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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, EQUIPMENT 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 sub-clause 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 description 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 concerning RATED current and mode of operation of
EQUIPMENT, the required type and rating of fuses shall be indicated in at least the technical 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.
d)
Environmental conditions for transport and storage The technical description shall contain a specification of
the permissible environmental conditions for transport and storage which shall be repeated on the outside of
the packaging of the EQUIPMENT [see Sub-clause 6.1 v)]
6.8.4 Not used.
6.8.5 Not used.
Compliance with the requirements of Sub-clause 6.8 is checked by inspection of the ACCOMPANYING
DOCUMENTS.
GENERAL USE