PiezoWave2 Control Unit Instructions for Use V3.0 July 2021

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, illustrations and technical data may deviate slightly from the current state. For further information about our products please contact Richard Wolf GmbH or your 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 information ...

5

1.1

Safety instructions and levels of danger...

5

1.2

Symbols...

5

2

General safety notes and instructions for use ...

7

3

Product description...

8

4

Intended purpose ...

9

5

Indications ... 10

6

Contraindications and side effects ... 11

6.1

Contraindications... 11

6.2

Side effects... 12

7

Combinations ... 13

7.1 7.1.1

Combinable therapy sources... 13 Requirements for the products/components of a combination ... 13

7.2

Electromagnetic compatibility (EMC) - IEC 60601-1-2 : 2014 ... 15

7.3

Equipotentality ... 17

8

Illustration ... 18

8.1

Front view – Control unit... 18

8.2

Rear view – Control unit ... 19

8.3

Figure: Device cart – PiezoWave2 ... 20

8.4

Figure: 3-pedal footswitch ... 21

9

Checks... 22

9.1

Visual check ... 22

9.2

Function check ... 22

10

Preparation / Commissioning ... 23

10.1

Footswitch connector ... 24

10.2

Connecting the therapy source ... 24

10.3 10.3.1 10.3.2 10.3.3

Preparation ... 25 Device cart parking brakes ... 25 Device cart shelves ... 25 Installation/removal of control unit on device cart ... 26

11

Use ... 27

11.1 11.1.1

General notes and instructions for use... 28 Operating principle ... 28

11.2 11.2.1 11.2.2 11.2.3 11.2.4

Control elements and operating modes ... 29 Setting the shock wave intensity ... 29 Setting the pulse rate ... 29 Display of software version ... 29 Preselection of the total number of shock wave pulses to be applied ... 29

11.3 11.3.1 11.3.2 11.3.3

Operating the product... 29 Treatment sequence ... 29 Evaluating the shockwave therapy ... 31 Taking out of service ... 31

12

Reprocessing and maintenance ... 32

12.1

Reprocessing ... 32

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12.2 12.2.1

Maintenance ... 33 Maintenance intervals ... 33

13

Technical description... 34

13.1 13.1.1 13.1.2

Troubleshooting... 34 Status and error messages on the display ... 34 Device errors ... 35

13.2 13.2.1 13.2.2 13.2.3

Technical data ... 35 PiezoWave 2 ... 35 Device cart... 36 3-pedal footswitch ... 36

13.3

Essential performance characteristics... 36

13.4 13.4.1

Operating, storage, transport, and shipping conditions ... 36 Transporting the device cart and control unit ... 37

14

Spare parts ... 38

14.1

Spare parts ... 38

14.2 14.2.1

Replacing parts ... 38 Device fuses ... 38

15

Disposal... 39

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1

General information

1.1

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.

1.2

Symbols

Symbols

Designation Follow the instruction manual Off (no power supply, disconnected from line power) On (power supply, connected to line power) Equipotentality TYPE B APPLIED PART Fuse Alternating current (AC) Number of shockwaves “Reset” button Shockwave intensity

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Symbols

Designation Pulse rate

Increase value Decrease value “Function” button Footswitch for shockwave triggering and intensity change Footswitch shockwave triggering

Therapy source

Data transfer

Permissible total weight

Permissible shelf weight

Permissible weight of center shelf

Manufacturer Manufacturing date Recycle the product separately. Do not discard together with other waste.

A Registered Trademark of a Recognized Testing Laboratory, confirms the compliance to the standard of Medical Electrical Equipment CAN/CSA C22.2 No.60601-1 (c) and ANSI/AAMI ES60601-1 (US) A Registered Trademark of a Recognized Testing Laboratory, confirms the compliance to the standard of Medical Electrical Equipment CAN/CSA C22.2 No.60601-1 (c) and ANSI/AAMI ES60601-1 (US) CE identification with code number of the competent authority in conformity with Directive 93/42/ EEC on medical products or EU regulation 2017/745 on medical products. Only valid if the product and/or the packaging is marked with this identification. Products where a notified body is not involved in the conformity assessment procedure are marked with the CE-identification without the code number of the notified body. 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.

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General safety notes and instructions for use WARNING n

n

The product 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.

CAUTION 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.

CAUTION n

Reprocess the products in accordance with the manual before every use and before return shipment to protect the patient, user and third parties.

CAUTION Tissue/vascular damage. n

Only use the products if you have a clear view of the treatment area.

Handle the products with care to avoid damage. 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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3

Product description The PiezoWave2 is a compact extracorporeal shockwave therapy device that enables treatment with piezoelectric shockwaves. The PiezoWave2 features a simple and intuitive user interface which allows the key treatment parameters to be set quickly and easily. The control unit can be used as a desktop device or as a mobile device in conjunction with the device cart. The optional footswitch extends the operating functions to assist with manually performed shockwave therapy. Different therapy sources can be connected to and combined with the control unit. A therapy source holder supports the handling and storage of multiple therapy sources. The device cart enables the storage of the gel pad ranges used in the various therapy sources.

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Intended purpose Control units for extracorporeal shockwave therapy (ESWT) sources 100505

PIEZOWAVE 2 CONTROL UNIT

The products are used for controlling compatible piezoelectric therapy sources. Footswitch for shockwave therapy devices 100038

FOOTSWITCH 3 PEDALS

The products are used to control control units and therapy sources for emitting sound waves into the human body. Therapy source holder 100915

THERAPY SOURCE HOLDER

The products are used for holding therapy sources. Device cart for shockwave devices 100905

PIEZOWAVE2 DEVICE CART

The products are used for transporting and storing shockwave therapy devices in practice environments. User This product is intended exclusively for use by medical experts and may only be used by adequately qualified and trained medical personnel.

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5

Indications The product is used in the disciplines of orthopedics, dermatology, and urology for extracorporeal shockwave therapy (ESWT) and trigger point shockwave therapy (TPST). Patient group For urology applications, use is restricted to male patients aged 14 or older. There is no restriction regarding ethnicity, height, weight, or other general conditions. For orthopedic applications, use is restricted to patients aged 14 or older. There is no restriction regarding ethnicity, sex, height, weight, or other general conditions. Regarding dermatological applications, the intended patient group is not limited with regard to ethnicity, age, sex, height, or weight. Before treatment, the responsible user must make sure that the product can be used safely on the patient with respect to its dimensions or settings.

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6

Contraindications and side effects

6.1

Contraindications When using the products, the following general contraindications must be taken into account: n n n n n

n

Infections in focus Lungs in focus Environment of a pacemaker Arterial hypertension Clotting disorders (the patient’s coagulation status is required) or treatment with blood-thinning drugs Brain or nerves in focus (central nervous system)

The following contraindications must be taken into account for use in urology: n n n n n n

Bacterial prostatitis Penile prosthesis Hypogonadism Neurological diseases (e.g., multiple sclerosis, brain diseases) Mental illnesses (e.g., manic/chronic depression) Alcohol/drug abuse

The following contraindications must be taken into account for use in dermatology: n n n n n n

Pregnancy Infectious wounds (grades B and D according to WagnerArmstrong) Necrotic wounds (grade 4–5 according to WagnerArmstrong) Thrombosis in the treated area Large blood vessels in the treated area Cartilage tissue during the growth phase

The following contraindications must be taken into account for use in orthopedics: n n n

Pregnancy Open growth plates in focus Cartilage tissue during the growth phase

The responsible user must decide on the basis of the patient’s general condition whether the intended treatment is possible or not.

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6.2

Side effects The following side effects must be taken into account for use in urology: Slight pain and petechiae. There is a possibility of short-term hematospermia (bloody semen), hematuria (reddish tinted urine), acute bacterial prostatitis, urinary tract infection, interim urinary retention (due to possible swelling of the prostate), or a temporary increase in PSA (prostate-specific antigen). The following side effects must be taken into account for use in dermatology and orthopedics: Petechial hemorrhage, local hematoma, edema, or irritation of the skin at the treatment area may occur.

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Combinations CAUTION Tissue/vascular damage. n

Observe the instruction manuals of the products used in combination with this product.

The product is combined with the therapy sources intended for this purpose.

7.1

Combinable therapy sources

100751

THERAPY SOURCE FB10 G6 with button for shockwave triggering

100671

THERAPY SOURCE F7 G3 with button for shockwave triggering

100681

THERAPY SOURCE F10 G4 with button for shockwave triggering

100731

THERAPY SOURCE FBL10X5 G2 with button for shockwave triggering

100691

THERAPY SOURCE F10 G10 with button for shockwave triggering

7.1.1

Requirements for the products/components of a combination WARNING Persons combining products to form a system are responsible for not impairing the system's compliance with performance and safety requirements, and for ensuring 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 environment they are used in, in particular IEC/ EN 60601-1 (3rd 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. The PiezoWave2 must only be used in conjunction with the therapy sources approved by Richard Wolf and in accordance with the instruction manual of the therapy source used.

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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.

7.2

Electromagnetic compatibility (EMC) - IEC 60601-1-2 : 2014 NOTE All instances of the word "product" in the context of a device/system in the following section of text refer to the product mentioned in the section on "Intended use".

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 internal functions. The HF emission is very low and is unlikely to interfere with adjacent electronic devices.

HF emissions to CISPR 11

Class B

Harmonic emissions to IEC 61000-3-2

Class A

The product is suitable for use in all buildings including residential buildings. Furthermore, it is suitable for use in buildings that are directly connected to the public power supply network that also supplies buildings used for residential purposes.

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

Compliance Electromagnetic environment – Guidelines

Electrostatic discharge (ESD) in accordance with IEC 61000-4-2

± 8 kV contact discharge ± 15 kV air discharge

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 in accordance with IEC 61000-4-4

± 2 kV for power caYes bles ± 1 kV for input/output cables

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

Surge voltages (surges) in accordance with IEC 61000-4-5

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

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

Voltage dips, short interruptions, and supply voltage fluctuations in accordance with IEC 61000-4-11

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

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 in accordance with IEC 61000-4-8

30 A/m

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

Yes

* 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 of the device must make sure that it is used in such an environment. Immunity tests

Test level acc. to IEC 60601

Compliance level

Electromagnetic environment – Guidelines

Conducted HF disturbances in accordance with IEC 61000-4-6

3 Veff 150 kHz to 80 MHz

3 Veff 150 kHz to 80 MHz

Portable and mobile RF communications equipment should be used no closer to any part of the device (including cables) than the recommended separation distance of 30 cm. The field strength from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the comb pliance level at all frequencies. Interference may occur in the vicinity of devices with the following symbol:

a

Radiated HF disturbances in accordance with IEC 61000-4-3

a

6 Veff ISM frequency bands 150 kHz to 80 MHz

6 Veff ISM frequency bands 150 kHz to 80 MHz

3 V/m 80 MHz to 2.7 GHz

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.

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The device is intended for use in the electromagnetic environment defined below. The user of the device must make sure that it is used in such an environment. Immunity tests

Test level acc. to IEC 60601

Compliance level

Electromagnetic environment – Guidelines

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 separation 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.

7.3

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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8

Illustration

8.1

Front view – Control unit

1.11

1.8

1.9

1.10

1.1 1.2 1.3 1.4 1.5 1.6

1.7

1.1

Increase pulse rate “+” button

1.7

Connection socket for therapy source (type B applied part)

1.2

Decrease pulse rate “-” button

1.8

“Pulse rate” display

1.3

“Reset” button

1.9

“Shockwave counter” and “Status and error messages” display

1.4

“F” function button

1.10

“Shockwave intensity” display

1.5

Increase shockwave intensity “+” button

1.11

Holder for therapy source

1.6

Decrease shockwave intensity “-” button

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8.2

Rear view – Control unit 1.11

1.16 1.15

1.14

1.13

1.12

1.11

Control unit identification plate

1.14

Socket for footswitch

1.12

“Potential equalization” connector

1.15

Power input connector with fuse holder

1.13

Data interface (for service only)

1.16

Power switch

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8.3

Figure: Device cart – PiezoWave2

3.0

Device cart

3.4

Lower shelf

3.1

Device cart identification plate

3.5

Double casters, front, with parking brake

3.2

Stowage area for control unit

3.6

Double casters, rear, with parking brake

3.3

Shelf with fixation for gel pad storage dishes

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