2
GA--A 181
1.2 Intended use
The ultrasound generator (US--LITHO) 2271 with transducer and sono-
trode is used in intracorporeal ultrasound lithotripsy exclusively for desin-
tegrating kidney stones, urinary bladder stones and ureter stones under
direct endoscopic view. The use of this device for purposes other than
the above is not admissible.
CAUTION!
In therapeutic use an adequate backup unit must be available for
the unlikely event that the device fails.
1.2.1 Contraindications
Contraindications directly related to the product are presently unknown.
On the basis of the patient’s general condition the doctor in charge must
decide whether the planned use is possible or not. For further information
please refer to the current medical literature.
.
NOTE!
Before the first use we recommend reading the relevant literature (see
chapter 9 literature“).
1.3 Combinations
W ARNING!
Danger of life-threatening embolism.
If used in combination with a peristaltic suction pump (e.g. Suction
Pump 2207) no air or liquid must be discharged from the tip of the
sonotrode. The sonotrode must be used exclusively for evacuating.
Strictly follow the instruction manual of the roller suction pump.
.
IMPORTANT
In addition to this instruction manual follow the manuals of the products
used in combination with this product.
1.3.1 Device combinations
The Ultrasound Lithotriptor consisting of Ultrasound Generator 2271 with
transducer and sonotrode may only be used in conjunction with a suitable
suction device, e.g. a suction pump. The R.Wolf “Suction Pump 2207” is
specially designed for use with the ultrasound generator and provides
ideal conditions for the use of this device.
If a different suction pump or suction device (different manufacturer) is
used, the operator/user must check whether the suction device features
a controllable, adjustable vacuum, which meets the requirements.
To ensure sufficient cooling of the transducer and the sonotrode, make
sure that the suction device can provide an adjustable vacuum of up to
--0.6 bar on a continuous basis.
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