3
GA--A 202
Meaning
Symbols
A Registered Trademark of a Recognized Testing Laboratory, confirm the compliance to the standard
of Medical Electrical Equipment CAN/CSA C22.2 No.60601-1 (c) and ANSI/AAMI ES60601-1 (us)
Identification in conformity with Medical Devices Directive 93/42/EEC only valid if the product and/
or packaging is marked with this symbol. Products of category IIa and above, as well as
sterile products or products with measuring function of category I, are additionally marked with the
code number of the notified body ( 0124)
1.2 Intended use
The POWER CONTROL 2303 in conjunction with POWER STICK M4
(8564.121) or, alternatively, POWER STICK M3 (8563.111/.311) serves
to drive WOLF rotary blades/abraders and morcellators (tissue punches)
for the removal of tissue in endoscopic operations.
At the same time aspiration allows continuous removal of ablated tissue.
This product is designed exclusively for use by specialized medical per
sonnel and may only be applied by medically qualified and adequately
trained persons.
1.3 Indications and field of use
For use with endoscopic accessories:
- In arthroscopy e.g. for meniscal resection, for the removal of soft tissue
as well as for intra-articular transsection or abrasion of osseous tissue
(e.g. in ACL or shoulder applications).
- In thorax surgery e.g. to remove hematomas.
- In sinus surgery e.g. to remove polyps.
- In spinal surgery (arthroscopic microdiscectomy (AMD)) e.g. for
removing degenerated tissue.
- In urology for fragmentation and removing of detached prostatic
adenomas after Laser-TURP.
1.4 Contraindications
Relative or absolute contraindications may result from the general condi-
tion of the patient, i.e. the general findings, or in special cases, where the
risk for the patient is significantly higher if motorized tools are used. Make
sure you o bserve the cases described in the relevant medical literature.
1.5 General notes and instruction s for use
CAUTION!
All R.Wolf disposable rotary blades and abraders are sterily packed
in double wrapping and are designed for single use only.
Any products which are not used should b e kept in the outer pack-
aging (cardboard box). Do not use products with damaged outer
sterile wrapping/packaging (plastic bag).
CAUTION!
The rotary blades and abraders are packed individually in pairs
(inner a nd outer blade / abrader tog ether).
These components must not be combined with inner or outer
blades/abraders from other packages.
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