Medoc PATHWAY - Safety and Regulatory Summary; Safety Requirements

Pathway Technical Reference Manual
Proprietary 16 of 190
1.2 Intended Use
The use of the Pathway system should be as intended by Medoc Ltd. and as specified in the
user manual. The PATHWAY is a pain management and pain research system intended to be
used for the quantitative assessment of small nerve fiber dysfunctions. It measures sensory
thresholds such as cold and warm sensation and heat-induced pain.
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 PATHWAY system complies with safety requirements for medical electrical
systems (based on the IEC 60601-1 standard).
 The PATHWAY system complies with electromagnetic emission levels (based on table
201 in the IEC 60601-1-2 standard).
 The PATHWAY 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 PATHWAY (based on table 206 in the IEC 60601-
1-2 standard).
1.4 Safety Requirements
The PATHWAY 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 PATHWAY system.
Connecting or replacing external PATHWAY accessories is allowed.
Keep all liquids away from the PATHWAY system.
Unplug the PATHWAY system if it is not to be used for a long period of time.
Do not block airflow anywhere around the PATHWAY system.
1.4.1 Warnings
 To avoid the risk of electric shock, this equipment must only be connected to a
supply mains with protective earth
 Only personnel properly trained to operate the PATHWAY system should use this
system.
 Do not turn on system power until all cables have been properly connected and
verified.
 Do not use any electrode paste, gel, or other material on the contact point between
the Thermode plate and the skin of the tested subject.
 Test Subject must be trained to use the panic button before performing any test with
the PATHWAY system in order to prevent damage.
 Test subject must hold the PATHWAY panic button throughout the entire duration of
the test.
 Using the PATHWAY system with the panic button disconnected is not allowed.