Monitoring Invasive Blood Pressure
Efficia CM Series Rack and Modules Instructions for Use 3-7
Dual IBP Safety Information
Dual IBP Safety Information
The Dual IBP module is suitable in the presence of electrosurgery.
Warnings Risk of performance degradation:
• Measurement accuracy may decrease temporarily while performing electro-surgery or
defibrillation. The recovery time is less than 10 seconds. This does not affect patient or
equipment safety.
• The monitor and its accessories must be tested by qualified service personnel at
regular intervals to ensure that performance has not been degraded by aging or
environmental conditions. Periodic performance verification tests can be performed,
as described in the Efficia CM Service Guide.
Risk of injury or health hazard:
• Explosion Hazard. Equipment not suitable for use in the presence of a flammable
anaesthetic mixture with air or oxygen or nitrous oxide. Oxygen concentrations must
be <25% and partial pressure <27.5 kPa when no other oxidants are present.
• To prevent or minimize burns caused by a defective neutral electrode connection, use
caution when handling electrodes, transducers, and cables in the presence of high-
frequency surgical equipment. Verify that the equipment is working correctly before
each use.
• To avoid injury, place the medical device on a secure and level platform. Do not place
the rack module, cables, hoses and/or sample line on the ground.
Do not place anything
on top of the medical device.
Risk of Electrical Shock:
• Do not attempt to disconnect the power cord with wet hands. Make certain that your
hands are clean and dry before touching the power cord.
• Do not remove monitor covers during operation or while power is connected in the
monitor.
Risk of Connecting External Equipment:
• When connecting external equipment (e.g. data capture computer), the system
leakage current must be checked and must be less than the IEC 60601-1 Clause 16
limit.
• The use of accessory equipment not complying with the equivalent safety
requirements of this equipment may lead to a reduced level of safety of the resulting
system. Consideration relating to the choice shall include:
• Use of the accessory in the patient vicinity.
• Evidence that the safety certification of the accessory has been performed in
accordance to the appropriate IEC 60601-1 harmonized national standard.
Risk of Environmental Hazards:
• Within the U.S.A., a hospital-grade outlet with proper grounding is required. The power
receptacle must be a three-wire grounded outlet. Never adapt the three-prong plug
from the monitor to fit a two-slot outlet. If the outlet has only two slots, make sure
that it is replaced with a three-slot grounded outlet before attempting to operate the
monitor.
• Whenever an event such as spillage of blood or solution occurs, re-test ground
leakage current before further use.
• Leakage current must be checked by a qualified biomedical engineering technician
whenever instrument case is opened.
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