2 Safety Information – Basic Device
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ergoselect 4 / 5
Danger
Explosion Hazard
The device is not designed for use in areas where
an explosion hazard may occur.
Explosion hazards may result from the use of flammable anes
thetics, skin cleansing agents, or disinfectants.
Warning
Patient Hazard, Equipment Damage
Do not expose the ergoselect to direct sunlight
to prevent system components from reaching
inadmissible high temperatures.
Do NOT use the ergoselect outdoors (medical device). Further
more, the device has no additional protection against the
ingress of humidity. Humidity inside the device may cause
equipment malfunctions and increases the risk of an electric
shock.
Additionally, the device should not be operated in the vicinity of
power systems, because they may impair equipment functions.
The ergoselect may only be used in combination with accesso
ries approved by ergoline GmbH.
Personal Injury
Before using the ergometer, the user must ascertain that it is
in correct working order and operating condition. The cables
and connectors, in particular, must be checked for signs of
damage. Damaged parts must be replaced immediately.
Equipment Malfunction
Only the special shielded cables supplied by ergoline may be
used to connect the device to other pieces of equipment.
Equipment Malfunction
Cellular telephones may not be used in the immediate vicinity
of the ergometer, because they might interfere with the proper
functioning of the ergometer.
Electromagnetic interference most probably exists when the
watt reading is unstable. If the displayed value changes fre
quently even though the speed is above 30 RPM, this may be
due to electromagnetic interference.
Warning
Shock Hazard
When the device is connected to other equip
ment or if a medical system is created, it must
be ensured that the added leakage currents do
not present a hazard. In case of questions, please contact your
ergoline dealer or the ergoline GmbH Service Department.
For use, the ergometer must always be connected to electric
installations that fulfill the local requirements.
Patient Hazard
The German Medical Device Operator Ordinance (MPBetreibV, § 5)
demands that users
• must be trained in the use of the ergometer
• must be familiar with the routines for handling and assembly
of the ergometer
• must be familiar with and observe the safety rules and regu
lations for operation of this type of equipment
• must be informed about any other pertinent rules and regu
lations (e.g., safety instructions)
• must be informed about the potential hazards arising from
the use of this type of equipment
• must make sure that no unauthorized changes are carried out.
Patient Hazard
The medical device is only intended for use by trained and
appropriately qualified staff.
Caution
Additional equipment connected to medical
electrical equipment must comply with the
respective IEC or ISO standards (e.g., IEC 60950
for data processing equipment).
Furthermore, all configurations must meet the requirements
of the applicable medical systems standards (see 3rd edition
of IEC 606011).
Anybody connecting additional equipment to medical electrical
equipment configures a medical system and is therefore respon
sible for the system´s compliance with the requirements for
medical electrical systems. Users are reminded that local laws
take priority over the above mentioned requirements.
If in doubt, please consult your local dealer or ergoline GmbH.
Note
Only the removal of the power cord will result in
an allpole disconnection of the device from the
power line.
2 Safety Information – Basic Device
Summary of Contents for ergoselect 4
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