Abbott GEMSTAR User manual

ABBOTT LABORATORIES, NORTH CHICAGO, IL 60064, USA
ABBOTT
TM
For use with the
Abbott GemStar Pump
List 13000-36
System Operating Manual
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)
Original Release N/A
430-600095-002
(Rev. 8/02)
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

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

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
[ALL CAPS] Keys Press [YES/ENTER] to continue.
ALL CAPS Display messages The pump displays END OF
INFUSION.
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.
dNote: A NOTE provides information to help clarify a procedure or statement.
fTip: A TIP emphasizes a procedure or statement that makes the pump easier to
use.

Abbott GemStar Pump Layout
2 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)
Introduction
POWER
ABBOTT
123
56
89
0
4
7
BACK-UP
CHANGE
OPTIONS
YES
ENTER
START
SILENCE
STOP
NO
HELP
PURGE

1 DISPLAY •Four-line display indicates the pump’s status.
2 SILENCE •Temporarily silences alarm.
3 STOP •Stops infusion.
4 START •Starts infusion.
5 POWER INDICATOR •Indicates the pump is powered by AC mains when lit continuously.
•Indicates the pump is powered by external batteries when flashing.
6•Powers the pump on or off.
7 BACK-UP •Provides access to previous steps during programming.
•Exits Help, Change, and Options menus.
8 CHANGE •Provides access to these menu items from the STOP or RUN
mode*:
1 Review/Resume
2 New Container
3 New Program
4 Change Program
5 Piggybacking
• Corrects an entry during a programming step.
9 OPTIONS • Provides access to these menu items from the STOP or RUN
mode*:
1 Review Program
2 Histories
3 Keypad Lock
4 Pump Settings
5 Set Clock
6 Print
7 Speed Protocol
8 Next Dose
10 •Scrolls through display messages.
•UP arrow enters a decimal point in numeric entries.
11 YES/ENTER •Responds “YES” to display questions.
•Accepts entries and advances to the next step.
12 NO •Responds “NO” to display questions.
13 HELP •Provides context-sensitive information during programming steps
and alarm conditions.
•Otherwise displays Shift Totals.
14 PURGE •Clears an AIR-IN-LINE alarm.
•Primes an Abbott GemStar Pump Set.
*Not all menu items are available with all modes. Refer to the appropriate section for more information.
Introduction
Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 3
ON/OFF

Abbott GemStar Pump Components
4 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)
Introduction
1 Bolus Button Press this button to initiate a bolus
delivery if available in the current
program.
2 Pole Clamp Track Use to connect to an optional pole
clamp.
3 Cassette Release
Button
Push down on this button to release
the cassette from the pump.
4 Power Connector Use to connect AC mains adaptor to
the pump.
5 Data Port
Connector
Use to connect a printer or computer
to the pump.
6 Bolus Connector Use to connect a bolus cord to the
pump.
7 Tubing Channel Align pump set tubing in this channel.
8 Cassette Pocket Load the cassette into this pocket.
9 Battery Pack
Connector
Use to connect the Abbott GemStar
Rechargeable Battery Pack to the
pump.
10 Battery
Compartment
Install two fresh, disposable AA
batteries in this compartment for
battery power.
Top View

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
BOLUS
LOADING
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
dNote: Menu items may vary depending on the pump’s configuration.
Introduction
Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 5

Abbott GemStar Pump Features
•Adjustable
Settings
Adjusts the distal occlusion pressure limits,
air sensor sensitivity, real-time clock, and
audible alarm volume.
Refer to the “Options Menu”
section.
•Alerts and
Alarms
Signals audible and visual alarms when
attention is required.
Refer to the “Troubleshooting”
section.
•Audible Keypad
Response
Sounds a single beep when any key is
pressed. If an invalid key is pressed, the
pump sounds a flutter tone.
Refer to Abbott GemStar Pump
Layout in this section for keypad
information.
•Keypad Lock Restricts access to various options. Four lock
levels are available.
Refer to the “Options Menu” and
“Clinician Instructions” sections.
•New Container Repeats the current program without
reprogramming the pump.
Refer to the “Basic Operation”
section.
•Piggybacking Allows delivery from a secondary container
during a Continuous or mL/hr Only program.
Refer to the appropriate therapy
section.
•Power-on
Self-test
Performs a self-test each time the pump is
powered on.
Refer to the “Basic Operation”
section.
•Operation Test Performs user-assisted tests to verify the
pump is functioning properly.
Refer to the “Operation Test”
section.
•Program
History
Maintains a history event log, with a date
and time stamp of each event for each
program. Review the history on the display,
or download it to a printer or computer.
Refer to the “Options Menu”
section.
•Speed Protocols Stores up to nine frequently used programs
in the pump’s memory for quick access.
Refer to the “Options Menu”
section.
6 Abbott GemStar Manual 430-600095-002 (Rev. 8/02)
Introduction

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.
dNote: Menu items may vary depending on the pump’s configuration.
fTip: 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
the Programming Menu. Refer to the “Basic
Operation” section for more information on accessing
the Programming Menu.
1 WEIGHT DOSED
2 PAIN MANAGEMENT
3 ML/HR ONLY
4 INTERMITTENT
5 TPN
6 CONTINUOUS
7 VARIABLE TIME
Press the number key
corresponding to the
therapy type to be
programmed. For example,
press [2] to select Pain
Management.
Refer to the appropriate therapy
section for instructions on
entering a program.
Change Menu Press [CHANGE] to access the Change Menu.
1 REVIEW/RESUME
2 NEW CONTAINER
3 NEW PROGRAM
4 CHANGE PROGRAM
5 PIGGYBACKING
Press the number key
corresponding to the
desired Change Menu
function.
Note: Piggybacking is only
available in mL/hr Only and
Continuous therapies.
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 Press [OPTIONS] to access the 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 the number key
corresponding to the
desired Option Menu
function.
Refer to the “Options Menu”
section for instructions.
Introduction
Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 7

Operating Modes
The Abbott GemStar Pump has four operating modes:
•Help Mode The pump enters the HELP mode when [HELP] is pressed while
programming or during an alarm condition. The HELP mode displays
additional information.
•Programming Mode The pump enters the PROGRAMMING mode after the pump is
powered on or when [CHANGE] is pressed.
•Run Mode After [START] is pressed, the pump enters the RUN mode, even
during periods of non-delivery.
•Stop Mode 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.
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)
Introduction
STERILE
2

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

WARNING: Delayed respiratory depression following continuous epidural
administration of preservative-free morphine sulfate has been
reported.
For epidural administration, the following is recommended:
6Nylon or Teflon® catheter
6Pump sets without Y-sites
6Stickers for the tubing indicating ongoing administration
dNote: 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
6Federal (USA) law restricts this device to sale by or on the order of a physician or other
licensed practitioner.
6Manual references to specific values are approximate only, unless indicated otherwise.
Air-in-line sensitivity values are approximate only.
6Disconnect the pump from the patient BEFORE connecting the pump to a computer or
printer.
6For 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)
Introduction

Regarding Drugs Used, Pump Sets, and Containers
6USE 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.
6NEVER use drugs that are incompatible with silicone rubber or PVC plastic.
6To 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.
6DO NOT use medications which are unstable under infusion conditions.
6ALWAYS use connections with Luer Lock™ fittings.
6Use aseptic technique with all fluid-path connections. Remove the protective
coverings as assembly progresses.
6ALWAYS close the slide clamps before removing the cassette from the pump.
6Ensure the cassette is properly installed before using the pump.
6Arrange tubing, cords, and cables to minimize the risk of patient strangulation or
entanglement.
6When using the pump for secondary delivery (piggybacking), ensure the fluids being
administered are chemically and physically compatible.
6NEVER use vented fluid containers (e.g., glass or rigid plastic) unless suspended from a
pole.
6Stop infusion if signs or symptoms of infiltration occur.
6In 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.
6Failure to use the anti-siphon valve may result in unrestricted flow.
6When 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.
6If the cassette is removed from the pump, ALWAYS disconnect the pump set from the
patient and purge the line before restarting therapy.
Regarding Air-In-Line and Infusion
6To reduce the risk of infusing air, use an air-eliminating filter when the air sensitivity
is set to OFF.
6ALWAYS 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.
6ALWAYS set the Air Sensitivity to either ON or 2mL when using vented drip chambers.
Introduction
Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 11

Regarding Pump Operation
6If the pump does not perform as stated in this manual, remove the pump from service
IMMEDIATELY.
6ALWAYS 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.
6USE ONLY the AC mains adaptors specifically labeled for use with the Abbott GemStar
Pump.
6Installing 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.
6The use of rechargeable batteries in the battery compartment is NOT recommended.
6ALWAYS avoid sources of high-intensity electromagnetic radiation (e.g., radio
transmitters, MRI scanners, microwave ovens, X-ray machines, and CAT scanners).
6Use 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.
6Possible 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.
6Non-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
6Product 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.
6ALWAYS fully close the battery door when using disposable batteries.
6ALWAYS avoid dropping or hitting the pump. If the pump is dropped or hit, ALWAYS
verify programmed data.
6NEVER use sharp objects (e.g., fingernails, pens, pencils, or other probes) to program
or clean the pump.
6Use 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

6To 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.
6Some 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.
6DO 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.
6USE ONLY the AC mains adaptor specifically labeled for use with the Abbott GemStar
Pump to charge the battery pack.
6The 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.
6During 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.
6Please comply with local disposal and recycling regulations as appropriate for
disposable batteries, rechargeable battery packs, medical electronic components, and
pump sets.
Introduction
Abbott GemStar Manual 430-600095-002 (Rev. 8/02) 13