AlgoMed Technical Reference Manual
Proprietary 10 of 110
INSTRUCTION: Indicates an instruction where it is important to follow
the user manual literally as described.
1.2 Intended use
The use of the AlgoMed system should be as intended by Medoc Ltd. and as specified in the
user manual. The AlgoMed is a pain management and pain research system intended to be
used for the quantitative assessment of small nerve fiber dysfunctions. It measures sensory
pain thresholds and tolerance.
1.3 Safety and Regulatory Summary
Read and follow all WARNINGS, CAUTIONS and NOTES provided in this manual. To avoid the
possibility of injury, damage to your system, or loss of data, always follow these precautions
during system operation.
The AlgoMed system complies with safety requirements for medical electrical systems
(based on the IEC 60601-1 standard).
The AlgoMed system complies with electromagnetic emission levels (based on table 201 in
the IEC 60601-1-2 standard).
The AlgoMed system complies with electromagnetic immunity levels (based on tables 202
and 204 in the IEC 60601-1-2 standard).
This device complies with 93/42/EEC MDD.
It is recommend keeping a distance of 3 meters between portable and mobile RF
communications equipment and the AlgoMed (based on table 206 in the IEC 60601-1-2
standard).
1.4 Safety Requirements
The AlgoMed 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 AlgoMed system.
Connecting or replacing external AlgoMed accessories is allowed.
Keep all liquids away from the AlgoMed system.
Unplug the AlgoMed system if it is not to be used for a long period of time.
1.4.1 Warnings
Only personnel properly trained to operate the AlgoMed system should use this system.
Do not turn on system power until all cables have been properly connected and verified.
The Algometer tip must be covered with a standard disposable biocompatible finger cot
before it is placed on the skin.
The computer that is used to operate the AlgoMed system must be powered through
Medical Grade Isolation Transformer only.
The computer that is used to operate the AlgoMed system must never be connected to
network while it is used for running tests.
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