AirSep MN118-1 B User Manual
Page 8
MN118-1 rev B
02/14
3
Method for disposing of waste: All waste from the NewLife Intensity (patient circuit,
etc.) must be disposed of using appropriate methods specified by local authorities.
Method for disposing of the device: In order to preserve the environment, the
concentrator must only be disposed of using the appropriate methods specified by local
authorities.
Conformity with EN 60-601 (§ 6.8.2 b):
“The manufacturer, assembler, installer or importer are not considered to be responsible
themselves for the consequences on the safety, reliability and characteristics of a device
unless:
- The assembly, fitting, extensions, adjustments, modifications, or repairs have been
performed by persons authorized by the party in question.
- The electrical installation of the corresponding premises complies with IEC regulations.
- The device is used in accordance with the instructions for use.” If the replacement parts
used for the periodic servicing by an approved technician do not comply with the
manufacturer’s specifications, the latter is absolved from all responsibility in the event of
an accident. Do not open the device while in operation: risk of electrical shock. This
device complies with the requirements of the 93/42/EEC European directive but its
operation may be affected by other devices being used close by, such as diathermy and
high frequency electro-surgical equipment, defibrillators, short wave therapy equipment,
mobile telephones, CB and other portable devices, microwave ovens, induction plates or
even remote control toys, and more generally electromagnetic interferences, which exceed
the levels specified by the EN 60601-1-2 standard.
Classification
Type of protection against electric shock:
Class II
Protection from electric shock is achieved by DOUBLE INSULATION.
Protective earthing or reliance upon installation conditions are not required.
Degree of protection against electric shock:
Type B
Equipment providing a particular degree of protection against electric
shock, particularly regarding:
1) allowable leakage current;
2) reliability of protective earth connection (if present).
Not intended for direct cardiac application.
Degree of protection against harmful ingress of water:
Drip-proof equipment – IPX1.
Equipment provided with an enclosure preventing entry of such an amount
of falling liquid as might interfere with the satisfactory and safe operation
of the equipment.
Method of cleaning and infection control allowed:
Please refer to the Provider Instructions section in the NewLife Intensity
Service Manual.
Degree of safety of application in the presence of flammable anesthetic gases:
Equipment not suitable for such application.
Mode of operation: Continuous duty.