POWER DRIVE ART 1 Instruction Manual Ver 7.0 July 2016

Important general notes and instructions Make sure that this product is used only as intended and described in this instruction manual and by adequately trained and qualified medical personnel, Maintenance and repair must be 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 appli­ cation and if the performance characteristics and safety requirements are met. The product must not be altered in any way. Reprocess the product in accordance with the manual before every use and before return shipment to protect the pa­ tient, user and third parties. This manual is an integral part of the product and must be stored in such a way that it is accessible at any time during its entire life cycle. This manual must be passed on to any subsequent owner or user. Immediately upon receipt, check the product and its accessories for completeness and possible damage. Should the shipment give rise to complaints, please inform the manufacturer or supplier immediately. Subject to technical changes! Due to ongoing developments the illustrations and technical data may deviate slightly.

Safety instructions and levels of danger Symbols

Level of danger

WARNING!

Failure to observe can result in death or extremely serious injuries.

CAUTION !

Failure to observe can result in slight injury or damage to the product.

GA-A 238

IMPORTANT!

Failure to observe can result in damage to the product or surroundings.

NOTE !

User tips for optimum device use and other useful information. GERMANY RICHARD WOLF GmbH 75438 Knittlingen Pforzheimerstr. 32 Telephone: +49 70 43 35-0 Telefax: +49 70 43 35-4300 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: 001 (847) 913 - 1113 Fax: 001 (847) 913 - 1488 [email protected] www.richardwolfusa.com

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

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

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

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

[email protected]

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

0

Contents 1 1.1 1.2 1.2.1 1.2.2 1.2.3 1.2.4 1.2.5 1.2.6 1.2.7 1.2.8 1.3 1.4 1.5 1.5.1 1.6 1.6.1 1.6.2 1.7 1.8

General information... 1 Symbols... 1 Intended use... 5 POWER DRIVE ART1... 5 Rotary blades... 5 Rotary burrs... 5 Universal resectors... 5 Removers... 5 Drill bits... 5 Target wires, Kirschner wires and surgical wires... 5 Saw blades... 5 Indications and fields of use... 6 Contraindications... 6 General notes and instructions for use... 6 Additional notes and instructions on tracheo-bronchoscopy... 7 Combinations... 8 Equipotentality... 9 Requirements for the products / components of a combination... 9 Electromagnetic compatibility (EMC)... 11 Combination with motirized handles and Power Drill... 13

2 2.1 2.2 2.3 2.4 2.5 2.6 2.6.1 2.7 2.7.1 2.8 2.8.1 2.9

Illustration... Illustration of POWER DRIVE ART1 front panel... Illustration of touchscreen... Illustration of POWER DRIVE ART1 rear panel... Illustration of footswitch... Illustration of Power Stick M5/3... Illustration of Power Stick M5/0... Illustration of rotary blade / burr interface on Power Sticks M5/0 and M5/3... Illustration of Micro Stick S1... Illustration of the rotary blade / burr interface of Micro Stick S1... Illustration of Power Stick M4... Illustration of rotary blade / burr interface of Power Stick M4... Illustration of Power Drill M1...

14 14 14 16 16 17 18 18 19 19 20 20 21

3 3.1 3.2 3.3 3.4 3.5

Setup... Preparation of POWER DRIVE ART1... Preparation of Power Stick M5/3 and M5/0... Preparation of Micro Stick S1... Preparation of Power Stick M4... Preparation of Power Drill M1...

22 23 23 24 24 25

4 4.1 4.2 4.2.1 4.2.2 4.2.3 4.2.4

Checks... Visual check... Function check... Function check of footswitch... Function check of Power Sticks M4, M5/3 and M5/0... Function check of Micro Stick S1... Function check of Power Drill M1...

26 26 27 27 27 28 28

GA-A 238

I

5 5.1 5.2 5.2.1 5.2.2 5.2.3 5.2.4 5.2.5 5.2.6 5.2.7 5.2.8 5.3 5.4 5.4.1 5.4.2 5.4.3 5.5

Use... Operation... Control elements and modes... Operation and display... POWER DRIVE ART1 ON/OFF... Footswitch mode in 2-pedal or 3-pedal operation... Emergency shutdown of handle motor... Automatic recognition of the connected handle and tool... Control of Power Stick M5/3 via the button cluster... Control of Micro Stick S1 via the button... Control of Power Drill M1... Setting the parameters on the device and via the footswitch... Operation of device... Speed settings... Positioning of the cutting window with the rotary blade / burr in place... Taking out of service... Error messages...

29 29 29 29 29 30 30 30 33 33 34 35 39 40 40 40 41

6 6.1 6.2 6.3 6.4 6.4.1 6.4.2

Operation within the core system... Functional principle within the core system... Combining and controlling the device... Connection to the core system... Overview of device messages in the core system... Status messages... Fault / error...

42 42 42 43 44 44 44

7 7.1 7.2 7.2.1 7.3 7.4 7.4.1 7.4.2 7.4.3 7.4.4

Reprocessing and maintenance... Reprocessing of device... Maintenance Device... Maintenance intervals... Reprocessing procedure... Reprocessing of Power Stick M4, M5/0, M5/3, Micro Stick S1... Disassembly before cleaning... Illustrations on reprocessing... Rotary blades and burrs... Power Drill M1 with accessories...

45 45 45 45 46 46 46 47 50 52

8 8.1 8.2 8.2.1 8.3 8.4 8.5 8.6 8.7 8.7.1 8.7.2 8.7.3

Technical description... Troubleshooting... Technical data of POWER DRIVE ART1... Interfaces... Technical data of footswitch... Technical data of motorized handles... Technial data of Power Drill M1 and tool holder... Operating, storage, transport and shipping conditions... Spare parts and accessories... POWER DRIVE ART1... Power Stick M4... Power Sticks M5/3 and M5/0...

54 54 55 55 55 56 56 57 58 58 58 58

II

GA-A 238

Contents 8.7.4 8.7.5 8.7.6 8.7.7 8.7.8 8.7.9 8.7.10 8.7.11 8.7.12 8.7.13 8.7.14 8.8 8.8.1 8.8.2 8.8.3

Micro Stick S1... Power Drill M1... Reusable rotary blade / burr; Interface for Micro Stick S1... Disposable rotary blade / burr (sterile); Interface for Micro Stick S1... Reusable rotary blade / burr; Interface for Power Sticks M5/0 and M5/3... Disposable rotary blade / burr (sterile); Interface for Power Sticks M5/0 and M5/3 . . . Reusable rotary blade / burr, interface with Power Stick M4... Disposable sagittal saw blades (sterile) (Power Drill M1)... Disposable reciprocating saw blades (sterile) (Power Drill M1)... Reusable Kirschner wires (Power Drill M1)... Disposable drillbit (sterile) (Power Drill M1)... Replacing parts... O-ring for valve lever Micro Stick S1... Device fuses... Disposal of product, packaging material and accessories...

9

Literature... 68

GA-A 238

58 58 59 59 61 63 65 66 66 66 66 67 67 67 67

III

1

General information

1.1

Symbols Symbol

Designation

device Attention, Caution Follow the instruction manual Off (power: disconnection from power/mains) On (power: connection to the power/mains) Equipotentality

µ

Mains / Line fuse Alternating current (AC) TYPE BF APPLIED PART Socket for footswitch Signal input (CAN BUS) Signal output (CAN BUS) Data transfer

Touch display -- operation level Confirm input Abort action Selection - when 2 handles are connected Speed adjustment Single step (toggle mode) Set torque Set oscillation rate Direction of rotation "counter-clockwise" (ccw) Direction of rotation "clockwise" (cw) "Oscillation" Direction of rotation "ccw" locked

1

GA-A 238

Symbol

Designation Direction of rotation "cw" locked "Oscillation" locked Defective tool memory "Increase value" "Decrease value"

Touch display -- user selection User selection Language selection Contrast / brightness menu Contrast adjustment Brightness adjustment Invert display Activate / deactivate handle buttons Device data Delete data Footswitch 2-pedal or 3-pedal mode

Indication for connected handle Power Stick M4 Power Stick M5/0 Power Stick M5/3, buttons active / inactive Micro Stick S1, button active / inactive Power Drill M1 Observe handle temperature! Reduced speed!

GA-A 238

2

Designation

Symbol

Footswitch Single step (toggle mode) Direction of rotation "ccw" Direction of rotation "oscillation" Direction of rotation "cw" "Increase value" "Decrease value"

Power Drill handle Lock / unlock B: Direction of rotation "ccw" A: Direction of rotation "cw" Steam-sterilizable

Power Sticks M4, M5/3, M5/0 and Micro Stick S1 handles Intermittent duty in accordance with the specifications on the handle X min / Y min (X= minutes on / Y= minutes off)

INT

General information Follow the instruction manual

REF

Order number Lot identification Number, amount Manufacturer Manufacturing date To be used before (date) For single use (do not reuse!) Do not resterilize Sterilized with ethylene oxide Do not use if package is damaged

XX° XX°

Limitation of temperature Keep away from sunlight

3

GA-A 238

Designation

Symbol XX% XX%

Humidity limitation 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) 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 identified with the code no. of the notified body (0124).

GA-A 238

4

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. At the same time aspiration allows continuous removal of ablated tissue. In conjunction with Power Drill M1: With the corresponding drill chucks as well as drill bits, alignment wires, Kirschner wires or surgical wires or the corresponding saw attachments as well as saw blades, it is used for working on bones or severing bones, respectively. Performance characteristics: -

Drive of Richard Wolf motorized handles Directions of rotation: CCLW, CLW andoscillation Adaptation of the opening angle on rotary instruments Automatic tool recognition and setting.

1.2.2

Rotary blades

1.2.3

Rotary burrs

1.2.4

Universal resectors

1.2.5

Removers

1.2.6

Drill bits

1.2.7

Target wires, Kirschner wires and surgical wires Target wires, Kirschner wires and surgical wires are used for creating an initial alignment bore.

1.2.8

Saw blades

Resectors, cutters, whiskers, incisors are used for the removal (severing and evacuation) of soft tissue parts. Cutters, burrs, acromionizers serve to ablate (sever and evacuate) tissue from osseous structures. 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. Removers are used for the removal of secretion.

Drill bits are used for drilling in bones.

Saw blades serve to cut through bones. These products are exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately instructed persons.

5

GA-A 238

1.3

Indications and fields of use The products are used in conjunction with endoscopic accessories: - In arthroscopy, the products are used e.g. for meniscal resection, the removal of soft parts as well as for intraarticular severing or abrasion of bone tissue in large or small joints. - In sinus surgery, the products are used for removing soft tissue (e. g. polyps). - In spinal surgery, the products are used e.g. for the removal of tissue parts (prolapse material, bone, cartilage) for the decompression of neutral structures. - In tracheo-bronchoscopy, the product is used for the removal of patho­ logically changed tissue and secretion.

1.4

Contraindications

1.5

General notes and instructions for use

GA-A 238

Contraindications directly related to the product are presently unknown. On the basis of the current level of medical knowledge and the patient's condition, the doctor in charge must decide whether the planned applica­ tion is possible or not. For further notes and instructions please refer to the latest medical literature. Limitation of the target group: Relative or absolute contraindications may result from the general patient findings or from special cases where there is a significantly increased risk for the patient if motorized tools are used. Corresponding cases described in literature must be observed. The patient selection for the use of the medical product to be assessed is not generally limited with regard to sex, age, proveniance, medical history and other framework conditions. Specific risk groups are not known. Gen­ eral contraindications to surgical interventions must be observed taking into account the patient's general condition. Follow the latest medical lit­ erature.

CAUTION! Possible instrument or device failure! In the case of therapeutic applications a similar instrument or a spare in­ strument should be available! CAUTION! All Richard Wolf disposable rotary blades and cutters are sterilely packed in double packaging and are intended for one 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 wrap­ ping/packaging (plastic bag). CAUTION! Do not interchange the inner parts (A) and the outer parts (B) of different rotary blades / burrs. If the inner parts (A) and the outer parts (B) of different rotary blades / burrs are interchanged, damage may occur on the product which will lead to patient injury. CAUTION! Excessive pressure of the rotary blades / burrs into the tissue will not im­ prove the cutting performance but, in extreme cases, can cause wear and tear on the inner part.

6

1.5.1

IMPORTANT! Rapid cooling of a hot motorized handle can cause stresses in the mate­ rial and may lead to failure of the device or a reduced service life.

Additional notes and instructions on tracheo-bronchoscopy

WARNING! Excessively high speeds! High speeds increase friction, Possible consequences are wear and tear and the formation of cracks on the product as well as the danger of thermal damage to the tissue as a result of excessive heat. Use tracheal resectors and tracheal secretion removers only in conjunc­ tion with POWER DRIVE ART1 "2304" and the preset directions of rota­ tion. WARNING! Incorrect direction of rotation! This may cause inadvertent tissue damage. Tracheal resectors cut soft tissue. The tracheal secretion remover transports the secretion only in "clockwise" direction of rotation. Use tracheal resectors and tracheal secretion removers only in conjunc­ tion with POWER DRIVE ART1 "2304" and the preset directions of rota­ tion. WARNING! Danger of injury if the tracheal secretion remover is not used as intended! This may cause inadvertent injuries. Do not use the tracheal secretion remover for the removal of tissue, stent material (wire, silicone) or foreign objects. Use the tracheal secretion remover only as intended for the removal of secretion from the tracheobronchial space. WARNING! Danger of injury by a blocked feed spiral! The feed spiral in the tracheal secretion remover may get blocked during use. This may cause inadvertent injuries. In this case, switch off the motorized handle immediately, either via:  Micro Stick S1 using the "ON / OFF" button or  the footswitch using the "+" / "-" pedals Remove the tracheal secretion remover from the patient and from the motorized handle. In addition, follow the manual for the "Instrument set for shaver-assisted tissue resection from the tracheobronchial space", order no. GA-G 134.

7

GA-A 238

1.6

Combinations

CAUTION! Be careful not to combine products incorrectly! Injuries of the patient, user or others as well as damage to the product are possible. The different products may only be combined if the intended use and the relevant technical data (working length, diameter, etc.) are the same. Follow the instruction manuals of the products used in combination with this product. Only use proved components and connection cables. Use only suction devices and devices for supplying irrigation fluid that do not reduce the protection rating ”BF” of the motorized handle in accor­ dance with IEC / EN 60601. The user is responsible for selecting a suit­ able irrigation fluid. Due to differing anatomy, it is not possible to quantify irrigation and suc­ tion rates. The user must adapt the flow to the prevailing conditions.

NOTE! In the case of rotary blades and burrs for spinal surgery, make sure that the working channel of discoscopes or the internal diameter of working sleeves is sufficiently large. Use instruments with diameters 2.5 mm, 3.0 mm and 4.0 mm through discoscopes. Use instruments with a diameter of 4.5 mm through suitable working sleeves. To facilitate the surgical access, rotary blades with a distal guide bore (hip arthroscopy) can be guided by a flexible guide wire with a diameter of ≤ 2.0 mm.

1.6.1

Equipotentality

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.

GA-A 238

8

1.6.2

Requirements for the products / components of a combination 1.5m

1.5m The general requirements depend on whether the products / com­ ponents 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

outside the patient environment

-

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

~ ** NMP

MP

~* *

~

NMP

MP

-

Verification of leakage currents

~ ** MP

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

-

or b) additional isolating transformer for medical applications **

NMP

~ MP

NMP

~ MP / NMP

MP

~ ** MP

NMP

~

~

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

-

MP

MP / NMP

~

~

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

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 = non-medical electrical device in accordance with product-specific IEC/EN/UL standards

MP NMP

* **

When connected via the same multiple socket strip under standard conditions, the earth leakage current of the socket strip must not exceed 5 mA. e.g. Richard Wolf video cart with "isolating transformer"

Only connect devices with a safety extra-low voltage of no more than 60 V DC / 42.4 V AC peak to the connectors for electrical connections, i.e. the signal inputs and outputs.

9

GA-A 238

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 / system in the following referred to as product always relates to POWER DRIVE ART1 2304. Guidelines and manufacturer's declaration - Electromagnetic emissions The product is intended for use in the environment specified below. The user must 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 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 must 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 rela­ tive 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 uninterrupt­ ible 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 lev­ els characteristic of a typical location in a commer­ cial or hospital environment.

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

GA-A 238

10

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 must 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 the equation applicable to the frequency of the transmit­ ter. Recommended separation distance:

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

Yes

d = 1.2

P

d = 1.2

P for 80 MHz to 800 MHz

d = 2.3 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 electromag­ netic 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 thetransmitter (W)

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

80 MHz to 800 MHz d = 1.2 P

800 MHz to 2.5 GHz d = 2.3 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 electromag­ netic waves is affected by absorption and reflexion from buildings, objects and people.

11

GA-A 238

1.8

Combination with motorized handles and Power Drill

4.0

4.1

2.0

1.0

A

5.1

3.0

5.0 A B

Fig. 1

Legend

1.0

POWER DRIVE ART1 2304

5.0

Power Drill M1

2.0

Power Stick M4, M5/0, M5/3 and Micro Stick S1

5.1

Replacable tool holders

3.0

Footswitch

4.0

Suction pump

4.1

Suction tube

GA-A 238

12

2

Illustration

2.1

Illustration of POWER DRIVE ART1 front panel

4 2 1

3 Fig. 2 Legend Item 1 2

2.2

Designation Power/mains switch Touch-screen

Item 3 4

Designation Socket for footswitch Connecting sockets for handles (type BF applied part)

Illustration of touchscreen 2.1

2.3 2.9 2.2

2.8

Dr. Bones

2.4 2.5

Fig. 3

2.6

2.7 Legend

Item 2.1 2.2 2.3 2.4 2.5

13

Designation Setting the necessary parameters

Item 2.6

Display of "set value" or "actual value" Tool recognition (see section 5.2.3) Standard (default) settings or selected user Select user

2.7 2.8 2.9

Designation Presetting of direction of handle - only Micro Stick S1 Selection buttons for "operation level" Selected footswitch mode Handle detection - selection or Activate / deactivate handle buttons

GA-A 238

2.3

Illustration of POWER DRIVE ART1 rear panel

6

8.1 8.2

5

Fig. 4

9

7

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

Legend Item

Designation

Item

Designation

5 6 7

Power input connector with fuse holder Equipotential connector Identification plate

8.1 8.2 9

CAN BUS input connector CAN BUS output connector Data interface (for service only)

2.4

Illustration of footswitch

10.2

10.6

10.1

10.7 10.3

10.4

Fig. 5

10.5 Legend

Item 10.1 10.2 10.3 10.4

Designation Increase speed Reduce speed Direction of rotation "clockwise" (cw) Direction of rotation "counter-clockwise" (ccw)

Item 10.5 10.6 10.7

Designation "Oscillation" Single step (blade position) Identification plate

(optionally in dual-pedal "oscillation" mode)

GA-A 238

14

2.5

Illustration of Power Stick M5/3 11.2

11.5

11.3 11.4

11.1

With fixed connection cable 11.5.2

11.5.1

11.5.3 11.4.1

With removable connection cable Fig. 6 Legend Item

Designation Tool locking mechanism 11.1 Valve insert 11.2 Suction tube 11.3 Connection cable, firmly connected 11.4 11.4.1 Connection cable, removable

15

Item 11.5 11.5.1 11.5.2 11.5.3

Designation Button cluster "Oscillation" button (secondary function: "single step") "cw" button (secondary function: speed "+") "ccw" button (secondary function: speed "-")

GA-A 238