Medoc PATHWAY - Cautions; System Protection; System Self-Test; Temperature Safety Mechanisms

Pathway Technical Reference Manual
Proprietary 18 of 190
 The Thermode is very delicate and can easily be damaged. Therefore, handle with
care.
 If you disconnect any cables, take care to reconnect them correctly to prevent
damage to the system or components.
 This equipment uses a three-wire power cord with a hospital grade plug (for non-
USA applications, the IEC 60601-1-approved plug).
 Inspect the power cord often for fraying or other damage. DO NOT operate the
apparatus if the power cord or plug is damaged.
 Portable and mobile RF communications equipment can affect medical electrical
equipment.
 Use caution when using the PATHWAY Thermode on patients with suspected
neuropathies as they may be more susceptible to soft tissue or nerve damage at
extreme temperatures. Also, patients with neuropathies may not be able to properly
discontinue use of the device during prolonged hot or cold stimulation.
 Test Subject should be trained to use the response unit before performing any test
with the PATHWAY system.
 Use of a stimulator, which was based on similar technology as the PATHWAY device,
in evaluating the functionality of human pain reception and transmission of sensory
pathways at 6°C has been reported to have comparable outcomes in assessment of
pain reception and sensory pathways to 0°C.
1.4.3 Equipment Classification
 Degree of protection against electric shock: Class I
 Type of protection against electric shock: BF
 Type of Operation: Continuous
 Protection against ingress of liquids: Not protected against ingress of liquids
 Ordinary equipment
 Computer must comply with IEC 950 - EN 60950 - UL 60950.
1.5 System Protection
1.5.1 System Self-Test
Upon start-up the system performs a self-test in which system sensors are being tested. If a
malfunction is detected, an appropriate message is displayed and the system cannot operate
until that malfunction is resolved.
1.5.2 Temperature Safety Mechanisms
Several safeguard mechanisms have been implemented in the system to safeguard against
extreme temperatures and to protect the tested subject and the unit.
Software protection mechanisms include:
 Temperature upper and lower limits – In normal operation, Thermode temperature
will always be within these limits.
 Time duration limits – Thermode temperature is limited in duration. If the Thermode
temperature maintains a specific temperature (or above) for a longer period of time
then specified for that temperature, the system will go into Safe Mode.
 Safe Mode – a protective state of the system in which it is not possible to run tests.
In any case of suspected malfunction or if any modification is made to system
hardware settings, system will remain in safe mode until a system Self-Test is
performed.