COOK Medical K-FTH-1012 Manuel D'instructions page 9

K-FTH-1012 Instructions for Use English
IMPORTANT NOTE: Use of 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.
1 3.3 Supply voltage selection
The Test Tube Heater can operate from supply voltages ranging from 100 to 240 VAC, 50 to 60 Hz. No
fuse selection is required. To avoid the risk of electric shock, equipment must only be connected to a
supply mains with protective earth.
WARNING: EXPLOSION HAZARD: Do not use the Test Tube Heater in the presence of flammable gases!
CAUTION: Determine if the available voltage corresponds to your device. Working with the wrong voltage
will cause the device to malfunction or may permanently damage the device.
The electrical components are not explosion proof. Do not use in an area where flammable gases are present.
3.4 Electromagnetic compatibility
The Test Tube Heater is designed to maintain the temperature of aspirated follicular fluid within a test
tube at a specified temperature with infrequent failures. It has been tested and found to comply with
the electromagnetic compatibility (EMC) limits for medical devices as specified by IEC 60601-1-2:2014.
These limits are designed to provide reasonable protection against harmful interference in a typical
medical installation.
Medical electrical equipment requires special precautions regarding EMC and must be installed and
operated according to these instructions. It is possible that high levels of radiated or conducted radio-
frequency electromagnetic interference (EMI) from portable and mobile RF communications equipment
or other strong or nearby radio-frequency sources could result in performance disruption of the Test
Tube Heater. Evidence of disruption may include erratic flashing of the indicator light, equipment
ceasing to operate, or other incorrect functioning. If this occurs cease using the Test Tube Heater and
contact your Cook authorised service agent.
Refer to the tables in §7 of this manual for guidance on electromagnetic emissions,
electromagnetic immunity, and recommended separation distance between portable and mobile RF
communications equipment and the Test Tube Heater.
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