Hospira GemStar 13088 User manual [gb]

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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® Infusion Pump

System Operating Manual

For use with the

Hospira GemStar® Pain Management Pump

List 13088-04-01/02

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 13088) call Hospira Customer Care:

1-877-9HOSPIRA

(1-877-946-7747)

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

Page 3

Change History

Part Number Description of Change Pages Changed

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

Original Issue N/A

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

Page 4

Contents

1. Introduction 1

GemStar® Pump Layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

GemStar® Pump Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

GemStar® Pump Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Menu System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Operating Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Indications for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Contraindications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Warnings and Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

2. Basic Operation 17

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Selecting a Power Source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Using the GemStar® Docking Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Powering On the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Accessing the Delivery Mode Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Programming the Pump. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Starting a New Container . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

GemStar® Pump Set. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Loading the Cassette. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Releasing the Cassette . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Priming a GemStar® Pump Set. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

3. Pain Management 45

Therapy Features and Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Pain Management Programming. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Bolus Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

Rate Titration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Loading Dose Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Changing a Pain Management Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Pain Management Programming Worksheet. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

4. Options Menu 55

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

Tips for Using the Options Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

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

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Contents

Review Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Histories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Keypad Lock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

Change Pump Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Set Clock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

Print . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Speed Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Connecting to the Data Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

Transferring Data Using a Computer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

5. Clinician Instructions 77

Clinician Locking Sequence Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

Program and Deliver a Clinician Activated Loading Dose . . . . . . . . . . . . . . . . . . . 79

Shift Totals and History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

6. Troubleshooting 81

Alarm Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

Alert Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

Other Display Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

7. Maintenance 95

Pump Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95

Cleaning and Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95

Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

8. Operation Test 99

Equipment Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

Test Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100

Performing the Operation Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100

Printing Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

Operation Test Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

9. Optional System Components 109

Connecting the Bolus Cord . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

Using the GemStar® Lockboxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

Using the Hospira Carrying Cases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115

Using the GemStar® Docking Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

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

Page 6

Contents

10. Pump Sets 123

11. GemStar® Pump Specifications 127

Occlusion Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

12. Warranty/Technical Assistance 145

A. Electrical Potentials 147

Guidance on EMC Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

Information Regarding Electrostatic Discharge (ESD) . . . . . . . . . . . . . . . . . . . . 148

Index 149

IEC Symbols inside back cover

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

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Notes

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

Page 8

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. 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

WARNING: A WARNING message contains special safety

Display messages The pump displays:

ENTER TO CONFIRM.

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.

G I G

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 Manual 430-10984-001 (Rev. 03/06) 1

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1. Introduction

GemStar® Pump Layout

Shown approximate size

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

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1. Introduction

DISPLAY

3 • Stops infusion.

4 • Starts infusion.

5 • Lights continuously when the pump is powered by AC mains.

6 • Powers the pump on or off. To power-off the pump, press and hold until the

7 • Returns to previous steps during programming.

CHANGE

10 • Toggles between AM and PM in time-based entries.

11 • Responds “YES” to display questions.

• Displays the pump’s status.

• Silences an alarm.

• This silences an alert for five minutes and an alarm for two minutes.

• Flashes when the pump is powered by external batteries (e.g., battery pack).

• Not lit when using disposable AA batteries.

display clears.

• Exits Help, Change, and Options menus.

• Displays the following menu items from the New Container Change Program New Program

• Resets a numeric value to zero.

• Displays the following Options Menu items from the 1 Review Program 4 Pump Settings 7 Speed Protocol 2 Histories 5 Set Clock 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.

• UP arrow enters a decimal point in numeric entries.

• Scrolls back by one screen in program review.

• Accepts entries and goes to the next step.

STOP or RUN mode*:

12 • Responds “NO” to display questions.

13 • Displays information during programming steps and alarm conditions.

• Displays Shift Totals, except during programming steps and alarm conditions.

15 [0] - [9] • Selects menu items and enters numeric values. If two numbers appear before a

* Not all menu items are available with all modes.

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 3

• Clears an

• Primes a GemStar® Pump Set.

menu item (e.g., 02), press both number keys to select that item.

AIR-IN-LINE alarm.

Page 11

1. Introduction

GemStar® Pump Components

Bolus Button Press this button to start a

bolus delivery if available in the current program.

Pole Clamp Track Use to connect to an optional

pole clamp.

Cassette Release

Button

Power Connector Use to connect the AC mains

Data Port

Connector

Bolus Connector Use to connect a bolus cord.

Tubing Channel Place the pump set tubing in

Cassette Pocket Load the cassette into this

I.V. Tubing Guide Use to hold the I.V. tubing.

Battery Pack

Connector

Battery Compartment Install two fresh, disposable

Push down on this button to release the cassette.

adaptor.

Use to connect the GemStar® serial cable.

this channel.

pocket.

Use to connect the GemStar® Rechargeable Battery Pack.

AA batteries in this compartment.

Top View

Bottom/Side View

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

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GemStar® Pump Features

Feature Description Reference Page

1. Introduction

• Adjustable Settings

• Alerts and Alarms

• Audible Keypad Response

•Keypad Lock

•New Container

• Power-on Self-test

• Operation Test

•Program History

•Speed Protocols

Adjusts the distal occlusion pressure limits, air sensor sensitivity, real-time clock, and audible alarm volume.

Signals audible and visual alarms when attention is required.

Sounds a single beep when any key is pressed. If an invalid key is pressed, the pump sounds a flutter tone.

Restricts access to various options. Four lock levels are available.

Repeats the current program without reprogramming the pump.

Performs a self-test each time the pump is powered on.

Performs user-assisted tests to verify the pump is operating properly.

Maintains a history event log, with a date and time stamp of each event for each program. Review the history on the display, or download it to a printer or computer.

Stores up to nine frequently used programs in the pump’s memory for quick access.

Chapter 4 Options Menu

Chapter 6 Troubleshooting

Chapter 1 Introduction,

GemStar® Pump Layout

Chapter 4 Options Menu and Chapter 5 Clinician Instructions

Chapter 2 Basic Operation

Chapter 8 Operation Te st

Chapter 4 Options Menu

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 5

Page 13

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 the 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 HISTORIES from the Options Menu.

G I

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 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 [ directly to SET CLOCK.

5] to go

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

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1. Introduction

To display this menu:

Delivery Mode Menu

Change Menu Press . 1 NEW CONTAINER

Do this: Menu Items Available

1 Press to display

the Change menu.

2 Select

CHANGE

NEW PROGRAM.

CHANGE

1 CONTINUOUS 2 BOLUS 3 CONT + BOLUS

2 NEW PROGRAM 3 CHANGE PROGRAM

Note: If the current therapy is Weight Dosed or mL/hr Only and the pump is in mode:

3 TITRATE VTBI

will replace

3 CHANGE PROGRAM

on the menu display.

Note: Piggybacking is available only in mL/hr Only and Continuous therapies.

Note: Menu items change depending on when Change Menu is viewed.

Options Menu Press .

1 REVIEW PROGRAM

2 HISTORIES

3 KEYPAD LOCK

4 PUMP SETTINGS

5 SET CLOCK

6 PRINT

7 SPEED PROTOCOL

RUN

For more information on: Refer to the following pages:

Delivery Mode Menu Chapter 3 Pain Management, page 45.

Change Menu 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) 7

Page 15

1. Introduction

Operating Modes

The GemStar® Pump has four operating modes:

Mode Description

Help Mode The pump enters the

programming or an alarm condition. The additional information about the current condition.

Programming Mode The pump enters the

powered on or when is pressed.

Run Mode After is pressed, the pump enters the

when not infusing.

Stop Mode When programming is complete, the pump enters the

mode until is pressed.

When the programmed therapy is complete, and during certain alarm conditions, the pump automatically enters the

Press to enter the CHECK CASSETTE alarm.

HELP mode when is pressed during

HELP mode displays

PROGRAMMING mode after the pump is

CHANGE

RUN mode, even

STOP mode.

STOP mode at any time, except during a

STOP

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

Page 16

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 of general I.V. fluids and medications. The epidural route is recommended to provide anesthesia or administer analgesia for periods up to 96 hours.

Note: Epidural administration of anesthetics is recommended in the continuous

mode only. Epidural administration of analgesics may be 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).

1. Introduction

WARNING: Delayed respiratory depression following continuous

epidural administration of preservative-free morphine sulfate has been reported.

For epidural administration, the following is recommended:

 Nylon or Teflon  Pump sets without Y-sites  Stickers for the tubing indicating ongoing administration

Note: Facilities practicing epidural anesthesia/analgesia must be staffed and

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 9

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.

catheter

Page 17

1. Introduction

Contraindications 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 System:

 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.

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 may be affected when used at extreme

operating temperatures (<10°C, >35°C), relative humidity (<20%) and delivery rates (<4.9 mL/hr, >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® clamp is open prior to inserting cassette.

 When using pre-filled vials, ensure vial and injector are securely locked in

lockbox before beginning delivery.

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

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1. Introduction

 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%.

 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 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.

 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).

 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) 11

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1. Introduction

from a pole.

 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.

 Failure to use the pressure-activated anti-siphon valve may result in unrestricted

flow if the cassette is not properly installed in the pump.

 Always close the slide clamps before removing the cassette from the pump.

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.

Regarding Pump Operation

 If the pump 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 [ 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.

STOP], close the slide clamp, and eject the

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

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 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.

 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

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 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.

 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

use the GemStar® AC

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 13

Page 21

1. Introduction

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 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:

 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® system 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 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 is connected

 Consult the manufacturer or field service technician for help

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

Page 22

1. Introduction

 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 8 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, and is therefore responsible for ensuring that the system complies 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.

 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).

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 15

Page 23

1. Introduction

 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.

 Please comply with local disposal and recycling regulations as appropriate for

disposable batteries, rechargeable battery packs, medical electronic components, and pump sets.

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

Page 24

Chapter 2

Basic Operation

The minimum elements required for using the GemStar® Pump are:

 GemStar® Pump

 Appropriate power source

 Appropriate GemStar® Pump Set

 Appropriate fluid container

 Patient-access device

Overview

To start a therapy:

1 Determine the program settings. Refer to the appropriate therapy chapter for a

worksheet that may be copied and used to record program settings.

2 Select a power source. Refer to Selecting a Power Source on page 18.

3 Prime the pump set. Refer to GemStar® Pump Set on page 30.

4 Load the cassette into the pump. Refer to Loading the Cassette on page 33.

5 Power-on the pump and go to the Delivery Mode Menu. Refer to Powering On

the Pump on page 25.

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 [

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 17

START] to begin delivery.

Page 25

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

GemStar® AC Mains Adaptor (USA)

GemStar® AC Mains Adaptor (Universal)

GemStar® Docking Station

GemStar® Battery Pack

Disposable Batteries Two disposable AA alkaline

Wall-mount adaptor plugs into a 110 VAC mains supply.

Wall-mount adaptor plugs into a 100-240 VAC mains supply.

Tabletop adaptor plugs into a 100–240 VAC mains supply.

Plugs into a 100–240 VAC Volt mains supply while mounted on an I.V. pole. The docking station’s rechargeable internal batteries power the GemStar® Pump during periods of transport.

The battery pack’s rechargeable internal batteries power the GemStar® Pump during periods of transport or when use of AC power is not desirable.

batteries (available from local sources)

••

•••

CAUTION: To ensure proper pump operation, ALWAYS replace BOTH

batteries 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 13.

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

Page 26

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.

2 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.

3 Pull the door free and remove any

existing batteries.

4 Install two fresh, disposable AA

batteries into the battery compartment. Ensure the batteries are inserted as shown.

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.

2. Basic Operation

7 Flip closed the tab of the battery door to

lock in place.

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 19

Page 27

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 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.

Note: The green LED on the pump remains lit when connected to AC mains power.

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

Page 28

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.

WARNING: DO NOT touch connector ports. Refer to caution on

page 15.

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 unplug AC mains power and contact Hospira Technical Support Operations.

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 is infusing at rates less than 125 mL/hr.

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 21

Page 29

2. Basic Operation

To connect the battery pack:

1 Line up the connectors on the top of the battery

pack with the holes on the bottom of the pump.

2 Snap the battery pack into place.

To release the battery pack:

1 Press the release button on the battery pack.

2 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

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

USING EXT BATT.

Page 30

2. Basic Operation

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)

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) 23

Page 31

2. Basic Operation

Using the GemStar® Docking Station

WARNING: DO NOT touch connector ports. Refer to caution on page

page 15.

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 13.

To Connect to the Pump

1 Mount the docking station to the I.V. pole and tighten

the knob.

2 Line up 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 remove the pump:

1 Press the release button on the top of the docking

station.

2 Slide the pump out.

To charge docking station (List 13075 all codes):

1 Connect the docking station to the AC mains power.

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 (5°C).

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

Page 32

2. Basic Operation

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.

Note: If a cassette is not properly loaded, the pump will sound an alarm after the 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, JUN 11, 04

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 .

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

disposable batteries.

LOW BATTERIES

ENTER TO CONFIRM

AC power and weak (low voltage) disposable batteries; or weak disposable batteries only.

No response required, the pump goes to the next step.

Press to confirm.

Power-off the pump and install two fresh, disposable AA batteries as a backup power source.

NO INTERNAL BATT

NO POWER LOSS

ALARM AVAILABLE

ENTER TO CONFIRM

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 25

No disposable batteries or dead disposable batteries; and external power.

Press to confirm.

Power-off the pump and install two fresh, disposable AA batteries as a backup power source.

Page 33

2. Basic Operation

Display Message Power Source(s) User Response

USING BATTERIES

ENTER TO CONFIRM

USING EXT BATT

ENTER TO CONFIRM

Disposable batteries only.

External batteries (docking station battery or battery pack) and disposable batteries.

Press to confirm.

If an external power source is in use, ensure the connections are secure.

Press to confirm.

If an AC mains adaptor is in use, ensure the connections are secure.

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 6 Troubleshooting for information on

clearing a CHECK CASSETTE alarm.

CAUTION: Ensure two fresh, disposable AA batteries are installed for backup

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.

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

Page 34

2. Basic Operation

Accessing the Delivery Mode Menu

1 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 Condition User Response

The pump displays the Delivery Mode Menu.

1 RESUME PROGRAM 2 CLR PROG&SHIFT

3 CLR PROG,SHIFT

AND HISTORY

Pump memory is clear.

A program is currently stored in pump memory.

! To enter a new program: Select a delivery

mode from the Delivery Mode Menu and enter a new program. Refer to Chapter 3 Pain Management for instructions.

! To continue the current program, press [1].

! To reset the current program:

1 PRESS [1]. 2 PRESS [

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.

CHANGE] TO DISPLAY THE

! 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:

1 Press [STOP] to place the pump in STOP mode.

2 Press [CHANGE] to display the Change Menu.

3 Select NEW PROGRAM. The pump clears the current program and

displays the Delivery Mode Menu.

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 27

Page 35

2. Basic Operation

Programming the Pump

Programming Overview

The pump’s menu system provides step-by-step guidance through all of the programming steps. Refer to Chapter 3 Pain Management for detailed programming instructions.

A programming worksheet is available at the end of Chapter 3 that lists the minimum and maximum value (program range) allowed for a Pain Management therapy. If a number outside of the program range is entered, the pump displays the minimum or maximum value allowed.

1 Select the desired delivery mode from the Delivery Mode Menu.

2 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] to return to previous program displays and make changes as desired.

3 Review the program, if required. Press to begin review. Press [

when done.

SAVING PROGRAM displays. The pump stores the program in memory and then

STOP mode.

enters

Tip: If you enter an incorrect number during programming, press [CHANGE]

BEFORE pressing [ correct number.

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

YES/ENTER] to reset the number to zero. Then enter the

YES/ENTER]

Page 36

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.

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.

Press to toggle between units of measure when entering concentrations.

Scrolls through program review and help messages.

Press to insert a decimal point in a numeric value.

CHANGE

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 29

When entering a numeric value during programming, press to reset the

value to zero.

Press to return to a previous display, to exit the Options Menu, or to exit

the

HELP mode.

CHANGE

Page 37

2. Basic Operation

Starting a New Container

Note: The NEW CONTAINER function is not available when the pump is in FULL Lock. Refer to Chapter 4 Options Menu, page 55 for more information on locking the keypad.

To repeat the current program with a new container:

1 From the

2 Select

CONTAINER

Note: In Pain Management therapy, the VTBI can be titrated without adding volume to initial container amount.

3 Review the program. Press to begin review.

4 Press [

STOP mode, press [CHANGE] to display the Change Menu.

NEW CONTAINER from the Change Menu. The pump displays NEW

for several seconds and clears the amount infused from memory.

START] to begin delivery.

GemStar® Pump Set

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 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.

STERILE

Note: GemStar® Pump Sets contain a pressure-activated anti-siphon valve to reduce

the potential for gravity flow at a typical 36-inch head height. Ensure slide clamp or lower CAIR® clamp is open prior to inserting cassette.

The system may underdeliver, and the system delivery accuracy may be reduced by as much as 5% when using the following:

• nonvented syringes

• PCA vials (except in a lockbox with a spring assist mechanism)

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

Page 38

A typical GemStar® Pump Set is shown below:

2. Basic Operation

1 Piercing Pin 6 Tubing

2 Proximal End 7 Slide Clamp

3 Cassette 8 Secure Lock

4 Flow Stop (open / close ) 9 Pressure-activated Anti-Siphon Valve

5 Distal End

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 31

Page 39

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 the pump.

To prevent contamination, use aseptic technique with all fluid-path connections. 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.

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

Page 40

Loading the Cassette

1 Identify the four black cassette latches inside the cassette pocket.

2. Basic Operation

2 Ensure slide clamp or lower

CAIR® clamp is open prior to inserting cassette.

3 Line up the cassette as shown

(with the flow stop button facing the pump).

4 Insert the cassette into the cassette

pocket by pushing firmly along the entire cassette until it is firmly seated.

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 33

Page 41

2. Basic Operation

5 Verify that all four cassette latches

are securely holding the cassette.

CAUTION: Ensure the cassette is properly installed. When properly installed, all four cassette latches are visibly holding the cassette securely in the cassette pocket.

6 Place the tubing in the

tubing channel.

Note: The pump cannot be powered

off during a CHECK CASSETTE alarm (except during

PROGRAMMING mode). Refer to

Chapter 6 Troubleshooting for information on clearing a CHECK CASSETTE alarm.

Releasing the Cassette

1 Close the slide clamp on the distal

line.

2 Push down on the cassette release

(large black button) on the top of the pump.

Note: Ensure the tubing is behind

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

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.

Page 42

2. Basic Operation

Priming a GemStar® Pump Set

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 Push down on the flow stop to

open (priming position) the cassette.

4 Invert the cassette approximately

45°.

5 While holding the rotated cassette,

squeeze or roll the container to remove air from the container and cassette.

6 Return the cassette to the upright

position. Continue priming until fluid fills the tubing.

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 35

Page 43

2. Basic Operation

7 Push down on the flow stop to

close the cassette.

8 Ensure slide clamp is open prior to

inserting cassette.

9 Load the cassette.

Note: Ensure the tubing is behind the tubing guide (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.

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

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 [ allowed before [ or after one of the following events occur when using Pain Management therapy:

 Complete Review of New

Program

 New Container  Air-in-Line Alarm

PURGE] is only

START] is pressed

Page 44

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

close the cassette.

2 Hold the container with the

administration port toward the ceiling and insert the piercing pin.

3 Ensure slide clamp is open prior to

inserting cassette.

4 Load the cassette.

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) 37

Page 45

2. Basic Operation

Note: Ensure the tubing is behind

the tubing guide (at the distal end).

5 Program desired therapy.

6 Press [

7 The pump displays

8 While holding the container with

PURGE].

PURGE

SET?

Press [YES/ENTER].

the administration port toward the ceiling, press and hold [

HELP

PRIME THE

PURGE].

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.

9 Connect the pump set to the

patient-access device.

Note: Purge rate is 250 mL/hr.

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

The pump purges for up to 2 minutes each time you press and hold [

Continue using the [ key until fluid fills the tubing. Ensure all air is removed from the container, cassette, and tubing.

PURGE].

PURGE]

Page 46

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 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 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).

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 39

Note: When using the GemStar® Lockbox with SAM, refer to the SAM pump set labeling and SAM lockbox insert for instructions.

1 If using a pump set with the

Y-extension, use the slide clamp to close off the KVO (Keep Vein Open) side of the tubing.

2 Open the upper and lower slide

clamps.

Page 47

2. Basic Operation

3 Push down on the flow stop to

close the cassette.

4 Connect the pump set to a Hospira

pre-filled vial and injector.

5 Push down on the flow stop to

open (priming position) the cassette.

6 Hold the vial and set upright

(vertically) on a flat surface with the pump set extending from the top.

7 Slowly push down on the injector

until fluid flows at the distal end of the tubing, which indicates that all

air is cleared from the vial, injector, cassette, and tubing.

8 Push down on the flow stop to

close the cassette.

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.

10 Ensure slide clamp is open on

KVO side prior to inserting cassette.

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

Page 48

2. Basic Operation

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 33.

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 Manual 430-10984-001 (Rev. 03/06) 41

Note: Ensure the tubing is behind the tubing guide (at the distal end).

Page 49

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

close the cassette.

2 Hold the container with the

administrative port toward the ceiling and insert the piercing pin.

3 Push down on the flow stop to

open (priming position) the cassette.

4 Invert the cassette approximately

45°.

5 While holding the rotated cassette,

squeeze or roll the container to remove air from the container and cassette.

6 Return the cassette to the upright

position. Continue priming until fluid fills the tubing.

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

Page 50

7 Push down on the flow stop to

close the cassette.

8 Connect the extension set to the

pump set.

9 Ensure the slide clamp is open

before inserting cassette.

2. Basic Operation

Note: Ensure the tubing is behind the tubing guide (at the distal end).

10 Load the cassette.

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) 43

11 Program the desired therapy.

12 Press [

13 The pump displays

SET?

14 Press and hold [

Note: Purge rate is 250 mL/hr. The

pump purges for up to 2 minutes each time you press and hold

[

Continue using the [ until fluid fills the tubing. Ensure

PURGE].

PURGE

Press [YES/ENTER].

PURGE].

HELP

PRIME THE

PURGE].

PURGE] key

Page 51

Notes

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.

15 Connect the pump set to the patient-access device.

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

Page 52

Chapter 3

Pain Management

Therapy Features and Specifications

This therapy allows programming of a continuous only, bolus only, or continuous with bolus delivery.

 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 delivered 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:

 Complete Review of New Program  New Container  Air-in-Line Alarm

 VTBI 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%.

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 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) 45

Page 53

3. Pain Management

Tip: 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:

Key Function Key Function

[0] - [9] Selects menu items and

enters numeric values.

Accepts entries or continues when done viewing a display.

Displays information during programming and alarm conditions.

CHANGE

Clears a numeric value (resets to zero) during programming.

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.

Returns to a previous display, exits the Options Menu, and exits the

HELP mode.

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

Page 54

Pain Management Programming.

1 Select the delivery mode from the Delivery Mode menu.

3. Pain Management

Note: If Continuous + Bolus is selected, the continuous delivery rate or bolus dose can be set to zero through the CHANGE menu without reprogramming the pump.

2 Select the unit of measure and concentration as required.

3 Set the continuous delivery rate.

4 Program a loading dose as required.

5 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.

6 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 to move to the mL line. Enter the mL value 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 [

WARNING: ALWAYS disconnect the pump set from the patient before

priming or purging.

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 47

PURGE] now.

Page 55

3. Pain Management

Bolus Delivery

Set bolus doses and delivery limits 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 9 Optional System Components, on page 112, for more information.

Delivering a Bolus Dose

From 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:

 Records the bolus request and delivery amount to the event and bolus history logs

 Adds the delivered boluses to the total bolus amount in the program amounts

 Resets the bolus lockout time (if applicable) and ignores other bolus requests until

 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

 Loading dose delivery in progress

 Bolus dose delivery in progress

 Bolus per-hour limit

 1-hour or 4-hour dose limit

RUN mode, press either the bolus button [+] on the top of the pump or the

the lockout time has elapsed

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

Page 56

3. Pain Management

Bolus Dose Interruptions

Bolus deliveries may be interrupted by:

 Pressing [STOP]

 An alarm condition

To continue bolus delivery after an interruption:

1 Press [START]. The pump displays COMPLETE BOLUS NOW?

2 Respond as follows:

To do this: Press this key: Bolus lockout time is set to:

Deliver the remaining bolus amount

Clear the undelivered bolus amount

Rate Titration

To titrate the rate while the pump is infusing:

1 In the

For example: if the current rate is 1.5 mL/hr, press [ change the rate to 2.5 mL/hr.

Note: You have approximately five seconds after pressing a key to press another

numeric key, the decimal key, or [ seconds, the rate does not change and the delivery continues as previously programmed.

NEW RATE displays with the new value.

• Press [ at the new rate.

• Press [

The time of delivery completion

The time the bolus was interrupted

RUN mode, press the number keys for the new rate. Press [YES/ENTER].

2][.] [5] [YES/ENTER] to

YES/ENTER]. If no key is pressed within five

YES/ENTER] within 10 seconds to accept the change and begin delivery

NO] to continue delivery at the previously programmed rate.

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 49

Page 57

3. 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.

Note: Loading dose amounts are included in a 1-hour or 4-hour dose limit.

Delivering a Loading Dose

1 After priming and programming, press [

2 The pump displays

begin loading dose.

When the loading dose is complete, the pump does the following:

 Automatically begins programmed infusion

 Records the dose amount to the history log

 Resets the bolus lockout time (if applicable) and ignores other bolus requests until

the lockout time has elapsed

Loading Dose Interruptions

Loading dose deliveries can be interrupted by:

 Pressing [STOP]

 An alarm condition

To continue a loading dose:

1 Resolve the interruption.

DELIVER THE LOADING DOSE NOW? Press [YES/ENTER] to

START].

2 Press [

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

START]. The pump displays COMPLETE THE LOADING DOSE?

Page 58

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

3. Pain Management

• Delivery rate

• Bolus

• Bolus lockout

• Container size

• Air sensitivity

• Dose limit amount

• Delivery mode

• Unit of measure

• 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

2 As each message displays, make the desired changes or press [

STOP mode, press [CHANGE] and select CHANGE PROGRAM.

YES/ENTER] to

accept the current setting.

3 Review the program. Press to begin review.

4 Press [

START] to begin delivery.

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 51

Page 59

3. Pain Management

Pain Management Programming Worksheet

GIVE:

GemStar®

Parameters Selections and/or Values to be

Programmable Ranges

Entered

Therapy Pain Management N/A Delivery Mode

Unit of Measure*

Continuous Rate*

Loading Dose

Bolus Dose* 0 - 2500 mg

Bolus Lockout

Optional Dose Limit

 Continuous  Bolus Only  Continuous + Bolus  Concentration: mg/mL

 Concentration: mcg/mL  mL

 No

 Yes Amount:

minutes 1 - 999 min

 4-hour limit Amount:

 1-hour limit Amount:

N/A

0.01 - 100 mg/mL

1 - 1000 mcg/mL

0.1 - 2500 mg/hr 1 - 25000 mcg/hr

0.1 - 25.0 mL/hr

0.1 - 2500 mg 1 - 25000 mcg

0.1 - 25.0 mL

0 - 25000 mcg 0 - 25.0 mL

4X rate - 400 mL, 40000 mg, 400000 mcg*

Rate - 100 mL, 10000 mg, 100000 mcg*

 # boluses/hourNumber:  No dose limit

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

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

Page 60

3. Pain Management

Parameters Selections and/or Values to be

Entered

Air Sensitivity**  On Alarms at approx. 0.5 mL of air

 2 mL Alarms at approx. 2 mL of air  Off 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.

Programmable Ranges

N/A

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 53

Page 61

Notes

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

Page 62

Chapter 4

Options Menu

Overview

1 Press [OPTIONS] from RUN or STOP mode 2 Select the number key for the desired function. 3 Follow the display messages for the selected

function. Refer to the appropriate description in this chapter for more information.

Note: Menu selections may vary depending on the

configuration of the pump.

When the pump exits mode it was in when [OPTIONS] was pressed.

OPTIONS, the pump returns to the

Tips for Using the Options Menu

The following keys are helpful when using the Options Menu:

Key Function Key Function

[0] - [7] Selects menu items and

enters numeric values.

Accepts entries or continues when done viewing a display.

1 REVIEW PROGRAM

2 HISTORIES

3 KEYPAD LOCK

4 PUMP SETTINGS

5 SET CLOCK

6 PRINT

7 SPEED PROTOCOL

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.

Returns to a previous display, exits the Options Menu, and exits the

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) 55

HELP mode.

6].

Page 63

4. Options Menu

Select this item from the Options Menu:

REVIEW PROGRAM

HISTORIES

KEYPAD LOCK

PUMP SETTINGS

SET CLOCK

SPEED PROTOCOLS

To do this function: Comments:

Display the current program settings.

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.

N/A

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 13.

Lock and unlock the keypad to prevent unauthorized changes to the program.

Change the air sensor, occlusion sensor, and sound level settings.

Set the clock. The clock can be displayed in

Print the history event log, bolus history (if available), current program settings, and speed protocols.

Assign, review/recall, and delete the stored protocols.

The lock levels allow the clinician to restrict access to various levels of pump operation.

N/A

12-hour or 24-hour format. Files may be downloaded to a

printer or personal computer.

Allows up to 9 speed protocols to be saved in pump memory.

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

Page 64

4. Options Menu

Review Program

1 Press [OPTIONS] and select REVIEW PROGRAM. The

pump displays

PROGRAM REVIEW.

2 Press to begin review.

3 Press [

YES/ENTER] or [BACK-UP] when done to exit

OPTIONS

Histories

1 Press [OPTIONS] and select HISTORIES.

2 Select the number key for the desired function.

3 Complete the appropriate steps for the selected

function.

1 REVIEW PROGRAM

2 HISTORIES

3 KEYPAD LOCK

4 PUMP SETTINGS

5 SET CLOCK

6 PRINT

7 SPEED PROTOCOL

1 REVIEW PROGRAM

2 HISTORIES

3 KEYPAD LOCK

4 PUMP SETTINGS

5 SET CLOCK

6 PRINT

7 SPEED PROTOCOL

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 57

Page 65

4. Options Menu

Select this item from the Histories Menu:

HISTORY

SHIFT TOTALS

VOLUME TOTALS

CONFIGURATI ON

CLEAR HISTORY

BOLUS HISTORY

OPERATION TEST

To do this function: Display includes:

Display history event log of the latest 400 events.

• 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

Display or clear shift totals.

Display volume totals. • Amount infused

Display pump configuration.

Clear history event log and bolus history.

Display bolus history in hourly increments for the last 48 hours.

Perform user-assisted Operation Test.

• Time and date when shift was cleared

• Volume infused in the shift

• Any relevant program-specific information

•VTBI

• Any relevant program-specific information

• Dependent upon pump configuration

CLEARING HISTORY displays for 3 to 4

• seconds

• Current date and time

• Number of boluses delivered

• Number of bolus demands

• Amount delivered through bolus delivery

• 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 pump.

Tip: Press and HOLD or to scroll through the history displays faster.

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

Page 66

4. Options Menu

History

To display the history event log:

1 Press [

2 Select

OPTIONS] and select HISTORIES.

HISTORY from the Histories Menu.

3 Press or to scroll the display.

4 Press [

BACK-UP] when done to exit OPTIONS.

Shift Totals

To display the shift totals:

1 Press [

2 Select

OPTIONS] and select

HISTORIES

SHIFT TOTALS from the Histories Menu.

3 The shift totals display. Press or to scroll

the display.

To clear the shift totals:

1 Follow the steps for displaying shift totals.

2 At the end of the shift totals, the pump displays

CLEAR TOTALS? YES OR NO:

• Press [YES/ENTER] to clear the shift totals.

• Press [

NO] to exit OPTIONS

without clearing the shift totals.

VERSION N.NNN

S/N XXXXXXXX

TIME IS 09:00 AM

FRI, JUN 11, 05

NEW CONTAINER

08:15AM JUN 11

HISTORY CLEARED

11:00PM JUN 10

EVENT LOG

PM11:18 SET ON

AIR SENSITIVITY

PM11:18 SET CONT

SIZE 100 mL

PM11:18 SET 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

Tip: Press [HELP] to display shift totals when the pump is not in PROGRAMMING mode or an alarm condition.

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 59

Page 67

4. Options Menu

Volume Totals

To display the volume totals:

1 Press [

2 Select

3 Press [

OPTIONS] and select HISTORIES.

VOLUME TOTALS from the Histories Menu.

BACK-UP] when done to exit OPTIONS.

To clear the volume totals:

1 Follow the steps for displaying volume totals.

2 At the end of the volume totals, the pump displays

CLEAR TOTALS? YES OR NO:

• Press [YES/ENTER] to clear the volume totals.

• Press [

NO] to exit OPTIONS

without clearing the volume totals.

Configuration

To display the pump configuration:

1 Press [

OPTIONS] and select HISTORIES.

2 Select CONFIGURATION from the Histories Menu.

3 Press [

BACK-UP] when done to exit OPTIONS.

END OF VOLUME TOTALS CLEAR TOTALS?

YES OR NO

Clear History

To clear the history event log and bolus history:

1 Press [

OPTIONS] and select HISTORIES.

2 Select CLEAR HISTORY from the Histories Menu.

3 The pump display

OPTIONS.

Tip: Press [BACK-UP] to exit OPTIONS immediately.

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

CLEARING HISTORY for 3–4 seconds before exiting

Page 68

Bolus History

To display the bolus history:

4. Options Menu

1 Press [

2 Select

OPTIONS] and select HISTORIES.

BOLUS HISTORY from the

Histories Menu.

3 Press [

BACK-UP] when done to exit OPTIONS.

TIME IS 09:15 AM

FRI, JUN 11, 05

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 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 8 Operation Test on page 99 for instructions.

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 61

Page 69

4. Options Menu

Keypad Lock

1 Press [OPTIONS] and select KEYPAD LOCK from

the Options Menu.

2 Select the desired lock level.

The following lock levels, listed from lowest to highest

1 REVIEW PROGRAM

2 HISTORIES

3 KEYPAD LOCK

4 PUMP SETTINGS

5 SET CLOCK

6 PRINT

7 SPEED PROTOCOL

restrictions, are available:

Lock Level Abbreviation

Rate Change Lock

Container Lock C

Full Lock F

1 RATE CHANGE

2 CONTAINER 3 FULL LOCK

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 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 5 Clinician Instructions on page 77 for detailed instructions.

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

Page 70

GemStar® Keypad Lock Level Functions

U = Unlock R = Rate Change Lock

Function U R C F Comments

Lock/Unlock Keypad

Power Pump On or Off

Start or Stop Infusion

Access Display, Help, Print, and Program Review Functions

Deliver a Bolus

Silence an Alarm

Select a New Container

Purge

Change a Program

Review/Recall Speed Protocol

Assign or Delete Speed Protocol

Set Air Sensitivity, Distal Occlusion Level, Sound Level, and Clock

Clear Shift Totals

Program and Deliver a Loading Dose (Outside of Programming Mode)

Enter a New Program

Operation Test

Clear History

C = Container Lock F = Full Lock

• = Function is Available

• • • •

If programmed.

• • • •

• • •

• •

Under Rate Change Lock, only the delivery rate or bolus dose volume can be changed and must be within the preset values.

•

• • •

•

4. Options Menu

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 63

Page 71

4. Options Menu

Change Pump Settings

1 Press [OPTIONS] and select PUMP SETTINGS.

2 Press the number key for the desired pump setting.

3 Follow the display messages. Refer to the

instructions of the desired pump setting for more information.

Select this item from the Pump Settings Menu:

AIR SENSOR

OCCL SENSOR

SOUND LEVEL

To do this function:

Change the air sensor sensitivity.

Change the distal occlusion sensor sensitivity.

Adjust the audible alarm level.

Comments:

The pump alarms when it detects an air bubble of approximately 0.5 mL when ON; or at approximately 2 mL when 2 mL is selected. The air alarm does not sound if OFF is selected.

Note: The pump setting is inactivated if custom-configured (by your facility) to ON or 2mL.

The air alarm can also be set during

programming if the current therapy allows

it.

Default Setting: High

The pump alarms when distal pressure is

greater than the selected occlusion

sensor limit.

Default Setting: Maximum

The alarm cannot be turned off

completely. The alarm automatically

reverts to the maximum volume if the user

does not respond within one minute.

1 REVIEW PROGRAM

2 HISTORIES

3 KEYPAD LOCK

4 PUMP SETTINGS

5 SET CLOCK

6 PRINT

7 SPEED PROTOCOL

Note: The current setting flashes on the display.

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

Page 72

4. 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:

ELIMINATING FILTER IS

Air

RECOMMENDED. ENTER TO CONFIRM

You must press [YES/ENTER] to confirm.

3 After selecting the desired Air Sensitivity, the

pump displays:

XXXX TO XXXX

• Press [

CHANGE AIR ALARM FROM

NO] to keep the current air sensitivity.

The current air alarm status displays and the pump exits

• Press [

OPTIONS.

YES/ENTER] to accept the new setting. The new air alarm status displays

and the pump exits OPTIONS.

Occlusion Sensor

1 Press [

2 Select

OPTIONS] and select PUMP SETTINGS.

DISTAL 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 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.

AIR SENSITIVITY 1 ON 2 2 mL 3 OFF

CHANGE AIR ALARM

FROM: XXXX

TO: XXXX

YES OR NO

DISTAL OCCLUSION 1 HIGH 2 MEDIUM 3 LOW

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 65

Page 73

4. Options Menu

Sound Level

1 Press [

2 Select

3 When the pump displays the Sound Level function, it

4 Press [YES/ENTER] when done.

Set Clock

1 Press [OPTIONS] and select SET CLOCK.

2 Select 12-Hour or 24-Hour format (24-Hour format is

3 Use the arrow keys to set the weekday and month.

4 Use the number keys to enter the current day, year,

OPTIONS] and select PUMP SETTINGS.

SOUND LEVEL from the Pump Settings Menu.

sounds intermittent beeps at the current sound level. The blocks on the top line of the display indicate the current sound level.

• Press to increase the sound level.

• Press to decrease the sound level.

• Press

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.

shown in example).

and time.

Note: When entering the time in 12-Hour format, press or to toggle between AM and PM.

[CHANGE] to restore the sound level to the default setting.

-  +

USE TO ADJUST THE SOUND LEVEL ENTER WHEN DONE

1 REVIEW PROGRAM

2 HISTORIES

3 KEYPAD LOCK

4 PUMP SETTINGS

5 SET CLOCK

6 PRINT

7 SPEED PROTOCOL

SET CLOCK TYPE 1 SELECT 12 HOUR 2 SELECT 24 HOUR

5 Press [

Note: The clock cannot be changed while an intermittent or variable time program is in progress.

Tip: To view the clock from the RUN or STOP mode, press [ [1]. The clock displays until [1] is released.

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

YES/ENTER] to confirm.

YES/ENTER ], then immediately press and HOLD

TIME IS 20:35

MON, JUL 26, 05

ENTER TO CONFIRM

Page 74

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 73 for more

information.

4. Options Menu

1 Press [OPTIONS] and select PRINT.

2 Press the number key for the desired print function.

3 When printing is complete, the pump exits

Select this item from the Print Menu:

PRINT HISTORY

PRINT PROGRAM

PRINT PROTOCOL

PRINT BOLUS Hx

STOP PRINT

To do this function:

Print the current program, shift and volume totals, and history event log (400 events).

Print the current program.

Print a specified speed protocol or a complete list of all speed protocols.

Print the current program, shift and volume totals, and the bolus history (Hx) for the latest 48 hours.

Cancel printing. This function is only available if the pump is printing.

OPTIONS.

1 REVIEW PROGRAM

2 HISTORIES

3 KEYPAD LOCK

4 PUMP SETTINGS

5 SET CLOCK

6 PRINT

7 SPEED PROTOCOL

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 67

Page 75

4. Options Menu

Speed Protocol

1 Press [OPTIONS] and select SPEED PROTOCOL.

2 Press the number key for the desired protocol

function.

3 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.

Select this item from the Speed Protocol Menu:

ASSIGN

REVIEW/RECALL

DELETE

Assign

1 Press [

2 Select

OPTIONS] and select SPEED PROTOCOL.

ASSIGN from the Speed Protocol menu.

To do this function:

Store a program in pump memory for later use. Review assigned protocols from the RUN or STOP

mode. Recall an assigned protocol from the STOP mode. Delete protocols from pump memory.

1 REVIEW PROGRAM

2 HISTORIES

3 KEYPAD LOCK

4 PUMP SETTINGS

5 SET CLOCK

6 PRINT

7 SPEED PROTOCOL

3 Select [

If the selected speed protocol is already assigned, the pump displays

PROTOCOL ASSIGNMENT?

1]–[9] to assign to the new protocol.

REPLACE

• Press [YES/ENTER] to replace the protocol. The pump displays the new speed protocol and exits

• Press [

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

NO] to keep the existing protocol and exit OPTIONS.

OPTIONS.

Page 76

Review/Recall

1 Press [

2 Select

OPTIONS] and select SPEED PROTOCOL.

REVIEW/RECALL from the Speed Protocol menu.

3 Select the desired protocol to review/recall.

4 Review the program. Press to begin review.

5 Press [

YES/ENTER]:

• If in the

STOP mode, press [1] to recall the protocol; or press [2] to review

another protocol.

• If in the

RUN mode, the pump exits OPTIONS.

Delete

4. Options Menu

1 Press [

2 Select

OPTIONS] and select SPEED PROTOCOL.

DELETE from the Speed Protocol Menu.

3 Select the desired protocol to delete.

4 Press [

YES/ENTER] to confirm deletion or [NO] to exit OPTIONS without deleting.

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 69

Page 77

4. Options Menu

Connecting to the Data Port

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 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.

••

•

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

Page 78

4. 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

Data Bits

Stop Bits

Parity

Carriage Return (+Line Feed)

Flow Control =

Note: When using the Seiko DPU 414 printer, the switch settings MUST be configured to work with the GemStar® Pump.

To configure the switch settings on the Seiko DPU 414:

1 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 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.

= 2400

= None

= CR+LF

None

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 71

Page 79

4. Options Menu

Switch Settings for Seiko DPU-414 Printer

Switch Function Setting Button to Press

SW1-1 Input Method: Serial Off FEED

SW1-2 Printing Speed: High On ONLINE

SW1-3 Auto Loading: On On ONLINE

SW1-4 CR function: CR and LF On ONLINE

SW1-5 DIP SW setting

SW1-6 Printing density: 100% Off FEED

SW1-7 Printing density: 100% On ONLINE

SW1-8 Printing density: 100% On ONLINE

SW2-1 Print Mode: 40 columns On ONLINE

SW2-2 User defined char: On On ONLINE

SW2-3 Ordinary

SW2-4 Zero Font: No slash On ONLINE

SW2-5 Character Set: American On ONLINE

SW2-6 Character Set: American On ONLINE

SW2-7 Character Set: American On ONLINE

SW2-8 Character Set: American Off FEED

SW3-1 Data bit length: 8 bits On ONLINE

SW3-2 Parity: No parity On ONLINE

SW3-3 Parity condition: Odd On ONLINE

SW3-4 Flow control: H/S busy On ONLINE

SW3-5 Baud rate: 2400 bps On ONLINE

SW3-6 Baud rate: 2400 bps Off FEED

SW3-7 Baud rate: 2400 bps Off FEED

SW3-8 Baud rate: 2400 bps On ONLINE

Enabled On ONLINE

command:

On On ONLINE

Characters:

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

Page 80

4. 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 printer 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 printer or computer.

1 Install a cassette into the pump. 2 Connect the GemStar® serial cable to the printer and to the data port on the

bottom of the pump.

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) 73

Page 81

4. 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 printer or computer.

1 Ensure slide clamp or lower CAIR® clamp is open prior to inserting cassette.

2 Install a cassette into the pump.

3 Connect the GemStar® serial cable to the null modem.

4 Connect the null modem to the serial gender changer.

5 Connect the serial gender changer to the serial port of the computer.

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.

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

Page 82

Transferring Data Using a Computer

4. Options Menu

The GemStar® can be connected to a Windows®-compatible computer. The following instructions apply to computers using Microsoft Windows NT

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:

1 Follow steps 1–4 in Using an Existing Connection on the following page.

2 If a 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.

4 Click OK.

5 From the Connect drop-down menu, select the appropriate COM port.

6 Click OK.

7 Verify that the following settings are correct:

4.0 or higher.

Baud Rate = 2400

Data Bits =8

Stop Bits =1

Windows® 95, Windows® 98, or

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.

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 75

Page 83

4. Options Menu

14 Click OK in the Properties window.

15 From the menu, select File > Save.

16 Exit HyperTerminal.

Using an Existing Connection

To transfer data from the GemStar® Pump to a computer:

1 From the Windows

2 Select Programs.

3 Select Accessories.

4 Select HyperTerminal.

5 Double click on the icon with the name entered in step 3, To create a new

connection, on page 70.

6 From the menu, select Call > Connect.

7 From the menu, select Trans fer > Capture Text.

8 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.

desktop, select the Start Menu.

Note: If the file name already exists, the new printout will be added to the end of

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

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.

9 Click Start.

10 Select the desired print function from the pump. Refer to the table of printing

functions on page 67.

11 Wait for the transmission to complete.

12 From the menu, select Trans fer > Capture Text > Stop.

13 Exit HyperTerminal.

14 Use any text editor to view or print the file.

Page 84

Chapter 5

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.

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].

Program a Loading Dose

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 77

From the Pain Management STOP MODE, press [YES/ENTER], and then press [0] to program a Loading Dose.

Page 85

5. Clinician Instructions

Clinician Locking Sequence Instructions

Locking the Pump

To lock the pump from the

1 Press [

2 Select

3 Select the desired lock level. For

4 For

5 Press [

6 Repeat steps 4 and 5 for a bolus dose if available in the current program.

7 Enter the lock sequence number [

Unlocking the Pump

OPTIONS] to display the Options Menu.

KEYPAD LOCK from the Options Menu.

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 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.

YES/ENTER] when done.

are entered.

Note: Default lock sequence numbers are shown.

RUN or STOP mode:

CONTAINER and FULL Lock, go to step 5.

1][3][0][0][0]. Asterisks display as the numbers

1 Press [

2 Select

3 Select the lock level to be unlocked.

4 Enter the lock sequence number for that level.

5 The pump displays the current lock level. Press [

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

OPTIONS] to display the Options Menu.

KEYPAD LOCK from the Options Menu.

mode the pump was in when [

OPTIONS] was pressed.

YES/ENTER] to return to the

Page 86

5. Clinician Instructions

Program and Deliver a Clinician Activated Loading Dose

This feature is available only when the keypad is UNLOCKED. 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 [

2 The pump displays:

Press [YES/ENTER].

3 Enter the loading dose. Press [

4 The pump displays:

To deliver the loading dose immediately, press [YES/ENTER].

Primary infusion DOES NOT begin automatically when the clinician activated loading dose is complete. Press [

To deliver the loading dose later, press [

The pump returns to the stop mode. The next time [ again displays:

• Press [

DELIVER LOADING DOSE NOW?

YES/ENTER] to deliver the loading dose. Primary infusion continues

automatically when the loading dose is complete.

• Press [

NO] to cancel the loading dose and continue primary infusion.

Shift Totals and History

Shift Totals

YES/ENTER] [0].

PROGRAM A LOADING DOSE?

YES/ENTER].

DELIVER THE LOADING DOSE NOW?

START] to continue primary infusion.

NO].

START] is pressed, the pump

1 Press [

2 Select

3 The shift totals display. Press

OPTIONS] and select HISTORIES.

SHIFT TOTALS from the Histories Menu.

and to scroll the display. When done, the

pump displays

CLEAR TOTALS? YES OR NO.

END OF

SHIFT TOTALS

CLEAR TOTALS?

YES OR NO

• Press [YES/ENTER] to clear the shift totals.

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 79

Page 87

5. Clinician Instructions

• Press [NO] to exit OPTIONS without clearing the shift totals.

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

1 Press [

2 Select

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

If a loading dose has been programmed but not delivered, displays the DELIVER LOADING DOSE NOW? screen

CURRENT DATE AND TIME

displaying

OPTIONS] and select HISTORIES.

CLEAR HISTORY.

CLEARING HISTORY displays and the pump exits OPTIONS.

Press Results

[YES/ENTER] + [0] Displays the PROGRAM A LOADING DOSE?

screen

[YES/ENTER] + [1] Displays the real time clock as long as 1 is held

down

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

Page 88

Chapter 6

Troubleshooting

This section contains information on audible and visual alarms that may occur with the GemStar® Pump.

CAUTION: If the 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 Support between 7:00 AM and 4:00 PM Pacific time. Have the pump serial number available.

In the USA

Outside the USA:

Tip: Press [HELP] for additional information during programming and alarm conditions.

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 81

Hospira Technical Support Operations 1-800-241-4002

Hospira, Inc. Technical Support Operations 755 Jarvis Drive Morgan Hill, CA 95037

Contact your local Hospira sales office.

Page 89

6. Troubleshooting

Alarm Messages

Alarm Display Message

Y = Yes

N = No

AIR IN LINE

• Pump automatically enters

STOP

mode.

Is the pump infusing?

N A/V The specified volume

Alarm Cause/

Condition

A = Audible alarm

V = Visual alarm

of air has been detected in the line distal to the cassette while infusing.

Remedy

1 Press [SILENCE] to quiet

the alarm for 1 minute.

2 Press [STOP] to clear the

alarm.

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.

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

Page 90

6. Troubleshooting

Alarm Display Message

Y = Yes

N = No

CHANGE BATTERIES N A/V The pump has

Is the pump infusing?

Alarm Cause/

Condition

A = Audible alarm

V = Visual alarm

entered the mode due to battery voltage below acceptable levels.

STOP

Remedy

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.

2 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) 83

Page 91

6. Troubleshooting

Alarm Display Message

Y = Yes

N = No

CHECK CASSETTE-X N A/V The cassette is

Is the pump infusing?

Alarm Cause/

Condition

A = Audible alarm

V = Visual alarm

improperly installed or not installed.

X indicates where to look for the cause of the alarm:

D = Distal

P = Proximal

Remedy

1 Press [SILENCE] to quiet

the alarm for 1 minute.

2 Press [STOP] to place the

pump in the

3 Ensure slide clamp or lower

CAIR® clamp is open prior to inserting cassette.

4 Reinstall the cassette.

STOP mode.

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 33.

5 Press [START] to begin

infusion.

Note: The pump cannot be powered off during a CHECK CASSETTE alarm (except during

PROGRAMMING mode).

CALL

1.800.XXX.XXXX

CODE: NN/MMM/TTT

(SERVICE ALARM)

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

N A/V The pump has

detected a condition that may require service.

1 Write down the telephone

number and code.

2 Power-off the pump. If the

pump does not power-off, disconnect external power and remove the batteries.

3 Call the telephone number

shown on the display message.

Page 92

6. Troubleshooting

Alarm Display Message

Y = Yes

N = No

DIST. OCCLUSION N A/V The pump has

Is the pump infusing?

Alarm Cause/

Condition

A = Audible alarm

V = Visual alarm

detected sustained distal pressure over the user-selected limit.

To avoid a bolus infusion after an occlusion, complete the following steps:

1Press [STOP]. 2 Close the distal

clamp.

3 Press the

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 Load the

cassette into the

pump. 8 Open the distal

clamp. 9 Review the

program. 10 Press [START]

to start the

pump.

Remedy

1 Press [SILENCE] to quiet

the alarm for 1 minute.

2 Press [STOP] to place the

pump in the stop mode.

3 Check for sources of 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 33.

5 Press [START] to begin

infusion.

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 85

Page 93

6. Troubleshooting

Alarm Display Message

Y = Yes

N = No

LOW BATTERIES Y A/V The pump has

Is the pump infusing?

Alarm Cause/

Condition

A = Audible alarm

V = Visual alarm

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

the condition has not been corrected after 15 minutes, the alarm continues.

If the pump is infusing and a

LOW BAT-

TERIES alarm

occurs, the pump continues for approximately 30 minutes* before it can no longer deliver due to insufficient power.

*If an external power source is used, the rate is changed, or the pump is powered-on after a

LOW BAT-

TERIES

those same batteries are still in the pump, this interval may be different.

alarm. If

alarm and

Remedy

1 Press [SILENCE] to quiet

the alarm for 15 minutes.

2 Press [STOP] to place the

pump in the

3 Connect the 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.

STOP mode.

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 13.

4 Power on the pump and

resume the current program. Refer to Accessing the Program Menu in Section 2 for more information page 13.

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.

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

Page 94

6. Troubleshooting

Alarm Display Message

Y = Yes

N = No

POWER LOSS N A/V The pump has

Is the pump infusing?

Alarm Cause/

Condition

A = Audible alarm

V = Visual alarm

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.

• Pump has been powered on with insufficient power source.

Remedy

1 Connect the pump to AC

mains adaptor, rechargeable battery pack, or replace both disposable batteries with fresh AA batteries.

2 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.

3 Press [START] to begin

infusion.

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 87

Page 95

6. Troubleshooting

Alarm Display Message

Y = Yes

N = No

PROX. OCCLUSION N A/V The pump has

Is the pump infusing?

Alarm Cause/

Condition

A = Audible alarm

V = Visual alarm

detected sustained negative pressure on its proximal side.

Remedy

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] 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 33

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

Page 96

6. Troubleshooting

Alarm Display Message

Y = Yes

N = No

USING BATTERIES Y V This is a normal

Is the pump infusing?

Alarm Cause/

Condition

A = Audible alarm

V = Visual alarm

response when:

• The pump has been powered on with only disposable batteries as a power source; or

• The pump has switched to internal power (disposable batteries) due to a loss of external power or a reduction in external power below acceptable levels.

Remedy

When powering on the pump:

• Press [YES/ENTER] to

confirm disposable batteries are the only power source.

When switching from AC Mains power:

• Press [SILENCE] to clear the

alarm.

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 89

Page 97

6. Troubleshooting

Alarm Display Message

Y = Yes

N = No

USING EXT BATT Y V This is a normal

Is the pump infusing?

Alarm Cause/

Condition

A = Audible alarm

V = Visual alarm

response when:

• The pump has been powered on with external batteries as a power source; or

• The pump has switched to external battery power due to a loss of AC mains power; or

• The pump has switched to external battery power while running on internal batteries.

Remedy

When powering on the pump:

• Press [YES/ENTER] to

confirm external battery power source.

When switching from AC Mains power:

• Press [SILENCE] to clear the

alarm.

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

Page 98

Alert Messages

6. Troubleshooting

Alert Display Message Is the

pump infusing?

Y = Yes

N = No

ALMOST EMPTY Y A/V Delivery will complete in

CHECK PRINTER Y A/V • The printer has not

AlarmCause/Condition Remedy

A = Audible alarm

V = Visual alarm

30 minutes or less.

For bolus only program, delivery will complete during the next bolus delivery.

responded to commands from the pump.

• The printer is not properly connected to the pump.

• Press [STOP] to clear the alarm and put the pump in Stop Mode.

• Press [SILENCE] to clear the alarm.

• No additional alarms sound.

Note: This alert is available only with Pain Management therapy.

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 Manual 430-10984-001 (Rev. 03/06) 91

Page 99

6. Troubleshooting

Alert Display Message Is the

pump infusing?

Y = Yes

N = No

EMPTY CONTAINER N A/V The pump has delivered

FLASHING DISPLAY

• Line four of the display flashes.

AlarmCause/Condition Remedy

A = Audible alarm

V = Visual alarm

the programmed container size or the pump has delivered the programmed VTBI; AND Auto KVO is delivering (if available in current program).

N A/V A Non-programming

Callback has occurred because the pump has been waiting for more than three minutes for a keypress on a nonprogramming input or a confirmation display.

1 Press [SILENCE] to

quiet the alarm for 2 minutes.

2 Press [STOP] to place

the pump in the mode and clear the alarm.

3 Use the NEW

CONTAINER function to repeat the current program. Refer to

Starting a New Container in Chapter 2

Basic Operation.

STOP

Note: Titration is allowed at

this time.

Follow the instructions on the display to clear the alarm.

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

Page 100

6. Troubleshooting

Alert Display Message Is the

pump infusing?

Y = Yes

N = No

NO INTERNAL BATT

NO POWER LOSS

ALARM AVAILABLE

ENTER TO CONFIRM

AlarmCause/Condition Remedy

A = Audible alarm

V = Visual alarm

N A/V No disposable batteries

or dead disposable batteries; AND external power.

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 source fails. Refer to the caution regarding Power Loss on page 13.

PROGRAMMING

INCOMPLETE

START

• START flashes on the display. Other parts of the display are not affected.

Hospira GemStar Manual 430-10984-001 (Rev. 03/06) 93

N A/V Programming has not

been completed and no keys have been pressed within three minutes.

N A/V A Stop Mode Callback

has occurred because the programmed pump has remained in the STOP mode for more than three minutes.

1 Press any key to clear

the alarm.

2 Complete the program

entries.

1 Press [SILENCE] to

quiet the alarm for 3 minutes.

2 Follow the instructions

on the display to clear the alarm.