Richard Wolf 2303 User manual

GA-A 202 /en /2012-04 V6.0 / PDG 11-5360
POWER CONTROL
2303
POWER STICK M4 8564.121
POWER STICK M3 8563.111/.311
Instruction Manual
2303
POWER CONTROL

0
GA-A 202
Important general notes and instructions for use
Make sure that this product is used only as intended and described in this instruction manual, by adequately
trained and qualified medical personnel, and that maintenance and repair are only carried out by authorized
experts.
Use the product only in the combinations and with the accessories and spare parts specified in this instruction
manual. Use other combinations, accessories and replacement parts only if they are expressly intended for
the planned application and if the performance characteristics and safety requirements are not impaired. Do
not alter the product.
Reprocess the products before each use and before return shipment as required by the instruction manual
to protect the patient, user and others.
Immediately upon receipt, check the product and its accessories for completeness and possible damage.
Should the shipment give right to complaints, please inform the manufacturer or supplier immediately.
Subject to technical changes!
Due to the continuous development of our products, the illustrations and technical data may deviate slightly.
Safety instructions and levels of danger
Symbol Level of danger
WARNING!
Failure to observe can result in death or serious injury.
CAUTION!
Failure to observe can result in slight injury or damage to the product.
.
IMPORTANT!
Failure to observe can result in damage to the product or surroundings.
.
NOTE!
Tips for optimum use and other useful information.
GERMANY
RICHARD WOLF GmbH
75438 Knittlingen
Pforzheimerstr. 32
Telephone: [phone]
Telefax: [phone]
MANUFACTURER
[email protected]
www.richard-wolf.com
USA
RICHARD WOLF
Medical Instruments Corporation
353 Corporate Woods Parkway
Vernon Hills, Illinois 60061
Toll Free: 001 (800) 323 - 9653
Phone: [phone] - 1113
Fax: [phone] - 1488
[email protected]
www.richardwolfusa.com
UK
RICHARD WOLF UK Ltd.
Waterside Way
Wimbledon
SW17 0HB
Telephone: + 44 20 89 44 74 47
Telefax: [phone]
[email protected]
www.richardwolf.uk.com
BELGIUM / NETHERLANDS
N.V. Endoscopie
RICHARD WOLF Belgium S.A.
Industriezone Drongen
Landegemstraat 6
9031 Gent Drongen
Telephone: [phone]
Telefax: [phone]
[email protected]
www.richard-wolf.be
FRANCE
RICHARD WOLF France S.A.R.L.
Rue Daniel Berger
Z.A.C. La Neuvillette
F-51100 Reims
Telephone: [phone]
Telefax: [phone]
[email protected]
AUSTRIA
RICHARD WOLF Austria
Ges.m.b.H.
Wilhelminenstraße 93 a
A-1160 Vienna
Telephone: [phone]
Telefax: [phone]
[email protected]
www.richard-wolf.com
Marketing Office
U.A.E
RICHARD WOLF Middle East
P.O. Box 500283
AL Thuraya Tower 1
9th Floor,
Room 904, Dubai
Telephone: + 9 71 43 68 19 20
Telefax: + 9 71 43 68 61 12
[email protected]
www.richard-wolf.com
INDIA
RICHARD WOLF India Private Ltd.
JMD Pacific Square
No. 211 A, Second Floor
Behind 32nd Milestone
Gurgaon - 122 001
National Capitol Region
Telephone: + 91 12 44 31 57 00
Telefax: [phone]
[email protected]
www.richard-wolf.com

Contents
I
GA--A 202
1 General information 1.......................................................
1.1 Symbols 1..................................................................
1.2 Intended use 3..............................................................
1.3 Indications and field of use 3..................................................
1.4 Contraindications 3...........................................................
1.5 General notes and instructions for use 3........................................
1.6 Combinations 4..............................................................
1.6.1 Potential equalization 4.......................................................
1.6.2 Requirements for the products / components of a combination 5....................
1.7 Electromagnetic compatibility (EMC) 6..........................................
1.7.1 Combination with POWER STICK M4 and, alternatively, POWER STICK M3 8.......
1.7.2 Legend 8...................................................................
2 Illustration 9................................................................
2.1 Figure: POWER CONTROL front panel 9.......................................
2.1.1 Legend 9...................................................................
2.2 Figure: LCD display 9.........................................................
2.2.1 Legend 9...................................................................
2.3 Figure: POWER CONTROL rear panel 10........................................
2.3.1 Legend 10...................................................................
2.4 Figure: Footswitch 10..........................................................
2.4.1 Legend 10...................................................................
2.5 Figure: POWER STICK M3 (8563.111 / .311) 11...................................
2.5.1 Legend 11...................................................................
2.6 Figure: POWER STICK M4 (8564.121) 11........................................
2.6.1 Legend 11...................................................................
3Setup 12....................................................................
3.1 Preparation of POWER CONTROL 12...........................................
3.2 Preparation of POWER STICK M4 13............................................
3.3 Preparation of POWER STICK M3 (8563.111 / .311) 13............................
3.3.1 Attaching the irrigation adaptor (only 8563.311) 14.................................
4 Checks 15...................................................................
4.1 Visual check 15...............................................................
4.2 Function check 15.............................................................
4.2.1 Function control of footswitch 16................................................
4.2.2 Function check -- POWER STICK M4 (8564.121) 16...............................
4.2.3 Function check -- POWER STICK M3 (8563.111 / .311) 17..........................
5Use 18......................................................................
5.1 Operating principle 18.........................................................
5.2 Control elements / modes 18...................................................
5.2.1 General notes and instructions for use 18........................................
5.2.2 Operation of POWER CONTROL via the sensor surface 19........................
5.2.3 Language selection 20.........................................................
5.2.4 Setting the parameters with the footswitch connected 20...........................
5.2.5 Setting the parameters at the POWER CONTROL, with no footswitch connected 22...
5.2.6 Changing the factory settings 23................................................

II GA--A 202
5.2.7 POWER STICK M3 24.........................................................
5.2.8 POWER STICK M4 24.........................................................
5.3 Operation of device 25.........................................................
5.3.1 Speed adjustment 26..........................................................
5.3.2 Instructions and notes on morcellation in urology 27...............................
5.4 Alarms 28....................................................................
5.5 Emergency shutdown of POWER STICK 28......................................
5.5.1 Taking out of service 28........................................................
6 Operation in the RIWO NET SYSTEM 29.......................................
6.1 Combination with RIWO NET SYSTEM 29.......................................
6.2 Operation 29.................................................................
6.3 Setting of “ID” rotary coding switch 29...........................................
6.4 Connection to the RIWO NET SYSTEM 30.......................................
6.5 Controlling the devices using the RIWO--NET menu 31.............................
6.5.1 Controlling the devices via the different input media 31.............................
6.5.2 Illustration of menu 31.........................................................
6.5.3 Main menu 32................................................................
6.5.4 Speed range function 32.......................................................
6.5.5 Speed function 32.............................................................
6.5.6 Oscillation function 32.........................................................
6.5.7 Positioning function 32.........................................................
6.6 System messages 33..........................................................
6.6.1 Status messages 33...........................................................
6.6.2 Warnings 33..................................................................
6.6.3 Errors 33.....................................................................
7 Reprocessing and maintenance 34............................................
7.1 Reprocessing of device 34.....................................................
7.2 Maintenance Device 34........................................................
7.2.1 Maintenance intervals 34.......................................................
7.3 Reprocessing of POWER STICK M4 (8564.121) 35................................
7.3.1 Manual reprocessing 35.......................................................
7.3.2 Machine reprocessing 36......................................................
7.3.3 Assembly 36.................................................................
7.3.4 Function check 36.............................................................
7.3.5 Sterilization 36................................................................
7.4 Reprocessing of POWER STICK M3 (8563.111 / .311) 37..........................
7.4.1 Manual reprocessing 37.......................................................
7.4.2 Machine reprocessing 38.......................................................
7.4.3 Assembly 39.................................................................
7.4.4 Function check 39.............................................................
7.4.5 Sterilization 40................................................................
7.5 Reprocessing of re--usable irrigation adapter 40...................................
7.5.1 Manual reprocessing 40.......................................................
7.5.2 Machine reprocessing 41.......................................................
7.5.3 Visual check 41...............................................................
7.5.4 Sterilization 41................................................................
7.6 Reprocessing of the re--usable rotary blades, abraders and morcellators 42...........
7.6.1 Manual reprocessing 42.......................................................

Contents
III
GA--A 202
7.6.2 Machine reprocessing 42......................................................
7.6.3 Checks 42...................................................................
7.6.4 Sterilization 42................................................................
8 Technical description 43.....................................................
8.1 Trouble shooting 43...........................................................
8.1.1 POWER CONTROL 43........................................................
8.1.2 POWER STICK 43............................................................
8.2 Technical data of POWER CONTROL 44.........................................
8.2.1 Interfaces 44.................................................................
8.3 Technical data of POWER STICK 45............................................
8.4 Technical data of footswitch 45..................................................
8.5 Operating, storage, transport and shipping conditions 45...........................
8.6 Spare parts and accessories 46.................................................
8.6.1 POWER CONTROL 46........................................................
8.6.2 POWER STICK M4 46.........................................................
8.6.3 POWER STICK M3 46.........................................................
8.6.4 Reusable rotary blades and abraders 47.........................................
8.6.5 Disposable rotary blades and abraders 47........................................
8.6.6 Reusable rotary blades and abraders for spinal surgery (POWER STICK M4) 48......
8.6.7 Reusable rotary morcellator for urology 48........................................
8.6.8 Disposable Rotary Morcellator for urology. 48.....................................
8.7 Replacing parts on POWER STICK M4 (8564.121) 49.............................
8.7.1 POWER STICK M4 connection cable 49.........................................
8.8 Replacing parts on POWER STICK M3 (8563.111 / .311) 49........................
8.8.1 O--ring for twist--lock mechanism 49.............................................
8.8.2 O--ring for suction/irrigation plunger 49...........................................
8.8.3 Sealing cap of suction/irrigation system (connecting hole to handle) 49...............
8.8.4 POWER STICK M3 connection cable 49.........................................
8.9 Device fuses 50...............................................................
8.9.1 Disposal of the product, packing material and accessories 50.......................

1GA--A 202
1 General information
1.1 Symbols
Symbols Meaning
Attention, Caution
Follow the instruction manual
Off (power: disconnection from power/mains)
On (power: connection to the power/mains)
Equipotentality
Fuse
μAlternating current (AC)
TYPE BF APPLIED PART
Socket for footswitch
Alarm
Ready (Triggering of function check)
Signal input (CAN-BUS)
Signal output (CAN-BUS)
Identification of sensor field
Display blinks: “No footswitch"
Display blinks: “No POWER STICK"
Indication “CCW rotation"
Indication “CW rotation"
Indication “Oscillation"
Selected speed range display
Counter-clockwise rotation
Clockwise rotation
Oscillation
Back to previous menu
Increase value by one
Decrease value by one

2
GA--A 202
Meaning
Symbols
Selection
Confirm value
Single step
“Adjust speed" selector
“Select speed range" selector
“Device settings“ selector
Oscillation rate adjustment
max
min
12
34 Speed range adjustment
Speed adjustment
Adjust stop position (works only without footswitch)
Reset to factory setting
Language selection
Control level “B" activated
Footswitch
Change between control levels “A" and “B"
A: Speed range 1 through 4 B: Single step
A: “CCW“ rotation B: Reduce speed
A: “CW“ rotation B: Increase speed
A: “Oscillating“ rotation B: Speed control
REF Order number
Lot identification number
Manufacturing date
To be used before (date):
Do not reuse!
Sterilized with ethylene oxide
Recycle the product separately. Do not discard together with other waste.
A Registered Trademark of ETL, a Recognized Testing Laboratory, listing compliance as
Medical Electrical Equipment to standard CAN/CSA C 22.2 No. 601.1 (c) and UL 60601--1 (us)

3GA--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 observe the cases described in the relevant medical literature.
1.5 General notes and instructions 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 be 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 and outer blade / abrader together).
These components must not be combined with inner or outer
blades/abraders from other packages.

4
GA--A 202
CAUTION!
Reduced cutting performance and wear on the rotary blade/abrader !
If the rotary blade/abrader is pushed against the tissue at high
pressure this will not improve the cutting performance but may ins-
tead cause damage, increased wear and tear on the inner blade/ab-
rader.
.IMPORTANT!
Quick cooling of a hot motorized handle can cause stresses in the mater-
ial and may lead to failure of the device or a reduced service life.
1.6 Combinations
.IMPORTANT!
In addition to this instruction manual be sure to follow the instruction manuals of
the products used in combination with this product.
If other products are used in combination with this product, make sure that the
intended uses and relevant technical data (working length, diameter etc.) are the
same.
When using rotary blades/abraders for spinal surgery, ensure that the working
channel of discoscopes and the internal diameter of working sleeves is sufficiently
large. Use instruments with 2.5 mm, 3.5 mm and 4.0 mm diameter through disco-
scopes and instruments with 4.5 mm diameter through suitable working sleeves.
Only suction/aspiration devices and irrigation fluid supply systems that do not
reduce the protection rating ”BF” of the motorized handle in accordance with IEC /
EN 60601 may be used. The user is responsible for selecting a suitable irrigation
fluid.
.IMPORTANT!
As a result of differing anatomy, it is not possible to quantify irrigation and suction
rates. It is the user’s responsibility to adapt the settings to the requirements.
1.6.1 Potential equalization
The potential equalization cable establishes a direct connection between
a medical electrical device and an equipotential bonding rail.
It serves to equalize differences in potential between enclosures of elec
trical equipment and firmly installed conductive parts in the patient envi
ronment.

5GA--A 202
1.6.2 Requirements for the products / components of a combination
1.5m
IEC 60601-1, 3. Ed.
1.5m
1.5m
The general requirements depend on whether the products /
components are inside or outside the patient environment.
Medically used room Non-medically
used room
Requirements / measures
inside the
patient environment
outside the
patient environment
Leakage currents to section 16.6
IEC 60601-1:2005 / EN 60601-1:2006 *
MP MP
~~- - Verification of the total patient leakage current
MP MP
~**
-
-
Verification of leakage currents
a) additional protective earth connection
(consult the corresponding manufacturer),
or
b) additional isolating transformer for medical applications **
MP
~
NMP
~**
MP NMP
~**
NMP
~
MP
MP NMP
~
MP MP / NMP
~**
MP
~
NMP
~
-
Verification of leakage currents
a) no plugs with metal housing, or
b) additional isolation device (to avoid voltage differentials)
MP
~
MP / NMP
~
Verification of leakage currents
a) common protective earth connection, or
b) additional protective earth connection at MP (clarify with the corre
ponding manufacturer), or
c) additional isolation device (to avoid voltage differentials), or
d) no plugs with metal housing in the patient environment
additional "isolating transformer" to IEC/ EN60601-1
**
additional isolating device to IEC/
EN 60601-1 Multiple socket strip
Functional connection ~Power supply grid
MP =medical electrical device to IEC/ EN 60601-1, ANSI/AAMI es60601-1, CSA C22.2 No. 60601-1 08
NMP =non-medical electrical device in accordance with product-specific IEC/EN/UL standards
*When connected via a power bar under standard conditions the earth leakage current of the power bar must not exceed 5 mA.
** e.g. Richard Wolf video cart with "isolating transformer"