GE eBike with Control Terminal PC Operator's Manual page 43

1.2 Safety Information
Danger
Explosion Hazard —
The device is not designed for use in areas where an
explosion hazard may occur. An explosion hazard
may result from the use of flammable anesthetics,
skin cleansing agents and disinfectants.
Warning
Patient Hazard, Equipment Damage —
– Protect the eBike from direct sunlight.
Otherwise equipment components may reach
inadmissible high temperatures. The eBike is a
medical device and must NEVER be used
outdoors. Furthermore, the device has no
additional protection against ingress of
humidity. Humidity that has entered the device
may cause equipment failure and can increase
the risk of electric shock.
Also, do not operate the eBike in the vicinity of
power installations, because they may impair
equipment functions.
– The eBike may only be used in conjunction with
accessories approved by GE Medical Systems
Information Technologies.
Risk to Persons —
Before using the ergometer, the operator must
ascertain that it is in correct working order and
operating condition. In particular, the cables and
connectors must be checked for signs of damage.
Damaged parts must be replaced immediately,
before use.
Equipment Failure —
– The special shielded cables supplied by GE
Medical Systems Information Technologies
must be used to connect the device to other
pieces of equipment.
2018112-001 Revision B
Intended Use, Safety Information
Equipment Failure —
– Cellular telephones must not be used in the
immediate vicinity, because they may interfere
with the proper functioning of the ergometer.
Electromagnetic interference most probably
exists when the watt reading is unstable. If the
displayed value changes frequently even though
the speed is above 30 RPM, this may be due to
electromagnetic interference.
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. If you have questions
about this issue, please contact your GE
Medical Systems Information Technologies
dealer or GE Medical Systems Information
Technologies Service.
– For use, the ergometer may only be connected to
electric installations that fulfill the local
requirements.
Patient Hazard —
The German Medical Device Operator Ordinance
(MPBetreibV, § 5) demands that users
– must have been trained in the use of the
ergometer
– must be familiar with the routines for the
handling and assembly of the ergometer
– must be familiar with and observe the safety
rules and regulations for the operation of this
type of equipment
– must be informed about any other pertinent
rules and regulations (e.g. safety instructions)
– must be informed about the potential hazards
arising from the use of this type of equipment.
eBike with Control Terminal PC
Warning
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