Richard Wolf PowerDrive ART1 User manual

GA-A 238-USA /USA /2012-10 V5.0 / ECO 2012-0554 (RW: 2012-04 V5.0 / ÄM: PDG 11-5390)
Instruction Manual
POWER DRIVE ART1
2304.007
Power Stick M4 , M5/3 , M5/0
Micro Stick S1
Power Drill M1

0
GA-A 238-USA
Important general instructions for use
Ensure that this product is used only as intended and described in this instruction manual, by ad
equately trained and qualified personnel, and that maintenance and repair is only carried out by
authorized specialized technicians.
Use this product only with the combinations and with the accessories and spare parts listed in this
instruction manual. Use other combinations, accessories and replacement parts only if they are
expressly intended for this use and if the performance and safety requirements are met.
Reprocess the products before every application and before returning them for repair as required
by the instruction manual in order to protect the patient, user or third parties.
Subject to technical changes!
Due to continuous development of our products, illustrations and technical data may deviate
slightly from the data in this manual.
CAUTION :
Federal law restricts this device to sale by or on the order of a physician.
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 surrounding.
.
NOTE!
Tips for optimum use and other useful information.
USA
RICHARD WOLF
Medical Instruments Corp.
353 Corporate Woods Parkway
Vernon Hills, Illinois 60061
Telephone: [phone]
Telefax: [phone]
sales&[email protected]
www.richardwolfusa.com
GERMANY
RICHARD WOLF GmbH
75438 Knittlingen
Pforzheimerstr. 32
Telephone: [phone]
Telefax: [phone]
MANUFACTURER
[e-mail]
www.richard--wolf.com
UK
RICHARD WOLF UK Ltd.
Waterside Way
Wimbledon
SW17 0HB
Telephone: + 44 20 89 44 74 47
Telefax: [phone]ad-
[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]
[e-mail]
www.richard--wolf.be
FRANCE
RICHARD WOLF France S.A.R.L.
Rue Daniel Berger
Z.A.C. La Neuvillette
51100 Reims
Telephone: [phone]
Telefax: [phone]
[e-mail]
AUSTRIA
RICHARD WOLF Austria
Ges.m.b.H.
Wilhelminenstraße 93 a
1160 Vienna
Telephone: [phone]
Telefax: [phone]
[e-mail]
www.richard--wolf.at
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
[e-mail]
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: [phone]
Telefax: [phone]
[e-mail]
www.richard--wolf.com

Contents
I
G A -- A 2 3 8 -- U S A
1 General information 1.......................................................
1.1 Symbols 1..................................................................
1.2 Intended use 4..............................................................
1.2.1 POWER DRIVE ART1 4......................................................
1.2.2 Rotary blades 4..............................................................
1.2.3 Rotary cutters 4..............................................................
1.2.4 Universal resectors 4.........................................................
1.2.5 Drillbits 4...................................................................
1.2.6 Target wires, Kirschner wires and surgical wires 4................................
1.2.7 Saw blades 4................................................................
1.3 Indications and fields of use 4.................................................
1.4 Contraindications 5...........................................................
1.5 General notes and instructions for use 5........................................
1.6 Combinations 5..............................................................
1.6.1 Potential equalization 7.......................................................
1.6.2 Requirements for products / components of a combination 7.......................
1.7 Electromagnetic compatibility (EMC) 8..........................................
1.8 Combination with motorized handles and power drill 10.............................
1.8.1 Legend 10...................................................................
2 Illustration 11................................................................
2.1 POWER DRIVE ART1 front panel 11............................................
2.1.1 Legend 11...................................................................
2.2 Touchscreen 11...............................................................
2.2.1 Legend 11...................................................................
2.3 POWER DRIVE ART1 rear panel 12.............................................
2.3.1 Legend 12...................................................................
2.4 Foot switch 12................................................................
2.4.1 Legend 12...................................................................
2.5 Illustration of Power Stick M5/3 13...............................................
2.6 Illustration of Power Stick M5/0 14...............................................
2.7 Illustration of Micro Stick S1 15.................................................
2.8 Illustration of Power Stick M4 15................................................
2.9 Power Drill M1 16.............................................................
2.9.1 Legend 16...................................................................
3Set--up 17...................................................................
3.1 Preparation -- POWER DRIVE ART1 18..........................................
3.2 Preparation -- Power Stick M5/3 and M5/0 18.....................................
3.3 Preparation of Micro Stick S1 19................................................
3.4 Preparation -- Power Stick M4 19................................................
3.5 Preparation -- Power Drill M1 20.................................................
4 Checks 21...................................................................
4.1 Visual check 21...............................................................
4.2 Function check 22.............................................................
4.2.1 Function check of foot switch 22................................................
4.2.2 Function check -- Power Stick M4, M5/3 and M5/0 22..............................
4.2.3 Function check of Micro Stick S1 23.............................................
4.2.4 Function check of Power Drill M1 23.............................................

II G A -- A 2 3 8 -- U S A
5Use 24......................................................................
5.1 Operating principle 24.........................................................
5.2 Controls and modes 24........................................................
5.2.1 Control and display 24.........................................................
5.2.2 POWER DRIVE ART1 ON/OFF 24.............................................
5.2.3 Foot switch mode in 2--pedal or 3--pedal mode 25.................................
5.2.4 Emergency shut--down of handle motor 25.......................................
5.2.5 Automatic recognition of the connected handle and tool 25.........................
5.2.6 Controlling Power Stick M5/3 via its control buttons 28.............................
5.2.7 Controlling the Micro Stick S1 using the button 28.................................
5.2.8 Controlling Power Drill M1 29...................................................
5.3 Setting the parameters on the device and using the foot switch 30...................
5.4 Device operation 34...........................................................
5.4.1 Speed setting 35..............................................................
5.4.2 Positioning the cutting window with connected rotary blade 35.......................
5.5 Error messages 36............................................................
6 Operation in the RIWO NET SYSTEM 37.......................................
6.1 Combination with RIWO NET SYSTEM 37.......................................
6.2 Operation 37.................................................................
6.3 Connection to the RIWO--NET SYSTEM 38......................................
6.4 Controlling the devices using the RIWO--NET menu 39.............................
6.4.1 Controlling the devices via the different input media 39.............................
6.4.2 Menu layout 39...............................................................
6.4.3 Main menu 40................................................................
6.4.4 Function of handle 40..........................................................
6.4.5 Speed function 40.............................................................
6.4.6 Window function 40...........................................................
6.4.7 Torque function 40............................................................
6.4.8 Oscillation function 40.........................................................
6.4.9 Direction of rotation function 40.................................................
6.5 System messages 41..........................................................
6.5.1 Operator’s notes 41...........................................................
6.5.2 Fault/error 41.................................................................
7 Cleaning, sterilization and maintenance 42....................................
7.1 Disinfecting of POWER DRIVE ART1 42.........................................
7.2 Maintenance of POWER DRIVE ART1 42........................................
7.2.1 Maintenance intervals 42.......................................................
7.3 Reprocessing procedures 43...................................................
7.3.1 Power Stick M4, M5/0, M5/3, Micro Stick S1 43...................................
7.3.2 Rotary blades / cutters 46......................................................
7.3.3 Power Drill M1 with accessories 48..............................................
7.4 Low--temperature sterilization 49................................................
7.4.1 Gas 49......................................................................
7.4.2 Alternate sterilization methods 49...............................................
8 Technical description 50.....................................................
8.1 Troubleshooting 50............................................................
8.2 Technical data of POWER DRIVE ART1 51.......................................
8.2.1 Interfaces 51.................................................................

Contents
III
G A -- A 2 3 8 -- U S A
8.3 Technical data of foot switch 51.................................................
8.4 Technical data of motorized handle 52...........................................
8.5 Technical data of Power Drill M1 and tool holders 52...............................
8.6 Operating, storage, transport and shipping conditions 53...........................
8.7 Spare parts and accessories 54.................................................
8.7.1 POWER DRIVE ART1 54......................................................
8.7.2 Power Stick M4 54............................................................
8.7.3 Power Stick M5/3 and M5/0 54..................................................
8.7.4 Micro Stick S1 54.............................................................
8.7.5 Power Drill M1 54.............................................................
8.7.6 Reusable rotary blades / cutters (Micro Stick S1) 55...............................
8.7.7 Disposable rotary blades / cutters (Micro Sticks S1) 55.............................
8.7.8 Reusable rotary blades / cutters (Power Sticks M5/0 and M5/3) 55...................
8.7.9 Disposable rotary blades / cutters (Power Sticks M5/0 and M5/3) 56.................
8.7.10 Reusable rotary blade / --cutter (Power Stick M4) 57...............................
8.7.11 Disposable rotary blades / cutters (Power Stick M4) 57.............................
8.7.12 Reusable rotary blades / cutters for spinal surgery (Power Stick M4) 58..............
8.7.13 Reusable rotary blades / cutters for spinal surgery (Power Stick M5) 58..............
8.7.14 Disposable sagittal sawblades (Power Drill M1) 59.................................
8.7.15 Disposable reciprocal sawblades (Power Drill M1) 59..............................
8.7.16 Reusable Kirschner wires (Power Drill M1) 59.....................................
8.7.17 Disposable drill bits (Power Drill M1) 60..........................................
8.8 Replacement of spare parts 61..................................................
8.8.1 O--ring for valve lever Micro Stick S1 61..........................................
8.8.2 Device fuses 61...............................................................
8.8.3 Disposal of the product, packaging material and accessories 61.....................
9 Literature 62.................................................................
10 Warranty and Customer Service 63............................................

1G A -- A 2 3 8 -- U S A
1 General information
1.1 Symbols
Symbols Meaning
Device
Attention, consult ACCOMPANYING DOCUMENTS
Off (no power: disconnection from the line voltage)
On (power: connection to the line voltage)
Potential equalization
Fuse
μAlternating current (AC)
TYPE BF APPLIED PART
Socket for foot switch
Signal input (CAN-BUS)
Signal output (CAN-BUS)
Data transfer
Touchscreen display -- Mode level
Confirm input
Abort action
Selection - if 2 handles are connected
Adjusting the speed
Single step (toggle mode)
Adjusting the torque
Adjusting the oscillation rate (frequency)
Direction of rotation “counter-clockwise"
Direction of rotation “clockwise"
“Oscillation"
Direction of rotation "ccw" locked

2
G A -- A 2 3 8 -- U S A
Meaning
Symbols
Direction of rotation "cw" locked
"Oscillation" locked
Defective tool memory
"Increase value"
"Increase value"
"Decrease value"
Touchscreen display -- user selection
User selection
Language setting
Contrast / brightness menu
Contrast / brightness adjustment
Brightness adjustment
Invert display
Activate / deactivate handle buttons
Device data
Delete data
Foot switch mode 2-pedal or 3-pedal operation
Displayofhandletype
Power stick M4
Power stick M5/0
Power stick M5/3, buttons active / not active
Micro stick S1, button active / not active
Power drill M1
Beware of hand grip temperature! Reduced rotational speed!

3G A -- A 2 3 8 -- U S A
Meaning
Symbols
Foot switch
Single-step mode (toggle mode)
Direction of rotation “counter-clockwise“
Direction of rotation “oscillation“
Direction of rotation “clockwise“
"Increase value"
"Decrease value"
Power Drill handle
Lock / unlock
Direction of rotation “counter-clockwise“
Direction of rotation “clockwise“
Steam-sterilizable
General information
REF Order number
Lot identification number
Manufacturing date
Use--by date:
Do not reuse (for single use only)
Sterilized with ethylene oxide
Do not place product in general waste bin. Recycle separately.
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)
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)

4
G A -- A 2 3 8 -- U S A
1.2 Intended use
1.2.1 POWER DRIVE ART1
In conjunction with a motorized handle (e.g. Power Stick M5/3):
it is used as a drive unit for Richard Wolf rotary blades / burrs to remove
tissue in endoscopic interventions.
Simultaneous suction allows the continuous removal of the ablated tis
sue.
In conjunction with Power Drill M1:
and with the corresponding chucks as well as drillbits, drill wires,
Kirschner wires or surgical wires and the corresponding saw attachments
and saw blades it is used for working on bones or severing bones, re
spectively.
1.2.2 Rotary blades
Resectors, cutters, whiskers, incisors are used for the removal (severing
and evacuation) of soft tissue parts.
1.2.3 Rotary cutters
Cutters, burrs, acromionizers serve to ablate (sever and evacuate) tissue
from osseous structures.
1.2.4 Universal resectors
Universal resectors are used for the removal (severing and evacuation) of
soft tissue parts and for the ablation (severing and evacuation) of os
seous structures.
1.2.5 Drillbits
Drillbits are used for drilling in bones.
1.2.6 Target wires, Kirschner wires and surgical wires
Target wires, Kirschner wires and surgical wires are used for the initial
creation of targeting bores.
1.2.7 Saw blades
Saw blades serve to cut through bones.
These products are exclusively intended for use by medical staff and may
only be used by medically qualified and adequately trained doctors.
1.3 Indications and fields of use
The product is used in conjunction with endoscopic accessories for
the following purposes:
- In arthroscopy, e.g. resection of the meniscus, for removing soft tissue
as well as intraarticular severing or abrasion of bone tissue (e.g. ACL,
shoulder or hip applications).
- In thoracic surgery, e.g. for the removal of hematomas.
- In sinus surgery, e.g. for the removal of polyps.
- In spinal surgery (arthroscopic microdiscectomy (AMD) for removing
degenerated tissue.

5G A -- A 2 3 8 -- U S A
1.4 Contraindications
Contraindications resulting from the patient's general condition and de
scribed in the relevant literature must be observed. For further notes and
instructions please refer to the latest medical literature. We recommend
reading the relevant literature before the first application of the products.
On the basis of the patient's general condition, the surgeon in charge
must always decide whether the planned application is possible or not.
If the patient is suspected of having the Creutzfeld-Jacob-Syndrome or
TSE, BSE or other infectious diseases or the latter has been diagnosed,
adequate measures must be taken to prevent possible transmission to
other patients, users and third parties. For this purpose, the country-spe
cific laws and regulations must be observed.
1.5 General notes and instructions for use
CAUTION!
All Richard Wolf disposable rotary blades and abraders are double-
packaged in sterile packaging material and are designed for single
use only.
Store any products which are not used in the storage packaging
(exterior cardboard box). Do not use products in damaged outer
sterile packaging (foil bag).
CAUTION!
The rotary blades and abraders are packed individually (inner and
outer blades / abraders, respectively).
Do not combine these components with inner or outer blades
/abraders from other packages.
CAUTION!
Do not push the rotary blades / abraders against the tissue applying high
pressures! This will not increase the cutting performance but in extreme
cases it may cause wear and damage to the inner blade / abrader.
. IMPORTANT!
Shock-cooling the hot motorized handle will cause stresses in the mater
ial and may cause failure or a reduced service life of the handle.
1.6 Combinations
. IMPORTANT!
In addition to this Manual, also follow the instruction manuals of the
products used in combination with this product.
Different products should only be used in combination if their intended
uses and relevant technical data (working length, diameter, etc.) are the
same.
In the case of rotary blades or abraders for spinal surgery, make sure
that in discoscopes the working channel or in working sleeves the inner
diameter is sufficiently large. Use instruments with 2.5 mm, 3.0 mm and
4.0 mm diameter through discoscopes, instruments with 4.5 mm diameter
through suitable working sleeves.
Only use suction devices or devices to supply irrigation fluid which do not
lower the type BF degree of protection of the motorized handle in accord
ance with IEC / EN 60601. It is the responsibility of the user to select a
suitable irrigation fluid.
To facilitate the surgical passage, rotary blades with distal guide hole (hip
arthroscopy) can be guided by a flexible guide wire with ≤2.0 mm dia
meter.