Medoc PATHWAY - Warnings

Pathway Technical Reference Manual
Proprietary 17 of 190
 To reduce the risk of injury, attach the Thermode to the subject only prior to running
a test while MEDOC Main Station is in Test screen. Remove the Thermode from the
subject skin before leaving the Test Screen.
 Connect the Thermode to the patient’s skin ONLY during the test; not during system
Self-Test, programming or maintenance.
 To reduce the risk of injury while working in MR environment, follow the safety
instructions as presented in section 14, page 142
 The computer that is used to operate the PATHWAY system must be connected to
the PATHWAY power outlet or to a Medical Grade Isolation Transformer only.
 The computer that is used to operate the PATHWAY system must never be connected
to a network while it is used for running tests.
 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
PATHWAY system is not allowed.
 Using a Thermode without the appropriate calibration table may result in potential
harm or injury.
 Using the PATHWAY system not according to instructions may result in potential
harm or injury.
 fMRI Thermodes should be used ONLY in fMRI scanners. Outside the fMRI scanner
use only the Standard Thermodes. Using fMRI Thermodes outside of the scanner
may result in damage to the fMRI Thermode or PATHWAY system.
 Adverse Reaction: Skin irritation (in addition to pain sensation) beneath the probes
has been reported with the use of a stimulator, which was based on similar
technology as the PATHWAY device.
 Be aware of potential risk of skin damage caused by wrong parameter combination.
 Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary, this
equipment and the other equipment should be observed to verify that they are
operating normally.
 Use of accessories, transducers and cables other than those specified or provided by
the manufacturer of this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result in
improper operation.
 Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to
any part of the Pathway, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
 NOTE The EMISSIONS characteristics of this equipment make it suitable for use in
industrial areas and hospitals (CISPR 11 class A). If it is used in a residential
environment (for which CISPR 11 class B is normally required) this equipment might
not offer adequate protection to radio-frequency communication services. The user
might need to take mitigation measures, such as relocating or re-orienting the
equipment
1.4.2 Cautions
 Proper use of this device depends on careful reading of all instructions and labels.
 Turn OFF system power before connecting or disconnecting any system
component(s) or accessories. Otherwise, you may damage the device(s).