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EN109-1631750-48 IFU
9
Precautionary instructions
If the use of this device may have caused or contributed to an undesirable event such as
death or serious injury to the user, the manufacturer AND the competent authority of the
Member State MUST be notified immediately!
In case of damage from transport is noticed, contact your local distributor.
DO NOT USE the device!
The device should not be used when any sort of mechanical damage is noticed.
Do not place the device in a location where the power cord could be tripped over or pulled
out during treatment!
It is recommended that the Sonopuls 190 should not be used after extreme temperature
fluctuations.
Federal law (USA only) restricts this device to sale by, or on the order of, a physician or
licensed practitioner. This device should be used only under the continued supervision of a
physician or licensed practitioner.
Make certain that the unit is electrically grounded by connecting only to a grounded electrical
service receptacle conforming to the applicable national and local electrical codes.
Do not operate the unit in an environment of short-wave or micro-wave diathermy use as this
can result in burns beneath the electrodes.
Care must be taken when operating this equipment around other equipment. Potential
electromagnetic or other interference could occur to this or to the other equipment. Try to
minimize this interference by not using other equipment in conjunction with it.
This equipment is not suitable for use in the presence of flammable anaesthetic mixture with
air, oxygen, or nitrous oxide.
This device should be kept out of the reach of children.
Use of controls or adjustments or performance of procedures other than those specified
herein may result in hazardous exposure to ultrasonic energy.
Handle ultrasound applicator with care. Inappropriate handling of the ultrasound applicator
may adversely affect its characteristics.
Inspect ultrasound applicator for cracks and other mechanical defects which may allow the
ingress of conductive fluid before each use.
Inspect ultrasound applicator cables and associated connectors before each use.
Do not operate the Sonopuls 190 when connected to any unit other than Enraf-Nonius BV
devices.
This unit should be operated in temperatures between 10 °C and 40 °C (50 °F and 104 °F),
with a Relative Humidity ranging from 10%-90 % (non-condensing).
Do not expose the unit to direct sunlight, heat radiated from a heat radiator, excessive
amounts of dust, moisture, vibrations and mechanical shocks.
In the case of ingress of liquids, unplug the unit from the mains supply and have it checked
by an authorized person (see the paragraph on technical maintenance).
Before administering any treatment to a patient, you should become acquainted with the
operating procedures for each mode of treatment available, as well as the indications,
contraindications, warnings and precautions. Consult other resources for additional
information regarding the application of ultrasound therapy.
Always determine the dosage based on the patient’s perception of heat. Any sensation
greater than mild warmth could cause a burn.
Do not use this device in so called “Wet
Rooms” (hydrotherapy rooms).
The device should be installed in such a way, that its warmth can be passed on to the
surroundings. Do not cover the ventilation openings.
Before performing any user maintenance, switch off the device and disconnect the plug from
the mains supply.
