Hospira Gemstar Operations 6 2010 Precalculus

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Page 1

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Hospira GemStar® Infusion System

System Operating Manual

For use with the

Hospira GemStar® Infusion System

List 13086-04 List 13087-04 List 13088-04

PLEASE

Read this entire manual before

using the Hospira GemStar® Pump

This manual is designed for use by healthcare professionals, caregivers, and patients. The Hospira Technical Support Operations hotline is available 24 hours a day (in the USA) to provide consultation and technical assistance regarding the Hospira

GemStar

Pump.

In the USA: Hospira Technical Support Operations

1-800-241-4002

Outside the USA: Contact your local Hospira

sales office

To order additional copies of this manual

(List 13086,13087,13088) call Hospira Customer Care:

1-877-9HOSPIRA

(1-877-946-7747)

Hospira GemStar® System Operating Manual i

Page 3

Change History

Part Number Description of Change Pages Changed

430-96527-001 (Rev. 03/06)

430-96527-002 (Rev. 01/07)

430-96527-003 (A, 08/08)

Original Issue N/A

Second Release All

Third Release All

ii Hospira GemStar® System Operating Manual

Page 4

Content s

1. Introduction 1

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

GemStar

Therapies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

GemStar

Menu System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Operating Modes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Indications for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Contraindications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Warnings and Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Pump Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Pump Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

2. Basic Operation 19

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Selecting a Power Source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Powering On the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Accessing the Programming Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Programming the Pump. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Starting a New Container . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

GemStar

Loading the Cassette. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Releasing the Cassette . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Priming a GemStar

Pump Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Pump Set. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

3. Total Parenteral Nutrition (TPN)

- Not Applicable to List 13088 53

Therapy Features and Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

TPN Programming. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Changing a TPN Program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

TPN Auto Taper Down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

TPN Programming Worksheet. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

4. Pain Management

- Not Applicable to List 13086 59

Therapy Features and Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Pain Management Programming. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

Hospira GemStar® System Operating Manual iii

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Contents

Bolus Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

Loading Dose Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Changing a Pain Management Program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

5. Intermittent

- Not Applicable to List 13088 69

Therapy Features and Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Intermittent Programming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

Intermittent Delivery Interruptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

Changing an Intermittent Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

Intermittent Programming Worksheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

6. Continuous

- Not Applicable to List 13088 77

Therapy Features and Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Continuous Programming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

Rate Titration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Piggybacking. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Changing a Continuous Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

Continuous Programming Worksheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83

7. Weight Dosed

- Not Applicable to List 13088 85

Therapy Features and Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85

Weight Dosed Programming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86

Auto KVO. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

Rate Titration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

VTBI Titration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

Changing a Weight Dosed Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

GemStar Programming a Precedex GemStar

Worksheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

Weight Dosed Programming Worksheet . . . . . . . . . . . . . . . . . . . . . . . 89

Precedex® (dexmedetomidine hydrochloride injection) Programming

(dexmedetomidine hydrochloride injection) Delivery. 90

8. mL/hr Only

- Not Applicable to List 13088 93

Therapy Features and Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

mL/hr Only Programming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

iv Hospira GemStar® System Operating Manual

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Contents

Auto KVO. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95

Rate Titration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95

VTBI Titration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96

Piggybacking. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96

Changing a mL/hr Only Program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

mL/hr Only Programming Worksheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100

9. Variable Time

- Not Applicable to List 13088 101

Therapy Features and Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

Variable Time Programming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102

Variable Time Delivery Interruptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

Changing a Variable Time Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104

GemStar

10. Options Menu 107

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

Tips for Using the Options Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

Review Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

Histories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

Keypad Lock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114

Change Pump Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116

Set Clock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118

Print. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

Speed Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

Next Dose (Not available for List 13088). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

Connecting to the Data Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122

Transferring Data Using a Computer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

Variable Time Programming Worksheet . . . . . . . . . . . . . . . . . . . . . . 105

11. Clinician Instructions 129

Clinician Locking Sequence Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

Program and Deliver a Clinician Activated Loading Dose. . . . . . . . . . . . . . . . . . 132

Shift Totals and History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

12. Troubleshooting 135

Alarm Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136

Alert Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145

Other Display Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149

Hospira GemStar® System Operating Manual v

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Contents

13. Maintenance 151

Pump Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151

Cleaning and Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151

Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153

14. Operation Test 155

Equipment Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

Test Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156

Performing the Operation Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156

Printing Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161

GemStar

Operation Test Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163

15. Optional System Components 165

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163

Connecting the Bolus Cord . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168

Using the GemStar

Using the Hospira Carrying Cases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171

Using the GemStar

Lockboxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168

Docking Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177

16. Pump Sets 179

17. GemStar® Pump Specifications 183

Occlusion Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186

18. Warranty/Technical Assistance 199

A. Electrical Potentials 201

Guidance on EMC Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201

Information Regarding Electrostatic Discharge (ESD) . . . . . . . . . . . . . . . . . . . . 202

Index 203

IEC Symbols inside back cover

vi Hospira GemStar® System Operating Manual

Page 8

Chapter 1

Introduction

The GemStar® Pump is a small and lightweight, single-channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is

required. The GemStar battery pack, docking station, or two disposable AA alkaline batteries. When powered

by batteries, the GemStar

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

information and must be observed at all times. Failure to observe a warning message could be life threatening.

Pump can be powered by AC mains adaptor, rechargeable

Pump is ideal for ambulatory patients.

Display messages The pump displays:

ENTER TO CONFIRM.

CAUTION: A CAUTION contains information that could prevent

irreversible product damage or hardware failure. Failure to observe a caution could result in serious patient or user injury.

  

Note: A NOTE contains information or examples to help explain instructions.

Tip: A TIP contains information that makes the pump easier to use.

Note: Examples are provided only to help explain a pump function and may not be clinically relevant. Graphics are for illustrative purposes only and may not reflect the actual product.

Hospira GemStar® System Operating Manual 1

Page 9

Chapter 1. Introduction

GemStar® Pump Layout

Shown approximate size

2 Hospira GemStar® System Operating Manual

Page 10

Chapter 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 display

7 • Returns to previous steps during programming.

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.

clears.

• Exits Help, Change, and Options menus.

• Displays the following menu items from the

New Container Change Program (or Titrate VTBI) New Program Piggybacking

• 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 8 Next Dose 3 Keypad Lock 6 Print

• Scrolls through program review and help messages.

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

• DOWN arrow toggles between units of measure when entering concentrations.

• 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® System Operating Manual 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

Chapter 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

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.

Install two fresh, disposable AA batteries in this compartment.

Top View

Bottom/Side View

4 Hospira GemStar® System Operating Manual

Page 12

Chapter 1. Introduction

Therapies

Seven types of therapy are available for infusion of medications and fluids. The following table lists possible applications and available features of each therapy.

Therapy Possible Applications

TPN Total Parenteral Nutrition

fluid delivery

Pain Management

Infusion of analgesics or anesthetics for patientcontrolled pain management (PCA), epidural infusion and parenteral administration of general I.V. fluids

Intermittent Interval-based therapies

such as antibiotics

Continuous Infusion of mg, mcg, or

mL/hr with a selectable KVO (Keep Vein Open) option

Weight Dosed Critical care, pediatrics

mL/hr Only Simple rate programming

Variable Time Chronotherapy

• = Available

••

•• •

••• •

••

•



Note: pain management is the only therapy available for List 13088.

Hospira GemStar® System Operating Manual 5

Page 13

Chapter 1. Introduction

GemStar® Pump Features

Feature Description Reference Page

• Adjustable Settings

• Alerts and Alarms

•Audible Keypad Response

• Keypad Lock

•New Container

• Piggybacking

•Power-on Self-test

• Operation Te st

• 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.

Allows delivery from a secondary container during a Continuous or mL/hr Only program.

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 10 Options Menu

Chapter 1 Introduction,

GemStar® Pump Layout

Chapter 1 Introduction,

GemStar® Pump Layout

Chapter 10 Options Menu and Chapter 11 Clinician Instructions

Chapter 2 Basic Operation

Chapter 6 Continuous Not Applicable to List 13088 and Chapter 8 mL/hr Only - Not Applicable to List 13088

Chapter 2 Basic Operation

Chapter 14 Operation Te st

Chapter 10 Options Menu

6 Hospira GemStar® System Operating Manual

Page 14

Chapter 1. Introduction

Menu System

The GemStar® Pump uses a menu system that provides step-by-step instructions through all of the pump’s functions. Refer to 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 [ Menu.

2] to select PAIN MANAGEMENT from the Programming





Note: Menu items may vary depending on the pump’s configuration.

Tip: A menu item does not have to be on the display to be selected. For example, when the Programming Menu first displays, only the first four therapies are shown. Instead of pressing the down arrow to see the other menu items, press [7] to go directly to Variable Time Programming.

Hospira GemStar® System Operating Manual 7

Page 15

Chapter 1. Introduction

To display this menu:

Programming Menu

Delivery Mode

(FOR LIST

13088 ONLY)

Do this: Menu Items Available

1 Press to

display the Change menu.

2 Select

NEW

PROGRAM

1 TPN 2 PAIN MANAGEMENT 3 INTERMITTENT 4 CONTINUOUS 5 WEIGHT DOSED 6

mL/HR ONLY

7 VARIABLE TIME

1 CONTINUOUS 2 BOLUS 3 CONT + BOLUS

Note: If a program is not currently stored in pump memory at power-on, the Programming Menu automatically displays after the self-test.

Change Menu Press . 1 NEW CONTAINER

2 NEW PROGRAM 3 CHANGE PROGRAM 4 PIGGYBACKING

Note: If the current therapy is Weight Dosed or

mL/hr Only and the pump is in

3 TITRATE VTBI

will replace

3 CHANGE PROGRAM

on the menu display.

RUN mode:

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

8 Hospira GemStar® System Operating Manual

2 HISTORIES 3 KEYPAD LOCK 4 PUMP SETTINGS 5 SET CLOCK 6 PRINT 7 SPEED PROTOCOL 8 NEXT DOSE (NOT AVAILABLE FOR LIST 13088)

Page 16

Chapter 1. Introduction

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

Programming Menu Chapter 2 Basic Operation, page 19.

Change Menu For menu item [

in Chapter 2 Basic Operation, on page 32. For menu items [ therapy chapter.

Options Menu Chapter 10 Options Menu, page 107.

1], refer to Starting a New Container

2], [3], and [4], refer to the appropriate

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

RUN mode, even

STOP mode.

STOP mode at any time, except during a

STOP

Hospira GemStar® System Operating Manual 9

Page 17

Chapter 1. Introduction

Indications for Use

Physicians or certified, licensed healthcare professionals should always oversee infusions. Healthcare professionals should always supervise pump users and instruct users in pump operation and troubleshooting. Instruction should include how to prevent intravenous (I.V.) related complications, including how to prevent accidental infusion of air.

The pump is suitable for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products.

Intended parenteral administrations include but are not limited to: intravenous (within a vein), arterial, subcutaneous (tissue just below the skin), regional (located to specific areas of the body) and epidural analgesia, intrathecal analgesia, intraspinal analgesia, combined spinal-epidural analgesia, short term epidural infusion, intraspinal (within the spinal canal), intrathecal (within the subarachnoid or subdural space), intraoperative sites (soft tissue, body cavity or surgical wounds), intraarticular (within a joint), intraperitoneal (within the peritoneal cavity), and intracerebroventricular infusions. The indications for use include hospital, homecare and ambulatory environments. The system has also been qualified for use in fixed and rotary wing aircrafts (e.g., helicopters). The pump must be used with sterile, dedicated, GemStar® administration sets.

Note: Epidural administration of anesthetics is recommended in the continuous



mode only. Epidural administration of analgesics may be delivered by continuous, bolus, or continuous with bolus.

For epidural use, the administration of drugs is restricted to those anesthetic and analgesic drugs approved for continuous epidural administration: e.g., Chloroprocaine Hydrochloride USP, Lidocaine Hydrochloride USP, and Morphine Sulfate Injection USP (Preservative Free).

WARNING: Delayed respiratory depression following continuous

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

10 Hospira GemStar® System Operating Manual

Page 18

For epidural administration, the following is recommended:

Chapter 1. Introduction

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

catheter

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



equipped to manage cardio-pulmonary resuscitation (CPR). Supplies should include oxygen, naloxone, and other appropriate resuscitative drugs and equipment. Monitor patients continuously (e.g., oximetry) during epidural administration. Frequently observe patient for side effects (for up to 24 hours) following completion of drug administration by the epidural route.

Contraindications for Use

Persons who do not have the mental and physical capability or the emotional stability to properly use the GemStar

DO NOT use the following with the GemStar

 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.

Pump should not operate this pump.

Pump:

General Warnings and Cautions

 Federal (USA) law restricts this device to sale by or on the order of a physician or

other licensed practitioner.

 Manual references to specific values are approximate only, unless indicated

otherwise. Air-in-line sensitivity values are approximate only.

 When a proximal occlusion alarm activates, DO NOT power-off the pump.  Closely supervise patients who are likely to be adversely affected by unintended

operations and failures, including interrupted medication or fluid infusion. Ensure provisions for immediate corrective action are available.

Hospira GemStar® System Operating Manual 11

Page 19

Chapter 1. Introduction

Regarding Drugs Used, Pump Sets, and Containers

 USE ONLY GemStar

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

cassette.

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

lockbox before beginning delivery.

 A cracked vial might not show evidence of leakage until delivery pressure is

applied.

 When using nonvented syringes, the system may underdeliver. System delivery

accuracy could be reduced by as much as 5%.

 When using PCA vials (except in a lockbox with a spring assist mechanism), the

system may underdeliver. System delivery accuracy could be reduced by as much as 5%.

 When using viscous fluids, the system may underdeliver. System delivery

accuracy could be reduced by as much as 5%.

 Variations in filling head (such as container height) may affect delivery accuracy

by no more than 5%.

 When using the GemStar

ONLY GemStar® Pump Sets designated for use with the GemStar 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.

Pump Sets with the GemStar® Pump. Use of unauthorized

(roller) clamp is open prior to inserting

Spring Assist Mechanism (SAM) Lockbox, USE

SAM

12 Hospira GemStar® System Operating Manual

Page 20

Chapter 1. Introduction

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

Remove the protective coverings as assembly progresses.

 ALWAYS place the flow stop in the closed position when the set is not in the pump.

 Before installing the cassette in the pump, ensure all slide or lower CAIR

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

from a pole. When using a vented drip set, ALWAYS use an air-eliminating filter OR set the air sensitivity to either ON or 2 mL.

 Stop infusion if signs or symptoms of infiltration occur.  GemStar® Pump Sets contain a pressure-activated anti-siphon valve to reduce the

potential for gravity flow at a typical 36-inch head height.

 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.  When using the pump for secondary delivery (piggybacking), ensure the fluids

being infused are chemically and physically compatible.

 When infusing short-half-life drugs (i.e. those dosed with units of mcg/kg/min) at

very low rates (0.8 mL/hr or less) the rate may be too slow for that drug. Consider using a lower drug concentration with these drugs so a pump rate above 0.8 mL/hr can be used.

(roller)

Regarding Air-In-Line and Infusion

 To reduce the risk of infusing air, use an air-eliminating filter when the air

sensitivity is set to OFF.

 ALWAYS prime the pump set to remove all air from the cassette, tubing, and

injection site prior to connecting to the patient.

 ALWAYS disconnect the pump set from the patient prior to priming or purging.

Hospira GemStar® System Operating Manual 13

Page 21

Chapter 1. Introduction

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

 USE ONLY the AC mains adaptor specifically labeled for use with the GemStar

Pump.

Pump to charge the battery pack.

 The GemStar

GemStar

AC mains adaptor is for use with the GemStar® Pump or

Rechargeable Battery Pack only. DO NOT use the GemStar® AC

mains adaptor with other products.

 During charging, the battery pack is warm. If the rechargeable battery pack

becomes hot to the touch, IMMEDIATELY unplug the AC mains adaptor and 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

STOP], close the slide clamp, and eject the

14 Hospira GemStar® System Operating Manual

Page 22

Chapter 1. Introduction

bottom of the pump), firmly grasp the connector and pull straight out. DO NOT twist or bend the cord or connector.

 To ensure proper pump operation, ALWAYS replace BOTH disposable batteries

with fresh, disposable AA batteries when a change is required.

 ALWAYS fully close the battery door when using disposable batteries.  DO NOT use rechargeable batteries in the battery compartment.  Ensure two fresh, disposable AA batteries are installed for backup power when

using other external power sources (e.g., AC mains adaptor, docking station, battery pack). The pump will continue to operate on backup power if the external power source 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 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

in accordance with:

Pump has been tested and found to comply with EMC/EMI limits

Hospira GemStar® System Operating Manual 15

Page 23

Chapter 1. Introduction

 IEC/EN 60601-1-2 (2001) when using two AA disposable batteries or when

connected to the GemStar

 IEC/EN 60601-1-2 (2001) (ESD exemption) when using Li-Ion Docking

AC Adaptor

Station or Li-Ion Battery Pack

When connected to other power sources or optional system components in

commercial distribution before November 30, 2004, the GemStar

Pump complies with EMC/EMI limits in accordance with IEC/EN 60601-1-2 (1993). These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. The equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference with other devices, which 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  The use of portable and mobile RF equipment may have an impact on this and

other pieces of medical equipment

 Prior to using the GemStar

Pump and optional system components, refer to Appendix A for additional information and precautionary procedures regarding electrical potentials (electromagnetic compatibility and electrostatic discharge).

Regarding Handling and Maintenance

 Use proper care during unpacking, installation, and operation of the pump. If the

pump is inadvertently mishandled, check connections and programmed data to ensure there is no damage. Refer to Chapter 14 Operation Test for further information.

 Accessory equipment connected to the analog and digital interfaces must be

certified according to the respective IEC standards, (e.g., IEC 60950 for data processing equipment, and ICE 60601-1 for medical equipment). Furthermore, all configurations shall comply with the system standard IEC 60601-1-1. Any person who connects additional equipment to the signal input or output part configures a medical system, and is therefore responsible for ensuring that the system complies

16 Hospira GemStar® System Operating Manual

Page 24

Chapter 1. Introduction

with the requirements of IEC 60601-1-1. If in doubt, contact Hospira Technical Support Operations.

 ALWAYS avoid dropping or hitting the pump. If the pump is dropped or hit,

ALWAYS check connections and programmed data.

 NEVER use sharp objects (e.g., fingernails, pens, pencils, or other probes) to

program or clean the pump.

 Use care not to damage the silicone seals around the sensor bodies in the cassette

pocket.

 To avoid mechanical or electronic damage, NEVER submerge pump in water or

other fluids and avoid fluid spills. If the pump becomes wet, dry it immediately with a dry, lint-free cloth. Check connections and programmed data.

 DO NOT touch connector ports. Connector ports may be susceptible to

Electrostatic Discharge (ESD) damage.

 Some cleaning and sanitizing compounds may slowly degrade components made

from some plastic materials. DO NOT use compounds containing combinations of isopropyl alcohol and dimethyl benzyl ammonium chloride (i.e., alcohol wipes).

 DO NOT sterilize by heat, steam, ethylene oxide (ETO), or radiation. Apply

disinfectants to the outside surface of the pump only. DO NOT use abrasive cleaners or materials on the pump. Using abrasive cleaners or cleaning solutions not recommended by Hospira may result in product damage.

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

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

Fixed and Rotary Wing Aircraft

 Do not lay the IV bag flat because air can potentially be introduced into the line

causing an alarm condition. Recommend the use of extension set tubing be applied prior to patient transport.

 The GemStar® pump has only been tested using battery power in fixed and rotary

wing aircraft.

 Auditory alarms may not be heard in a noisy flight environment. Care providers

should rely on visual indicators on the pump display to determine if there are any alarms or other system malfunctions.

Hospira GemStar® System Operating Manual 17

Page 25

Notes

18 Hospira GemStar® System Operating Manual

Page 26

Chapter 2

Basic Operation

The following elements are required to use the GemStar® Pump:

6 GemStar 6 Appropriate power source

6 Appropriate GemS tar 6 Appropriate fluid container 6 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 20. 3 Prime the pump set. Refer to GemStar® Pump Set on page 32.

Pump

Pump Set

4 Load the cassette into the pump. Refer to Loading the Cassette on page 35. 5 Power-on the pump and go to the Programming Menu. Refer to Powering On

the Pump on page 27.

6 Select the appropriate optional system components, such as a bolus cord. 7 Select the therapy type and enter a program. Refer to the appropriate therapy

chapter for detailed instructions.

Note: List 13088 only delivers therapy in the Pain management Mode.

8 Press [

Hospira GemStar® System Operating Manual 19

START] to begin delivery.

Page 27

Chapter 2. Basic Operation

Selecting a Power Source

The GemStar® Pump may be powered by one or more of the following:

Power Source Description Ambulatory Hospital Home

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 1 10 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 periods of transport.

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

batteries (available from local sources)

Pump during periods of

Pump during

••

•••

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 14.

20 Hospira GemS tar® System Operating Manual

Page 28

Installing Disposable Batteries

1 Flip open the tab of the battery door o n

the bottom of the pump.

Chapter 2. Basic Operation

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.

7 Flip closed the tab of the battery door to

lock in place.

Hospira GemStar® System Operating Manual 21

Page 29

Chapter 2. Basic Operation

Connecting the GemStar® AC Mains Adaptor

1 Connect the cord of the AC mains adaptor to the connector port labeled “3 VDC”

on the bottom of 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

When removing the cord from the bottom of the pump, firmly grasp the connector and pull straight out. DO NOT twist or bend the cord or connector.

Ensure two fresh, disposable AA batteries are installed for backup power when using other power sources (e.g., AC mains adaptor, docking station, battery pack). The pump will continue to operate on backup power if the external power source fails. Refer to the caution regarding Power Loss on page 14.

Pump.

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

22 Hospira GemS tar® System Operating Manual

Page 30

Chapter 2. Basic Operation

Using the GemStar® Rechargeable Battery Pack

Use the GemStar

[Universal]) to recharge the GemStar

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

CAUTION: ALWAYS connect to a grounded AC mains outlet when using AC

AC Mains Adaptor (List 13026-01 [USA], 13026-03 [Universal] or 13072-01

Battery Pack (List 13073-03).

page 16.

mains adaptor. Use only AC mains adaptors specifically labeled for use with the

GemStar 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

• The LED indicator on the GemStar 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 information and precautions regarding activating and charging the Li-Ion Battery Pack.

Pump to charge the battery pack.

Li-Ion Battery Pack:

Li-Ion Battery Pack flashes

Li-Ion Battery Pack insert for important

Hospira GemStar® System Operating Manual 23

Note: A charged battery pack will last approximately 24 hours when the pump is infusing at rates less than 125 mL/hr.

Page 31

Chapter 2. Basic Operation

To connect the battery pack:

1 Line up the connectors on the top of th e 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

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).

24 Hospira GemS tar® System Operating Manual

USING EXT BATT.

Page 32

Chapter 2. Basic Operation

CAUTION: When removing the cord from the battery pack, firmly grasp the

connector and pull straight out. DO NOT twist or bend the cord or connector.

Using the GemStar

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

page 14.

Docking Station

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

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.

Hospira GemStar® System Operating Manual 25

Page 33

Chapter 2. Basic Operation

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).

26 Hospira GemS tar® System Operating Manual

Page 34

Chapter 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 [

completes a self-test and displays the time and date. No response is required.

ON/OFF] to power-on the pump. The pump

GEMSTAR 7

UNIT SELF-TEST

TIME IS 10:00 AM

FRI, NOV 10, 06

Note: The self-test takes approximately 30 seconds to complete. If the pump is locked, lock symbols appear at the beginning and end of the second line:

UNIT SELF-TEST .

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® System Operating Manual 27

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 35

Chapter 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 12 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 10 Options Menu, on page 118. Locking the keypad Keypad Lock in Chapter 10 Options Menu, on

page 114.

28 Hospira GemS tar® System Operating Manual

Page 36

Chapter 2. Basic Operation

Accessing the Programming Menu

After power-on, the pump checks its memory for a stored program. Respond to the display message as shown in the following table:

Display Message Condition User Response

The pump displays the Programming 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 therapy

from the Programming Menu and enter a new program. Refer to the appropriate therapy chapter for instructions.

> To continue the current program, press [1]. > To reset the current program:

1 Press [1]. 2 Press [CHANGE] to display the Change

Menu and select

NEW CONTAINER.

> To enter a new program and clear shift

totals: Press [ program and shift totals from memory and enters PROGRAMMING mode.

> To enter a new program, clear shift totals,

and clear history: Press [ 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:

2]. The pump clears the

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 Programming Menu.

3]. The pump

Hospira GemStar® System Operating Manual 29

Page 37

Chapter 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 the appropriate therapy chapter for detailed programming instructions.

Programming worksheets are available at the end of each therapy chapter. Each worksheet lists the minimum and maximum value (program range) allowed for that therapy. If a number outside of the program range is entered, the pump displays the minimum or maximum value allowed.

Note: For Continuous, Intermittent, and Variable time therapies, the pump only

delivers in increments of 0.1 mL. These therapies are rounded to the nearest 0.1 mL. For example, at a concentration of 15 mg/mL, a rate of 5 mg rounds to 4.5 mg.

When a value is rounded, the pump sounds four quick beeps, disp lays ROUNDING for a few seconds, and then displays the rounded value. Press accept the rounded value and continue to the next step.

Rounding only occurs in Variable, Continuous and Intermittent therapies.

1 Select the desired therapy from the Programming Menu.

5 mg = 0.333 mL

4.5 mg = 0.3 mL

[YES/ENTER] to

2 Respond to display messages and enter requested values.

Note: Program entries can be changed any time before the Program Review is

30 Hospira GemS tar® System Operating Manual

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

YES/ENTER]

Page 38

Chapter 2. Basic Operation

Programming Tips

The following table explains how to use the keypad during programming:

Key Function

[

0] - [9] Press the number keys to select menu items and to enter numeric values.

Note: Some menu items require pr essing two number keys to select that item.

For example, when selecting a unit of measure for a weight dosed program, the menu may display as:

01 mcg/kg/mg 02 mcg/kg/hr 03 mcg/kg/min 04 mg/kg/min

To select mg/kg/min, press [

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.

0][4].

The DOWN arrow toggles between units of measure when entering concentrations. Scrolls through program review and help messages.

The UP arrow inserts a decimal point in a numeric value.

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

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

HELP mode.

the

Hospira GemStar® System Operating Manual 31

Page 39

Chapter 2. Basic Operation

Starting a New Container



Note: The Refer to Chapter 10 Keypad Lock, page 114 for more information.

To repeat the current program with a new container:

1 From the

2 Select

3 If Program Review is desired, press [OPTIONS] then press [1] to begin review.

4 Press [

NEW CONTAINER

STOP

NEW CONTAINER

CONTAINER

Note: In Weight Dosed, mL, and Pain Management therapies, the VTBI can be titrated without adding volume to initial container amount.

START

for several seconds and clears the amount infused from memory.

] 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.

function is not available when the pump is in

mode, press [

from the Change Menu. The pump displays

CHANGE

] to display the Change Menu.

STERILE

FULL

NEW

Lock.

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 False occlusion alarms and fluid delivery inconsistencies may occur when pumping

viscous fluids in microbore tubing at rates greater than 500 mL/hr. The system may underdeliver, and the system delivery accuracy may be reduced by as

much as 5% when using the following:

• viscous fluids

• nonvented syringes

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

32 Hospira GemStar® System Operating Manual

clamp is open prior to inserting cassette.

Page 40

A typical GemStar® Pump Set is shown below:

Chapter 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® System Operating Manual 33

Page 41

Chapter 2. Basic Operation

WARNING: ALWAYS prime the pump set to remove air from the

cassette, tubing, and injection sites prior to connecting to the patient. ALWAYS disconnect the pump set from the patient prior to priming or purging. Arrange tubing, cords, and cables to minimize the risk of patient strangulation or entanglement.

Failure to use the pressure-activated anti-siphon valve may result in unrestricted flow if the cassette is not properly installed in the pump.

CAUTION: USE ONLY GemStar® Pump Sets with the GemStar® Pump. Use of

unauthorized sets may result in injury to the patient or damage to 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

remove the contents.

Pump Set package and

2 Remove the protective covers from the fluid

container administration port and the pump set.

34 Hospira GemS tar® System Operating Manual

Page 42

Chapter 2. Basic Operation

Loading the Cassette

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

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® System Operating Manual 35

Page 43

Chapter 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 12 Troubleshooting for information on clearing a CHECK CASSETTE alarm.

Releasing the Cassette

1 Close the CAIR® (roller) clamp or

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

36 Hospira GemS tar® System Operating Manual

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 44

Chapter 2. Basic Operation

Priming a GemSta r® 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® System Operating Manual 37

Page 45

Chapter 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.

CAUTION: Ensure all four cassette latches are clearly visible after the cassette is installed. Refer to Loading the Cassette on page 35.

Note: Ensure the tubing is behind

the tubing guide (at the distal end).

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:

6 Complete Review of New

Program

6 New Container 6 Air-in-Line Alarm

PURGE] is only

START] is pressed

38 Hospira GemS tar® System Operating Manual

Page 46

Chapter 2. Basic Operation

Priming Pump Sets WITHOUT a Drip Chamber Using the PURGE Key

WARNING: Failure to use the pressure-activated anti-siphon valve

may result in unrestricted flow if the cassette is not properly installed in the pump.

Note: The PURGE function is available only if there is a program in the pump.

1 Push down on the flow stop to

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 35.

Hospira GemStar® System Operating Manual 39

Page 47

Chapter 2. Basic Operation

Note: Ensure the tubing is behind

the tubing guide (at the distal end).

5 Program desired therapy.

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.

6 Press [

7 The pump displays

8 While holding the container with

PURGE].

PRIME THE

SET?

the administration port toward the ceiling, press and hold [

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

Press [YES/ENTER].

PURGE].

Note: Purge rate is 250 mL/hr. The pump purges for up to 2 minutes each time you press and

PURGE].

hold [

PURGE]

40 Hospira GemS tar® System Operating Manual

Page 48

Chapter 2. Basic Operation

Priming Pump Sets WITH 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.

When using a vented chamber, ALWAYS use an air-eliminating filter OR set the air sensitivity to either ON or 2 mL.

1 Push down on the flow stop to

close the cassette.

2 Insert the piercing pin into the

container. Suspend the container on an I.V. Pole.

3 Squeeze the drip chamber until

filled halfway.

4 Push down on the flow stop to

open (priming position) the cassette.

5 Ensure the CAIR

(roller) clamp

is open prior to inserting cassette.

6 Invert the cassette approximately

45°.

Hospira GemStar® System Operating Manual 41

Page 49

Chapter 2. Basic Operation

7 While holding the rotated cassette,

remove air from the container and cassette.

8 Return the cassette to the upright

position. Continue priming until fluid fills the tubing.

9 Push down on the flow stop to

close the cassette.

11 Load the cassette.

CAUTION: Ensure all four cassette latches are clearly visible after the cassette is installed. Refer to Loading the Cassette on page 35.

10 Ensure lower CAIR® clamp is

open prior to inserting cassette.

42 Hospira GemS tar® System Operating Manual

Page 50

Note: Ensure the tubing is behind

the tubing guide (at the distal end).

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.

Chapter 2. Basic Operation

Hospira GemStar® System Operating Manual 43

Page 51

Chapter 2. Basic Operation

Priming Pump Sets WITH a Drip Chamber Using the PURGE Key

WARNING: Failure to use the pressure-activated anti-siphon valve

may result in unrestricted flow if the cassette is not properly installed in the pump.

When using a vented set, ALWAYS use an air-eliminating filter OR set the air sensitivity to either ON or 2 mL.

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 Insert the piercing pin into the

container. Suspend the container on an I.V. Pole.

3 Squeeze the drip chamber until

filled halfway.

4 Push down on the flow stop to

open (priming position) the cassette.

5 Ensure the lower CAIR

clamp is open prior to inserting cassette.

(roller)

44 Hospira GemS tar® System Operating Manual

Page 52

6 Load the cassette.

Chapter 2. Basic Operation

7 Program the desired therapy.

CAUTION: Ensure all four cassette latches are clearly visible after the cassette is installed. Refer to Loading the Cassette on page 35.

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

8 Press [

9 The pump displays

10 Press and hold [

PURGE].

SET?

Press [YES/ENTER].

Note: Purge rate is 250 mL/hr. The pump purges for up to 2 minutes each time you press and

PURGE].

hold [

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

CAUTION: When priming is complete, ensure no fluid flows at the distal end of the pump set. If flow is observed, DO NOT use the pump set.

PRIME THE

PURGE].

PURGE] key

11 Connect the pump set to the

patient-access device.

Hospira GemStar® System Operating Manual 45

Page 53

Chapter 2. Basic Operation

Priming Pump Sets Using Pre-filled Vials

WARNING: Failure to use the pressure-activated anti-siphon valve

may result in unrestricted flow if the cassette is not properly installed in the pump.

A cracked vial might not show evidence of leakage until delivery pressure is applied.

When using the GemStar (SAM) Lockbox, USE ONLY GemStar designated for use with the GemStar

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 Spring Assist Mechanism (SAM).

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

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.

Spring Assist Mechanism

2 Open the upper and lower slide

clamps.

Pump sets

SAM Lockbox.

Lockbox with

46 Hospira GemS tar® System Operating Manual

Page 54

Chapter 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.

air is cleared from the pre-filled 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.

6 Hold the pre-filled 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

Hospira GemStar® System Operating Manual 47

10 Ensure slide clamp is open on

KVO side prior to inserting cassette.

Page 55

Chapter 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 35

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.

Note: Ensure the tubing is behind

48 Hospira GemS tar® System Operating Manual

the tubing guide (at the distal end).

Page 56

Chapter 2. Basic Operation

Priming Pump Sets with Extensions

WARNING: Failure to use the pressure-activated anti-siphon valve

may result in unrestricted flow if the cassette is not properly installed in the pump.

1 Push down on the flow stop to

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.

Hospira GemStar® System Operating Manual 49

Page 57

Chapter 2. Basic Operation

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

prior to inserting cassette.

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

10 Load the cassette.

11 Program the desired therapy. 12 Press [

CAUTION: Ensure all four cassette latches are clearly visible after the cassette is installed. Refer to Loading the Cassette on page 35.

50 Hospira GemS tar® System Operating Manual

13 The pump displays

PURGE].

SET?

Press [YES/ENTER].

PRIME THE

Page 58

14 Press and hold [PURGE].

Note: Purge rate is 250 mL/hr.

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

PURGE].

hold [

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

CAUTION: When priming is complete, ensure no fluid flows at the distal end of the pump set. If flow is observed, DO NOT use the pump set.

15 Connect the pump set to the

patient-access device.

Chapter 2. Basic Operation

PURGE] key

Hospira GemStar® System Operating Manual 51

Page 59

Notes

52 Hospira GemS tar® System Operating Manual

Page 60

Total Parenteral Nutrition (TPN)

- Not Applicable to List 13088

Therapy Features and Specifications

This therapy allows programming of Total Parenteral Nutrition (TPN) protocols.

6 Taper Up and Taper Down may be programmed to gradually increase and

decrease the infusion rate at the beginning and end of a therapy. If Taper Down is selected during programming, the pump allows auto tapering if the continuous delivery is stopped before the programmed volume has been infused.

6 Set an optional KVO (Keep Vein Open) during programming.

Tip: The Programming Worksheet at the end of this chapter lists the minimum and

maximum values allowed for this protocol. Use copies of the programming worksheet to record program values before programming the pump.

TPN Programming Tips

The following table explains how to use the keypad during TPN programming:

Chapter 3

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.

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

Hospira GemStar® System Operating Manual 53

The DOWN arrow toggles between units of measure when entering concentrations. Scrolls through program review and help messages.

The UP arrow inserts a decimal point in a numeric value.

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

HELP mode.

Page 61

Chapter 3. Total Parenteral Nutrition

TPN Programming

1 Select TPN from the Programming Menu. 2 Select the TPN delivery mode. 3 Enter the total VTBI (Volume To Be Infused).

Note: Maximum VTBI is 9600 mL minus any taper amount.

4 Enter the Taper Up and Taper Down times (if applicable).

Note: Time is entered in hours:minutes (00:00). For one hour thirty minutes, press [1] [3] [0]; not [9] [0].

5 Enter the total time to infuse. 6 Enter the KVO rate. If no KVO is desired, press [

displayed is zero.

Note: KVO runs after Taper Down until the total container is infused.

7 Enter the container size (VTBI + KVO).

Note: If KVO is programmed, increase the container size to accommodate the desired KVO volume.

8 Select the air sensitivity, if required. 9 Review the program. Press to begin review. 10 If using the

WARNING: ALWAYS disconnect the pump set from the patient before

PURGE key to prime the pump set, press [PURGE] now.

priming or purging.

YES/ENTER] while the value

54 Hospira GemS tar® System Operating Manual

Page 62

Changing a TPN Program

Chapter 3. Total Parenteral Nutrition

Can be changed before

is pressed

•VTBI

• Taper times

• Total TPN time

Can be changed at any time

•KVO rate

• Increase container size only

• Air sensitivity

Cannot be changed

• Delivery mode

Note: Y ou cannot change a pr ogram when the pump is in FULL or CONTAINER Lock.

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 infusion.

Hospira GemStar® System Operating Manual 55

Page 63

Chapter 3. Total Parenteral Nutrition

TPN Auto Taper Down

Auto Taper Down is available only if a Taper Down time was entered during programming. Auto Taper Down may be activated when the continuous delivery portion of a TPN with Taper Down protocol is stopped. Auto Taper Down is not available while the pump is in an alarm condition.

1 Press [

2 Enter the Auto Taper Down time.

3 Press [

STOP] during TPN delivery.

The pump displays

• Press [NO] to return to the STOP mode. Then press [START] to continue

therapy.

• Press [

The maximum Auto Taper Down time is three hours or two times the remaining volume divided by the continuous infusion rate, whichever is less.

Note: Time is entered in hours:minutes (00:00). For one hour thirty minutes, press [1] [3] [0]; not [9] [0].

Taper Down.

YES/ENTER] to set Auto T aper Down.

YES/ENTER] to return to the RUN mode, then press [START] to begin Auto

DO YOU WANT AUTO TAPERING?

56 Hospira GemS tar® System Operating Manual

Page 64

Chapter 3. Total Parenteral Nutrition

GemStar

TPN Programming Worksheet

GIVE:

Parameters Selections and/or Values to be

Entered

Therapy TPN N/A Delivery Mode

VTBI (Volume To Be Infused)

Taper Up  No

Taper Down  No

Total Time to Infuse

KVO (Keep Vein Open)  No KVO Rate: 0.0

 Continuous  Continuous + Taper Down  Continuous + Taper Up  Continuous + Taper Up and Down

mL 1 - 9600 mL*

 Yes hrs:min 1 min - 3 hrs

 Yes hrs:min 1 min - 3 hrs**

hrs:min 1 min - 24 hrs

Programmable Ranges

N/A

 Yes KVO Rate: 1.0 - 5.0 mL/hr

Container Size (VTBI + KVO) mL 9999 mL max

Air Sensitivity***

* Maximum VTBI is 960 0 mL minus any taper amount. ** Programmable ranges for taper down are 1 minute to 3 hours or 2 times the remaining volume

divided by the continuous delivery rate, whichever is less.

*** Air Sensitivity may not show in all setting configurations.

Hospira GemStar® System Operating Manual 57

 On Alarms at approx. 0.5 mL of air  2 mL Alarms at approx. 2 mL of air  Off No alarm

N/A

Page 65

Notes

58 Hospira GemS tar® System Operating Manual

Page 66

Chapter 4

Pain Management

- Not Applicable to List 13086

Therapy Features and Specifications

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

6 In Co ntinuous + Bolu s protocols, yo u 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.

6 The default bolus delivery rate is 125 mL/hr.

Hospira GemStar® System Operating Manual 59

Note: The delivery rate is administered in increments of .01.

6 The maximum continuous delivery rate is 25 mL/hr. 6 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.

6 Priming u si ng [ PURGE] is only allowed before [START] is pressed or after one of

the following events occur:

6 Complete Review of New Program 6 New Cont ain er 6 Air-in-Line Alarm

6 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%.

Page 67

Chapter 4. Pain Management

Note: New Container is allowed only when at least 1/2 of the container volume has

been infused or 1 hour has elapsed since starting the infusion.

The use of a lockbox is recommended with pain management protocols. Refer to Chapter 15 Optional System Components, page 165, for instructions on using a lockbox with the GemStar® Pump.

Tip: The Programming W ork sheet at the e nd of this chap ter list s the min imum 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.

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

60 Hospira GemStar® System Operating Manual

The DOWN arrow toggles between units of measure when entering concentrations. Scrolls through program review and help messages.

The UP arrow inserts a decimal point in a numeric value.

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

HELP mode.

Page 68

Pain Management Programming

1 Select PAIN MANAGEMENT from the Programming Menu. 2 Select the delivery mode.

Note: If Continuous + Bolus is selected, the continuous delivery rate or bolus dose

can be set to zero without reprogramming the pump. Press [ [CHANGE], then select CHANGE PROGRAM.

3 Select the unit of measure and concentration as required. 4 Set the continuous delivery rate. 5 Program a loading dose as required. 6 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 pr ogr ess 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.

Chapter 4. Pain Management

STOP] and press

7 If programmed in units of mcg or mg, the line displaying the units flashes. Enter

the container size in proper unit measure.

Hospira GemStar® System Operating Manual 61

Note: To enter the total in mL when programming a concentration, press to move to the mL line. Enter the mL value when

8 Select the air sensitivity, if required. 9 Review the program. Press to begin review. 10 If using the PURGE key to prime the pump set, press [

WARNING: ALWAYS disconnect the pump set from the patient before

priming or purging.

mL flashes on the display.

PURGE] now.

Page 69

Chapter 4. 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 15 Optional System Components, on page 168, 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:

6 Records the bolus request and delivery amount to the event and bolus history logs 6 Adds the delivered boluses to the total bolus amount in the program amounts 6 Resets the bolus lockout time (if applicable) and ignores other bolus requests until

6 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:

6 Bolus lockout period 6 Loading dose delivery in progress 6 Bolus dose delivery in progress 6 Bolus per-hour limit 6 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

62 Hospira GemStar® System Operating Manual

Page 70

Chapter 4. Pain Management

Bolus Dose Interruptions

Bolus deliveries may be interrupted by:

6 Pressing [STOP] 6 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

The time of delivery completion

The time the bolus was interrupted

Hospira GemStar® System Operating Manual 63

Page 71

Chapter 4. Pain Management

Loading Dose Delivery

You can set a loading dose during programming, if desired. A loading dose can be delivered after programming and priming are complete.

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

to begin loading dose.

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

6 Automatically begins programmed infusion 6 Records the dose amount to the history log 6 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:

6 Pressing [STOP] 6 An alarm condition

To continue a loading dose: 1 Resolve the interruption.

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

START].

2 Press [

64 Hospira GemStar® System Operating Manual

START]. The pump display s COMPLETE THE LOADING DOSE?

Page 72

Chapter 4. Pain Management

3 Respond as follows:

To do this: Press this key:

Deliver the remaining loading dose amount

Clear the remaining loading dose amount

Changing a Pain Management Program

Can be changed at any time Cannot be ch an ge d

• 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® System Operating Manual 65

Page 73

Chapter 4. Pain Management

GemStar

Pain Management Programming Worksheet

GIVE:

Parameters Selections and/or Values to be

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:

Programmable Ranges

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*

 1-hour limit Amount:

 # boluses/hour Number:  No dose limit

Rate - 100 mL, 10000 mg, 100000 mcg*

1 - 12 *For continuous plus bolus delivery.

Note: For Bolus Only, the 1-hour or 4-hour dose limit minimum is 1 bolus dose.

Container Size 0.1 - 99999 mg

1 - 9999000 mcg

0.1 - 9999 mL

66 Hospira GemStar® System Operating Manual

Page 74

Chapter 4. Pain Management

Parameters Selections and/or Values to be

Entered

Air Sensitivity**

* 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.

 On Alarms at approx. 0.5 mL of air  2 mLAlarms at approx. 2 mL of air  Off No alarm

Programmable Ranges

N/A

Hospira GemStar® System Operating Manual 67

Page 75

Notes

68 Hospira GemStar® System Operating Manual

Page 76

- Not Applicable to List 13088

Therapy Features and Specifications

This therapy allows programming of multiple doses at regular intervals.

6 Optional KVO (Keep Vein Open) can be set during programming. 6 The pump can be disconnected from the patient between dose deliveries. A call

back alarm can be set to alert the patient or caregiver to reconnect the pump before the next scheduled delivery begins. The pump must remain powered on for the call back alarm to function. At the set time before each dose, the pump produces an audible and visual alarm and flashes

Tip: The Programming Worksheet at the end of this chapter lists the

minimum and maximum values allowed for this protocol. Use copies of the programming worksheet to record program values be fore programming the pump.

Intermittent Programming Tips

The following table explains how to use the keypad during intermittent programming:

Chapter 5

Intermittent

START on the display.

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.

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

Hospira GemStar® System Operating Manual 69

The DOWN arrow toggles between units of measure when entering concentrations. Scrolls through program review and help messages.

The UP arrow inserts a decimal point in a numeric value.

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

HELP mode.

Page 77

Chapter 5. Intermittent

Intermittent Programming

1 Select INTERMITTENT from the Programming Menu. 2 Enter the dose amount in mL. 3 Enter the infusion time for each dose in hours:minutes (00:00).

For example, press [

4 Enter the frequency of dose deliveries.

For example, press [

5 Enter the total number of doses in the container.

To determine the number of doses in the container, divide the volume in the container by the dose amount.

6 Enter the KVO rate in mL.

KVO delivers before a delayed start time, between doses, and after the last dose until the total container is infused.

4] [0] if each dose is to deliver for 40 minutes.

4] [0] [0] to start a dose every four hours.

If no KVO is desired, press [

7 Enter the container size.

The pump automatically calculates the minimum container size required to deliver the number of programmed doses and KVO between doses.

Note: If KVO is desired before a delayed start, increase the container size to include the desired KVO volume.

8 Select the air sensitivity, if required.

Note: DO NOT press [YES/ENTER] after selecting the air sensitivity. If [YES/ENTER] is accidentally pressed and a call back alarm is not desired, press [

BACK-UP] to return to the beginning of step 9 and press [NO].

9 The pump displays

• Press [NO] if you do not want to set the call back alarm.

• Press [ Enter the time before the next dose that the alarm should sound. For example,

press [ scheduled delivery.

YES/ENTER] to set the call back alarm.

1] [0] to set the alarm to sound 10 minutes before the start of the next

SET CALL BACK ALARM FOR NEXT DOSE?

YES/ENTER] while the value displayed is zero.

70 Hospira GemStar® System Operating Manual

Page 78

Chapter 5. Intermittent

Note: When programming the call back alarm, be sure to allow enough time for the patient or caregiver to reconnect the pump to the patient and to press [ BEFORE the scheduled dose start time.

10 The pump displays the current time.

• If the displayed time is correct, press [

• To set the clock, press [

OPTIONS].

YES/ENTER].

START]

11 The pump displays the current time and

• Press [YES/ENTER] to begin delivery when the pump enters the RUN mode.

• Press [

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

PM.

12 Review the program. Press to begin review. 13 If using the

WARNING: ALWAYS disconnect the pump set from the patient before

Note: The call back alarm works only when the pump is powered on AND in the

STOP mode. DO NOT power-off the pump while it is disconnected from the patient

if you have set the call back alarm.

When the alarm sounds, press [ Then reconnect the pump to the patient.

Tip: To use a delayed start without specifying a start time:

NO] to set a delayed start time. The pump displays SET START TIME.

Enter the desired start time and press [

PURGE key to prime the pump set, press [PURGE] now.

priming or purging.

SILENCE] to silence the alarm for three minutes.

START NOW?

YES/ENTER] when done.

1 Press [YES/ENTER]. 2 Complete the program review. 3 Power-off the pump. 4 When the pump is powered on again, complete the program review, then

press [

START] to begin delivery.

Hospira GemStar® System Operating Manual 71

Page 79

Chapter 5. Intermittent

Intermittent Delivery Interruptions

Missed Start Time

6 If the programmed start time is missed, it can be changed through the Options

Menu. Refer to Next Dose (Not available for List 13088) in Chapter 10 Options Menu, on page 121.

6 If the pump remains in the STOP mode and the first dose is missed, press

[

START] to begin delivery immediately and all remaining doses will be shifted.

6 If the pump is programmed with a delayed start time and is then powered off

before [ programmed start time.

For example, the current time is 10:00 PM. The user sets the delayed start time for 10:30 PM and then powers off the pump. The user does not power on the pump until 10:40 PM, which is 10 minutes AFTER the scheduled start time. The pump does not begin delivery until 10:30 PM the FOLLOWING day.

START] is pressed, the pump will skip to the NEXT occurrence of the

Dose Interruptions

To understand how interruptions are resolved, compare the normal Intermittent delivery diagram below for a 1-hour dose every four hours, to the interruption diagrams shown in the examples:

6 If an Intermittent dose is interrupted and the pump is placed in the RUN mode

during the on or off cycle of the current dose, the dose continues delivery from the

72 Hospira GemStar® System Operating Manual

Note: The clock cannot be changed while an Intermittent Program is in progress.

12123456789101112

Dose Delivered -

Page 80

Chapter 5. Intermittent

point where it was interrupted and all remaining doses are shifted. For example, in the following diagram, an intermittent dose was started at 2:00.

The dose was interrupted during the current dose cycle and was started again before the end of the current dose cycle.

12123456789101112

Dose Delivered - Dose Interrupted -

6 If an Intermittent dose is interrupted and the pump is placed in the RUN mode

after the off cycle of the current dose, the next dose begins delivery . All remaining doses are shifted if necessary.

For example, in the following diagram, an intermittent dose was started at 2:00. It was interrupted during the current delivery cycle at 2:30, but was not started again until after the current delivery cycle at 6:45:

12123456789101112

Dose Delivered - Dose Interrupted -

6 When the dose is complete, the start time for the Next Dose displays. To change

the start time refer to Chapter 10 Options Menu, page 107.

6 Any missed Intermittent doses, except the first dose, are added to the end of the

delivery schedule.

Hospira GemStar® System Operating Manual 73

Page 81

Chapter 5. Intermittent

Changing an Intermittent Program

Can be changed at any time

• Dose parameters

• KVO rate

• Container size

• Air sensitivity

• Call back alarm

Can be changed if no dose is in progress

• Next dose start time • Current time

Cannot be changed after is pressed

Note: You cannot change a program when the pump is in FULL or CONTAINER Lock.

To change a program:

1 From the

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

2 As each message displays, make the desired changes or press [YES/ENTER] to

accept the current setting.

3 Review the program. Press to begin review. 4 Press [

START] to begin delivery.

74 Hospira GemStar® System Operating Manual

Page 82

Chapter 5. Intermittent

GemStar

Intermittent Programming Worksheet

GIVE:

Parameters Selections and/or Values to be Entered Programmable

Ranges

Therapy Intermittent N/A

Dose Amount

0.1 - 9600 mL

Infusion Time Per Dose

Dose Frequency

Number of Doses Per Container

KVO (Keep Vein Open)

Container Size*

Air Sensitivity**

Call Back Alarm

Start Time

 No KVO Rate: 0.0  Yes KVO Rate:

 On Alarms at approx. 0.5 mL of air  2 mL Alarms at approx. 2 mL of air  Off No alarm

 No  Yes

Alarm: hrs:min before start

 Start immediately after programming

hrs:min 1 min - 24 hrs

(Infusion time per dose + 1 min) to 96 hrs

hrs:min

1 - 999

0.1 -5.0 mL/hr

0.1 - 9999 mL N/A

1 min to time between doses

 Start time:

Specify AM or PM if not 24-hour clock.

* The pump automatically calculates the minimum container size required to deliver the number of

12:00 AM - 11:59 PM or 00:00 - 23:59

programmed doses and KVO between doses. If KVO is desired before a delayed start, increase the container size to include the desired KVO volume.

** Air sensitivity may not show in all setting configurations.

Hospira GemStar® System Operating Manual 75

Page 83

Notes

76 Hospira GemStar® System Operating Manual

Page 84

- Not Applicable to List 13088

Therapy Features and Specifications

This therapy allows programming of a continuous delivery.

6 Optional KVO (Keep Vein Open) can be set during programming. 6 The rate can be titrated while the pump is infusing. 6 An optional secondary container can be “piggybacked” on the primary container

during regular delivery using a GemStar Piggybacking in this chapter for more information.

Tip: The Programming Worksheet at the end of this chapter lists the minimum

and maximum values allowed for this protocol. Use copies of the prog ramming worksheet to record program values before programming the pump.

Continuous Programming Tips

The following table explains how to use the keypad during continuous programming:

Chapter 6

Continuous

Piggyback Pump Set. Refer to

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.

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

Hospira GemStar® System Operating Manual 77

The DOWN arrow toggles between units of measure when entering concentrations. Scrolls through program review and help messages.

The UP arrow inserts a decimal point in a numeric value.

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

HELP mode.

Page 85

Chapter 6. Continuous

Continuous Programming

1 Select CONTINUOUS from the Programming Menu. 2 Select the unit of measure and concentration as required. 3 Enter the rate. 4 Enter the VTBI (Volume to be Infused). 5 Enter the KVO rate, if desired.

KVO runs after the programmed VTBI until the total container is infused. If no KVO is desired, press [

6 Enter the container size (VTBI + KVO).

VTBI is the default value on the

Note: If KVO is programmed, increase the container size to include the KVO

delivery. To enter the total in mL when programming a concentration, press to move to

the mL line. Enter the mL size when

7 Select the air sensitivity, if required. 8 Review the program. Press to begin review.

YES/ENTER] while the value displayed is zero.

CONTAINER display.

mL flashes on the display.

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.

78 Hospira GemStar® System Operating Manual

PURGE] now.

Page 86

Rate Titration

To titrate the rate while the pump is infusing:

1 In the

For example: if the current rate is 50 mL/hr, press [ change the rate to 100 mL/hr.

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

numeric key, the decimal key, or [YES/ENTER]. If no key is pressed within five seconds, the rate does not change and the delivery continues as previously programmed.

NEW RATE displays with the new value.

• Press [ delivery at the new rate.

• Press [

Piggybacking

Piggybacking with the GemStar® Pump requires a GemStar® Primary Piggyback Pump Set with a proximal Y-site backcheck valve and a secondary piggyback set with an extension hook. The secondary container must be higher than the primary container. Refer to the instructions included with the piggyback pump set for more information.

Chapter 6. Continuous

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

1][0] [0] [YES/ENTER] to

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

NO] to continue delivery at the previously programmed rate.

WARNING: When using the pump for secondary delivery (piggybacking),

ensure the fluids being infused are chemically and physically compatible.

The piggyback rate and piggyback VTBI display until the secondary container has been delivered. Then the primary infusion continues.

Note: The piggyback infusion amount is NOT added to the primary programmed infusion amount.

Hospira GemStar® System Operating Manual 79

Page 87

Chapter 6. Continuous

Preparing for Secondary Delivery (Piggybacking)

1 Ensure a primary piggyback pump set with a

proximal Y-site backche ck valve is in place.

2 Use the extension hook from the secondary set

to suspend the primary container from the I.V. pole.

3 Prepare the secondary set according to the

instructions included with the set.

4 Attach a needle or blunt cannula (if appropriate)

and prime the secondary set.

5 Suspend the secondary container from the I.V.

pole.

Note: When using a secondary container of

500 mL or greater, ensure the bottom of the secondary container is at least 7 inches (17.8 cm) above the fluid level in the primary container. Use additional extension hooks if necessary.

6 Connect the secondary set to the proximal

Y-site (or proximal luer port).

80 Hospira GemStar® System Operating Manual

Page 88

Chapter 6. Continuous

Programming a Secondary Delivery (Piggybacking)

Note: To distinguish the piggyback delivery from the primary delivery, PIGGYBACK displays and the piggyback VTBI counts down to completion. For example, a piggyback rate of 250 mL/hr with a remaining VTBI of

218.5 mL will display as 219 mL.

Tip: Prepare an d set up cont ain ers BEFORE progr amming the pum p for pigg yback delivery.

1 Press [ 2 Enter the dose amount for the secondary container. 3 Enter the infusion time for the secondary container. 4 Open the slide clamp or lower CAIR

5 Press [

Note: Primary flow stops until the secondary VTBI is delivered; then primary flow continues. Any remaining secondary fluid will be delivered at the primary rate. The maximum piggyback rate is 300 mL/hr. For secondary rates above 300 mL/hr, flow may occur from the primary container.

Changing a Piggyback Delivery

1 Press [

CHANGE] and select PIGGYBACKING from the Change Menu.

(roller) clamp on the tubing of the

secondary container.

YES/ENTER] to begin piggyback delivery.

CHANGE] and select PIGGYBACKING from the Change Menu.

PIGGYBACK

RATE 250 mL/hr

VTBI 219 mL

2 Press [ 3 Enter the new piggyback dose amount and press [ 4 Set the infusion time for the secondary container. 5 Press [

Note: Y ou must know the amount that ha s alr eady been deliver ed. When the piggyback dose amount is changed, the pump begins a new VTBI countdown.

Hospira GemStar® System Operating Manual 81

CHANGE] to reset the dose amount to zero.

YES/ENTER].

YES/ENTER] to begin piggyback delivery.

Page 89

Chapter 6. Continuous

Canceling a Piggyback Delivery

1 Press [ 2 Press [ 3 Press [

CHANGE] and select PIGGYBACKING from the Change Menu. CHANGE] to reset the dose amount to zero. YES/ENTER] to cancel piggyback delivery.

Alarms Affecting Piggyback Delivery

The following delivery-related Operational Alarms occur during a Piggyback Delivery:

6 Check Cassette 6 Air in Line 6 Distal Occlusion 6 Proximal Occlusion

If an alarm occurs during the programming sequence, piggyback dose programming is completed.

Changing a Continuous Program

Can be changed at any time Cannot be changed

• Delivery rate

•VTBI

• KVO rate

• Container size

• Air sensitivity

• Piggybacking

• Unit of measure

• Concentration

Note: Y ou cannot change a program when the pump is in FULL or CONTAINER Lock.

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 [

82 Hospira GemStar® System Operating Manual

START] to begin delivery.

Page 90

Chapter 6. Continuous

GemStar

Continuous Programming Worksheet

GIVE:

Parameter Selections and/or Values to be

Entered

Therapy Continuous N/A

Unit of Measure

Rate 0.1 - 9999 mg/hr

VTBI (Volume To Be

Infused) KVO

(Keep Vein Open)

Container Size (VTBI + KVO)

Air Sensitivity*

Piggyback Dose Amount 1 - 7200 mL

Piggyback Infusion Time

*Air Sensitivity may not show in all setting configurations.

 Concentration: mg/mL

 Concentration: mcg/mL  mL

 No KVO Rate: 0.0

 Yes KVO Rate:

 On Alarms at approx. 0.5 mL of air  2 mL Alarms at approx. 2 mL of air  Off No alarm

hrs:min

Programmable Ranges

0.1 - 1000 mg/mL

1 - 1000 mcg/mL

1 - 999900 mcg/hr

0.1 - 1000 mL/hr

0.1 - 99999 mg 1 - 9999000 mcg

0.1 - 9999 mL

0.1 - 5.0 mL/hr

0.1 - 99999 mg 1 - 9999000 mcg

0.1 - 9999 mL N/A

1 min or dose amount / 300 mL/hr to 24 hrs or dose amount / 0.1 mL/hr

Hospira GemStar® System Operating Manual 83

Page 91

Notes

84 Hospira GemStar® System Operating Manual

Page 92

Weight Dosed

- Not Applicable to List 13088

Therapy Features and Specifications

This therapy allows programming of delivery rate as a function of body weight.

6 The air sensit ivity in a Weight Dosed program is automatically set to ON. This

setting can be changed through the Options Menu after programming is complete. Refer to Air Sensitivity in Chapter 10 Options Menu, on page 117.

6 The pump automatically delivers KVO (Keep Vein Open) after the programmed

VTBI (Volume To Be Infused) has completed.

6 The rate can be titrated while the pump is infusing. 6 VTBI can be titrated.

Tip: The Programming Worksheet at the end of this chapter lists the minimum and

maximum values allowed for this protocol. Use copies of the programming worksheet to record program values before programming the pump.

WARNING: When using a vented drip set, ALWAYS use an air-

eliminating filter or set the air sensitivity to either ON or 2 mL.

Chapter 7

CAUTION: When infusing short-half-life drugs (i.e., those dosed with units of

mcg/kg/min) at very low rates (0.8 mL/hr or less) the rate may be too slow for that drug. Consider using a lower drug concentration with these drugs so a pump rate above 0.8 mL/hr can be used.

Hospira GemStar® System Operators Manual 85

Page 93

Chapter 7. Weight Dosed

Weight Dosed Programming Tips

The following table explains how to use the keypad during weight dosed 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.

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

Weight Dosed Programming

1 Select WEIGHT DOSED from the Programming Menu. 2 Select the unit of measure.

Note: If two numbers appear before a menu time (e.g., 02), press both number keys to select that item.

3 Enter the patient weight, if required. 4 Enter the concentration:

• Enter the value for the unit of measure when it flashes on the display.

• Press [

YES/ENTER] to confirm.

The DOWN arrow toggles between units of measure when entering concentrations. Scrolls through program review and help messages.

The UP arrow inserts a decimal point in a numeric value.

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

HELP mode.

86 Hospira GemStar® System Operators Manual

Tip: Press to toggle between units of measure.

5 Enter the rate.

Note: The pump automatically displays the mL/hr equivalent even when another unit of measure is selected.

6 Enter the VTBI. 7 Review the program. Press to begin review.

Page 94

Chapter 7. Weight Dosed

8 If using the PURGE key to prime the pump set, press [PURGE] now.

WARNING: ALWAYS disconnect the pump set from the patient before

priming or purging.

Auto KVO

When the programmed VTBI has completed delivery, Auto KVO delivery begins automatically and the empty container alarm sounds.

Note: Auto KVO delivers even while the empty container alarm sounds. Press [SILENCE] to quiet the alarm for 2 minutes.

If the weight dosed rate is: Auto KVO delivers at:

Greater than or equal to 1 mL/hr 1 mL/hr Less than 1 mL/hr The weight dosed rate

Rate Titration

To titrate the rate while the pump is infusing:

1 In the

For example: if the current rate is 7.5 mcg/kg/min, press [ change the rate to 10 mcg/kg/min.

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

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

NEW RATE displays with the new value.

• Press [

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

1][0] [YES/ENTER] to

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

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

delivery at the new rate.

NO] to continue delivery at the previously programmed rate.

Hospira GemStar® System Operators Manual 87

Page 95

Chapter 7. Weight Dosed

VTBI Titration

To titrate the VTBI while the pump is infusing:

1 Press [ 2 Press the number keys for the new VTBI. Press [

CHANGE] and select TITRATE VTBI.

For example: if the current VTBI is 0 mL, press [ mL.

Note: You have approximately five seconds after pressing a key to press another numeric key, the decimal key, or [ seconds, the VTBI does not change and the delivery continues as previously programmed.

NEW VTBI displays with the new rate.

• Press [

Note: Titrating VTBI does not change initial container volume.

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

delivery with the new VTBI.

NO] to continue delivery at the previously programmed VTBI.

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

Changing a Weight Dosed Program

Can be changed at any time Cannot be chan ged

• Delivery rate

•VTBI

• Patient weight

YES/ENTER].

1][0] to change the VTBI to 10

• Unit of measure

• Concentration (amount of drug)

Note: You cannot change a program when the pump is in FULL or CONTAINER Lock.

To change a program:

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

accept the current setting.

3 Review the program. Press to begin review. 4 Press [

88 Hospira GemStar® System Operators Manual

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

YES/ENTER] to

START] to begin delivery.

Page 96

Chapter 7. Weight Dosed

GemStar® Weight Dosed Programming Worksheet

GIVE:

Parameter Selections and/or Values to be Entered Programmable

Ranges

Therapy Weight Dosed N/A Unit of Measure**

 mcg/kg/min  mcg/kg/hr  mcg/min  mg/kg/min  mg/kg/hr  mg/min  mL/hr  mg/hr

 mcg/hr  grams/hr  ng/kg/min  U/kg/hr  U/min  U/hr  mUn/min  mEq/hr

N/A

Patient Weight (When programming in kg/min or kg/hr)

2.0 - 200.0 kg Concentration (2 entries are

required. Use to toggle)

(For all units of measure EXCEPT mL/hr)

mg U mEq in in in

mL mL mL

0.1 - 9999000 mg

0.1 - 99999999 U

0.1 - 9999 mEq

0.1 - 9999 mL Rate

(see below *)

VTBI (Volume To Be Infused)

* Programmable Ranges for Rate (not all units of measure are available in all pump configurations):

0.001 - 833 mg/kg/min 0.1 - 1000 mL/hr 0.001 - 99999999 U/min

0.001 - 500000 mg/kg/hr 0.001 - 999999 mg/hr 0.001 - 99999999 U/hr

0.001 - 16666 mg/min 0.001 - 9999999 mcg/hr 0.001 - 999999999 mUn/min

0.001 - 166666 mcg/kg/min 0.001 - 999 grams/hr 0.001 - 999 mEq/hr

0.001 - 9999999 mcg/kg/hr 0.009 - 999 ng/kg/hr

0.002 - 166666 mcg/min 0.001 - 99999999 U/kg/hr

0.1 - 9999 mL

Note: Numbers increment by hundredths—for example, 0.1 increments to 0.11, then to 0.12.

** If two numbers appear before a menu item (e.g., 02), press both number keys to select that item.

CAUTION: When infusing short-half-life drugs (i.e., those dosed with units of mcg/kg/min) at very low rates (0.8 mL/hr or less) the rate may be too slow for that drug. Consider using a lower drug concentration so a pump rate above 0.8 mL/hr can be used.

Hospira GemStar® System Operators Manual 89

Page 97

Chapter 7. Weight Dosed

Programming a Precedex® (dexmedetomidine hydrochloride injection) Delivery

If configured and used by your facility, you can program a Precedex® delivery while programming a Weight Dosed therapy.

Note: Titrate rate, loading dose, and titrate VTBI are available in Precedex® therapy.

To program a Precedex

1 Select 2 Select 3 The pump displays 4 Enter patient weight in kg, and then press [ 5 Enter the concentration:

6 Enter the rate, and then press [

Note: Rate is entered in mcg/kg/hr, and then displays in mL/hr.

7 Enter the VTBI in mL, and then press [ 8 The pump displays

9 If programming a loading dose, specify a dose, time, and rate using the key

10 Review the program using the key; when finished, press [

WEIGHT DOSED from the Programming menu. MCG/KG/HR as the unit of measure.

6 Enter the unit of measure for the value flashing on the display. 6 Use the key to toggle between the values, and then press [YES/ENTER].

program a loading dose or [

to toggle between the parameters, and then press [

delivery:

IS THIS A PRECEDEX THERAPY? Press [YES/ENTER].

YES/ENTER].

PROGRAM A LOADING DOSE? Press [YES/ENTER] to

NO] to review the program.

YES/ENTER].

WARNING: ALWAYS disconnect the pump set from the patient before

priming or purging.

11 If using the PURGE key to prime the pump set, press [ 12 Press [

90 Hospira GemStar® System Operators Manual

START] to begin the Precedex

delivery.

PURGE] now.

Page 98

Chapter 7. Weight Dosed

GemStar® Precedex® (dexmedetomidine hydrochloride

injection) Programming Worksheet

GIVE:

Parameter Selections and/or Values to be Entered Programmable

Therapy Weight Dosed N/A Unit of Measure mcg/kg/hr N/A Precedex®

Therapy? Patient Weight

Concentration (Add values are

required. Use to toggle between fields)

Rate

VTBI (Volume To Be Infused)

Loading Dose (2 entries are

required. Use to toggle between mg and mL entry points.)

* Package Insert recommends 0.2 to 0.7 mcg/kg/hr. The delivery rate is programmable and is delivered in increments of .01.

** Package Insert recommends 1 mcg/kg over10 min . Cannot enter less than 10 min.

[YES/ENTER] N/A

kg mcg

in mL

mcg/kg/hr

(mL/hr is automatically calculated)

 No  Yes

Dose mcg/kg Time**

Ranges

2.0 - 200.0 kg

1.0- 1000

0.1 - 1000

0.1 - 1000*

0.1 - 9999 mL

0 - 1.0**

Note: Numbers increment by hundredths—for example, 0.1 increments to 0.11, then to 0.12.

Hospira GemStar® System Operators Manual 91

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Notes

92 Hospira GemStar® System Operators Manual

Page 100

Chapter 8

mL/hr Only

- Not Applicable to List 13088

Therapy Features and Specifications

This therapy allows quick programming of delivery rate in milliliters (mL) only.

6 The air sensitivity is aut omatically set to ON. This setting can be changed through

the Options Menu after programming is complete. Refer to Air Sensitivity in Chapter 10 Options Menu, on page 117.

6 The pump automatically delivers KVO (Keep Vein Open) after the programmed

VTBI (Volume To Be Infused) is complete.

6 The rate can be titrated while the pump is infusing. 6 An optional secondary container can be “piggybacked” onto the primary container

during regular delivery using a GemStar Piggybacking in this chapter for more information.

6 A program review is not required and is available only through the Options Menu. 6 VTBI can be titrated.

Piggyback Pump Set. Refer to

Tip: The Programming Worksheet at the end of this chapter lists the minimum and

maximum values allowed for this protocol. Use copies of the programming worksheet to record program values before programming the pump.

WARNING: When using a vented set, ALWAYS use an air-eliminating

filter or set the air sensitivity to either ON or 2 mL.

Hospira GemStar® System Operating Manual 93

Hospira Gemstar Operations 6 2010 Precalculus

Specifications and Main Features

Frequently Asked Questions

User Manual

Introduction

GemStar® Pump Layout

GemStar® Pump Components

Therapies

Operating Modes

Indications for Use

Contraindications for Use

Warnings and Cautions

General Warnings and Cautions

Regarding Air-In-Line and Infusion

Regarding Handling and Maintenance

Basic Operation

Overview

Selecting a Power Source

Installing Disposable Batteries

Programming the Pump

Programming Overview

Programming Tips

Starting a New Container

GemStar® Pump Set

Opening the Pump Set

Loading the Cassette

Releasing the Cassette

Priming Pump Sets WITHOUT a Drip Chamber

Priming Pump Sets WITHOUT a Drip Chamber Using the PURGE Key

Priming Pump Sets Using Pre-filled Vials

Therapy Features and Specifications

TPN Programming Tips

TPN Programming

Changing a TPN Program

TPN Auto Taper Down

Therapy Features and Specifications

Pain Management Programming Tips

Pain Management Programming

Bolus Delivery

Delivering a Bolus Dose

Loading Dose Delivery

Delivering a Loading Dose

Loading Dose Interruptions

Therapy Features and Specifications

Intermittent Programming Tips

Intermittent Programming

Intermittent Delivery Interruptions

Missed Start Time

Dose Interruptions

Changing an Intermittent Program

Therapy Features and Specifications

Continuous Programming Tips

Continuous Programming

Rate Titration

Preparing for Secondary Delivery (Piggybacking)

Programming a Secondary Delivery (Piggybacking)

Changing a Piggyback Delivery

Canceling a Piggyback Delivery

Alarms Affecting Piggyback Delivery

Therapy Features and Specifications

Weight Dosed Programming Tips

Rate Titration

GemStar® Weight Dosed Programming Worksheet

Programming a Precedex® (dexmedetomidine hydrochloride injection) Delivery

Therapy Features and Specifications