2303 Motor Control Unit Instructions for Use V12.0 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 ... 10

2.4 2.4.1

Intended use... 10 Performance characteristics ... 10

2.5

Indications and field of use ... 11

2.6

Contraindications and side effects ... 11

2.7

General notes and instructions for use... 12

2.8 2.8.1 2.8.2

Combinations ... 13 Equipotentality ... 13 Requirements for the products / components of a combination ... 14

2.9

Electromagnetic compatibility (EMC) - IEC 60601-1-2 : 2014 ... 16

2.10 2.10.1

Combination with POWER STICK M4... 19 Legend ... 19

3

Illustration ... 20

3.1 3.1.1

Illustration of POWER CONTROL front panel ... 20 Legend ... 20

3.2 3.2.1

Illustration of LCD display... 21 Legend ... 21

3.3 3.3.1

Illustration of POWER CONTROL rear panel... 22 Legend ... 22

3.4 3.4.1

View of footswitch... 23 Legend ... 23

3.5 3.5.1

Illustration of POWER STICK M4 with valve (8564.121)... 24 Legend ... 24

3.6 3.6.1

Illustration of POWER STICK M4 with open sealing insert (8564122) – only for urological applications ... 24 Legend ... 24

4

Commissioning ... 25

4.1

Preparation – POWER CONTROL ... 26

4.2

Preparation – POWER STICK M4 (8564.121/8564122) ... 27

5

Checks... 28

5.1

Visual checks ... 28

5.2 5.2.1 5.2.2

Function check ... 28 Function check – footswitch ... 29 Function check – POWER STICK M4 (8564.121/8564122) ... 29

6

Use ... 30

6.1

Operating principle ... 30

6.2 6.2.1 6.2.2 6.2.3 6.2.4 6.2.5 6.2.6

Control elements and operating modes ... 30 General notes and instructions for use... 30 Operation of POWER CONTROL via the sensor field ... 31 Language selection ... 31 Setting the parameters with the footswitch connected ... 32 Setting the parameters on the POWER CONTROL, with no footswitch connected ... 34 Changing the factory settings ... 35

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6.2.7 6.2.8

POWER STICK M4 with valve... 36 POWER STICK M4 with open sealing insert... 36

6.3 6.3.1 6.3.2

Operating the device ... 37 Speed settings... 38 Instructions and notes on morcellation in urology ... 38

6.4

Alarms ... 39

6.5 6.5.1

Emergency shutdown of POWER STICK... 40 Taking out of service ... 40

7

Operation in the RIWO NET SYSTEM ... 41

7.1

Combination with RIWO NET SYSTEM ... 41

7.2

Operating principle ... 41

7.3

Adjusting rotary encoding switch "ID"... 41

7.4

Connection to the RIWO NET SYSTEM ... 42

7.5 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.5.6 7.5.7

Controlling the devices using the RIWO NET menu ... 43 Controlling the devices using the different input media ... 43 Illustration of menu ... 43 Main menu... 44 Speed range function ... 44 Speed function ... 44 Oscillation function ... 44 Positioning function ... 44

7.6 7.6.1 7.6.2 7.6.3

System messages ... 44 Operating messages ... 44 Warnings ... 45 Failure/fault... 45

8

Reprocessing and maintenance ... 46

8.1

Reprocessing ... 46

8.2 8.2.1

Maintenance ... 47 Maintenance intervals ... 47

8.3 8.3.1 8.3.2

Reprocessing procedure ... 48 POWER STICK M4 (8564.121/8564122) ... 49 Reprocessable rotary blades, burrs, and morcellators ... 52

9

Technical description... 54

9.1 9.1.1 9.1.2

Troubleshooting... 54 POWER CONTROL ... 54 POWER STICK ... 54

9.2 9.2.1

Technical data – Motor control unit 2303 ... 55 Interfaces... 55

9.3

Technical data for motor handpiece ... 55

9.4

Technical data of footswitch ... 56

9.5

Operating, storage, transport, and shipping conditions ... 56

9.6 9.6.1 9.6.2 9.6.3 9.6.4 9.6.5 9.6.6 9.6.7

Spare parts and accessories ... 57 POWER CONTROL ... 57 POWER STICK M4 ... 57 Reprocessable rotary blades and burrs ... 58 Reprocessable rotary blades and burrs for spinal surgery (POWER STICK M4) ... 58 Reprocessable rotary Morcellator for urology ... 59 Disposable rotary Morcellator for urology... 59 Accessories for reprocessing ... 59

9.7

Replacing spare parts for POWER STICK M4 ... 60

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9.7.1

POWER STICK M4 connection cable ... 60

9.8 9.8.1

Device fuses ... 61 Disposal of the product, packaging material, and accessories ... 61

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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 accessories in accordance with the instruction manual before and after every use and before return shipment to protect the patient, user, and third parties. 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 Alarm

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Ready (triggering of function check)

Signal input (CAN bus) Signal output (CAN bus) Identification of operating field Display flashes: "No footswitch" Display flashes: "No POWER STICK"

"Counterclockwise rotation" display "Clockwise rotation" display "Oscillation" display

Selected speed range display

Counterclockwise rotation Clockwise rotation Oscillation Back to previous menu Increase value by one

Decrease value by one

Selection Confirm value Single step "Adjust speed" selector "Select speed range" selector "Device settings" selector

Oscillation frequency adjustment Speed range adjustment

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Adjust speed Adjust stop position (works only without footswitch) Reset to factory settings

Language selection Control level "B" activated

footswitch Switch between control levels "A" and "B" A: Speed range 1 to 4 B: Single step A: Direction of rotation "CCW" B: Reduce speed A: Direction of rotation "CW" B: Increase speed A: Direction of rotation "oscillation" B: Check the speed

Catalogue Number Batch identification Units, amount

manufacturer Manufacturing Date Expiry date: 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

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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 CE marking in conformity with Directive 93/42/EEC on medical products or EU Regulation 2017/745 on medical devices. Only valid, if the product and/or packaging is marked with this identification. Products as of category IIa, sterile products and products of class I, products with measuring function of class I, as well as reusable surchical instruments are additionally marked with the four-digit code number of the competent authority. The CE identification on the title page of these instructions for use relates exclusively to the Richard Wolf main product or, if serveal identical products are described, to the Richard Wolf product with the highest classification. The CE identification of the other Richard Wolf products and, if applicable, of products made by other manufacturers, described in these instructions for use results exclusively from the identification on the product and/or packaging.

2.3

Overview of motor handpieces

Product No

Short description

Richard Wolf designation

8564.121

Motor handpiece BNDL

POWER STICK M4

8564122

Motor handpiece max. 6000 rpm

POWER STICK M4

2.4

Intended use POWER CONTROL 2303 in conjunction with POWER STICK M4 (8564.121/8564122) is used for energizing R.WOLF rotary blades, burrs, and morcellators (tissue punches) for removing tissue in endoscopic procedures. At the same time, suction allows continuous removal of ablated tissue. User The product is exclusively intended for use by specialized medical personnel and may only be used by medically qualified and adequately trained persons.

2.4.1

Performance characteristics n n n

10

Drive of Richard Wolf motor handpieces. Directions of rotation: CCW, CW, and oscillation. Adaptation of the opening angle on the rotary instruments.

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

n n n

n

In arthroscopy, e.g., for meniscal resection, for the removal of soft tissue as well as for intraarticular transection or abrasion of osseous tissue (e.g., in ACL or shoulder applications) In chest 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 the fragmentation and the removal of detached prostatic adenomas after laser TURP.

ATTENTION In conjunction with the open sealing insert (15178145), the POWER STICK M4 may only be used for urological applications.

CAUTION In therapeutic applications, an adequate backup device with the same capabilities must be available should the device fail.

2.6

Contraindications and side effects 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 WARNING This product must only be applied in combination with the devices approved by Richard Wolf and following the corresponding device instruction manual.

CAUTION Incorrect combination of products! Injury may result to the patient, user, or others, and damage may result to the product. The different products may only be combined if the intended use and the relevant technical data (working length, diameter, etc.) are the same. The instructions for use of the products used in the product combination must be observed.

CAUTION All Richard Wolf disposable rotary blades and burrs are sterilely packed in double wrapping and are designed for 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 Reduced cutting performance and wear on the rotary blade/burr. If the rotary blade/burr is pushed against the tissue at high pressure this will not improve the cutting performance but may instead cause damage and increased wear and tear on the inner blade/burr.

CAUTION In the packaging, the inner and outer parts of the rotary blades and burrs are not connected. Do not mix up the inner and outer parts of the same or different rotary blades and burrs. If the inner and outer parts of the rotary blades and burrs are interchanged, the product may be damaged, causing patient injuries.

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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2.8

Combinations ATTENTION In addition to this instruction manual, follow the manuals for 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. Use only approved components and connection cables. When using rotary blades/burrs 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. 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.

ATTENTION Due to 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.

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.

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2.9

Electromagnetic compatibility (EMC) - IEC 60601-1-2 : 2014 NOTE The device or system, in the following referred to as the product, always relates to the POWER CONTROL 2303 and accessories.

Guidelines and manufacturer's declaration – Electromagnetic emissions 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"

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

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

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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

Compliance Electromagnetic environment – Guidelines

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.

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.

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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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2.10

Combination with POWER STICK M4

2.10.1

Legend

1.0

POWER CONTROL 2303

2.0

POWER STICK M4

3.0

footswitch

4.0

Suction pump

4.1

Suction tube

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3

Illustration

3.1

Illustration of POWER CONTROL front panel

3.1.1

Legend

1

Power switch

5

Sensor field

2

"Alarm" display

6

Socket for motor handpiece (Type BF applied part)

3

"Ready" button

7

Socket for footswitch

4

LCD

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