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:
ConventionUseExample
d
f
[ALL CAPS]
ALL CAPSDisplay messagesThe 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
1
4
7
PURGE
STOP
2
5
START
3
6
89
0
HELP
NO
POWER
BACK-UP
CHANGE
OPTIONS
YES
ENTER
2Abbott GemStar Manual 430-600095-002 (Rev. 8/02)
Introduction
1DISPLAY
2SILENCE
3STOP
4START
5POWER INDICATOR
6
7BACK-UP
8CHANGE
9OPTIONS
10
11YES/ENTER
12NO
13HELP
14PURGE
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*:
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
1Bolus ButtonPress this button to initiate a bolus
2Pole Clamp TrackUse to connect to an optional pole
3Cassette Release
Button
4Power ConnectorUse to connect AC mains adaptor to
5Data Port
Connector
6Bolus ConnectorUse to connect a bolus cord to the
7Tubing ChannelAlign pump set tubing in this channel.
8Cassette PocketLoad the cassette into this pocket.
9Battery Pack
Connector
10Battery
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
4Abbott 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.
TherapyPossible Applications
AUTO KVO
TITRATION
PIGGY-
BACKING
Introduction
BOLUS
DOSE
LOADING
TAPER UP /
DOWN
d
Weight DosedCritical care, pediatrics
Pain ManagementAdministration of
analgesics or anesthetics
for patient-controlled pain
management (PCA)
mL/hr OnlySimple rate programming
IntermittentInterval-based therapies
such as antibiotics
TPNTotal Parenteral Nutrition
fluid delivery
ContinuousDelivery of mg, mcg, or
mL/hr with a selectable
KVO (Keep Vein Open)
option
Variable TimeChronotherapy
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 PumpLayout 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.
Refer to the “Options Menu”
section.
6Abbott 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 MenuSelect 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
2
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.
8Abbott 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
1Piercing Pin
2Proximal End
3Cassette
4Distal End
5Tubing
6Slide Clamp
7Flow Stop
8Secure Lock
9Anti-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.
d
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.
6
Nylon or Teflon® catheter
6
Pump sets without Y-sites
6
Stickers for the tubing indicating ongoing administration
d
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
6
Federal (USA) law restricts this device to sale by or on the order of a physician or other
licensed practitioner.
6
Manual references to specific values are approximate only, unless indicated otherwise.
Air-in-line sensitivity values are approximate only.
6
Disconnect the pump from the patient BEFORE connecting the pump to a computer or
printer.
6
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.
USE ONLY Abbott GemStar Pump Sets with the Abbott GemStar Pump. Use of
6
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.
6
To reduce the loss of potency for drugs known to be absorbed by PVC plastic and
6
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.
6
ALWAYS use connections with Luer Lock™ fittings.
6
Use aseptic technique with all fluid-path connections. Remove the protective
6
coverings as assembly progresses.
ALWAYS close the slide clamps before removing the cassette from the pump.
6
Ensure the cassette is properly installed before using the pump.
6
Arrange tubing, cords, and cables to minimize the risk of patient strangulation or
6
entanglement.
When using the pump for secondary delivery (piggybacking), ensure the fluids being
6
administered are chemically and physically compatible.
NEVER use vented fluid containers (e.g., glass or rigid plastic) unless suspended from a
6
pole.
Stop infusion if signs or symptoms of infiltration occur.
6
6
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.
6
Failure to use the anti-siphon valve may result in unrestricted flow.
6
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.
6
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
6
To reduce the risk of infusing air, use an air-eliminating filter when the air sensitivity
is set to OFF.
6
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.
6
ALWAYS set the Air Sensitivity to either ON or 2mL when using vented drip chambers.
If the pump does not perform as stated in this manual, remove the pump from service
6
IMMEDIATELY.
ALWAYS connect to a grounded AC mains power source when using AC mains power.
6
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
6
Pump.
Installing disposable batteries is recommended, regardless of the power source used,
6
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.
6
ALWAYS avoid sources of high-intensity electromagnetic radiation (e.g., radio
6
transmitters, MRI scanners, microwave ovens, X-ray machines, and CAT scanners).
Use of radio-frequency emitting devices, such as cellular telephones, 2-way radios,
6
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
6
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
6
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
6
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.
6
ALWAYS fully close the battery door when using disposable batteries.
6
ALWAYS avoid dropping or hitting the pump. If the pump is dropped or hit, ALWAYS
verify programmed data.
6
NEVER use sharp objects (e.g., fingernails, pens, pencils, or other probes) to program
or clean the pump.
6
Use care not to damage the silicone seals around the sensor bodies in the cassette
pocket.
To avoid mechanical or electronic damage, NEVER submerge pump in water or other
6
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
6
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
6
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
6
Pump to charge the battery pack.
The Abbott GemStar AC Mains Adaptor is for use with the Abbott GemStar Pump or
6
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
6
touch, IMMEDIATELY unplug the AC mains adaptor and contact Abbott Customer
Support.
Please comply with local disposal and recycling regulations as appropriate for
6
disposable batteries, rechargeable battery packs, medical electronic components, and
pump sets.
The minimum elements required for using the Abbott GemStar Pump are:
6
Abbott GemStar Pump
6
Appropriate power source
6
Appropriate Abbott GemStar Pump Set
6
Appropriate fluid container
6
Patient access device
Air-eliminating filters and extension sets may be added to the line as required by the
therapy.
d
Note: Contact an Abbott Laboratories Representative for more information on selecting the
appropriate pump set configuration.
Setup Overview
1Select an appropriate power source.
2Prime the pump set.
3Load the cassette into the pump.
4Select 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:
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
1Flip up the tab of the battery
door (A) on the bottom of the
pump.
2While 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.
3Install two fresh, disposable
AA batteries into the battery
compartment. Ensure the
negative and positive battery
terminals are inserted
according to the diagram at
right.
A
B
C
4Return the battery door to the
battery compartment (D).
5Turn 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).
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
d
d
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
1Open the Abbott GemStar Pump Set package and
remove the contents.
Note: Packaging may differ from the diagram shown.
2Remove 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.