Combined-languages-d1 - Flipbook - Page 32
USER'S MANUAL
EVOLUTION VETERINARY DENTAL UNITS
1. SAFETY
iM3 has developed and designed the system in such a
way that dangers are effectively ruled out if the unit is
used in accordance with the intended use.
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1.5
General safety notes
» Always comply with the specifications of all guidelines,
laws, and other rules and regulations applicable at the
site of operation for the operation of this unit.
Despite this, the following residual risks can remain:
» Check the function, condition and fill level of the unit
» Personal injury due to incorrect use/misuse
» Personal injury due to mechanical effects
» Personal injury due to lack of hygiene, e.g. infection
» Do not convert or modify the unit.
» Comply with the specifications of the Installation and
prior to every use.
Operating Instructions.
» The Installation and Operating Instructions must be
1.1
Intended Purpose
The iM3 Bottle System is used to supply water to
dental treatment units and in particular to the dental
instruments connected to them.
1.2
Intended Use
Fill the iM3 bottle with a suitable solution. This can either
be distilled water, or iM3’s CLS Solution at the correct
dilution – 1 parts CLS to 3 parts water.
The system must be connected to a compressed air line as
well as to the line supplying the treatment unit with water
(see “6 Mounting”). The system may only be used with the
supplied safety pressure regulator. The integrated stop
valve enables the bottle to be screwed in and out while
the system is switched on.
accessible to all operators of the unit at all times.
» When filling the bottle, watch out for spilled liquids danger of slipping.
1.6
Where applicable, the requirements for medical products
have been taken into account in the development and
construction of the device. As a result, this device is
suitable for installation within medical supply equipment.
» Where this device is integrated in other medical supply
equipment, the requirements of European Union
Medical Device Regulation (EU) 2017/745 and the
relevant standards must be observed.
1.7
1.3
Improper Use
Any other usage or usage beyond this scope is deemed
to be improper. The manufacturer accepts no liability for
damage resulting from improper usage. In such cases,
the user/operator will bear the sole risk. Do not use any
liquids or solids that are unsuitable for the iM3 Bottle
System.
1.4
Systems, connection with
other devices
Additional devices connected with medical devices must
be proven to conform with their corresponding IEC or ISO
standards. All configurations must continue to comply
with the standard requirements for medical systems (see
IEC 60601-1).
Whoever connects additional devices to medical devices
automatically becomes the system configurator and is
responsible for ensuring that the system corresponds
with the standard requirements for systems. Local laws
take priority over the requirements outlined above.
Combining devices safely
Specialist personnel
Handling
Unit operating personnel must ensure safe and correct
handling based on their training and knowledge.
» Instruct or have every operator instructed in handling
the unit.
The following groups are not permitted to operate or
use a commercially operated unit:
» People without the necessary experience and
knowledge
» People with reduced physical, sensory or mental
capabilities
» Children
Installation and repairs
» All installation, resetting, alteration, extension
and repair work must be carried out either by iM3
personnel or by a suitably qualified person approved
by iM3.
