStar Pump Set Chapter 2 Basic Operation Priming Pump Sets WITHOUT a Drip Chamber WARNING Failure to use the pressure activated anti siphon valve may result in unrestricted flow if the cassette is not properly installed in the pump 1 Push down on the flow stop to close the cassette 2 Hold the container with the administration port toward the ceiling and insert the piercing pin 3 Pushdown on the flow stop to open priming position the cassette Hospira GemStar System Operating Manual 4 Invert the cassette approximately While holding the rotated cassette squeeze or roll the container to remove air from the container and cassette Return the cassette to the upright position Continue priming until fluid fills the tubing 37 Chapter 2 Basic Operation
97. g AC mains adaptor docking station battery pack The pump will continue to operate on backup power if the external power source fails Refer to the caution regarding Power Loss on page 14 To connect to the Pump 1 Mount the docking station to the I V pole and tighten the knob Line up 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 Connect the docking station to AC mains power Hospira GemStar System Operating Manual 25 9 Chapter 2 Basic Operation 26 To remove the pump l Press the release button on the top of the docking station lt 2 Slide the pump out fc To charge docking station List 13075 all codes KNN 1 Connect the docking station to the AC mains power n 2 Leave the Li Ion Docking Station connected to AC mains power for at least 6 hours when not in use or to recharge the docking station Note The Li Ion docking station List 13075 03 light is yellow while the docking station is charging When the docking station is charged or not charging the light is green The Li Ion docking station cannot be charged when the room temperature is greater than 104 F 40 C or less than 41 F 5C Hospira GemStar System Operating Manual Chapter 2 Basic Operation Powering On the Pump CAUTION If the pump does not display the self test or if beeps do
98. g AC mains power and contact Hospira Technical Support Operations Ensure two fresh disposable AA batteries are installed for backup power when using other power sources e g AC mains adaptor docking station battery pack The pump will continue to operate on backup power if the external power source fails Refer to the caution regarding Power Loss on page 14 When removing the cord from the bottom of the battery pack firmly grasp the connector and pull straight out DO NOT twist or bend the cord or connector Regarding the GemStar Li Ion Battery Pack The LED indicator on the GemStar Li Ion Battery Pack flashes green yellow when an error condition has occurred or when the temperature is too high to charge the battery pack In temperatures above 95 F 35 C cycle AC power to confirm if battery is charged or if error condition exists If LED flashes green yellow do not rely on external battery Move device to cooler temperature and recharge prior to use Refer to the GemStar Li Ion Battery Pack insert for important information and precautions regarding activating and charging the Li Ion Battery Pack Note A charged battery pack will last approximately 24 hours when the pump lt is infusing at rates less than 125 mL hr Hospira GemStar System Operating Manual 23 Chapter 2 Basic Operation 9 9 24 To connect the battery pack l Lineup the connectors on the top of the battery pack with the holes on the bo
99. g Manual 73 9 Chapter 5 Intermittent Changing an Intermittent Program Can be changed at Can be changed if no Cannot be changed any time dose is in progress after D is pressed Dose parameters Next dose start time Current time KVOrate Container size Air sensitivity Call back alarm Note You cannot change a program when the pump is in FULL or CONTAINER Lock To change a program 1 From the STOP mode press CHANGE and select CHANGE PROGRAM 2 As each message displays make the desired changes or press YES ENTER to accept the current setting 3 Review the program Press AA to begin review 4 Press START to begin delivery 74 Hospira GemStar System Operating Manual Chapter 5 Intermittent 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 Infusion time per Frequency j dose 1 min to 96 hrs hrs min Number of Doses Per Container 1 999 KVO 2 No KVO Rate 0 0 Keep Vein Open Q Yes KVO Rate 0 1 5 0 mL hr Container PS 0 1 9999 mL Air Q On Alarms at approx 0 5 mL of air N A Sensitivity Q 2mL Alarms at approx 2 mL of air Off No alarm Call Back a No Alarm Q Yes 1 min to time between Alarm hrs min before start doses Start Time Q Start im
100. ge and begin delivery with the new VTBI e Press NO to continue delivery at the previously programmed VTBI Note Titrating VIBI does not change initial container volume Piggybacking 96 Piggybacking with the GemStar Pump requires a 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 infused are chemically and physically compatible The piggyback rate and piggyback VTBI display until the secondary container has been delivered Then the primary infusion continues Note The piggyback infusion amount is NOT added to the primary programmed infusion amount Hospira GemStar System Operating Manual 9 Preparing for Secondary Delivery Piggybacking 1 Ensure a primary piggyback pump set with a proximal Y site backcheck valve is in place Use the extension hook from the secondary set to suspend the primary container from the I V pole Prepare the secondary 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 I V pole Note When using a secondary
101. 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 Hospira GemStar System Operators Manual 85 Chapter 7 Weight Dosed Weight Dosed Programming Tips The following table explains how to use the keypad during weight dosed programming Function Function 0 9 Selects menu items and The DOWN arrow toggles enters numeric values A between units of measure when entering concentrations Scrolls through program review and help messages Accepts entries or continues The UP arrow inserts a decimal when done viewing a display point in a numeric value Displays information during Returns to a previous display HELP programming and alarm BACK UP exits the Options Menu and conditions exits the HELP mode Clears a numeric value resets Co to zero during programming Weight Dosed Programming l Select WEIGHT DOSED from the Programming Menu 2 Select the unit of measure Note If two numbers appear before a menu time e g 02 press both number keys to select that item 3 Enter the patient weight if required 4 Enter the concentration Enter the value for the unit of measure when it flashes on the display e Press YES ENTER to confirm Tip Press P to toggle between units of measure
102. he following table for a list of functions in each menu Use the keypad to select menu items respond to display messages and enter numeric values For example press 2 to select PAIN MANAGEMENT from the Programming Menu Note Menu items may vary depending on the pump s configuration Tip A menu item does not have to be on the display to be selected For example when the Programming Menu first displays only the first four therapies are shown Instead of pressing the down arrow to see the other menu items press 7 to go directly to Variable Time Programming Hospira GemStar System Operating Manual Chapter 1 Introduction Do this To display this menu Menu Items Available Programming 1 Press to Menu display the Change menu 2 Select NEW PROGRAM Or Delivery Mode Menu FOR LIST 13088 ONLY TPN PAIN MANAGEMENT INTERMITTENT CONTINUOUS WEIGHT DOSED mL HR ONLY VARIABLE TIM Q QI QI N HS ru 1 CONTINUOUS 2 BOLUS 3 CONT BOLUS Note Ifa program is not currently stored in pump memory at power on the Programming Menu automatically displays after the self test Press o Change Menu NEW CONTAINER NEW PROGRAM CHANGE PROGRAM PIGGYBACKING Note Ifthe current therapy is Weight Dosed or mL hr Only and the pump is in RUN mode 3 TITRATE VTBI will replace 3 CHANGE PROGRAM on the menu display mS IN Pe Note Piggybacking is available only in mL hr On
103. he silicone seals around the sensor bodies l Remove the cassette if installed 2 Useacotton swab moistened with an approved cleaning solution to clean the sensor faces A tubing channel B plunger tip C and sensor pins D 3 Dry the sensor faces and tubing channel and ensure the sensor faces are free of detergent film and or debris Repair The GemStar Pump has no user serviceable components with the exception of disposable batteries If the display clock stops working contact Hospira Technical Support Operations to arrange for internal 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 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 Chapter 18 Warranty Technical Assistance page 199 for details Refer all service to Hospira certified technicians only A GemStar Technical Field Service Manual is available to Hospira certified technicians Hospira GemStar System Operating Manual 153 Notes 154 Hospira GemStar System Operating Manual 9 Chapter 14 Operation Test This test is designed to ensure the GemStar Pump is operating properly Hospira recommends performing this test a minimum of once every 12 months Refer
104. hr 1 mL hr Less than 1 mL hr The programmed rate Rate Titration To titrate the rate while the pump is infusing 1 Inthe RUN mode press the number keys for the new rate 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 previously programmed 9 2 NEW RATE displays with the new value Press YES ENTER within 10 seconds to accept the change and begin delivery at the new rate Press NO to continue delivery at the previously programmed rate Hospira GemStar System Operating Manual 95 9 AS 9 Chapter 8 mL hr VTBI Titration To titrate the VIT BI while the pump is infusing 1 Press CHANGE and select TITRATE VTBI 2 Press the number keys for the new VTBI Press YES ENTER For example if the current VTBI is 0 mL press 1 0 to change the VTBI to 10 mL 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 VTBI does not change and the delivery continues as previously programmed 3 NEW VTBI displays with the new rate Press YES ENTER within 10 seconds to accept the chan
105. hr Programming Tips The following table explains how to use the keypad during mL hr programming Key Function Key Function The DOWN arrow toggles O between units of measure when entering concentrations Scrolls through program review and help messages 0 9 Selects menu items and enters numeric values Accepts entries or continues The UP arrow inserts a decimal when done viewing a display point in a numeric value Displays information during Returns to a previous display HELP programming and alarm BACK UP exits the Options Menu and conditions exits the HELP mode Clears a numeric value resets Co to zero during programming mL hr Only Programming l Select mL hr Only from the Programming Menu 2 Enter the rate 3 Enter the VTBI 4 If using the PURGE key to prime the pump set press PURGE now WARNING ALWAYS disconnect the pump set from the patient before priming or purging 9 Note A program review is not required for mL hr Only programs 94 Hospira GemStar System Operating Manual Chapter 8 mL hr Auto KVO When the programmed VTBI has completed delivery Auto KVO delivery begins automatically and the empty container alarm sounds 4 Note Auto KVO delivers even while the empty container alarm sounds Press EN pty i SILENCE fo quiet the alarm for 2 minutes If the weight dosed rate is Auto KVO delivers at Greater than or equal to 1 mL
106. ies with fresh disposable AA batteries when a change is required DO NOT use rechargeable batteries in the battery compartment Ensure two fresh disposable AA batteries are installed for backup power when using other power sources e g AC mains adaptor docking station battery pack The pump will continue to operate on backup power if the external power source fails Refer to the caution regarding Power Loss on page 14 20 Hospira GemStar System Operating Manual 9 Chapter 2 Basic Operation Installing Disposable Batteries 1 Flip open the tab of the battery door on the bottom of the pump Note Turn off the pump before removing or installing batteries With the pump keypad facing up hold onto the tab and turn the battery door to the left counterclockwise until it is released from the battery compartment Pull the door free and remove any existing batteries Install two fresh disposable AA batteries into the battery compartment Ensure the batteries are inserted as shown Return the battery door to the battery compartment Turn the battery door to the right clockwise Ensure the battery door is secured under the slot Flip closed the tab of the battery door to lock in place Hospira GemStar System Operating Manual 21 Chapter 2 Basic Operation Connecting the GemStar AC Mains Adaptor 1 Connect the cord of the AC mains adaptor to the connector port labeled 3 VDC on the bottom of
107. iggyback rate is 300 mL hr For secondary rates above 300 mL hr flow may occur from the primary container Changing a Piggyback Delivery A WN HG 5 Press CHANGE and select 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 the secondary container Press YES ENTER to begin piggyback delivery 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 Hospira GemStar System Operating Manual Chapter 8 mL hr Canceling a Piggyback Delivery 1 Press CHANGE and select PIGGYBACKING from the Change Menu 2 Press CHANGE to reset the dose amount to zero 3 Press YES ENTER to cancel piggyback delivery Changing a mL hr Only Program Can be changed at any time Delivery rate Piggybacking Container size e VTBI Note You cannot change a program when the pump is in FULL or CONTAINER Lock To change a program 1 From the STOP mode press CHANGE and select CHANGE PROGRAM 2 As each message displays make the desired changes or press YES ENTER to accept the current setting 3 Press START to begin delivery Note A program review is not required and is available only through the Change or n Options Menu Hospira GemStar System Operating Manual 99 Chapter 8 mL hr
108. ill in the pump this interval may be different 1 Press SILENCE to quiet the alarm for 15 minutes 2 Press STOP to place the pump in the STOP mode 3 Connectthe pump to AC mains adaptor rechargeable battery pack or press the On Off key to turn off the pump and replace both disposable batteries with fresh AA batteries CAUTION In the event that the internal batteries are removed while the pump is operating the power loss event may not be logged in the history the programmed therapy may not be retained and the alarms audible and visual may not occur Refer to the caution regarding Power Loss on page 14 4 Poweron the pump and resume the current program Refer to Accessing the Program Menu in Section 2 for more information 5 Press START to begin infusion Note In case of low battery alarm during printing replace the batteries and reprint or Plug in AC main and reprint 140 Hospira GemStar System Operating Manual Chapter 12 Troubleshooting Alarm Display Is the Alarm Cause Remedy Message pump Condition infusing Y Yes A Audible alarm N No V Visual alarm POWER LOSS N A N The pump has Connect the pump to AC detected a power failure due to one of the following Batteries have been removed while the pump was on battery source External power has failed or has been disconnected and no batteries are installed
109. in the intended environment Manage the electromagnetic environment to permit the device to perform as intended without disturbing other equipment Separate the device from all other electronic equipment If the device must be used near other electrical equipment monitor the equipment to ensure there is no electromagnetic interference Devices should not be used adjacent to or stacked with other equipment If the device must be used adjacent to or stacked with other equipment monitor the devices to verify normal operation USE ONLY components specifically labeled for use with the GemStar Infusion System to help ensure the device operates as intended If you suspect external RF sources or other equipment are influencing device operation contact the biomedical engineering department for additional guidelines concerning electromagnetic immunity Portable mobile RF communications equipment including cellular phones and stationery RF devices i e microwave ovens can affect the operation of medical electrical equipment Cellular phones should be turned off within 10 feet of all electronic medical devices Other RF equipment should be used no closer to any part of the device including all cables than Hospira GemStar System Operating Manual 201 Appendix A Electrical Potentials required Monitor the devices to verify normal operation Contact the biomedical engineering department for additional information in the technical
110. isplays The pump stores the program in memory and then enters STOP mode Tip If you enter an incorrect number during programming press CHANGE BEFORE pressing YES ENTER to reset the number to zero Then enter the correct number Hospira GemStar System Operating Manual Chapter 2 Basic Operation Programming Tips The following table explains how to use the keypad during programming Key Function 0 9 Press the number keys to select menu items and to enter numeric values Note Some menu items require pressing two number keys to select that item For example when selecting a unit of measure for a weight dosed program the menu may display as 01 mcg kg mg 02 mcg kg hr 03 mcg kg min 04 mg kg min To select mg kg min press O 4 Press to accept entries or to continue when done viewing a display Press during programming and alarm conditions to display information about the current condition The DOWN arrow toggles between units of measure when entering concentrations Scrolls through program review and help messages The UP arrow inserts a decimal point in a numeric value When entering a numeric value during programming press fff to reset the value to zero 8 008 P Press to return to a previous display to exit the Options Menu or to exit the HELP mode w D gt S trs S lt Hospira GemStar System Operating Manual 31 Chapter 2 Basic Operation Starting a
111. l Menu 3 Select the desired protocol to delete 4 Press YES ENTER to confirm deletion or NO to exit OPTIONS without Next Dose Not available for List 13088 1 REVIEW PROGRAM This function is only available when the current therapy is HISTORIES Intermittent and the pump is not delivering a dose 3 KEYPAD LOCK 4 PUMP SETTINGS To set the time for the next dose 5 SET CLOCK l Press OPTIONS and select NEXT DOSE B PRINT j 7 SPEED PROTOCOL deleting o Use the number keys to enter the start time for the next dose Press YES ENTER to accept the change and exit OPTIONS Tip When entering the time in 12 hour format press D or P to toggle between AM and PM Hospira GemStar System Operating Manual 121 Chapter 10 Options Menu Connecting to the Data Port 122 Use the Data Port to connect the 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 local sources these files can also be transferred to a computer WARNING Ensure a cassette is installed in the pump before connecting to a printer or computer If the pump is connected to a patient BEFORE connecting the pump to a computer or printer press STOP close the slide clamp and eject the cassette Leave the pump
112. lus Dn Unit of Concentration mg mL 0 01 100 mg mL Measure Q Concentration mcg mL 1 1000 mcg mL Q mL Continuous 0 1 2500 mg hr Rate 1 25000 mcg hr 0 1 25 0 mL hr Loading Dose Q No 0 1 2500 mg 1 25000 mcg Q Yes Amount 0 1 25 0 mL Bolus Dose 0 2500 mg 0 25000 mcg 0 25 0 mL Bolus Lockout minutes 1 999 min Optional Dose Limit 4 hour limit Amount Q 1 hour limit Amount Q boluses hour Number Q No dose limit 4X rate 400 mL 40000 mg 400000 mcg Rate 100 mL 10000 mg 100000 mcg 1 12 For continuous plus bolus delivery Note For Bolus Only the 1 hour or 4 hour dose limit minimum is 1 bolus dose Container Size 0 1 99999 mg 1 9999000 mcg 0 1 9999 mL 66 Hospira GemStar System Operating Manual Chapter 4 Pain Management Parameters Selections and or Values to be Programmable Ranges Entered Air Sensitivity Q On Alarms at approx 0 5 mL of air N A Q 2mLAlarms at approx 2 mL of air Q Off No alarm The delivery rate is programmable and is delivered in increments of 01 Air Sensitivity may not show in all setting configurations KN Note Titrating VTBI does not change initial container volume Hospira GemStar System Operating Manual 67 Notes 68 Hospira GemStar System Operating Manual Chapter 5 Intermittent Not Applicable to List 13088 Th
113. lutions 152 repair 153 warnings and cautions 16 Menu Programming Change Options 7 mL Hr Only therapy V TBI Titration 96 mL hr Only therapy 5 93 100 Auto KVO 95 changing a mL hr Only program 99 features and specifications 93 piggybacking 96 99 programmable ranges 100 programming of 93 94 Programming Worksheet 100 rate titration 95 N new container 6 starting a new container 32 troubleshooting 146 149 New Container Lock locking the pump 130 unlocking the pump 132 next dose 108 121 O occlusion 116 changing the occlusion sensor settings 117 occlusion information 186 188 206 occlusion sensitivity 185 See also distal occlusion proximal occlusion occlusion sensor changing the occlusion sensor settings 117 See also occlusion distal occlusion proximal occlusion Operating Modes Help Programming Run Stop 9 operation test 155 163 air in line test 161 cassette pocket and latch inspection 157 display test 158 distal occlusion test 160 equipment required 155 keypad test 158 LED test 159 Operation Test Checklist 163 power check 158 printing the results 161 proximal occlusion test 160 test setup 156 volume accuracy test 159 optional system components 165 178 OPTIONS key 3 display shift totals 111 133 Options Menu 8 107 126 change Pump Settings 116 connecting to the data port 122 126 Histories 109 Keypad Lock 114 Next Dose 121 O
114. ly and Continuous therapies Note Menu items change depending on when Change Menu is viewed Options Menu Press QU EVIEW PROGRAM ISTORIES EYPAD LOCK UMP SETTINGS ET CLOCK RINT PEED PROTOCOL EXT DOSE NOT AVAILABLE FOR LIST 13088 Ama 0o J O 1 00 N20 S Zi n tg wW Hospira GemStar System Operating Manual Chapter 1 Introduction For more information on Refer to the following pages Programming Menu Chapter 2 Basic Operation page 19 Change Menu For menu item 1 refer to Starting a New Container in Chapter 2 Basic Operation on page 32 For menu items 2 3 and 4 refer to the appropriate therapy chapter Options Menu Chapter 10 Options Menu page 107 Operating Modes The GemStar Pump has four operating modes Mode Description Help Mode The pump enters the HELP mode when C9 is pressed during programming or an alarm condition The HELP mode displays additional information about the current condition Programming Mode The pump enters the PROGRAMMING mode after the pump is powered on or when Co is pressed Run Mode After D is pressed the pump enters the RUN mode even when not infusing Stop Mode When programming is complete the pump enters the STOP mode until D is pressed When the programmed therapy is complete and during certain alarm conditions the pump automatically enters the STOP mode Press D to enter the STOP mode at an
115. m and Deliver a Loading jj Dose Outside of Programming Mode e ff Enter a New Program JE Under Therapy Lock the new program must be of the same type that was programmed when the pump was locked Piggybacking je VTBI Titration e fe Rate Titration fe Operation Test Clear History Select Another Therapy Hospira GemStar System Operating Manual 115 9 Chapter 10 Options Menu Change Pump Settings l Press OPTIONS and select PUMP SETTINGS 1 REVIEW PROGRAM 2 Press the number key for the desired pump setting 2 HISTORIES 3 Follow the display messages Refer to the 3 KEYPAD LOCK instructions of the desired pump setting for more information 5 SET CLOCK 6 PRINT 7 SPEED PROTOCOL 8 NEXT DOSE Select this item from To do this Comments the Pump Settings function Menu AIR SENSOR Change the air The pump alarms when it detects an air sensor sensitivity 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 Note The air sensor is not accessible for configuration if pre configured by your facility to ON or 2mL The air alarm can also be set during programming if the current therapy allows it OCCL SENSOR Change the distal Default Setting High occlusion sensor
116. may be affected when used at extreme operating temperatures 10 C gt 35 C relative humidity lt 20 and delivery rates 4 9 mL hr gt 350 mL hr Refer to individual set labels for specific instructions and operating conditions Delivery accuracy may be impacted when there is air present in the cassette Follow the instructions in the individual set labels to remove any visible air from the cassette Ensure slide clamp or lower CAIR roller clamp is open prior to inserting cassette When using pre filled vials ensure vial and injector are securely locked in lockbox before beginning delivery A cracked vial might not show evidence of leakage until delivery pressure is applied When using nonvented syringes the system may underdeliver System delivery accuracy could be reduced by as much as 5 When using PCA vials except in a lockbox with a spring assist mechanism the system may underdeliver System delivery accuracy could be reduced by as much as 5 When using viscous fluids the system may underdeliver System delivery accuracy could be reduced by as much as 5 Variations in filling head such as container height may affect delivery accuracy by no more than 5 When using the GemStar Spring Assist Mechanism SAM Lockbox USE ONLY GemStar Pump Sets designated for use with the GemStar SAM Lockbox Failure to use designated sets could result in unrestricted flow NEVER use drugs that are incompatible with
117. mediately after programming Q Starttime 1 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 increase the container size to include the desired KVO volume Air sensitivity may not show in all setting configurations Hospira GemStar System Operating Manual 75 Notes 76 Hospira GemStar System Operating Manual Chapter 6 Continuous Not Applicable to List 13088 Therapy Features and Specifications This therapy allows programming of a continuous delivery Optional KVO Keep Vein Open can 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 a GemStar Piggyback Pump Set Refer to Piggybacking in this chapter for more information Tip The Programming Worksheet at the end of this chapter lists the minimum and maximum values allowed for this protocol Use copies of the programming worksheet to record program values before programming the pump Continuous Programming Tips The following table explains how to use the keypad during continuous programming Key 0 9 Function Selects menu items and enters numeric values
118. mp N inside the large zipper case or other carrying case 12 Zip the large case closed 13 If desired route the tubing through the loops on the bottom of the carrying case Ensure the tubing is not kinked 14 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 Hospira GemStar System Operating Manual 175 Chapter 15 Optional System Components Hospira GemStar System Operating Manual 176 9 Chapter 15 Optional System Components Using the GemStar Docking Station List 13075 all codes WARNING DO NOT touch connectors Refer to caution on page 16 CAUTION Ensure two fresh disposable AA batteries are installed for backup power when using other power sources e g AC mains adaptor docking station battery pack The pump will continue to operate on backup power if the external power source fails Refer to caution regarding Power Loss on page 14 To connect the pump 1 Mount the docking station to the LV pole and tighten the knob Install fresh batteries 2 Align the connectors on the bottom of the pump with the connectors on the docking station 3 Slide the pump into the docking station until it snaps into place 4 Connect the docking station to AC mains power To charge docking station 1 Connect the docking station to the AC mains power 2 Leave the Li Ion Docki
119. nd dry environment 4 F to 4140 F 20 C to 60 C 10 to 90 0 10 000 ft 0 3 000 m equivalent pressure Operating Environment Ambient Temperatures 441 F to 4104 F 45 C to 440 C Power Sources AC Mains List 13026 01 USA complies with UL544 List 13026 03 Universal complies with CSA 22 2 NO 601 1 and IEC UL 60601 1 List 13072 01 Universal complies with CSA 22 2 NO 601 1 and IEC UL 60601 1 Battery Battery Pack List 13073 Hospira GemStar System Operating Manual Wall mount AC mains adaptor 6 ft 1 8 m cord molded plug Input 110 VAC Output 3 0 VDC Wall mount AC mains adaptor 6 ft 1 8 m cord molded plug Input 100 240 VAC Output 3 0 VDC Tabletop AC mains adaptor molded plug Input 100 240 VAC Output 3 0 VDC Two disposable AA alkaline batteries Rechargeable using GemStar AC mains adaptor Lithium ion rechargeable battery 183 Chapter 17 GemStar Pump Specifications Docking Station List 13075 03 Mounts on an I V pole 10 ft 3 m cord Input 100 240 VAC Output 3 0 VDC Internal lithium ion rechargeable battery Power Capacity Using two fresh disposable AA batteries or a charged battery pack at temperatures between 59 F and 95 F 15 C and 35 C 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
120. ng Manual 9 Chapter 4 Pain Management 3 Respond as follows To do this Press this key Deliver the remaining loading dose amount Clear the remaining loading dose amount Changing a Pain Management Program 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 Note You cannot change a program when the pump is in FULL or CONTAINER Lock With a RATE CHANGE Lock the continuous delivery rate and bolus amount can be changed within the set ranges Although the delivery mode cannot be changed if Continuous Bolus is programmed the continuous rate or bolus amount can be changed to zero The minimum values set with a RATE CHANGE Lock could restrict this function To change a program 1 From the STOP mode press CHANGE and select CHANGE PROGRAM 2 As each message displays make the desired changes or press YES ENTER to accept the current setting 3 Review the program Press Ww to begin review Press START to begin delivery Hospira GemStar System Operating Manual 65 Chapter 4 Pain Management GemStar Pain Management Programming Worksheet GIVE Parameters Selections and or Values to be Programmable Ranges Entered Therapy Pain Management N A Delivery Mode Q Continuous N A Bolus Only Q Continuous Bo
121. ng PCA vials except in a lockbox with a spring assist mechanism the system may underdeliver System delivery accuracy could be reduced by as much as 5 When using pre filled vials ensure vial and injector are securely locked in lockbox before beginning delivery USE ONLY purge priming with the GemStar Lockbox with Spring Assist Mechanism SAM Note When using the GemStar Lockbox with SAM refer to the SAM pump set labeling and SAM lockbox insert for instructions l Ifusing a pump set with the 2 Open the upper and lower slide Y extension use the slide clamp to clamps close off the KVO Keep Vein Open side of the tubing i 46 Hospira GemStar System Operating Manual Chapter 2 Basic Operation 3 Pushdownon the flow stop to air is cleared from the pre filled close the cassette vial injector cassette and tubing X 2 VO 4 Connect the pump set to a Hospira a pre filled vial and injector l 5 Push down on the flow stop to open priming position the 8 Push down on the flow stop to close the cassette N cassete 9 If the set includes a KVO Y extension close the slide clamp below the pre filled vial and open the slide clamp on the KVO side Prime the KVO Y extension 6 Hold the pre filled vial and set upright vertically on a flat surface with the pump set extending from the top
122. ng Station connected to AC mains power for at least 6 hours when not in use or to recharge the docking station Note The Li Ion docking station light is yellow while the docking station is charging When the docking station is charged or not charging the light is green The Li Ion docking station cannot be charged when the room temperature is greater than 104 F 40 C or less than 41 F 5 C Hospira GemStar System Operating Manual 177 Chapter 15 Optional System Components To connect the bolus cord and printer cable WARNING Ensure a cassette is installed in the pump before connecting to a printer or computer If the pump is connected to a patient BEFORE connecting the pump to a computer or printer press STOP close the slide clamp and eject the cassette Leave the pump set connected to the patient Install another cassette in the pump before connecting to a printer or computer DO NOT touch connector ports Refer to caution on page 16 1 Plug the bolus cord into the bolus To remove the pump port on the rear right side of the 1 Press the release button on the top docking station of the docking station j Z P 2 Plug the printer cable into the printer port on the rear right side 2 Slide the pump out of the docking station Ne c ARE AY 178 Hospira GemStar System Operating Manual
123. ng regulations as appropriate for disposable batteries rechargeable battery packs medical electronic components and pump sets Fixed and Rotary Wing Aircraft Do not lay the IV bag flat because air can potentially be introduced into the line causing an alarm condition Recommend the use of extension set tubing be applied prior to patient transport The GemStar pump has only been tested using battery power in fixed and rotary wing aircraft e Auditory alarms may not be heard in a noisy flight environment Care providers should rely on visual indicators on the pump display to determine if there are any alarms or other system malfunctions Hospira GemStar System Operating Manual 17 Notes 18 Hospira GemStar System Operating Manual 9 Chapter 2 Basic Operation The following elements are required to use the GemStar Pump GemStar Pump Appropriate power source Appropriate GemStar Pump Set Appropriate fluid container Patient access device Overview To start a therapy 1 Ui BW N 9 Determine the program settings Refer to the appropriate therapy chapter for a worksheet that may be copied and used to record program settings Select a power source Refer to Selecting a Power Source on page 20 Prime the pump set Refer to GemStar amp Pump Set on page 32 Load the cassette into the pump Refer to Loading the Cassette on page 35 Power on the pump and go to the Programming Menu Refer t
124. nu Switch Settings for Seiko DPU 414 Printer Switch Function Setting Button to Press Input Method Serial Printing Speed High ONLINE Auto Loading On ONLINE CR function CR and LF ONLINE DIP SW setting Enabled ONLINE command Printing density 10096 Printing density 10096 ONLINE Printing density 10096 ONLINE Print Mode 40 columns ONLINE User defined char On ONLINE Ordinary On ONLINE Characters SW2 4 Zero Font No slash ONLINE SW2 5 Character Set American ONLINE SW2 6 Character Set American ONLINE SW2 7 Character Set American ONLINE SW2 8 Character Set American SW3 1 Data bit length 8 bits ONLINE SW3 2 Parity No parity ONLINE SW3 3 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 124 Hospira GemStar System Operating Manual Chapter 10 Options Menu Connecting to the Seiko Printer WARNING Ensure a cassette is installed in the pump before connecting to a printer or computer If the pump is connected to a patient BEFORE connecting the pump to a computer or printer press STOP close the slide clamp and eject the cassette Leave the pump set connected to the patient Install another cassette in the pump before connecting to a printer or computer Refer to the printer documentation or contact the printe
125. o Powering On the Pump on page 27 Select the appropriate optional system components such as a bolus cord Select the therapy type and enter a program Refer to the appropriate therapy chapter for detailed instructions Note List 13086 only delivers therapy in the Pain management Mode 8 Press START to begin delivery Hospira GemStar System Operating Manual 19 Chapter 2 Basic Operation Selecting a Power Source The GemStar Pump may be powered by one or more of the following Power Source Description Ambulatory Hospital Home G Wall mount adaptor plugs into a e e emStar AC Mains Adaptor 110 VAC mains supply USA GemStar Wall mount adaptor plugs into a AC Mains Adaptor 100 240 VAC mains supply Universal GemStar Tabletop adaptor plugs into a AC Mains Adaptor 100 240 VAC mains supply Universal GemStar Docking Plugs into a 100 240 VAC Volt Station mains supply while mounted on an I V pole The docking station s rechargeable internal batteries power the GemStar Pump during periods of transport GemStar Battery The battery pack s rechargeable Pack internal batteries power the GemStar Pump during periods of transport or when use of AC power is not desirable Disposable Batteries Two disposable AA alkaline batteries available from local sources CAUTION To ensure proper pump operation ALWAYS replace BOTH batter
126. oncentration 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 Q No Q Yes Start time 12 00 AM 11 59 PM Stop time or 00 00 23 59 Rate 0 1 400 mL hr 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 Q No KVO Rate 0 0 Keep Vein Open Q Yes KVO Rate 0 0 5 0 mL hr Container Size 0 1 99999 mg Total Daily Amount X 1 9999000 mcg Number of Days of Therapy 0 1 9999 mL Air Sensitivity u On Alarms at approx 0 5 mL of air N A Q 2mL Alarms at approx 2 mL of air Q Off No alarm Sum of all phases must equal 100 when programmed in percentages Air Sensitivity may not show in all setting configurations Hospira GemStar System Operating Manual 105 Chapter 9 Variable Time Start Time Stop Time Percentage 1 2 4 5 6 7 8 9 10 11 12 13 14 16 18 Note The sum of all phases must equal 100 when programmed in percentages 106 Hospira GemStar System Operating Manual Chapter 10 Options Menu Overview l Press OPTIONS from RUN or STOP mode 2 Select the number key for the desired function 3 Follow the display messages for the selected fun
127. ons for Use Persons who do not have the mental and physical capability or the emotional stability to properly use the GemStar Pump should not operate this pump DO NOT use the following with the GemStar Pump Drugs not compatible with silicone rubber or PVC plastic Drugs not stable under infusion conditions Warnings and Cautions Pay attention to the following warnings and cautions when operating the GemStar Pump These warnings and cautions are repeated in the manual when relevant to the procedure being discussed Pay attention to all alert messages General Warnings and 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 When a proximal occlusion alarm activates DO NOT power off the pump Closely supervise patients who are likely to be adversely affected by unintended operations and failures including interrupted medication or fluid infusion Ensure provisions for immediate corrective action are available Hospira GemStar System Operating Manual 11 Chapter 1 Introduction Regarding Drugs Used Pump Sets and Containers USE ONLY GemStar Pump Sets with the GemStar Pump Use of unauthorized sets may result in injury to the patient or damage to the pump Some microbore tubing delivery accuracy
128. ontact 1 800 241 4002 For additional technical assistance including Technical Service Bulletins technical training and product information visit the web site at www hospiraparts com After authorization ship prepaid product returns to the following address Hospira Inc Technical Support Operations 755 Jarvis Drive Morgan Hill CA 95037 KN Note Outside the U S contact your local Hospira sales office 200 Hospira GemStar System Operating Manual Appendix A Electrical Potentials There is a shared responsibility between manufacturers customers and users to ensure that Medical Equipment and Systems are designed and operated as intended Medical electrical equipment needs special precautions regarding electromagnetic compatibility and needs to be installed and used according to the electromagnetic compatibility information provided in this manual Guidance on EMC Compatibility This device uses RF energy only for its internal functions Its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The device is suitable for use in all establishments including domestic establishments If extended operation during power mains interruption is needed use the battery pack or the docking station s internal battery Always manage the electromagnetic environment The guidance included in this manual provides information needed to Determine the device s suitability for use
129. ontact Hospira Technical Support Operations Use only the Li Ion Docking Station and Li Ion Battery Pack with the GemStar Pump With the Li Ion Battery Pack the LED indicator flashes yellow green when an error condition has occurred or when the temperature is too high to charge the battery pack In temperatures above 95 F 35 C cycle AC power to confirm if battery is charged or if error condition exists If LED flashes green yellow do not rely on external battery Move device to cooler temperature and recharge prior to use Refer to the battery pack insert for important information and precautions regarding activating and charging the Li Ion Battery Pack When removing the cord from the docking station bottom of the battery pack or Hospira GemStar System Operating Manual Chapter 1 Introduction bottom of the pump firmly grasp the connector and pull straight out DO NOT twist or bend the cord or connector To ensure proper pump operation ALWAYS replace BOTH disposable batteries with fresh disposable AA batteries when a change is required ALWAYS fully close the battery door when using disposable batteries DO NOT use rechargeable batteries in the battery compartment Ensure two fresh disposable AA batteries are installed for backup power when using other external power sources e g AC mains adaptor docking station battery pack The pump will continue to operate on backup power if the external power source
130. oo PEED PROTOCOL EVIEW PROGRAM ISTORIES EYPAD LOCK UMP SETTINGS ET CLOCK RINT zJ v on ovx mov EXT DOSE Store a program in pump memory for later use RE VIEW RECALL Review assigned protocols from the RUN or the STOP mode STOP mode Recall an assigned protocol from ELETE Delete protocols from pump memory Assign 1 2 3 120 Press OPTIONS and select SPEED PROTOCOL Select ASSIGN from the Speed Protocol menu Select 1 9 to assign to the new protocol If the selected speed protocol is already assigned the pump displays REPLACE PROTOCOL ASSIGNMENT Press YES ENTER to replace the protocol The pump displays the new speed protocol and exits OPTIONS e Press NO to keep the existing protocol and exit OPTIONS Hospira GemStar System Operating Manual Chapter 10 Options Menu Review Recall l Press OPTIONS and select SPEED PROTOCOL 2 Select REVIEW RECALL from the Speed Protocol menu 3 Select the desired protocol to review recall 4 Review the program Press P to begin review 5 Press YES ENTER fin the STOP mode press 1 to recall the protocol or press 2 to review another protocol e fin the RUN mode the pump exits OPTIONS Delete 1 Press OPTIONS and select SPEED PROTOCOL 2 Select DELETE from the Speed Protoco
131. or 1 minute 2 Press STOP to place the pump in the stop mode 3 Check for sources of distal occlusion Kinked tubing below the pump Clamped patient access device Clogged I V filter Other obstructions 4 If the problem continues remove and reinstall the cassette CAUTION Ensure all four cassette latches are clearly visible after the cassette is installed Note Ensure the tubing is behind the tubing guide at the distal end Refer to Loading the Cassette on page 35 5 Press START to begin infusion Hospira GemStar System Operating Manual 139 Chapter 12 Troubleshooting Alarm Display Message Is the pump infusing Alarm Cause Condition Remedy Y Yes N No A Audible alarm V Visual alarm LOW BATTE RIE A V The pump has detected battery voltage below acceptable levels and the batteries are the primary power source Note The pump allows the user to clear the LOW BAT TERIES alarm If the condition has not been corrected after 15 minutes the alarm continues If the pump is infusing anda LOW BAT TERIES alarm occurs the pump con tinues for approxi mately 30 minutes before it can no longer deliver due to insuffi cient power If an external power source is used the rate is changed or the pump is powered on aftera LOW BAT TERIES alarm and those same batteries are st
132. ot kinked 4 Use the large Velcro flap D on the upper left side of the case to secure the tubing on the outside of the case 5 Close the zipper Ensure the tubing exits the side of the case near the zipper tab when the zipper is closed E 6 Place the case around the waist Snap the buckle together to secure 7 Adjust the belt for a snug comfortable fit Carrying Case 500 mL List 13079 01 or 1000 mL List 13980 01 These soft sided carrying cases can be worn around the waist or over the shoulder They are designed to hold the GemStar Pump and up to a 500 mL List 13079 01 or a 1000 mL List 13980 01 flexible fluid bag 172 Hospira GemStar System Operating Manual Chapter 15 Optional System Components l Place the pump on the inside front window A Ensure the keypad is facing the window 2 Secure the pump with the large side straps B and C Then secure the top D and bottom E straps 3 Place the fluid bag on the backside of the compartment F 4 Secure the bag with flaps G and H 5 Secure the bag spike with strap 1 Ensure the fluid flow is not restricted 6 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 7 Zip the case closed Ensure the tubing exits through one of the sides near the zipper tab when the case is closed Hospira GemStar System Operating Manual 1
133. ot want to set the call back alarm e Press YES ENTER to set the call back alarm Enter the time before the next dose that the alarm should sound For example press 1 0 to set the alarm to sound 10 minutes before the start of the next scheduled delivery Hospira GemStar System Operating Manual Chapter 5 Intermittent 2 Note 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 10 The pump displays the current time e If the displayed time is correct press YES ENTER e To set the clock press OPTIONS 11 The pump displays the current time and START NOW e Press YES ENTER to begin delivery when the pump enters the RUN mode Press NO to set a delayed start time The pump displays SET START TIME Enter the desired start time and press YES ENTER when done aoe When entering the time in 12 hour format press or to toggle between AM and A 12 Review the program Press KA to begin review 13 If using the PURGE key to prime the pump set press PURGE now WARNING ALWAYS disconnect the pump set from the patient before priming or purging 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 9
134. oth positive and negative from the programmed 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 pump sets used in this test are comparable to GemStar Pump Set List 13273 The typical accuracy for this device is 5 of the programmed 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 A single fault condition occurs when a single means for protection against a safety hazard in equipment is defective or a single external abnormal condition is present The maximum over infusion volume from a single fault condition is based upon the calculation of the maximum time to generate an alarm times the maximum rate possible 1000 mL hr as a consequence of the fault This has been determined not to exceed 2 78 mL 188 Hospira GemStar System Operating Manual Chapter 17 GemStar Pump Specifications CAUTION The system may underdeliver and system delivery accuracy may be reduced by as much as 5 when using the following e viscous fluids e nonvented syringes e PCA vials except in a lockbox with a spring assist mechanism Some microbore tubing delivery accuracy may be
135. p The Programming Worksheet at the end of this chapter lists the minimum and maximum values allowed for this therapy Use copies of the programming worksheet to record program values before programming the pump Pain Management Programming Tips The following table explains how to use the keypad during pain management programming Function Function 0 9 Selects menu items and The DOWN arrow toggles enters numeric values A between units of measure when entering concentrations Scrolls through program review and help messages Accepts entries or continues The UP arrow inserts a decimal when done viewing a display gz point in a numeric value Displays information during Returns to a previous display HELP programming and alarm BACK UP exits the Options Menu and conditions exits the HELP mode Clears a numeric value resets Co to zero during programming 60 Hospira GemStar System Operating Manual 9 9 9 Chapter 4 Pain Management Pain Management Programming 1 2 OUA U 8 9 Select PAIN MANAGEMENT from the Programming Menu Select the delivery mode Note If Continuous Bolus is selected the continuous delivery rate or bolus dose can be set to zero without reprogramming the pump Press STOP and press CHANGE then select CHANGE PROGRAM Select the unit of measure and concentration as required Set the continuous delivery rate Program a loading dose as req
136. peration Test 113 Print 119 Review Program 109 Set Clock 118 Speed Protocol 120 tips for using the options menu 107 Hospira GemStar System Operating Manual Index other display messages 149 P Pain Management therapy 5 59 67 1 Hour or 4 Hour Dose Limit 61 alert messages 145 bolus delivery 62 changing a Pain Management therapy 65 features and specifications 59 loading dose delivery 64 programmable ranges 66 programming of 61 62 Programming Worksheet 66 piggybacking 5 6 canceling a piggyback delivery 82 99 changing a piggyback delivery 81 98 in Continuous therapy 79 82 in mL hr Only therapy 96 99 preparing for secondary delivery 80 97 programming a secondary delivery 81 98 power indicator 3 power loss warning 14 power sources power check 158 selecting 20 powering on the pump 27 Precedex programming 90 Precedex Programming Worksheet Weight Dosed 91 prime 3 34 priming 12 priming extension sets 49 priming pump sets using pre filled vials 46 priming pump sets with a drip chamber 41 priming pump sets with a drip chamber using the PURGE Key 44 Hospira GemStar System Operating Manual priming pump sets without a drip chamber using the PURGE Key 39 pump sets without a drip chamber 37 See also prime purge Print 119 programmable ranges in Continuous therapy 83 in Intermittent therapy 75 in mL hr Only therapy 100 in Pain Management therapy 66 in TPN th
137. play the Options Menu Select KEYPAD LOCK from the Options Menu Note If a lock level is already applied to the pump the Lock Sequence Number must be entered before a second lock level can be applied Refer to Adding a Second Lock Level on page 131 for more information Select the desired lock level For THERAPY 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 Tip Press P 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 steps 4 and 5 for a bolus dose if available in the current program Enter the lock sequence number Asterisks display as the numbers are entered For THERAPY Lock enter 0 0 0 3 1 e For UNLOCKED FULL CONTAINER and RATE CHANGE lock levels enter 1 3 E0 0 0 Note Default lock sequence numbers are shown Hospira GemStar System Operating Manual Chapter 11 Clinician Instructions Adding a Second Lock Level 1 2 3 4 Press OPTIONS to display the Options Menu Select KEYPAD LOCK from the Options Menu Enter the Lock Sequence Number For RATE CHANGE Lock set the minimum and maximum programmable ranges for the continuous delivery rate and bolus dose in a Pain Management program Tip Press P to toggle
138. ps below to print the test results An example of the printed test results is shown WARNING Refer to the printer documentation or contact the printer manufacturer for more information regarding Electrostatic Discharge ESD susceptibility of printer connector ports Note For maximum battery life operate the pump on AC power when connected to a printer or computer 9 1 Connect the serial printer cable to the pump Refer to Connecting to the Seiko Printer in Chapter 10 Options Menu on page 125 2 Press YES ENTER to print the test results 3 The pump displays the Programming Menu when the results have finished transmitting or if NO is pressed Hospira GemStar System Operating Manual 161 Chapter 14 Operation Test Ck ck ck Ck ck ck Ck Ck Ck Ck Ck Ck CC Ck kk Sk Sk A Mk kr ko ko ko ko ko i HOSPIRA GemStar ui OPERATION TEST x RESULTS Ck ck ck ck ck Ck Ck C Ck Kk Ck SC Ck 2k Ck CC Ck Ck E kk kA ko Sk 2k ko ko ko ko PUMP SERIAL NUMB Cd R XXXXXXXXX 10 45AM NOV 10 06 VERSION X X X 1 Case Inspection PASS 2 Cassette Pocket amp Latch PASS 3 Power Check PASS 4 Keypad Test PASS 5 Display Test FAIL 6 LED Test PASS 7 Volume Accuracy Test PASS 8 Distal Occlusion Test PASS 9 Proximal Occlusion Test PASS 10 Air in Line Test PASS Ck ck occ ck Kk Ck KC 0000 CC C0 C Ck kk Sk kk ko ko ko ko ko m VERIFIED BY Ck ck cC Ck Ck Ck KC SC SCC
139. r manufacturer for more information regarding Electrostatic Discharge ESD susceptibility of printer connector ports CAUTION DO NOT connect the GemStar AC mains adaptor to a printer Note For maximum battery life operate the pump on AC mains when connected to a n printer or computer 1 2 3 Install a cassette into the pump Connect the GemStar bottom of the pump serial cable to the printer and to the data port on the Ensure the printer is ONLINE and ready to receive data Refer to printer documentation for more information Ensure paper is loaded in the printer Select the desired print function from the pump menu Hospira GemStar System Operating Manual 125 Chapter 10 Options Menu Connecting to a Computer WARNING Ensure a cassette is installed in the pump before connecting to a printer or computer If the pump is connected to a patient BEFORE connecting the pump to a computer or printer press STOP close the slide clamp and eject the cassette Leave the pump set connected to the patient Install another cassette in the pump before connecting to a computer or printer Refer to the computer documentation or contact the computer manufacturer for more information regarding Electrostatic Discharge ESD susceptibility of computer connector ports Note For maximum battery life operate the pump on AC mains when connected to a a printer or computer
140. r 2 Basic Operation Accessing the Programming Menu After power on the pump checks its memory for a stored program Respond to the display message as shown in the following table Display Message The pump displays the Programming Menu Condition Pump memory is clear User Response To enter a new program Select a therapy from the Programming Menu and enter a new program Refer to the appropriate therapy chapter for instructions 1 RESUME PROGRAM 2 CLR PROG amp SHIFT 3 CLR PROG SHIFT AND HISTORY A program is currently stored in pump memory v To continue the current program press 1 To reset the current program 1 Press 1 2 Press CHANGE to display the Change Menu and select NEW CONTAINER To enter a new program and clear shift totals Press 2 The pump clears the program and shift totals from memory and enters PROGRAMMING mode To enter a new program clear shift totals and clear history Press 3 The pump clears the program shift totals and history from memory and enters PROGRAMMING mode Tip To enter a new program when the pump is already powered on Press STOP to place the pump in STOP mode Press CHANGE to display the Change Menu Select NEW PROGRAM The pump clears the current program and 1 2 3 displays the Programming Menu Hospira GemStar System Operating Manual 29 9 9 Chapter 2 Basic Ope
141. r rigid plastic unless suspended from a pole When using a vented drip set ALWAYS use an air eliminating filter OR set the air sensitivity to either ON or 2 mL Stop infusion if signs or symptoms of infiltration occur GemStar Pump Sets contain a pressure activated anti siphon valve to reduce the potential for gravity flow at a typical 36 inch head height e Failure to use the pressure activated anti siphon valve may result in unrestricted flow if the cassette is not properly installed in the pump e Always close the slide clamps before removing the cassette from the pump When using the pump for secondary delivery piggybacking ensure the fluids being infused are chemically and physically compatible 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 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 prime the pump set to 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 Hospira GemStar System Operating Manual 13 Chapter 1 Introduction Regarding Pump Operation If the pump
142. ram Press SILENCE to delivery will complete quiet the alarm during the next bolus x No additional alarms delivery sound Note This alert is available only with Pain Management ther apy CHECK PRINTER Y AN The printer has not 1 Press SILENCE to quiet the alarm for 2 minutes 2 Ensure the printer is properly connected to the pump by checking the following Printer is powered on and in ONLINE mode Cable is plugged in to both the pump and the printer Cable part number and printer settings are correct 3 If the problem continues select STOP PRINT from the Print Menu to cancel all print jobs Hospira GemStar System Operating Manual 145 Chapter 12 Troubleshooting The pump delivers KVO if selected the entire programmed protocol 1 Alert Display Message Is the Alarm Cause Condition Remedy pump infusing Y Yes A Audible alarm N No V Visual alarm EMPTY CONTAINER N A V The pump has delivered 1 Press SILENCE to the programmed quiet the alarm for 2 container size or the minutes pump has delivered the 2 press STOP to place programmed VTBI AND the pump in the Auto KVO is delivering STOP mode and if available in current clear the alarm progiem 3 Use the New Container function to repeat the current program Refer to Starting a New Containerin Chapter 2 Basic Operation Note Titration is allowed at thi
143. ransmission to complete 12 From the menu select Transfer gt Capture Text gt Stop 13 Exit HyperTerminal 14 Use any text editor to view or print the file 128 Hospira GemStar System Operating Manual Chapter 11 Clinician Instructions The instructions in this section apply to special features available to clinicians Remove this section from the manual to prevent unauthorized access to these features The GemStar Pump provides quick access to commonly used functions Instead of accessing these functions by navigating through the menu system you can enter the key combinations shown in this table Function Quick Access Key Combination Unlock Keypad Place the pump in STOP mode and then enter the lock sequence to unlock a Full Container or Rate Lock You cannot use quick access keys to unlock a Therapy Lock Program a Loading Dose Displays Shift Totals Place the pump in STOP mode and then press HELP to display Shift Totals Display Clock Place the pump in STOP mode press YES and then press and hold 1 The clock displays until you release 1 From the Pain Management STOP mode press YES ENTER and then press 0 to program a Loading Dose Hospira GemStar System Operating Manual 129 9 9 Chapter 11 Clinician Instructions Clinician Locking Sequence Instructions Locking the Pump To lock the pump from the RUN or STOP mode 1 2 130 Press OPTIONS to dis
144. rapy 59 65 in TPN therapy 53 56 Continuous therapy 5 77 83 changing a Continuous Program 82 Clinician instructions 130 131 features and specifications 77 piggybacking in Continuous therapy 79 82 programmable ranges 83 programming of 77 Programming Worksheet 83 rate titration 79 continuous therapy programming 78 contraindications for use 11 D Data Port connecting to 122 126 configuration settings 123 connecting to a computer 126 connecting to the Seiko printer 125 connector 4 distal end 33 38 159 distal occlusion 6 116 alarm message 139 occlusion sensitivity 185 occlusion sensor setting 117 test of 160 troubleshooting 139 docking station 167 charge 26 connecting the pump 177 to charge 177 using 177 dose limit 61 drip chamber priming pump sets with a drip chamber 41 Hospira GemStar System Operating Manual Index priming pump sets with a drip chamber using the PURGE Key 44 E electrical potentials 201 EMC compatibility 201 ESD 202 precautionary procedures 202 event log 6 history display 110 print 108 F flow stop 33 36 37 39 41 44 47 49 186 Full Lock 114 lock level functions 115 locking the pump 130 unlocking the pump 132 G GemStar Docking Station 25 connect pump 25 GemStar pump components 4 GemStar pump features 6 GemStar infusion system layout 3 H handling warnings and cautions 16 HELP key 3 9 3
145. ration Programming the Pump 30 Programming Overview The pump s menu system provides step by step guidance through all of the programming steps Refer to the appropriate therapy chapter for detailed programming instructions Programming worksheets are available at the end of each therapy chapter Each worksheet lists the minimum and maximum value program range allowed for that therapy If a number outside of the program range is entered the pump displays the minimum or maximum value allowed 4 Note For Continuous Intermittent and Variable time therapies the pump only delivers in increments of 0 1 mL These therapies are rounded to the nearest 0 1 mL For example at a concentration of 15 mg mL a rate of 5 mg rounds to 4 5 mg 5 mg 0 333 mL 4 5 mg 0 3 mL When a value is rounded the pump sounds four quick beeps displays ROUNDING for a few seconds and then displays the rounded value Press YES ENTER to accept the rounded value and continue to the next step Rounding only occurs in Variable Continuous and Intermittent therapies Select the desired therapy from the Programming Menu Respond to display messages and enter requested values Note Program entries can be changed any time before the Program Review is complete Press BACK UP fo return to previous program displays and make changes as desired Review the program if required Press P to begin review Press YES ENTER when done SAVING PROGRAM d
146. resh disposable AA batteries in this compartment Te r A K r Bottom Side View Hospira GemStar System Operating Manual 9 Chapter 1 Introduction Therapies Seven types of therapy are available for infusion of medications and fluids The following table lists possible applications and available features of each therapy Therapy Possible Applications TPN Total Parenteral Nutrition fluid delivery Pain Infusion of analgesics or Management anesthetics for patient controlled pain management PCA epidural infusion and parenteral administration of general I V fluids Intermittent Interval based therapies such as antibiotics Continuous Infusion of mg mcg or mL hr with a selectable KVO Keep Vein Open option Weight Dosed Critical care pediatrics mL hr Only Simple rate programming e e e Variable Time Chronotherapy e e Available Note pain management is the only therapy available for List 13088 Hospira GemStar System Operating Manual 5 Chapter 1 Introduction GemStar Pump Features Feature Description Reference Page e Adjustable Adjusts the distal occlusion pressure limits Chapter 10 Options Settings air sensor sensitivity real time clock and Menu audible alarm volume e Alerts and Signals audible and visual alarms when Chapter 1 Intro
147. rmation during programming and alarm conditions HELP Clears a numeric value resets to zero during programming Hospira GemStar System Operating Manual BACK UP Returns to a previous display exits the Options Menu and exits the HELP mode 53 9 9 9 9 Chapter 3 Total Parenteral Nutrition TPN Programming 1 2 3 8 9 Select TPN from the Programming Menu Select the TPN delivery mode Enter the total VTBI Volume To Be Infused Note Maximum VTBI is 9600 mL minus any taper amount Enter the Taper Up and Taper Down times if applicable Note Time is entered in hours minutes 00 00 For one hour thirty minutes press 1 3 0 not 9 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 VTBI KVO Note If KVO is programmed increase the container size to accommodate the desired KVO volume Select the air sensitivity if required Review the program Press O to begin review 10 If using the PURGE key to prime the pump set press PURGE now WARNING ALWAYS disconnect the pump set from the patient before priming or purging 54 Hospira GemStar System Operating Manual 9 Chapter 3 Total Parenteral Nutrition Changing a TPN Program
148. rt between 7 00 AM and 4 00 PM Pacific time Have the pump serial number available In the USA Hospira Technical Support Operations 1 800 241 4002 Hospira Inc Technical Support Operations 755 Jarvis Drive Morgan Hill CA 95037 Outside the USA Contact your local Hospira sales office Tip Press HELP for additional information during programming and alarm conditions Hospira GemStar System Operating Manual 135 Chapter 12 Troubleshooting Alarm Messages Alarm Display Is the Alarm Cause Remedy Message pump Condition infusing Y Yes A Audible alarm N No V Visual alarm AIR IN LINE N ANN The specified volume 1 Press SILENCE to quiet P of air has been the alarm for 1 minute Abe oom detected in the line Press STOP to clear the automatically distal to the cassette alarm l enters STOP while infusing ARDE mode 3 Disconnect the patient from the pump set 4 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 Purge volume may be limited in a Pain Management program 5 Reconnect the pump set to the patient access device 6 Press START to begin infusion 136 Hospira GemStar System Operating Manual Chapter 12 Troubleshooting entered the STOP mode due to battery voltage below acceptable levels Alarm Display Is the Alarm Cause Remed
149. s kk cece K 85 Weight Dosed Programming k kk kk kk kK KK KEK RIK ne 86 Auto IVO Dr dR gd 87 Hate TIlrd NO ear xen n wan dak bar requi pe ed ad n Ay uen usa k end 87 MIB Titration y lt a rete tap ADA yaaa daha X XR e Ee RIPE RE ARMOR ROCA 88 Changing a Weight Dosed Program uk kk kk kK kK KK KK KK KK KK KI KK KK KIR 88 GemStar Weight Dosed Programming Worksheet 0005 89 Programming a Precedex dexmedetomidine hydrochloride injection Delivery 90 GemStar Precedex dexmedetomidine hydrochloride injection Programming Worksheet eoe tu RE malc deals du MA nt E HS 91 8 mL hr Only Not Applicable to List 13088 93 Therapy Features and Specifications s kk kk cece KEK KK 93 mL hr Only Programming 0 00 kk kK KK KK KK KK KK KK K KOK KI KK KK KK Ke 94 v Hospira GemStar System Operating Manual Contents Alto KV O ced k To ee euer eus dat biased bt eet du LA ERE 95 Hate Traio aye er henne de auntie e ee dre egeat den d bee eqno 95 ao DD x Rr Ere as REPRE EUH e RU RUP d 96 Piggybacking cr atten eene e Suse p e ere RD ERT 96 Changing a mL hr Only Programs 0 6 ox a tua Tech kK kK eb en KK KK KK KK KK 99 mL hr Only Programming Worksheet 4 xax ie KK KK KK KK KK KK KK KK KIR 100 9 Variable Time Not Applicable to List 13088 101 Therapy Features and Specifications 0 00 KEREKER KK gt 101 Variable Time Programming k kk kk kk k
150. s UNLOCKED or when THERAPY is the only lock level The default loading dose rate is 125 mL hr Note Loading dose amounts are included in a 1 hour or 4 hour dose limit 1 From the STOP mode press YES ENTER 0 The pump displays PROGRAM A LOADING DOSE Press YES ENTER 3 Enter the loading dose Press YES ENTER The pump displays DELIVER THE LOADING DOSE NOW To deliver the loading dose immediately press YES ENTER Primary infusion DOES NOT begin automatically when the clinician activated loading dose is complete Press START to continue primary infusion To deliver the loading dose later press NO 132 Hospira GemStar System Operating Manual Chapter 11 Clinician Instructions The pump returns to the STOP mode The next time START is pressed the pump again displays DELIVER LOADING DOSE NOW Press YES ENTER to deliver the loading dose Primary infusion continues automatically when the loading dose is complete e Press NO to cancel the loading dose and continue primary infusion Shift Totals and History Shift Totals l Press OPTIONS and select HISTORIES 2 Select sHIFT TOTALS from the Histories Menu END OF 3 The shift totals display Press SHIFT TOTALS and 9 to scroll the display When done the CLEAR TOTALS pump displays CLEAR TOTALS YES OR NO YES OR NO A e Press YES ENTER to clear the shift totals e Press NO to exit O
151. s during programming The default bolus dose delivery rate in a Pain Management therapy is 125 mL hr A bolus cord is available for patient bolus requests Refer to Connecting the Bolus Cord in Chapter 15 Optional System Components on page 168 for more information 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 The pump flashes BOLUS DELIVERY on the display and the amount infused accrues as the delivery progresses When the bolus dose is complete the pump does the following e Records the bolus request and delivery amount to the event and bolus history logs e Adds the delivered boluses to the total bolus amount in the program amounts e Resets the bolus lockout time if applicable and ignores other bolus requests until the lockout time has elapsed e Continues programmed infusion Note ALL bolus requests are recorded to the event and bolus history logs If the bolus delivery does not start it could be locked out by one of the following conditions Bolus lockout period e Loading dose delivery in progress Bolus dose delivery in progress Bolus per hour limit l hour or 4 hour dose limit Hospira GemStar System Operating Manual Chapter 4 Pain Management Bolus Dose Interruptions Bolus deliveries may be interrupted by e Pressing STOP An alarm condition To continu
152. s only or continuous with bolus delivery 9 In Continuous Bolus protocols you can enter zero for either the continuous rate or the bolus dose when entering or changing a program The continuous rate and bolus dose cannot be zero at the same time The default bolus delivery rate is 125 mL hr Note The delivery rate is administered in increments of 01 The maximum continuous delivery rate is 25 mL hr A loading dose may be set during programming which can be delivered after programming and priming are complete The default loading dose rate is 125 mL hr Rate bolus dose concentration can be programmed in increments of 0 01 Priming using PURGE is only allowed before START is pressed or after one of the following events occur e Complete Review of New Program e New Container e Air in Line Alarm V TBI can be titrated CAUTION When using PCA vials except in a lockbox with a spring assist mechanism the system may underdeliver System delivery accuracy could be reduced by as much as 5 Hospira GemStar System Operating Manual 59 9 Chapter 4 Pain Management Note New Container is allowed only when at least 1 2 of the container volume has been infused or 1 hour has elapsed since starting the infusion The use of a lockbox is recommended with pain management protocols Refer to Chapter 15 Optional System Components page 165 for instructions on using a lockbox with the GemStar amp Pump Ti
153. s time END OF INFUSION N A V The pump has delivered If no KVO is selected Press SILENCE to quiet the alarm for 2 minutes 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 Press STOP to place the pump in STOP mode and clear the alarm 146 Hospira GemStar System Operating Manual Chapter 12 Troubleshooting NO POWER LOSS ALARM AVAILABLE ENTER TO CONFIRM or dead disposable batteries AND external power Alert Display Message Is the Alarm Cause Condition Remedy pump infusing Y Yes A Audible alarm N No V Visual alarm FLASHING DISPLAY N A V ANon programming Follow the instructions on Callback has occurred the display to clear the Line four of the because the pump has alarm display flashes been waiting for more than three minutes for a keypress on a non programming input or a confirmation display O INTERNAL BATT N A V No disposable batteries 1 Press YES ENTER to confirm 2 Power off the pump and install two fresh disposable AA batteries as a backup power source CAUTION Ensure two fresh disposable AA batteries are installed for backup power when using other power sources e g AC mains adaptor docking station battery pack The pump will continue to operate on backup power if the external power sour
154. sable AA batteries are installed for backup power when using other power sources e g AC mains adaptor docking station battery pack The pump will continue to operate on backup power if the external power source fails Refer to the caution regarding Power Loss on page 14 SHIFT TOTALS Display or clear shift totals Time and date when shift was cleared Volume infused in the shift Anyrelevant program specific information VOLUME TOTALS Display volume totals Amount infused e VTBI Anyrelevant program specific information CONFIGURATION Display pump configuration Dependent upon pump configuration CLEAR HISTORY Clear history event log and bolus history CLEARING HISTORY displays for 3 to 4 seconds BOLUS HISTORY Display bolus history in hourly increments for Current date and time Number of boluses delivered Number of bolus demands 4 pump 110 user assisted Operation Test the last 48 hours Amount delivered through bolus delivery OPERATION TEST Perform Messages that guide the user through each section of the test Note Some menu items may not be available depending on the configuration of the Hospira GemStar System Operating Manual Chapter 10 Options Menu Tip Press and HOLD or O to scroll through the history displays faster History To display the history event log l Press
155. sable AA batteries as a backup power source Hospira GemStar System Operating Manual 27 9 Chapter 2 Basic Operation Power Source s USING BATTERIES Disposable batteries Press to confirm only TER TO CONFIRM If an external power source is in use ensure the connections are secure USING EXT BATT External batteries Press to confirm docking station ENTER TO CONFIRM pattery or battery If an AC mains adaptor is in use pack and disposable ensure the connections are secure batteries Display Message User Response Note To power off the pump press and hold until the display clears The pump cannot be powered off during a CHECK CASSETTE alarm except during PROGRAMMING mode Refer to Chapter 12 Troubleshooting for information on clearing a CHECK CASSETTE alarm CAUTION Ensure two fresh disposable AA batteries are installed for backup power when using other power sources e g AC mains adaptor docking station battery pack The pump will continue to operate on backup power if the external power source fails Refer to the caution regarding Power Loss on page 14 LL For more information on Refer to the following pages Setting the clock Set Clock in Chapter 10 Options Menu on page 118 Locking the keypad Keypad Lock in Chapter 10 Options Menu on page 114 28 Hospira GemStar System Operating Manual Chapte
156. secondary container has been delivered Then the primary infusion continues Note The piggyback infusion amount is NOT added to the primary programmed infusion amount Hospira GemStar System Operating Manual 79 9 Chapter 6 Continuous Preparing for Secondary Delivery Piggybacking l Ensure a primary piggyback pump set with a proximal Y site backcheck valve is in place Use the extension hook from the secondary set to suspend the primary container from the I V pole Prepare the secondary set according to the instructions included with the set Attach a needle or blunt cannula if appropriate and prime the secondary set Suspend the secondary container from the I V pole 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 Connect the secondary set to the proximal Y site or proximal luer port 80 Hospira GemStar System Operating Manual 9 9 9 Chapter 6 Continuous Programming a Secondary Delivery Piggybacking Note To distinguish the piggyback delivery from the primary delivery PIGGYBACK displays and the piggyback VTBI counts down to completion For example a piggyback rate of 250 mL hr with a remaining VTBI of 216 5 mL will display as 219 mL 122227 PIGGYBACK RATE 250 mL hr VTB
157. sette is not properly installed in the pump When using a vented chamber ALWAYS use an air eliminating filter OR set the air sensitivity to either ON or 2 mL 1 Push down on the flow stop to close the cassette 2 Insert the piercing pin into the container Suspend the container on an I V Pole HERE 3 Squeeze the drip chamber until filled halfway Hospira GemStar System Operating Manual 4 Push down on the flow stop to open priming position the cassette Ensure the CAIR roller clamp is open prior to inserting cassette 7 Invert the cassette approximately 45 41 Chapter 2 Basic Operation 7 While holding the rotated cassette remove air from the container and cassette 8 Return the cassette to the upright position Continue priming until fluid fills the tubing 9 Push down on the flow stop to close the cassette 10 Ensure lower CAIR clamp is open prior to inserting cassette 42 11 Load the cassette CAUTION Ensure all four cassette latches are clearly visible after the cassette is installed Refer to Loading the Cassette on page 35 Hospira GemStar System Operating Manual Note Ensure the tubing is behind the tubing guide at the distal end
158. silicone rubber or PVC plastic unless these items are specially treated and labeled to be compatible with such drugs To reduce the loss of potency for drugs known to be absorbed by PVC plastic and silicone begin infusion as soon as practical after priming the pump set Use of high flow rates during infusion will minimize drug absorption DO NOT use medications that are unstable under infusion conditions ALWAYS use connections with Luer Lock fittings Hospira GemStar System Operating Manual Chapter 1 Introduction To prevent contamination use aseptic technique with all fluid path connections Remove the protective coverings as assembly progresses ALWAYS place the flow stop in the closed position when the set is not in the pump Before installing the cassette in the pump ensure all slide or lower CAIR roller clamps are open Failure to open the slide or lower CAIR roller clamps BEFORE installing the cassette may result in restricted flow DO NOT back prime the pump set using a syringe Back priming may result in restricted flow Ensure the cassette is properly installed When properly installed all four cassette latches are visibly holding the cassette securely in the cassette pocket Ensure the tubing is behind the tubing guide at the distal end e Arrange tubing cords and cables to minimize the risk of patient strangulation or entanglement NEVER use vented fluid containers e g glass o
159. t 9 0 Press YES ENTER to return to the RUN mode then press START to begin Auto Taper Down Hospira GemStar System Operating Manual Chapter 3 Total Parenteral Nutrition GemStar TPN Programming Worksheet GIVE Parameters Selections and or Values to be Programmable Entered Ranges Therapy TPN N A Delivery Mode Q 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 Q No Q Yes hrs min 1 min 3 hrs Taper Down Q No Q Yes hrs min 1 min 3 hrs Total Time to Infuse hrs min 1 min 24 hrs KVO Keep Vein Open Q No KVO Rate 0 0 Q Yes KVO Rate 1 0 5 0 mL hr Container Size VTBI KVO mL 9999 mL max Air Sensitivity Q On Alarms at approx 0 5 mL of air N A Q 2mL Alarms at approx 2 mL of air u 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 Air Sensitivity may not show in all setting configurations Hospira GemStar System Operating Manual 57 Notes 58 Hospira GemStar System Operating Manual Chapter 4 Pain Management Not Applicable to List 13086 Therapy Features and Specifications This therapy allows programming of a continuous only bolu
160. t the change and begin delivery at the new rate Press NO to continue delivery at the previously programmed rate Hospira GemStar System Operators Manual 87 Chapter 7 Weight Dosed VTBI Titration To titrate the VTBI while the pump is infusing 1 Press CHANGE and select TITRATE VTBI 2 Press the number keys for the new VTBI Press YES ENTER For example if the current VTBI is 0 mL press 1 0 to change the VTBI to 10 mL 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 VTBI does not change and the delivery continues as previously programmed 9 3 NEW VTBI displays with the new rate e Press YES ENTER within 10 seconds to accept the change and begin delivery with the new VTBI e Press NO to continue delivery at the previously programmed VTBI SNC GA Note Titrating VTBI does not change initial container volume Changing a Weight Dosed Program Can be changed at any time Cannot be changed Delivery rate Unit of measure e VTBI Concentration amount of drug Patient weight 9 Note You cannot change a program when the pump is in FULL or CONTAINER Lock To change a program 1 From the STOP mode press CHANGE and select CHANGE PROGRAM 2 As each message displays make the desired changes or press YES ENTER to accept the current se
161. te or ceramic tile flooring If floors are covered with synthetic material the relative humidity should be at least 30 To reduce the potential of damage from ESD Touch the frame of the device earth or a large metal object to discharge one s body Use a grounding wrist strap prior to touching connectors 202 Hospira GemStar System Operating Manual Index Numerics 1 hour dose limit 61 4 hour dose limit 61 A AC mains power connector 4 power indicator 3 Pump Specifications 183 regarding handling and maintenance 14 regarding pump operation 14 warnings and cautions 15 AC mains adaptor connecting to 22 warnings and cautions 15 administration set See pump set air sensitivity 85 93 117 regarding air in line infusion 13 specifications 185 air in line alarm 11 air in line alarm 13 test of 161 alarm messages 136 144 alert messages 145 148 anti siphon valve 13 33 34 Auto KVO 5 in mL hr Only therapy 95 in Weight Dosed therapy 87 Auto Taper Down in TPN therapy 56 See also taper down taper up Hospira GemStar System Operating Manual auto tapering See Auto Taper Down taper down taper up B backcheck valve 79 80 96 97 BACK UP key 3 31 112 base rate 102 103 104 Basic Operation 19 batteries 125 alarm messages 137 144 battery compartment 4 battery pack connector 4 installing disposable batteries 21 maintenance 151 power check 158 specifications 183 using
162. that it is temporarily not delivering fluid if clinically acceptable 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 The GemStar Pump has been tested and found to comply with EMC EMI limits in accordance with Hospira GemStar System Operating Manual 15 Chapter 1 Introduction IEC EN 60601 1 2 2001 when using two AA disposable batteries or when connected to the GemStar AC Adaptor IEC EN 60601 1 2 2001 ESD exemption when using Li Ion Docking Station or Li Ion Battery Pack When connected to other power sources or optional system components in commercial distribution before November 30 2004 the GemStar Pump complies with EMC EMI limits in accordance with IEC EN 60601 1 2 1993 These limits are designed to provide reasonable protection against harmful interference in a typical medical installation The equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to other devices in the vicinity However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference with other devices which
163. the cassette is 3 Align the pump with the lockbox C installed Refer to Loading the 4 Slide the pump down into the Cassette on page 35 lockbox until fully seated mir i COCOS e 5 Flip the top door down JM AG 6 Connect the pump set to the P Note Ensure the tubing is in the pre filled vial and prime tubing guide at the distal end 7 Place the pre filled vial inside the lockbox D 9 Ensure the tubing will not be pinched when closing the lockbox 10 Close and lock the lockbox 11 Remove the key Hospira GemStar System Operating Manual 169 Chapter 15 Optional System Components 250 mL Lockbox List 13024 01 1 Open the lockbox A 2 Flip the top door up B la NR Y 3 Align the pump with the lockbox C 4 Slide the pump down into the lockbox until fully seated OOS 5 Flip the top door down 6 Connect the pump set to the bag and prime 7 Place the flexible container inside the lockbox with the administrative port down D 170 9 Hang the bag on the hook inside the lockbox E Ensure slide clamp is open prior to inserting cassette 10 Load the cassette F g j val ty CAUTION Ensure all four cassette latches are clearly visible after the cassette is installed
164. the program If programming a loading dose specify a dose time and rate using the P key to toggle between the parameters and then press YES ENTER 10 Review the program using the P key when finished press YES ENTER WARNING ALWAYS disconnect the pump set from the patient before priming or purging 11 If using the PURGE key to prime the pump set press PURGE now 12 Press START to begin the Precedex delivery 90 Hospira GemStar System Operators Manual Chapter 7 Weight Dosed GemStar Precedex dexmedetomidine hydrochloride injection Programming Worksheet GIVE Parameter Selections and or Values to be Entered Programmable Ranges Therapy Weight Dosed N A Unit of Measure mcg kg hr N A Precedex YES ENTER N A Therapy Patient Weight 2 0 200 0 kg kg Concentration mcg 1 0 1000 Add values are in required Use mL 0 1 1000 to toggle between fields Rate mL hr is automatically calculated VTBI Volume To Be Infused mL 0 1 9999 mL Loading Dose O No 2 entries are Yes required Use Dose mcg kg 0 1 0 to toggle between mg and mL entry Time points Package Insert recommends 0 2 to 0 7 mcg kg hr The delivery rate is programmable and is delivered in increments of 01 Package Insert recommends I mcg kg over10 min Cannot enter less than 10 min Note Numbers increment by hundredths for example 0 1 incr
165. the pump 2 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 GemStar Pump When removing the cord from the bottom of the pump firmly grasp the connector and pull straight out DO NOT twist or bend the cord or connector Ensure two fresh disposable AA batteries are installed for backup power when using other power sources e g AC mains adaptor docking station battery pack The pump will continue to operate on backup power if the external power source fails Refer to the caution regarding Power Loss on page 14 POWER Note The green LED on the pump remains lit when connected to AC mains Power 22 Hospira GemStar System Operating Manual Chapter 2 Basic Operation Using the GemStar Rechargeable Battery Pack Use the GemStar AC Mains Adaptor List 13026 01 USA 13026 03 Universal or 13072 01 Universal to recharge the GemStar Battery Pack List 13073 03 WARNING DO NOT touch connector ports Refer to caution on page 16 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 GemStar Pump to charge the battery pack During charging the battery pack is warm If the battery pack becomes hot to the touch IMMEDIATELY unplu
166. there is air present in the cassette Follow the instructions in the individual set labels to remove any visible air from the cassette 179 Chapter 16 Pump Sets The following sets are a representation of the GemStar Pump Sets currently available List No Description Ambulatory Sets 13263 Latex Free GemStar Pump Set and Extension Set with Integral Pressure Activated Anti Siphon Valve Secure Lock Nonvented Microbore Tubing 96 in 244 cm 13264 Latex Free LifeShield GemStar Pump Set with 0 2 Micron Filter Secure Lock Prepierced reseal injection site Nonvented Pre Attached Pressure Activated Anti Siphon Valve Microbore Tubing 96 in 244 cm 13265 Latex Free LifeShield GemStar Pump Set with 1 2 Micron filter Secure Lock Prepierced reseal injection site Nonvented Pre Attached Pressure Activated Anti Siphon Valve NonPhthalate Non DEHP Microbore Tubing 96 in 244 cm 13273 Latex Free GemStar Pump Set Secure Lock Nonvented Pre Attached Pressure Activated Anti Siphon Valve Microbore Tubing 96 in 244 cm 13612 Latex Free Lifeshield GemStar Primary Set with orange polyethylene lined light resistant tubing 3 inch segment clear PVC tubing Pre Attached Pressure Activated Anti Siphon Valve Secure Lock Nonvented Microbore tubing 96 inch 244 cm 20634 GemStar Pump Set with orange polyethylene Lined Light Resistant Tubing 3 inch Segment of Clear PVC
167. ting Piggyback Delivery The following delivery related Operational Alarms occur during a Piggyback Delivery Check Cassette e Air in Line Distal Occlusion Proximal Occlusion If an alarm occurs during the programming sequence piggyback dose programming is completed Changing a Continuous Program 82 Can be changed at any time Cannot be changed Delivery rate Container size Unit of measure VTBI Air sensitivity Concentration KVO rate Piggybacking Note You cannot change a program when the pump is in FULL or CONTAINER Lock To change a program 1 From the STOP mode press CHANGE and select CHANGE PROGRAM 2 As each message displays make the desired changes or press YES ENTER to accept the current setting 3 Review the program Press to begin review 4 Press START to begin delivery Hospira GemStar System Operating Manual Chapter 6 Continuous GemStar Continuous Programming Worksheet GIVE Parameter Selections and or Values to be Programmable Ranges Entered Therapy Continuous N A Unit of Measure Concentration mg mL 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 1 9999000 mcg Infused 0 1 9999 mL KVO Q No KVO Rate 0 0 Keep Vein Open q Yes KVO Rate 0 1 5 0 mL hr Container Size 0 1 99999 mg VTBI KVO 1
168. tting 3 Review the program Press KA to begin review 4 Press START to begin delivery 88 Hospira GemStar System Operators Manual Chapter 7 Weight Dosed GemStar Weight Dosed Programming Worksheet GIVE Parameter Selections and or Values to be Entered Programmable Ranges Therapy Weight Dosed N A Unit of Measure mcg kg min Q mog hr N A Q mcg kg hr grams hr Q mcg min Q ng kg min Q mg kg min Q U kg hr Q mg kg hr Q U min Q mg min Q Uhr Q mL hr Q mUn min Q mg hr Q mEg hr Patient Weight When programming in kg min or kg hr 2 0 200 0 kg Concentration For all units of measure EXCEPT mL hr 0 1 9999000 mg 2 entries are mg U mEq 0 1 99999999 U required Use in in in 0 1 9999 mEq to toggle mL mL mL 0 1 9999 mL Rate see below VTBI Volume To Be Infused 0 1 9999 mL Programmable Ranges for Rate not all units of measure are available in all pump configurations 0 001 833 mg kg min 0 001 500000 mg kg hr 0 001 16666 mg min 0 001 166666 mcg kg min 0 001 9999999 mcg kg hr 0 002 166666 mcg min 0 1 1000 mL hr 0 001 999999 mg hr 0 001 9999999 mcg hr 0 001 999 grams hr 0 009 999 ng kg hr 0 001 99999999 U kg hr 0 001 99999999 U min 0 001 99999999 U hr 0 001 999999999 mUn min 0 001 999 mEq hr Note Numbers increment by hundredths for example 0 1 increments to 0 11 then to 0 12
169. ttom of the pump 2 Snap the battery pack into place To release the battery pack l Press the release button on the battery pack Pull the battery pack straight out from the pump Note When the pump is connected to the battery pack the pump s green LED flashes and the battery pack light is off When the pump is connected to the battery pack at power on the pump displays USING EXT BATT To charge the battery pack 1 Plug the pin connector of the AC mains adaptor into the port on the bottom of the battery pack 2 Plug the AC mains adaptor into a standard wall outlet 3 Leave the battery pack connected to the AC mains adaptor for at least 12 hours to charge the battery pack Note The Li Ion battery pack List 13073 03 light is yellow while the battery pack is charging and green when the battery pack is charged or not charging Li Ion batteries cannot be charged when the room temperature is greater than 95 F 35 C or less than 41 F 5 C Hospira GemStar System Operating Manual Chapter 2 Basic Operation CAUTION When removing the cord from the battery pack firmly grasp the connector and pull straight out DO NOT twist or bend the cord or connector Using the GemStar Docking Station WARNING DO NOT touch connector ports Refer to caution on page 14 CAUTION Ensure two fresh disposable AA batteries are installed for backup power when using other power sources e
170. uired 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 can 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 1 hour or 4 hour dose limit record the pump accepts bolus requests or resumes continuous delivery if programmed Note If a 1 hour or 4 hour dose limit is programmed a bolus in progress will stop when the amount infused reaches the dose limit Loading doses are included in a 1 hour or 4 hour dose limit A dose limit in effect could 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 Note To enter the total in mL when programming a concentration press P to move to the mL line Enter the mL value when mL flashes on the display Select the air sensitivity if required Review the program Press to begin review 10 If using the PURGE key to prime the pump set press PURGE now WARNING ALWAYS disconnect the pump set from the patient before priming or purging Hospira GemStar System Operating Manual 61 9 Chapter 4 Pain Management Bolus Delivery 62 Set bolus doses and delivery limit
171. urce and batteries are connected Press e 2 Remove battery door and press qn The display indicates that only external power is connected Press 3 Return the battery door to the closed position 4 Disconnect the external power source and press qn 5 The display indicates that only batteries are connected and displays the test results Press qn 6 Ifthe pump fails reconnect the external power source and press to rerun the test or press YES ENTER to confirm failure Keypad Test 1 Press each key including the Bolus Button Press YES ENTER last 2 Enter the results e feach key makes an audible tone press YES ENTER e If any key does not make an audible tone press NO Display Test l 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 2 Enter the results e Ifthe display fills with solid boxes press YES ENTER e Ifthe display does not fill with solid boxes press NO Hospira GemStar System Operating Manual Chapter 14 Operation Test LED Test l Verify that both the Power green and Alarm red LEDs are lit Refer to GemStar Pump Layout on page 2 for the location of the LEDs 2 Enter the results e f both LEDs are lit press YES ENTER e feither of the LEDs does not light press NO Tip Use two microbore pump sets to save time during the next four tests
172. wing aircrafts e g helicopters The pump must be used with sterile dedicated GemStar administration sets Note Epidural administration of anesthetics is recommended in the continuous mode only Epidural administration of analgesics may be delivered 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 WARNING Delayed respiratory depression following continuous epidural administration of preservative free morphine sulfate has been reported 10 Hospira GemStar System Operating Manual 9 Chapter 1 Introduction For epidural administration the following is recommended Nylon or Teflon catheter Pump sets without Y sites Stickers for the tubing indicating ongoing administration Note Facilities practicing epidural anesthesia analgesia must be staffed and equipped to manage cardio pulmonary resuscitation CPR Supplies should include oxygen naloxone and other appropriate resuscitative drugs and equipment Monitor patients continuously e g oximetry during epidural administration Frequently observe patient for side effects for up to 24 hours following completion of drug administration by the epidural route Contraindicati
173. y Message pump Condition infusing Y Yes A Audible alarm N No V Visual alarm CHANGE BATTERIE N ANN The pump has 1 Replace both disposable batteries with fresh AA batteries and press to restart the pump or connect the pump to the AC mains adaptor and the pump will automatically restart Replace both batteries as Soon as possible CAUTION Ensure two fresh disposable AA batteries are installed for backup power when using other power sources e g AC mains adaptor docking station battery pack The pump will continue to operate on backup power if the external power source fails Refer to the caution regarding Power Loss on page 14 2 After power on resume the current program Refer to Accessing the Programming Menu in Chapter 2 Basic Operation for more information Hospira GemStar System Operating Manual 137 Chapter 12 Troubleshooting 1 800 XXX XXXX CODE N SERVICE MMM TTT ALARM detected a condition that may require service Alarm Display Is the Alarm Cause Remedy Message pump Condition infusing Y Yes A Audible alarm N No V Visual alarm CHECK CASSETTE X N A V _ The cassette is Press SILENCE to quiet improperly installed the alarm for 1 minute or not installed Press STOP to place the x indicates where to pamp me STOR mode look for the cause of Ensure slide clamp or lower the alarm CAIR clamp is
174. y time except during a CHECK CASSETTE alarm Hospira GemStar System Operating Manual 9 9 Chapter 1 Introduction Indications for Use Physicians or certified licensed healthcare professionals should always oversee infusions Healthcare professionals should always supervise pump users and instruct users in pump operation and troubleshooting Instruction should include how to prevent intravenous I V related complications including how 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 Intended parenteral administrations include but are not limited to intravenous within a vein arterial subcutaneous tissue just below the skin regional located to specific areas of the body and epidural analgesia intrathecal analgesia intraspinal analgesia combined spinal epidural analgesia short term epidural infusion intraspinal within the spinal canal intrathecal within the subarachnoid or subdural space intraoperative sites soft tissue body cavity or surgical wounds intraarticular within a joint intraperitoneal within the peritoneal cavity and intracerebroventricular infusions The indications for use include hospital homecare and ambulatory environments The system has also been qualified for use in fixed and rotary

Manual - OSO Home Care

Contents

Download Pdf Manuals

Related Search

Related Contents