Gem Premier 3000 Operator's Guide

Critical
Operator’s Care
Guide
GEM ® Premier™ 3000
Manufacturer:
Instrumentation Laboratory Company
180 Hartwell Rd.
Bedford, MA 01730-2443 U.S.A.
EU Authorized Representative:
Part. No 00024001596 Instrumentation Laboratory SpA
Rev. 00 February 2014 Viale Monza 338 - 20128 Milano, Italy
GEM ® Premier™ 3000
Operator’s Guide
Part. No 00024001596 Rev. 00 February 2014
This Manual contains all the basic instructions on how to operate the IL GEM Premier 3000 analyzer.
For more details, please refer to the IL GEM Premier 3000 Operator’s Manual.
This publication and any or all materials (including software) herewith enclosed are of a proprietary nature and are communicated on a
strictly confidential basis; they may not be reproduced or recorded without Instrumentation Laboratory’s prior written consent. Information
contained herein is believed by Instrumentation Laboratory (IL) to be accurate: in any event, no responsibility, whether expressed or implied,
is assumed by IL for, or in connection with the use thereof, or from any representation or omissions contained therein. Information is subject
to change and/or updating without notice.
GEM Premier 3000
Table of Contents
1. General Description (Intended Use, Optional Modules & Connectivity,

Graphical Symbols, Warnings and Precautions)
2. Instrument Installation
3. Start Up
4. Configuration
5. iQM™
6. Patient Sampling
7. Active Process Control - Checking for Interfering Substances
and Micro-clots
8. External Quality Control – Material Definition
9. External Quality Control – QC Sampling
10. Cartridge Removal
11. Saving Cartridge Data
12. Shutdown and Transport
13. GEMweb™
14. Diagnostics
15. Training
16. Troubleshooting, Software Upgrades & Cleaning
17. Database Recall
18. Operating Principles
19. System Specifications
20. Ordering Information
21. Warranty Information
22. Worldwide Locations
Instrumentation Laboratory Table of Contents

1. General Description
GEM Premier 3000 systems were cleared through the FDA 510(k) and Canadian license processes
as part of their regulatory requirements for the United States and Canada. They meet the requirements
of the European Union IVD directive 98/79/EC, according to which, they are CE marked.
Intended Use Front View and Cartridge

The GEM Premier 3000 is intended as
1. Color touch screen
a portable system for use by health care
2. Sampling area
professionals to rapidly analyze whole blood
3. Printer paper compartment
samples in any clinical setting. The instrument
4. Diskette drive
provides both measured and calculated results
5. Bar code wand
for Blood Gases, Hematocrit, Electrolytes,
6. Ampoule barcode reader
Glucose and Lactate.
7. Ampoule breaker & ampoule drawer
8. Cartridge door
9. Multi-use, disposable cartridge
10. Cartridge bar code
GEM Premier 3000 Analyzer and Cartridge

1
6 4
3
7 10
350328R0
1. General Description Instrumentation Laboratory

Rear View
1. Power socket
2. Power switch
3. Serial ports (3) (RS-232)
4. Parallel port
5. Network port (Ethernet)
6. Bar code reader port
7. Handle
8. Color touch screen tilt adjuster
9. Instrument Serial Number
8
7
3
9
4 6
5
2
Instrumentation Laboratory 1. General Description

Optional Modules and Connectivity

The GEM Premier 3000 may be used in conjunction with IL external CO-Oximeter devices (IL 682
or GEM OPL®) and/or the GEM PCLTM portable coagulation analyzer, to have CO-Ox and coagulation
parameters integrated into the GEM Premier 3000 result printouts and database (CO-Ox data only).
Other devices that may be connected to the GEM Premier 3000 are the LIS/HIS and an external parallel
printer. The Network port enables access to an ethernet (local) network and personal computers.
GEM Premier 3000 Interface Specifications are available upon request.
Barcode Reader
Ethernet
LIS or HIS/GEMweb via Intranet
Serial
GEM OPL or IL 682/GEM PCL/LIS or HIS
Parallel
External Printer
1. General Description Instrumentation Laboratory

Graphical symbols
CAUTION: Batch Code

risk of electric’s shock
ATTENTION, Catalog number

see instructions for use
Biological risk Serial number
NOTE: important In vitro diagnostic

user information device
ATTENTION, Authorized
consult accompanying representative
documents
CE mark ∑ Contains sufficient ∑

for <n> tests
Temperature limitation Protective conductor

terminal
Use by On (supply)
Manufacturer Off (supply)
Instrumentation Laboratory 1. General Description

2. Instrument Installation
1. Place the instrument in a convenient location. 2. Plug the power cord in (frequency and voltage are
There should be at least 12 inches (30.5 cm) to the right automatically adapted). For serial, parallel, network or
of the instrument to allow for opening of cartridge door. barcode reader port connection, connect the relevant
cable.
3. Before turning “ON”, install printer paper as follows: 4. Turn the power switch on the back of the instrument
a - Open the printer paper compartment door. to “ON”.
b - Move the lever “UP”.
c - Place the new paper roll into the cup in the base
of the door.
d - Push the paper into the printer and thread it over
the top roller.
e - Move the lever “DOWN”.
To prevent electrical shock to the operator, connect this device to a properly wired and grounded receptacle.
f - Thread the paper over the door and close the door.
Use only the medical grade power cord supplied with the instrument.
5. The message shown above will be displayed.
2. Instrument Installation Instrumentation Laboratory

3. Start Up
1. Turn the power switch to “ON”. The instrument 2. Set “Date and Time” (if necessary*) by selecting
will automatically start the power up cycle (1 minute). this option from “Configuration” menu.
* Changing the date or time requires an instrument
restart.
3a. Using the keypad, enter the Key Operator Password. 3b. Then touch “ENTER” to confirm.
3c. Touch “OK” to acknowledge the screen message.
Instrumentation Laboratory 3. Start Up

3. Start Up
4. Touch the “Date” field. 5. Enter the correct date using the keypad and touch
“ENTER” to confirm.
If Daylight Savings Time is enabled, the time

will move forward by one hour on the first
Sunday in April, and will fall back by one hour on the
last Sunday in October.
6. Touch the “Time” field.
7. Enter the correct time using the keypad and touch 8. Touch “OK” to leave the “System Date and Time”
“ENTER” to confirm. screen.
If there is any moisture inside the foil bag

DO NOT use that cartridge.
9. To prepare cartridge, grasp the tab end of the
plastic protective cover. Pull firmly to remove cover.
3. Start Up Instrumentation Laboratory

3. Start Up
350328
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10. Insert cartridge within one minute of removing 11. Check if date/time are correct. If incorrect, select
the protective cover. NO and correct (The Key Operator Password is
required to change date/time).
12. Wait for “Ready” screen to appear (warm-up takes 13a. “Ready” screen with iQM enabled.
approximately 30 minutes).
13b. “Ready” screen with iQM disabled (iQM cartridge 13c. “Ready” screen with a non-iQM cartridge
inserted). inserted.
Instrumentation Laboratory 3. Start Up

3. Start Up
3. Start Up
Configuration
Restore KOPW
Enter Key Operator Password
Sample Setup QC Setup iQM Setup Calibration Setup Instrument Setup Interface Setup Security Setup Save Config
Analyte Mandatory QC iQM Mode Calibration Reports Date Format Port Configuration Disable Patient Restore Config**
Enable/Disable (off, Requested, Required) (on, off) (off, Errors, (MM-DD-YYYY, Sample Analysis
Network Setup*
Summary, Full) DD/MM/YYYY (on, off) Set Date and Time**
Panel Setup QC Failure & CVP Material
YYY/MM/DD) Printer Setup (Daylight Savings Time)*
Patient Results Setup Low Oxygen Enable E-mail
Demographics
(flag results, Calibration Time Language Sample Results
Setup
blank-out results) (02:00) (on, off)
Instrument Name*
Units of Measure Network Tab
QC Material Setup (blank, entered) Operator Security
Sample Print Mandatory GEMweb Tab (on, off)
CO-Ox QC Patient ID Touch Key Sound
Options
Material Setup (on, off) (high, low, off) Network Printer Tab Default Operator
Correlation Factors (on, off)
Routine QC Default Patient Select Colors
Patient Ranges Schedule Setup (on, off) (A, B, C, D) Authorized
Internal Printer Operators Setup*
Print Ranges New Cartridge QC Demographics (on, off)
with Results Schedule Setup Lookup Save Authorized
(on, off) (on, off) Parallel Printer Operators
QC Statistic (on, off)
Patient Sample Set Ranges Patient Verification Restore Authorized
Auto-Accept Requirements (on, off) Network Printer Operators
(on, off) (on, off)
Host Confirmation Change Key
Flag Patient Results Timeout External Printer Operator Password
for Interference and 5 - 300s (15s) Header Lines
Micro Clots 0 - 14 (0)
(on, off)
* Configuration settings not

Enable Duplicate transferred with the Save
Reports Configuration and Restore
(on, off) Configuration commands;
Network settings include only
Sample Reports IP address, host name, and
Title GEMweb access checkbox
(entered, blank) setting,
** These options can only be

accessed when no cartridge
is inserted.
Instrumentation Laboratory
4. Configuration
1. Select the “Configuration” pull-down menu. 2. Select a command from the Configuration menu.
(The instrument will prompt for entry of the Key Operator
Password.)
3. Enter the “Key Operator Password” (touch the desired 4. Touch “ENTER” to confirm.
characters on the keypad).
5. Modify the setup selecting the appropriate option. 5. Modify the setup selecting the appropriate option.
(a. Sample Setup) (b. Sample Setup - Analyte Enable/Disable (Measured))
(c. Sample Setup - Analyte Enable/Disable (Derived)) (d. Sample Setup - Analyte Enable/Disable (Entered))
Instrumentation Laboratory 4. Configuration

4. Configuration
(e. Sample Setup - Analyte Enable/Disable (O2/Vent)) (f. Sample Setup - Demographics)
(g. QC) (h. iQM)
(i. Calibration) (j. Instrument)
(k. Interface) (l. Security)
4. Configuration Instrumentation Laboratory

5. iQM (Intelligent Quality Management) with Active Process Control
To activate the iQM program

for an iQM cartridge, “iQM
Mode” must be enabled,
and the CVP (Calibration
Validation Product) attributes
must be entered.
1. Select iQM Setup in Configuration 2. Enable iQM Mode. Select “CVP Material Setup”.
3. Touch ADD from the CVP Material Setup Screen. 4. Enter the CVP attributes by scanning the insert bar
codes (CVP ranges cannot be entered manually).
5. CVP Material Information screen. 6. When iQM Mode is ON and an iQM cartridge has
completed warm-up, a prompt will appear to run all
CVP levels for analytes enabled.
7. To run CVP touch CVP on the Ready Screen. 8. Select the proper material or scan CVP ampoule
in the ampoule bar code reader.
Instrumentation Laboratory 5. iQM (Intelligent Quality Management) with Active Process Control
5. iQM (Intelligent Quality Management) with Active Process Control
9. Confirm CVP sample aspiration and run all levels of 10. Check the CVP result.
CVP required for the analytes enabled in Configuration.
• CVP Levels 1 and 2 for Blood Gas/Electrolytes/Glu/Lac
• CVP Levels 3 and 4 for Hematocrit
The sensor will not change to “Green OK” on

the “Ready” screen until all CVP materials are
run for analytes enabled in Configuration, and
pass the limits bar coded into the analyzer.
Only then will iQM become active. If an iQM Delta Charts and Corrective Action
analyte does not pass, open and run a new Reports can be viewed from the Database
ampoule (same level and lot). menu, and CVP Reports can be printed
iQM’s Active Process Control programs from the Database menu.
Treat all patient and QC specimens as highly infectious. Use proper technique and care to not contaminate yourself and not to create aerosols.
monitors cartridge integrity and system

performance, including automatic corrective
action and documentation, for the entire
on-board use-life of the cartridge.
11. Check iQM Reports. 12. Review Delta Charts.
13. Review Corrective Action Report. 14. Review CVP Samples.
5. iQM (Intelligent Quality Management) with Active Process Control Instrumentation Laboratory
6. Patient Sampling (syringe or capillary)
Use either Sodium or Lithium

Heparin anticoagulants. The
final concentration of Heparin
in the sample should be
approximately 25 IU/mL.
Samples must be mixed
thoroughly immediately upon
drawing to ensure adequate
mixing of the anticoagulant
with the blood sample. Proper
mixing will help prevent the
formation of clots and will
create a homogeneous
sample.
1. Check for the presence of the “Ready” screen. 2. If desired select the appropriate Test Panel as follows:
a. Touch the “Panel” button on the “Ready” screen.
b. Select the desired test panel. 3. Analytes may also be selected/deselected from the
c. Confirm by touching the “OK” button. Ready Screen.
4. Select Sample Type (touch “Arterial”, “Venous”, 5. If requested (when Operator Security is turned on),
“Capillary”, “Other”). enter authorized operator’s password. If not requested,
move directly to step 7.
6. Touch “ENTER”.
Instrumentation Laboratory 6. Patient Sampling

6. Patient Sampling
7. If Mandatory Patient ID is ON, enter Patient ID 8. The analyzer then prepares to accept a sample.
and touch Enter.
Treat all patient and QC speciments as highly infectious. Use proper technique and care to not contaminate yourself, not create aerosols.
9. Mix and position sample so that the sampler is near but not touching the bottom of the syringe plunger.
For capillary sampling, the IL capillary kit (P/N 82590-00) may be used.
10. Select “OK” to begin aspirating sample. 11. When the instrument beeps four times remove the
sample.
6. Patient Sampling Instrumentation Laboratory

6. Patient Sampling
12. Dispose of the sample in a biohazard waste 13. Enter sample information, via keyboard or barcode
container. wand (if requested), or user-entered analytes (if enabled)
by filling in the appropriate field.
14. Touch “OK” to confirm. 15. When analysis is complete, review results on “Patient
Sample Results” screen and set sample disposition by
touching “Accept”, or “Discard”, only if Auto-Accept is
disabled.
16. Press “Exit” to return to the “Ready” screen or, wait 17. When the “Show History” button is selected on
90 seconds and the screen will automatically refresh to the Result screen, results from the last 7 accepted
“Ready”. If Auto-Accept is disabled and the sample is samples of a single patient ID are displayed.
not Accepted or Discarded, the results will be “Pending”.
Instrumentation Laboratory 6. Patient Sampling

7. Active Process Control: Checking for Interfering Substances and Micro-Clots
For both iQM and non-iQM

cartridges, if flagging of
patient results for interfering
substances and micro-clots
is enabled, results are
flagged if an interference or
micro-clot is detected, and
reporting is delayed until
Process Control Solution
B is analyzed.
1. Check in progress. 2. Micro-clot pattern detected for an iQM cartridge.

Press “OK” to acknowledge.
Both iQM and non-iQM cartridges employ

Failure Pattern Recognition (FPR) checks
for micro-clots and interfering substances.
If flagging of results for micro-clots and
interfering substances is not enabled,
following sample analysis and evaluation
of Process Control Solution B, the presence
of one of the FPR patterns is communicated
to the operator on the screen. The message
disappears only after operator acknowledge-
ment. The operator must then follow the
facility’s policy on how the results of that
sample will be handled.
3. Attempted iQM cartridge correction in progress.
4. Interference detected. 5. When interference or micro-clot patterns are

detected results are flagged when the flagging option
is enabled.
For non-iQM cartridges and iQM cartridges with

the iQM Mode turned off: following detection and
attempted automatic correction, the System does not
verify that the micro-clot or interfering substance has
been eliminated. The operator will be prompted by the
analyzer to run external QC to verify that the analyzer
can be used.
6. If the failure cannot be corrected the relevant
parameter(s) will be disabled (only with an iQM
cartridge inserted and iQM Mode turned ON).
7. Active Process Control: Checking for Interfering Substances and Micro-Clots Instrumentation Laboratory
8. External Quality Control Material Definition
1. To define QC material, touch the “Configuration” 2. Enter the Key Operator Password and touch “ENTER”
pull-down menu and select “QC Setup”. to confirm.
3. Select the relevant “QC Material Setup” 4. Touch “Add”
5. For IL QC solutions, scan the barcode insert to QC solution information may be entered manually.
enter the lot number and QC ranges. (Manual entry is required for non-IL QC solutions.)
QC only needs to be defined in Configuration

when a new lot number of QC is received.
6. When all values have been entered touch “OK”
three times to return to the “Ready” screen.
Instrumentation Laboratory 8. External Quality Control Material Definition

9. Quality Control - QC Sampling
1. Touch the “QC” button on the “Ready” screen. 2. If requested, enter the authorized operator’s
password by touching the desired characters
on the keypad.
3. Touch “ENTER” to confirm. 4a. Select the QC material previously defined

in QC Material Setup and press “OK”...
4b. or insert IL QC ampoule in the bar code reader. 5. Mix, break off the ampoule neck in the ampoule bre-
aker and present the control vial to the sampler.
9. Quality Control - QC Sampling Instrumentation Laboratory

9. Quality Control - QC Sampling
6. Press “OK” to begin aspirating sample. 7. When the instrument beeps four times remove control
vial.
8. Dispose of the control vial in an appropriate 9. The “Sample Information” screen will appear. The
biohazard waste container operator, via keypad or wand, may enter their ID
and add any comments. Confirm by touching “OK”.
10. When analysis is complete, review the results and set

the QC sample disposition by touching the appropriate
button: “Accept” or “Discard”. The screen automatically
refreshes to the “Ready” screen.
Instrumentation Laboratory 9. Quality Control - QC Sampling

10. Cartridge Removal
When cartridge removal

is required, the GEM
Premier 3000 will unlock
the cartridge door and
display the “Remove
Cartridge” screen.
If the screen displays “Remove cartridge” proceed to 2. Touch “YES” to confirm. If Operator Security is
Step 3. If cartridge removal is at operator’s request: turned ON, the system will prompt for the operator’s
1. Select “Remove Cartridge” from the “Cartridge” menu. password.
GEM ®
350328
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3. Follow the prompt on the screen. 4. Slide the handle/lock of the cartridge door towards
the front of the instrument to open, and remove the
cartridge.
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5. Dispose of the cartridge in an appropriate biohazard 6. If required, insert a new cartridge.

container.
GEM Premier 3000 saves sample and

calibration data for at least the last 20 cartridges.
The instrument deletes the data of the oldest 20 cartridges
when the 41st cartridge is inserted and database
maintenance is requested. Sample and calibration data
can be saved to disk.
Cartridges cannot be reused once they have been
removed!
Cartridge Removal must only be done when 1) prompted
by screen or 2) manually requested through the “Cartridge”
menu.
DO NOT REMOVE CARTRIDGE

WHEN ANALYZER IS OFF.
10. Cartridge Removal Instrumentation Laboratory

11. Saving Cartridge Data
“The GEM Premier 3000

Database can contain up
to 40 cartridges. Before the
41st cartridge is inserted,
the instrument performs
Database Maintenance.
It deletes the data from
the oldest 20 cartridges
and keeps only the most
recent 20.
The data from a specific

cartridge can be copied to
a standard, high density,
1.44 MB PC formatted
diskette (Diskettes may be
purchased from IL). Each car-
tridge requires one diskette. 1. Select “Copy Cartridge Data” from the 2. Select the cartridge to be copied in the “Select
DIAGNOSTICS menu. Cartridge to Copy” screen.
3. Touch “Copy”. 4. Insert a blank, high density, 1.44 MB PC-format

diskette into the disk drive and touch “OK”.
The instrument will display:

“Preparing data for copying. Please wait”,
and then:
“Copying data to diskette. Please wait.”
5a. Once copying is complete, press the button by the

disk drive, and ...
5b. remove diskette. Touch “EXIT” to return to “Ready” 6. iQM Data must be copied separately, and to a
screen. different diskette. To copy, select “Copy iQM Data” from
the Diagnostics menu and follow the screen prompts.
Instrumentation Laboratory 11. Saving Cartridge Data

12. Shutdown / Transport
1. Select “Shutdown” from the Shutdown menu and touch 2. A prompt will be displayed when it is safe to turn
“YES” to confirm. If Operator Security is turned ON the the analyzer off.
system will prompt for the Operator’s password.
Note: If the instrument is turned off, or power

removed without selecting “Shutdown”, data
loss may result.
To transport the instrument to a new location do

not remove the cartridge. Access "Shutdown"
menu and turn the power switch to "OFF" at
the appropriate prompt.
The cartridge must be removed if the instrument:

a. remains without power for more than one hour and
no blood is on the sensors and a low oxygen or “A”
calibration is not in progress, or
b. remains without power for more then 20 minutes
with blood on the sensors, or a low oxygen or “A” 3. Once the prompt is displayed, turn the power switch
calibration is in progress. (located on the instrument back panel) OFF and unplug
from the power receptacle.
When power is restored under the above

conditions the GEM Premier 3000 restarts
and an automatic “Recovery Cycle” begins,
which will take 3 to 12 minutes.
12. Shutdown / Transport Instrumentation Laboratory

13. GEMwebTM: Instrument Setting
1. Using a dedicated cable, connect the cable to the 2. In “Interface Setup”, select “Network Setup”.
network port (ethernet) of the GEM Premier 3000.
3. Contact the Network Administrator and configure 4. Contact the Network Administrator and configure
the Network table accordingly. the GEMweb table accordingly. Enable GEMweb
access.
To prevent electrical shock to the operator, connect this device to a properly wired and grounded receptacle.
5. In “Security Setup” select “Authorized Operator 6. Add Authorized Operators ID (and password) and
Setup”. enable the relevant Network and GEM access, in
order to allow the operator access to the analyzer
and GEMweb.
Instrumentation Laboratory 13. GEMweb: Instrument Setting

13. GEMweb: PC Setting
7. Using the PC browser, enter the GEM Premier 3000 8. Enter Operator ID and password.
IP Address to connect the PC to the analyzer.
9. Enter the GEM Premier 3000 Home Page (it contains

a snapshot of the screen currently displayed on the GEM)
and select the desired function.
13. GEMweb: PC Setting Instrumentation Laboratory

13. GEMweb: GEMweb Functions
10. Sample review (Patient, QC, CVP, All) can be... 10a. ... selected.
10b. ... reviewed. 10c. ... e-mailed to any valid Internet address.
11. For diagnostic review by IL, Diagnostic Data of one 12. Review the Analyzer status (Sensor, iQM status,
selected cartridge can be e-mailed to a pre-defined QC, Cartridge Expiration...).
recipient (normally the Service Department).
Instrumentation Laboratory 13. GEMweb: GEMweb Functions

13a. Remote Control for analytes - Enable/Disable. 13b. Remote Control for operator, analyzer and network
access - Enable/Disable.
13c. Remote Control for sample analysis - Enable/Disable. 13d. Remote Control to perform a 2-point Calibration.
14. Send message to the analyzer. 15. Review iQM reports.
13. GEMweb: GEMweb Functions Instrumentation Laboratory

15a. Select month, analyte and PC Solution to chart 15b. Review the iQM Delta chart selected.
(12 months stored on the analyzer).
15c. View a Corrective Action Report (12 months stored 15d. View CVP Report (12 months stored on the
on the analyzer). analyzer).
16. Terminate the session by selecting LOGOUT.
Instrumentation Laboratory 13. GEMweb: GEMweb Functions

14. Diagnostics
1. The “Diagnostics” menu provides access to diagnostic 2a. The “Ports” menu provides access to the
information related to the GEM Premier 3000 PAK communication ports available on the GEM Premier
cartridge and the analyzer. 3000 and to the status of LIS/DMS interface.
2b. 3. The “Printer Diagnostic” screen displays status

information, print queue information, and diagnostics
for the internal, external and network printer.
4. The “System Information” menu displays software 5. Copy IL Data copies important files to a diskette to
versions, software installation date and type, instrument assist IL in solving problems. Patient name and ID will
serial number and cartridge information. be blanked out for privacy.
The Copy IL Data
command is used
to copy files for IL’ s use in
diagnosing problems. To
save sample data for a
cartridge, use the Copy Cart.
Data command.
6. 2-pt Calibration initiates a manual 2-point calibration. 7. Copy Cart. Data and Copy iQM Data is described
This may be used during troubleshooting to correct in Section II, Saving Cartridge Data.
previous calibration errors prior to repeating QC or CVP
ampoules.
14. Diagnostics Instrumentation Laboratory
15. Training
Video files are supplied for

the purpose of customer
training. The video training
topics supplement the
information located in the
Operator’s Guide.
1. Select the “Training” button on the “Ready” screen. 2. Select one of the main topics.
3. When available, select “Subtopics”. 4. Play the video.
If “Play All” is selected, all video topics will be

played. To EXIT from the Play All Mode, the
operator must Exit from every individual video topic.
To access the video menu bar (Rewind,

Pause, Step, Play, Loop OFF, Exit), touch the
video while it is playing.
Instrumentation Laboratory 15. Training

16. Troubleshooting, Software Upgrades and Cleaning
16.0 Troubleshooting This section describes how to contact Instrumentation Laboratory (IL) for help, how to handle system
& Cleaning problems, and provides instructions for returning materials to IL. Instructions are also provided for
installing system software and cleaning the instrument.
16.1 Contact In order for Technical Support to serve you efficiently, please have the following information available
before you call:
Instrumentation • Operating software version and instrument serial number (from the Diagnostics, System Info screen).
Laboratory • The error number and/or message the instrument is displaying, if applicable.
• The bar code number of the GEM Premier 3000 PAK cartridge currently installed in the instrument
(from the Diagnostics, System Info screen).
16.2 Error Messages, In certain situations, during the operation of the GEM Premier 3000, the instrument may notify the
Alarms, and operator of problems through Alarms or Error Messages.
Corrective
Actions Alarms
Alarms will address either problems with transmitting data or problems with the on-board printer.
The instrument notifies operators of Alarms with the Messages button, which is displayed on the
Restart, Remove Cartridge, Insert Cartridge, Cartridge Warm-up, and Ready screens. The Messages
button will be displayed in yellow when at least one
message or alarm is present. Each alarm entry
will show the date and time the alarm occurred
and the alarm message. To clear all alarms,
touch the Clear button. The Alarms listed in
the following table are types that will require
attention.
Alarm Message Possible Cause Corrective Action
Printer Out The printer is out of paper, or Install paper in printer, then clear
of Paper there is paper in the printer but alarm.
the paper lever is up, or there
If alarm occurs again, cycle
is a problem with the printer
power on instrument.
or printer cable.
If alarm continues to occur,
contact Technical Support.
Printer Error Verify paper is in the printer and

There is a hardware problem paper lever is down, then clear
with the printer or printer cable. alarm.
If alarm occurs again, cycle
power on instrument.
If alarm continues to occur,
contact Technical Support.
Transmission Error Check connections to the RS-232

or Ethernet port and to the
Data could not be transmitted to receiving computer system.
the LIS (Laboratory Information
Check configuration of LIS
System) successfully. The LIS
system.
cable may be faulty or the LIS
system configured incorrectly. If alarm occurs again, cycle
instrument power.
If alarm continues, contact
Technical Support.
16. Troubleshooting, Software Upgrades and Cleaning Instrumentation Laboratory

• Biohazard waste bags

• Non-abrasive, mild cleaning solution
Make sure the cleaning cloth is only moist, not dripping wet. Avoid letting water or cleaning
solution enter the unit enclosure. If cleaning solution enters the enclosure, do not reconnect
the instrument to AC power. Instead, contact Technical Support.
Preparation for Cleaning
Error Message Possible Cause Corrective Action
Heater block temperature The operating environment is out- Check ambient temperature.
out of range. The instrument side the expected range, or a Contact Technical Support.
has been halted. hardware failure has occurred.
Insufficient sample volume. Sample volume was less than Aspirate another sample. Ensure
Test cancelled. the minimum requirement, or greater volume and that end of
Please repeat test. Hematocrit it is greater than 65%. the sampler is continuously
submerged during sampling.
The cartridge shelf-life has Select and insert a cartridge that

expired. Please remove the The cartridge shelf-life read by has not exceeded its expiration
cartridge now and use the instrument or bar code wand date.
another cartridge. has been exceeded.
Verify that instrument’s internal
clock is set to the current date.
16.3 Return Goods to Error Messages

Instrumentation Error Messages are individually numbered to identify the specific type of error. Many of the messages
Laboratory will provide corrective action information to act upon. The remainder of the error messages will refer
operators to Technical Support. When contacting Technical Support, record and communicate the
particular error number and message the instrument is displaying.
The messages listed in the following table are the types of errors that will require attention.
If the GEM Premier 3000 or related components require service, contact Technical Support. If a return
is necessary, IL, or its authorized agent, will issue you a Return Goods Authorization number. Prior to
packaging the instrument for return, please refer to cleaning instructions. Please ensure that the
16.4 Software
Upgrade ampoule breaker container has been emptied and the printer paper has been removed prior to
shipping the instrument.
Do not attempt to return a product without first receiving a Return Goods Authorization number.
Reference the number on the shipment packing list. It should be clearly visible on all packages.
From time to time, IL may update the operating software that controls the GEM Premier 3000. The
following instructions provide the steps required to upgrade the instrument’s operating software,
unless special instructions are received with the new software.
To see the version number of the operating software currently in use by the instrument, select
System Info. on the Diagnostics menu.
Never load an older version of the software on the GEM Premier 3000. The instrument cannot
be downgraded to previous versions of software.
To Upgrade the Software:

1. Select Shutdown from the Shutdown menu, and power off the instrument.
2. Insert the Upgrade Disk, label facing forward, into the floppy disk drive. Follow the upgrade
instructions provided in the upgrade kit.
16.5 Cleaning 3. If the instrument was previously customized through Configuration, save the configuration
Procedure information.
Discard any configuration disks generated under older versions of the software, as these will
not be useable with the new software version.
With proper care, the GEM Premier 3000 requires very little cleaning. The following paragraphs
describe how to clean and disinfect the instrument as necessary.
Recommended Supplies
The following supplies are recommended for cleaning the GEM Premier 3000:
• Disposable latex or rubber gloves
• Laboratory coat or jacket
• Soft cleaning cloths
• 50/50 mixture of liquid chlorine bleach and water
Instrumentation Laboratory 16. Troubleshooting, Software Upgrades and Cleaning

The GEM Premier 3000 processes patient samples that may be highly infectious.
When cleaning the instrument, use proper technique and care to avoid contaminating
yourself or others.
1. Put on rubber or latex gloves and a laboratory coat or jacket before handling the instrument.
2. Prepare a biohazard waste bag for waste disposal.
Cleaning the Touch Screen:

You do not need to disconnect the GEM Premier 3000 from AC power when cleaning the touch
screen. However, be careful to prevent water or cleaning solution from entering the unit enclosure.
1. Dampen a soft cleaning cloth with water or mild cleaning solution.
2. Carefully wipe the face of the touch screen free of fingerprints and other smudges.
Use only a soft cloth moistened with water or a mild cleaning solution. Do not use abrasive
cleaner or any bleach mixture to clean the touch screen, as this will damage the screen.
To Clean the Instrument:

1. Shut down the instrument.
2. Disconnect the instrument from AC power (AC outlet or uninterruptible power supply (UPS)).
If a cartridge is inserted, power must be restored to the instrument within 20 minutes or one
hour, depending upon the message displayed during the shutdown process.
3. If the instrument is cabled to another instrument or a computer, disconnect this cable from the
instrument.
4. Place the unit on a non-porous surface.
5. Remove any blood or dust from the outer surface of the case using a clean, soft cloth moistened
with the 50/50 bleach mixture.
6. Inspect the gutter area into which the GEM Premier 3000 PAK cartridge is inserted, and clean
as necessary.
If moisture is evident, wipe the bottom of the gutter and exit hole using a cotton-tipped swab
moistened with cleaning solution.
7. Remove the QC ampoule-breaker storage container, and empty its contents into an appropriate
biohazard waste container.
8. Remove QC solution stains on the instrument or in the ampoule storage container using cleaning
solution.
9. If necessary, remove the instrument from the work surface, then clean the work surface using
a cloth or paper towel moistened with the 50/50 bleach mixture.
10. Place any used cloth or paper towel in an appropriate biohazard waste bag.
11. (Optional) With the AC power cord unplugged from the power source, wipe the AC power cord
completely from end to end using a soft cloth moistened with cleaning solution.
12. Return the instrument to its place of operation.
13. Connect the instrument to a properly grounded and wired AC outlet (AC outlet or UPS).
Check to make sure the plug and cord are dry before engaging the plug.
16. Troubleshooting, Software Upgrades and Cleaning Instrumentation Laboratory

17. Database Operations
1. Selecting Database from the Ready Screen allows retrieval of

Sample, QC and CVP data. The last 2-pt calibration may be printed
from this menu, and iQM Delta Charts and Corrective Action Reports
may be viewed and printed. The CVP Report can also be printed.
Instrumentation Laboratory 17. Database Operations

Blood gas, Electrolyte, Glucose, Lactate and Hematocrit measurements may by performed on arterial,
capillary, or venous blood. Proper collection of the blood sample before analysis ensures that the data
obtained corresponds directly to the actual state of the blood “in-vivo.”
18.1 Principles The central component of the GEM Premier 3000 PAK cartridge is the sensor card, which provides
of Operation a low volume, gas tight chamber in which the blood sample is presented to the sensors. The pH,
pCO2, pO2, Na+, K+, Ca++, Glucose, Lactate, and Hematocrit sensors, together with the reference
electrode, are integral parts of the chamber, with chemically sensitive membranes permanently
bonded to the chamber body. When the cartridge is installed in the instrument, the chamber resides in
a thermal block which maintains the sample temperature at 37 ± 0.3°C and provides the electrical
interface to the sensors.
Pump
Driver
Electrode Waste
Thermal Heater/
Card
Control Thermistor
Microprocessor
Electrode
Interface Solution
D
Arm Peristaltic
Driver Pump
Valve
Driver
Solution
RS-232 Printer A
Port Air
Solution Sample Inlet
B
Touch Diskette Air
Screen Solution
C Multi-port
Valve
Figure 1: GEM Premier 3000 Block Diagram
Included in the cartridge are two solutions called “A” and “B.” These solutions allow for calibrations
and/or internal process control checks. The “A” and “B” solutions provide high and low concentrations
for all parameters except Hematocrit, which calibrates at one level using the “B” solution. Prior to
calibration, the “A” and “B” solutions are read as unknown solutions, and these values are recorded in
the instrument’s database. During calibration, these values are adjusted for any slope or drift that may
occur over time. There is a third solution called “C” that is used to calibrate the low oxygen level. The
“C” solution is also used for conditioning the Glucose and Lactate sensors, removing micro-clots, and
cleaning the sample path.
Each solution is contained
Sampling Position in a gas-impermeable bag.
The solutions are tonomete-
red
to the appropriate gas levels
at the time of manufacture,
then the bags are filled in
such a manner as to eliminate
any head space. The lack of
head space, or gas bubbles,
in the solution allows it to be
maintained and used over a
range of temperatures and
barometric pressures with
no change in dissolved gas
concentration. The cartridge
also includes a reference
solution, distribution valve,
pump tubing, sampler, and
waste bag. Blood samples
that have been analyzed are
prevented from flowing back
out of the waste bag due to
the presence of a one-way
Figure 2: GEM Premier 3000 cartridge Component Diagram check valve in the waste line.
18. Operating Principles Instrumentation Laboratory

Electrochemical Sensors
The electrochemical sensors used in the GEM Premier 3000 PAK disposable cartridge are all formed
on a common plastic substrate. A schematic of the sensor card is shown in figure 3 . The tube marked
“Reference Inlet” supplies a silver nitrate solution to a flowing-junction reference electrode that provides
a highly stable reference potential for the system.
The individual sensors, with the exception of Hematocrit and reference, are formed from layers of
polymer films, which are bonded to the substrate. A metallic contact under each sensor is brought to
the surface of the substrate to form the electrical interface with the instrument.
Counter electrode
Glucose
Lactate
pCO2
Waste
pH
K+
Ca ++
Reference inlet Na +
Reference electrode
pO2
Hematocrit
Solution inlet Sensor channel
Figure 3: Schematic of GEM Premier 3000 Sensor Card
Instrumentation Laboratory 18. Operating Principles

19. Specifications
19.1 Dimensions Metric English

GEM Premier 3000
Height: 43.2 cm 17 inches
Width: 30.5 cm 12.0 inches
Depth: 30.7 cm 12.0 inches
Weight: 13.4 kg 29.5 pounds
GEM Premier 3000 PAK
Height: 15.2 cm 6.0 inches
Width: 21.6 cm 8.5 inches
Depth: 7.6 cm 3.0 inches
Weight: 1.9 kg 4.2 pounds
19.2 Power Power Requirements: Switching power supply accommodates 85 to 265 VAC,
Requirements
and Product 45/65 Hz. Power interrupts of up to 60 minutes are allowed
Safety for instrument transport. The instrument cannot be operated
during power interruptions.
Product Safety: CSA International Safety Approved. Complies with IEC 1010-1.
19.3 Ambient External Ambient Temperature Limits: 15°C (59°F) to 35°C (95°F)
Environmental
Requirements Relative Humidity Limits: 5% to 90%
Barometric Pressure Limits: None applicable. Calibration bags have zero head space for
operation over a wide range of atmospheric pressures with
no change in dissolved gas concentration.
In accordance with IEC regulations, no breakdown or safety hazard will occur in the temperature
ranges between 5 to 40°C (41 to 104°F).
19.4 Storage Instrument Storage: Store in original packaging.

Requirements
GEM Premier 3000 PAK Storage: 15 to 25°C (59 to 77°F).
GEM Premier 3000 PAK Shelf Life: Expires on the date indicated on the label of each cartridge.
A cartridge may be inserted up to and including the date
of expiration.
19.5 Sampling/
Measurements Use only Sodium Heparin or Lithium Heparin anticoagulant.
Sample Volume:
150µL BG/Hct/Lytes/Glu/Lac cartridges
145µL (capillary mode) BG/Hct/Lytes/Glu/Lac cartridges
135µL BG/Hct/Lytes cartridges
135µL BG/Hct cartridges
Sample Type: Whole blood with addition of approximately 25 IU/mL Sodium
Heparin or Lithium Heparin only
Time To Results: 85 seconds
19.6 Measurement Amperometric: pO2, Glucose, Lactate

Methodology
Potentiometric: pH, pCO2, Na+, K+, Ca++
Conductivity: Hct
Internal Temp. Control: Electrode chamber maintained at 37°C (98.6°F) nominal
Instrumentation Laboratory 19. Specifications

19. Specifications
19.7 Limitations Samples Contaminated Especially samples having a very low or high pO2 content.
with Room Air Similarly, pCO2 may be affected and subsequently pH and
Ca++ results as well.
Metabolic Changes Errors can occur due to metabolic changes if there is a
delay in measurement of the sample.
Elevated White Blood Cells Samples will deteriorate more rapidly, even when kept
or Reticulocyte Counts in ice water.
Improper Mixing Errors will be introduced if sample is not properly mixed
immediately after drawing or prior to measurement.
Changes to Manufacturer’s Instructions Data obtained may be compromised.
or Protocols
Improper Installation The instrument must be installed per the manufacturer’s
instructions. Prior to initiating any method evaluation
protocol, acceptable cartridge performance must be
demonstrated by acceptable calibration (no slope or drift
errors), and all levels of QC solutions within acceptable
ranges for non-iQM cartridges; all levels of CVP must be
run and within acceptable ranges for iQM cartridges.
Under-Heparinized Sample Blood clot can form in the sensor chamber causing
sensor failure if sample is not properly heparinized.
19.8 Interferences The following substances can potentially interfere with sample analysis:
• Severely abnormal plasma osmolarities or abnormal levels of proteins or lipids. Hematocrit values
produced by the GEM Premier 3000 may differ significantly from the values produced by a cell
counter. In general, abnormally high protein or lipid values may cause higher Hematocrit values,
and vice-versa.
• Benzalkonium Chloride or Benzalkonium Heparin: Arterial lines and sampling devices coated with
Benzalkonium Chloride may interfere with Sodium and Ionized Calcium determinations, causing
falsely elevated Sodium and Ionized Calcium readings.
• Thiopental Sodium: May interfere with the Sodium, Potassium, pCO2 and Ionized Calcium readings.
• The anesthetic Halothane may produce unreliable pO2 results due to interferences with the pO2
sensor.
• The following tested drugs may interfere with Glucose or Lactate determination, causing falsely
low readings:
Drug Interference Observed High “Normal” Level*

Flaxedil Ž 2 mg/dL 1.4 mg/dL
Ethanol Ž 350 mg/dL 100 mg/dL (toxic)
• The following tested drugs may interfere with Glucose and Lactate determinations, causing falsely
elevated readings:
Drug Interference Observed Maximum Therapeutic Level*

Acetaminophen (Tylenol) Ž 15 mg/dL 2 mg/dL
Isoniazide (Nydrazid) Ž 2 mg/dL 0.7 mg/dL (toxic)
Thiocyanate Ž 10 mg/dL 2.9 mg/dL
Hydroxyurea Ž 0.5 mg/dL 2 mg/dL
• The following tested anticoagulants may interfere with Glucose and Lactate determinations,
causing falsely low readings:
Anticoagulant Positive Interference

Sodium fluoride Ž 1 g/dL
Potassium oxalate Ž 1 g/dL
19. Specifications Instrumentation Laboratory

19. Specifications
Notes
1. Both iQM and non-iQM cartridges employ Failure Pattern Recognition (FPR) checks. One of
the FPR checks that the GEM Premier 3000 recognizes is for the positively charged lipophilic
compound Benzalkonium. Following sample analysis, and analysis of Process Control Solution B,
if Benzalkonium Chloride or Benzalkonium Heparin patterns are detected, the following message
will be displayed on the analyzer:
Sensor Interference Detected for Na and iCa on last sample likely due to Benzalkonium
The GEM Premier 3000 offers the operator the ability to enable flagging of patient results if an
interference pattern is detected. In addition, this option, when enabled, delays the reporting of
results until Process Control Solution B is evaluated for interference patterns, following sample
analysis. If flagging of patient results for an interference is enabled, the following message (plus
progress bar) will be presented while the post analysis Process Control Solution B check is
underway:
Checking for presence of interference and micro clots
This message will remain displayed until the Process Control Solution B analysis is complete. If an
interfering substance pattern is detected, the affected blood result(s) will be flagged. In addition,
the analyzer will beep three times to alert the operator. The following message disappears only
after operator acknowledgment:
Sensor Interference Detected for Na and iCa on last sample likely due to Benzalkonium
2. Another FPR check that the GEM Premier 3000 recognizes is for negatively charged lipophilic
compounds such as Thiopental Sodium. Thiopental Sodium is also known by other names,
including Thiomebumal Sodium, Penthiobarbital Sodium, Thiopentone Sodium, Thionembutatal,
Pentothal Sodium, Nesdonal Sodium, Intraval Sodium, Traoanal, and Thiothal Sodium.
Following sample analysis and analysis of Process Control Solution B, if the associated pattern is
detected in Process Control Solution B, the following message will be displayed on the analyzer:
Sensor Interference Detected for xxxxx on last sample
(where xxxx is the analyte or analytes affected)
The GEM Premier 3000 offers the operator the ability to enable flagging of patient results if an
interference pattern is detected. In addition, this option, when enabled, delays the reporting of
results until Process Control Solution B is evaluated for interference patterns. If flagging of patient
results for an interference is enabled, the following message (plus progress bar) will be presented
while the post analysis Process Control Solution B check is underway:
Checking for presence of interference and micro clots
This message will remain displayed until the Process Control Solution B analysis is complete. If
the associated pattern is detected, the affected blood result(s) will be flagged. In addition, the
analyzer will beep three times to alert the operator. The following message disappears only after
operator acknowledgment:
Sensor Interference Detected for xxxxx on last sample
(where xxxx is the analyte or analytes affected)

19. Specifications
19.9 Measured Measured Analyte Reportable Range Resolution

Analytes
pH 6.80 to 7.80 0.01
pH 15.8 to 158.5 nmol/L 0.1 nmol/L
pH 15.8 to 158.5 nEq/L 0.1 nEq/L
pCO2 5 to 115 mmHg 1 mmHg
pCO2 0.7 to 15.3 kPa 0.1 kPa
pO2 0 to 760 mmHg 1 mmHg
pO2 0.0 to 101.3 kPa 0.1 kPa
Na+ 100 to 200 mmol/L 1 mmol/L
Na+ 100 to 200 mEq/L 1 mEq/L
K+ 0.1 to 20.0 mmol/L 0.1 mmol/L
K+ 0.1 to 20.0 mEq/L 0.1 mEq/L
Ca++ 0.10 to 5.00 mmol/L 0.01 mmol/L
Ca++ 0.20 to 10.00 mEq/L 0.01 mEq/L
Ca++ 0.40 to 20.04 mg/dL 0.01 mg/dL
Glu 20 to 500 mg/dL 1 mg/dL
Glu 1.1 to 27.8 mmol/L 0.1 mmol/L
Lac 0.3 to 15.0 mmol/L 0.1 mmol/L
Lac 3 to 135 mg/dL 1 mg/dL
Hct 15 to 65% 1%
*THb
*O2Hb
*COHb Refer to your CO-Oximeter Operator’s manual
for reportable ranges.
*MetHb
*HHb
*SO2
*These analytes will be measured only if an IL CO-Oximeter device has been configured in Instrument Setup.
19.10 Calculated Derived Parameter Reportable Range Resolution

Analytes
HCO3- std 3.0 to 60.0 mmol/L 0.1 mmol/L
HCO3- 3.0 to 60.0 mmol/L 0.1 mmol/L
TCO2 3.0 to 60.0 mmol/L 0.1 mmol/L
BEecf -30.0 to +30.0 mmol/L 0.1 mmol/L
BE(B) -30.0 to +30.0 mmol/L 0.1 mmol/L
SO2c 0 to 100% 1%
Ca++ (7.4) 0.10 to 5.00 mmol/L 0.01 mmol/L
THbc 2.0 to 22.0 g/dL 0.1 g/dL
THbc 20 - 222 g/L 1 g/L
THbc 1.2 to 13.6 mmol/L 0.1 mmol/L
*O2ct Refer to your CO-Oximeter Operator’s manual
*O2cap for reportable ranges.
A-aDO2 ** 1 mmHg
pAO2 ** 1 mmHg
paO2/pAO2 ** 0.01
RI ** 0.1
CaO2 ** 0.1 mL/dL
CvO2 ** 0.1 mL/dL
CcO2 ** 0.1 mL/dL
a-vDO2 ** 0.1 mL/dL
Qsp/Qt ** 0.1
P50 ** 1 mmHg
*O2ct and O2cap are derived on an attached IL CO-Oximeter device and then transmitted to the GEM Premier 3000.
**Depends on the reportable range of the measured analytes used to calculate the parameter.

19. Specifications
19.11 User-Entered Entered Analyte Reportable Range

Analytes Temperature 15°C to 45°C (59°F to 113°F)
*Glu 0 to 999 mg/dL
*Glu 0.0 - 55.4 mmol/L
*Lac 0 to 30 mmol/L
*Lac 0 - 270 mg/dL
**THb 2.0 g/dL to 25.0 g/dL
**THb 20 to 250 g/L
**THb 1.2 to 15.5 mmol/L
**SO2 0% to 100%
**O2Hb 0% to 100%
**COHb 0% to 100%
**MetHb 0% to 30%
**HHb 0% to 60%
APTT-P 0.0 to 999.9 seconds
PT-P 0.0 to 999.9 seconds
PT INR 0.0 to 99.9 seconds
ACT 0.0 to 9999 seconds
ACT-LR 0.0 to 999 seconds
*Only available when BG/Hct or BG/Hct/Lytes cartridge is inserted.
**If an IL CO-Oximeter device has been configured in instrument setup, these analytes will be available as measured analytes.
User-Entered O2 and Vent Settings

Entered Analyte Reportable Range
O2 0.0 to 99.0 L/min
FiO2 20% to 100%
VT 0 to 9999 mL
Mode N/A
Mech Rate 0 to 9999 bpm
Spon Rate 0 to 9999 bpm
Peak Press 0.0 to 999.9 cm H2O
Itime (sec) 0.0 to 99.9 sec
Itime (%) 0 to 99 %
MAP 0.0 to 999.9 cm H2O
PEEP 0.0 to 99.9 cm H2O
CPAP 0.0 to 99.9 cm H2O
BIPAP (I) 0.0 to 99.9 cm H2O
BIPAP (E) 0.0 to 99.9 cm H2O
19.12 Input Input Parameter Maximum Length/Amount

Parameters
Patient ID 16 alphanumeric characters
Patient Last Name 16 alphanumeric characters
Patient First Name 16 alphanumeric characters
Operator ID 16 alphanumeric characters
Operator Password 10 alphanumeric characters
Accession Number 16 alphanumeric characters
Sample Comment 48 alphanumeric characters
User Measurement Panels 1 default panel; 9 user-defined panels
Panel Name 16 alphanumeric characters
Report Title 6 lines, 24 alphanumeric characters each
QC Lot Number 10 alphanumeric characters
QC Description 20 alphanumeric characters
Definable QC Solutions 20
Routine QC Schedules 250
New Cartridge QC Schedules 10
CVP Lot Number 10 alphanumeric characters
CVP Description 20 alphanumeric characters
Definable CVP Solutions 20

19. Specifications
19.13 Calibration One-Point Calibrations

Schedules Cartridge life (after warm-up) One-point calibration frequency
0.5 to less than 3 hours every 2 minutes
3 hours to less than 6 hours every 4 minutes
80 hours or greater every 30 minutes
Between one-point calibrations, all sensor outputs are being monitored every 30 seconds and
an automatic one-point calibration will be initiated if excessive drift in any channel is detected.
Two-Point Calibrations
Cartridge life (after warm-up) Two-point calibration frequency
30 minutes to less than 50 minutes every 20 minutes
50 minutes to less than 80 minutes every 30 minutes
80 minutes to less than 2 hours every 40 minutes
2 hours to less than 8 hours every hour
8 hours to less than 20 hours every 2 hours
20 hours to less than 40 hours every 3 hours*
40 hours or greater every 4 hours*
*or 20 samples, whichever comes first.
Low O2 Calibrations
Low O2 calibrations occur once every 24 hours throughout cartridge life (after warm-up). Following
the low O2 calibration, the instrument will perform one-point calibrations every three minutes for
15 minutes, then return to the previous schedule. The exact time of day for performing the low O2
calibration is determined by the user.
19.14 Performance Introduction

Characteristics The following analytical data were collected during evaluation studies at Instrumentation Laboratory’s
Summary facilities and at an external field site. These studies demonstrate the typical performance characteristics
of the GEM Premier 3000.
Quality Control Material Precision

Blood Gas precision data were generated by using three aqueous control levels of ContrIL 9 for
pH, pCO2, pO2, Na+, K+, Ca++, Glucose, Lactate and two control levels of GEM critCheck for
Hematocrit. Based on NCCLS guidelines, control levels were run in replicates of two once a day
for 14 days (twice on day one) for a total of 30 replicates on each of seven different GEM Premier
3000 instruments (N=210). The following table lists the combined results of the seven instruments.
SD is used for pH since differences are so small that %CV would be misleading.
Combined Precision Data for ContrIL 9 or GEM critCheck

Level 1
Parameter Mean Within Run Day to Day Total
%CV (or SD) %CV (or SD) %CV (or SD)
pH 7.15 0.008 (SD) 0.005 (SD) 0.009 (SD)
pCO2 (mmHg) 67 2.69 0.48 2.74
pO2 (mmHg) 72 1.25 2.3 2.63
Na+ (mmol/L) 159 0.50 0.71 0.86
K+ (mmol/L) 5.8 0.60 0.40 0.71
Ca++ (mmol/L) 1.59 0.76 1.56 1.74
Glucose (mg/dL) 274 2.04 0.70 2.16
Lactate (mmol/L) 5.1 2.13 1.13 2.41
Hematocrit (%) 24 0.91 1.20 1.50

19. Specifications
Level 2
pH 7.46 0.004 (SD) 0.002 (SD) 0.005 (SD)
pCO2 (mmHg) 35 1.59 0.21 1.60
pO2 (mmHg) 106 0.87 1.27 1.48
Na+ (mmol/L) 140 0.55 0.47 0.73
K+ (mmol/L) 4.0 0.99 0.59 1.11
Ca++ (mmol/L) 1.13 1.03 0.56 1.17
Glucose (mg/dL) 91 2.21 0.93 2.39
Lactate (mmol/L) 1.0 4.11 0.87 4.23
Hematocrit (%) 42 0.75 0.76 1.07
Level 3
pH 7.66 0.004 (SD) 0.003 (SD) 0.005 (SD)
pCO2 (mmHg) 17 2.28 1.70 2.78
pO2 (mmHg) 163 0.63 0.31 0.70
Na+ (mmol/L) 120 0.32 1.04 1.09
K+ (mmol/L) 2.8 0.94 1.30 1.69
Ca+ (mmol/L) 0.65 0.72 2.11 2.23
Glucose (mg/dL) 63 1.71 2.24 2.95
Lactate (mmol/L) 2.8 1.46 2.70 3.02
Hematocrit (%) NA NA NA NA
GEM CVP Precision – iQM Cartridges

Precision data were generated at Instrumentation Laboratory using GEM CVP (Calibration
Validation Product): two levels for pH, Blood Gases, Electrolytes and Metabolites, and two levels
for Hematocrit. Based on NCCLS guidelines, the verification material levels were run in singlet
once a day for 14 days (twice on Day 1) for a total of 15 replicates on each of 9 different GEM
Premier 3000 instruments (N=135). The table below lists the combined results of the 9 instruments.
SD is used for pH since differences are so small that %CV would be misleading.
GEM CVP Level 1

Parameter Mean Day-to-Day %CV Total %CV
(or SD) (or SD)
pH 7.200 0.005 (SD) 0.007 (SD)
pCO2 (mmHg) 70.8 1.39 1.63
pO2 (mmHg) 54.5 4.97 5.16
Na+ (mmol/L) 129.3 0.46 0.55
K+ (mmol/L) 2.90 0.25 0.70
Ca++ (mmol/L) 1.493 0.95 1.26
Glucose (mg/dL) 46.1 2.23 2.99
Lactate (mmol/L) 0.93 4.73 4.87
GEM CVP Level 2

(or SD) (or SD)
pH 7.640 0.002 (SD) 0.003 (SD)
pCO2 (mmHg) 29.9 1.78 1.91
pO2 (mmHg) 148.2 1.33 1.93
Na+ (mmol/L) 158.7 0.44 0.56
K+ (mmol/L) 6.46 0.75 0.98
Ca++ (mmol/L) 0.486 1.15 2.06
Glucose (mg/dL) 192.8 1.67 1.78
Lactate (mmol/L) 5.54 1.85 2.19

19. Specifications
GEM CVP Level 3

(or SD) (or SD)
Hematocrit (%) 23.4 2.14 2.11
GEM CVP Level 4

(or SD) (or SD)
Hematocrit (%) 43.8 1.21 1.23
Whole Blood Precision

Whole blood precision testing was performed, spanning the three-week cartridge use-life. Six
levels (for pH, Blood Gases, and Glucose), five levels (for Lactate), and seven levels (for Electrolytes
and Hematocrit) were evaluated using whole blood from healthy adult volunteers. Samples were
altered with various levels of analytes (salts, gases or plasma) to span the claimed measuring
range and tested in four replicates per run. Glucose was tested once per week for three weeks
while pH, Blood Gases, Electrolytes and Hematocrit were tested in weeks one and three on seven
different GEM Premier 3000 instruments. Lactate was tested once in week two on 9 different GEM
Premier 3000 instruments. Shown in the following tables are the within-run standard deviations and
%CV pooled to determine the average imprecision per level.
Because of various factors, not all levels of analytes had the same number of replicates.
Combined Within Run Precision Data for Whole Blood
pH Whole Blood Precision

N per Level Mean SD %CV
55 7.153 0.012 0.17
56 7.175 0.007 0.10
49 7.280 0.011 0.14
56 7.381 0.007 0.09
56 7.504 0.006 0.08
56 7.682 0.009 0.11
pCO2 Whole Blood Precision

N per Level Mean (mmHg) SD %CV
56 8.3 0.47 5.63
56 22.9 0.40 1.75
56 39.8 0.57 1.43
49 61.2 1.53 2.50
56 92.2 2.33 2.53
55 105.3 2.97 2.82
pO2 Whole Blood Precision

N per Level Mean (mmHg) SD %CV
55 29.4 0.79 2.67
56 51.2 1.42 2.77
49 103.9 2.07 1.99
42 211.5 3.46 1.67
42 401.8 5.80 1.46
42 683.7 8.51 1.25

19. Specifications
Na+ Whole Blood Precision

N per Level Mean (mmol/L) SD %CV
54 110.4 0.50 0.46
54 121.3 0.89 0.74
53 132.0 1.53 1.16
55 138.0 0.84 0.61
56 155.9 0.77 0.50
56 169.3 1.58 0.93
56 187.0 1.70 0.91
K+ Whole Blood Precision

56 2.36 0.083 3.53
54 3.47 0.116 3.34
54 4.59 0.080 1.74
54 5.58 0.160 2.86
56 7.24 0.057 0.79
56 9.48 0.107 1.13
54 17.0 0.253 1.48
Ca++ Whole Blood Precision

56 0.62 0.018 2.83
56 0.99 0.016 1.65
49 1.50 0.026 1.74
26 1.62 0.021 1.28
54 2.71 0.102 3.75
56 3.44 0.081 2.36
32 4.96 0.121 2.44
Glucose Whole Blood Precision

N per Level Mean (mg/dL) SD %CV
84 30.0 1.50 5.00
84 53.1 2.08 3.92
84 97.6 3.02 3.10
84 177.4 6.93 3.91
84 348.5 14.9 4.28
84 441.0 21.1 4.78
Lactate Whole Blood Precision

33 1.15 0.07 6.26
36 3.09 0.06 1.94
36 6.29 0.09 1.47
36 11.58 0.36 3.09
36 15.54 0.21 1.35
Hematocrit Whole Blood Precision

N per Level Mean (%) SD %CV
55 16.0 0.58 3.64
47 22.1 0.56 3.39
55 22.1 0.22 2.14
49 28.3 0.54 2.59
53 35.1 0.85 2.62
56 44.5 0.40 1.42
53 61.6 1.03 1.65

19. Specifications
Whole Blood Inaccuracy

The data from the whole blood precision study were used in the following inaccuracy calculations.
Tonometry was used as the reference for pCO2 and pO2, and manual spun Hematocrit was used as
the reference for Hematocrit. A traditional laboratory blood gas and electrolyte system was used to
obtain reference values for pH, Na+, K+, Ca++, Glucose and Lactate. The bias results were calculated
using the pooled GEM Premier 3000 instrument results and subtracting the reference (target) test
results. The bias for each parameter at each level was then compared to the acceptance criteria
as shown in the table below and on the next page. All parameter levels passed specification.
Specification (Ea) is the allowable error established from CLIA 88 or from internal
specification claims (bias at upper 95% confidence limit).
pH Whole Blood Inaccuracy

N per Level Mean Target Bias Specification (Ea)
(pH Units) (pH Units) (pH Units)
55 7.153 7.136 0.017 ± 0.04
56 7.175 7.160 0.015 ± 0.04
49 7.280 7.267 0.014 ± 0.04
56 7.381 7.373 0.008 ± 0.04
56 7.504 7.501 0.003 ± 0.04
56 7.682 7.681 0.001 ± 0.04
pCO2 Whole Blood Inaccuracy

(mmHg) (mmHg) (mmHg)

56 8.3 10.8 -2.49 ± 5.0
56 22.9 25.2 -2.28 ± 5.0
56 39.8 41.5 -1.70 ± 5.0
49 61.2 62.4 -1.19 ± 5.0
56 92.2 93.6 -1.37 ± 7.5
55 105.3 109.4 -4.06 ± 8.8
pO2 Whole Blood Inaccuracy

(mmHg) (mmHg) (mmHg)

55 29.4 31.1 -1.70 ± 7.8
56 51.2 52.4 -1.20 ± 10.5
49 103.9 104.3 -0.40 ± 10.4
42 211.5 207.1 4.4 ± 20.7
42 401.8 417.3 -15.5 ± 41.7
42 683.7 708.7 -25.0 ± 70.9
Na+ Whole Blood Inaccuracy

(mmol/L) (mmol/L) (mmol/L)

54 110.4 109.8 0.6 ± 4.0
54 121.3 121.3 0.0 ± 4.0
53 132.0 131.9 0.1 ± 4.0
55 138.0 136.5 1.5 ± 4.0
56 155.9 155.6 0.3 ± 4.0
56 169.3 169.0 0.3 ± 4.0
56 187.0 187.0 0.0 ± 4.0

19. Specifications
K+ Whole Blood Inaccuracy


56 2.36 2.36 0.00 ± 0.5
54 3.47 3.35 0.12 ± 0.5
54 4.59 4.58 0.01 ± 0.5
54 5.58 5.56 0.02 ± 0.5
56 7.24 7.39 -0.15 ± 0.5
56 9.48 9.90 -0.42 ± 1.0
54 17.02 17.59 -0.57 ± 1.8
Ca++ Whole Blood Inaccuracy


56 0.62 0.69 -0.07 ± 0.10
56 0.99 1.02 -0.03 ± 0.10
49 1.50 1.52 -0.02 ± 0.10
26 1.62 1.67 -0.05 ± 0.10
54 2.71 2.67 -0.04 ± 0.27
56 3.44 3.58 -0.14 ± 0.43
32 4.96 4.65 0.31 ± 0.70
Glucose Whole Blood Inaccuracy

(mg/dL) (mg/dL) (mg/dL)
84 30.0 30.2 -0.2 ± 9.1
84 53.1 53.3 -0.2 ± 5.3
84 97.6 97.8 -0.2 ± 9.8
84 177.4 175.5 1.9 ± 17.6
84 348.5 342.9 5.6 ± 34.3
84 441.0 432.1 8.9 ± 43.2
Lactate Whole Blood Inaccuracy

N per Level Mean Target Bias ± Bias Spec.
33 1.15 1.22 -0.07 ± 0.20
36 3.09 3.11 -0.02 ± 0.22
36 6.29 6.33 -0.04 ± 0.38
36 11.58 11.58 0.00 ± 0.85
36 15.54 14.95 0.59 ± 1.10
Hematocrit Whole Blood Inaccuracy

(%) (%) (%)
55 16.0 17.6 -1.6 ± 3.0
47 22.1 19.9 2.2 ± 3.0
55 22.1 24.0 -1.9 ± 4.0
49 28.3 27.9 0.4 ± 4.0
53 35.1 34.0 1.1 ± 4.0
56 44.5 43.8 0.7 ± 4.0
53 61.6 60.5 1.1 ± 4.0

19. Specifications
Linearity
The data from the whole blood precision study were used in the following linearity calculations.
Parameter N per Level Slope Intercept R2
pH 49 to 56 0.970 0.231 0.997
pCO2 (mmHg) 49 to 56 1.020 -2.65 0.996
pO2 (mmHg) 42 to 56 0.961 3.395 0.999
Na+ (mmol/L) 53 to 56 0.995 1.177 0.997
K+ (mmol/L) 54 to 56 0.954 0.192 0.999
Ca++ (mmol/L) 26 to 56 1.043 -0.106 0.990
Glucose (mg/dL) 84 1.023 -1.686 0.995
Lactate (mmol/L) 33 to 36 1.0346 -0.1752 0.9954
Hct (%) 47 to 56 1.039 -1.035 0.989
19.15 Calculation Bicarbonate

of Derived
Parameters Actual Bicarbonate (HCO3-)
HCO3- = 10 (pH + log(pCO2) - 7.608)
Standard Bicarbonate (HCO3- std)

Standard bicarbonate is the bicarbonate concentration from blood that has been equilibrated at
37°C with a pCO2 of 40 mmHg and a pO2 to produce full oxygen saturation.
HCO3- std = 25 + 0.78 x BE(B) + 0.002 x Hgb x (M - 100)

Where:
BE(B) = Base Excess in mmol/L
Hgb = THb from attached IL CO-Oximeter in g/dL or 0.31 x Hct if no CO-Oximeter is
attached; Hct = 40% if Hct is unavailable
M= O2Hb from attached IL CO-Oximeter in % or SO2c if no CO-Oximeter is attached
Oxygen Saturation (SO2c)

Oxygen saturation is a ratio, expressed as a percentage of the volume of oxygen carried, to the
maximum volume that the blood could carry. Knowing the SO2 is useful for predicting the amount
of oxygen available for tissue perfusion.

SO2C = 100/ 1 +
23400
(pO2pp)3 + 150 x pO2pp [ ]
Where:
pO2pp= Partial pressure of oxygen in blood at pH=7.4
pO2pp = pO2 x e(((pO2/26.7) ) + 0.003 x BE(B) - 2.2) x (7.4 - pH)

0.184
Where:
e= 2.718 and BE(B) is in-vitro base excess and is calculated from the formula
described by Siggaard-Anderson:
BE(B) = (1 - 0.014 x Hgb) x [HCO3- - 24 + (1.63 x Hgb + 9.5) x (pH - 7.4)]

Hgb= 0.31 x Hct
Total Carbon Dioxide (TCO2)

Concentration of free and bound CO2 in plasma.
TCO2 = HCO3- + (0.0307 x pCO2)

Where:
HCO3-= Actual bicarbonate

19. Specifications
In-vivo Base Excess BE(ecf)

Base excess of extracellular fluid is a term that approximates the amount of acid or base that
would be needed to titrate one liter of extracellular fluid to a pH of 7.40 with a pCO2 of 40 mmHg at
37°C. Also called standard base excess, in-vivo base excess reflects the metabolic, nonrespiratory
component of pH disturbances.
• IL equation:
BE(ecf) = (1 - 0.004 x Hgb) x (HCO3- - 24) + (9 + 0.03 x Hgb) x

(pH - 7.4) - (0.03 * Hgb) x (100 - SO2)/100
• NCCLS equation:
BE(ecf) = HCO3- - 24.8 + 16.2 x (pH - 7.4)
In-vitro Base Excess BE(B)

In-vitro base excess is a term that approximates the amount of acid or base that would be needed
to titrate one liter of blood back to a normal pH of 7.40.
• IL equation:
BE(B) = (1 - 0.014 x Hgb) x [HCO3- - 24 + (1.63 x Hgb + 9.5) x (pH - 7.4)]
• NCCLS equation:
BE(B) = (1 - 0.014 x Hgb) x [HCO3- - 24.8 + (7.7 + 1.43 x Hgb) x (pH - 7.4)]
Where:
Hgb= THb from attached IL CO-Oximeter in g/dL or 0.31 x Hct if no CO-Oximeter
is attached; Hct = 40% if Hct is unavailable
HCO3-= Actual bicarbonate derived from the sample
pH= pH result from the sample
O2ct
Oxygen content, is calculated externally on the attached IL 682 or GEM OPL CO-Oximeter. The
GEM Premier 3000 will report the result as received without performing any limit checks on the value.
If the current sample is blood gas only, this parameter is not reported.
O2cap
Oxygen capacity, is calculated externally on the attached IL 682 or GEM OPL CO-Oximeter. The
GEM Premier 3000 will report the result as received without performing any limit checks on the value.
If the current sample is blood gas only, this parameter is not reported.
A-aDO2
The alveolar-arterial oxygen gradient, is calculated using the following equation:
A-aDO2 = pAO2 - paO2(T)
Where:
pAO2= Alveolar oxygen partial pressure, corrected for patient temperature
paO2(T)= pO2 for the current arterial sample, corrected for patient temperature.
Use non-temperature corrected value if pO2(T) is unavailable.
pAO2
The alveolar oxygen partial pressure gives a general indication of the efficiency of the oxygen
exchange process in the alveolar-capillary unit. The following equation is used:
pAO2 = FiO2 x (BP - 47 x paCO2(T))
Where:
FiO2= Fraction of inspired oxygen (operator entered %FiO2/100)
BP= Operator entered barometric pressure in mmHg
T= Operator entered patient temperature in Celsius (use 37°C if not entered)
paCO2(T)= pCO2 for the current arterial sample, corrected for patient temperature.
Use non-temperature corrected value if pCO2(T) is not available.

19. Specifications
paO2/pAO2
The arterial-alveolar oxygen ratio, is calculated by dividing:
Use non-temperature corrected value if the temperature was not entered.
by:
pAO2= Alveolar oxygen partial pressure, in mmHg (see previous equation).
RI
The respiratory index, RI, is calculated with the following equation:
RI = A-aDO2/paO2(T)
Where:
A-aDO2= Alveolar-arterial oxygen gradient in mmHg (see previous equation)
Use non-temperature corrected value of pO2(T) is not available.
CaO2
CaO2 is the arterial oxygen content. If CaO2 is reported for the current sample (and not incalculable),
O2Ct (from an attached IL CO-Oximeter) will not be reported. The following equation will be used:
CaO2 = (0.0139 x THb x O2Hb) + (0.0031 x paO2(T))
Where:
THb= THb received from the external IL CO-Oximeter for current arterial sample, in g/dL
O2Hb= O2Hb received from the external IL CO-Oximeter for current arterial sample, %
paO2(T)= pO2 (mmHg) for the current arterial sample, corrected for patient temperature.
Use non-temperature corrected value if pO2(T) is not available.
CvO2
CvO2 is the mixed venous oxygen content. If CvO2 is reported for the current sample (and not incalcu-
lable), O2Ct from an attached IL CO-Oximeter will not be reported. The following equation will be used:
CvO2 = (0.0139 x THb x O2Hb) + (0.0031 x pvO2(T))
Where:
THb= THb received from the external IL CO-Oximeter for current venous sample, in g/dL
O2Hb= O2Hb received from the external IL CO-Oximeter for current venous sample, %
pvO2(T)= pO2 (mmHg) for the current venous sample, corrected for patient temperature.
CcO2
The end pulmonary capillary oxygen content is calculated using the following equation:
CcO2 = (1.39 x THb x alpha) + (0.0031 x pAO2)

Where:
alpha = (1 - COHb/100) - C
C= 0 if pAO2 is greater than 150
C= 0.01 if pAO2 is greater than 125 and less than or equal to 150
C= 0.02 if pAO2 less than or equal to 125
THb= THb received from the external IL CO-Oximeter for the current arterial sample, in g/dL
COHb= COHb received from the external IL CO-Oximeter for current arterial sample, %
pAO2= Alveolar oxygen partial pressure for the current arterial sample, mmHg, as calculated
in an earlier section.
a-vDO2 Calculation
The arterial-mixed venous oxygen gradient is calculated only for venous samples using the following
equation:
a-vDO2 = CaO2 - CvO2

Where:
CaO2= Arterial oxygen content, mL/dL, from the last arterial sample analyzed for the same
patient within the previous 30 minutes. If no patient ID was entered for the current
venous sample, or if no matching arterial sample is found, or if the matching arterial
was not an accepted sample, a-vDO2 will not be calculated for the current venous
sample.
CvO2= Venous oxygen content for the current venous sample, in mL/dL
Qsp/Qt
The physiological shunt, Qsp/Qt, is calculated only for venous samples using the following equation:
19. Specifications
Qsp/Qt = 100 x (CcO2 - CaO2) / (CcO2 - CvO2)%

Where:
CcO2, CaO2= End pulmonary capillary oxygen content and Arterial oxygen content (mL/dL), from
the last arterial sample analyzed for the same patient within the previous 30 minutes.
If no patient ID was entered for the current venous sample, or if no matching
arterial sample is found, or if the matching arterial was not an accepted sample,
Qsp/Qt will not be calculated for the current venous sample.
CvO2= Venous oxygen content from the current venous sample, in mL/dL.
P50
The partial pressure of O2 in a Hemoglobin solution having an oxygen saturation of 50%, P50, is
calculated only for venous samples. The following equation will be used:
P50 = 10 -(Q / 2.7)

Q = log (R / (100 - R)) - 2.7 * log (pvO2(T))
Where:
R= O2Hb or SO2, as selected in configuration
pvO2(T)= pO2 (mmHg) for the current venous sample, corrected for patient temperature.
O2Hb= O2Hb received from external CO-Ox for current venous sample, %. If O2Hb is not
in the range 30 - 75%, P50 becomes incalculable.
SO2= O2 saturation as received from the external IL CO-Oximeter for current venous
sample, %. If SO2 is not in the range 30 - 75%, P50 becomes incalculable.
Total Hemoglobin (THbc)

The estimated total Hemoglobin (THbc) in the sample is obtained from the measured Hematocrit. The
system estimates total Hemoglobin as follows:
THbc = 0.31 x Hct
Where:
Hct= Reported Hct value in %.
THbc will not be calculated if measured THbc is reported from an attached IL CO-Oximeter.
The following equations are used to calculate the temperature corrected blood gas parameters. All
temperature corrections are done to the standard default unit of measure. All temperature-correction
19.16 Temperature equations are based on a standard temperature of 37°C. The measured value to be temperature-
Correction corrected must be rounded to the display resolution before it is used in these equations.
pH Temperature Correction
IL equation:
pH(T) = pH - 0.015 x (TEMP - 37)
NCCLS equation:
pH(T) = pH + (TEMP - 37) x [-0.0147 + 0.0065 x (7.4 - pH)]
Where:
pH= pH measured at 37°C
TEMP= Patient temperature to be corrected
pH(T)= Temperature-corrected pH
pCO2 Temperature Correction

IL equation:
pCO2(T) = pCO2 x 100.021 x (TEMP - 37)
NCCLS equation:
pCO2(T) = pCO2 x 100.019 x (TEMP - 37)
Where:
pCO2= pCO2 measured at 37°C
TEMP= Patient temperature to be corrected to
pCO2(T)= Temperature-corrected pCO2
pO2 Temperature Correction
IL equation:

19. Specifications
pO2(T) = pO2 x 10[C x (TEMP - 37)]
Where:
C= 0.0052 + 0.0268 x (1 - e[-0.3 x (100 - SO2)])
NCCLS equation:
C= (5.49 x 10-11 x pO2 3.88 + 0.071)/(9.72 x 10-9 x pO2 3.88 + 2.3)
where:
pO2= pO2 measured at 37°C
TEMP= Patient temperature to be corrected to
pO2(T)= Temperature-corrected pO2,
e= 2.718
C= Temporary, subordinate calculation
SO2= Oxygen saturation value from attached IL CO-Oximeter or the calculated saturation
(SO2c) if measured SO2 is unavailable.

Cartridges
Test Menu non-iQM iQM Capacity Use-Life
Blood Gases, Hct N/A 24407584 75 4 weeks
24307504 24307584 75 3 weeks
24315004 24315084 150 3 weeks
24330004 24330084 300 3 weeks
24345004 24345084 450 3 weeks
Blood gases, Hct, 24307507 24307587 75 3 weeks
Electrolytes 24315007 24315087 150 3 weeks
24330007 24330087 300 3 weeks
24345007 24345087 450 3 weeks
24360007 24360087 600 2 weeks
Blood Gases, Hct, N/A 24307589 75 3 weeks
Electrolytes, Glucose, 24315009 24315089 150 3 weeks
Lactate 24330009 24330089 300 3 weeks
24345009 24345089 450 3 weeks
24360009 24360089 600 2 weeks
Analyzer
Part Number Description
0057000100/0057000200 GEM Premier 3000
Supplies
005508 Print paper, 5 rolls
000825900 Capillary Sample kit, 200 tubes
005330 Formatted Blank Diskette, 10/pack
24005419 Quick Reference Guide
Accessories
005315 Mounting Bracket
24000130 Bar code gun (optional)
Instrumentation Laboratory 20. Ordering Information

CVP and Quality Control Solutions

Product Description
GEM CVP
For verification of GEM Premier 3000 iQM cartridges prior to use with patient samples
P/N 24001587 Multipak, 20 ampoules x 2.5 mL x 4 levels
P/N 24001811 CVP 1, 20 ampoules x 2.5 mL
For non-iQM cartridges:
ContrIL 7
For Blood Gas and Electrolyte quality control
P/N 24001380 Multipak, 30 ampoules x 2mL x 3 levels
P/N 24001381 Level 1, 30 ampoules x 2mL
P/N 24001382 Level 2, 30 ampoules x 2 mL
P/N 24001383 Level 3, 30 ampoules x 2 mL
ContrIL 9
For Blood Gas, Electrolyte, Glucose, and Lactate quality control
P/N 24001418 Multipak, 30 ampoules x 2mL x 3 levels
GEM critCheck
For Hematocrit quality control
P/N 002309 Low and High, 15 ampoules x 5mL x 2 levels
If you are using an IL CO-Oximeter device with the GEM Premier 3000, refer to the operator’s
manual for the CO-Oximeter for information about QC solutions for use with the device.
20. Ordering Information Instrumentation Laboratory

21. Warranty Information
21.1 Instrument IL declares to the original purchaser that each instrument manufactured and sold by IL, or sold by
an authorized IL distributor, shall be free from defects in material and workmanship and, under
normal and proper use conditions, warrants it for a period of one year from installation and no more
than 13 months from the shipping date, except as otherwise provided in writing.
IL’ s obligation is limited to repairing, replacing, or modifying (at IL’ s undisputed judgment) at IL’ s
factory, or elsewhere, the material whose defects have been verified, on condition that the purchaser
has informed IL of any defects found within 15 days from receipt. Damages caused by or connected
to transport are excluded. Transport to and from IL facility will be at purchaser’s charge and risk, and
shall also be prepaid for reshipment, except as otherwise provided in writing. These replacements,
repairs, or alterations will in no case determine extension to the above specified warranty period.
The warranty does not cover those parts that deteriorate, or which are in any case considered
consumables, or those parts or “items”, which by their nature are normally required to be replaced
periodically consistent with normal maintenance. It is also understood that, following the purchase
and delivery of the instrument, the purchaser shall be deemed liable for any losses, damages, or
complaints concerning persons or things incurred by the use, or misuse of the instrument, on behalf
of the purchaser, its employees, co-operators, or others. IL does not assume any obligation or
warranty engagement concerning precision and/or accuracy of the measurements, as well as
for any damage to the instrument, directly or indirectly resulting from the use of reagents and/or
consumables different from those produced by IL specifically for its own instruments, and for the
same properly tested.
Warranty will not apply to those defective instruments or materials showing defects or damage
arising from the following causes:
1. Insufficient or negligent care by the purchaser
2. Insufficient or negligent maintenance by the purchaser in relation to the instructions contained
in the manuals prepared by IL for this purpose; tampering or alterations of the instruments, or in any
case interventions or repairs made by any person not duly authorized by IL.
3. Misuse due to carelessness, negligence, or inexperience.
4. Employment of materials under heavier conditions than those for which they have been designed
and manufactured, and use of the same in combination with incompatible or dangerous products.
5. Non-observance of the regulations relevant to installation, power supply, and operation of the
instruments (with particular regard to the regulations for accident prevention).
THIS WARRANTY IS GIVEN EXPRESSLY AND IN LIEU OF ALL OTHER WARRANTIES,
EXPRESS
OR IMPLIED. PURCHASER AGREES THAT THERE IS NO WARRANTY OR MERCHANTABILITY
AND THAT THERE ARE NO OTHER REMEDIES OR WARRANTIES, EXPRESS OR IMPLIED,
WHICH
EXTEND BEYOND THE CONTENTS OF THIS AGREEMENT.
No agent or employee of IL is authorized to extend any other warranty or to assume for IL any
liability except as above set forth.
21.2 Cartridge
GEM Premier 3000 cartridges, supplied by Instrumentation Laboratory (hereinafter “IL”), are warranted
against defects in materials and workmanship to the Expiration Date stamped on the product.
Excluded from this warranty are any defects caused by misuse. This warranty is limited to credit for
the unused portion of the cartridge. The cartridge data indicating the defect (as defined in the next
paragraph) must be returned within 30 days from the occurrence for warranty adjustment. Cartridge
data may be returned to IL via diskette or through the GEMwebTM feature. (In some instances, IL
may also request the return of an unused cartridge, prior to issuing credit.)
For GEM Premier 3000 cartridges, a defect is defined as follows:
• Visible leakage or mechanical defect as noted at the time the foil wrapper is removed
• Sensor failure as indicated by an error message displayed or printed at time of initial cartridge
calibration
• For an iQM cartridge, a Calibration Validation Product (CVP) failure, after 3 ampoules of the level
have been run
• For a non-iQM cartridge, an IL QC product failure, indicated by a result falling outside of the
IL package insert range, after 3 QC ampoules of the same lot and level have failed
At IL’ s discretion, credit for the unused portion of a cartridge may be given when an unrecoverable
sensor failure occurs during cartridge use-life. The cartridge data indicating the failure must be
returned within 30 days from the occurrence for credit to be issued.
This warranty is expressly in lieu of all other warranties, express or implied, including any implied
warranty of merchantability or fitness for a particular purpose. It is the responsibility of the purchaser
to determine the fitness of this product for any particular application, and to take any necessary
actions to determine fitness of the product at time of use.
The purchaser agrees that any liability against IL for a breach of this warranty shall be limited to
reimbursement for the unused portion of the cartridge. No other remedy including, but not limited
to, incidental, or consequential damages or lost profits, lost sales, injury to person or property, or
any other incidental or consequential loss shall be available to the purchaser.
Exceptions to the warranty policy stated above will be provided in writing, by IL or its authorized
representative.
Instrumentation Laboratory 21. Warranty Information

22. IL Worldwide Locations
Internet address: Corporate Headquarters

http://www.ilww.com CH-Werfen and Instrumentation Laboratory
Aragon 90
P.O. Box 35027 (08080)
08015 Barcelona Spain
Telephone: 34-3-4010101
Fax: 34-3-4513745
USA, Canada, Latin America Argentina
Headquarters Werfen Medical S.A.
Instrumentation Laboratory J A Cabrera 3965/69
101 Hartwell Avenue Ciudadde Buenos Aires
Lexington, MA 02421-3190 Argentina C1186AAW
U.S.A. Telephone: 54-1-14867-1800
Telephone: 1-800-955-9525 Fax: 54-1-14867-1850
Fax: 1-781-861-1908
Mexico
USA Headquarters Instrumentation Laboratory
Instrumentation Laboratory Diagnostics, S.A. DE C.V.
180 Hartwell Rd. Londres 47 - Colonia Juarez
Bedford, MA 01730-2443 Mexico, D.F. 06600
U.S.A. Telephone: 525-8599
Telephone: 1-800-955-9525 Fax: 525-0148
Fax: 1-781-861-1908
Europe, Middle East, Africa Headquarters Hungary
Instrumentation Laboratory SpA Instrumentation Laboratory Hungary
Viale Monza 33820128 Milan Rõbert Kõroly Krt. 82-84
Italy H-1135 Budapest, Hungary
Telephone: 39-2-25221 Telephone: 36-1-4527810
Fax: 39-2-2575250 Fax: 36-1-4527812
IL Hungary is the Diagnostic Division of Comesa Budapest,
Austria a CH-Werfen Company
Instrumentation Laboratory Ges m.b.H.
Baldassgasses, 5-Postfach 54 Poland
1121 Wein Instrumentation Laboratory Poland
Austria Wolinska 4, 03-699 Warszawa, Poland
Telephone: 43-1-2565800-0 Telephone: 48-22-3361800
Fax: 43-1-2565800-88 Fax: 48-22-6788572
IL Poland is the Diagnostic Division of Comesa Polska,
Germany a CH-Werfen Company
Instrumentation Laboratory GmbH
Klausnerring 4 The Netherlands
D-85551 Kircheim bei München Instrumentation Laboratory (Netherlands) B.V.
Germany Moskesbaan 2, 4823 AH Breda, Netherlands
Telephone: 49-89-909070 Telephone: 31-76-5480100
Fax: 49-89-90907116 Fax: 31-76-5480102
Italy Belgium
Instrumentation Laboratory SpA Instrumentation Laboratory(Belgium) N.V./S.A.
Viale Monza 33820128 Milan Excelsioriaan 81 bus 1
Italy 1930 Zaventem (Brussel)
Telephone: 39-2-25221 Belgium
Fax: 39-2-2575250 Telephone: 32-2-7252052
Fax: 32-2-7212409
Lithuania
Instrumentation Laboratory (Lietuva) B.I. France
Savanoriu 281A Instrumentation Laboratory S.A.
3009 Kaunas-Lithuania 32, avenue de Saint-Mandé
Telephone: 370-7-313157 B.P. 3575560 Paris Cedex 12
Fax: 370-7-313159 France
Telephone: 33-1-53338600
Czech Fax: 33-1-53338601
Instrumentation Laboratory Czech
Plananskal United Kingdom
10800 Praha 10, Czech Instrumentation Laboratory (U.K.) Ltd.
Telephone: 420-2-7816047 Kelvin Close - Birchwood Science Park
Fax: 420-2-7817434 Warrington, Cheshire WA3 7PB
IL Czech is the Diagnostic Division of Comesa Czech, England
a CH-Werfen Company Telephone: 44-1925-81-0141
Fax: 44-1925-826708
Pacific Headquarters/Japan Hong Kong
Instrumentation Laboratory IL HK SpA
Hamamatsucho General Bldg 6F 29th Floor Wing on Centre
2-2-15 Hamamatsucho, Minato-ku 111 Connaught Road Central - Hong Kong
Tokyo 103-0015 - Japan Telephone: 852-2-7927773
Telephone: 81-3-3437-6350 Fax: 852-2-7919972
Fax: 81-3-3437-6352
Korea
Japan Werfen Medical IL Ltd.
Instrumentation Laboratory 202 Han Kook Bldg.
Hamamatsucho General Bldg 6F 90-9, Yang Jae-Dong
2-2-15 Hamamatsucho, Minato-ku Seo Cho-Ku
Tokyo 103-0015 - Japan Seoul, 137-890 - Korea
Telephone: 81-3-3437-6350 Telephone: 82-2571-9246
Fax: 81-3-3437-6352 Fax: 82-2571-9247
22. IL Worldwide Locations Instrumentation Laboratory

Operator’s Guide GEM ® PremierTM 3000
Instrumentation Laboratory US, Canada, Latin America,

Corporate Headquarters Headquarters
Aragón 90-08015 Barcelona, Spain Instrumentation Laboratory Company
P.O. Box 35027 (08080) 180 Hartwell Rd.
Telephone: 34-93-4010101 Bedford, MA 01730-2443
Fax: 34-93-4513745 U.S.A.Telephone: 1-781-861-0710
www.ilww.com Fax: 1-781-861-1908
www.ilus.com
Pacific Headquarters Europe, Middle East, Africa

Instrumentation Laboratory Japan Co., Ltd. Headquarters
Hamamatsucho General Bldg. 9F Instrumentation Laboratory SpA
2-2-15 Hamamatsucho Viale Monza 338 - 20128 Milano, Italy
Minato-ku, Tokyo 105-0013, Japan Telephone: 39-02-25221
Telephone: 81-3-3437-6350 Fax: 39-02-2575250
Fax: 81-3-3437-6352

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GEM ® Premier™ 3000

Part. No 00024001596 Rev. 00 February 2014

1. General Description (Intended Use, Optional Modules & Connectivity,

Instrumentation Laboratory Table of Contents

Intended Use Front View and Cartridge

GEM Premier 3000 Analyzer and Cartridge

1. General Description Instrumentation Laboratory

Instrumentation Laboratory 1. General Description

Optional Modules and Connectivity

1. General Description Instrumentation Laboratory

CAUTION: Batch Code

ATTENTION, Catalog number

Biological risk Serial number

NOTE: important In vitro diagnostic

CE mark ∑ Contains sufficient ∑

Temperature limitation Protective conductor

Manufacturer Off (supply)

Instrumentation Laboratory 1. General Description

5. The message shown above will be displayed.

2. Instrument Installation Instrumentation Laboratory

3c. Touch “OK” to acknowledge the screen message.

Instrumentation Laboratory 3. Start Up

If Daylight Savings Time is enabled, the time

If there is any moisture inside the foil bag

3. Start Up Instrumentation Laboratory

Instrumentation Laboratory 3. Start Up

* Configuration settings not

** These options can only be

Instrumentation Laboratory 4. Configuration

4. Configuration Instrumentation Laboratory

To activate the iQM program

The sensor will not change to “Green OK” on

monitors cartridge integrity and system

11. Check iQM Reports. 12. Review Delta Charts.

13. Review Corrective Action Report. 14. Review CVP Samples.

Use either Sodium or Lithium

Instrumentation Laboratory 6. Patient Sampling

6. Patient Sampling Instrumentation Laboratory

Instrumentation Laboratory 6. Patient Sampling

For both iQM and non-iQM

1. Check in progress. 2. Micro-clot pattern detected for an iQM cartridge.

Both iQM and non-iQM cartridges employ

3. Attempted iQM cartridge correction in progress.

4. Interference detected. 5. When interference or micro-clot patterns are

For non-iQM cartridges and iQM cartridges with

3. Select the relevant “QC Material Setup” 4. Touch “Add”

QC only needs to be defined in Configuration

Instrumentation Laboratory 8. External Quality Control Material Definition

3. Touch “ENTER” to confirm. 4a. Select the QC material previously defined

9. Quality Control - QC Sampling Instrumentation Laboratory

10. When analysis is complete, review the results and set

Instrumentation Laboratory 9. Quality Control - QC Sampling

When cartridge removal

5. Dispose of the cartridge in an appropriate biohazard 6. If required, insert a new cartridge.

GEM Premier 3000 saves sample and

DO NOT REMOVE CARTRIDGE

10. Cartridge Removal Instrumentation Laboratory

“The GEM Premier 3000

The data from a specific