Hospira GEMSTAR 13088-04-01 System Operating Manual
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Hospira GEMSTAR 13088-04-01 System Operating Manual

Hospira GEMSTAR 13088-04-01 System Operating Manual

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Infusion Pump
System Operating Manual
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Hospira GemStar Pain Management Pump
List 13088-04-01/02
Hospira, Inc., Lake Forest, IL 60045
430-10984-001 (Rev. 01/06)

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Summary of Contents for Hospira GEMSTAR 13088-04-01

  • Page 1 ® Infusion Pump System Operating Manual For use with the ® Hospira GemStar Pain Management Pump List 13088-04-01/02 Hospira, Inc., Lake Forest, IL 60045 430-10984-001 (Rev. 01/06)
  • Page 2 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®...
  • Page 3 Change History Part Number Description of Change Pages Changed 430-10984-001 Original Issue (Rev. 03/06) Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 4: Table Of Contents

    Tips for Using the Options Menu ........55 Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 5 Using the Hospira Carrying Cases ........
  • Page 6 Guidance on EMC Compatibility ........147 Information Regarding Electrostatic Discharge (ESD) ....148 Index IEC Symbols inside back cover Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 7 Notes Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 8: Introduction

    Chapter 1 Introduction The Hospira GemStar® Pain Management 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.

  • Page 9: Gemstar® Pump Layout

    1. Introduction GemStar® Pump Layout Shown approximate size Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 10 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 Manual 430-10984-001 (Rev. 03/06)

  • Page 11: Gemstar® Pump Components

    I.V. Tubing Guide Use to hold the I.V. tubing. Battery Pack Use to connect the GemStar® Connector Rechargeable Battery Pack. Battery Compartment Install two fresh, disposable AA batteries in this compartment. Bottom/Side View Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 12: Gemstar® Pump Features

    Review the history on the display, or download it to a printer or computer. • Speed Stores up to nine frequently used programs Chapter 4 Options Menu Protocols in the pump’s memory for quick access. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 13: Menu System

    Options Menu first displays, only the first four menu items are shown. Instead of pressing the down arrow to see the other menu items, press [ ] to go directly to SET CLOCK. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 14 For menu item [1], refer to Starting a New Container in Chapter 2 Basic Operation, on page 30. For menu items [2] and [3], refer to Chapter 3 Pain Management, page 45. Options Menu Chapter 4 Options Menu, page 55. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 15: Operating Modes

    When the programmed therapy is complete, and during certain STOP alarm conditions, the pump automatically enters the mode. STOP Press to enter the mode at any time, except during a CHECK CASSETTE alarm. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 16: Indications For Use

    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. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 17: Contraindications For Use

    Follow the instructions in the individual set labels to remove any visible air from the cassette. Ensure slide clamp or lower CAIR® clamp is open prior to inserting cassette. When using pre-filled vials, ensure vial and injector are securely locked in lockbox before beginning delivery. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 18 Ensure the tubing is behind the tubing guide (at the distal end). Arrange tubing, cords, and cables to minimize the risk of patient strangulation or entanglement. NEVER use vented fluid containers (e.g., glass or rigid plastic) unless suspended Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 19 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.
  • Page 20 1. Introduction The Hospira 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 battery pack becomes hot to the touch, IMMEDIATELY unplug the AC mains adaptor and contact Hospira Technical Support Operations.
  • Page 21 Increase the separation between the equipment Connect the equipment to an outlet on a circuit different from that to which the other device is connected Consult the manufacturer or field service technician for help Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 22 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.
  • Page 23 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. Please comply with local disposal and recycling regulations as appropriate for disposable batteries, rechargeable battery packs, medical electronic components, and pump sets.

  • Page 24: Basic Operation

    6 Select the appropriate optional system components, such as a bolus cord. 7 Select the delivery mode and enter a program. Refer to Chapter 3 Pain Management, page 45 for detailed instructions. 8 Press [ ] to begin delivery. START Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 25: Selecting A Power Source

    (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 13. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 26 5 Return the battery door to the battery compartment. 6 Turn the battery door to the right (clockwise). Ensure the battery door is secured under the slot. 7 Flip closed the tab of the battery door to lock in place. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 27 Refer to the caution regarding Power Loss on page 13. Note: The green LED on the pump remains lit when connected to AC mains power. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 28 During charging, the battery pack is warm. If the battery pack becomes hot to the touch, IMMEDIATELY unplug 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).
  • Page 29 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 Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 30 Li-Ion batteries cannot be charged when the room temperature is greater than 95°F (35°C) or less than 41°F (5°C) 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. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 31: Using The Gemstar® Docking Station

    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 Manual 430-10984-001 (Rev. 03/06)

  • Page 32: Powering On The Pump

    CAUTION: 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.
  • Page 33 For more information on: Refer to the following pages: Setting the clock Set Clock in Chapter 4 Options Menu, on page 66. Locking the keypad Keypad Lock in Chapter 4 Options Menu, on page 62. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 34: Accessing The Delivery Mode Menu

    Press [ ] to place the pump in STOP mode. STOP Press [ ] to display the Change Menu. CHANGE Select NEW PROGRAM. The pump clears the current program and displays the Delivery Mode Menu. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 35: Programming The Pump

    The pump stores the program in memory and then SAVING PROGRAM enters mode. STOP Tip: If you enter an incorrect number during programming, press [ CHANGE BEFORE pressing [ to reset the number to zero. Then enter the YES/ENTER] correct number. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 36 When entering a numeric value during programming, press to reset the CHANGE CHANGE value to zero. Press to return to a previous display, to exit the Options Menu, or to exit HELP mode. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 37: Starting A New Container

    S T E R I L E 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®...
  • Page 38 2. Basic Operation A typical GemStar® Pump Set is shown below: Piercing Pin Tubing Proximal End Slide Clamp Cassette Secure Lock Flow Stop (open / close Pressure-activated Anti-Siphon Valve Distal End Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 39 Remove protective coverings as assembly progresses. Opening the Pump Set 1 Open the GemStar® Pump Set package and remove the contents. 2 Remove the protective covers from the fluid container administration port and the pump set. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 40: Loading The Cassette

    CAIR® clamp is open prior to pocket by pushing firmly along the inserting cassette. entire cassette until it is firmly seated. 3 Line up the cassette as shown (with the flow stop button facing the pump). Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 41: Releasing The Cassette

    Note: Ensure the tubing is behind the tubing guide (at the distal 3 Remove the cassette. end). Note: When the cassette is released from the pump, the cassette flow stop automatically closes, preventing free flow. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 42: Priming A Gemstar® Pump Set

    3 Push down on the flow stop 6 Return the cassette to the upright open (priming position) the position. Continue priming until cassette. fluid fills the tubing. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 43 Priming using [ ] is only PURGE allowed before [ ] is pressed START or after one of the following events occur when using Pain Management therapy: Complete Review of New Program New Container Air-in-Line Alarm Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 44 CAUTION: Ensure all four cassette latches are clearly visible after the cassette is installed. Refer to Loading the Cassette on page 33. 3 Ensure slide clamp is open prior to inserting cassette. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 45 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. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 46 SAM lockbox insert for instructions. 1 If using 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. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 47 3 Push down on the flow stop air is cleared from the vial, close the cassette. injector, cassette, and tubing. 4 Connect the pump set to a Hospira pre-filled vial and injector. 8 Push down on the flow stop close the cassette.
  • Page 48 CAUTION: Ensure all four cassette latches are clearly visible after the cassette is installed. Refer to Loading the Cassette on page 33. Note: Ensure the tubing is behind the tubing guide (at the distal end). Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 49 3 Push down on the flow stop 6 Return the cassette to the upright open (priming position) the position. Continue priming until cassette. fluid fills the tubing. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 50 2 minutes installed. Refer to Loading the each time you press and hold Cassette on page 33. PURGE Continue using the [ ] key PURGE until fluid fills the tubing. Ensure Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 51 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. 15 Connect the pump set to the patient-access device. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 52: Pain Management

    1 hour has elapsed since starting the infusion. The use of a lockbox is recommended with pain management protocols. Refer to Chapter 9 Optional System Components, page 109, for instructions on using a lockbox with the GemStar® Pump. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 53 Displays information Returns to a previous during programming and display, exits the Options alarm conditions. Menu, and exits the HELP mode. Clears a numeric value CHANGE (resets to zero) during programming. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 54: Pain Management Programming

    8 Review the program. Press to begin review. 9 If using the PURGE key to prime the pump set, press [ ] now. PURGE WARNING: ALWAYS disconnect the pump set from the patient before priming or purging. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 55: Bolus Delivery

    If the bolus delivery does not start, it could be locked out by one of the following conditions: Bolus lockout period Loading dose delivery in progress Bolus dose delivery in progress Bolus per-hour limit 1-hour or 4-hour dose limit Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 56: Rate Titration

    NEW RATE • Press [ ] within 10 seconds to accept the change and begin delivery YES/ENTER at the new rate. • Press [ ] to continue delivery at the previously programmed rate. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 57: Loading Dose Delivery

    Loading dose deliveries can be interrupted by: Pressing [ STOP An alarm condition To continue a loading dose: 1 Resolve the interruption. 2 Press [ ]. The pump displays START COMPLETE THE LOADING DOSE? Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 58: Changing A Pain Management Program

    2 As each message displays, make the desired changes or press [ ] to YES/ENTER accept the current setting. 3 Review the program. Press to begin review. 4 Press [ ] to begin delivery. START Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 59: Pain Management Programming Worksheet

    *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 Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 60 2 mL Alarms at approx. 2 mL of air No alarm The delivery rate is programmable and is delivered in increments of .01. ** Air Sensitivity may not show in all setting configurations. Note: Titrating VTBI does not change initial container volume. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 61 Notes Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 62: 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 [ Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 63 (if available), current printer or personal computer. program settings, and speed protocols. Assign, review/recall, and delete Allows up to 9 speed protocols to SPEED the stored protocols. be saved in pump memory. PROTOCOLS Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 64: Review Program

    1 Press [ HISTORIES ] and select OPTIONS HISTORIES KEYPAD LOCK 2 Select the number key for the desired function. PUMP SETTINGS 3 Complete the appropriate steps for the selected SET CLOCK function. PRINT SPEED PROTOCOL Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 65 OPERATION section of the test Operation Test. TEST Note: Some menu items may not be available depending on the configuration of the pump. Tip: Press and HOLD to scroll through the history displays faster. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 66 • Press [ ] to exit OPTIONS without clearing the shift totals. Tip: Press [ ] to display shift totals when the pump is not in PROGRAMMING HELP mode or an alarm condition. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 67 ] and select HISTORIES OPTIONS 2 Select from the Histories Menu. CLEAR HISTORY 3 The pump display for 3–4 seconds before exiting CLEARING HISTORY OPTIONS. Tip: Press [ ] to exit OPTIONS immediately. BACK-UP Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 68 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 8 Operation Test on page 99 for instructions. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 69: Keypad Lock

    STOP appears in the lower left corner of the display and the lock level abbreviation appears in the lower right corner. Clinicians: refer to Chapter 5 Clinician Instructions on page 77 for detailed instructions. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 70 Occlusion Level, Sound Level, and Clock Clear Shift Totals • • • Program and Deliver a Loading • Dose (Outside of Programming Mode) Enter a New Program • Operation Test • • Clear History Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 71: Change Pump Settings

    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. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 72 24 hours. • Press [ ] to permanently change the distal occlusion setting. The YES/ENTER new setting will remain in effect until the setting is changed again through the Options Menu. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 73: Set Clock

    MON, JUL 26, 05 Tip: To view the clock from the RUN or STOP mode, ENTER TO CONFIRM press [ ], then immediately press and HOLD YES/ENTER ]. The clock displays until [ ] is released. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 74: Print

    Print the current program, shift and volume totals, and the PRINT BOLUS Hx bolus history (Hx) for the latest 48 hours. Cancel printing. This function is only available if the pump is STOP PRINT printing. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 75: Speed Protocol

    REPLACE PROTOCOL ASSIGNMENT? • Press [ ] to replace the protocol. The pump displays the new speed YES/ENTER protocol and exits OPTIONS • Press [ ] to keep the existing protocol and exit OPTIONS Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 76 SPEED PROTOCOL OPTIONS 2 Select from the Speed Protocol Menu. DELETE 3 Select the desired protocol to delete. 4 Press [ ] to confirm deletion or [ ] to exit without deleting. OPTIONS YES/ENTER Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 77: Connecting To The Data Port

    • 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 Manual 430-10984-001 (Rev. 03/06)
  • Page 78 3 Set the 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 Manual 430-10984-001 (Rev. 03/06)
  • Page 79 SW3-3 Parity condition: ONLINE SW3-4 Flow control: H/S busy ONLINE SW3-5 Baud rate: 2400 bps ONLINE SW3-6 Baud rate: 2400 bps FEED SW3-7 Baud rate: 2400 bps FEED SW3-8 Baud rate: 2400 bps ONLINE Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 80 3 Ensure the printer is ONLINE and ready to receive data. Refer to printer documentation for more information. 4 Ensure paper is loaded in the printer. 5 Select the desired print function from the pump menu. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 81 6 Connect the GemStar® serial cable to the data port on the bottom of the pump. 7 Configure the communication software on the computer. Refer to Configuration Settings on page 71. Tip: After the data transfer is complete, use any text editor to view or print the file. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 82: Transferring Data Using A Computer

    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. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 83 67. 11 Wait for the transmission to complete. 12 From the menu, select Transfer > Capture Text > Stop. 13 Exit HyperTerminal. 14 Use any text editor to view or print the file. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 84: Clinician Instructions

    Place the pump in STOP mode, press [YES], and then press and hold [1]. The clock displays until you release [1]. Program a Loading From the Pain Management STOP MODE, press Dose [YES/ENTER], and then press [0] to program a Loading Dose. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 85: Clinician Locking Sequence Instructions

    4 Enter the lock sequence number for that level. 5 The pump displays the current lock level. Press [ ] to return to the YES/ENTER mode the pump was in when [ ] was pressed. OPTIONS Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 86: Program And Deliver A Clinician Activated Loading Dose

    3 The shift totals display. Press SHIFT TOTALS to scroll the display. When done, the CLEAR TOTALS? pump displays CLEAR TOTALS? YES OR NO. YES OR NO • Press [ ] to clear the shift totals. YES/ENTER Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 87 Displays the PROGRAM A LOADING DOSE? been programmed screen but not delivered, displays the DELIVER LOADING DOSE NOW? screen CURRENT DATE [YES/ENTER] + [1] Displays the real time clock as long as 1 is held AND TIME down displaying Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 88: Troubleshooting

    Hospira Technical Support Operations hotline (available 24 hours a day). To return the pump for service, first contact Hospira Customer Support between 7:00 AM and 4:00 PM Pacific time. Have the pump serial number available. In the USA...

  • Page 89: Alarm Messages

    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. Reconnect the pump set to the patient-access device. Press [START] to begin infusion. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 90 Refer to the caution regarding Power Loss on page 13. After power-on, resume the current program. Refer to Accessing the Delivery Mode Menu in Chapter 2 Basic Operation for more information. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 91 Power-off the pump. If the CODE: NN/MMM/TTT service. pump does not power-off, (SERVICE ALARM) disconnect external power and remove the batteries. Call the telephone number shown on the display message. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 92 Close the flow the Cassette on page 33 stop. Press [START] to begin Load the infusion. cassette into the pump. Open the distal clamp. Review the program. 10 Press [START] to start the pump. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 93 Press [START] to begin this interval may be infusion. different. Note: In case of low battery alarm during printing, replace the batteries and reprint Plug in AC main and reprint. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 94 (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 13. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 95 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 33 Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 96 (e.g., AC Mains levels. 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 13. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 97 (e.g., AC Mains internal batteries. 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 13 Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 98: Alert Messages

    Cable is plugged in to both the pump and the printer. Cable part number and printer settings are correct. If the problem continues, select STOP PRINT from the Print Menu to cancel all print jobs. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 99 • Line four of the because the pump has display flashes. been waiting for more than three minutes for a keypress on a non- programming input or a confirmation display. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 100 Other remained in the STOP Follow the instructions parts of the display mode for more than three on the display to clear are not affected. minutes. the alarm. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 101: Other Display Messages

    Press [YES/ENTER] to return to THIS OPTION NOT AVAILABLE WHILE access a function that is not the first programming display. PROGRAMMING THE available from the first Complete programming. PUMP programming display. Access desired function. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 102: Maintenance

    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.
  • Page 103 3 Clean the exposed surfaces of the pump with a soft, lint-free cloth dampened with the appropriate cleaning solution. 4 Wipe the solution from the pump surface with a water-moistened, lint-free cloth. 5 Use a dry, lint-free cloth to dry the pump after cleaning. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 104: Repair

    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.
  • Page 105 Notes Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 106: Operation Test

    Chapter 8 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 to facility requirements to determine additional testing needs. The test can be performed when the pump is in the...

  • Page 107: Test Setup

    If the pump is free of damage and all the screws and labels are in place, press YES/ENTER • If damage is found on the case or keypad, or any screws or labels are missing, press [ Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 108 If the cassette pocket area and latches are free of damage, and ALL of the above steps are verified, press [ YES/ENTER • If damage is found, or ANY of the above steps cannot be verified, press [ Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 109 10 seconds. To view the solid boxes for another 10 seconds after the display times-out, press 2 Enter the results: • If the display fills with solid boxes, press [ YES/ENTER • If the display does not fill with solid boxes, press [ Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 110 4 Press [ START 5 Enter the results: • If the pump delivers between 19.0 to 21.0 mL, press [ YES/ENTER • If the pump does not deliver between 19.0 to 21.0 mL, press [ Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 111 If the test is failed, clean the sensors and press to rerun the test or press ] to confirm failure. YES/ENTER Note: Clean the sensor pins before repeating the proximal occlusion test. Refer to Chapter 7 Maintenance for instructions. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 112: Printing Test Results

    Printer in Chapter 4 Options Menu, on page 73. 2 Press [ ] to print the test results. YES/ENTER 3 The pump displays the Delivery Mode Menu when the results have finished transmitting or if [ ] is pressed. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 113 8. Operation Test Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 114: 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: Date: Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 115 Notes Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 116: Optional System Components

    Locks the GemStar® Pump and up to a 250 mL Lockbox 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). Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 117 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 Manual 430-10984-001 (Rev. 03/06)
  • Page 118 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. GemStar® System 13981-01 Provides operating instructions for patients and Operating Manual caregivers. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 119: Connecting The Bolus Cord

    AC mains connector, 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. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 120 (at the distal end). and prime. 7 Place the vial inside the lockbox 9 Ensure the tubing will not be pinched when closing the lockbox. 10 Close and lock the lockbox. 11 Remove the key. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 121 6 Connect the pump set to the bag and prime. 7 Place the flexible container inside the lockbox with the Note: Ensure the tubing is in the administrative port down ( tubing guide (at the distal end). Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 122: Using The Hospira Carrying Cases

    GemStar® Pump and up to a 250 mL flexible fluid bag. 1 Place the fluid bag in the zippered compartment ( ) on the backside of the case. Ensure the bag spike is positioned so that the fluid flow is not restricted. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 123 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. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 124 ( ) and ). 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 Manual 430-10984-001 (Rev. 03/06)
  • Page 125 GemStar® Pump with batteries or a battery pack, and up to a 3 liter flexible fluid bag. Note: This carrying case includes an interior support (Hospira 3 Liter Carrier List 13590-01) that may be removed from the case and used separately.
  • Page 126 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 Manual 430-10984-001 (Rev. 03/06)
  • Page 127 9. Optional System Components Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 128: Using The Gemstar® Docking Station

    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 Manual 430-10984-001 (Rev. 03/06)
  • Page 129 2 Plug the printer cable into the printer port on the rear, right side of the docking station. To remove the pump: 1 Press the release button on the top of the docking station. 2 Slide the pump out. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 130: Pump Sets

    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.
  • Page 131 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, Non-vented, Microbore tubing, 110 in (279 cm), Yellow Striped Tubing Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 132 Anti-Siphon Valves, Secure Lock, Microbore Tubing, 99 inch (251 cm) 20705 Latex Free, GemStar® Pump Set with Injector, 2 Integral Pressure-Activated Anti-Siphon Valves and Y-Extension with Backcheck Valve, Secure Lock, Microbore Tubing, 97 inch (246 cm) Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 133 Notes Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 134: Gemstar® Pump Specifications

    (Universal) complies with CSA 22.2 Input: 100–240 VAC N0 601.1 and UL 60601-1 Output: 3.0 VDC Battery: Two disposable AA alkaline batteries Battery Pack: Rechargeable using GemStar® AC Mains Adaptor List 13073 Lithium-ion rechargeable battery Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 135 Accuracy of ±5 minutes per month or better at temperatures Real Time Clock between 59° F and 95° F (15° C and 35° C) Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 136 Error and alarm conditions are indicated by both audible and visual alarms; delivery in progress is stopped, if appropriate (refer to Chapter 6 Troubleshooting) Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 137: Occlusion Information

    3 Press the cassette release button to eject the cassette from the pump. 4 Press down on to open the flow stop. 5 Wait 10 seconds. 6 Press down on to close the flow stop. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 138 CAUTION: Ensure all four cassette latches are clearly visible after the cassette is installed. Refer to Loading the Cassette on page 33. Note: Ensure the tubing is behind the tubing guide (at the distal end). Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 139 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. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 140 +2.8% and -0.5% from the nominal rate. The average delivery rate error over the entire 2nd hour was +1.6% ( For other time intervals look at other points at the horizontal axis and determine corresponding limits as above. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 141 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 nominal rate. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 142 0.1 mL, 0mm Hg Delivery Head, Start Up Time (minutes) — Actual Rate --- Programmed Rate PERCENT ERROR 0.1 mL, 0 mm Hg Delivery Head, Start Up Observation Interval (minutes) Observation Interval (minutes) Mean Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 143 0.1 mL, 0mm Hg Delivery Head, Hour 96 Time (minutes) — Actual Rate --- Programmed Rate PERCENT ERROR 0.1 mL, 0 mm Hg Delivery Head, Hour 96 Observation Interval (minutes) Observation Interval (minutes) Mean Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 144 1 mL, 0mm Hg Delivery Head, Start Up -0.2 -0.4 Time (minutes) — Actual Rate --- Programmed Rate PERCENT ERROR 1 mL, 0 mm Hg Delivery Head, Start Up 30.0% 20.0% 10.0% 0.0% -10.0% -20.0% -30.0% Observation Interval (minutes) Mean Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 145 1 mL, 0mm Hg Delivery Head, Hour 96 -0,2 -0,4 Time (minutes) — Actual Rate --- Programmed Rate PERCENT ERROR 1 mL, 0 mm Hg Delivery Head, Hour 96 30.0% 20.0% 10.0% 0.0% -10.0% -20.0% -30.0% Observation Interval (minutes) Mean Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 146 15.0 10.0 -5.0 -10.0 Time (minutes) — Actual Rate --- Programmed Rate PERCENT ERROR 25 mL, 0 mm Hg Delivery Head, Start Up 15.0% 10.0% 5.0% 0.0% -5.0% -10.0% -15.0% Observation Interval (minutes) Mean Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 147 15.0 10.0 -5.0 -10.0 Time (minutes) — Actual Rate --- Programmed Rate PERCENT ERROR 25 mL, 0 mm Hg Delivery Head, 96 Hour 15.0% 10.0% 5.0% 0.0% -5.0% -10.0% -15.0% Observation Interval (minutes) Mean Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 148 15.0 10.0 -5.0 -10.0 Time (minutes) — Actual Rate --- Programmed Rate PERCENT ERROR 25 mL, -100 mm Hg Delivery Head, Start Up 15.0% 10.0% 5.0% 0.0% -5.0% -10.0% -15.0% Observation Interval (minutes) Mean Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 149 15.0 10.0 -5.0 -10.0 Time (minutes) — Actual Rate --- Programmed Rate PERCENT ERROR 25 mL, +100 mm Hg Delivery Head, Start Up 15.0% 10.0% 5.0% 0.0% -5.0% -10.0% -15.0% Observation Interval (minutes) Mean Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 150 Time (minutes) — Actual Rate --- Programmed Rate PERCENT ERROR 25 mL, 0 mm Hg Delivery Head, -20 in H20 Filling Head, Start Up 15.0% 10.0% 5.0% 0.0% -5.0% -10.0% -15.0% Observation Interval (minutes) Mean Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 151 Notes Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 152: Warranty/Technical Assistance

    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.
  • Page 153 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 Note: Outside the U.S, contact your local Hospira sales office. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 154: Electrical Potentials

    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 required. Monitor the devices to verify normal operation. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 155: Information Regarding Electrostatic Discharge (Esd)

    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. Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

  • Page 156: Index

    Change History, installing disposable batteries, CHANGE key, maintenance, Change Menu, power check, clinician instructions, – specifications, locking the pump, using the rechargeable battery pack, Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 157 – connecting the pump, in Pain Management therapy, to charge, loading the cassette, to remove the pump, lock, dose limit, Container Lock, – Full Lock, – keypad lock, Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 158 Delivery Mode menu, changing the occlusion sensor features and specifications, settings, loading dose delivery, See also occlusion; distal occlusion; programmable ranges, proximal occlusion programming of, – Operating Modes Programming Worksheet, Help, Programming, Run, Stop, power indicator, Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 159 See also pump settings pump layout, – pump set, – – warnings and cautions, pump settings, Weight Dosed therapy air sensitivity, rate titration, change pump settings, occlusion sensor, YES/ENTER key, sound level, Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
  • Page 160 Electrostatic Discharge (ESD) damage. GemStar and LifeShield are registered trademarks of Hospira, Inc. Luer Lock is trademark of Hospira, Inc. Super Edisonite, Seiko, Vesphene II se, Manu-Klenz, Formula C, Teflon, Velcro, CLAVE, and Microsoft, Windows, and Windows NT are not trademarks of Hospira.
  • Page 161 Hospira GemStar Manual 430-10984-001 (Rev. 03/06)

This manual is also suitable for:

Gemstar 13088-04-02

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