PiezoWave2 Control Unit Instructions for Use V3.0 Sept 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 ...

8

3

Product description...

9

4

Intended purpose ... 10

5

Indications ... 11

6

Contraindications and side effects ... 12

6.1

Contraindications... 12

6.2

Side effects... 13

7

Combinations ... 14

7.1

Overview of permissible combinations and requirements ... 14

7.2

Requirements for the products / components of a combination ... 15

7.3

Electromagnetic compatibility (EMC) - IEC 60601-1-2 : 2014 ... 17

7.4

Equipotentality ... 19

8

Illustration ... 20

8.1

Figure: Front view of PiezoWave2 control unit ... 20

8.2

Figure: Rear view of PiezoWave2 control unit ... 21

8.3 8.3.1 8.3.2 8.3.3

Other figures... 22 Side view of the PiezoWave2 control unit ... 22 View of PiezoWave2 device cart ... 23 View of footswitch with 3 pedals... 24

9

Checks... 25

9.1

Visual check ... 25

9.2

Function check ... 25

10

Preparation / Commissioning ... 26

10.1 10.1.1 10.1.2

Connection ... 28 Connecting the footswitch with 3 pedals ... 28 Connecting the therapy source ... 28

10.2 10.2.1 10.2.2 10.2.3 10.2.4 10.2.5

Preparation ... 29 Device cart parking brakes ... 29 Device cart shelves ... 29 Installing the control unit on the device cart ... 30 Removing the control unit from the device cart ... 30 Setting the language ... 30

11

Use ... 31

11.1 11.1.1

General notes and instructions for use... 31 Operating principle ... 32

11.2 11.2.1 11.2.2 11.2.3 11.2.4 11.2.5 11.2.6

Control elements and operating modes ... 32 Power switch ... 32 Connecting the therapy source ... 33 Menu structure ... 33 Setting the shockwave intensity ... 34 Setting the pulse rate ... 34 Setting the shockwave target sum ... 34

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11.2.7

Resetting the treatment settings... 35

11.3 11.3.1 11.3.2 11.3.3 11.3.4 11.3.5 11.3.6 11.3.7 11.3.8 11.3.9 11.3.10

Operating the product... 35 Treatment sequence ... 35 Extended functions ... 36 Setting the extended parameter view ... 36 Setting T-burst frequency mode ... 37 Setting T-ramp frequency mode ... 37 Setting the control unit volume ... 37 Displaying the statistics ... 38 Displaying the software version... 38 Licenses ... 38 Taking out of service ... 38

12

Reprocessing and maintenance ... 39

12.1

Reprocessing ... 39

12.2 12.2.1

Maintenance ... 40 Maintenance intervals ... 40

13

License conditions ... 41

14

Technical description... 42

14.1 14.1.1 14.1.2

Troubleshooting... 42 Status and error messages on the display ... 42 Device errors ... 43

14.2 14.2.1 14.2.2 14.2.3

Technical data ... 43 Technical data – control unit... 43 Technical data – device cart ... 44 Technical data – footswitch with 3 pedals ... 44

14.3

Performance characteristics ... 44

14.4

Operating, storage, transport and shipping conditions ... 45

15

Spare parts ... 46

15.1

Spare parts ... 46

15.2

Replacing parts ... 46

16

Disposal... 47

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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 Medical device Off/On (supply, disconnection from/connection to the power supply) Equipotentality TYPE B APPLIED PART Fuse Alternating current (AC) Number of shockwaves Shockwave intensity

Pulse rate

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Symbols

Designation T-burst frequency mode

Pulse duration

Pause duration

T-ramp frequency mode

Initial frequency

Time frame

Target frequency

Increase value Decrease value Stop at Delete last input “Reset” button Substages activated/deactivated

Volume loud/quiet

Menu Confirm input Cancel input Therapy source

Positive peak pressure

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Symbols

Designation Energy flux density Treatment duration Remaining treatment duration Check box not selected/selected

Option field not selected/selected

Secure area Footswitch Footswitch shockwave triggering

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) USB interface Network, LAN (Ethernet) interface 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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2

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 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 n

n

Use the product only in the combinations and with the accessories and spare parts specified in this instruction manual. The product must not be altered in any way.

NOTE 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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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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4

Intended purpose Control units for extracorporeal shockwave therapy (ESWT) sources 100506

PiezoWave2 Control Unit

Active and reusable control units for extracorporeal shockwave therapy (ESWT) sources are used for short (under 60 minutes), non-invasive interventions. The products are used for controlling compatible piezoelectric therapy sources. Footswitch for shockwave devices 100038

FOOTSWITCH 3 PEDALS

Non-active and reusable footswitches for shockwave devices are used for short, non-invasive interventions (under 60 minutes). 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

Non-active and reusable therapy source holders are used for non-invasive interventions. The products are used for holding therapy sources. Device cart for shockwave devices 100905

PIEZOWAVE2 DEVICE CART

Non-active and reusable device carts for shockwave devices are used for non-invasive interventions. The products are used for transporting and storing shockwave devices in practice environments. User The 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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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 Wagner-Armstrong) Necrotic wounds (grade 4–5 according to Wagner-Armstrong) 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.

ATTENTION 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 system components, check that they meet the requirements for the medical environment in which they are to be used (IEC/EN 60601-1 in particular). 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) 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.

7.1

Overview of permissible combinations and requirements Product no. Designation

14

100671

THERAPY SOURCE F7 G3

100681

THERAPY SOURCE F10 G4

100691

THERAPY SOURCE F10 G10

100731

THERAPY SOURCE FBL10X5 G2

100751

THERAPY SOURCE FB10 G6

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7.2

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 -------

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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)

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Medically used room within the patient environment

outside the patient environment

Non-medically used room

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

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.

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7.3

Electromagnetic compatibility (EMC) - IEC 60601-1-2 : 2014 NOTE The device/system in the following called product always refers to the product mentioned in the chapter on "intended purpose".

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 with

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 immediately 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 specialized medical staff. In residential areas this product can cause radio interference which may require taking adequate remedial measures such as new alignment, new location or screening the product or filtering the connection to the installation 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 assure 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 mains power Yes lines ± 1 KV for input and output lines

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

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

± 1 KV voltage Phase to phase ± 2 KV voltage phase to earth

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

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Yes

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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

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 periods

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 uninterruptible power supply or battery.

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

30A/m

Yes

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

* REMARK: UT is the line / mains voltage prior to application of the test levels.

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 assure that the product is used in such an environment. Immunity tests

Test level to IEC 60601

Compliance level

HF conducted disturbances to IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms 150 kHz to 80 MHz

a

6 V rms in ISM frequency bands 150 kHz to 80 MHz

Radiated HF interference 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 80 of on-site investigations should be below b MHz the compliance level for all frequences. In the vicinity of devices with the folowing symbol interference is possible: 3 V/m 80 MHz to 2.7 GHz

REMARKS: These guidelines may not apply in all situations. The propagation of electromagnetic waves is affected by absorption and reflexion 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 to 13.567 MHz; 26.957 MHz to 27.283 MHz and 40.66 MHz to 40.70 MHz. b) The field strength from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the equipment is used exceeds the applicable RF compliance leve above, the equipment should be observed to verify normal operation. In the case of unusual behaviour during operation, additional measures may be necessary, such as a changed alignment or a different location of of the device.

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Recommended safety distances between portable and mobile HF telecommunication devices and the producte Definition relative to high-frequency wireless communication devices 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

Pulse – 18 Hz a

28

a

28

a

9

Puls – 217 Hz Pulse – 217 Hz Pulse – 217 Hz

REMARKS: Between portable HF communication devices transmitting in the specified frequency band and the product, a minimum safety distance of 30 cm should be maintained. This comprises mobile phones, LAN, RFID and Bluetooth devices. Non-compliance can cause the power characteristics of the device to be impaired. a) Pulse modulation is defined as a square signal with a 50% duty cycle.

7.4

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

Figure: Front view of PiezoWave2 control unit 1.2

1.4

1.1

1.3

Fig. 1

20

1.1

Connection socket for therapy source (type B applied part)

1.3

Operating and display unit

1.2

Holder for therapy source

1.4

Tablet holder

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