Custo Med Ergometer custo ec5000, Operating Manual

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Ergometer custo ec5000 | EXT 0001 – DK 1585 | Version 001 – 2015-11-13
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 fl ammable anes-
thetics, skin cleansing agents or disinfectants.
Warning
• Patient Hazard, Equipment Damage •
Do not expose the ec5000 to direct sunlight to prevent system
components from reaching inadmissible high temperatures.
Do NOT use the ec5000 outdoors (medical device). Furthermore
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 ec5000 may only be used in combination with accessories
approved by custo med.
• Risk to Persons •
Before using the ergometer, the operator 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 custo med 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 electro magnetic interference.
Warning
• Shock Hazard •
When the ergometer is connected to other equipment 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 custo med dealer or the custo med Service
Department.
For use, the ergometer must always be connected to electric
installations that fulfi ll 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
regulations for operation of this type of equipment
• must be informed about any other pertinent rules and
regulations (e.g. safety features)
• must be informed about the potential hazards arising from
the use of this type of equipment.
• make sure that no unauthorized changes are carried out.
S
AFETY
I
NFORMATION
Note
Only the removal of the power cord will result in an all pole
disconnection of the device from mains.
Caution
Additional equipment connected to medical electrical equip-
ment must comply with the respective IEC or ISO standards
(e.g. IEC 60950 for data processing equipment).
Furthermore all confi gurations shall comply with the require-
ments for medical electrical systems (see IEC 60601-1-1 or
clause 16 of the 3Ed. of IEC 60601-1, respectively).
Anybody connecting additional equipment to medical electrical
equipment confi gures a medical system and is therefore respon-
sible that the system complies with the requirements for medical
electrical systems. Attention is drawn to the fact that local laws
take priority over the above mentioned requirements.
If in doubt, consult your local dealer or custo med.
• IEC 60601-1+Al +A2:1995: 6.8.2.c, 19.2.b, 19.2.c,
• IEC 60601-1:2005: 7.9.2.5, 8.1, 16.2.d,
• MDD 93/42/EEC: Annex I clause 13.6.c