Service Manual – 2 / 63
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3.2. Using the unit: warnings and cautions
Tissue exposure to ultrasound energy: the ABSOLU unit is designed for use in ophthalmology
only. While QUANTEL MEDICAL is not aware of any reports of adverse effects from using
ophthalmologic ultrasound unit, even at FDA pre-enactment levels, no other use is intended
or implied. The system controls limit the output energy to within the parameters specified
for its intended purpose. No control of ultrasound energy is available to the user other than
the duration of exposure.
WARNINGS
USA Federal Law requires that this device be sold only by on the prescription of a physician.
This device is not intended for foetal use.
Disconnect AC power before cleaning the case.
AC power should be disconnected every time after turning the system OFF
To avoid risk of electric shock, this equipment must only be connected to supply mains with
protective earth.
While using the unit, mains plug must be easily accessible.
The ABSOLU IOL calculator will calculate negative IOL values if such is predicted by the
entered data. These are displayed with a minus sign (-). Do not ignore this sign.
Be careful not to compress the cornea when measuring axial length.
No modification of this equipment is allowed.
Before adding any other equipment to the basic configuration, please refer to the:
ABSOLU User Manual: II- Technical information
Section 5 – Installation: technical information
Do not modify the equipment (ABSOLU provided by QUANTEL MEDICAL) without authorization
of the manufacturer.
In case the equipment (ABSOLU provided by QUANTEL MEDICAL) is modified, appropriate
inspection and testing must be conducted to ensure continued safe use of the equipment.
Only connect Medical Electrical Equipment which has been specified as some parts of the
equipment or as compatible with the equipment.
The equipment has to be disconnected from the telecom, IT network and/or USB accessories
during examination, if the connected accessories are not separated with a network isolator
and/or USB isolator (that comply with IEC 60601-1 and IEC 60950 standards, moreover the
installation of accessories / isolators have to be performed or checked by the responsible
organizations: clause 16 IEC 60601-1, third edition).
Only use a network device or USB accessories that comply with IEC 60601-1 and IEC 60950
standards.
Each time new equipment (not delivered by QUANTEL MEDICAL) is connected to the
equipment (via USB, network...), the leakage current measurements and checks have to be
performed by the responsible organizations with the new equipment installation: clause 16
IEC 60601-1, third edition.
Do not use flammable anesthetics product.
Do not use in oxygen rich atmosphere.
Some persons are extremely allergic to isopropyl alcohol.
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