Custo Med Bicycle Ergometer ec3000e, Руководство по эксплуатации

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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
ec3000e
to direct sunlight to prevent system
components from reaching inadmissible high temperatures.
Do NOT use the ec3000e 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 electric power plants, because they may impair equipment
functions.
The ec3000e ergometer may only be used in combination with
accessories approved by custo med GmbH .
• 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, before use.
• 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 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
regulations for operation of this type of equipment
• must be informed about any other pertinent rules and regu-
lations (e.g. safety features)
• must be informed about the potential hazards arising from
the use of this type of equipment.
s
afety
i
nformation
Hint
Removing the power cord results in complete disconnection
from mains (all poles)..
Danger
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 shall comply with the re‑
quirements 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 config ures a medical system and is
therefore responsible 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 representative or the technical service department.
•
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 93142lEEC: Annex I clause 13.6.c