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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 mainte-
nance. 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 necessary, identify
suitable sterilization agents, and list the temperature, pressure, humidity and time limits
which such EQUIPMENT parts can tolerate.
e) Mains operated EQUIPMENT with additional power source
Instructions for use of mains operated EQUIPMENT containing an additional power
source not automatically maintained in a fully usable condition shall contain a warning
statement referring to the necessity for periodical checking or replacement of such an
additional power source. If CLASS I EQUIPMENT is specified for operation connected to a
SUPPLY MAINS and alternatively using an INTERNAL ELECTRICAL POWER SOURCE,
instructions for use shall contain a statement saying that where the integrity of the
external protective conductor in the installation or its arrangement is in doubt, EQUIP-
MENT shall be operated from its INTERNAL ELECTRICAL POWER SOURCE.
f ) Removal of primary batteries
Instructions for use of EQUIPMENT containing primary batteries shall contain a
warning to remove these batteries if EQUIPMENT is not likely to be used for some time,
unless there is no risk of a SAFETY HAZARD arising.
g) Rechargeable batteries
Instructions for use of EQUIPMENT containing rechargeable batteries shall contain
instructions to ensure safe use and adequate maintenance.
h) EQUIPMENT with a specified power supply or battery charger
Instructions for use shall identify power supplies or battery chargers necessary to
ensure compliance with the requirements of this Standard.
j ) Environmental protection
Instructions for use shall:
— identify any risks associated with the disposal of waste products, residues, etc.
and of the EQUIPMENT and ACCESSORIES at the end of their useful lives;
— provide advice on minimizing these risks.
6.8.3 Technical description
a) *General
The technical description shall provide all data, which is essential for safe operation.
This shall include:
— data mentioned in subclause 6.1;
— all characteristics of the EQUIPMENT, including range(s), accuracy, and
precision of the displayed values or an indication where they can be found.
In addition to details required to be included in instructions for use, the technical descrip-
tion shall state whether particular measures or particular conditions are to be observed for
installing EQUIPMENT and bringing EQUIPMENT into use.
b) Replacement of fuses and other parts
— If the type and rating of fuses utilized in the mains supply circuit external to
PERMANENTLY INSTALLED EQUIPMENT is not apparent from the information concern-
ing RATED current and mode of operation of EQUIPMENT, the required type and rating of
fuses shall be indicated in at least thetechnical description.
— The technical description shall contain instructions for replacement of
interchangeable and/or detachable parts which are subject to deterioration during
NORMAL USE.
c) Circuit diagrams, component part lists, etc.
The technical description shall contain a statement that the supplier will make
available on request circuit diagrams, component part lists, descriptions, calibration
instructions, or other information which will assist the USER’s appropriately qualified
technical personnel to repair those parts of EQUIPMENT which are designated by the
manufacturer as repairable.
