POWER DRIVE ART 1 Instruction for Manual V10.0 Oct 2020

Richard Wolf reserves all rights in this document, in particular relating to reproduction, distribution, public communication and public dissemination. This document may not be modified, and texts and images must not be reproduced or translated without the express prior permission of Richard Wolf GmbH.

Copyright © RICHARD WOLF GmbH

Subject to technical changes! Due to ongoing development, the product descriptions, figures, and technical data may deviate slightly from the current state. For further information about our products, please contact Richard Wolf GmbH or a local representative.

Manufacturer RICHARD WOLF GmbH Pforzheimer Straße 32 75438 Knittlingen GERMANY Telephone: +49 70 43 35-0 Telefax: +49 70 43 35-4300

www.richard-wolf.com

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Contents 1

General safety instructions and guidance for use ...

6

2

General information ...

7

2.1

Safety instructions and levels of danger...

7

2.2

Symbols...

7

2.3

Overview of motor handpieces ... 11

2.4 2.4.1 2.4.2 2.4.3 2.4.4 2.4.5 2.4.6 2.4.7 2.4.8

Intended use... 12 POWER DRIVE ART1... 12 Rotary blades ... 12 Rotary burrs... 12 Universal resectors... 12 Removers ... 12 Drills... 12 Target wires, Kirschner wires, and surgical wires ... 12 Saw blades ... 12

2.5

Indications and fields of use ... 13

2.6

Contraindications... 13

2.7 2.7.1

General notes and instructions for use... 14 Additional notes and instructions on tracheo-bronchoscopy ... 15

2.8 2.8.1 2.8.2

Combinations ... 16 Equipotentality ... 16 Requirements for the products / components of a combination ... 17

2.9

Electromagnetic compatibility (EMC) - IEC 60601-1-2 : 2014 ... 18

2.10

Combination with motor handpieces and Power Drill ... 21

3

Illustration ... 22

3.1

Illustration of POWER DRIVE ART1 front panel ... 22

3.2

Illustration of touchscreen ... 23

3.3

Illustration of POWER DRIVE ART1 rear panel ... 24

3.4

View of footswitch... 25

3.5

Illustration of Power Stick M5/3 ... 26

3.6 3.6.1

Illustration of Power Stick M5/0 ... 27 Illustration of rotary blades and burrs; interface on Power Sticks M5/0 and M5/3 ... 28

3.7 3.7.1

Illustration of Micro Stick S1 ... 28 Illustration of the rotary blades and burrs; interface with Micro Stick S1 ... 29

3.8 3.8.1

Illustration of Power Stick M4 ... 30 Illustration of rotary blades and burrs; interface with Power Stick M4 ... 30

3.9

Illustration of Power Drill M1... 31

4

Commissioning ... 33

4.1

Preparation – POWER DRIVE ART1 ... 35

4.2

Preparation – Power Stick M5/3 and M5/0 ... 35

4.3

Preparation – Micro Stick S1 ... 36

4.4

Preparation – Power Stick M4 ... 37

4.5

Preparation – Power Drill M1... 38

5

Checks... 39

5.1

Visual checks ... 39

5.2

Function check ... 40

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5.2.1 5.2.2 5.2.3 5.2.4

Function check – footswitch ... 40 Function check – Power Sticks M4, M5/3, and M5/0... 41 Function check – Micro Stick S1 ... 41 Function check – Power Drill M1 ... 41

6

Use ... 42

6.1

Operating principle ... 42

6.2 6.2.1 6.2.2 6.2.3 6.2.4 6.2.5 6.2.6 6.2.7 6.2.8

Control elements and operating modes ... 42 Operation and display ... 42 POWER DRIVE ART1 ON/OFF ... 43 Footswitch mode in 2-pedal or 3-pedal operation ... 43 Emergency shutdown of handle motor ... 43 Automatic detection of the connected handle and tool... 43 Control of Power Stick M5/3 via the button cluster... 46 Control of Micro Stick S1 via the button ... 46 Control of Power Drill M1... 47

6.3

Setting the parameters on the device and via the footswitch ... 48

6.4 6.4.1 6.4.2 6.4.3

Operating the device ... 51 Speed settings... 52 Positioning of the cutting window with the rotary blade / burr in place ... 53 Taking out of service ... 53

6.5

Error messages ... 54

7

Operation in the core system ... 55

7.1

Operating principle in the core system ... 55

7.2

Combination and device operation ... 55

7.3

Connection to the core system ... 56

7.4 7.4.1 7.4.2

Overview of device messages in the core system ... 57 Operating messages ... 57 Failure/fault... 57

8

Reprocessing and maintenance ... 58

8.1

Reprocessing ... 58

8.2 8.2.1

Maintenance ... 59 Maintenance intervals ... 59

8.3 8.3.1 8.3.2 8.3.3

Reprocessing procedure ... 59 POWER STICK M4, M5/0, M5/3, MICRO STICK S1 ... 61 Reprocessable rotary blades and burrs ... 65 Power Drill M1 and accessories ... 67

9

Technical description... 70

9.1

Troubleshooting... 70

9.2 9.2.1

Technical data of POWER DRIVE ART1 ... 71 Interfaces... 71

9.3

Technical data of footswitch ... 71

9.4

Technical data of motor handpieces ... 72

9.5

Technical data of Power Drill M1 and tool holder ... 73

9.6

Operating, storage, transport, and shipping conditions ... 74

9.7 9.7.1 9.7.2 9.7.3 9.7.4

Spare parts and accessories ... 74 POWER DRIVE ART1... 74 Power Stick M4... 75 Power Sticks M5/3 and M5/0... 75 Micro Stick S1... 75

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9.7.5 9.7.6 9.7.7 9.7.8 9.7.9 9.7.10 9.7.11 9.7.12 9.7.13 9.7.14 9.7.15

Power Drill M1 ... 75 Reprocessable rotary blade / burr; interface with Micro Stick M1 ... 76 Disposable rotary blades / burrs (sterile); interface with Micro Stick S1 ... 77 Reprocessable rotary blades and burrs; interface with Power Stick M5/0 and M5/3 ... 77 Disposable rotary blades and burrs (sterile); interface with Power Stick M5/0 and M5/3 ... 80 Reprocessable rotary blades and burrs, interface with Power Stick M4 ... 81 Disposable sagittal saw blades (sterile) (Power Drill M1) ... 82 Disposable reciprocating saw blades (sterile) (Power Drill M1) ... 83 Reprocessable Kirschner wires (Power Drill M1) ... 83 Disposable drill bit (sterile) (Power Drill M1)... 83 Accessories for reprocessing ... 84

9.8 9.8.1 9.8.2 9.8.3

Replacing parts ... 85 O-ring for valve lever Micro Stick S1 ... 85 Device fuses ... 85 Disposal of the product, packaging material, and accessories ... 86

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Bibliography... 87

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1

General safety instructions and guidance for use The product and its accessories must only be used as intended following the instruction manual 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 application and if the performance characteristics and safety requirements are still fulfilled. The product must not be altered in any way. Reprocess the products and the accessories in accordance with the instruction manual before and after each use and before any return shipment to protect the patient, user, and others. The instruction manual is an integral part of the product and must be stored in such a way that it is accessible at all times during the entire life cycle. It 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. Any severe incident occurring in conjunction with this product must be reported to the manufacturer and the competent authority of the country where the user and/ or patient resides.

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2

General information

2.1

Safety instructions and levels of danger WARNING This signal word is used to indicate a potentially dangerous situation. Not avoiding this situation can result in death or extremely serious injuries.

CAUTION This signal word is used to indicate a potentially dangerous situation. Not avoiding this situation can result in minor or moderate injury.

ATTENTION This signal word without warning sign is used to indicate a potential danger of material damage.

NOTE This signal word indicates additional useful information for the reader, such as hints for easier operation as well as cross references.

2.2 Symbols

Symbols Designation Device Caution; Warning Follow the instruction manual Off (power supply, disconnection from line power) On (power supply, connection to line power) Potential equalization Line fuse Alternating current (AC) TYPE BF APPLIED PART Socket for footswitch Signal input (CAN bus)

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Signal output (CAN bus) Data transfer

Touch display – operating level Confirm input

Abort action

Selection – when 2 handles are connected

Adjust speed

Single step (toggle mode)

Set torque

Set oscillation frequency

"CCW" direction of rotation

"CW" direction of rotation "Oscillation"

"CCW" direction of rotation locked

"CW" direction of rotation locked

"Oscillation" locked

Defective tool memory

"Increase value"

"Decrease value"

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Touch display – user selection User selection

Language selection

Contrast / brightness menu

Contrast / brightness adjustment

Brightness adjustment

Invert display

Activate / deactivate handle buttons

Device data

Delete data

Footswitch 2-pedal or 3-pedal mode

Display 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!

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footswitch Single step (toggle mode)

"CCW" direction of rotation

"Oscillation" direction of rotation "CW" direction of rotation

"Increase value" "Decrease value"

Power Drill handle Lock / unlock B: "CCW" direction of rotation

A: "CW" direction of rotation

Steam-sterilizable

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

General information Follow the instruction manual Catalogue Number Batch identification Units, amount

manufacturer Manufacturing Date Expiry date:

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For single use (do not reuse) Do not resterilize Sterilized with ethylene oxide Do not use if package is damaged Temperature limit

Keep away from sunlight

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, confirms compliance with the Medical Electrical Equipment CAN/CSA C22.2 No.60601-1 (C) and ANSI/AAMI ES60601-1 (US) standards Identification in conformity with Medical Products Directive 93/42/EEC, only valid if the product and/or the packaging is marked with this identification. Products of Class IIa and above, as well as sterile products or products with measuring function of Class I, are additionally identified with the code no. of the notified body (0124).

2.3

Overview of motor handpieces

Product No

Short description

Richard Wolf designation

8564.021

MOTOR HANDPIECE MAX. 6000RPM

POWER STICK M4

89955.0003

MOTOR HANDPIECE MAX. 16000RPM

POWER STICK M5/3

8995500031

MOTOR HANDPIECE MAX. 16000RPM

POWER STICK M5/3

89955.0000

MOTOR HANDPIECE MAX. 16000RPM

POWER STICK M5/0

8995500001

MOTOR HANDPIECE MAX. 16000RPM

POWER STICK M5/0

89951.0001

MOTOR HANDPIECE MAX. 3000RPM

MICRO STICK S1

8995.0000

MOTOR HANDPIECE MAX. 1000RPM

POWER DRILL M1

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2.4

Intended use

2.4.1

POWER DRIVE ART1 In conjunction with a motor handpiece (e.g., Power Stick M5/3): It is used as a drive unit for Richard Wolf rotary blades and burrs to remove tissue in endoscopic procedures. At the same time, suction allows continuous removal of ablated tissue. In conjunction with the 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. Performance characteristics: n n n n

2.4.2

Drive for Richard Wolf handpieces Directions of rotation: CCW, CW, and oscillation Adaptation of the opening angle on the rotary instruments Automatic tool recognition and setting

Rotary blades Resectors, cutters, whiskers, and incisors are used for the removal (severing and suction) of soft tissue parts.

2.4.3

Rotary burrs Burrs and acromionizers are used to ablate (sever and suction) tissue from bone structures.

2.4.4

Universal resectors Universal resectors are used for the removal (severing and suction) of soft tissue parts and for the ablation (severing and suction) of bone structures.

2.4.5

Removers Removers are used for the removal of secretion.

2.4.6

Drills Drills are used for drilling in bones.

2.4.7

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

2.4.8

Saw blades Saw blades are used to cut through bones. These products are exclusively intended for use by specialized medical experts and may only be used by adequately qualified and trained medical personnel.

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2.5

Indications and fields of use For use in conjunction with endoscopic accessories: n

n n

n

2.6

In arthroscopy, the products are used, e.g., for meniscal resection, for 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 pathologically changed tissue and secretion.

Contraindications There are currently no known contraindications directly related to the product. On the basis of the latest medical knowledge and the patient’s condition, the doctor in charge must decide whether the planned use is possible or not. For further information, please refer to the most recent medical literature. Limitations in the target group: 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. Corresponding cases described in the relevant 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, provenance, medical history, and other general conditions. Specific risk groups are not known. General contraindications to surgical interventions must be observed, taking into account the patient’s general condition. Follow the latest medical literature.

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2.7

General notes and instructions for use CAUTION Possible instrument or device failure! In therapeutic applications, an adequate backup device with the same capabilities must be available should the device fail.

CAUTION All Richard Wolf disposable rotary blades and burrs are sterilely packaged in double packaging and are intended for one single use only. Any products that are not used should be kept in the outer packaging (cardboard box). Do not use products with damaged outer sterile packaging (plastic bag).

CAUTION Do not interchange the inner parts (A) and the outer parts (B) of different rotary blades and burrs. If the inner parts (A) and the outer parts (B) of different rotary blades and burrs are interchanged, damage may occur on the product, which will lead to patient injury.

CAUTION Excessive pressure of the rotary blades and burrs into the tissue will not improve the cutting performance but, in extreme cases, may cause wear and tear on the inner part.

ATTENTION Rapid cooling of a hot motor handpiece can cause stresses in the material and may lead to failure of the device or a reduced service life.

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2.7.1

Additional notes and instructions on tracheo-bronchoscopy WARNING Excessively high speeds! High speeds increase friction, which may result in wear and tear, and the formation of cracks on the product as well as the risk of thermal damage to the tissue as a result of excessive heat. Use the tracheal resectors and the tracheal secretion remover only in conjunction with POWER DRIVE ART1 "2304" and the preset speeds.

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 the "clockwise" direction of rotation. Use tracheal resectors and tracheal secretion removers only in conjunction with POWER DRIVE ART1 "2304" and the preset directions of rotation.

WARNING Risk 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 Risk of injury by a blocked feed spiral! The feed spiral in the tracheal secretion remover may become blocked during use. This may cause inadvertent injuries. In this case, switch off the motor handpiece immediately, either via: ● the 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 motor handpiece. In addition, follow the instruction manual for the "Instrument set for shaver-assisted tissue resection from the tracheobronchial space", order no. GA-G 134.

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2.8

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. n The products must only be used jointly if the intended use and the relevant technical data such as working length, diameter, etc. are the same. n Also follow the instruction manuals of the products used in conjunction with this product. Use only approved components and connection cables. Use only suction devices and devices for supplying irrigation fluid that do not reduce the protection rating "BF" of the motor handpiece in accordance with IEC / EN 60601. The user is responsible for selecting a suitable irrigation fluid. Due to differing anatomy, it is not possible to quantify irrigation and suction rates. The user must adapt the flow to the respective 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 of 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 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.

2.8.1

Equipotentality The potential equalization cable represents a direct connection between a medical electrical device and a potential equlization rail. It serves to equalize differences in potential between enclosures of electrical equipment and firmly installed conductive parts in the patient environment.

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2.8.2

Requirements for the products / components of a combination The general requirements depend on whether the products/components are inside or outside the patient environment.

Medically used room within the patient environment

outside the patient environment -------

Non-medically used room

Requirements / measures Leakage currents to IEC/EN 60601-1

-------

Measurement of leakage currents a) additional protective earth connection (to be clarified with the corresponding manufacturer), or b) additional isolating transformer **

-------

Measurement of leakage currents a) no plugs with metal housing, or b) additional separating device (to avoid voltage differentials) Verification of leakage currents a) joint protective earth connection, or b) additional protective earth connection at MP (verify with the corresponding manufacturer), or c) additional separating device (to avoid voltage differentials), or d) no plugs with metal housing in the patient environment

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additional "isolating transformer with galcanic separation to IEC/EN 60601-1 **

additional isolating device to IEC/ EN 60601-1

Multi-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

NMP

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

*

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.

ATTENTION 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 choosing the system components make sure that these meet the necessary requirements for the medical environment they are used in, in particular IEC/EN 60601-1. 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.

2.9

Electromagnetic compatibility (EMC) - IEC 60601-1-2 : 2014 Please note: The device / system, in the following referred to as the product, always relates to the POWER DRIVE ART1 2304 and accessories.

The product is intended for use in the environment specified below. The user must make sure 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 A

Harmonic emissions to IEC 61000-3-2

Class A

The product is suitable for use in buildings other than residential buildings and buildings that are directly connected to the public power supply network that also supplies buildings used for residential purposes, provided the following warning is observed: Warning: The product is only intended for use by specialist medical staff. In residential buildings, this product may generate radio interference, making it necessary to take suitable remedial measures, such as reorientation, repositioning, or shielding of the product, or installation of a filter in the lines going to the site.

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

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Guidelines and manufacturer's declaration – Electromagnetic immunity The product is intended for use in the environment specified below. The user must make sure that the product is used in such an environment. Immunity tests

IEC 60601 test level

Electrostatic discharge (ESD) ± 8 kV contact disto IEC 61000-4-2 charge ± 15 kV air discharge

Compliance Electromagnetic environment – Guidelines Yes

Floors should be wood, concrete, or ceramic tile. With floors made of synthetic material, the relative humidity of the ambient air must be at least 30%.

Electrical fast transients/ bursts to IEC 61000-4-4

± 2 kV for power cables Yes ± 1 kV for input/output cables

Line power quality should be that of a typical commercial or hospital environment.

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

± 1 kV line-to-line voltage ± 2 kV line-to-ground voltage

Yes

Line power quality should be that of a typical commercial or hospital environment.

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

0% UT * ; 1/2 period at 0, 45, 90, 135, 180, 225, 270, and 315 degrees 0% UT * ; 1 period and 70% UT * ; 25/30 periods Single-phase: at 0 degrees 0% UT * ; 250/300 cycles

Yes

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

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

30 A/m

Yes

Power frequency magnetic fields should be at levels characteristic of a typical commercial or hospital environment.

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

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Guidelines and manufacturer's declaration – Electromagnetic immunity for products that are not life-supporting The device is intended for use in the electromagnetic environment defined below. The user must ensure that the product is used in such an environment. Immunity tests

Test level acc. to IEC 60601

Compliance level

Conducted HF interference to IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms 150 kHz to 80 MHz

a

6 Vrms in ISM frequency bands 150 kHz to 80 MHz

Radiated HF interference according to IEC 61000-4-3

3 V/m 80 MHz to 2.7 GHz

Electromagnetic environment – Guidelines

Portable and mobile RF communications equipment should be used no closer to the device, including cables, than the recommended separation distance of 30 cm. a 6 Vrms in ISM freThe field strength of stationary radio quency bands transmitters determined within the scope 150 kHz to of on-site investigations should be below b 80 MHz the compliance level for all frequencies. Interference may occur in the vicinity of devices with the following symbol: 3 V/m 80 MHz to 2.7 GHz

NOTES: These guidelines may not apply in all situations. The propagation of electromagnetic waves is affected by absorption and reflection from buildings, objects, and people. a) The ISM frequency bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz, and 40.66 MHz to 40.70 MHz. b) The field strength of fixed transmitters such as base stations for radio (cellular, cordless) telephones and land mobile radios, amateur radio, AM and FM radio, and TV transmitters cannot be predicted theoretically with accuracy. To assess the electromagnetic environment in terms of fixed transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location where the device is used exceeds the applicable compliance levels above, the device must be observed to verify it is functioning normally. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device.

Recommended safety distances between portable and mobile HF telecommunication devices and the product Definition for high-frequency wireless communication equipment Frequency band (MHz)

Test frequency (MHz)

Modulation a

Compliance level (V/m)

380–390

385

Pulse – 18 Hz

27

430–470

450

FM ± 5 kHz deviation or a pulse – 18 Hz

28

704–787

710, 745, 780

Pulse – 217 Hz

800–960 1700–1990 2400–2570 5100–5800

810, 870, 930 1720, 1845, 1970 2450 5240, 5500, 5785

a

9

a

28

a

28

a

28

a

9

Pulse – 18 Hz Pulse – 217 Hz Pulse – 217 Hz Pulse – 217 Hz

NOTES: A minimum safety distance of 30 cm should be maintained between the product and portable HF communication devices emitting in the specified frequency band. This includes cell phones as well as WLAN, RFID, and Bluetooth devices, for example. Non-compliance may impair the product's performance. a) Pulse modulation is defined as a square-wave signal with a 50% duty cycle.

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