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Principles
2.2 Preconditions for operation
2.2.1 Operating personnel
The DUOLITH
®
SD1 is intended exclusively for use by healthcare professionals who
have been trained to use the device.
Such a specialist is expected to have practical knowledge of medical procedures and
applications as well as of the technology, and should be experienced in treating the
indications stated in Chapter 2.1.1 indiCatiOns.
Users must have basic physical and cognitive abilities such as vision, hearing and lit-
eracy, and have basic functional use of their upper extremities.
The device is designed for a demographic target group between 18 and 65 years.
2.2.2 Training of the operator
Operators of the DUOLITH
®
SD1 must have been adequately trained in using
this system safely and efciently before they operate the device described in this
handbook. An introduction to the principles of operation will be provided by
your STORZ MEDICAL dealer with reference to this operating manual and will be
documented in the system logbook.
The operator must be instructed in the following points:
– Instruction in the operation and designated use of the device with practical
exercises
– Mechanism of action and function of the device and the energies delivered by it
– All component settings
– Indications for use of the device
– Contraindications and side effects of the therapy waves
– Explanation of the warnings in all operating modes
– Instruction in how to perform the functional checks
Further training requirements vary from country to country. It is the operator’s
responsibility to ensure that the training meets the requirements of all applicable
local laws and regulations. Further information about training in the operation of this
system can be obtained from your STORZ MEDICAL dealer. However, you can also
contact the following address directly:
STORZ MEDICAL AG Telephone: +41 (0) 71 677 45 45
Lohstampfestrasse 8 Fax: +41 (0) 71 677 45 05
Postfach
CH-8274 Tägerwilen
Switzerland
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