Monitoring Anesthetic and Respiratory Gases
Efficia CM Series Rack and Modules Instructions for Use 6-17
Gas Measurement Safety Information
• Used sample lines may be infectious due to the breathing gases that passed through
them. Foreign particles, pathogenic germs and bacterial contamination can occur if
the sample lines are not replaced. Sampling lines are not reusable and must be
replaced after each patient unless a bacterial filter is in place between sample line
and patient. Observe the replacement intervals of the water trap.
• Serious contamination hazards can occur with used sampling lines, HMEs, water traps
and using a contaminated module and require appropriate disposal. See your
biomedical engineer for appropriate action.
• Ensure proper ventilation of the place where the monitor and Gas module are located.
When anesthetic gases are improperly vented in a room and prolonged exposure of
the users to such mixtures with concentrations above the commonly accepted values,
could lead to minor injury (dizziness and reduced accountability).
• Do not expose the gas analyzer to excessive heat or sunlight as this could lead to
overheating of the instrument and result in injuries.
• Avoid any restriction or blockage of air flow as this could cause overheating of the gas
analyzer and result in injuries.
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.
• When you are connecting the electrodes or the patient cable, make sure that the
connectors never come into contact with other conductive parts, or with earth. In
particular, ensure that all of the ECG electrodes are attached to the patient to prevent
them from contacting conductive parts or earth.
Risk of electromagnetic interference:
• Do not use the monitor and gas measurement module during magnetic resonance
imaging (MRI) scanning. Induced current could potentially cause burns. The monitor
may affect the MRI image, the MRI unit may affect the accuracy of the monitor’s
measurements and the magnetic force could accelerate devices towards the MRI
magnet.
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