Instrument Driver Power System Model 2303 for Power Stick M3 or M4 Instructions for Use April 2012

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!

.

NOTE!

Failure to observe can result in damage to the product or surroundings. Tips for optimum use and other useful information.

GERMANY RICHARD WOLF GmbH 75438 Knittlingen Pforzheimerstr. 32 Telephone: +49 70 43 35-0 Telefax: +49 70 43 35-300 MANUFACTURER [email protected] www.richard-wolf.com BELGIUM / NETHERLANDS N.V. Endoscopie RICHARD WOLF Belgium S.A. Industriezone Drongen Landegemstraat 6 9031 Gent Drongen Telephone: +32 92 80 81 00 Telefax: +32 92 82 92 16 [email protected] www.richard-wolf.be 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

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USA RICHARD WOLF Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Toll Free: 001 (800) 323 - 9653 Phone: 001 (847) 913 - 1113 Fax: 001 (847) 913 - 1488 [email protected] www.richardwolfusa.com FRANCE RICHARD WOLF France S.A.R.L. Rue Daniel Berger Z.A.C. La Neuvillette F-51100 Reims Telephone: +33 3 26 87 02 89 Telefax: +33 3 26 87 60 33

UK RICHARD WOLF UK Ltd. Waterside Way Wimbledon SW17 0HB Telephone: + 44 20 89 44 74 47 Telefax: + 44 20 89 44 13 11 [email protected] www.richardwolf.uk.com

[email protected]

[email protected] www.richard-wolf.com

AUSTRIA RICHARD WOLF Austria Ges.m.b.H. Wilhelminenstraße 93 a A-1160 Vienna Telephone: +43 14 05 51 51 Telefax: +43 14 05 51 51 45

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: + 91 12 44 31 57 05 [email protected] www.richard-wolf.com

0

Contents 1 1.1 1.2 1.3 1.4 1.5 1.6 1.6.1 1.6.2 1.7 1.7.1 1.7.2

General information... Symbols... Intended use... Indications and field of use... Contraindications... General notes and instructions for use... Combinations... Potential equalization... Requirements for the products / components of a combination... Electromagnetic compatibility (EMC)... Combination with POWER STICK M4 and, alternatively, POWER STICK M3... Legend...

1 1 3 3 3 3 4 4 5 6 8 8

2 2.1 2.1.1 2.2 2.2.1 2.3 2.3.1 2.4 2.4.1 2.5 2.5.1 2.6 2.6.1

Illustration... Figure: POWER CONTROL front panel... Legend... Figure: LCD display... Legend... Figure: POWER CONTROL rear panel... Legend... Figure: Footswitch... Legend... Figure: POWER STICK M3 (8563.111 / .311)... Legend... Figure: POWER STICK M4 (8564.121)... Legend...

9 9 9 9 9 10 10 10 10 11 11 11 11

3 3.1 3.2 3.3 3.3.1

Setup... Preparation of POWER CONTROL... Preparation of POWER STICK M4... Preparation of POWER STICK M3 (8563.111 / .311)... Attaching the irrigation adaptor (only 8563.311)...

12 12 13 13 14

4 4.1 4.2 4.2.1 4.2.2 4.2.3

Checks... Visual check... Function check... Function control of footswitch... Function check -- POWER STICK M4 (8564.121)... Function check -- POWER STICK M3 (8563.111 / .311)...

15 15 15 16 16 17

5 5.1 5.2 5.2.1 5.2.2 5.2.3 5.2.4 5.2.5 5.2.6

Use... Operating principle... Control elements / modes... General notes and instructions for use... Operation of POWER CONTROL via the sensor surface... Language selection... Setting the parameters with the footswitch connected... Setting the parameters at the POWER CONTROL, with no footswitch connected . . . Changing the factory settings...

18 18 18 18 19 20 20 22 23

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I

5.2.7 5.2.8 5.3 5.3.1 5.3.2 5.4 5.5 5.5.1

POWER STICK M3... POWER STICK M4... Operation of device... Speed adjustment... Instructions and notes on morcellation in urology... Alarms... Emergency shutdown of POWER STICK... Taking out of service...

24 24 25 26 27 28 28 28

6 6.1 6.2 6.3 6.4 6.5 6.5.1 6.5.2 6.5.3 6.5.4 6.5.5 6.5.6 6.5.7 6.6 6.6.1 6.6.2 6.6.3

Operation in the RIWO NET SYSTEM... Combination with RIWO NET SYSTEM... Operation... Setting of “ID” rotary coding switch... Connection to the RIWO NET SYSTEM... Controlling the devices using the RIWO--NET menu... Controlling the devices via the different input media... Illustration of menu... Main menu... Speed range function... Speed function... Oscillation function... Positioning function... System messages... Status messages... Warnings... Errors...

29 29 29 29 30 31 31 31 32 32 32 32 32 33 33 33 33

7 7.1 7.2 7.2.1 7.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.4 7.4.1 7.4.2 7.4.3 7.4.4 7.4.5 7.5 7.5.1 7.5.2 7.5.3 7.5.4 7.6 7.6.1

Reprocessing and maintenance... Reprocessing of device... Maintenance Device... Maintenance intervals... Reprocessing of POWER STICK M4 (8564.121)... Manual reprocessing... Machine reprocessing... Assembly... Function check... Sterilization... Reprocessing of POWER STICK M3 (8563.111 / .311)... Manual reprocessing... Machine reprocessing... Assembly... Function check... Sterilization... Reprocessing of re--usable irrigation adapter... Manual reprocessing... Machine reprocessing... Visual check... Sterilization... Reprocessing of the re--usable rotary blades, abraders and morcellators... Manual reprocessing...

34 34 34 34 35 35 36 36 36 36 37 37 38 39 39 40 40 40 41 41 41 42 42

II

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Contents 7.6.2 7.6.3 7.6.4

Machine reprocessing... 42 Checks... 42 Sterilization... 42

8 8.1 8.1.1 8.1.2 8.2 8.2.1 8.3 8.4 8.5 8.6 8.6.1 8.6.2 8.6.3 8.6.4 8.6.5 8.6.6 8.6.7 8.6.8 8.7 8.7.1 8.8 8.8.1 8.8.2 8.8.3 8.8.4 8.9 8.9.1

Technical description... Trouble shooting... POWER CONTROL... POWER STICK... Technical data of POWER CONTROL... Interfaces... Technical data of POWER STICK... Technical data of footswitch... Operating, storage, transport and shipping conditions... Spare parts and accessories... POWER CONTROL... POWER STICK M4... POWER STICK M3... Reusable rotary blades and abraders... Disposable rotary blades and abraders... Reusable rotary blades and abraders for spinal surgery (POWER STICK M4)... Reusable rotary morcellator for urology... Disposable Rotary Morcellator for urology... Replacing parts on POWER STICK M4 (8564.121)... POWER STICK M4 connection cable... Replacing parts on POWER STICK M3 (8563.111 / .311)... O--ring for twist--lock mechanism... O--ring for suction/irrigation plunger... Sealing cap of suction/irrigation system (connecting hole to handle)... POWER STICK M3 connection cable... Device fuses... Disposal of the product, packing material and accessories...

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43 43 43 43 44 44 45 45 45 46 46 46 46 47 47 48 48 48 49 49 49 49 49 49 49 50 50

III

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

μ

Alternating 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

1

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Symbols

Meaning Selection Confirm value Single step “Adjust speed" selector “Select speed range" selector “Device settings“ selector Oscillation rate adjustment

12

max

34

min

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"

REF

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

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)

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2

Symbols

Meaning 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 condition 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 packaging (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.

3

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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 instead cause damage, increased wear and tear on the inner blade/abrader.

. IMPORTANT!

Quick cooling of a hot motorized handle can cause stresses in the material 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 discoscopes 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.

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4

1.6.2

Requirements for the products / components of a combination 1.5m

1.5m The general requirements depend on whether the products / components are inside or outside the patient environment.

1.5m

IEC 60601-1, 3. Ed.

Medically used room inside the patient environment MP

MP

~

~

MP

MP

~

NMP

~

~

MP

NMP

MP

Non-medically used room

-

-

Requirements / measures Leakage currents to section 16.6 IEC 60601-1:2005 / EN 60601-1:2006 *

Verification of the total patient leakage current

**

MP

~

outside the patient environment

**

-

Verification of leakage currents

**

a) additional protective earth connection (consult the corresponding manufacturer),

-

or

NMP

b) additional isolating transformer for medical applications **

~ MP

NMP

~ MP / NMP

MP

~

**

MP

NMP

~

~

MP

MP / NMP

~

~

additional "isolating transformer" to IEC/ EN60601-1 ** Functional connection MP NMP

Verification of leakage currents a) no plugs with metal housing, or b) additional isolation device (to avoid voltage differentials)

-

~

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 device to IEC/ EN 60601-1

Multiple socket strip

Power supply grid

= medical electrical device to IEC/ EN 60601-1, ANSI/AAMI es60601-1, CSA C22.2 No. 60601-1 08 = 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"

5

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.

1.7

IMPORTANT! The persons combining products to form a system are responsible for not impairing the system's compliance with performance and safety requirements, and that the technical data and the intended use are adequately fulfilled. Possible electromagnetic or other interference that may occur between the product and other products can cause faults or malfunctions. When selecting the system components, make sure that they meet the necessary requirements of the medical envi­ ronment they are used in, in particular IEC/ EN 60601-1 (3. Edition IEC/EN 60601-1, section 16). In case of doubt contact the manufacturer(s) of the system components. Do not touch connectors for electrical connections between various components (such as signal input connectors and signal output connectors for video signals, data exchange, controls etc.) and the patient at the same time.

Electromagnetic compatibility (EMC)

NOTE: The device or system in the following called product always relates to the POWER CONTROL 2303. The product does not have any performance features classified as essential performance features in accordance with IEC/EN 60601-1.

Guidelines and manufacturer's declaration - Electromagnetic emissions The product is intended for use in the environment specified below. The user should assure that the product is used in such an environment. Emissions measurement / test

Compliance

Electromagnetic environment - Guidelines

HF emissions to CISPR 11

Group 1

The product uses HF energy for its internal function. The HF emission level is extremely low and it is not likely to cause any interference in nearby electronic equipment.

HF emissions to CISPR 11

Class B

Harmonic emissions to IEC 61000-3-2

Class A

In conformity with IEC 61000-3-3 “Emission of voltage fluctuations / flicker"

The product is suitable for use in all establishments, including domestic establishments. This also includes establishments directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.

Guidelines and manufacturer's declaration - Electromagnetic immunity The product is intended for use in the environment specified below. The user should assure that the product is used in such an environment. Immunity tests

IEC 60601 test level

Compliance

Electromagnetic environment - Guidelines

Electrostatic discharge (ESD) to IEC 61000-4-2

 6 KV contact discharge  8 KV air discharge

Yes

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the re­ lative humidity should be at least 30%.

Electrical fast transience, bursts to IEC 61000-4-4

 2 KV for power supply lines  1 KV for input and output lines

Yes

Mains/line power quality should be that of a typical commercial or hospital environment.

Surge voltage (surges) to IEC 61000-4-5

 1 KV line to line voltage  2 KV line to ground voltage

Yes

Mains/line power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and sup­ ply voltage variations to IEC 61000-4-11

Voltage dip for 0.5 cycle > 95% UT * Voltage dip for 5 cycles 60% UT * Voltage dip for 25 cycles 30% UT * Voltage dip for 5 sec > 95% UT *

Yes

Mains/line power quality should be that of a typical commercial or hospital environment. If the user of the product requires continued operation during power mains/line interruptions it is recommended that the product be powered from an uninterrupti­ ble power supply or battery.

Power frequency (50/60 Hz) magnetic field, to IEC 61000-4-8

3 A/m

Yes

Power frequency magnetic fields should be at le­ vels characteristic of a typical location in a com­ mercial or hospital environment.

* NOTE: UT is the line / mains voltage prior to application of the test level.

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6

Guidelines and manufacturer's declaration - Electromagnetic immunity for products that are not life-supporting The product is intended for use in the environment specified below. The user should assure that the product is used in such an environment. Immunity tests

IEC 60601 test level

Compliance

Electromagnetic environment - Guidelines Portable and mobile RF communications equipment should be used no closer to any part of the product, including ca­ bles, than the recommended separation distance calculated from equation applicable to the frequency of the transmitter. Recommended separation distance: d = 1.2 p P

Conducted HF interference to IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

Radiated HF interference to IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

d = 1.2 p P for 80 MHz to 800 MHz Yes

d = 2.3 p P for 800 MHz to 2.5 GHz P = Nominal power output rating of the transmitter in watts (W) (according to the transmitter manufacturer)

d = recommended separation distance in meters (m) Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey1, should be less than the compliance level in each frequency range2. Interference may occur in the vicinity of devices with the following symbol:

REMARKS: At 80 MHz and 800 MHz the higher frequency range applies. These guidelines may not apply in all situations. The propagation of elec­ tromagnetic waves is affected by absorption and reflexion from buildings, objects and people. 1 = The field strength of stationary transmitters (e.g. base station for radio phone, earth to earth radio stations,, amateur radio stations, radio and television transmitters) cannot be exactly predicted in theory. To assess the EMC environment due to fixed transmitters an electromagnetic site survey should be conducted. If the measured field strength in the location in which the product is used exceeds the applicable compliance level above, the product should be observed to verify normal operation. If abnormal performance is observed, additional measures may be required, such as reorienting or relocating the product. 2 = Over the frequency range between 150 kHz and 80 MHz the field strength should be below 3 V/m.

Recommended separation distances between portable and mobile HF telecommunication devices and devices which are not life-supporting The product is intended for use in an electromagnetic environment where HF disturbances are controlled. The user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile HF telecommunica­ tions equipment and the product. Rated nominal output power of the­ transmitter (Watts)

Separation distance as a function of transmitter frequency (m) 150 kHz to 80 MHz d = 1.2 p P

80 MHz to 800 MHz d = 1.2 p P

800 MHz to 2.5 GHz d = 2.3 p P

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

For transmitters rated at a nominal output power not listed in the table above, the recommended separation distance (d) in meters (m) can be determined using the applicable equation (observe frequency). P = nominal power of the transmitter in Watts (W). REMARKS: At 80 MHz and 800 MHz the higher frequency range applies. These guidelines may not apply in all situations. The propagation of elec­ tromagnetic waves is affected by absorption and reflexion from buildings, objects and people.

7

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1.7.1

Combination with POWER STICK M4 and, alternatively, POWER STICK M3 4.0 6.0

5.0

6.1 4.0

4.1

2.0

4.1

1.0

5.1 3.0

1.7.2

Legend

1.0

POWER CONTROL 2303

5.0

POWER STICK M3 with irrigation connector (8563.311)

2.0

POWER STICK M4

5.1

Adapter for M3

3.0

Footswitch

6.0

Irrigation fluid container (only for 8563.311)

4.0

Suction pump

6.1

Irrigation tube kit (only for 8563.311)

4.1

Suction tube

.

NOTE! Instead of POWER STICK M4, POWER STICK M3 with irrigation connector (8563.311) can be connected to POWER CONTROL 2303 using adapter 2303.911.

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8

2

Illustration

2.1

Figure: POWER CONTROL front panel

3

4

5

2

2303

6

POWER CONTROL

1

7

2.1.1

Legend

1 2

Power switch ”Alarm” indicator

5 6

3 4

“Ready” button LCD

7

2.2

Figure: LCD display 4.1

4.4

Sensor field (sensor surface) Socket for motorized handle (Type BF applied part) Socket for footswitch

4.3

4.7

4.5

4.2

4.6 4.8

5.1

5.3

5.2

5.4

5.5

2.2.1

Legend

4.1 4.2

“Minimum speed” “Preselected speed”

4.8 5.1

“No footswitch” indicator “Rotate CCW” sensor

4.3 4.4 4.5

“Maximum speed” “Actual direction of rotation” indication “Actual speed”

5.2 5.3 5.4

“Rotate CW” sensor “Oscillation” sensor “Device settings” sensor

4.6 4.7

“Preselected speed range” Speed indication

5.5

“Speed / stop position adjustment” sensor field

9

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2.3

Figure: POWER CONTROL rear panel

11.1

9

11.3

11.2

8

10 FEDERAL LAW RESTRICTS THIS UNIT TO BE USED OR SOLD, EXCEPT UNDER THE SUPER-VISION OF A MEDICAL DOCTOR.

2.3.1

Legend

8

Power connector with fuse holder

11.1

CAN--BUS address selector

9

Equipotential connector

11.2

CAN--BUS input

10

Indentification plate

11.3

CAN--BUS output

2.4

Figure: Footswitch

12 12.2

12.1

1

2 3 4

12.3

12.4 12.5

2.4.1

Legend 12

Footswitch

12.1

Switchover between functions “A” and “B”

12.2

A: Speed range 1 through 4

B: Single step (Blade position)

12.3

A: “CCW“ rotation

B: Reduce speed

12.4

A: “CW“ rotation

B: Increase speed

12.5

A: “Oscillation“

B: Speed control

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10

2.5

Figure: POWER STICK M3 (8563.111 / .311)

13.5

13.10

13.6

13.2

13.8

13.3 13.4

13.9 13.1

13.7

2.5.1

Legend

13.1

Clamping chuck

Irrigation control valve (only 8563.311)

13.6

13.2

Suction connector

13.7

Rubber sleeve

13.3

Connection cable with connectors

13.8

Suction/suction and irrigation system

13.4

Irrigation connector (only 8563.311)

13.9

Drive unit

13.5

Suction control valve

13.10

Cover

2.6

Figure: POWER STICK M4 (8564.121) 14.4

14.5

14.3 14.2 14.1

2.6.1

Legend

14.1

Clamping chuck

14.4

Suction connector

14.2

Suction control valve

14.5

Connection cable with connectors

14.3

Grip sleeve

11

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3

Setup WARNING! The device is not protected against explosions. Explosion hazard. Do not operate this device in areas where there is the danger of explosion.

WARNING! Danger if a power supply without protective earth is used. Danger of electric shock! Connect the device only to a power supply with protective earth.

. NOTE!

Check that the mains/line voltage is the same as the voltage specified on the identification plate. Connect the device only with the supplied power cable or a power cable meeting the same specifications. Make sure that the vent slots are not blocked. CAUTION! Danger of faults and malfunctions. To guarantee the safety of the user, the patient and others use only accessories and spare parts specified by the manufacturer of this product. Other accessories or spare parts can cause the emission of increased electromagnetic radiation or reduced immunity against interference.

. IMPORTANT!

Medical devices are subject to special precautions with regard to electromagnetic compatibility (EMC). Make sure you observe the notes on EMC for installation and operation. Medical electrical devices can be influenced by mobile HF communication devices. If it is necessary to stack the devices or place them next to each other and HF interference is observed, make sure you observe the intended use of the devices.

3.1

Preparation of POWER CONTROL Z Connect device to mains/power. Z Connect footswitch cable to device. Z Switch on the power switch. B

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. NOTE:

To disconnect the cable from the device, pull back locking sleeve (B) on connector (front portion with red marking).

12

3.2

Preparation of POWER STICK M4 C

Z Connecting the cable to POWER STICK M4. ' Align connector (the red marking (C) must be positioned exactly below the suction connector) and push home. Z Connect suction tube between suction pump and suction connector on POWER STICK M4. Set suction valve to “OFF”. Z Inserting the rotary blades. ' Retract ring (14.8) on clamping chuck. ' Insert rotary blade in such a way that the cam is aligned with groove (14.10) on the clamping chuck. ' Let go of ring, the rotary blade is locked in place. Z Connect the cable of POWER STICK M4 to the POWER CONTROL unit. 14.8 14.10

. IMPORTANT!

The inner and outer blades are supplied in matched pairs. Do not mix with other blades.

3.3

Preparation of POWER STICK M3 (8563.111 / .311) Z Connecting the cable to POWER STICK M3: ' Turn the plug with the rubber sleeve under slight pressure until it engages in the socket connector. Then push both the plug and the protection sleeve home (for this the plug must be in home position).

13.5

13.6

Z Connecting the suction tube between the suction pump and the suction connector of the motorized handle. ' Set the suction control valve (13.5) to ”closed”. Z In the case of motorized handle 8563.311 also connect the irrigation connector. ' Set irrigation control valve (13.6) to ”closed”.

. NOTE!

The irrigation pressure can be adjusted by varying the height difference (hydrostatic pressure) between the working height and the height of the irrigation fluid container or suction pump. Z Inserting the rotary blades. ' Retract ring (13.1.1) of clamping chuck. ' Insert rotary blades in such a way that cam (13.12) is aligned with groove (13.11) on clamping chuck (13.1). ' Let go of ring, the rotary blade is locked in place.

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GA--A 202

. IMPORTANT!

The inner and outer blades are supplied in matched pairs. Do not mix with other blades. Z Use the adapter to connect the POWER STICK M3 connection cable to the POWER CONTROL unit.

3.3.1

Attaching the irrigation adaptor (only 8563.311) Z Check that the sealing element (13.14.2) is installed on irrigation tube (13.14.1). Z Push irrigation adapter (13.14) onto the rotary blade. Z Insert irrigation tube (13.14.1) in opening (13.13) on the clamping chuck, then push the irrigation adapter onto the rotary blade as far as it will go. 13.14

13.14.1

13.11 13.12 13.14.2 13.13 13.1.1

GA--A 202

13.1

14

4

Checks

. IMPORTANT!

Run through the checks before and after each use. Do not use the products if they are damaged or incomplete or have loose parts. Return damaged products together with any loose parts for repair. Do not attempt to do any repairs yourself.

4.1

Visual check Z Carry out the following checks: ' Check devices, instruments and accessories for damage, hygienic condition, completeness and corrosion. ' Check all connection cables and tubes for damage. ' Check lettering/labeling for completeness and good legibility. ' Check that the cable connector on the motorized handle is in home position, i.e. fully inserted. ' Check that the valve is plugged in. ' Check that the cutting edges and windows of the blades/abraders are in perfect working order. ' Check footswitch and connection cables for damage and cracks in the insulation of the connection cable. ' Check the sensor surfaces on the POWER CONTROL unit.

4.2

Function check

. NOTE!

Make sure that the tools are immersed in liquid (cooling of the heat generated by friction). Do not operate in dry condition! The POWER CONTROL M4 self--test can be activated at any time. Z Switch on the power switch. Z Press the blinking “Ready” button. ' The device carries out a self--test. In the case of an error the result is displayed on the LCD. ' If no footswitch is connected, the “No footswitch” indicator blinks. ' If no POWER STICK is connected, the “No POWER STICK” indicator blinks.

15

GA--A 202