Q-Sense Technical Reference Manual
Proprietary
16 of 188
1.5
Safety Requirements
The Q-SENSE system can be tested according to IEC 62353 Recurrent test
and test after repair of medical electrical equipment.
Do not modify or replace any component of the Q-SENSE system.
Connecting or replacing external Q-SENSE accessories is allowed.
No modification of this equipment is allowed.
To avoid the risk of electric shock, this equipment must only be connected
to a supply mains with protective earth
Keep all liquids away from the Q-SENSE system.
Unplug the Q-SENSE system if it is not to be used for a long period of
time.
Do not block airflow anywhere around the Q-SENSE system.
1.5.1
Warnings
Only personnel properly trained to operate the Q-SENSE system should use this
system.
Do not turn on system power until all cables have been properly connected and
verified.
To avoid the risk of electric shock, this equipment must only be connected to a supply
mains with protective earth
Do not use any power supply which not supplied by Medoc (Medoc’s power supply
Cat.# DT 00017).
Do not use any electrode paste, gel, or other materials on the contact point between
the Thermode plate and the skin of the tested subject.
To reduce the risk of injury, place the Thermode on the subject only before starting the
test and while the test screen is visible. After the test is complete, remove the
Thermode from the subject’s skin while the test screen is still visible.
Connect the Thermode to the patient's skin ONLY during the test; not during system
Self-Test, programming or maintenance.
The computer that is used to operate the Q-SENSE system must be powered through a
Medical Grade Isolation Transformer only.
The use of accessories or cables other than those specified, with the exception of
accessories or cables sold by the manufacturer as replacement parts, may result in
increased emissions or decreased electrical immunity of the device.
Connecting any device or accessory that has no medical grade certificate to the Q-
SENSE system is not allowed.
Using a Thermode without the appropriate calibration table may result in potential
harm or injury.
Using the Q-SENSE system not according to instructions may result in potential harm
or injury.
Summary of Contents for TSA 2001
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Page 99: ...Q Sense Technical Reference Manual Proprietary 99 of 188 Analysis Report Examples ...
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Page 181: ...Q Sense Technical Reference Manual Proprietary 181 of 188 Figure 114 Pain Rating Limits ...