Front Cover Pain.fm Page i Wednesday, January 12, 2005 2:43 PM
430-00899-A02, C (Rev. 04/2007)
Infusion Pump
System Operating Manual
For use with the
®
Hospira GemStarPain Management Pump
®
Hospira, Inc., Lake Forest, IL 60045
430-00899-A02 (Rev. 02/05)
List 13150-04-07/08
Page 2
430-00899-002.book Page i Friday, November 19, 2004 9:43 AM
Hospira GemStar® Infusion Pump
System Operating Manual
Hospira GemStar Pain Management Pump
Read this entire manual before
using the Hospira GemStar Pump
For use with the
List 13150-04-07/08
PLEASE
This manual is designed for use by healthcare professionals, caregivers, and patients.
The Hospira Technical Support Operations hotline is available 24 hours a day (in the
USA) to provide consultation and technical assistance regarding the Hospira GemStar
Pump.
430-00899-002.book Page 1 Friday, November 19, 2004 9:43 AM
The GemStar® Pain Management Pump is a small and lightweight, single-channel
infusion device designed for use in the home, in the hospital, or anywhere electronic
infusion is required. The GemStar Pump can be powered by AC mains adaptor,
rechargeable battery pack, docking station, or two disposable AA alkaline or lithium
batteries. When powered by batteries, the GemStar Pump is ideal for ambulatory
patients.
The following conventions are used throughout this manual:
ConventionUseExample
Chapter 1
Introduction
d
f
d
[ALL CAPS]Pump keysPress [YES/ENTER] to continue.
ALL CAPS
WARNING: A WARNING message contains special safety
CAUTION:A CAUTION contains information that could prevent
Note: A NOTE contains information or examples to help explain instructions.
Tip: A TIP contains information that makes the pu mp easier to use.
Note: Examples are pr ovided only to help explain a pump function and may not
be clinically relevant. Graphics are for illustrative purposes only and may not
reflect the actual product.
Display messagesThe pump displays:
ENTER TO CONFIRM.
information and must be observed at all times. Failure
to observe a warning message could be life
threatening.
irreversible product damage or hardware failure. Failure to
observe a caution could result in serious patient or user injury.
430-00899-002.book Page 5 Friday, November 19, 2004 2:21 PM
GemStar Pump Features
FeatureDescriptionReference Page
1. Introduction
•Adjustable
Settings
•Alerts and
Alarms
•Audible
Keypad
Response
•Keypad
Lock
•New
Container
•Power-on
Self-test
•Operation
Test
•Program
History
•Speed
Protocols
Adjusts the distal occlusion pressure limits,
air sensor sensitivity, real-time clock, and
audible alarm volume.
Signals audible and visual alarms when
attention is required.
Sounds a single beep when any key is
pressed. If an invalid key is pressed, the
pump sounds a flutter tone.
Restricts access to various options. Four
lock levels are available.
Repeats the current program without
reprogramming the pump.
Performs a self-test each time the pump is
powered on.
Performs user-assisted tests to verify the
pump is operating properly.
Maintains a history event log, with a date
and time stamp of each event for each
program. Review the history on the display,
or download it to a printer or computer.
Stores up to nine frequently used programs
in the pump’s memory for quick access.
Chapter 4 Options Menu
Chapter 6
Troubleshooting
Chapter 1 Introduction,
GemStar Pump Layout
Chapter 4 Options Menu
and Chapter 5 Clinician
Instructions
430-00899-002.book Page 6 Friday, November 19, 2004 9:43 AM
1. Introduction
Menu System
The GemStar Pump uses a menu system that provides step-by-step instructions
through all of the pump’s functions. Refer to the following table for a list of functions
in each menu.
Use the keypad to select menu items, respond to display messages, and enter numeric
values. For example, press [
2] to select HISTORIES from the Options Menu.
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. For example,
when the Options Menu first displays, only the first four menu items are shown.
Instead of pressing the down arrow to see the other menu items, press [
directly to SET CLOCK.
430-00899-002.book Page 8 Friday, November 19, 2004 9:43 AM
1. Introduction
Indications for Use
Physicians or certified, licensed healthcare professionals should always oversee
infusions. Healthcare professionals should always supervise pump users and instruct
users in pump operation and troubleshooting. Instruction should include how to
prevent intravenous (I.V.) related complications, including how to prevent accidental
infusion of air.
The pump is suitable for intravenous, arterial, subcutaneous, short-term epidural
infusion of general I.V. fluids and medications. The epidural route is recommended to
provide anesthesia or administer analgesia for periods up to 96 hours.
Note: Epidural administration of anesthetics is recommended in the continuous
d
mode only. Epidural administration of analgesics may be delivered by continuous,
bolus, or continuous with bolus.
For epidural use, the administration of drugs is restricted to those anesthetic and
analgesic drugs approved for continuous epidural administration: e.g., Chloroprocaine
Hydrochloride USP, Lidocaine Hydrochloride USP, and Morphine Sulfate Injection
USP (Preservative Free).
WARNING: Delayed respiratory depression following continuous
epidural administration of preservative-free morphine
sulfate has been reported.
For epidural administration, the following is recommended:
6Nyl on or Teflon
6Pump sets without Y-sites
6Stickers for the tubing indicating ongoing administration
Note: Facilities practicing epidural anesthesia/analgesia must be staffed and
equipped to manage cardio-pulmonary resuscitation (CPR). Supplies should
include oxygen, naloxone, and other appropriate resuscitative drugs and
equipment. Monitor patients continuously (e.g., oximetry) during epidural
administration. Frequently observe patient for side effects (for up to 24 hours)
following completion of drug administration by the epidural route.
®
catheter
Page 16
430-00899-002.book Page 9 Friday, November 19, 2004 9:43 AM
Contraindications for Use
Persons who do not have the mental and physical capability or the emotional stability
to properly use the GemStar Pump should not operate this pump.
DO NOT use the following with the Hospira GemStar Pump System:
6Drugs not compatible with silicone rubber or PVC plastic
6Drugs not stable under infusion conditions
Warnings and Cautions
Pay attention to the following warnings and cautions when operating the Hospira
GemStar Pump. These warnings and cautions are repeated in the manual when
relevant to the procedure being discussed. Pay attention to all alert messages.
General Warnings and Cautions
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.
6When a Proximal Occlusion alarm activates, DO NOT power-off the pump.
6Closely supervise patients who are likely to be adversely affected by unintended
operations and failures, including interrupted medication or fluid infusion. Ensure
provisions for immediate corrective action are available.
1. Introduction
Regarding Drugs Used, Pump Sets, and Containers
6USE ONLY GemStar Pump Sets with the 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.
430-00899-002.book Page 10 Friday, November 19, 2004 9:43 AM
1. Introduction
6DO NOT use medications that are unstable under infusion conditions.
6ALWAYS use connections with Luer Lock™ fittings.
6To prevent contamination, use aseptic technique with all fluid-path connections.
Remove the protective coverings as assembly progresses.
6ALWAYS place the flow stop in the closed position when the set is not in the
pump.
6Make sure the cassette is properly installed. When properly installed, all four
cassette latches are visibly holding the cassette securely in the cassette pocket.
6Ensure the tubing is behind the tubing guide (at the distal end).
6Arrange tubing, cords, and cables to minimize the risk of patient strangulation or
entanglement.
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.
6GemStar Pump Sets contain an anti-siphon valve to reduce the potential for
gravity flow at a typical 36-inch head height.
6Failure to use the anti-siphon valve may result in unrestricted flow.
6ALWAYS close the slide clamps before removing the cassette from the pump.
6When using pre-filled vials, the system may underdeliver at low flow rates.
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 prime the pump set to remove all air from the cassette, tubing, and
injection site prior to connecting to the patient.
6ALWAYS disconnect the pump set from the patient prior to priming or purging.
Regarding Pump Operation
6If the pump does not perform as stated in this manual, remove the pump from
service IMMEDIATELY.
6If the pump does not display the self-test or if beeps do not sound at power-on,
check all power connections and install two fresh, disposable AA batteries. If the
problem continues, contact Hospira Technical Support Operations before using
the pump.
430-00899-002.book Page 11 Friday, November 19, 2004 9:43 AM
6Ensure a cassette is installed in the pump before connecting to a printer or
computer. If the pump is connected to a patient: BEFORE connecting the pump
to a computer or printer, press [
cassette. Leave the pump set connected to the patient. Install another cassette in
the pump before connecting to a printer or computer.
6Disconnect the pump from the patient BEFORE performing the Operation Test.
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 GemStar
Pump.
6USE ONLY the AC mains adaptor specifically labeled for use with the GemStar
Pump to charge the battery pack.
6The GemStar AC Mains Adaptor is for use with the GemStar Pump or GemStar
Rechargeable Battery Pack only. DO NOT
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 Hospira
Technical Support Operations.
6When removing the cord fro m the bottom of the pump, firmly grasp the connector
and pull straight out. DO NOT twist or bend the cord or connector.
6To ensure proper pump operation, ALWAYS replace BOTH disposable batteries
with fresh, disposable AA batteries when a change is required.
6ALWAYS fully close the battery door when using disposable batteries.
6DO NOT use rechargeable batteries in the battery compartment.
6Ensure two fresh, disposable AA batteries are installed for backup power when
using other power sources (e.g, docking station, battery pack). The pump will
continue to operate on backup power if the external power source fails.
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.
430-00899-002.book Page 12 Friday, November 19, 2004 9:43 AM
1. Introduction
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 (if clinically acceptable).
Disappearance of the abnormality indicates that it was probably caused by
electronic noise generated by the infusion device. Proper setup and maintenance
of the monitoring equipment should eliminate the artifact. Refer to the appropriate
monitoring system documentation for setup and maintenance instructions.
6Th e GemStar pump, when connected to the GemStar AC adaptor, has been tested
and found to comply with EMC/EMI limits in accordance with IEC/EN
60601-1-2 (2001). When connected to other power sources and/or optional system
components, the GemStar system complies with EMC/EMI limits in accordance
with IEC/EN 60601-1-2 (1993). These limits are designed to provide reasonable
protection against harmful interference in a typical medical installation. The
equipment generates, uses and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, may cause harmful
interference to other devices in the vicinity. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause
harmful interference with other devices, which can be determined by turning the
equipment off and on, the user is encouraged to try to correct the interference by
one or more of the following measures:
6Reorient or relocate the receiving device
6Increase the separation between the equipment
6Connect the equipment to an outlet on a circuit different from that to which
the other device is connected
6Consult the manufacturer or field service technician for help
6Th e use of portable and mobile RF equipment may have an imp act on this and
430-00899-002.book Page 13 Friday, November 19, 2004 9:43 AM
Regarding Handling and Maintenance
6Use proper care during unpacking, installation, and operation of the pump. If the
pump is inadvertently mishandled, check connections and programmed data to
ensure there is no damage. Refer to Chapter 8 Operation Test for further
information.
6ALWAYS avoid dropping or hitting the pump. If the pump is dropped or hit,
ALWAYS check connections and 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.
6To avoid mechanical or electronic damage, NEVER submerge pump in water or
other fluids and avoid fluid spills. If the pump becomes wet, dry it immediately
with a dry, lint-free cloth. Check connections and programmed data.
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 (i.e., alcohol wipes).
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 Hospira may result in product damage.
6Please comply with local disposal and recycling regulations as appropriate for
disposable batteries, rechargeable battery packs, medical electronic components,
and pump sets.
Basic_Operation.fm Page 15 Monday, November 22, 2004 12:29 PM
The minimum elements required for using the GemStar Pump are:
GemStar Pump
Appropriate power source
Appropriate GemStar Pump Set
Appropriate fluid container
Patient-access device
Overview
Chapter 2
Basic Operation
To start a therapy:
1Determine the program settings. Refer to Chapter 3 Pain Management for a
worksheet that may be copied and used to record program settings.
2Select a power source. Refer to Selecting a Power Source on page 16.
3Prime the pump set. Refer to GemS tar Pump Set on page 27.
4Load the cassette into the pump. Refer to Loading the Cassette on page 30.
5Power-on the pump and go to the Delivery Mode Menu. Refer to Powering On
the Pump on page 22.
6Select the appropriate optional system components, such as a bolus cord.
7Select the delivery mode and enter a program. Refer to Chapter 3 Pain
430-00899-002.book Page 16 Friday, November 19, 2004 9:43 AM
2. Basic Operation
Selecting a Power Source
The GemStar Pump may be powered by one or more of the following:
Power SourceDescriptionAmbulatoryHospital Home
GemStar
AC Mains Adaptor
(USA)
GemStar
AC Mains Adaptor
(Universal)
GemStar Docking
Station
GemStar Battery
Pack
Disposable Batteries Two disposable AA alkaline or
Wall-mount adaptor plugs into a
1 10 VAC mains supply.
Tabletop adaptor plugs into a
100–240 VAC mains supply.
Plugs into a 100–240 VAC Volt
mains supply while mounted on an
I.V. pole. The docking station’s
internal batteries power the
GemStar Pump during periods of
transport.
The battery pack’s internal
batteries power the GemStar
Pump during periods of transport
or when use of AC power is not
desirable.
lithium batteries (available from
local sources)
••
••
•••
•••
•••
CAUTION: To ensure proper pump operation, ALWAYS replace BOTH
batteries with fresh, disposable AA batteries when a change is
required.
DO NOT use rechargeable batteries in the battery compartment.
Ensure two fresh, disposable AA batteries are installed for backup
power when using other power sources (e.g, docking station,
battery pack). The pump will continue to operate on backup power
if the external power source fails.
430-00899-002.book Page 22 Friday, November 19, 2004 9:43 AM
2. Basic Operation
Powering On the Pump
CAUTION: If the pump does not display the self-test or if beeps do not sound at
power-on, check all power connections and install two fresh,
disposable AA batteries. If the problem continues, contact Hospira
Technical Support Operations before using the pump.
d
d
Note: If a cassette is not properly loaded, the pump will alarm after the power -on test is
complete.
1Press [
ON/OFF] to power-on the pump. The pump
completes a self-test and displays the time and date. No
response is required.
GEMSTAR 7
UNIT SELF-TEST
TIME IS 10:00 AM
FRI, JUN 11, 04
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 .
2The pump checks for available power sources. Respond to the display message as
shown in the following table:
Display MessagePower Source(s)User Response
No message displaysAC power and
disposable batteries.
LOW BATTERIES
ENTER TO CONFIRM
NO INTERNAL BATT
NO POWER LOSS
ALARM AVAILABLE
ENTER TO CONFIRM
AC power and weak
(low voltage)
disposable batteries;
or weak disposable
batteries only.
No disposable
batteries or dead
disposable batteries;
and external power.
No response required, the pump goes
to the next step.
Press to confirm.
Power-off the pump and install two
fresh, disposable AA batteries as a
backup power source.
Press to confirm.
Power-off the pump and install two
fresh, disposable AA batteries as a
backup power source.
430-00899-002.book Page 25 Friday, November 19, 2004 9:43 AM
Programming the Pump
Programming Overview
The pump’s menu system provides step-by-step guidance through all of the
programming steps. Refer to Chapter 3 Pain Management for detailed programming
instructions.
A programming worksheet is available at the end of Chapter 3 that lists the minimum
and maximum value (program range) allowed for a Pain Management therapy. If a
number outside of the program range is entered, the pump displays the minimum or
maximum value allowed.
1Select the desired delivery mode from the Delivery Mode Menu.
2Respond to display messages and enter requested values.
Note: Program entries can be changed any time before the Program Review is
d
complete. Press [BACK-UP] to return to previous program displays and make
changes as desired.
2. Basic Operation
3Review the program, if required. Press to begin review. Press [
when done.
4
SAVING PROGRAM displays. The pump stores the program in memory and then
STOP mode.
enters
Tip: If you enter an incorrect number during programming, press [CHANGE]
430-00899-002.book Page 27 Friday, November 19, 2004 9:43 AM
Starting a New Container
2. Basic Operation
d
Note: The NEW CONTAINER function is not available when the pump is in FULL Lock.
Refer to Chapter 4 Options Menu, page 49 for more information on locking the keypad.
To repeat the current program with a new container:
1From the
2Select
CONTAINER
3Review the program. Press to begin review.
4Press [
STOP mode, press [CHANGE] to display the Change Menu.
NEW CONTAINER from the Change Menu. The pump displays NEW
START] to begin delivery.
GemStar Pump Set
The GemStar Pump Set is a sterile, single-use, disposable pump set. It is designed for
one-time use only and should be properly discarded after use.
Fluid path and areas beneath undisturbed protective set
covers are sterile and nonpyrogenic in the intact unit
package.
Contact a Hospira representative for more information on selecting the appropriate
pump set configuration. Additional disposable components, such as air-eliminating
filters and extension sets, may be added to the line as required. To use a GemStar
Pump Set, follow the instructions included with the set.
for several seconds and clears the amount infused from memory.
STERILE
2
Note: GemStar Pump Sets contain an anti-siphon valve to reduce the potential for
430-00899-002.book Page 29 Friday, November 19, 2004 9:43 AM
WARNING: ALWAYS prime the pump set to remove air from the
cassette, tubing, and injection sites prior to connecting to
the patient. ALWAYS disconnect the pump set from the
patient prior to priming or purging. Arrange tubing, cords,
and cables to minimize the risk of patient strangulation or
entanglement.
Failure to use the anti-siphon valve may result in
unrestricted flow.
CAUTION: USE ONLY GemStar Pump Sets with the GemStar Pump. Use of
unauthorized sets may result in injury to the patient or damage to
the pump.
To prevent contamination, use aseptic technique with all fluid-path
connections. Remove protective coverings as assembly progresses.
430-00899-002.book Page 31 Friday, November 19, 2004 9:43 AM
2. Basic Operation
4Verify that all four cassette latches
are securely holding the cassette.
CAUTION: Ensure the cassette
is properly installed. When
properly installed, all four
cassette latches are visibly
holding the cassette securely in
the cassette pocket.
430-00899-002.book Page 41 Friday, November 19, 2004 9:43 AM
Therapy Features and Specifications
This therapy allows programming of a continuous only , bolus only, or continuous with
bolus delivery .
6In Continuo us + Bolus protoco ls, you can enter zero for either the continuous rate
or the bolus dose when entering or changing a program. The continuous rate and
bolus dose cannot be zero at the same time.
6The default bolus delivery rate is 125 mL/hr.
6A loading dose may be set during programming, which can be delivered after
programming and priming are complete. The default loading dose rate is 125
mL/hr.
6Priming using [PURGE] is only allowed before [START] is pressed or after one of
the following events occur:
6Complete Review of New Program
6New Cont ain er
6Air-in-Line Alarm
Chapter 3
Pain Management
CAUTION:When using pre-filled vials, the system may underdeliver at low
flow rates.
Note: New Container is allowed only when at least 1/2 of the container volume has
d
f
been infused or 1 hour has elapsed since starting the infusion.
The use of a lockbox is recommended with pain management protocols. Refer to
Chapter 9 Optional System Components, page 103, for instructions on using a
lockbox with the GemStar Pump.
Tip: The Programming W ork sheet at the e nd of this chap ter list s the min imum and
maximum values allowed for this protocol. Use copies of the programming
worksheet to record program values before programming the pump.
PainMgmt.fm Page 42 Monday, November 22, 2004 12:47 PM
3. Pain Management
Pain Management Programming Tips
The following table explains how to use the keypad during pain management
programming:
KeyFunctionKeyFunction
[0] - [9]Selects menu items and
enters numeric values.
Accepts entries or
continues when done
viewing a display.
Displays information
during programming and
alarm conditions.
Pain Management Programming.
1Select the delivery mode from the Delivery Mode Menu.
Note: If Continuous + Bolus is selected, the continuous delivery rate or bolus dose
can be set to zero through the CHANGE menu without reprogramming the pump.
2Select the unit of measure and concentration as required.
Scrolls through program
review and help
messages. The up arrow
inserts a decimal point in
a numeric value. The
down arrow toggles units
of measure when entering
concentrations.
Clears a numeric value
(resets to zero) during
programming.
Returns to a previous
display, exits the Options
Menu, and exits the
PainMgmt.fm Page 43 Monday, November 22, 2004 12:37 PM
3Set 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 = 0.333 mL
4.5 mg = 0.3 mL
When a value is rounded, the pump sounds four quick beeps, disp lays ROUNDING
for a few seconds, and then displays the rounded value. Press
accept the rounded value and continue to the next step.
4Program a loading dose as required.
5Program a bolus dose with lockout time and dose limit as required.
Regarding a 1-Hour or 4-Hour Dose Limit: The hour dose limit is the
maximum volume (continuous plus bolus or bolus only amount) that can be
delivered over the selected period. When the programmed dose limit is reached,
the continuous delivery stops and a new bolus is not allowed. As the oldest
delivery amounts age out of the 1-hour or 4-hour dose limit record, the pump
accepts bolus requests or resumes continuous delivery (if programmed).
3. Pain Management
[YES/ENTER] to
Note: If a 1-hour or 4-hour dose limit is programmed, a bolus in pr ogr ess will stop
WARNING: ALWAYS disconnect the pump set from the patient before
when the amount infused reaches the dose limit.
Loading doses are included in a 1-hour or 4-hour dose limit. A dose limit in effect
could prevent the delivery of a loading dose.
6If programmed in units of mcg or mg, the line displaying the units flashes. Enter
the container size in proper unit measure.
Note: To enter the total in mL when programming a concentration, press to
move to the mL line. Enter the mL value when
7Select the air sensitivity, if required.
8Review the program. Press to begin review.
9If using the PURGE key to prime the pump set, press [
priming or purging.
mL flashes on the display.
PURGE] now.
Page 51
430-00899-002.book Page 44 Friday, November 19, 2004 9:43 AM
3. Pain Management
Bolus Delivery
Set bolus doses and delivery limits 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 Chapter 9 Optional System Components, on page 106, for more information.
Delivering a Bolus Dose
d
From the
RUN mode, press either the bolus button [+] on the top of the pump or the
button on the end of the bolus cord to begin bolus dose delivery. The pump flashes
BOLUS DELIVERY on the display and the amount infused accrues as the delivery
progresses.
When the bolus dose is complete, the pump does the following:
6Records the bolus request and delivery amount to the event and bolus history logs
6Adds the delivered boluses to the total bolus amount in the program amounts
6Resets the bolus lockout time (if applicable) and ignores other bolus requests until
the lockout time has elapsed
6Continues programmed infusion
Note: ALL bolus requests are recorded to the event and bolus history logs.
If the bolus delivery does not start, it could be locked out by one of the following
conditions:
6Bolus lockout period
6Loading dose delivery in progress
6Bolus dose delivery in progress
6Bolus per-hour limit
61-hour or 4-hour dose limit
430-00899-002.book Page 45 Friday, November 19, 2004 9:43 AM
Bolus Dose Interruptions
Bolus deliveries may be interrupted by:
6Pressing [STOP]
6An alarm condition
To continue bolus delivery after an interruption:
1Press [START]. The pump displays COMPLETE BOLUS NOW?
2Respond as follows:
To do this:Press this key:Bolus lockout time is set to:
3. Pain Management
Deliver the remaining
bolus amount
Clear the undelivered
bolus amount
Loading Dose Delivery
You can set a loading dose during programming, if desired. A loading dose can be
delivered after programming and priming are complete.
d
Note: Loading dose amounts are included in a 1-hour or 4-hour dose limit.
Delivering a Loading Dose
1After priming and programming, press [
2The pump displays
begin loading dose.
When the loading dose is complete, the pump does the following:
6Automatically begins programmed infusion
6Records the dose amount to the history log
6Resets the bolus lockout time (if applicable) and ignores other bolus requests until
the lockout time has elapsed
The time of delivery completion
The time the bolus was
interrupted
START].
DELIVER THE LOADING DOSE NOW? Press [YES/ENTER] to
430-00899-002.book Page 46 Friday, November 19, 2004 9:43 AM
3. Pain Management
Loading Dose Interruptions
Loading dose deliveries can be interrupted by:
6Pressing [STOP]
6An alarm condition
To continue a loading dose:
1Resolve the interruption.
2Press [
START]. The pump displays COMPLETE THE LOADING DOSE?
3Respond as follows:
To do this:Press this key:
Deliver the remaining loading dose amount
Clear the remaining loading dose amount
Changing a Pain Management Program
Can be changed at any timeCannot be changed
d
• Delivery rate
• Bolus
• Bolus lockout
Note: You cannot change a program when the pump is in FULL or CONTAINER
Lock. With a RATE CHANGE Lock, the continuous delivery rate and bolus amount
can be changed within the set ranges.
Although the delivery mode cannot be changed, if Continuous + Bolus is
programmed, the continuous rate or bolus amount can be changed to zero. The
minimum values set with a
430-00899-002.book Page 50 Friday, November 19, 2004 9:43 AM
4. Options Menu
Select this item
from the Options
Menu:
REVIEW
PROGRAM
HISTORIES
KEYPAD LOCK
PUMP SETTINGS
SET CLOCK
PRINT
SPEED
PROTOCOLS
T o 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. Display the
Operation Test.
Lock and unlock the keypad to
prevent unauthorized changes to
the program.
Change the air sensor, occlusion
sensor, and sound level settings.
Set the clock.The clock can be displayed in
Print the history event log, bolus
history (if available), current
program settings, and speed
protocols.
Assign, review/recall, and delete
the stored protocols.
N/A
N/A
The lock levels allow the clinician
to restrict access to various levels
of pump operation.
N/A
12-hour 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.
430-00899-002.book Page 55 Friday, November 19, 2004 9:43 AM
Bolus History
To display the bolus history:
4. Options Menu
d
1Press [
2Select
OPTIONS] and select HISTORIES.
BOLUS HISTORY from the
Histories Menu.
3Press [
BACK-UP] when done to exit OPTIONS.
TIME IS 09:15 AM
FRI, JUN 11, 04
BOL DEL 30
BOL DEM 37
BOL AMT 30.0 mL
06:10A TO 09:14A
Sample Bolus History
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
The Operation Test checks several pump functions to ensure the GemStar Pump is
working properly. Refer to Chapter 8 Operation Test on page 93 for instructions.
430-00899-002.book Page 58 Friday, November 19, 2004 9:43 AM
4. Options Menu
Change Pump Settings
1Press [OPTIONS] and select PUMP SETTINGS.
2Press the number key for the desired pump setting.
3Follow the display messages. Refer to the
instructions of the desired pump setting for more
information.
Select this item from
the Pump Settings
Menu:
AIR SENSOR
OCCL SENSOR
SOUND LEVEL
To do this
function:
Change the air
sensor sensitivity.
Change the distal
occlusion sensor
sensitivity .
Adjust the audible
alarm level.
Comments:
The pump alarms when it 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 can also be set during
programming if the current therapy allows
it.
Default Setting: High
The pump alarms when distal pressure is
430-00899-002.book Page 59 Friday, November 19, 2004 9:43 AM
Air Sensitivity
WARNING: To reduce the risk of infusing air, use an air-eliminating
filter when the air sensitivity is set to OFF.
4. Options Menu
d
1Press [
OPTIONS] and select AIR SENSITIVITY. The current air sensitivity
flashes on the display.
2Select the desired Air Sensitivity level.
Note: If OFF is selected, the pump displays:
AIR ELIMINATING
FILTER IS RECOMMENDED.
ENTER TO CONFIRM
You must press [YES/ENTER] to confirm.
3After selecting the desired Air Sensitivity, the
pump displays:
XXXX TO XXXX
•P ress [
CHANGE AIR ALARM FROM
:
NO] to keep the current air sensitivity.
The current air alarm status displays and the
pump exits
•Press [
and the pump exits
OPTIONS.
YES/ENTER] to accept the new setting. The new air alarm status displays
OPTIONS.
Occlusion Sensor
1Press [
2Select
OPTIONS] and select PUMP SETTINGS.
DISTAL OCCLUSION from
the Pump Settings Menu.
3Select the desired setting.
4The pump displays
MAKE XXXXX DEFAULT?
•P ress [NO] to temporarily change the distal
occlusion setting. The new setting will be in effect
until a new program is entered or the pump has been off for more than 24
hours.
•P ress [
YES/ENTER] to permanently change the distal occlusion setting. The
new setting will remain in effect until the setting is changed again through the
Options Menu.
430-00899-002.book Page 64 Monday, November 22, 2004 10:43 AM
4. Options Menu
Connecting to the Data Port
Use the data port to connect the 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: Ensure a cassette is installed in the pump before
connecting to a printer or computer.
If the pump is connected to a patient: BEFORE
connecting the pump to a computer or printer, press
STOP], close the slide clamp, and eject the cassette.
[
Leave the pump set connected to the patient. Install
another cassette in the pump before connecting to a
printer or computer.
430-00899-002.book Page 65 Monday, November 22, 2004 10:43 AM
Configuration Settings
Refer to the printer or computer documentation for information on configuration
settings. Configure the printer or computer as follows to use the data port:
4. Options Menu
d
Baud Rate
Data Bits
Stop Bits
Parity
Carriage Return (+Line Feed)
Flow Control =
Note: When using the Seiko DPU 414 printer, the switch settings MUST be configured
to work with the GemStar Pump.
To configure the switch settings on the Seiko DPU 414:
1Press and hold the ONLINE button while sliding the POWER switch to ON.
2When the list of the current settings start printing, release the ONLINE button.
3Set the switches according to the following table.
Press the ONLINE button to continue setting switches.
•Press ONLINE to set switch ON.
•Press FEED to set switch OFF.
4Continue setting switches until “Dip SW setting complete!!” is printed.
command:
SW1-6Prin ting density:100%OffFEED
SW1-7Prin ti ng density:100%OnONLINE
SW1-8Prin ti ng density:100%OnONLINE
SW2-1Print Mode :40 columns OnONLINE
SW2-2User defined char:OnOnONLINE
SW2-3Ordinary
430-00899-002.book Page 68 Friday, November 19, 2004 9:43 AM
4. Options Menu
Connecting to a Computer
WARNING: Ensure a cassette is installed in the pump before
connecting to a printer or computer.
If the pump is connected to a patient: BEFORE
connecting the pump to a computer or printer, press
[
STOP], close the slide clamp, and eject the cassette.
Leave the pump set connected to the patient. Install
another cassette in the pump before connecting to a
computer or printer.
d
f
Note: For maximum battery life, operate the pump on AC mains when connected to a
printer or computer.
1Install a cassette into the pump.
2Connect the GemStar serial cable to the null modem.
3Connect the null modem to the serial gender changer.
4Connect the serial gender changer to the serial port of the computer.
5Connect the GemStar serial cable to the data port on the bottom of the pump.
6Configure the communication software on the computer. Refer to Configuration
Settings on page 65.
Tip: After the data transfer is complete, use any text editor to view or print the file.
430-00899-002.book Page 70 Friday, November 19, 2004 9:43 AM
4. Options Menu
Creating a New Connection
d
Note: The following procedure is only needed to create a “New Connection” the first
time the pump is connected to the computer.
To create a new connection:
1Follow steps 1–4 in Using an Existing Connection on the following page.
2If a message appears asking if a modem is necessary for a connection, click NO.
3Enter a name for the new connection (e.g., GemStar Print Files) and choose an
icon.
4Click OK.
5From the Connect drop-down menu, select the appropriate COM port.
6Click OK.
7Verify that the following settings are correct:
Baud Rate =2400
Data Bits =8
Stop Bits =1
Parity =None
Flow Control =None
8Click OK.
9Select the Properties icon.
10 Select the Settings tab.
11 Select the ASCII setup button.
12 Ensure ‘Append line feeds to incoming line ends’ is checked.
13 Click OK in the ASCII setup window.
14 Click OK in the Properties window.
15 From the menu, select File > Save.
16 Exit HyperTerminal.
430-00899-002.book Page 71 Friday, November 19, 2004 2:21 PM
Using an Existing Connection
To transfer data from the GemStar Pump to a computer:
®
1From the Windows
2Select Programs.
3Select Accessories.
4Select HyperTerminal.
5Double click on the icon with the name entered in step 3, To create a new
connection, on page 70.
6From the menu, select Call > Connect.
7From the menu, select Transfer > Capture Text.
8Type the path and file name where the printout should be saved.
Ensure the file extension is “.txt”.
The default path is: c:\windows\accessories\hyperterminal.
desktop, select the Start Menu.
4. Options Menu
Note: If the file name already exists, the new printout will be added to the end of
the existing file. For example, use a patient’s name or id number as the file name.
Then select that file for all of that patient’s printouts.
9Click Start.
10 Select the desired print function from the pump. Refer to the table of printing
functions on page 61.
11 Wait for the transmission to complete.
12 From the menu, select Transfer > Capture Text > Stop.
13 Exit HyperTerminal.
14 Use any text editor to view or print the file.
Page 79
430-00899-002.book Page 72 Friday, November 19, 2004 9:43 AM
Clinician.fm Page 73 Wednesday, February 16, 2005 11:21 AM
The instructions in this section apply to special features available to clinicians.
Remove this section from the manual to prevent unauthorized access to these
features.
The GemStar pump provides quick access to commonly used functions. Instead of
accessing these functions by navigating through the menu system, you can enter the
key combinations shown in this table:
FunctionQuick Access Key Combination
Unlock KeypadPlace the pump in STOP mode and then enter the lock
sequence to unlock a Full Container or Rate Lock.
Displays Shift TotalsPlace the pump in STOP mode and then press [HELP] to
display Shift Totals.
Chapter 5
Clinician Instructions
Display ClockPlace the pump in STOP mode, press [YES], and then press
and hold [1]. The clock displays until you release [1].
430-00899-002.book Page 77 Friday, November 19, 2004 9:43 AM
This section contains information on audible and visual alarms that may occur with
the GemStar Pump.
CAUTION: If the pump does not perform as stated in this manual, stop using it
IMMEDIATELY.
For consultation and technical support contact either an authorized Hospira
representative or the Hospira Technical Support Operations hotline (available 24
hours a day).
To return the pump for service, first contact Hospira Customer Support between 7:00
AM and 4:00 PM Pacific time. Have the pump serial number available.
Chapter 6
Troubleshooting
In the USA
Outside the USA:
f
Tip: Press [HELP] for additional information during programming and alarm conditions.
Hospira Technical Support Operations
1-800-241-4002
Hospira, Inc.
Technical Support Operations
755 Jarvis Drive
Morgan Hill, CA 95037
Contact your local Hospira sales
office.
Page 85
430-00899-002.book Page 78 Friday, November 19, 2004 9:43 AM
6. Troubleshooting
Alarm Messages
Alarm Display
Message
Y = Yes
N = No
AIR IN LINE
• Pump automatically
enters
STOP mode.
CHANGE BATTERIESNA/VThe pump has
Is the
pump
infusing?
NA/VThe specified volume
Alarm Cause/
Condition
A = Audible alarm
V = Visual alarm
of air has been
detected in the line
distal to the cassette
while infusing.
entered the
mode due to battery
voltage below
acceptable levels.
STOP
Remedy
1Press [SILENCE] to quiet
the alarm for 1 minute.
2Press [STOP] to clear the
alarm.
3Disconnectthepatient
fromthepumpset.
4Press 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]. Purge volume
may be limited in a Pain
Management program.
5Reconnect the pump set to
the patient-access device.
6Press [START] to begin
infusion.
1Replace both disposable
batteries with fresh AA
batteries and press to
restart the pump; OR
connect the pump to the
AC mains adaptor and the
pump will automatically
restart. Replace both
batteries as soon as
possible.
430-00899-002.book Page 84 Friday, November 19, 2004 9:43 AM
6. Troubleshooting
Alarm Display
Message
Y = Yes
N = No
USING BATTERIESYVThi s is a normal
USING EXT BATTYVThis is a normal
Is the
pump
infusing?
Alarm Cause/
Condition
A = Audible alarm
V = Visual alarm
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.
response when:
• The pump has
been powered on
with external
batteries as a
power source; or
• The pump has
switched to
external battery
power due to a
loss of AC mains
power; or
• The pump has
switched to
external battery
power while
running on
internal batteries.
Remedy
When powering on the pump:
• Press [YES/ENTER] to
confirm disposable batteries
are the only power source.
When switching from AC mains
power:
• Press [SILENCE] to clear
the alarm.
When powering on the pump:
• Press [YES/ENTER] to
confirm external battery
power source.
430-00899-002.book Page 86 Friday, November 19, 2004 9:43 AM
6. Troubleshooting
Alert Display MessageIs the
pump
infusing?
Y = Yes
N = No
EMPTY CONTAINERNA/VThe pump has delivered
FLASHING DISPLAY
• Line four of the
display flashes.
AlarmCause/ConditionRemedy
A = Audible alarm
V = Visual alarm
the programmed
container size or the
pump has delivered the
programmed VTBI; AND
Auto KVO is delivering
(if available in current
program).
NA/VA Non-programming
Callback has occurred
because the pump has
been waiting for more
than three minutes for a
keypress on a nonprogramming input or a
confirmation display.
1Press [SILENCE] to
quiet the alarm for 2
minutes.
2Press [STOP] to
place the pump in the
STOP mode and
clear the alarm.
3Use the NEW
CONTAINER
function to repeat the
current program.
Refer to Starting a New Container in
Chapter 2 Basic
Operation.
Follow the instructions on
the display to clear the
alarm.
User has attempted to
access a function that is not
available from the first
programming display.
1Press [YES/ENTER] to return to
the first programming display.
2Complete programming.
3Access desired function.
Page 96
430-00899-002.book Page 89 Friday, November 19, 2004 9:43 AM
Pump Storage
Store the GemStar Pump in a cool, dry place. Remove the disposable batteries and
the battery pack before storing the pump.
Program and event history are protected in the software memory for at least one year
when power is removed from the pump.
Cleaning and Disinfecting
Establish a routine schedule for cleaning the pump to keep the case exterior, cassette
pocket, and tubing channel free of contamination.
Chapter 7
Maintenance
CAUTION: To avoid mechanical or electronic damage, do not immerse pump in
any fluids or cleaning solutions.
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, ETO, or radiation. Apply
disinfectants to the outside surface of the pump only. Do not use
abrasive cleaners or materials on the pump. Using abrasive
cleaners or cleaning solutions not recommended by Hospira may
result in product damage.
To avoid pump damage, cleaning solutions should be used only as
directed in the table on the following page. The disinfecting
properties of cleaning solutions vary; consult the manufacturer for
specific information.
Never use sharp objects (such as pens, pencils, fingernails, paper
clips, needles, etc.) to clean the pump.
430-00899-002.book Page 91 Friday, November 19, 2004 9:43 AM
Cleaning the Cassette Pocket and Tubing Channel
The area containing the ultrasonic sensors, located in the cassette pocket, should be
cleaned on a regular basis.
CAUTION: Use care not to damage the silicone seals around the sensor bodies.
1Remove the cassette, if installed.
2Use a cotton swab, moistened with an
approved cleaning solution, to clean the
sensor faces (
plunger tip (
A), tubing channel (B),
C), and sensor pins (D).
3Dry the sensor faces and tubing channel
and ensure the sensor faces are free of
detergent film and/or debris.
7. Maintenance
D
A
C
B
Repair
6The GemStar Pump has no user-serviceable components, with the exception of
disposable batteries.
6If the display clock stops working, contact Hospira Technical Support Operations
to arrange for internal lithium battery replacement.
6Homecare Customers: Call your healthcare professional or homecare company
regarding any required service or repairs. DO NOT attempt to repair the pump for
any reason.
6The GemStar Pump is covered by a manufacturer’s warranty for one year after
purchase. During this time, opening the pump case for any reason voids this
warranty. Refer to Chapter 12 Warranty/Technical Assistance, page 137 for
details.
6Refer all service to Hospira certified technicians only. A GemStar T echnical Field
Service Manual is available to Hospira certified technicians.
430-00899-002.book Page 93 Friday, November 19, 2004 9:43 AM
This test is designed to ensure the GemStar Pump is operating properly. Hospira
recommends performing this test a minimum of once every 12 month s. Refer to
facility requirements to determine additional testing needs.
Chapter 8
Operation Test
The test can be performed when the pump is in the
approximately 15 minutes to complete. The pump provides step-by-step instructions
through each section of the test.
d
Note: This test is available only when the pump is UNLOCKED.
WARNING: Disconnect the pump from the patient BEFORE
performing the Operation Test.
Equipment Required
6GemStar Pump
6Two GemStar Microbore Pump Sets without a filter
6Reservoir with at least 50 mL of water
620+ mL or larger graduated cylinder (graduated in 0.1 mL)
6Two fresh, disposable AA batteries
6Appropriate GemStar AC Mains Adaptor or other Hospira approved external