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Contents:
Purpose................................................................................................................................................................. 2
Scope .................................................................................................................................................................... 2
Policy and Procedure Statement........................................................................................................................... 2
Proficiency Testing ................................................................................................................................................ 2
Regulatory Requirements ..................................................................................................................................... 3
Competency Assessment ..................................................................................................................................... 3
Limitations and Interferences ................................................................................................................................ 4
Test Kit/Supplies/Equipment ................................................................................................................................. 5
Quality Control and Calibration ............................................................................................................................. 5
Calibration Verification / PVP ................................................................................................................................ 8
Specimen Collection ............................................................................................................................................. 8
Patient Test Procedure ....................................................................................................................................... 11
Result Reporting ................................................................................................................................................. 12
Reference Values................................................................................................................................................ 12
Instrument Maintenance...................................................................................................................................... 13
Technical Support ............................................................................................................................................... 15
References.......................................................................................................................................................... 15
Written by: Paul Pappagianopoulos
Date: 6/01/2005
Purpose
This document outlines policies and procedures that deal with blood gas and lactate testing on the GEM 3500.
In an effort to be concise some information may be excluded from the manufacturers recommended
procedure. It is recommended that operators familiarize themselves with the manufacturers product
information that accompanies each package and their manual if one exists.
Scope
Testing site: The Pulmonary and Critical Care Laboratory
Level of Personnel: Pulmonary Technologists
Proficiency Testing
The College of American Pathologists (CAP) sends unknown samples to the laboratory for analysis several times per
year. Results are submitted to the CAP within 10 days of survey receipt. If a site fails 2 out of 3 events or two
consecutive events, according to federal law, it may be required to discontinue testing.
All Survey results are to be handled and reported in the same manner as clinical results following the directions on
the CAP Survey package insert. The samples are not to be analyzed in duplicate unless clinical specimens are
analyzed in duplicate. Actions or decisions must be documented.
Participation must be random and not assigned to specific individuals. Successful participation may be used as
demonstrating successful competency for that year.
The POCT program will contact the participating departments regarding the survey and the timeline of the
survey to be performed.
Once results are obtained, they should be reported to POCT, who will report them to CAP via mail, fax or electronic
entry on the CAP website.
Site Director and CLIA certificate Director or designees shall review survey results to assess performance and ensure
compliance with the standard and comment.
Scores between 100% and 80% requires a comprehensive investigation and remedial action documented of
unsuccessful challenges.
Scores less than 80% requires a comprehensive investigation and documentation of remedial action of unsuccessful
challenges. Scores of less than 80 percent may jeopardize a sites ability to continue to perform testing.
Should a site fail proficiency, they will be required to immediately perform a comprehensive investigation and
document remedial action. Operator re-training may be required.
In order to avoid cessation of testing a site failing a challenge will be expected to develop and implement a more
aggressive plan for performance improvement.
Each site is responsible for completing survey challenges when they arrive.
AQ2 (ABG)
Product Receipt
Evaluation Receipt
March
April
June
July
October
November
Regulatory Requirements
I. Each testing site must have a documented quality control program, which is developed in collaboration with or has
been approved by the MGH Pathology Service.
II. All test results must be maintained in patient records with all required information for four years
Required information:
1. Patients name
2. Medical Record Number
3. Patients gender
4. Patients age or date of birth
5. Date & time test collected, performed and reported
6. Ordering Physician
7. Responsible physician (if not 6)
8. Reference or Target Range
9. Test Performed
10. Test units
11. Lab name
III. Additional information that must be retained for four years:
1. Testing personnel records
2. Quality control results
3. Product information (i.e. serial number, lot numbers, expiration dates, etc.), information on quality control and
any remedial action
4. QC charts, maintenance sheets, reference and critical ranges
IV. Other:
1. Universal precautions must be observed when handling any patient specimen.
2. A physicians order or standing order is required is required prior to performing test.
3. The Hospital Hand Hygiene policy must be adhered to at all times.
V. Linearity/ Calibration Verification
The testing site will perform and document linearity/calibration verification checks every six months.
Competency Assessment
Title (with LTR): GEM 3500 Procedure (LTR11953)
Last Approved: Gregory, Kimberly (Electronic Signature Timestamp: 6/11/2013 11:05:33 AM)
3
All operators must read the procedure manual, complete the GEM 3500 Quiz and run external (CVP) controls after initial
training. For Blood Gas and Lactate analyses the competency assessment process is done at 6 months during the first
year, then annually thereafter.
Competency is assessed using six methods, examples of which are below:
1.
2.
3.
4.
5.
6.
Expired Operators:
Operators that fail to meet competency requirements within 365 days will be locked out of the system. They will be
required to undergo retraining and competency assessment according to above.
Room Air
Metabolic Changes
Elevated White Blood Cells or
Reticulocyte Counts
Improper Mixing
Hemolysis
Under-Heparinized Sample
Changes to Manufacturers
Instructions or Method
Verification Protocols
Improper Installation
Thiopental sodium (see Note 2 in this section): May interfere with the sodium, potassium, pCO2 and ionized
calcium readings (see Note 3 in this section).
The anesthetic halothane may produce unreliable pO2 results due to interferences with pO2 sensor.
The following tested drugs may interfere with glucose or lactate determination, causing falsely low readings:
Drug
Flaxedil
Ethanol
Interference Observed
2 mg/dL
350 mg/dL
The following tested drugs may interfere with glucose and lactate determinations, causing falsely elevated
readings:
Drug
Interference Observed
Maximum Therapeutic Level*
Acetaminophen (Tylenol)
15 mg/dL
2 mg/dL
Isoniazide (Nydrazid)
2 mg/dL
0.7 mg/dL (toxic)
Title (with LTR): GEM 3500 Procedure (LTR11953)
Last Approved: Gregory, Kimberly (Electronic Signature Timestamp: 6/11/2013 11:05:33 AM)
4
Thiocyanate
Hydroxyurea
10 mg/dL
0.5 mg/dL
2.9 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
1 g/dL
Potassium oxalate
1 g/dL
Test Kit/Supplies/Equipment
Description
GEM Premier 3500 Analyzer and
Accessory Pack
Printer Paper, 5 rolls per Box
GEM Premier 3500 PAK Cartridge
Part Number
00026000000
00025000500
00026315089 (150 tests)
00026330089 (300 tests)
Intelligent Quality Management (iQM ) is used as the quality control and assessment system for the GEM Premier
3500 analyzer. iQM is an active, quality process control program designed to provide continuous monitoring of the
analytical process with real-time, automatic error detection, automatic correction of the system and automatic
documentation of all corrective actions, replacing the use of traditional external quality controls. As part of this
program, GEM CVP (Calibration Valuation Product) are external solutions intended to complete the calibration
process and final accuracy assessment of the iQM cartridge calibration after initial warm-up. The reported values for
the two levels of GEM CVP (two levels for pH, blood gases, and lactates) must meet manufacturers specifications
before the iQM cartridge can be used for patient sample measurements. Once the cartridge calibration is verified, the
internal iQM Process Control solutions, internal checks and software pattern recognition monitors the status of the
system during the cartridge use life.
GEM CVP
External Calibration Valuation Product is used to complete the calibration process of the GEM Premier 3500
analyzer prior to use with patient samples and is comprised of the following three ampoule configurations:
GEM CVP 1: Low pH, pO2, lactate and high pCO2
GEM CVP 2: High pH, pO2, lactate and low pCO2
Contril 9:
Level 2, 96%
Ordering Information
Part Number
0024001811
0024001812
0024001420
Description
GEM CVP 1 PAK
GEM CVP 2 PAK
Contril 9 L2
Package Configuration
20 ampoules x 2.5 mL
20 ampoules x 2.5 mL
30 ampoules x 2.0 ml
Each time you insert a new cartridge, the GEM Premier 3500 analyzer will prompt you to run CVP testing.
Testing will require approximately 3 minutes per ampoule to complete, and during this time, the analyzer will
be unavailable for patient sampling.
Cartridge Insertion and Warm-up
1. Unlatch the cartridge door on the instruments right side by sliding the lock handle to the front and opening the door.
2. Check the label on the foil bag containing the GEM Premier 3500 PAK cartridge to be sure that the cartridge is not
past its expiration date.
CAUTION: Do not use an expired cartridge. The GEM Premier 3500 will not accept an expired cartridge unless that
date is set incorrectly. Please refer to the Operators Manual, page 2.7 for instructions on setting the date/time.
3. Open the foil bag, and remove the cartridge.
4. Check the inside of the foil bag to be sure that it is dry.
CAUTION: If there is any moisture inside the foil bag, DO NOT USE the cartridge. Open a fresh GEM Premier 3500
PAK cartridge and call Technical Support at Instrumentation Laboratory.
5. Grasp the tab end of the plastic protective cover. Pull firmly to remove the cover.
NOTE: The cartridge must be inserted into the instrument within one minute of removing the protective cover.
Align the cartridge according to the labels. Using a rapid, smooth, continuous motion, insert the cartridge into the
instruments cartridge compartment.
NOTE: The cartridge will not insert all the way into the compartment. A small lip of the cartridge will rest on the door.
6. When the instrument has successfully read and validated the barcode and the date/time has been accepted, it will
prompt you to close the cartridge door. If the instrument displays a message that the barcode reader did not read the
label, follow the directions on the screen to complete the insertion process. The instrument will make three attempts
to read the barcode before prompting the operator to use the barcode gun. If the barcode cannot be read, contact IL
Technical Support.
7. The instrument will prompt: Is the date/time correct? If correct, select YES to proceed with warm-up. Otherwise,
select NO to correct the date/time. The instrument will prompt: Remove cartridge. Remove the cartridge (see 5.9
Cartridge Removal) to begin the process again, changing the date and time when prompted.
8. Close the door, and slide the lock handle toward the back of the unit.
9. The cartridge door will lock. The GEM Premier 3500 will display the Cartridge Warm-up screen.
10. Cartridge Warm-up
11. Cartridge warm-up requires approximately 30 minutes. Samples cannot be analyzed during cartridge warm-up, but
the instrument does allow access to many of the menu commands.
12. During cartridge warm-up, the instrument brings the measuring chamber to the proper temperature and performs
several rinses and calibrations. If an error occurs during warm-up, the instrument will prompt for removal of the
cartridge (see 5.9 Cartridge Removal for instructions).
13. The GEM Premier 3500 will also determine the type of cartridge during cartridge warm-up. If a non-iQM cartridge is
inserted, the instrument will continue with warm-up. If an iQM cartridge is inserted, the instruments response will
depend upon how iQM Mode has been configured:
14. If iQM Mode is ON, it will be left ON.
15. After iQM Mode has been configured (ON or OFF), the mode cannot be changed for the duration of the inserted iQM
cartridge. After the cartridge is removed, iQM Mode will remain at its current setting but will be available for changing,
if desired.
16. When cartridge warm-up is complete, the instrument will display the Ready screen.
17. If an iQM cartridge is inserted and iQM Mode is ON, the instrument will display a reminder to run all levels of CVP
material, and the status of all analytes will be set to Pending CVP. All levels of CVP material (i.e. CVP 1 and CVP 2)
and Contril 9 L2 must be run and within range before patient samples can be reported.
A. Touch CVP on the Ready screen.
B. Enter an operator ID by entering the appropriate characters on the keypad or with the barcode gun. Touch
ENTER.
C. Select the CVP material to be used:
D. Open the door to the ampoule spinner, and insert and release the ampoule. The reader will spin the ampoule
and read the barcode.
E. If the lot number is not found, the instrument will prompt for a different ampoule or for selection of material
from a list of defined material.
F. If the lot number matches the lot number of a defined material, the instrument will prompt for sample
aspiration. If the selected material only contains analytes that have failed calibration, the instrument will abort
the sampling process.
G. Prepare the CVP material:
Title (with LTR): GEM 3500 Procedure (LTR11953)
Last Approved: Gregory, Kimberly (Electronic Signature Timestamp: 6/11/2013 11:05:33 AM)
6
4. If the original failure is corrected but a new analyte fails, repeat the CVP with freshly opened CVP material from the
same CVP lot one more time.
5. If the failure is corrected, ACCEPT the CVP results.
6. If the failure is not corrected, remove the cartridge and notify Technical Support (see 4.5 Cartridge Removal).
NOTE: If a CVP failure persists, the analyte(s) will not be available.
IMPORTANT: Ensure that enough CVP material is on hand toward the end of a lot to clear any existing failure
conditions. Only CVP material from the same lot can clear an error condition for that lot.
If a patient sample is run while an analyte is in the Pending CVP or Failed CVP state, the result will not be reported.
On the screen, the result will be flagged with V and blanked out. The printed report will display PENDING CVP or
FAILED CVP as appropriate.
Description
IL PVP
Package Configuration
4 ampoules x 5 levels x 2.5mL
IL PVP unopened ampoules are stable when stored at 15-25C for up to 3 months, or at 2-8C until the expiration date
shown on the label. DO NOT FREEZE.
PVP Directions for Use
1.
2.
3.
4.
5.
6.
7.
8.
Specimen Collection
Sample Volumes
The syringe that is used must be filled nearly to capacity to prevent excessive heparin concentration in the sample.
Minimum sample requirements for the cartridge in use are as follows:
Sample Volume:
Menu:
150 L
145 L
Sample Types
The sample type that is collected depends upon the type of study to be performed:
1. Level 1 Study: Venous Blood, Post Exercise
Title (with LTR): GEM 3500 Procedure (LTR11953)
Last Approved: Gregory, Kimberly (Electronic Signature Timestamp: 6/11/2013 11:05:33 AM)
8
26. Pressure sterile dressing should be applied and patient instructed to remove after 2 hours. Bleeding after removal
should warrant another dressing. If bleeding persists, notify closest Emergency Dept.
If there is difficulty in placing a line, after two attempts, the fellow should get a second year fellow or staff person to place
the line. If a line can not be placed, then oximetry should be performed so that saturation with exercise can be reported.
Arterial Puncture for Arterial Blood Gas Sampling
1. Assemble the blood gas puncture tray to include the following items:
Alcohol Prep Pads
3X3 Sponges
Arterial Blood Gas Sampling kits (Pulsator Plus) which includes:
Arterial blood gas sampling kits (23.5 I.U. Units Heparin/mL)
Needles 23GA 1 inch
Caps
Alcohol preps
Sponges
Bandaids
Iodophor Prep Pad
2. Arterial blood gas sample syringe (Portex #4042 with dry lithium heparin)
3. Butterfly needles (23 GA 0.75 inch with 12 inch tubing)
4. ID the patient ( name & date of birth) and explain the process
5. Follow steps #3- #7 above
6. If both hands fail the Allens Test, the test should be cancelled and the referring physician notified.
7. Technologists should observe hand hygiene policy and wear gloves
8. The artery should be palpated again and the wrist cleaned with an alcohol swab
9. A local anesthetic may be used, if necessary
10. A small wheal is raised with a local anesthetic through a 27 GA needle. (It has been documented that the majority of
punctures are accomplished on the first attempt, however, a wheal allows another attempt to be made without pain)
11. Any gauge needle from 21-25 may be used to obtain a sample from the radial or ulnar arteries
12. When ready to perform the puncture, inform the patient
13. Technologist should assemble the needle to syringe or ready the syringe for attachment to a butterfly needle when
blood begins to flow into tubing
14. Two different methods are used to collect arterial blood:
15. For syringe with needle technique, go to #17
16. For Butterfly needle without syringe technique, go to #20
17. Technologist should puncture the skin at 45-90 degree angle
18. When artery is pierced, blood will flow into the syringe. Blood pressure will drive flow and fill the syringe. Do not
withdraw blood using the plunger of the syringe as that method may introduce venous blood.
19. Go to #23
20. Technologist should puncture the skin at 45-90 angle
21. When artery is pierced, blood should begin flowing into the butterfly tubing. When flow is achieved, attach the syringe
to the butterfly tubing. Blood pressure will drive then flow and fill the syringe. Do not withdraw blood using the plunger
of the syringe as that method may introduce venous blood.
22. Go to #23
23. The needle should be withdrawn after 2 mL of blood is obtained in the syringe and the artery is compressed at the
site for 5 minutes (Technologist may allow the patient to compress, if understaffed, to allow for analysis of the
sample)
24. Needle should be disposed of according to Needle Disposal Policy
25. Air should be tapped out of sample using a sponge to prevent contamination and the sample should be capped.
26. Analyze the sample ASAP, in less than 20 minutes
27. Upon release of compression, the puncture site is observed for evidence of leak
28. Bandaid or other sterile dressing should be applied.
Sample Mixing
For syringe samples:
1. Expel all air.
2. Mix the sample thoroughly.
3. Invert at least 3 times, and roll between outstretched palms at least 5 times if drawn within 5 minutes of sampling.
Manually or mechanically rotate through 2 axes for at least 2 minutes if sample is drawn more than 5 minutes from
time of analysis.
4. Push out a few drops of the sample onto a gauze pad to ensure there is no clot in the syringe tip.
Title (with LTR): GEM 3500 Procedure (LTR11953)
Last Approved: Gregory, Kimberly (Electronic Signature Timestamp: 6/11/2013 11:05:33 AM)
10
ID the patient (name & date of birth) and explain the process
Drape a chux pad on the patient table to provide a clean surface and a method to contain any blood contamination
Technologists should observe hand hygiene policy and wear gloves
Apply the tourniquet to the preferred arm above the elbow
Needle should be attached to the vacutainer and all tubes readied.
Vein should be palpated and skin should be cleaned with an alcohol prep pad
Inform the patient when ready to perform the venipuncture.
Technologist should puncture the skin at 15-30 degree angle pulling up on the needle to prevent a deep stick below
the vein
When technologist determines that needle is in vein or at least below skin level:
Vacutainer tube is advanced, while maintaining stability or needle/barrel assembly. This prevents puncturing the vein
If needle is in the vein, blood will fill the vacutainer tube
If needle is not in vein, blood will not fill the vacutainer tube. Needle/barrel assembly should be redirected to the vein.
When first tube is filled, it should be retracted, mixed if necessary, and another vacutainer tube is advanced, while
maintaining stability of needle/barrel assembly
When all tubes are filled, remove the tourniquet
Withdraw the needle/barrel assembly and compress the vein at the site for a few minutes using a 3 X 3 sponge
(Technologist may allow the patient to compress, if understaffed, to allow for analysis of the sample)
Dispose of needle according to Needle Disposal Policy
Upon release of compression, the puncture site is observed for evidence of leak
Apply bandaid or other sterile dressing.
9. Remove the syringe, capillary tube, or capillary and adapter from the sampler when the instrument beeps four times
and prompts you to do so. CAUTION: Care should be taken to remove the sample quickly so as not to bend the
sampler.
10. Dispose of sample in a biohazard waste container.
11. The instrument will take 85 seconds to process the sample and display results. During this time, a progress indicator
will be displayed. The Patient Information screen will also be displayed to prompt for entry of sample information.
12. If the sample analysis includes CO-Ox analytes, the instrument will prompt for introduction of the CO-Ox sample.
Touch OK, and introduce the sample to the CO-Oximeter.
Result Reporting
The Patient Sample Results screen is displayed after:
you have touched EXIT at the Patient Information screen (if that screen was presented), and
The Patient Sample Results screen will be displayed for 90 seconds. After 90 seconds,
If Patient Sample Auto-Accept is ON, the sample will be given a disposition of ACCEPTED.
If Patient Sample Auto-Accept is OFF, the sample will keep whatever disposition you have assigned it. If no
disposition has been set, it will be given a disposition of PENDING
It is the policy in Pulmonary CCU that each result is manually accepted by the technologist. The
Patient Sample Auto-Accept should be OFF:
Touch ACCEPT to assign the sample an ACCEPTED disposition. The instrument will:
Refresh the screen to show the ACCEPTED disposition
Print the Patient Sample Report
Send the results to IMPACT (see IMPACT Reporting Policy)
Touch DISCARD to assign the sample a DISCARDED disposition. The instrument will:
Prompt to confirm the disposition
Refresh the screen to show the DISCARDED disposition. Discarded samples must be
manually printed and transmitted. They will be included with all other samples when the
sample database is copied.
Touch EXIT without first selecting one of the other dispositions to assign the sample a PENDING
disposition. The instrument will:
Save the sample to the sample database withn a Pending Disposotion
Return to the READY screen
Touch EXIT after selecting one of the other dispositions to assign the disposition, save the sample to the
database, and return to the Ready screen.
Reference Values
Test
PCO2 (arterial or venous) mmHg
pH (arterial or venous)
PO2 (arterial or venous) mmHg
Lactate
Analytical
Range
Reference Range
36 44 mmHg
>50 mmHg
10 - 97
7.377.43
<7.34
6.95 7.72
8799 mmHg
<55 mmHg
37 552
>4 mmol/L
0.4 13.4
*Note: Values that are trending towards the critical MGH values are called to the ordering provider (referring physician)
as a courtesy.
1. Validate low pO2 values with oximetry:
If the pO2 is <60, then oximetry should be checked to help validate that the pO2 was accurate. For pO2 of
55, expected O2 Sat is 88%: for pO2 of 50, expected o2 is 80%.
If the O2 Sat is much better that was expected from pO2 (e.g.: pO2 of 46 and O2 Sat 90%) then venous
sample was most likely drawn. An arterial blood gas should be redrawn.
2. If a critical value is detected, the sample must be analyzed again to verify the results. Time is recorded after
the sample has been analyzed and documented as time (a)
3. Ordering provider is immediately notified of the critical value:
If the ordering provider is not reached within 5 minutes, another all/page is sent.
If the ordering provider is not reached within 10 minutes, the responsible physician will be the Pulmonary
Function Fellow
If unavailable, both Pulmonary Consult Fellows will assume this responsibility
If unavailable, PFT Lab Attending Physician will assume this responsibility.
4. Notification should include:
Written evidence of notification should be recorded in the critical value result log in the monthly section of
the ABG COOX Troubleshooting Review Log for the current year and Critical Value Reporting/Notification
Report
For Inpatients: Send a Preliminary report to the floor with a brief note in the progress note section with
blood gas or oximetry results
For Outpatients: Send a Preliminary Report to the patients physician if the patient is returning on the
same day
A phone call or email to the physicians office should be made
The patient must remain in the lab until cleared by the physician or until patient signs a refusal statement
on the Critical Value Reporting/Notification Report
5. Compliance Documentation:
All notification times (b-a) from the Critical Value Reporting/Notification Report must be less than 40
minutes.(b= time that referring physician or designee receives the report; a= time sample run)
All patient blood results shall be printed at the end of each month to assure that critical values were not
missed and documented in the monthly section of the Gem 3500 Corrective Action Log with patient name,
DOS, and Compliance. Instances of noncompliance will be reviewed at the weekly PFT Lab meeting so
that corrective action can be planned. NO should also be reported.
All Critical Value Reporting/Notification Reports will be reviewed monthly and compliance must be greater
that 95%.
Instrument Maintenance
Cartridge Removal
The cartridge must be replaced when its use-life or sample capacity has been reached . A cartridge must also be replaced
if the power has been off for more than one hour or off more than 20 minutes if blood has rested on the sensors or an A
or low O2 calibration is in progress. The instrument displays Remove and discard the cartridge, as well as a reason for the
removal request.
The instrument saves the data from 20 to 40 cartridges. After 40 cartridges have been inserted, the instrument will prompt
you to perform database maintenance. See 5.5.1 Copy Cartridge Data in the GEM 3500 SOP for information about
saving cartridge data.
1. Slide the handle on the right side of the instrument toward the front of the instrument and open the door.
2. Grasp the cartridge in the compartment, and pull it straight out.
3. Dispose of cartridge in an appropriate biohazard container.
4. Install a new cartridge when the instrument displays the Insert Cartridge screen.
Copy Cartridge Data
You can copy the data that the instrument has generated while a cartridge is in use whenever the instrument is at the
Ready screen, or between instrument acknowledgment of cartridge removal and insertion of a new cartridge. One data
diskette must be used per cartridge, even if the cartridge has processed only part of its full capacity. NOTE: If the disk
already contains cartridge data, the instrument will give you the opportunity to replace the disk or overwrite the data.
1. Touch COPY CART DATA on the DIAGNOSTICS menu.
2. Select the cartridge to be copied by touching its entry in the listing.
3. Touch COPY.
4. Insert a blank, PC-formatted, high-density 3.5 diskette, with its label facing the front of the instrument.
5. Touch OK. When copying is complete, the instrument will display a message stating so.
6. Remove the disk, and touch EXIT.
7. Write-protect the disk by sliding the square tab on the back of the disk toward the edge to expose the small hole.
8. Label and store the disk in a safe place.
Copy iQM Data
You can copy the iQM performance data stored by the instrument to a diskette with COPY iQM DATA on the
DIAGNOSTICS menu. Copying iQM data does not remove it from the instrument. iQM data will be removed from the
instrument only when the data is older than 1 year. At that point, the data from the oldest month will be automatically
deleted.
1. Select COPY iQM DATA from the DIAGNOSTICS menu.
2. Insert a blank, PC-formatted, high-density, 3.5" , with its label facing the front of the instrument.
3. Touch OK. When copying is complete, the instrument will display a message stating so.
4. Remove the disk, and touch EXIT.
5. Write-protect the disk by sliding the square tab on the back of the disk toward the edge to expose the small hole.
6. Label and store the disk in a safe place.
Instrument Cleaning
Wipe the outer surface of the case using a soft cloth moistened with a hospital approved disinfectant and cleaning
solution.A 10% mixture of liquid chlorine bleach (Mercury free) and water may also be used.
Wipe the surface of the touch screen using a soft cloth moistened with water or a mild, non-bleach cleaning solution.
CAUTION: Do not use an abrasive cleanser, bleach, or organic solvent as this will scratch the screen. Do not pour
solution directly onto the screen.
Inspect the area into which the cartridge inserts, and clean as necessary.
Instrument Maintenance
1. Empty Ampoule-Breaker Storage Container: Periodically remove the QC ampoule breaker storage container
and empty contents into an appropriate container. QC solution stains may be removed using a mild cleaning
solution.
2. Replace Printer Paper: The MESSAGES button on most main screens will turn yellow when the internal
printer runs out of paper.CAUTION: Use only paper supplied by Instrumentation Laboratory. Other papers
can damage the printer.
Title (with LTR): GEM 3500 Procedure (LTR11953)
Last Approved: Gregory, Kimberly (Electronic Signature Timestamp: 6/11/2013 11:05:33 AM)
14
a.
b.
c.
d.
e.
f.
g.
NOTE: The GEM Premier 3500 uses thermal paper that can only be printed on one side.
Technical Support
Call Tech Support for questions or troubleshooting assistance at 1-800-678-0710
References
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