Mindray SynoVent E5, Operator'S Manual

Page: 17 / 196

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WARNING

Positive pressure breathing may be accompanied by some side effects such as
barotrauma, hypoventilation, hyperventilation etc.
 Using the ventilator in the vicinity of high-frequency electrosurgery units,
defibrillators or short-wave therapy equipment may impair correct functioning of
the ventilator and endanger the patient.
 Do not use antistatic or conductive masks or breathing hoses. They can cause burns
if they are used near high frequency electrosurgical equipment.
 Do not use the ventilator in a hyperbaric chamber to avoid potential fire hazard
due to an oxygen-enriched environment.
 If the equipment internal monitoring system malfunctions, an alternative plan
must be available to ensure adequate level of monitoring. The operator of the
ventilator must be responsible for proper patient ventilation and safety under all
circumstances.

As required by the relevant rules and regulations, oxygen concentration should be
monitored when the equipment is used on the patient. If your ventilator is not
configured with such monitoring function or this function is turned off, use a
monitor which complies with the relevant international rules and regulations for
oxygen concentration monitoring.

When auxiliary electrical outlets are configured, the voltage and current
specifications of the devices connected to the electrical outlets must be within the
permissible ranges for those of the electrical outlets. When the protection
grounding is defective, connection of equipment to the auxiliary electrical outlet
may increase the patient leakage current to values exceeding the allowable limits.

When the auxiliary electrical outlet does not work normally, check if the
corresponding fuse is burned.
 All analog or digital products connected to this system must be certified passing the
specified IEC standards (such as IEC 60950 for data processing equipment and
IEC 60601-1 for medical electrical equipment). All configurations shall comply
with the valid version of IEC 60601-1-1. The personnel who are responsible for
connecting the optional equipment to the I/O signal port shall be responsible for
medical system configuration and system compliance with IEC 60601-1-1 as well.

Do not touch the patient when connecting the peripheral equipment via the I/O
signal ports or replacing the oxygen cell to prevent patient leakage current from
exceeding the requirements specified by the standard.

This product must be operated by doctors, respiration therapist or other specially
trained and authorized personnel. Anyone unauthorized or untrained must not
perform any operation on it.

This equipment is not suitable for use in an MRI environment.