R5913897 /00
MDMX-MNA
22
5.1 Safety information
General Safety Requirements and Compliance
The MDMX-MNA must be installed and connected only by the manufacturer or system integrator. Any
modifications or enhancements of the configuration must be carried out solely by the manufacturer.
The MDMX-MNA is a device of protection class I and complies with the necessary requirements of EN 60601-
1. It is suitable for use in medical facilities, treatment rooms and medical intensive care units, except for those
areas in which there is a potential fire or explosion risk.
•
The MDMX-MNA must not be used in a flammable or potentially explosive environment.
•
No parts of the MDMX-MNA are intended for internal use within the patient
’
s body.
This device complies with the essential requirements of medical products as defined by the European
Standard EN 60601-1-2. Nevertheless, a malfunction caused by other devices producing high levels of
electromagnetic interference is still possible. Malfunctions of this nature may temporarily disrupt full
functionality of the device, but pose no risk to patient or operator. To avoid such eventualities, all sources of
electromagnetic interference of any kind near to the device should be removed where possible.
Review and maintenance of the MDMX-MNA are recommended on a yearly basis by authorized service
personnel only.
Some components contain batteries, that enable the correct functioning of modules. These batteries should
be renewed every three years by authorized service personnel only.
Electrical Shock or Fire Hazard
To prevent electric shock or fire hazard, do not remove cover parts.
No serviceable parts inside. Refer servicing to qualified personnel.
Do not expose this apparatus to rain or moisture.
Preventive maintenance
Periodic maintenance inspections are essential to keep the product in optimum condition and ensure safe
operation.
Provide full attention to safety during periodic maintenance and examination of this equipment.
General recommendations:
•
Keep the product clean to prolong its operational lifetime.
•
LCD panel performance may deteriorate in the long term. Periodically check that it is correctly operating.
•
Periodically check the tightness of the mount screws. If not sufficiently tight, the product may detach from
the mounting brackets, which may result in injury or equipment damage.
Type of protection (Electrical)
Equipment with internal power supply: Class I equipment
Degree of safety (flammable anesthetic mixture):
•
Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or
nitrous oxide.
•
The equipment shall not be operable when the air oxygen content is above 25%.
Non-patient care equipment
•
Equipment primarily for use in a health care facility that is intended for use where contact with a patient is
unlikely (no applied part).
•
The equipment shall not be used with life support equipment.
•
The user should not touch the equipment, nor its signal input ports (SIP)/signal output ports (SOP) and the
patient at the same time.
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