User Guide

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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
EQUIPMENT CLASSIFICATION &