Gemstar Infusion Pump System Operating Manual Rev July 2006

Change History

ii

Part Number

Description of Change

Pages Changed

430-10983-001 (Rev. 03/06)

Original Issue

N/A

430-10983-002 (Rev. 07/06)

Second Release

All

GemStar™ Manual 430-10983-002 (Rev. 07/06)

Contents 1. Introduction

1

GemStar™ Pump Layout... 2 GemStar™ Pump Components... 4 Therapies... 5 GemStar™ Pump Features... 6 Menu System... 7 Operating Modes... 9 Indications for Use... 10 Contraindications for Use... 11 Warnings and Cautions... 11

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™ Pump Set... 32 Loading the Cassette... 35 Releasing the Cassette... 36 Priming a GemStar™ Pump Set... 37

3. Total Parenteral Nutrition (TPN)

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

59

Therapy Features and Specifications... 59 Pain Management Programming... 61 Bolus Delivery... 62 Loading Dose Delivery... 64

GemStar™ Manual 430-10983-002 (Rev. 07/06)

iii

Contents Changing a Pain Management Program... 65

5. Intermittent

69

Therapy Features and Specifications... 69 Intermittent Programming... 70 Intermittent Delivery Interruptions... 72 Changing an Intermittent Program... 74 Intermittent Programming Worksheet... 75

6. Continuous

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

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™ Weight Dosed Programming Worksheet... 89 Programming a Precedex® (dexmedetomidine hydrochloride injection) Delivery. 90 GemStar™ Precedex® (dexmedetomidine hydrochloride injection) Programming Worksheet... 91

8. mL/hr Only

93

Therapy Features and Specifications... 93 mL/hr Only Programming... 94 Auto KVO... 95 Rate Titration... 95 VTBI Titration... 96 Piggybacking... 96 Changing a mL/hr Only Program... 99 mL/hr Only Programming Worksheet... 100

iv

GemStar™ Manual 430-10983-002 (Rev. 07/06)

Contents 9. Variable Time

101

Therapy Features and Specifications... 101 Variable Time Programming... 102 Variable Time Delivery Interruptions... 103 Changing a Variable Time Program... 104 GemStar™ Variable Time Programming Worksheet... 105

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... 121 Connecting to the Data Port... 122 Transferring Data Using a Computer... 127

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

13. Maintenance

151

Pump Storage... 151 Cleaning and Disinfecting... 151 Repair... 153

GemStar™ Manual 430-10983-002 (Rev. 07/06)

v

Contents 14. Operation Test

155

Equipment Required... 155 Test Setup... 156 Performing the Operation Test... 156 Printing Test Results... 161 GemStar™... 163 Operation Test Checklist... 163

15. Optional System Components

165

Connecting the Bolus Cord... 168 Using the GemStar™ Lockboxes... 168 Using the Hospira Carrying Cases... 171 Using the GemStar™ 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 IEC Symbols

vi

203 inside back cover

GemStar™ Manual 430-10983-002 (Rev. 07/06)

Chapter 1

Introduction The GemStar™ Pump is a small and lightweight, single-channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar™ Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, the GemStar™ Pump is ideal for ambulatory patients. The following conventions are used throughout this manual: Convention

Use

Example

[ALL CAPS]

Pump keys

Press [YES/ENTER] to continue.

ALL CAPS

Display messages

The pump displays:

ENTER TO CONFIRM.

WARNING: A WARNING message contains special safety information and must be observed at all times. Failure to observe a warning message could be life threatening. CAUTION:

  

A CAUTION contains information that could prevent irreversible product damage or hardware failure. Failure to observe a caution could result in serious patient or user injury.

Note: A NOTE contains information or examples to help explain instructions. Tip: A TIP contains information that makes the pump easier to use.

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

GemStar™ Manual 430-10983-002 (Rev. 07/06)

1

1. Introduction

GemStar™ Pump Layout

Shown approximate size

2

GemStar™ Manual 430-10983-002 (Rev. 07/06)

1. Introduction 1

DISPLAY •

2

• •

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

3

•

Stops infusion.

4

•

Starts infusion.

5

• • •

Lights continuously when the pump is powered by AC mains. Flashes when the pump is powered by external batteries (e.g., battery pack). Not lit when using disposable AA batteries.

6

•

Powers the pump on or off. To power-off the pump, press and hold until the display clears.

7

• •

Returns to previous steps during programming. Exits Help, Change, and Options menus.

•

Displays the following menu items from the STOP or RUN mode*: New Container Change Program (or Titrate VTBI) New Program Piggybacking (Secondary Delivery) Resets a numeric value to zero.

8

CHANGE

•

Displays the pump’s status.

9

•

Displays the following Options Menu items from the STOP or RUN mode*: 1 Review Program 4 Pump Settings 7 Speed Protocol 2 Histories 5 Set Clock 8 Next Dose 3 Keypad Lock 6 Print

10

• • •

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.

10

• • •

Toggles between AM and PM in time-based entries. UP arrow enters a decimal point in numeric entries. Scrolls back by one screen in program review.

11

• •

Responds “YES” to display questions. Accepts entries and goes to the next step.

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.

14

• •

Clears an AIR-IN-LINE alarm. Primes a GemStar™ Pump Set.

15 [0] - [9] •

Selects menu items and enters numeric values. If two numbers appear before a menu item (e.g., 02), press both number keys to select that item.

* Not all menu items are available with all modes.

GemStar™ Manual 430-10983-002 (Rev. 07/06)

3

1. Introduction

GemStar™ Pump Components 1

Bolus Button

Press this button to start a bolus delivery if available in the current program.

2

Pole Clamp Track

Use to connect to an optional pole clamp.

3

Cassette Release Button

Push down on this button to release the cassette.

4

Power Connector

Use to connect the AC mains adaptor.

5

Data Port Connector

Use to connect the GemStar™ serial cable.

6

Bolus Connector

Use to connect a bolus cord.

7

Tubing Channel

Place the pump set tubing in this channel.

8

Cassette Pocket

Load the cassette into this pocket.

9

I.V. Tubing Guide

Use to hold the I.V. tubing.

10 Battery Pack Connector

11 Battery Compartment

Top View

Use to connect the GemStar™ Rechargeable Battery Pack. Install two fresh, disposable AA batteries in this compartment.

Bottom/Side View

4

GemStar™ Manual 430-10983-002 (Rev. 07/06)

1. Introduction

Therapies

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

AUT

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

•



TA /DOPER U WN P TIT VTB RATE I OPT KVO IONA L

TPN

LO DOSADING E

Possible Applications O K VO TIT RAT RA TE E

Therapy

PI BACGGYKIN G BOL US

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

•

•

•

•

• • • •

• •

•

• • •

• •

•

= Available

Note: Not all therapies are available in all pump configurations.

GemStar™ Manual 430-10983-002 (Rev. 07/06)

5

1. Introduction

GemStar™ Pump Features

6

Feature

Description

Reference Page

•

Adjustable Settings

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

Chapter 10 Options Menu

•

Alerts and Alarms

Signals audible and visual alarms when attention is required.

Chapter 1 Introduction, GemStar™ Pump Layout

•

Audible Keypad Response

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

Chapter 1 Introduction, GemStar™ Pump Layout

•

Keypad Lock

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

Chapter 10 Options Menu and Chapter 11 Clinician Instructions

•

New Container

Repeats the current program without reprogramming the pump.

Chapter 2 Basic Operation

•

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

Chapter 6 Continuous and Chapter 8 mL/hr Only

•

Power-on Self-test

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

Chapter 2 Basic Operation

•

Operation Test

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

Chapter 14 Operation Test

•

Program History

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.

Chapter 10 Options Menu

•

Speed Protocols

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

Chapter 10 Options Menu

GemStar™ Manual 430-10983-002 (Rev. 07/06)

1. Introduction

Menu System The GemStar™ Pump uses a menu system that provides step-by-step instructions through all of the pump’s functions. Refer to the following table for a list of functions in each menu. Use the keypad to select menu items, respond to display messages, and enter numeric values. For example, press [2] to select PAIN MANAGEMENT from the Programming Menu.



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



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

GemStar™ Manual 430-10983-002 (Rev. 07/06)

7

1. Introduction

To display this menu:

Do this:

Programming Menu

1 2

Menu Items Available

Press CHANGE to display the Change menu. Select NEW PROGRAM.

1 2 3 4 5 6 7

TPN PAIN MANAGEMENT INTERMITTENT CONTINUOUS WEIGHT DOSED mL/HR ONLY VARIABLE TIME

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 CHANGE .

1 2 3 4

NEW CONTAINER NEW PROGRAM CHANGE PROGRAM PIGGYBACKING

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

3 TITRATE VTBI will replace

3 CHANGE PROGRAM on the menu display.

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

8

Press

.

1 2 3 4 5 6 7 8

REVIEW PROGRAM HISTORIES KEYPAD LOCK PUMP SETTINGS SET CLOCK PRINT SPEED PROTOCOL NEXT DOSE

GemStar™ Manual 430-10983-002 (Rev. 07/06)

1. Introduction

For more information on:

Refer to the following pages:

Programming Menu

Chapter 2 Basic Operation, page 19.

Change Menu

For menu item [1], refer to Starting a New Container in Chapter 2 Basic Operation, on page 32. For menu items [2], [3], and [4], refer to the appropriate therapy chapter.

Options Menu

Chapter 10 Options Menu, page 107.

Operating Modes The GemStar™ Pump has four operating modes: Mode

Description

Help Mode

is pressed during The pump enters the HELP mode when programming or an alarm condition. The HELP mode displays additional information about the current condition.

Programming Mode

The pump enters the PROGRAMMING mode after the pump is powered on or when CHANGE is pressed.

Run Mode

After is pressed, the pump enters the RUN mode, even when not infusing.

Stop Mode

When programming is complete, the pump enters the STOP mode until is pressed.

START

START

When the programmed therapy is complete, and during certain alarm conditions, the pump automatically enters the STOP mode. Press to enter the STOP mode at any time, except during a CHECK CASSETTE alarm.

GemStar™ Manual 430-10983-002 (Rev. 07/06)

9

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. The epidural route is recommended to provide anesthesia or administer analgesia for periods up to 96 hours. Note: Epidural administration of anesthetics is recommended in the continuous mode only. Epidural administration of analgesics may be delivered by continuous, bolus, or continuous with bolus.



For epidural use, the administration of drugs is restricted to those anesthetic and analgesic drugs approved for continuous epidural administration: e.g., Chloroprocaine Hydrochloride USP, Lidocaine Hydrochloride USP, and Morphine Sulfate Injection USP (Preservative Free). WARNING: Delayed respiratory depression following continuous epidural administration of preservative-free morphine sulfate has been reported. For epidural administration, the following is recommended:   

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

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.



10

GemStar™ Manual 430-10983-002 (Rev. 07/06)

1. Introduction

Contraindications for Use Persons who do not have the mental and physical capability or the emotional stability to properly use the GemStar™ Pump should not operate this pump. DO NOT use the following with the GemStar™ Pump System:  Drugs not compatible with silicone rubber or PVC plastic  Drugs not stable under infusion conditions

Warnings and Cautions Pay attention to the following warnings and cautions when operating the GemStar™ Pump. These warnings and cautions are repeated in the manual when relevant to the procedure being discussed. Pay attention to all alert messages. General Warnings and Cautions  Federal (USA) law restricts this device to sale by or on the order of a physician or other licensed practitioner.  Manual references to specific values are approximate only, unless indicated otherwise. Air-in-line sensitivity values are approximate only.  When a proximal occlusion alarm activates, DO NOT power-off the pump.  Closely supervise patients who are likely to be adversely affected by unintended operations and failures, including interrupted medication or fluid infusion. Ensure provisions for immediate corrective action are available. Regarding Drugs Used, Pump Sets, and Containers  USE ONLY GemStar™ Pump Sets with the GemStar™ Pump. Use of unauthorized sets may result in injury to the patient or damage to the pump.  Some microbore tubing delivery accuracy may be affected when used at extreme operating temperatures (<10°C, >35°C), relative humidity (<20%) and delivery rates (<4.9 mL/hr, >350 mL/hr). Refer to individual set labels for specific instructions and operating conditions.  Delivery accuracy may be impacted when there is air present in the cassette. Follow the instructions in the individual set labels to remove any visible air from the cassette.  Ensure slide clamp or lower CAIR® clamp is open prior to inserting cassette.  When using pre-filled vials, ensure vial and injector are securely locked in lockbox before beginning delivery. GemStar™ Manual 430-10983-002 (Rev. 07/06)

11

1. Introduction   

  





    

   

12

A cracked vial might not show evidence of leakage until delivery pressure is applied. When using nonvented syringes, the system may underdeliver. System delivery accuracy could be reduced by as much as 5%. When using PCA vials (except in a lockbox with a spring assist mechanism), the system may underdeliver. System delivery accuracy could be reduced by as much as 5%. When using viscous fluids, the system may underdeliver. System delivery accuracy could be reduced by as much as 5%. Variations in filling head (such as container height) may affect delivery accuracy by no more than 5%. When using the GemStar™ Spring Assist Mechanism (SAM) Lockbox, USE ONLY GemStar™ Pump sets designated for use with the GemStar™ SAM Lockbox. Failure to use designated sets could result in unrestricted flow. NEVER use drugs that are incompatible with silicone rubber or PVC plastic, (unless these items are specially treated and labeled to be compatible with such drugs). To reduce the loss of potency for drugs known to be absorbed by PVC plastic and silicone, begin infusion as soon as practical after priming the pump set. Use of high flow rates during infusion will minimize drug absorption. DO NOT use medications that are unstable under infusion conditions. ALWAYS use connections with Luer Lock™ fittings. To prevent contamination, use aseptic technique with all fluid-path connections. Remove the protective coverings as assembly progresses. ALWAYS place the flow stop in the closed position when the set is not in the pump. Before installing the cassette in the pump, ensure all slide or lower CAIR® (roller) clamps are open. Failure to open the slide or lower CAIR® (roller) clamps BEFORE installing the cassette may result in restricted flow. DO NOT back-prime the pump set using a syringe. Back priming may result in restricted flow. Ensure the cassette is properly installed. When properly installed, all four cassette latches are visibly holding the cassette securely in the cassette pocket. Ensure the tubing is behind the tubing guide (at the distal end). Arrange tubing, cords, and cables to minimize the risk of patient strangulation or entanglement.

GemStar™ Manual 430-10983-002 (Rev. 07/06)

1. Introduction 

     

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.

Regarding Air-In-Line and Infusion  To reduce the risk of infusing air, use an air-eliminating filter when the air sensitivity is set to OFF.  ALWAYS prime the pump set to remove all air from the cassette, tubing, and injection site prior to connecting to the patient.  ALWAYS disconnect the pump set from the patient prior to priming or purging. Regarding Pump Operation  If the pump does not perform as stated in this manual, remove the pump from service IMMEDIATELY.  If the pump does not display the self-test or if beeps do not sound at power-on, check all power connections and install two fresh, disposable AA batteries. If the problem continues, contact Hospira Technical Support Operations before using the pump.  Ensure a cassette is installed in the pump before connecting to a printer or computer. If the pump is connected to a patient: BEFORE connecting the pump to a computer or printer, press [STOP], close the slide clamp, and eject the cassette. Leave the pump set connected to the patient. Install another cassette in the pump before connecting to a printer or computer.  Disconnect the pump from the patient BEFORE performing the Operation Test.

GemStar™ Manual 430-10983-002 (Rev. 07/06)

13

1. Introduction 

  



 



   

14

ALWAYS connect to a grounded AC mains power source when using AC mains power. If the quality of the grounding source is in doubt, operate the pump only with batteries. USE ONLY the AC mains adaptors specifically labeled for use with the GemStar™ Pump. USE ONLY the AC mains adaptor specifically labeled for use with the GemStar™ Pump to charge the battery pack. The GemStar™ AC mains adaptor is for use with the GemStar™ Pump or GemStar™ Rechargeable Battery Pack only. DO NOT use the GemStar™ AC mains adaptor with other products. During charging, the battery pack is warm. If the rechargeable battery pack becomes hot to the touch, IMMEDIATELY unplug the AC mains adaptor and contact Hospira Technical Support Operations. Use only the Li-Ion Docking Station and Li-Ion Battery Pack with the GemStar™ Pump. With the Li-Ion Battery Pack, the LED indicator flashes yellow/green when an error condition has occurred or when the temperature is too high to charge the battery pack. In temperatures above 95°F (35°C), cycle AC power to confirm if battery is charged or if error condition exists. If LED flashes green/yellow, do not rely on external battery. Move device to cooler temperature and recharge prior to use. Refer to the battery pack insert for important information and precautions regarding activating and charging the Li-Ion Battery Pack. When removing the cord (from the docking station, bottom of the battery pack, or bottom of the pump), firmly grasp the connector and pull straight out. DO NOT twist or bend the cord or connector. To ensure proper pump operation, ALWAYS replace BOTH disposable batteries with fresh, disposable AA batteries when a change is required. ALWAYS fully close the battery door when using disposable batteries. DO NOT use rechargeable batteries in the battery compartment. Ensure two fresh, disposable AA batteries are installed for backup power when using other external power sources (e.g., AC mains adaptor, docking station, battery pack). The pump will continue to operate on backup power if the external power source fails. In the event that the internal batteries are removed while the pump is operating, the power loss event may not be logged in the history, the programmed therapy may not be retained, and the alarms (audible and visual) may not occur.

GemStar™ Manual 430-10983-002 (Rev. 07/06)