GEM Hemochron 100 User Manual

1 - Introduction
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000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual
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000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual
1.6 Operational Warnings and Precautions
● For in vitro diagnostic use. For near-patient, laboratory, and healthcare professional use. Rx only.
● The system requires the use of personal protective equipment (gloves, gowns, safety glasses, etc.) where
there could be contact with the skin when handling potentially infectious substances or surfaces, such as
human samples or reagents.
● The GEM Hemochron 100 system should only be used by near‑patient, laboratory, and healthcare
professionals trained, experienced, and certied in the use of the GEM Hemochron 100 system in
accordance with healthcare facility policies and procedures.
● While running a patient or LQC test, keep the instrument on a horizontal and stable surface.
● DO NOT operate the instrument in an environment that is not within the specied range. See “Operation”
(page 18) .
● DO NOT store or transport the instrument in an environment that is not within the specied range. See
“Storage and Transport” (page 18) or box label.
● DO NOT drop the instrument. If the instrument was dropped during a test, DO NOT use the test results.
● DO NOT disassemble the instrument.
● When the power supply cable is disconnected from the instrument or from the wall, DO NOT grasp the
electrical cable. Instead, grasp the connector.
● The use of accessory equipment not identied in this manual, or equipment that does not comply with
either the equivalent safety requirements of this equipment or relevant EMC standards, may compromise
safety when using the instrument.
● The instrument is designed for use with GEM Hemochron 100 test cartridges only.
● Test cartridges and LQC products are for single-use only, DO NOT reuse.
● DO NOT use test cartridges or LQC products that are past their marked expiration date or have been
improperly stored.
● Refer to the package insert accompanying the test cartridges or LQC products for storage and handling
instructions.
● DO NOT force a test cartridge into the instrument. If resistance to insertion is encountered, gently remove
the test cartridge and examine the Test Cartridge Insertion Chamber of the instrument. Remove any
obstruction before attempting further use of the instrument (see “Routine Maintenance” (page 65) ).
● If a sample is not applied within 5 minutes, the test will time out. If this occurs, dispose of the test cartridge
and repeat the test using a new test cartridge.
● Patient blood samples, blood collection materials, used test cartridges, and LQC products are potentially
infectious and must IMMEDIATELY be discarded into a container designed for sharp, medical biohazard
waste and disposed per local and regional regulations. Use caution when handling and disposing of any
sharp device. Strictly adhere to the institution’s policies for the proper handling and disposal of
biohazardous materials.
● The materials included as part of the GEM Hemochron 100 system are not made with natural rubber latex.
● Deleted test results cannot be recovered.
● Do not prepare the LQC product until the instrument displays (Warming Test Cartridge). If the
LQC product is prepared too early, premature clotting may adversely a󰀨ect test result.
● If the EQC test feature is required (Yes), the instrument will be required to perform validation testing at
regular intervals. The factory default setting for this feature is required (Yes) but can be changed using
CCM. The manufacturer recommends that it be required (Yes). The decision to require (Yes) or not
require (No) this feature shall be determined by and is the responsibility of the each institution.
● If the LQC test feature is required (Yes), the instrument will be required to run LQC tests at regular
intervals. The factory default setting for this feature is not required (No) but can be changed using CCM.
The manufacturer recommends that it be required (Yes). The decision to require (Yes) or not require (No)
this feature shall be determined by and is the responsibility of the each institution.
WARNING: Use of this instrument in a manner other than as specied in this manual may lead to injury.

GEM Hemochron 100 Specifications

General

Brand	GEM
Model	Hemochron 100
Category	Measuring Instruments
Language	English