User Manual

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EQUIPMENT and its APPLIED PARTS shall be classified by marking and /or identification as described in Clause 6.
This includes:
5.1 According to the type of protection against electric shock:
a) EQUIPMENT energized from an external electrical power source:
— CLASS I EQUIPMENT;
— CLASS II EQUIPMENT.
b) INTERNALLY POWERED EQUIPMENT.
5.2 According to the degree of protection against electric shock:
— TYPE B APPLIED PART;
— TYPE BF APPLIED PART;
— TYPE CF APPLIED PART.
5.3 According to the degree of protection against ingress of water as detailed in the current edition of IEC 529[see 6.1
1)].
5.4 According to the method(s) of sterilization or disinfection recommended by the manufacturer.
5.5 According to the degree of safety of application in the presence of a FLAMMABLE ANAESTHETIC MIXTURE
WITH AIR or WITH OXYGEN OR NITROUS OXIDE:
— EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH
AIR or WITH OXYGEN OR NITROUS OXIDE;
— CATEGORY AP EQUIPMENT;
— CATEGORY APG EQUIPMENT.
5.5 According to the mode of operation:
— CONTINUOUS OPERATION;
— SHORT-TIME OPERATION;
— INTERMITTENT OPERATION;
— CONTINUOUS OPERATION WITH SHORT-TIME LOADING;
— CONTINUOUS OPERATION WITH INTERMITTENT LOADING.
6.8 ACCOMPANYING DOCUMENTS
6.8.1* General EQUIPMENT shall be accompanied by documents containing at least instructions for use, a technical
description and an address to which the USER can refer. The ACCOMPANYING DOCUMENTS shall be regarded
as a component part of EQUIPMENT.
All applicable classifications specified in Clause 5 shall be included in both the instructions for use and the technical
description, if separable. All markings specified in Sub-clause 6.1 shall be included in full in the ACCOMPANYING
DOCUMENTS if they have not been permanently affixed to EQUIPMENT by the manufacturer. See also Sub-
clause 6.1 d). Warning statements and the explanation of warning symbols (marked on the EQUIPMENT) shall be
provided in the ACCOMPANYING DOCUMENTS.
6.8.2 Instructions for use
a) *General information
— Instructions for use shall state the function and intended application of the EQUIPMENT.
— Instructions for use shall contain all information necessary to operate the EQUIPMENT in accordance with
its specification. This shall include explanation of the function of controls, displays and signals, the sequence
of operation, connection and disconnection of detachable parts and ACCESSORIES, replacement of material
which is consumed during operation.
— Instructions for use shall provide the USER or OPERATOR with information regarding potential
electromagnetic or other interference between the EQUIPMENT and other devices together with advice
regarding avoidance of such interference.
— Instructions for use shall include indications on recognized ACCESSORIES, detachable parts and materials, if
the use of other parts or materials can degrade minimum safety.
— Instructions for use shall instruct the USER or OPERATOR in sufficient detail concerning cleaning,
preventive inspection and maintenance to be performed by him, including the frequency of such
maintenance. Such instructions shall provide information for the safe performance of routine maintenance.
Additionally, instructions for use shall identify the parts on which preventive inspection and maintenance shall
be performed by other persons, including the periods to be applied, but not necessarily including details about
the actual performance of such maintenance.
— the meaning of figures, symbols, warning statements and abbreviations on EQUIPMENT shall be explained in
the instructions for use.
b) *Responsibility of the manufacturer Not used (see Appendix A).
c) SIGNAL OUTPUT and SIGNAL INPUT PARTS If a SIGNAL OUTPUT or SIGNAL INPUT PART is intended
only for connection to specified EQUIPMENT complying with the requirements of this Standard, this shall be
stated in the instructions for use
d) Cleaning, disinfection and sterilization of parts in contact with the PATIENT For EQUIPMENT parts which
come into contact with the PATIENT during NORMAL USE, instructions for use shall contain details about
cleaning or disinfection or sterilization methods that may be used (see also Sub-clause 44.7) or, where
EQUIPMENT CLASSIFICATION &