Abbott Gemstar User manual

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ABBOTT

System Operating Manual

For use with the

Abbott GemStar Pump

List 13000-36

ABBOTT LABORATORIES, NORTH CHICAGO, IL 60064, USA

430-600095-002 (Rev. 8/02)

Abbott GemStar™Pump

System Operating Manual

For use with the

Abbott GemStar Pump

List 13000-36

PLEASE

Read this entire manual before

using the Abbott GemStar Pump

This manual is designed for use by healthcare professionals, caregivers, and patients.

For consultation and technical support, contact your local Abbott

Laboratories sales office.

This manual is designed for use with Abbott GemStar Pumps used in the United

Kingdom, Australia, and other English-speaking countries.

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) i

Change History

Part Number Description of Change Pages Changed

430-600095-001 (Rev. 3/00)

430-600095-002 (Rev. 8/02)

Original Release N/A

Second Release N/A

ii Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Contents

Introduction 1

Abbott GemStar Pump Layout ......................... 2

Abbott GemStar Pump Components ...................... 4

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

Abbott GemStar Pump Features ........................ 6

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

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

Abbott GemStar Pump Set ........................... 8

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

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

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

System Setup 15

Setup Overview ................................ 15

Selecting a Power Source ........................... 15

Priming an Abbott GemStar Pump Set .................... 18

Loading the Cassette ............................. 26

Releasing the Cassette ............................ 27

Basic Operation 29

Quick Start ................................... 29

Operating Tips ................................. 29

Powering On the Pump ............................ 30

Accessing the Programming Menu ...................... 30

Programming the Pump ............................ 31

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

Weight Dosed 33

Therapy Features and Specifications ..................... 33

Weight Dosed Programming .......................... 33

Auto KVO ................................... 34

Rate Titration ................................. 34

Changing a Weight Dosed Program ...................... 35

Weight Dosed Programming Worksheet .................... 36

Pain Management 37

Therapy Features and Specifications ..................... 37

Pain Management Programming ....................... 37

Bolus Delivery ................................. 38

Loading Dose Delivery ............................. 40

Changing a Pain Management Program .................... 41

Pain Management Programming Worksheet ................. 42

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) iii

mL/hr Only 43

Therapy Features and Specifications ..................... 43

mL/hr Only Programming ........................... 43

Auto KVO ................................... 43

Rate Titration ................................. 44

Piggybacking .................................. 44

Changing a mL/hr Only Program ....................... 47

mL/hr Only Programming Worksheet ..................... 48

Intermittent 49

Therapy Features and Specifications ..................... 49

Intermittent Programming ........................... 49

Intermittent Delivery Interruptions ....................... 51

Changing an Intermittent Program ....................... 53

Intermittent Programming Worksheet ..................... 54

Total Parenteral Nutrition (TPN) 55

Therapy Features and Specifications ..................... 55

TPN Programming ............................... 55

Changing a TPN Program ........................... 56

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

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

Continuous 59

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

Continuous Programming ........................... 59

Rate Titration ................................. 60

Piggybacking .................................. 60

Changing a Continuous Program ....................... 63

Continuous Programming Worksheet ..................... 64

Variable Time 65

Therapy Features and Specifications ..................... 65

Variable Time Programming .......................... 65

Variable Time Delivery Interruptions ..................... 66

Changing a Variable Time Program ...................... 66

Variable Time Programming Worksheet .................... 67

Options Menu 69

Overview .................................... 69

Tips for Using the Options Menu ....................... 69

Review Program ................................ 70

Histories .................................... 71

Keypad Lock .................................. 73

Change Pump Settings ............................ 75

Set Clock .................................... 77

iv Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Print ...................................... 77

Speed Protocol ................................ 78

Next Dose ................................... 79

Connecting to the Data Port .......................... 80

Clinician Instructions 85

Clinician Locking Sequence Instructions ................... 85

Program and Deliver a Clinician Activated Loading Dose ........... 86

Display Shift Totals .............................. 87

Troubleshooting 89

Alarm Messages ................................ 89

Alert Messages ................................ 94

Other Display Messages ............................ 97

Maintenance 99

Pump Storage ................................. 99

Cleaning and Disinfecting ........................... 99

Repair .................................... 101

Operation Test 103

Equipment Required ............................. 103

Test Setup .................................. 103

Performing the Operation Test ........................ 104

Printing Test Results ............................. 107

Operation Test Checklist ........................... 108

Optional System Components 109

Connecting the Bolus Cord .......................... 110

Recharging the Battery Pack ......................... 111

Using the Abbott GemStar Lockboxes .................... 112

Using the Abbott Carrying Cases ....................... 114

Using the Abbott GemStar Docking Station ................. 119

Pump Sets 121

Abbott GemStar Pump Specifications 123

Occlusion Information ............................ 126

Warranty 137

IEC Symbols inside back cover

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) v

Notes

vi Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Introduction

The Abbott GemStar™ Pump is a small and lightweight, single-channel infusion device that can be powered by AC mains adaptor, rechargeable battery pack, two disposable AA batteries, or the Abbott GemStar Docking Station. The Abbott GemStar Pump is designed for use in the home, in the hospital, or anywhere electronic infusion is required. When powered by batteries, the Abbott GemStar Pump is ideal for ambulatory patients.

The following conventions are used throughout this manual:

Convention Use Example

d f

[ALL CAPS]

ALL CAPS Display messages The pump displays END OF

WARNING: A WARNING message contains special safety emphasis and

must be observed at all times. Failure to observe a warning message is potentially life threatening.

CAUTION: A CAUTION usually appears in front of a procedure or statement. It

contains information that could prevent irreversible product damage or hardware failure. Neglecting to pay attention to a caution could result in serious patient or user injury.

Note: A NOTE provides information to help clarify a procedure or statement.

Tip: A TIP emphasizes a procedure or statement that makes the pump easier to use.

Keys

Press [YES/ENTER] to continue.

INFUSION.

Introduction

Abbott GemStar Pump Layout

SILENCE

ABBOTT

4 7

PURGE

STOP

2 5

START

6 89 0

HELP

POWER

BACK-UP

CHANGE

OPTIONS

YES

ENTER

2 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Introduction

1 DISPLAY

2 SILENCE

3 STOP

4 START

5 POWER INDICATOR

7 BACK-UP

8 CHANGE

9 OPTIONS

11 YES/ENTER

12 NO

13 HELP

14 PURGE

ON/OFF

Four-line display indicates the pump’s status.

•

Temporarily silences alarm.

•

Stops infusion.

•

Starts infusion.

•

Indicates the pump is powered by AC mains when lit continuously.

• Indicates the pump is powered by external batteries when flashing.

•

Powers the pump on or off.

•

Provides access to previous steps during programming.

• Exits Help, Change, and Options menus.

•

Provides access to these menu items from the STOP or RUN

• mode*:

1 Review/Resume 2 New Container 3 New Program

• Corrects an entry during a programming step.

• Provides access to these menu items from the STOP or RUN mode*:

1 Review Program 2 Histories 3 Keypad Lock 4 Pump Settings

•

Scrolls through display messages.

•

UP arrow enters a decimal point in numeric entries.

•

Responds “YES” to display questions.

•

Accepts entries and advances to the next step.

•

Responds “NO” to display questions.

•

Provides context-sensitive information during programming steps and alarm conditions.

•

Otherwise displays Shift Totals.

•

Clears an AIR-IN-LINE alarm.

•

Primes an Abbott GemStar Pump Set.

4 Change Program 5 Piggybacking

5 Set Clock 6 Print 7 Speed Protocol 8 Next Dose

Not all menu items are available with all modes. Refer to the appropriate section for more information.

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 3

Introduction

Abbott GemStar Pump Components

1 Bolus Button Press this button to initiate a bolus

2 Pole Clamp Track Use to connect to an optional pole

3 Cassette Release

Button

4 Power Connector Use to connect AC mains adaptor to

5 Data Port

Connector

6 Bolus Connector Use to connect a bolus cord to the

7 Tubing Channel Align pump set tubing in this channel.

8 Cassette Pocket Load the cassette into this pocket.

9 Battery Pack

Connector

10 Battery

Compartment

delivery if available in the current program.

clamp.

Push down on this button to release the cassette from the pump.

the pump.

Use to connect a printer or computer to the pump.

pump.

Use to connect the Abbott GemStar Rechargeable Battery Pack to the pump.

Install two fresh, disposable AA batteries in this compartment for battery power.

Top View

4 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Therapies

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

Therapy Possible Applications

AUTO KVO

TITRATION

PIGGY-

BACKING

Introduction

BOLUS

DOSE

TAPER UP /

DOWN

Weight Dosed Critical care, pediatrics

Pain Management Administration of

analgesics or anesthetics for patient-controlled pain management (PCA)

mL/hr Only Simple rate programming

Intermittent Interval-based therapies

such as antibiotics

TPN Total Parenteral Nutrition

fluid delivery

Continuous Delivery of mg, mcg, or

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

Variable Time Chronotherapy

Legend: • = Available

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

··

···

··

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 5

Introduction

Abbott GemStar Pump Features

Adjustable

•

Settings

Alerts and

•

Alarms

Audible Keypad

•

Response

Keypad Lock

•

New Container

•

Piggybacking

•

Power-on

•

Self-test

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.

Refer to the “Options Menu” section.

Refer to the “Troubleshooting” section.

Refer to Abbott GemStar Pump Layout in this section for keypad information.

Refer to the “Options Menu” and “Clinician Instructions” sections.

Refer to the “Basic Operation” section.

Refer to the appropriate therapy section.

Refer to the “Basic Operation” section.

•

Operation Test

•

Program History

•

Speed Protocols

Performs user-assisted tests to verify the pump is functioning 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.

Refer to the “Operation Test” section.

Refer to the “Options Menu” section.

6 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Menu System

The Abbott GemStar Pump uses a menu system that provides step-by-step guidance through all of the pump’s functions. Refer to the following table for a list of functions within each menu. Use the keypad to select menu items, answer display prompts, and enter numeric values as required.

Introduction

d f

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.

Programming Menu Select NEW PROGRAM from the Change Menu to access

1 WEIGHT DOSED 2 PAIN MANAGEMENT 3 ML/HR ONLY 4 INTERMITTENT 5 TPN 6 CONTINUOUS 7 VARIABLE TIME

Change Menu

1 REVIEW/RESUME 2 NEW CONTAINER 3 NEW PROGRAM 4 CHANGE PROGRAM 5 PIGGYBACKING

the Programming Menu. Refer to the “Basic Operation” section for more information on accessing the Programming Menu.

Press the number key corresponding to the therapy type to be programmed. For example, press [2] to select Pain Management.

Press [CHANGE] to access the Change Menu.

Press the number key corresponding to the desired Change Menu function.

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

Refer to the appropriate therapy section for instructions on entering a program.

For menu item [2], refer to Starting a New Container in the “Basic Operation” section for instructions.

For menu items [3], [4], and [5], refer to the appropriate therapy section for instructions.

Options Menu

1 REVIEW PROGRAM 2 HISTORIES 3 KEYPAD LOCK 4 PUMP SETTINGS 5 SET CLOCK 6 PRINT 7 SPEED PROTOCOL 8 NEXT DOSE

Press [OPTIONS] to access the Options Menu.

Press the number key corresponding to the desired Option Menu function.

Refer to the “Options Menu” section for instructions.

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 7

Introduction

Operating Modes

The Abbott GemStar Pump has four operating modes:

Help Mode

•

Programming Mode

•

Run Mode

•

Stop Mode

•

The pump enters the HELP mode when [HELP] is pressed while programming or during an alarm condition. The HELP mode displays additional information.

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

After [START] is pressed, the pump enters the RUN mode, even during periods of non-delivery.

When programming is complete, the pump enters the STOP mode until [START] is pressed to begin the programmed therapy.

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

Press [STOP] to enter the STOP mode at any time.

Abbott GemStar Pump Set

The Abbott GemStar Pump must be operated with an Abbott GemStar Pump Set, which is a sterile, single-use, disposable pump set.

STERILE

Fluid path and areas beneath undisturbed protective set covers are sterile and nonpyrogenic in the intact unit package.

Contact an Abbott Laboratories 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 by the therapy. To use an Abbott GemStar Pump Set, follow the instructions included with the set.

8 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

The basic components of the Abbott GemStar Pump Set are shown below:

Indications for Use

Physicians or certified, licensed healthcare professionals should always oversee infusions. Pump users should be under the supervision of a healthcare professional and should be instructed in using and troubleshooting the pump. Instruction should emphasize preventing intravenous (I.V.) related complications, including appropriate precautions to prevent accidental infusion of air.

Introduction

1 Piercing Pin

2 Proximal End

3 Cassette

4 Distal End

5 Tubing

6 Slide Clamp

7 Flow Stop

8 Secure Lock

9 Anti-Siphon

Valve

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.

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 9

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).

Introduction

WARNING: Delayed respiratory depression following continuous epidural

For epidural administration, the following is recommended:

administration of preservative-free morphine sulfate has been reported.

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. Supplies should include oxygen, naloxone, and other appropriate resuscitative drugs and equipment. Continuous monitoring (e.g., oximetry) is recommended for the patient during epidural administration, as well as frequent patient observation for side effects (for up to 24 hours) following completion of drug administration by the epidural route.

Contraindications for Use

The Abbott GemStar Pump should not be operated by persons who do not have the mental and physical capability or the emotional stability to properly operate this pump.

Drugs not compatible with silicone rubber or PVC plastic, or not stable under infusion conditions, should not be used with this system.

Warnings and Cautions

The following is a list of warnings and cautions that should be heeded when operating the Abbott GemStar Pump. Elsewhere in this manual, warnings and cautions that are relevant to the procedure being discussed are repeated. Pay attention to all alert messages.

General 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.

Disconnect the pump from the patient BEFORE connecting the pump to a computer or printer.

For those patients who are likely to be adversely affected by unintended operations and failures, including interrupted medication or fluid delivery from the device, close supervision and provision for immediate corrective action should be provided.

10 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Regarding Drugs Used, Pump Sets, and Containers

USE ONLY Abbott GemStar Pump Sets with the Abbott GemStar Pump. Use of

unauthorized sets may result in injury to the patient or damage to the pump. NEVER use drugs that are incompatible with silicone rubber or PVC plastic.

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 which are unstable under infusion conditions.

ALWAYS use connections with Luer Lock™ fittings.

Use aseptic technique with all fluid-path connections. Remove the protective

coverings as assembly progresses. ALWAYS close the slide clamps before removing the cassette from the pump.

Ensure the cassette is properly installed before using the pump.

Arrange tubing, cords, and cables to minimize the risk of patient strangulation or

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

administered are chemically and physically compatible. NEVER use vented fluid containers (e.g., glass or rigid plastic) unless suspended from a

pole. Stop infusion if signs or symptoms of infiltration occur.

In vitro studies have shown that infusing older units of additive solution packed red blood cells or frozen deglycerolized red blood cells at rates greater than 200 mL/hr may produce some level of hemolysis that may be considered clinically unacceptable.

Failure to use the anti-siphon valve may result in unrestricted flow.

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.

If the cassette is removed from the pump, ALWAYS disconnect the pump set from the patient and purge the line before restarting therapy.

Introduction

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 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.

ALWAYS set the Air Sensitivity to either ON or 2mL when using vented drip chambers.

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 11

Introduction

Regarding Pump Operation

If the pump does not perform as stated in this manual, remove the pump from service

IMMEDIATELY. 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 Abbott GemStar

Pump. Installing disposable batteries is recommended, regardless of the power source used,

to provide continuing operation if the external power source fails. ALWAYS replace BOTH batteries with new batteries when a change is required.

The use of rechargeable batteries in the battery compartment is NOT recommended.

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. 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.

Regarding Handling and Maintenance

Product damage may occur if proper care is not exercised during unpacking, installation, and use. Should the pump inadvertently be subjected to mishandling, check connections and programmed data to confirm no damage has occurred. Refer to the “Operation Test” section for further information.

ALWAYS fully close the battery door when using disposable batteries.

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

12 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Introduction

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

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

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.

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 Abbott Laboratories may result in product damage.

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

Pump to charge the battery pack. The Abbott GemStar AC Mains Adaptor is for use with the Abbott GemStar Pump or

Abbott GemStar Battery Pack only. DO NOT use the Abbott GemStar AC mains adaptor with other products.

During charging, the battery pack is warm. If the battery pack becomes hot to the

touch, IMMEDIATELY unplug the AC mains adaptor and contact Abbott Customer Support.

Please comply with local disposal and recycling regulations as appropriate for

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

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 13

Notes

14 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

System Setup

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

Abbott GemStar Pump

Appropriate power source

Appropriate Abbott GemStar Pump Set

Appropriate fluid container

Patient access device

Air-eliminating filters and extension sets may be added to the line as required by the therapy.

Note: Contact an Abbott Laboratories Representative for more information on selecting the appropriate pump set configuration.

Setup Overview

1 Select an appropriate power source. 2 Prime the pump set. 3 Load the cassette into the pump. 4 Select the appropriate optional system components, such as a bolus cord, as

required.

Selecting a Power Source

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

Abbott GemStar AC Mains Adaptor

Abbott GemStar Battery Pack

Two disposable AA batteries

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 15

System Setup

CAUTION: To ensure proper pump operation, ALWAYS replace BOTH batteries with

fresh, disposable AA batteries when a change is required.

Use of rechargeable batteries in the battery compartment is NOT recommended.

Installing disposable batteries is recommended, regardless of the power source used, to provide continuing operation if the external power source fails.

Installing Disposable Batteries

1 Flip up the tab of the battery

door (A) on the bottom of the pump.

2 While holding onto the tab,

turn the battery door counterclockwise (B) until it is released from the battery compartment. Pull the door free (C) and remove any existing batteries.

3 Install two fresh, disposable

AA batteries into the battery compartment. Ensure the negative and positive battery terminals are inserted according to the diagram at right.

4 Return the battery door to the

battery compartment (D).

5 Turn the battery door

clockwise (E). Ensure the battery door is secured under the slot. Snap the tab down to lock the battery door in place (F).

16 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Connecting the Rechargeable Battery Pack

To connect the battery pack:

1 Align the connectors on the top

of the battery pack (A) with the connectors on the bottom of the pump (B).

2 Snap the battery pack into place.

System Setup

To release the battery pack:

1 Press the release button (C) on

the battery pack.

2 Remove the battery pack from

the pump.

Connecting the Abbott GemStar AC Mains Adaptor

1 Connect the cord of the AC mains

adaptor to the connector labeled “3VDC” 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 Abbott GemStar Pump.

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 17

System Setup

Priming an Abbott GemStar Pump Set

The Abbott GemStar Pump Set must be primed to eliminate air from the cassette and tubing before loading into the pump.

WARNING:

CAUTION: USE ONLY Abbott GemStar Pump Sets with the Abbott GemStar Pump. Use

Note: Refer to the appropriate instructions included with the pump set for more information.

False occlusion alarms and fluid delivery inconsistencies may occur when pumping viscous fluids in microbore tubing at rates greater than 500 mL/hr.

Opening the Pump Set

1 Open the Abbott GemStar Pump Set package and

remove the contents.

Note: Packaging may differ from the diagram shown.

2 Remove the protective covers from the fluid container

administration port and the pump set.

ALWAYS remove 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. Arrange tubing, cords, and cables to minimize the risk of patient strangulation or entanglement.

Failure to use the anti-siphon valve may result in unrestricted flow.

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.

18 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Priming Pump Sets WITHOUT a Drip Chamber

System Setup

WARNING:

Failure to use the anti-siphon valve may result in unrestricted flow.

1 Push down on the flow stop to ensure the cassette

is in the open (priming) position.

2 Hold the flexible fluid container with the administration

port pointed toward the ceiling and insert the piercing pin.

3 Open the slide clamp.

4 Invert the cassette approximately 45°.

5 While holding the inverted cassette, squeeze or roll the

flexible fluid container to eliminate air from the container, cassette, and tubing.

6 If necessary, tap the cassette to eliminate any remaining

air bubbles.

7 Return the cassette to the upright position. Continue

priming until fluid fills the tubing.

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 19

System Setup

8 Push down on the flow stop to ensure the cassette

is in the closed position.

9 Insert the cassette into the cassette pocket. Refer to

“Loading the Cassette” on page 26.

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 Pump Sets WITHOUT a Drip Chamber Using the PURGE Key

WARNING:

Failure to use the anti-siphon valve may result in unrestricted flow.

1 Push down on the flow stop to ensure the cassette

is in the closed position.

2 Hold the flexible fluid container with the administration

port pointed toward the ceiling and insert the piercing pin.

3 Insert the cassette into the cassette pocket. Refer to “Loading the Cassette” on

page 26.

4 Press [PURGE]. PRIME THE SET? displays. Press [YES/ENTER].

5 While holding the flexible fluid container with the administration port pointing

toward the ceiling, press and hold [

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

PURGE].

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

CAUTION: When priming is complete, ensure no fluid flows at the distal end of

the pump set. If flow is observed, DO NOT use the pump set.

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

20 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Priming Pump Sets WITH a Drip Chamber

System Setup

WARNING:

Failure to use the anti-siphon valve may result in unrestricted flow.

ALWAYS set the Air Sensitivity to either ON or 2mL when using vented drip chambers.

1 Push down on the flow stop to ensure the cassette

is in the open (priming) position.

2 Close the CAIR® (roller) clamp.

3 Insert the piercing pin into the container. Suspend the

container on an I.V. Pole.

4 Squeeze the drip chamber until filled halfway.

5 Invert the cassette approximately 45°.

6 Open the CAIR® (roller) clamp.

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 21

System Setup

7 If necessary, tap the cassette to eliminate any remaining

air bubbles.

8 Return the cassette to the upright position. Continue

priming until fluid fills the tubing.

9 Push down on the flow stop to ensure the cassette

is in the closed position.

10 Insert the cassette into the cassette pocket. Refer to

“Loading the Cassette” on page 26.

CAUTION: When priming is complete, ensure no fluid flows at the distal end of

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

the pump set. If flow is observed, DO NOT use the pump set.

22 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Priming Pump Sets WITH a Drip Chamber Using the PURGE Key

System Setup

WARNING:

Failure to use the anti-siphon valve may result in unrestricted flow.

ALWAYS set the Air Sensitivity to either ON or 2mL when using vented drip chambers.

1 Push down on the flow stop to ensure the cassette

is in the open (priming) position.

2 Close the CAIR® (roller) clamp.

3 Insert the piercing pin into the container. Suspend the

container on an I.V. Pole.

4 Squeeze the drip chamber until filled halfway.

5 Open the CAIR

(roller) clamp.

6 Insert the cassette into the cassette pocket. Refer to

“Loading the Cassette” on page 26.

7 Press [PURGE]. PRIME THE SET? displays. Press

[

YES/ENTER].

8 Press and hold [PURGE].

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

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

CAUTION: When priming is complete, ensure no fluid flows at the distal end of the

PURGE].

pump set. If flow is observed, DO NOT use the pump set.

9 Connect the pump set to the patient-access device

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 23

System Setup

Priming Pump Sets with Extensions

WARNING:

Failure to use the anti-siphon valve may result in unrestricted flow.

1 Push down on the flow stop to ensure the cassette

is in the open (priming) position.

2 Hold the flexible fluid container with the administration

port pointed toward the ceiling and insert the piercing pin.

3 Open the slide clamp.

4 Invert the cassette approximately 45°.

5 While holding the inverted cassette, squeeze or roll the

flexible fluid container to eliminate air from the container, cassette, and tubing.

6 If necessary, tap the cassette to eliminate any remaining

air bubbles.

7 Return the cassette to the upright position. Continue

priming until fluid fills the tubing.

24 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

System Setup

8 Push down on the flow stop to ensure the cassette

is in the closed position.

9 Insert the cassette into the cassette pocket. Refer to “Loading the Cassette” on page

26.

Note: Extension set with anti-siphon valve must be attached before patient-use.

10 Connect the extension set to the pump set (refer to the instructions that come with

the pump set).

11 Press [PURGE]. PRIME THE SET? displays. Press [YES/ENTER].

12 Press and hold [PURGE].

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

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

CAUTION: When priming is complete, ensure no fluid flows at the distal end of

13 If extension set has a Y-extension, prime it if needed. 14 Connect the pump set to the patient-access device.

PURGE].

the pump set. If flow is observed, DO NOT use the pump set.

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 25

System Setup

Loading the Cassette

1 Align the cassette as shown. 2 Insert the cassette into the

cassette pocket.

3 Push the cassette into the

pocket until it is firmly seated. When properly installed, the cassette cannot be removed from the pocket unless the cassette release button is pushed.

CAUTION: Ensure the cassette is

properly installed.

4 Align the tubing in the tubing

channel.

CAUTION: Before connecting to

the patient-access device, ensure no fluid flows at the distal end of the pump set while the pump is in the mode. If flow is observed, DO NOT use the pump set.

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

STOP

26 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Releasing the Cassette

System Setup

1 Close the slide clamp or CAIR

distal line.

2 Push down on the cassette release button on the top of

the pump.

3 Remove the cassette.

Note: When the cassette is released from the pump, the cassette flow stop automatically reverts to the closed position, preventing free flow.

(roller) clamp on the

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 27

Notes

28 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Quick Start

To start a therapy:

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

worksheet (that may be copied) to record the program settings.

2 Set up the pump and prime the cassette. Refer to the “System Setup” section. 3 Power-on the pump and access the Programming Menu. Refer to Powering On the

Pump in this section.

4 Select the therapy type and follow the display prompts to enter the program.

Refer to the appropriate therapy section for detailed instructions.

5 Press [START] to begin delivery.

Basic Operation

Tip: To enter a new program when the pump is already powered on: (1) Press [

STOP] to place the pump in STOP mode, (2) press [CHANGE] to access the

Change Menu, and (3) select pump displays the Programming Menu.

Operating Tips

Many of the pump’s functions advance to the next step automatically when the display prompt is answered. Use the number keys to enter requested values, then press [

YES/ENTER] to advance to the next step. The following keys are useful during

programming:

[HELP] During programming and alarm conditions press [HELP] to display

[CHANGE]

[BACK-UP] Press [BACK-UP] to return to a previous display, to exit OPTIONS,

Note: To power-off the pump, press and HOLD until the display clears.

NEW PROGRAM. The current program clears and the

information about the current condition. Otherwise press [HELP]to display shift totals.

Press the up or down arrow to scroll through long display messages. Press the up arrow to insert a decimal point in a numeric value.

If you enter an incorrect numeric value during programming, press [CHANGE] before pressing [YES/ENTER] to reset the value to zero.

or to exit the HELP mode.

ON/OFF

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 29

Basic Operation

Powering On the Pump

CAUTION: If the self-test does not display or if beeps do not sound at power-on,

contact Abbott Customer Support before using the pump.

1 Press [ ] to power-on the pump. The pump

ON/OFF

completes a self-test and displays the currently set time. No response is required. If the set time is not correct, refer to Setting the Clock in the “Options Menu” section.

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 evaluates the available power source(s). Respond to the display message

as described in the following table:

Display Message Power Source(s) User Response

No message displays AC power and disposable

LOW BATTERIES

ENTER TO CONFIRM

NO INTERNAL BATT

NO POWER LOSS

ALARM AVAILABLE

ENTER TO CONFIRM

USING BATTERIES

ENTER TO CONFIRM

USING EXT BATT

ENTER TO CONFIRM

batteries

AC power and low voltage disposable batteries; or low voltage disposable batteries only

No disposable batteries or dead disposable batteries; and external power

Disposable batteries only

Docking station battery or battery pack; and disposable batteries

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

Press [YES/ENTER] to confirm.

Power-off the pump and install two fresh disposable AA batteries to ensure backup power source.

Press [YES/ENTER] to confirm.

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

Press [YES/ENTER] to confirm.

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

Press [YES/ENTER] to confirm.

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

GEMSTAR 7

UNIT SELF-TEST

TIME IS 10:00 A M

FRI, 1 JAN 99

Accessing the Programming Menu

After powering on, the pump determines if a program is currently stored in its memory. Respond to the display message as described in the following table:

30 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Display Message Condition User Response

To enter a new program:

No message; the pump

displays the

Programming Menu.

CURRENT THERAPY:

(type of therapy)

USE CURRENT?

YES OR NO

Pump memory is clear.

A program is currently stored in pump memory.

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

To continue the current program:

Press [YES/ENTER].

Note: A program review is required if the pump has been powered off for 5 or more minutes.

To reset the current program:

1. Press [YES/ENTER].

2. Press [CHANGE] to access the Change Menu.

Refer to Starting a New Container on the following page.

Note: If the pump has been powered off for 5 or more minutes, the Change Menu displays automatically.

ä To enter a new program:

1. Press [NO]. CLEARING PROGRAM displays.

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

Programming the Pump

The pump’s menu system provides step-by-step guidance through the programming process. Refer to the appropriate therapy section for more information on programming the pump.

Basic Operation

1 Select the desired therapy from the Programming Menu. 2 Enter the requested parameters as prompted. Refer to the appropriate therapy

section for a programming worksheet.

Note: Program parameters can be changed at any time until the Program Review is complete. Press [ desired. Changing some parameters may require new entries for subsequent program displays.

BACK-UP] to return to previous program displays and make changes as

3 Review the program, if required. Press [YES/ENTER] when done. 4 SAVING PROGRAM displays and the program is stored in the pump’s memory, then

the pump enters the

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 31

Tip: If you enter an incorrect numeric value during programming, press [CHANGE] BEFORE pressing [ value.

STOP mode.

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

Basic Operation

Starting a New Container

Note: The NEW CONTAINER function is not available when the pump is in FULL Lock. Refer to the “Options Menu” section for more information on locking the keypad.

To repeat the current program with a new container:

1 From the STOP mode, press [CHANGE] to access the Change Menu. 2 Select NEW CONTAINER from the Change Menu. NEW CONTAINER displays for

several seconds and the amount infused clears from the pump’s memory.

3 Review the program. 4 Press [START] to begin delivery.

32 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Weight Dosed

Therapy Features and Specifications

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

Programming ranges are listed in the programming worksheet included in this

section. If a number outside of the acceptable program range is entered, an error message displays the minimum or maximum value allowed.

The air sensitivity in a Weight Dosed program is automatically set to ON. This setting

may be changed through the Options Menu after programming is complete. Refer to Air Sensitivity in the “Options Menu” section for more information.

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

(Volume To Be Infused) has completed. The rate can be titrated while the pump is infusing.

WARNING:

ALWAYS set the Air Sensitivity to either ON or 2mL when using vented drip chambers.

Weight Dosed Programming

1 Select WEIGHT DOSED from the Programming Menu. 2 Select the unit of measure. 3 Enter the patient weight, if required.

Note: Total concentration is ALWAYS entered as mg in mL, even if mcg is the selected unit of measure.

4 Enter the concentration as mg in mL:

Tip: Use [ ] to toggle between mL and mg.

•

Enter the value in mg when “mg” flashes on the display.

•

Enter the value in mL when “mL” flashes on the display.

•

Press [YES/ENTER] to confirm.

5 Enter the rate.

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

6 Enter the VTBI. 7 Review the program.

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 33

Weight Dosed

WARNING: IIf the cassette is removed from the pump, ALWAYS disconnect

Auto KVO

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

the pump set from the patient and purge the line before restarting therapy.

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 greater than or equal to 1 mL/hr, the Auto KVO delivers at 1 mL/hr. If the weight dosed rate is less than 1 mL/hr, the Auto KVO delivers at the same rate.

Rate Titration

To titrate the rate while the pump is infusing:

1 In the RUN mode, press the numeric keys corresponding to the new rate. The rate

flashes on the display. Press [

For example: if the current rate is 4.0 mg/kg/hr, press [ the rate to 5.0 mg/kg/hr.

Press [ ] to enter the rate in mL. When using units other than mL, the pump automatically adjusts the mL/hr value.

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

2 NEW RATE displays with the new value.

•

Press [YES/ENTER] within 10 seconds to accept the change and begin delivery at the new rate.

•

Press [NO] to continue delivery at the programmed rate.

YES/ENTER].

5][YES/ENTER] to change

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

34 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Changing a Weight Dosed Program

Weight Dosed

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

Can be changed at any time Cannot be changed

Delivery rate

• VTBI

• Patient weight

•

To change a program:

Unit of measure

• Concentration (amount of drug)

•

1 From the STOP mode, press [CHANGE] and select [4] CHANGE PROGRAM. 2 As each program parameter displays, make the desired changes or press

[

YES/ENTER] to accept the current setting.

3 Review the program. 4 Press [START] to begin delivery.

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 35

Weight Dosed

Abbott GemStar

™

Weight Dosed Programming Worksheet

GIVE:

Parameter Selections and/or Values to be

Entered

Therapy Weight Dosed N/A

Unit of Measure

Patient Weight

Concentration (2 entries are required. Use to

toggle)

Rate

VTBI (Volume To Be Infused)

mcg/kg/min

mcg/kg/hr

mcg/min

mg/kg/min

mg/kg/hr

mg/min

mL/hr

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

(For all units of measure EXCEPT mL/hr)

Programmable Ranges

N/A

2.0 - 200.0 kg

0.1 - 9999000 mg

0.1 - 9999 mL

(see below *)

0.1 - 9999 mL

* Programmable Ranges for Rate:

0.1 - 8333 mg/kg/min

0.1 - 500000 mg/kg/hr

0.1 - 16666 mg/min

0.01 - 166666 mcg/kg/min

0.01 - 9999999 mcg/kg/hr

0.01 - 166666 mcg/min

0.1 - 1000 mL/hr

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.

36 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Pain Management

Therapy Features and Specifications

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

Programming ranges are listed in the programming worksheet included in this

section. If a number outside of the acceptable program range is entered, an error message displays the minimum or maximum value allowed.

In Continuous + Bolus protocols, you may zero either the continuous rate or the

bolus when entering or changing a program. The continuous rate and bolus volume cannot be zero at the same time.

The default bolus delivery rate is 125 mL/hr.

A loading dose may be set during programming, which can be delivered after

programming and priming are complete. The loading dose rate is 125 mL/hr.

Note: The use of a lockbox is recommended with pain management protocols. Refer to "Using the Abbott GemStar Lockboxes" on page 106 for instructions on using a lockbox with the Abbott GemStar Pump.

Pain Management Programming

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

Note: If you select Continuous + Bolus, you can change the continuous delivery rate or bolus amount to zero through the

3 Select the unit of measure and concentration as required. 4 Set the continuous delivery rate.

Note: The pump only delivers in increments of 0.1 mL. Values entered in a Pain Management therapy may be rounded to the nearest 0.1 mL. For example, at a concentration of 15 mg/mL, a rate of 5 mg rounds to 4.5 mg.

5 mg = .333 mL

4.5 mg = .3 mL

When a value is rounded, the pump sounds four quick beeps, few seconds, and then the rounded value displays. Press [ rounded value and continue to the next step.

5 Program a loading dose as required.

CHANGE menu without reprogramming the pump.

ROUNDING displays for a

YES/ENTER] to accept the

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 37

Pain Management

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 may 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 Hour Dose Limit record, the pump accepts bolus requests or resumes continuous delivery (if programmed).

Note: If a 1-hour or 4-hour dose limit is programmed, a bolus in progress does not stop until the individual bolus volume has been delivered. Therefore, a bolus delivery initiated before the programmed dose limit is reached may exceed the dose limit at the completion of the bolus.

Loading doses are not included in the hour dose limit volume and a dose limit in effect does not prevent the delivery of a loading dose.

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

container size in proper unit measure or see the note below.

Note: In order 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. 9 Review the program.

WARNING: I

Bolus Delivery

Bolus doses and delivery limits are set during programming. The default bolus dose delivery rate in a pain management protocol is 125 mL/hr.

A bolus cord is available for patient bolus requests; refer to Connecting the Bolus Cord in the “Optional System Components” section for more information.

mL flashes on the display.

If the cassette is removed from the pump, ALWAYS disconnect the pump set from the patient and purge the line before restarting therapy.

38 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Pain Management

Delivering a Bolus Dose

From the button on the end of the bolus cord to begin bolus dose delivery. flashes on the display, and the amount infused accrues as the delivery progresses.

When the bolus dose is complete, the following will occur:

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

BOLUS DELIVERY

The bolus request and delivery amount are recorded to the event and bolus history logs.

Delivered boluses are added to the total bolus amount in the program amounts.

The bolus lockout time is reset (if applicable) and subsequent bolus requests are ignored until the lockout time has elapsed.

Programmed infusion continues.

Note: ALL bolus requests are recorded to the Event and Bolus History logs.

If the bolus delivery does not start, it may be locked out by one of the following conditions:

Bolus lockout period

Loading dose delivery in progress

Bolus dose delivery in progress

Bolus per-hour limit

1-hour or 4-hour dose limit

Bolus Dose Interruptions

Bolus deliveries may be interrupted by pressing [

When [

START] is pressed again, COMPLETE BOLUS NOW? displays. Refer to the

following table for the appropriate response:

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

Deliver the remaining bolus amount

Clear the undelivered bolus amount

[YES/ENTER]

[NO]

STOP] or by an alarm condition.

The time of delivery completion

The time the bolus was interrupted

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 39

Pain Management

Loading Dose Delivery

A loading dose is set during programming and can be delivered after programming and priming are complete.

Note: Loading dose amounts are not included in a 1-hour or 4-hour limit.

Delivering a Loading Dose

1 After priming and programming are complete, press [START]. 2 DELIVER THE LOADING DOSE NOW? displays. Press [YES/ENTER] to begin

delivery.

When the loading dose is complete, the following will occur:

Programmed infusion begins automatically.

The dose amount is recorded to the history log.

The bolus lockout time is reset (if applicable) and subsequent bolus requests are ignored until the lockout time has elapsed.

Loading Dose Interruptions

Loading dose deliveries may be interrupted by pressing condition.

When the interruption is resolved, press [ displays. Refer to the following table for the appropriate response:

To do this: Press this key:

Deliver the remaining loading dose amount

Clear the undelivered loading dose amount

[STOP] or by an alarm

START]. COMPLETE THE LOADING DOSE?

[YES/ENTER]

[NO]

40 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Changing a Pain Management Program

Pain Management

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

RATE CHANGE Lock, the continuous delivery rate and bolus amount can be changed

within the set ranges.

Can be changed at any time Cannot be changed

Delivery rate

• Bolus

• Bolus lockout

•

Note: Although the delivery mode cannot be changed, if a Continuous + Bolus therapy is programmed, the continuous rate or bolus amount can be changed to zero. This function may be restricted by the minimum values set with a

To change a program:

Container size

• Air sensitivity

• Dose limit amount

•

RATE CHANGE Lock.

Delivery mode

• Unit of measure

• Concentration

• Dose limit type

•

1 From the STOP mode, press [CHANGE] and select [4] CHANGE PROGRAM. 2 As each program parameter displays, make the desired changes, or press

[

YES/ENTER] to accept the current setting.

3 Review the program. 4 Press [START] to begin delivery.

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 41

Pain Management

Abbott 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

Continuous

Bolus Only

Continuous + Bolus

Concentration:

q No

q Yes Amount:

mg/mL

mcg/mL

™

Programmable Ranges

N/A

0.1 - 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 - 2500 mg 0 - 25000 mcg 0 - 25.0 mL

Bolus Lockout

Optional Dose Limit

Container Size

Air Sensitivity

4-hour limit Amount:

1-hour limit Amount:

# boluses/hour Number:

No dose limit

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

On Alarms at approx. 0.5 mL of air

2 mL Alarms at approx. 2 mL of air

Off No alarm

minutes 5 - 999 min

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

Rate - 100 mL, 10000 mg, 100000 mcg*

1-12

For continuous plus bolus delivery.

0.1 - 99999 mg 1 - 9999000 mcg

0.1 - 9999 mL

N/A

42 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Therapy Features and Specifications

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

Programming ranges are listed in the programming worksheet included in this

section. If a number outside of the acceptable program range is entered, an error message displays the minimum or maximum value allowed.

The air sensitivity is automatically set to ON. This setting may be changed through

the Options Menu after programming is complete. Refer to Air Sensitivity in the “Options Menu” section for more information.

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

(Volume To Be Infused) is complete. The rate can be titrated while the pump is infusing.

An optional secondary container can be “piggybacked” on the primary container

during regular delivery using an Abbott GemStar Piggyback Pump Set. Refer to Piggybacking in this section for more information.

A program review is not required and is only available through the Change or Options

Menu.

mL/hr Only

WARNING:

ALWAYS set the Air Sensitivity to either ON or 2mL when using vented drip chambers.

mL/hr Only Programming

1 Select mL/hr Only from the Programming Menu. 2 Enter the rate. 3 Enter the VTBI.

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 43

Note: A program review is not required for mL/hr Only programs.

WARNING: I

If the cassette is removed from the pump, ALWAYS disconnect the pump set from the patient and purge the line before restarting therapy.

mL/hr Only

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 mL/hr Only rate is greater than or equal to 1 mL/hr, the Auto KVO delivers at 1 mL/hr. If the mL/hr Only rate is less than 1 mL/hr, the Auto KVO delivers at the same rate.

Rate Titration

To titrate the rate while the pump is infusing:

1 In the RUN mode, press the numeric keys corresponding to the new rate. The rate

flashes on the display. Press [

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

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

2 NEW RATE displays with the new value.

•

Press [YES/ENTER] within 10 seconds to accept the change and begin delivery at the new rate.

•

Press [NO] to continue delivery at the programmed rate.

Piggybacking

Piggybacking with the Abbott GemStar Pump requires the use of an Abbott 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.

YES/ENTER].

5][0][YES/ENTER] to change

YES/ENTER]. If no key is pressed within five seconds, the rate

WARNING:

The piggyback rate and piggyback VTBI display until the secondary container has been delivered. Then the primary delivery resumes automatically.

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

44 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

When using the pump for secondary delivery (piggybacking), ensure the fluids being administered are chemically and physically compatible.

Preparing for Secondary Delivery (Piggybacking)

1 Ensure a primary piggyback pump set

with a proximal Y-site backcheck valve is in place.

2 Use the extension hook from the

secondary pump set to suspend the primary container from the I.V. pole.

3 Prepare the secondary pump set

according to the instructions included with the set.

4 Attach a needle or blunt cannula (if

appropriate) and prime the secondary pump set.

5 Suspend the secondary container

from the I.V. pole.

mL/hr Only

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 pump set to

the proximal Y-site (or proximal port).

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 45

mL/hr Only

Programming a Secondary Delivery (Piggybacking)

Note: To distinguish the piggyback delivery from the primary delivery, down to completion. For example, a piggyback rate of 250 mL/hr with a remaining VTBI of 218.5 mL will display as shown.

Tip: Prepare and set up containers BEFORE programming the pump for piggyback delivery.

1 Press [CHANGE] and select [5] PIGGYBACKING from the Change Menu. 2 Enter the dose amount for the secondary container. 3 Enter the infusion time for the secondary container. 4 Open the slide clamp or CAIR® (roller) clamp on the tubing of the secondary set. 5 Press [YES/ENTER] to begin piggyback delivery.

Note: Primary flow stops until the secondary VTBI is delivered; then primary flow automatically resumes. 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 [5] PIGGYBACKING from the Change Menu. 2 Press [CHANGE] to reset the dose amount to zero. 3 Enter the new piggyback dose amount and press [YES/ENTER]. 4 Set the infusion time for the secondary container. 5 Press [YES/ENTER] to begin piggyback delivery.

PIGGYBACK displays and the piggyback VTBI counts

PIGGYBACK RATE 250.0 mL/hr VTBI 218.5 mL

UUUUU

Note: You must know the amount that has already been delivered. When the piggyback dose amount is changed, the pump begins a new VTBI countdown.

Canceling a Piggyback Delivery

1 Press [CHANGE] and select [5] PIGGYBACKING from the Change Menu. 2 Press [CHANGE] to reset the dose amount to zero. 3 Press [YES/ENTER] to cancel piggyback delivery.

46 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Changing a mL/hr Only Program

mL/hr Only

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

Can be changed at any time

Delivery rate

• Container size

• Piggybacking

•

To change a program:

1 From the STOP mode, press [CHANGE] and select [4] CHANGE PROGRAM. 2 As each program parameter displays, make the desired changes or press

[

YES/ENTER] to accept the current setting.

3 Press [START] to begin delivery.

Note: A program review is not required and is only available through the Change or Options Menu.

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 47

mL/hr Only

Abbott GemStar

™

mL/hr Only Programming Worksheet

GIVE:

Parameter Selections and/or Values to be

Entered

Therapy mL/hr Only N/A

Rate

VTBI

(Volume To Be Infused)

Programmable Ranges

0.1 - 1000 mL/hr

0.1 - 9999 mL

48 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Therapy Features and Specifications

This therapy allows programming of multiple doses at regular intervals.

Programming ranges are listed in the programming worksheet included in this

section. If a number outside of the acceptable program range is entered, an error message displays the minimum or maximum value allowed.

Optional KVO (Keep Vein Open) may be set during programming.

The pump may 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.

Intermittent Programming

1 Select INTERMITTENT from the Programming Menu. 2 Enter the dose amount. 3 Enter the infusion time for each dose.

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.

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

If no KVO is desired, press [

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.

2][0] if each dose is to deliver for 20 minutes.

2][0][0] to start a dose every two hours.

YES/ENTER] while the value displayed is zero.

Intermittent

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 49

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

8 Select the air sensitivity.

Intermittent

9 SET CALL BACK ALARM FOR NEXT DOSE? displays.

The pump may be disconnected from the patient between dose deliveries. The call back alarm can be set to alert the patient or caregiver to reconnect the pump before the next scheduled delivery begins. At the set time before each dose, the alarm sounds, silence the alarm for three minutes. Then reconnect the pump to the patient.

For example, press [ the next scheduled delivery.

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.

•

START flashes on the display, and the alarm LED flashes. Press [SILENCE]to

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

START]

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

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.

10 Confirm the displayed time is correct. Press [OPTIONS] to change the clock if

required.

11 The current time and START NOW? displays.

•

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

•

Press [NO] to set a delayed start time. SET START TIME displays. Enter the desired start time and press [

YES/ENTER] when done.

12 Review the program.

WARNING:

Tip: To use a delayed start without specifying a start time: (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 [ delivery.

If the cassette is removed from the pump, ALWAYS disconnect the pump set from the patient and purge the line before restarting therapy.

START] to begin

50 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Intermittent Delivery Interruptions

Missed Start Time

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

Refer to Next Dose in the “Options Menu” section more information. If the pump remains in the STOP mode and the first dose is missed, press [START]to

begin delivery immediately and all subsequent doses will be shifted. If the pump is programmed with a delayed start time and is then powered off before

[

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

start time.

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

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:

Intermittent

12123456789101112

Dose Delivered -

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 point where it was interrupted and all subsequent doses are shifted.

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 51

Intermittent

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 -

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 and all subsequent doses are shifted if necessary.

For example, in the following diagram, an intermittent dose was stared 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 -

When the dose is complete, the start time for the Next Dose displays. To change the start time refer to the “Options Menu” section.

Any missed Intermittent doses, except the first dose, are added to the end of the delivery schedule.

52 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Changing an Intermittent Program

Intermittent

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

Can be changed at any time

Dose parameters

• KVO rate

• Container size

• Air sensitivity

• Call back alarm

•

To change a program:

Can be changed if no dose is in progress

Next dose start time

•

Cannot be changed after [START] is pressed

Current time

•

1 From the STOP mode, press [CHANGE] and select [4] CHANGE PROGRAM. 2 As each program parameter displays, make the desired changes or press

[

YES/ENTER] to accept the current setting.

3 Review the program. 4 Press [START] to begin delivery.

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 53

Intermittent

Abbott GemStar

™

Intermittent Programming Worksheet

GIVE:

Parameters Selections and/or Values to be Entered Programmable Ranges

Therapy Intermittent N/A

Dose Amount

0.1 - 9600 mL

Infusion Time Per Dose

hrs:min 1 min - 24 hrs

Dose Frequency

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

1 - 999

0.1 -5.0 mL/hr

0.1 - 9999 mL

N/A

Number of Doses Per Container

KVO (Keep Vein Open)

Container Size*

Air Sensitivity

hrs:min

q No KVO Rate: 0.0

q Yes KVO Rate:

q On Alarms at approx. 0.5 mL of air

2 mL Alarms at approx. 2 mL of air

Off No alarm

Call Back Alarm

Start Time

The pump automatically calculates the minimum container size required to deliver the

Yes Alarm:

Start immediately after programming

Start time: Specify AM or PM if not 24-hour clock.

hrs:min before start

1 min - time between doses

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

number of programmed doses and KVO between doses. If KVO is desired before a delayed start, you must increase the container size to accommodate the desired KVO volume.

54 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Total Parenteral Nutrition (TPN)

Therapy Features and Specifications

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

Programming ranges are listed in the programming worksheet included in this

section. If a number outside of the acceptable program range is entered, an error message displays the minimum or maximum value allowed.

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

the rate of delivery 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 completed delivery.

Optional KVO (Keep Vein Open) may be set during programming.

TPN Programming

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

Maximum VTBI is 9600 mL minus any taper amount.

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

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 55

Note: Time is entered in hours:minutes. For one hour, press [1][0][0]; not [

6][0].

5 Enter the total time to infuse. 6 Enter the KVO rate. If no KVO is desired, press [YES/ENTER] while the value

displayed is zero.

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

7 Enter the container size (VTBI + KVO).

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

8 Select the air sensitivity. 9 Review the program.

WARNING: I

If the cassette is removed from the pump, ALWAYS disconnect the pump set from the patient and purge the line before restarting therapy.

Total Parenteral Nutrition (TPN)

Changing a TPN Program

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

Can be changed before [START] is pressed

VTBI

• Taper times

• Total TPN time

•

To change a program:

1 From the STOP mode, press [CHANGE] and select [4] CHANGE PROGRAM. 2 As each program parameter displays, make the desired changes or press

[

YES/ENTER] to accept the current setting.

3 Review the program. 4 Press [START] to begin delivery.

TPN Auto Taper Down

Auto Taper Down is only available 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 [STOP] during TPN delivery.

DO YOU WANT AUTO TAPERING? displays.

•

Press [NO] to return to the STOP mode and then, if desired, press [START]to resume therapy.

•

Press [YES/ENTER] to set Auto Taper Down.

2 Enter the Auto Taper Down time.

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

Can be changed at any time Cannot be changed

KVO rate

• Increase container size only

• Air sensitivity

•

Delivery mode

•

Note: Time is entered in hours:minutes. For one hour, press [1][0][0]; not [

6][0].

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

Taper Down.

56 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Total Parenteral Nutrition (TPN)

Abbott 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

Taper Down

Total Time to Infuse

Continuous

Continuous + Taper Down

Continuous + Taper Up

Continuous + Taper Up and Down

mL 1 - 9600 mL*

q No

q Yes

q No

q Yes

hrs:min 1 min - 24 hrs

hrs:min

Programmable Ranges

N/A

1 min - 3 hrs

1 min - 3 hrs**

KVO (Keep Vein Open)

No KVO Rate: 0.0

Yes KVO Rate:

1.0 - 5.0 mL/hr

Container Size (VTBI + KVO)

Air Sensitivity

On Alarms at approx. 0.5 mL of air

2 mL Alarms at approx. 2 mL of air

Off No alarm

mL 9999 mL max

N/A

* Maximum VTBI is 9600 mL minus any taper amount. ** Programmable ranges for taper down are 1 minute to 3 hours OR 2 times the remaining volume

divided by the continuous delivery rate, whichever is less.

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 57

Notes

58 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Therapy Features and Specifications

This therapy allows programming of a continuous delivery.

Programming ranges are listed in the programming worksheet included in this

section. If a number outside of the acceptable program range is entered, an error message displays the minimum or maximum value allowed.

Optional KVO (Keep Vein Open) may be set during programming.

The rate can be titrated while the pump is infusing.

An optional secondary container can be “piggybacked” on the primary container

during regular delivery using an Abbott GemStar Piggyback Pump Set. Refer to Piggybacking in this section for more information.

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. 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

YES/ENTER] while the value displayed is zero.

CONTAINER display.

Continuous

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 59

Note: If KVO is programmed, you must increase the container size to accommodate the KVO delivery.

In order to enter the total in mL when programming a concentration, press []to move to the mL line and enter the mL size.

7 Select the air sensitivity. 8 Review the program.

WARNING: I

If the cassette is removed from the pump, ALWAYS disconnect the pump set from the patient and purge the line before restarting therapy.

Continuous

Rate Titration

To titrate the rate while the pump is infusing:

1 In the RUN mode, press the numeric keys corresponding to the new rate. The rate

flashes on the display. Press [

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

YES/ENTER].

5][0][YES/ENTER] to change

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

2 NEW RATE displays with the new value.

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

•

the new rate. Press [NO] to continue delivery at the programmed rate.

•

Piggybacking

WARNING:

The piggyback rate and piggyback VTBI display until the secondary container has been delivered. Then the primary delivery resumes automatically.

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

YES/ENTER]. If no key is pressed within five seconds, the rate

When using the pump for secondary delivery (piggybacking), ensure the fluids being administered are chemically and physically compatible.

60 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Preparing for Secondary Delivery (Piggybacking)

1 Ensure a primary piggyback pump set

with a proximal Y-site backcheck valve is in place.

2 Use the extension hook from the

secondary pump set to suspend the primary container from the I.V. pole.

3 Prepare the secondary pump set

according to the instructions included with the set.

4 Attach a needle or blunt cannula (if

appropriate) and prime the secondary pump set.

5 Suspend the secondary container

from the I.V. pole.

Continuous

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 61

6 Connect the secondary pump set to

the proximal Y-site (or proximal luer port).

Continuous

Programming a Secondary Delivery (Piggybacking)

Note: To distinguish the piggyback delivery from the primary delivery, down to completion. For example, a piggyback rate of 250 mL/hr with a remaining VTBI of 218.5 mL will display as shown.

Tip: Prepare and set up containers BEFORE programming the pump for piggyback delivery.

Changing a Piggyback Delivery

PIGGYBACK displays and the piggyback VTBI counts

PIGGYBACK RATE 250.0 mL/hr VTBI 218.5 mL

UUUUU

Note: You must know the amount that has already been delivered. When the piggyback dose amount is changed, the pump begins a new VTBI countdown.

Canceling a Piggyback Delivery

1 Press [CHANGE] and select [5] PIGGYBACKING from the Change Menu. 2 Press [CHANGE] to reset the dose amount to zero. 3 Press [YES/ENTER] to cancel piggyback delivery.

62 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Changing a Continuous Program

Continuous

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

Can be changed at any time Cannot be changed

Delivery rate

• VTBI

• KVO rate

•

To change a program:

Container size

• Air sensitivity

• Piggybacking

•

Unit of measure

• Concentration

•

1 From the STOP mode, press [CHANGE] and select [4] CHANGE PROGRAM. 2 As each program parameter displays, make the desired changes or press

[

YES/ENTER] to accept the current setting.

3 Review the program. 4 Press [START] to begin delivery.

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 63

Continuous

Abbott GemStar

™

Continuous Programming Worksheet

GIVE:

Parameter Selections and/or Values to be

Entered

Therapy Continuous N/A

Unit of Measure

Rate

VTBI (Volume To Be Infused)

KVO (Keep Vein Open)

Concentration:

q No KVO Rate: 0.0

q Yes KVO Rate:

mg/mL

mcg/mL

Programmable Ranges

0.1 - 1000 mg/mL

1 - 1000 mcg/mL

0.1 - 9999 mg/hr 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

Container Size (VTBI + KVO)

0.1 - 99999 mg 1 - 9999000 mcg

0.1 - 9999 mL

Air Sensitivity

On Alarms at approx. 0.5 mL of air

2 mL Alarms at approx. 2 mL of air

Off No alarm

N/A

64 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Therapy Features and Specifications

This therapy allows programming of multiple doses at specified times.

Programming ranges are listed in the programming worksheet included in this

section. If a number outside of the acceptable program range is entered, an error message displays the minimum or maximum value allowed.

Optional KVO (Keep Vein Open) may be set during programming.

The default bolus delivery rate is 400 mL/hr.

Variable Time Programming

1 Select VARIABLE TIME from the Programming Menu. 2 Select the phase type. Press [1] for Percentages, [2] for Rates, or [3] for Doses. 3 Select the unit of delivery. 4 Change the displayed time if necessary. 5 Enter the optional base rate with start and stop time. 6 If programming in Rates or Doses, go to step 7. If programming in Percentages, set

the daily amount.

7 Enter the phase information for each phase. Up to 24 phases can be programmed.

Variable Time

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 65

Note: If programming in percentages, the total daily amount of all phases programmed must equal 100%.

8 Enter the optional bolus dose and its lockout. 9 Enter the optional KVO. 10 Enter the container size.

The pump calculates the minimum container size required to deliver the phases, base rate, and KVO for one day or in a 24-hour period. If delivering the protocol for more than one day, multiply this amount by the number of days of therapy.

Note: You must increase the container size to accommodate bolus deliveries.

11 Select the air sensitivity. 12 Review the program.

WARNING: I

If the cassette is removed from the pump, ALWAYS disconnect the pump set from the patient and purge the line before restarting therapy.

Variable Time

Note: With variable time programming, the pump keeps track of where it is in the program each minute of the entire 24-hour period. For example, if Phase 1 is missed, and the pump is placed in parameters from the middle of Phase 2.

RUN mode in the middle of Phase 2, it starts delivery according to the program

Variable Time Delivery Interruptions

If a phase is interrupted and the pump is placed in the RUN mode:

Before the end of the phase. The phase runs to its scheduled stop time.

After the end of the phase, but before the beginning of the next start time.

In the middle of a phase and the phase start was missed because of a program interruption or a missed program start.

Then:

The next phase begins delivery at the scheduled start time.

All applicable Base Rate or KVO delivery infuses while waiting for the start of the next phase.

The pump immediately begins delivery of the current phase at its current time-based point.

Changing a Variable Time Program

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

Can be changed at any time

Can ONLY be changed before [START] is pressed

Cannot be changed

•

KVO rate

•

Container size

•

Air sensitivity

•

Bolus

To change a program:

•

Current time

•

Base rate

•

Daily amount

•

Phase parameters

•

Unit of measure

•

Concentration

•

Phase type

1 From the STOP mode, press [CHANGE] and select [4] CHANGE PROGRAM. 2 As each program parameter displays, make the desired changes or press

[

YES/ENTER] to accept the current setting.

3 Review the program. 4 Press [START] to begin delivery.

Note: The container size cannot be made smaller than the daily total of phases, base rate, and KVO combined; or the current amount delivered, whichever is greater.

66 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Variable Time

Abbott GemStar

™

Variable Time Programming Worksheet

GIVE:

Parameter Selections and/or Values to be

Entered

Select Phase Type

Unit of Measure

Current Time Confirm or correct current time. 12:00 AM - 11:59 PM

Base Rate

Total Daily Amount for All Phases: __________ (required only when programming in percentages)

———- SEE ATTACHED WORKSHEET———-

Bolus Dose

Bolus Lockout

KVO (Keep Vein Open)

Percentages

Rates

Doses

Concentration:

q No

q Yes Start time:

Stop time: Rate:

No KVO Rate: 0.0

Yes KVO Rate:

mg/mL

mcg/mL

minutes 5 - 999 min

Programmable Ranges

0.1 - 100%*

0.1 - 400 mL/hr

0.1 - 9600 mL

0.1 - 1000 mg/mL 1 - 1000 mcg/mL

or 00:00 - 23:59

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

0.1 - 400 mL/hr

0.1 mL - 25.0 mL

0.1 mg - 2500 mg 1 mcg - 25000 mcg

0.0 - 5.0 mL/hr

Container Size (Total Daily Amount X Number of Days of Therapy)

Air Sensitivity

*Sum of all phases must equal 100% when programmed in percentages.

On Alarms at approx. 0.5 mL of air

2 mL Alarms at approx. 2 mL of air

Off No alarm

0.1 - 99999 mg 1 - 9999000 mcg

0.1 - 9999 mL

N/A

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 67

Variable Time

Phase Start Time Stop Time Percentage Rate Dose

TOTAL

Note: The sum of all phases must equal

100% when programmed in percentages.

68 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Overview

Options Menu

1 Press [OPTIONS] from the RUN or STOP mode. 2 Select the number key that corresponds to the

desired function.

3 Follow the display prompts for the selected function.

Refer to the appropriate Options Menu function description in this section for more information.

Note: Menu selections may vary depending on the configuration of the pump. Some Options Menu functions are not available in all modes.

Tips for Using the Options Menu

The following keys are helpful when using the Options Menu:

Press the corresponding number key to select a menu function.

viewing a display.

Press the up or down arrow to scroll through long display messages.

OPTIONS.

[1]-[8]

[YES/ENTER] Press [YES/ENTER] to accept changes, or to continue when done

[BACK-UP] Press [BACK-UP] to return to a previous display or to exit

Tip: A menu item does not have to be on the display to be selected. For example, only items 1 through 4 display when the Options Menu is first accessed. To select the Print Menu without scrolling the display, press [

1 REVIEW PROGRAM

2 HISTORIES

3 KEYPAD LOCK

4 PUMP SETTINGS

5 SET CLOCK

6 PRINT

7 SPEED PROTOCOL

8 NEXT DOSE

6].

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 69

Note: When the pump exits OPTIONS, the display returns to the mode the pump was in when the Options Menu was accessed.

Options Menu

Select this item from the Options Menu:

REVIEW PROGRAM

HISTORIES

KEYPAD LOCK

PUMP SETTINGS

SET CLOCK

SPEED PROTOCOLS

NEXT DOSE

To do this function: Comments:

Display the current program settings.

Display the history for the latest 400 events, shift or volume totals, bolus history (if available), or current configuration settings. Clear the history. Access the Operation Test.

Access the locking and unlocking functions to prevent unauthorized alteration of the infusion protocol.

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

Set the clock. The clock can be displayed in 12-hour

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

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

Change the start time of the next dose when an interruption has caused a missed dose in an intermittent program.

N/A

The lock levels allow the clinician to restrict access to various levels of pump operation. When the pump is locked under a particular level, a small lock symbol displays by the name of the applied lock level on the Keypad Lock Menu.

N/A

or 24-hour format.

Files may be downloaded to a printer or personal computer.

Allows up to 9 speed protocols to be saved in pump memory. Removing power has no effect on the Speed Protocol settings.

NEXT DOSE appears on the menu only when the pump is in an intermittent program and changing the next dose is allowed.

Review Program

1 Select REVIEW PROGRAM from the Options Menu;

PROGRAM REVIEW displays.

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

exit

OPTIONS.

Tip: PROGRAM REVIEW is also accessed by selecting Review/Resume from the Change Menu; or at power-on if a program is stored in the pump’s memory and the pump has been powered off for 5 or more minutes.

70 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

1 REVIEW PROGRAM

2 HISTORIES

3 KEYPAD LOCK

4 PUMP SETTINGS

5 SET CLOCK

6 PRINT

7 SPEED PROTOCOL

8 NEXT DOSE

Histories

1 Select HISTORIES from the Options Menu. 2 Select the number key that corresponds to the

3 Complete the appropriate steps for the selected

desired function.

function.

Options Menu

1 REVIEW PROGRAM

2 HISTORIES

3 KEYPAD LOCK

4 PUMP SETTINGS

5 SET CLOCK

6 PRINT

7 SPEED PROTOCOL

8 NEXT DOSE

Select this item from the Histories Menu:

HISTORY

SHIFT TOTALS

VOLUME TOTALS

CONFIGURATION

CLEAR HISTORY

BOLUS HISTORY

OPERATION TEST

To do this function: Display includes:

Display history event log of the latest 400 events.

Display or clear shift totals.

Display volume totals.

Display pump configuration.

Clear history event log and bolus history.

Display bolus history in hourly increments for the last 48 hours. Bolus History is available only when a bolus is programmed or has been programmed during the last 48 hours.

Perform user-assisted Operation Test.

Current date and time

• Date and time the program was

• cleared, a new container was selected, or a speed protocol was recalled

• History event log of the latest 400 events

• Time and date when shift was cleared

• Volume infused in the shift

• Any relevant program-specific information

• Amount infused

•

VTBI

•

Any relevant program-specific information

Dependent upon pump configuration

CLEARING HISTORY

displays for 3 to 4 seconds.

•

Current date and time

•

Number of boluses delivered

•

Number of bolus demands

•

Amount delivered through bolus delivery

•

Display messages guide the user through each section of the test

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 71

Options Menu

Display History, Shift Totals, Volume Totals, and Configuration

Note: Some menu items may not be available depending on the configuration of the pump.

1 Select the number key that corresponds to the desired

function.

2 Press [BACK-UP] when done to exit OPTIONS.

Note: For Shift Totals only, the pump displays CLEAR

TOTALS? YES OR NO

shift totals or press [

clearing the shift totals.

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

Clear History Event Log and Bolus History

1 Select CLEAR HISTORY from the Histories Menu. 2 CLEARING HISTORY displays for 3-4 seconds before the

pump exits

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

Display Bolus History

OPTIONS.

. Press [YES/ENTER] to clear the

NO] to exit OPTIONS without

VERSION N.NNN

S/N XXXXXXXX

TIME IS 09:00 AM

FRI, 11 JUN 99

NEW CONTAINER

08:15AM 11 JUN

HISTORY CLEARED

11:00PM 10 JUN

EVENT LOG

PM11:18 SET ON

AIR SENSITIVITY

PM11:18 SET CONT

SIZE 100 mL

PM11:18 SET RATE

1.0 mL/hr

PM11:18 SHIFT

CLEARED

END OF EVENT LOG

Sample History Event Log

1 Select BOLUS HISTORY from the Histories Menu. 2 Press [BACK-UP] when done to exit OPTIONS.

Note: Bolus History is only available if the current program has a bolus programmed, or had a bolus programmed at one time. The Bolus History is maintained in hourly increments for the latest 48 hours.

The Bolus History is cleared when a new program is entered, a Speed Protocol is recalled, or the History is cleared.

Operation Test

This function allows the testing of various pump operations to ensure the Abbott GemStar Pump is working properly. Refer to the “Operation Test” section for instructions.

72 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

TIME IS 09:15 AM

FRI, 11 JUN 99 BOL DEL NNNN BOL DEM NNNN BOL AMT XXXX.X mL

XX:XXM TO XX:XXM

Keypad Lock

1 Select KEYPAD LOCK from the Options Menu. 2 Select the desired lock level.

The following lock levels, listed from lowest to highest restrictions, are available:

Lock Level Abbreviation

Therapy Lock

Rate Change Lock

New Container Lock

Full Lock

The Abbott GemStar Pump allows two lock levels to be applied at the same time. Therapy Lock may be used with either Full Lock, New Container Lock or Rate Change Lock.

When two lock levels are applied, if a function is available under one lock level but not the other, the more stringent restrictions apply.

Options Menu

1 REVIEW PROGRAM

2 HISTORIES

3 KEYPAD LOCK

4 PUMP SETTINGS

5 SET CLOCK

6 PRINT

7 SPEED PROTOCOL

8 NEXT DOSE

1 THERAPY LOCK 2 RATE CHANGE 3 NEW CONTAINER 4 FULL LOCK

When the pump is locked under a particular level, a small lock symbol ( ) appears next to the applied lock level as shown above. When the pump is in

RUN or STOP mode, the

lock symbol appears in the lower left corner of the display and the lock level abbreviation appears in the lower right corner.

The table on the following page lists the functions available for each lock level. Refer to “Clinician Instructions” on page 85 for detailed instructions.

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 73

Options Menu

Abbott GemStar

U = Unlock T = Therapy Lock R = Rate Change Lock

Function U T R N F Comments

Lock/Unlock Keypad

Power Pump On or Off

Start or Stop Infusion

Access Display, Help, Print, and Program Review Functions

Deliver a Bolus

Silence an Alarm

Select a New Container

Purge

Change a Program

Review/Recall Speed Protocol

Assign or Delete Speed Protocol

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

Clear Shift Totals

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

Enter a New Program

Piggybacking

Rate Titration

Operation Test

Clear History

Select Another Therapy

™

Keypad Lock Level Functions

N = New Container Lock F = Full Lock

• = Function is Available

·····

Rate Change Lock is available only if the current program is Pain Management.

·····

If programmed.

·····

····

Under Rate Change Lock, only the delivery rate or

···

··

bolus dose volume can be changed and must be within the preset values.

Under Therapy Lock, the recalled protocol must be the same type that was programmed when the pump was locked.

··

····

··

Under Therapy Lock, the new program must be of the

··

same type that was programmed when the pump was locked.

··

74 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Change Pump Settings

1 Select PUMP SETTINGS from the Options Menu. 2 Select the number key that corresponds to the

desired pump setting.

3 Follow the display prompts. Refer to the

appropriate steps of the desired pump setting for more information.

Options Menu

1 REVIEW PROGRAM

2 HISTORIES

3 KEYPAD LOCK

4 PUMP SETTINGS

5 SET CLOCK

6 PRINT

7 SPEED PROTOCOL

8 NEXT DOSE

Select this item from the Pump Settings Menu:

AIR SENSOR

OCCL SENSOR

SOUND LEVEL

To do this function: Comments:

Change the air sensor sensitivity.

Change the distal occlusion sensor sensitivity.

Adjust the audible alarm level.

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

The air alarm may also be set during programming if the current therapy allows it. Removing power has no effect on the air alarm setting.

Default Setting: High The pump alarms when distal pressure is

greater than the selected occlusion sensor limit.

Default Setting: Maximum

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 75

Options Menu

Air Sensitivity

WARNING:

The current air sensitivity flashes on the display.

To reduce the risk of infusing air, use an air-eliminating filter when the air sensitivity is set to OFF.

1 Select the desired Air Sensitivity level:

If OFF is selected, AIR ELIMINATING FILTER IS

•

RECOMMENDED

If ON or 2mLis selected, CHANGE AIR ALARM

•

FROM XXXX TO XXXX

displays.

2 Select [YES/ENTER]or[NO]:

If [NO] is selected, the air sensitivity does not

•

change, the current air alarm status displays, and the pump exits

If [YES/ENTER] is selected, the new setting is

•

accepted, the air alarm status displays for approximately 3 seconds, before the pump exits

Occlusion Sensor

OPTIONS.

1 Select the desired setting. 2 MAKE XXXXX DEFAULT? displays. Select

[

YES/ENTER]or[NO].

•

If [NO] is selected, the distal occlusion setting is temporarily in effect until a new program is entered or the pump has been off for more than 24 hours.

•

If [YES/ENTER] is selected, the distal occlusion setting is permanent until the setting is changed again.

AIR SENSITIVITY 1ON 22mL 3 OFF

CHANGE AIR ALARM

FROM: XXXX

TO: XXXX

YES OR NO

OPTIONS.

DISTAL OCCLUSION 1 HIGH 2 MEDIUM 3 LOW

Sound Level

76 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

1 When the Sound Level function is accessed, the pump

sounds intermittent beeps at the current sound level. The blocks on the top line of the display indicate the current sound level. Use [ ] to increase the sound level. Use [ ] to decrease the sound level.

Tip: Press [CHANGE] to restore the sound level to the default setting.

2 Press [YES/ENTER] when done.

- nnnnnnnn +

USE st TO ADJUST THE SOUND LEVEL ENTER WHEN DONE

Options Menu

Set Clock

1 Select SET CLOCK from the Options Menu. 2 Select 12-Hour or 24-Hour format (24-Hour format

is shown in example).

3 Use the arrow keys to set the weekday and month. 4 Use the number keys to enter the current day, year,

and time.

Note: When entering the time in 12-Hour format, use

5 Press [YES/ENTER] to confirm.

Tip: To view the clock from the RUN or STOP mode, press [ HOLD [

WARNING: Disconnect the pump from the

Note: Ensure the printer is connected to the pump BEFORE selecting a print function. Refer to “Connecting to a Printer” in this section for more information.

1 Select PRINT from the Options Menu. 2 Select the number key that corresponds to the

desired print function.

3 When the print transmission is complete, the pump exits OPTIONS.

to toggle between AM and PM.

YES/ENTER], then immediately press and

1]. The clock displays until [1] is released.

patient BEFORE connecting the pump to a printer or computer.

1 REVIEW PROGRAM

2 HISTORIES

3 KEYPAD LOCK

4 PUMP SETTINGS

5 SET CLOCK

6 PRINT

7 SPEED PROTOCOL

8 NEXT DOSE

SET CLOCK TYPE

1 SELECT 12 HOUR 2 SELECT 24 HOUR

TIME IS 20:35

MON, 26 JUL 99

ENTER TO CONFIRM

1 REVIEW PROGRAM

2 HISTORIES

3 KEYPAD LOCK

4 PUMP SETTINGS

5 SET CLOCK

6 PRINT

7 SPEED PROTOCOL

8 NEXT DOSE

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 77

Options Menu

Select this item from the Print Menu:

PRINT HISTORY

PRINT PROGRAM

PRINT PROTOCOL

PRINT BOLUS Hx

STOP PRINT

Speed Protocol

1 Select SPEED PROTOCOL from the Options Menu. 2 Select the number key that corresponds to the

desired protocol function.

3 Follow the display prompts. Refer to the

appropriate Speed Protocol functions for more information.

To do this function:

Print the current program, shift and volume totals, and history event log up to the most recent 400 events since the history was last cleared.

Print the current program.

Print a specified speed protocol or a complete list of all speed protocols. If a protocol is not assigned, NOT ASSIGNED prints next to that protocol number.

Print the current program, shift and volume totals, and the bolus history (Hx) for the latest 48 hours, when the current program has a bolus programmed or had a bolus programmed at one time.

Cancel the print function. This function is only available if you have selected one of the print functions above.

1 REVIEW PROGRAM

2 HISTORIES

3 KEYPAD LOCK

4 PUMP SETTINGS

5 SET CLOCK

6 PRINT

7 SPEED PROTOCOL

8 NEXT DOSE

Select this item from the Speed Protocol Menu:

ASSIGN

REVIEW/RECALL

DELETE

To do this function:

Store a program in pump memory for later use.

Review assigned protocols from the RUN or STOP mode. Recall an assigned protocol from the STOP mode.

Delete protocols from pump memory.

78 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Assign

1 Select ASSIGN from the Speed Protocol menu. 2 Select [1]-[9] to assign to the new protocol.

Options Menu

If the selected speed protocol is already assigned,

ASSIGNMENT?

•

Review/Recall

1 Select REVIEW/RECALL from the Speed Protocol menu. 2 Select the desired protocol to review/recall. 3 Review the program. 4 Press [YES/ENTER]:

•

Delete

1 Select DELETE from the Speed Protocol Menu. 2 Select the desired protocol to delete. 3 Press [YES/ENTER] to confirm deletion, or [NO] to exit OPTIONS without deleting.

Next Dose

This function is only available when the current therapy is Intermittent and the pump is not delivering a dose.

To set the time for the next dose:

1 Select NEXT DOSE from the Options Menu. 2 Use the number keys to enter the start time for the

next dose. Press [ accept the change and exit

REPLACE PROTOCOL

displays.

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

Press [NO] to keep the existing protocol and exit OPTIONS.

If in the STOP mode, select [1] to recall the protocol; or select [2] to review another protocol.

If in the RUN mode, the pump exits OPTIONS.

OPTIONS.

YES/ENTER] when done to

OPTIONS.

1 REVIEW PROGRAM

2 HISTORIES

3 KEYPAD LOCK

4 PUMP SETTINGS

5 SET CLOCK

6 PRINT

7 SPEED PROTOCOL

8 NEXT DOSE

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 79

Tip: Use to toggle between AM and PM.

Options Menu

Connecting to the Data Port

The Data Port may be used to connect the Abbott GemStar Pump to a Seiko® DPU 414 or compatible serial printer to print the Operation Test results or the files available from the Print Menu. Using communication software included with most computer operating systems (or available from local sources), these files can also be transferred to a computer.

WARNING:

Equipment Needed

Abbott GemStar Pump

Abbott Serial Printer Cable List 13078-01

Seiko DPU 414 or Compatible Serial Printer

Serial DB9 Female-to-Female Gender Changer*

Null Modem*

Computer*

*Available from local sources.

Configuration Settings

Refer to the printer or computer documentation for information on configuration settings. The printer or computer must be configured as follows to use the Data Port:

Disconnect the pump from the patient BEFORE connecting the pump to a printer or computer.

Connect to Printer Connect to Computer

••

•

Baud Rate

Data Bits

Stop Bits

Carriage Return (+Line Feed)

Flow Control

Parity

= 2400 =8 =1 = None = CR+LF = None

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

80 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Options Menu

To configure the switch settings on the Seiko DPU 414:

1 Slide the POWER switch to ON while pressing the ONLINE button. 2 After the list of the current settings starts printing out, release the ONLINE button. 3 Set the switches according to the table below.

Push ONLINE button to continue setting switches.

Press ONLINE to set switch ON.

•

Press FEED to set switch OFF.

•

4 Continue setting switches until “Dip SW setting complete!!” is printed.

Switch Settings for Seiko DPU-414 Printer

Switch Function Setting Button to Press

SW1-1 Input Method: Serial Off FEED

SW1-2 Printing Speed: High On ONLINE

SW1-3 Auto Loading: On On ONLINE

SW1-4 CR function: CR and LF On ONLINE

SW1-5 DIP SW setting command: Enabled On ONLINE

SW1-6 Printing density: 100% Off FEED

SW1-7 Printing density: 100% On ONLINE

SW1-8 Printing density: 100% On ONLINE

SW2-1 Print Mode: 40 columns On ONLINE

SW2-2 User defined char: On On ONLINE

SW2-3 Ordinary Characters: On On ONLINE

SW2-4 Zero Font: No slash On ONLINE

SW2-5 Character Set: American On ONLINE

SW2-6 Character Set: American On ONLINE

SW2-7 Character Set: American On ONLINE

SW2-8 Character Set: American Off FEED

SW3-1 Data bit length: 8 bits On ONLINE

SW3-2 Parity: No parity On ONLINE

SW3-3 Parity condition: Odd On ONLINE

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

SW3-5 Baud rate: 2400 bps On ONLINE

SW3-6 Baud rate: 2400 bps Off FEED

SW3-7 Baud rate: 2400 bps Off FEED

SW3-8 Baud rate: 2400 bps On ONLINE

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 81

Options Menu

Connecting to the Seiko Printer

WARNING:

CAUTION: Do not connect the Abbott GemStar AC Mains Adaptor to a printer.

Note: For maximum battery life, the pump should be operated on AC mains when connected to a printer or computer.

1 Connect the serial printer cable to the printer and to the data port on the bottom of

the pump.

2 Ensure the printer is ONLINE and ready to receive data. Refer to printer

documentation for more information.

3 Ensure paper is loaded in the printer. 4 Select the desired print function from the pump menu.

Disconnect the pump from the patient BEFORE connecting the pump to a printer or computer.

82 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Connecting to a Computer

Options Menu

WARNING:

Note: For maximum battery life, the pump should be operated on AC mains when connected to a printer or computer.

1 Connect the serial printer cable to the null modem (A). 2 Connect the null modem to the serial gender changer (B). 3 Connect the serial gender changer to the serial port of the computer (C). 4 Connect the serial printer cable to the data port (D) on the bottom of the pump. 5 Configure the communications software on the computer. Refer to Configuration

Settings on page 80.

Tip: After the data transfer is complete, the file may be viewed or printed using any text editor.

Disconnect the pump from the patient BEFORE connecting the pump to a printer or computer.

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 83

Notes

84 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Clinician Instructions

The instructions in this section apply to special features available to clinicians. If desired, remove this section from the manual to prevent unauthorized access to these features.

Clinician Locking Sequence Instructions

Locking the Pump

To lock the pump from the

1 Press [OPTIONS] to display the Options Menu. 2 Select KEYPAD LOCK from the Options Menu.

Note: If the pump is already in a single lock state, the Lock Sequence Number must be entered before a second lock level can be applied. Refer to “Adding a Second Lock Level” for more information.

3 Select the desired lock level.

For

THERAPY, NEW CONTAINER and FULL Lock, go to step 5.

4 For RATE CHANGE Lock, set the minimum and maximum programmable ranges for

the continuous delivery rate and bolus dose in a Pain Management program.

Tip: Press [ ] to toggle between the MIN and MAX values.

•

MIN

flashes on the display. Enter the minimum value.

•

MAX

flashes on the display. Enter the maximum value.

•

Press [YES/ENTER] when done.

•

Repeat step 4 for bolus dose if available in the current program.

5 Enter the lock sequence number. Asterisks display as the numbers are entered.

•

For THERAPY Lock, enter [0][0][0][3][1].

•

For UNLOCKED, FULL, NEW CONTAINER, and RATE CHANGE lock levels, enter [

1][3][0][0][0].

Note: Default lock sequence numbers are shown.

RUN or STOP mode:

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 85

Clinician Instructions

Adding a Second Lock Level

1 Complete steps 1 and 2 for “Locking the Pump”.

Unlocking the Pump

Note: When the pump is in a single lock state, the pump displays ENTER LOCK

SEQUENCE NUMBER

Pain Management, and the clinician wants to add the pump will request the Lock Sequence Number before added.

2 Enter the Lock Sequence Number. 3 Complete steps 4 and 5 for “Locking the Pump”.

Note: When two lock levels are applied, if a function is available under one lock level but not the other, the more stringent restrictions apply.

1 Select the locked level from the Keypad Lock Menu. 2 Enter the lock sequence number for that level.

Note: If the pump is locked under two levels, each level must be unlocked separately. Unlocking one level has no effect on the other level. For example, if both

RATE CHANGE lock levels are applied, the clinician must unlock both the RATE CHANGE

3 The pump displays the current lock levels. Press [YES/ENTER] to return to the mode

the pump was in when the Options Menu was selected.

and THERAPY locks.

. For example, if the pump is currently under THERAPY LOCK for

RATE CHANGE as a second lock level,

RATE CHANGE lock can be

THERAPY and

Program and Deliver a Clinician Activated Loading Dose

This feature is available only when the keypad is UNLOCKED or when THERAPY is the only lock level. The loading dose rate is 125 mL/hr.

1 From the STOP mode, press [YES/ENTER] immediately followed by [0]. 2 PROGRAM A LOADING DOSE? displays. 3 Press [YES/ENTER] to continue. 4 Enter the loading dose. Press [YES/ENTER] when done. 5 DELIVER THE LOADING DOSE NOW? displays.

Note: If [YES/ENTER] is pressed, infusion DOES NOT begin automatically when the clinician activated loading dose is complete. Press [ loading dose is complete.

86 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

START] to resume infusion after the

Clinician Instructions

Note: If [NO] is pressed, the pump returns to the STOP mode. When [START] is pressed,

DELIVER LOADING DOSE NOW? displays again. Press [YES/ENTER] to deliver the

loading dose. Infusion resumes automatically when the loading dose is complete. Press

[

NO] to cancel the loading dose and resume infusion.

Press [YES/ENTER] to deliver the loading dose. After the loading dose is complete,

•

press [

START] to resume infusion.

Press [NO] to return to the STOP mode. Press [START] to resume infusion.

•

Display Shift Totals

1 Press [OPTIONS] and select HISTORIES. 2 Select SHIFT TOTALS from the Histories Menu. 3 The shift totals display. Use the [ ] and

[ ] to scroll the display. When done, the pump

displays

4 Press [YES/ENTER] to clear the shift totals or press

[

NO] to exit OPTIONS without clearing the shift totals.

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

CLEAR TOTALS? YES OR NO.

END OF

SHIFT TOTALS

CLEAR TOTALS?

YES OR NO s

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 87

Notes

88 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Troubleshooting

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

CAUTION: If the pump does not perform as stated in this manual, stop using it

IMMEDIATELY.

For consultation and technical support contact your local Abbott Laboratories sales office.

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

Alarm Messages

Alarm Display Message

Y = Yes N=No

AIR IN LINE

•

Pump automatically enters STOP mode.

Is the

pump

infusing?

N A/V

Alarm

Cause/

Condition

A = Audible alarm V = Visual alarm

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

Remedy

1. Press [SILENCE]to

quiet the alarm for 1 minute.

2. Press [STOP] to clear

the alarm.

3. Disconnect the patient from the pump set.

4. Press and hold [PURGE].

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

[PURGE].

5. Reconnect the pump set to the patient-access device.

6. Press [START] to begin delivery.

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 89

Troubleshooting

Alarm Display Message

Y = Yes N=No

CHANGE BATTERIES

CHECK CASSETTE-X

CALL

1.800.XXX.XXXX

CODE: NN/MMM/TTT

Is the

pump

infusing?

N A/V

Alarm

Cause/

Condition

A = Audible alarm V = Visual alarm

The pump has entered the STOP mode due to battery voltage below acceptable levels.

The cassette is improperly installed or not installed.

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

A = Air Sensor D = Distal P = Proximal

The pump has detected a condition that may require service.

Remedy

Replace both disposable batteries with fresh AA batteries and press

ON/OFF

[ ] to restart the pump; OR temporarily connect the pump to the AC mains adaptor and the pump will automatically restart. Replace both batteries as soon as possible.

2. After power-on, resume the current program. Refer to Accessing the Programming Menu in the “Basic Operation” section for more information.

1. Press [SILENCE]to quiet the alarm for 1 minute.

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

3. Reinstall the cassette.

4. Press [START] to begin delivery.

1. Write down the codes and telephone number.

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

3. Call the telephone number shown on the display message.

90 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Troubleshooting

Alarm Display Message

Y = Yes N=No

DIST. OCCLUSION

Is the

pump

infusing?

Alarm

Cause/

Condition

A = Audible alarm V = Visual alarm

N A/V The pump has detected

sustained distal pressure over the user-selected limit.

To avoid a bolus infusion after an occlusion,refer to page 126.

Remedy

1. Press [SILENCE]to quiet the alarm for 1 minute.

2. Press [STOP] to place the pump in the stop mode.

3. Check for sources of distal occlusion:

Kinked tubing below

the pump

Clamped patient-

access device

Þ Clogged I.V. filter

Þ Other obstructions

4. If the problem persists, remove and reinstall the cassette. Refer to Loading the Cassette in the “System Setup” section.

5. Press [START] to begin delivery.

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 91

Troubleshooting

Alarm Display Message

Y = Yes N=No

LOW BATTERIES

POWER LOSS

Is the

pump

infusing?

Y A/V

N A/V

Alarm

Cause/

Condition

A = Audible alarm V = Visual alarm

The pump has detected battery voltage below acceptable levels and the batteries are the primary power source.

Note: The pump allows the user to clear the LOW BATTERIES audible and visual alarm. If the condition has not been corrected after 15 minutes, the audible and visual alarms resume.

If the pump is infusing and a LOW BATTERIES alarm occurs, the pump continues for approximately 30 minutes* before it can no longer deliver due to insufficient power.

*If an external power source is used, the rate is changed, or the pump is powered-on after a LOW BATTERIES alarm and those same batteries are still in the pump, this interval may be different.

The pump has detected a power failure due to one of the following:

•

Batteries have been removed while the pump was on battery source.

•

External power has failed or has been disconnected and no batteries are installed.

•

Pump has been powered on with insufficient power source.

Remedy

1. Press [SILENCE]to quiet the alarm for 15 minutes.

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

3. Connect the pump to AC mains adaptor, rechargeable battery pack, OR replace both disposable batteries with fresh AA batteries.

4. Press [START] to begin delivery.

1. Connect the pump to AC mains adaptor, rechargeable battery pack, OR replace both disposable batteries with fresh AA batteries.

2. Power-on the pump. Review the program if

required.

3. Press [START] to begin delivery.

92 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)

Troubleshooting

Alarm Display Message

Y = Yes N=No

PROX. OCCLUSION

USING BATTERIES

Is the

pump

infusing?

Alarm

N A/V

Cause/

Condition

A = Audible alarm V = Visual alarm

The pump has detected sustained negative pressure on its proximal side.

This is a normal response when:

•

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

•

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

Remedy

1. Press [SILENCE]to quiet the alarm for 1 minute.

2. Press [STOP] to place the pump in the stop mode.

3. Check for sources of proximal occlusion:

Kinked tubing above

pump

Blockage in the bag

and in the spike

Þ Empty bag

Þ High torque syringe

Þ Other obstructions

4. If the problem persists, clamp the distal line and reinstall the cassette. Refer to Loading the Cassette in the “System Setup” section. If the alarm still persists, power-off the pump. Clamp the distal line, then power-on the pump.

5. Press [START] to begin delivery.

When powering on the pump:

•

Press [YES/ENTER]to confirm disposable batteries are the only power source.

When switching from AC mains:

•

Press [SILENCE]to clear the alarm.

Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 93

Abbott Gemstar User manual

Specifications and Main Features

Frequently Asked Questions

User Manual