USA

Instructions for Use

Z Wave Pro

Fig.1

Illustrations

Front of the Device

9

3

2

1

11

Selection and control elements

1 Control unit

2 Pulse energy controller

3 Display

4 Frequency controller

5 Slot for SD card

Handpiece

6 Power switch

7 Handpiece

8 Air vents, front

9 Air vents with fan, rear

10 Holder for handpiece

Footswitch

Accessories optional 12 Swivelling base

11 Footswitch

5

12

6

4

7

8

10

Fig.2

Illustrations

Rear of the Device

16

13

14

Switches / Connector sockets

13 Socket for power cord

14 Mains fuse

15 Socket for handpiece channel I

16 Socket for handpiece channel II

17 Socket for footswitch

18 Identification plate

18

17

15

Fig 3.

20

Illustrations

Screens / Displays

19

Display / Application screen

19 Status bar

20 Buttons on the screen

21 Navigation bar

Fig 4.

Navigation bar

Description of the functions

(A) Back

(B) Menu

Move back one step

Move to the selected menu

A

B

21

Fig.5

Illustrations

Applicator Head and Accessories

22

Applicator head

Accessories

23

22 39 mm applicator head

23 Silicone cap

Caution

!

Explanation of the Symbols

In this instructions for use, this symbol stands for “Danger”.

In this instruction for use, this symbol indicates “Caution” with regard to possible damage of the device.

Connection socket handpiece

Connection socket footswitch

Instructions for use

Follow instruction for use.

Serial number

Article number

Manufacturer

Date of manufacture

Value of accessible fuses

Interval operation – note the instructions for use

Instrument type BF

Table of Contents

1

Illustrations

Front of the Device

Rear of the Device

Screens / Displays

Applicator Head and Accessories

Explanation of the Symbols

Indications / Contraindications

2

Application Information

3

Warnings

4

Z Wave Pro – in brief

5

Set-up Device

Installation of Cables

6

Settings

7

Operation Instructions

7.1 Device Description

7.2 Notes on Operation

7.3 Performing the Application

7.4 Display and Buttons

7.5 SD Card

7.6 Favorites List – Retrieving Programs and Editing List

8

Technical Information

8.1 Info-Chart, Duration of Application

9

Cleaning / Disinfection

10

Scope of Delivery / Accessories

Page

1

5

4

2

3

6

22

19

20

21

10

11

8

13

15

16

Table of Contents

11

Safety and Maintenance

11.1 Safety

11.2 Maintenance

12

Function Test

13

14

Error Messages / Troubleshooting / Disposal

Manufacturer’s declaration of Electromagnetic Compatibility

Valid for the device ZWave Pro .

This instructions for use is an integral part of the device. It must be stored with the device and kept accessible at all times for anyone authorized to operate this device.

The instructions for use is valid as of July 2019.

U.S.A. Federal Law restricts this device to sale by or on the order of a practitioner licensed by the law of the State in which he/she practices to use or order the use of the device.

26

29

Page

23

24

25

Indications

Contraindications

Indications /

Contraindications

1

The application is recommended for the temporary reduction in the appearance of cellulite.

Application is contraindicated in the following cases:

 vascular diseases present in or near the area of application

 local infections in the area of application

 around malignant or benign tumors

 directly on cartilage surfaces or near the small facet joints of the spinal column

 directly over implanted electronic devices such as pacemakers, analgesic pumps, etc.

 in areas in which mechanical energy in the form of vibrations may lead to tissue damage such as metal implants after a fracture

In general we advise against applications

 if blood clotting disorders are present or the client is receiving treatment that results in a change in the blood clotting behavior as for example during pregnancy

 on clients with neurological diseases resulting in impairment of the vasomotor function in the area of application

 over air-filled cavities such as application on the thoracic spine, etc.

 on children, particularly around the epiphyseal plates

Care is required for clients

 with impaired sensibility

 with severe autonomic disorders

 under the influence of drugs and/or alcohol as circulatory stresses and inadequate application responses cannot be excluded.

Page 1

Caution

!

Caution

!

Caution

!

Caution

!

Caution

!

Caution

!

Application Information 2

Prior to using of the device on the patient, the user should become acquainted with the operation instructions and individual treatment methods as well as the indications / contraindications, warnings and other instructions. Additional sources of information about types of therapy should be consulted.

Before use, ensure that the device is operated using a properly earthed socket with earthing contact (electrical installation according to DIN VDE 0100 Part 710 or equivalent). The device must be only operated with the supplied power cord. The power cord must be protected against mechanical stress.

Operating the device near strong electromagnetic fields (e.g. tomography, x-ray, or diathermy equipment) may interfere with the operation of the device. Please keep a safe distance of several meters.

Z Wave Pro is not suitable for use in explosive, flammable, or combustive environments.

During use, the device must be located in a position that allows direct access to the mains power supply so that this can be disconnected at any time.

To prevent the risk of electric shock, the plug must be disconnected from the power supply before performing any maintenance or cleaning activities.

Inspect the device before use. If there is any damage, do not use the device.

Only use accessories from Zimmer MedizinSysteme GmbH.

The handpiece of the device is not designed for continuous operation. After a max.

6000 strokes, a treatment pause of 15 min is required.

If Z Wave Pro is not mounted on a designated wagon, ensure that the Z Wave Pro is placed on a stable surface.

To avoid heat accumulation in the handpiece, ensure that the vents on the top and especially the bottom of the handpiece are not blocked (i.e. by the hand or otherwise).

Page 2

Warnings 3

Users of Z Wave Pro must have the appropriate skills.

Any treatment instructions regarding treatment location, duration and intensity of application requires medical knowledge and may only be provided by persons with the appropriate expertise. These instructions must be followed.

The patient must not be left unattended during use.

People who are undergoing simultaneous treatment to reduce and/or alter blood clotting or to prolong blood-clotting time (e.g. acetylsalicylic acid) should consult their therapist about a possible suspension of this application because there is an increased risk of bleeding and haematoma with the use of radial pulses in these individuals.

Radial pulses are strongly scattered in air-filled areas and produce reflections that can have negative effects.

Therefore, do not perform direct applications on the pulmonary (intercostal space) or gastrointestinal tract.

Use in wet areas is not permitted and may, in case of non-compliance, lead to considerable damage and endanger both the persons undergoing application and the user.

This device should not be used over swollen or inflamed areas or skin eruptions. Do not use in the present of unexplained calf pain. Consult a physician.

Page 3

What is Z Wave Pro ?

Pulse application

What does

Z Wave Pro do?

How are pulses generated with

Z Wave Pro ?

What are the advantages of

Z Wave Pro ?

Note:

Z Wave Pro – in brief 4

A state of the art innovative therapeutic massager.

High energy radial pulse application is a procedure for the temporary reduction in the appearance of cellulite.

Creation of pulses using an ergonomic handpiece and transmission of pulses via a special applicator.

Z Wave Pro has a maximum penetration depth of about 35 mm in human tissue.

An electromagnetic field is generated via a coil in the back of the handpiece.

A projectile is accelerated as a result of the field; this strikes against the applicator head at the front of the handpiece and generates pulses, which spread out radially in the tissue.

The innovative technology allows a compact design with no need for a compressor.

The clear and modern color display showing all parameters relevant for application and the modern touch operation ensure pleasure and motivation when providing application.

Clear, simple menu navigation makes operation of the device easy and comfortable for users.

Infinitely variable frequencies allow application to be adapted to the particular condition of the client.

The ability to simultaneously connect 2 handpieces ensures a continuous application without wait.

ZWave Pro has been constructed and designed solely for the application on superficial skin problems in humans.

Page 4

Note:

Note:

Set-up Device

Installation of Cables

5

If the ZWave Pro is not mounted on the designated system trolley, please make sure that it is standing on a stable surface. .

Make sure that the power switch of the device is set to “0”.

Connect the power cable

Note:

Connect the power cable to the appropriate socket (13) in the device, and connect the cable to the power supply.

The device may only be connected to power outlets with earthing contact.

Connect the handpiece Connect the handpiece to one of the provided sockets channel I (15) or channel II

(16).

Note: Make sure that an applicator head is inserted to the handpiece and that it is correctly and completely screwed in.

Connect the foot switch

Connect the footswitch to the appropriate socket (17) and place it on the floor.

Switch on the device Turn on the device with the power switch (6).

Switch off the device The device is switched off using the power switch (6).

To completely disconnect the device from the mains (all poles), unplug the power cable.

All cables must be protected against clamping or other mechanical damage.

Caution

!

Page 5

Note:

Start-up screen

Operation Instructions

7.1 Device Description

7

Changes in the basic settings are only possible from the start-up screen.

After switching on the device and performing the self-test, the start-up screen opens.

Note:

Settings menu

Settings select

1

2

Activation of the “Protocols” button (2) immediately switches to the application screen.

In the settings menu, the factory settings can be individually changed and adjusted.

Activating the “Settings” button (1) opens the settings screen.

Page 6

Operation Instructions

7.1 Device Description

7

2

1

3

5

4

10

(1) Start settings

(2) Language

(3) Welcome text

(4) Volume

(5) Brightness

(6) Maintenance

(7) Version

(8) Load default

(9) Color scheme

(10) Handpiece

6

7

9 8

The default settings are pre-programmed as shown in the screen.

Start menu:

Individual options of the start menu. If you select the “Protocols (Body)” or the

“Protocols (List)” setting, application is selected via the list of application areas is in the start menu. If you select the “Favorites” setting, the start menu will consist of the favorites list. If you select “Custom program”, the start menu will consist of the application menu.

Choose language.

The selection is made directly in the corresponding line.

Activation of the “Welcome text” field opens a window with an alphanumeric keyboard for entering a welcome message on the start-up screen.

Activation of the button with the green hook saves the entered text.

Activation of the button with the red cross takes you back to the configuration menu.

Option to adjust the volume of the signal tones when activating the control panels.

The volume is adjusted via the two arrow keys.

Option to adjust the brightness of the screen. The brightness is adjusted via the two arrow keys.

The “maintenance” menu is not relevant for the user. The points listed here are used only if maintenance is performed by customer service.

Activation of the “Version” button opens a window with information about the current software version.

Activation of the “Load default” button restores the default factory settings.

Activation of the “Color scheme” button changes the display color from dark to bright and vice versa.

In this display panel, the counter status for the connected handpieces is illustrated.

By touching the button with the green arrow in the right bottom of the display the settings are saved and the configuration menu is closed.

Page 7

Handpiece

Note:

Interval operation

Note:

Recommendation:

Note:

Operation Instructions

7.1 Device Description

7

The handpiece (7) contains the pulse generator, a fan for heat dissipation, and the slot for the applicator head. It is connected to the control device (1).

The pulse generator in the handpiece is a wear part and needs to be replaced after a certain period as its ability to function decreases with time.

Zimmer MedizinSystemeGmbH guarantees unrestricted use of at least two million pulses per one pulse generator. Depending on the power and frequency, more than two million pulses can be generated.

More information on the necessity to replace the pulse generator is provided in

Chapter 13 .

To work with the handpiece on the patient, the applicator head must be screwed firmly and completely into the handpiece.

The handpiece is not suitable for continuous operation. Through frictional heat, the temperature of the applicator increases with increasing duration of application to the extent that thermal damage to the patient cannot be excluded.

Please refer to the figure in section 8.1, the maximum values for the applications.

After reaching the specified values, the application must be interrupted; it can only be resumed after cooling the applicator to room temperature.

Please note that the temperature control of the handpiece described on page 9 only presents a technical shutdown to protect the mechanical parts inside the handpiece.

It provides no information about the temperature of the applicator.

To avoid an interruption in applications with more than 6000 pulses, the connection of a second handpiece is recommended.

During the cooling phase of one handpiece, the operation can be switched to the second handpiece, and it can continue without delay.

While switching the handpieces during the ongoing application, the pulse frequency and the number of pulses remain unchanged. The pulse energy returns to 0 and must be reset.

Page 8

Operation Instructions

7.1 Device Description

7

Temperature monitoring / regulation handpiece

The generation of the mechanical pulse energy causes a substantial build-up of heat in the handpiece. To avoid reducing the life of the handpiece, a temperature switch is integrated. An internal shutdown mechanism forces the handpiece to cool if excessive temperatures are reached.

In addition to temperature monitoring, the Z Wave Pro provides temperature control by means of a temperature sensor in the handpiece. A ventilator in the handpiece is started when activated by the foot switch; it stops automatically if it reaches a certain temperature.

If the temperature reaches a critical level, a cooling phase is initiated. This is indicated by the following display message:

“Over temperature in handpiece. Please allow the handpiece to cool down.”

Output of pulse is no longer possible.

After confirming the message with the button with the green arrow, the handpiece cannot be selected any longer and the time is indicated until the handpiece will reach normal operating temperature again.

Application head

Meanwhile the application can be continued with the second handpiece.

A large applicator with Ø 39 mm is available for the application.

Change of applicator To change the applicator, hold the handpiece with one hand, and unscrew the

Note

Footswitch applicator head counter clockwise from the handpiece with the other hand.

Then screw in the new applicator clockwise to the stop position.

The applicator is a wear part and needs to be replaced after a certain period of use

(see chapter 11 Maintenance).

Place the corresponding foot switch in such a way that it can be reached easily during the application. The control panel of the switch is independent of direction; an exact alignment of the foot switch is therefore unnecessary.

To avoid damage, ensure that only slight pressure is exerted on the switch. The operation is performed with the front foot – not the heel.

The switch has no locking system i.e. the activation remains as long as pressure is applied on the switch.

Page 9

Application

Operation Instructions

7.2 Notes on Operation

Please hold the handpiece as shown below.

7

Caution

Note:

!

Note:

The Z Wave Pro operates with mechanical energy; it is transferred to the patient through a handpiece.

For this purpose, the handpiece with the applicator is placed vertically on the application area.

While the pulse is enabled, you can work dynamically on one area as well as stationary at one point.

In order to reduce friction on the skin, lotion provided as accessory should be applied.

Due to the weight of the handpiece, firmly pressing down on application area/point is usually not necessary.

The handpiece is placed and held in a relaxed posture using the hand.

If required, additional pressure can be applied in the direction of the fabric, and the angle of use can be varied.

Depending on the application, a different position of the handpiece and the formation of a skin-fold between applicator and the applicant’s hand can be useful. These and other instructions are noted in the operation instructions (see page 12).

When using the provided lotion or other lubricants, the applicator must be covered with the silicone cap.

Despite the high self-damping, due to the weight and design of the handpiece, the vibrations can strain the hand of the user.

Recommended safety precautions:

- Limitation of the loading duration

- Passive support

The patient should be carefully monitored during use.

Page 10

Note:

Program start

Operation Instructions

7.3 Performing the Application

7

All buttons, menus, and sub-menus can be directly activated on the screen by touching with your finger.

Activating the right button in the start screen opens the screen selected in the settings menu.

If “Protocols (Body)” or the “Protocols (List)” is selected in the start settings menu, a screen appears in which the application can be set via the list of application areas.

Application selection The application is selected in the corresponding row.

Page 11

Application recommendation

Operation Instructions

7.3 Performing the Application

After selecting the application, another window with detailed application recommendation will open.

7

Select application program

Place the handpiece / applicator

Note:

Note:

!

End of application

Activation of the “Application” button opens the application screen with the appropriate program. All relevant application recommendations are pre-set, but the pulse energy must be individually stepped up for each application.

Place the handpiece on the selected application field. Note the necessary, application-specific instructions. In order to avoid friction on the skin, some lotion should be applied to the application area prior to application.

When using lubricants, the applicator must be covered with the silicone cap.

Caution

Setting the pulse energy Set the pulse energy using the controller on the left side.

Application launch By activating the foot switch, the application starts.

The pulse generator should be activated by the foot after placing the handpiece on the patient.

By deactivating the foot switch, the application is interrupted or terminated.

During use, the patient must be monitored carefully, and the application must be adjusted if necessary or terminated if problems arise.

Page 12

Description of the display elements and buttons

Operation Instructions

7.4 Display and Buttons

1

2

3

(1) Energy

(2) Frequency

(3) Choice of

Handpiece

(4) Mode

7

4

5

6

7

10

9 8

Displays the set pulse energy. When the application is active, the bar graph is filled in.

The pulse energy can be set before and during the delivery of pulses. The pulse energy is adjustable between 60–185 mJ in 10 mJ steps.

Displays the set frequency.

Frequency range: 1–22 Hz, adjustable via the right controller. The maximum selectable frequency depends on the energy level selected.

Connection of one handpiece:

If only one handpiece is connected, the window selection displays the channel of the connected handpiece. The handpiece is activated automatically regardless of the connected channel.

Connection of two handpieces:

When connecting two handpieces, the handpiece at channel I is activated first.

The desired handpiece is activated by selecting directly the handpiece in the selection window.

The activated handpiece is presented by the orange applicator head.

Displays the selected operating mode. When activating the “mode” window, the selection menu appears with the operating modes:

Series pulses, burst 4 pulses, burst 8 pulses, burst 12 pulses.

The desired mode of operation is selected directly in the corresponding row.

Page 13

Operation Instructions

7.4 Display and Buttons

7

(5) Number of pulses Display of the preselected number of pulses and the currently emitted pulses as well as the total number of emitted pulses if the total number of emitted pulses is not preselected.

Display of the counting direction in ascending or descending order.

(6) Counting direction

Activation of the “preselection” field will open the input menu for entering a preselected number of pulses. The pre-selection can be done in 100 or 1000 steps.

Activation of the button determines the counting direction (ascending or descending)

(7) Reset

(8) Save

(9) Info

(10) Title bar of the number of pulses delivered.

Resets to 0 in the case of ascending counting order and to the pre-set number of pulses in the case of descending counting order.

Activation of the button opens the field for entering an individual program for storage in the favorites list.

Activation of the button opens a window with application information.

Display of the current program name and the selected handpiece.

Page 14

SD Card

Operation Instructions

7.5 SD Card

7

On the SD-card, the user-defined settings as well as the body regions and the application list are stored.

If the SD-card is not inserted, the display application recommendation will not open upon activation of the start button on the home page.

The following message appears:

“SD card not found. Use of treatment recommendations requires a SD-card.”

Insert the card and restart the device.

If you lose your card, please contact the customer service department.

On the SD card, the user-defined settings as well as the application list are stored.

If the SD card is not inserted, the application list will not open upon activation of the start button on the home page. Instead, the application program will open immediately.

In addition, the following message appears upon activating the “Favorites” or

“Memory” buttons:

“No SD card was found. The use of “Favorites” and “Memory” requires a SD card.”

Insert the card, and confirm with “OK”.

In the event of loss of your card, please contact the customer service department.

Page 15

Store and name program

Operation Instructions

7.6 Favorites Lists –

Retrieving Programs and Editing Lists

7

The parameters of the pre-defined programs can be modified individually and saved.

Activating the “save” button opens the field for entering the program name.

The program name is entered via the keyboard.

The programs can be saved in the favourites list. 99 storage locations are available. Note:

Save in favourites list Activation of the button with the green arrow button closes the screen and imports the program into the favourite list.

The program is always stored in the first available space of the list.

Activation of the button with the red cross interrupts the save process.

Note: If no program name is entered, the following message appears:

“Please insert a name!”

Confirm the message, enter the program name and repeat the storage process.

Page 16

Operation Instructions

7.6 Favorites Lists –

Retrieving Programs and Editing Lists

Select favorite list

Open program

Edit favorites list

Individually stored programs are listed in the favorites list.

These can be retrieved here

1.

for application,

2.

for editing (moving and deleting).

Activation of the “Favorites” button opens the favorites list.

The desired program is directly selected in the corresponding row

1

Activation of button (1) opens the “Edit” screen.

Select the favorites that are to be edited directly in the line.

7

Page 17

Edit favorites

Operation Instructions

7.6 Favorites Lists –

Retrieving Programs and Editing Lists

7

Note:

1 2 3 4

Activation of button (1) moves the program to the bottom.

Activation of button (2) moves the program to the top.

Activation of button (3) deletes the program.

Activation of button (4) saves the modifications and returns you to the program.

Activation of button (3) leads to a confirmation request:

“Do you really want to delete this program?”

Activating the button with the green arrow deletes the application.

Activation of the button with the red cross will cancel the deletion process.

Page 18

Technical Information

Basic device

Power supply

Fuses

100 – 240 V / 50/60 Hz

2 × T3A15L, 250V

Power consumption 250VA

Protection class

Frequency range

I

1 Hz – 22 Hz, adjustable in 1 Hz steps

3 burst modes with 4, 8, or 12 pulses

Pulse energy levels 60 – 185 mJ (on applicator) selectable in 10 mJ steps

Mode of operation

Accuracy

Dimensions

Z Wave Pro

Z Wave

Syscart

Weight

Z Wave

Z Wave

Pro

Pro

Pro

Syscart

Handpiece

Dimensions

Weight

Lifetime

Application head

Operation

Storage/

Transport

Note:

with syscart

with syscart at 22 Hz, max. 90 mJ at 16 Hz, max. 120 mJ at 10 Hz, max. 185 mJ

Interval operation

± 20%

H 138 cm × W 53 cm × L 52 cm

H 30 cm × W 35 cm × L 20 cm

H 138 cm × W 53 cm × L 52 cm

19.3 kg

3.8 kg

15.5 kg

230 mm long, 50 mm diameter

850 g

2,000,000 pulses (pulse generator)

39 mm diameter / tool-free changeable,

150,000 pulses guaranteed.

10 to 25 °C, 20 to 80% relative humidity, without condensation at 700 – 1060 hPa

−10 to 50°C, 10 to 90% relative humidity, without condensation at 700 – 1060 hPa

Storage and transport only in original packaging.

Subject to technical modifications!

8

Page 19

Technical Information

8.1 Info-Chart, Duration of Application

Max. possible pulses per application

8 frequency

Page 20

Cleaning

Disinfection

9

Housing / footswitch

Applicator head / handpiece

Note:

Caution

!

Note:

- Before starting any maintenance and cleaning measures, the device must always be turned off with the main switch, and the mains cable must be disconnected.

- Make sure that during the cleaning and disinfection the labelling of the device (such as warnings, label of control devices and identification plate) are not damaged.

- Make sure that no liquid enters the instrument, foot switch or applicator during cleaning or disinfection. Do not use sprays.

- If liquid enters into the device or applicator during the cleaning or disinfection process, please turn off the device, prevent it from getting used again, and contact your service representative.

- The device and its application device are considered as uncritical in relation to hygiene due to the use on uninjured and healthy skin.

Cleaning: In the event of visible contamination, the housing, footswitch and all cables can be cleaned using commercially available soft alcohol-free plastic cleaners. Wipe the surface until the dirt is removed, using a soft cloth soaked according to the specifications of the manufacturer of the cleaning agent but not dripping.

Disinfection: Housing, footswitch and all cables can be disinfected using disinfectant wipes. To do so, use a commercially available alcohol-free disinfectant for metal and plastic, with bactericidal, virucidal and fungicidal properties. Observe the application instructions of the manufacturer. Wipe all surfaces using a cloth soaked according to the specifications of the manufacturer of the disinfectant, but not dripping, or use preimpregnated disinfectant wipes (so-called wipes).

If applicable, also observe requirements for drying or post-cleaning.

Cleaning: Remove the silicone cap from the applicator before cleaning. Then proceed as indicated under “housing/footswitch”.

Disinfection: Remove the silicone cap from the applicator head before disinfecting.

Then proceed as indicated under “housing/foot switch”.

Caution: If flammable solutions are used for cleaning and disinfection, solutions must be allowed to evaporate before using the device. Otherwise, an inflammation may arise!

Use the device only in hygienic environment.

When using lubricants, the silicone cap must be placed over the applicator to avoid contamination.

If you are working without a protective cap, the lubricant may enter into the interior of the applicator and the handpiece, which can lead to permanent contamination and malfunction.

In this case, the warranty will expire.

Page 21

Scope of Delivery

Accessories

Scope of delivery combination with syscart

Set: Art. no. 5531-X01

Art. no.

5531

9160

5511

93133530

65137110

50500038

94130411

65410410

67250131

10102386

63061010

1 Z Wave Pro control unit

1 Syscart with tray mount

2 Handpieces

3 Applicator heads 39 mm

10 Silicone caps

1 Z Wave Lotion

1 Footswitch

1 Storage tray for accessories

1 Mains cable (US hospital grade)

1 Instructions for Use

1 Template

Scope of delivery Tabletop device

Set: Art. no. 5531-X03

5531

5511

93133530

65137110

50500038

94130411

65410410

67250131

93130411

10102386

63061010

1 Z Wave Pro control unit

2 Handpieces

3 Applicator heads 39 mm

10 Silicone caps

1 Z Wave Lotion

1 Footswitch

1 Storage tray for accessories

1 Mains cable (US hospital grade)

2 Holder for handpieces

1 Instructions for Use

1 Template

Accessories

Art. no.

5511

93130411

93133530

65137110

50500038

94130411

65410410

67250131

95800610

Handpiece

Silicone cap

Z Wave

Footswitch

Holder for handpiece

Applicator head 39 mm

Lotion

Storage tray for accessories

1 Mains cable (US hospital grade)

Swivelling base

10

Page 22

Legal Notice:

Safety and Maintenance

11.1 Safety

11

The Z Wave Pro is manufactured according to the DIN EN 60601-1 safety regulations.

Zimmer MedizinSysteme GmbH can only be held responsible for safety and reliability of the device if

 the device is operated using a proper power outlet with earth contact and the electrical installation complies with DIN VDE 0100 part 710,

 the device is operated in accordance with the operating instructions,

 extentions, readjustments or modifications are only performed by persons authorised by Zimmer MedizinSysteme GmbH,

 the user has been instructed in the functional safety, proper operating condition, and mechanical integrity of the device and handpiece prior to use,

 the device is only operated by properly trained personnel,

 the device is not operated in hazardous areas and/or a combustive atmosphere,

 the device is disconnected immediately from the power supply upon the penetration of liquid.

The device contains no parts that can be maintained or repaired by the operator.

For installation and operation of this equipment, national laws must be observed.

Page 23

Checking the impact dome

Safety and Maintenance

11.2 Maintenance

11

Before cleaning and maintenance, the device must always be switched off with the main switch, and the power cord must be disconnected.

At the applicator head, a deformation / shortening of the rear dome takes place during use. On a small scale, this will have no effect on functionality.

In cases of more extensive deformation of the dome or considerable shortening, the applicator head must be replaced.

To check the condition of the applicator head, a test template is supplied with the device, which can be used to check whether the wear limit has been reached.

Depending on the frequency of use, the device should be inspected at least once per month.

To do so, the applicator head is removed and measured with the enclosed test template.

Test template

Air gap  Applicator OK

Test template

Template is lying or air gap at the top  Wear limit reached

Page 24

Note:

Function test

Note:

Function Test 12

After the device is switched on, the Z Wave Pro performs a self-test, which checks all internal components.

In the event of a fault, an error message appears.

In addition, an extended function test can be performed as described below.

This test should be performed monthly or if there are any doubts about the viability of the device.

Before performing the functional test, ensure that the hand piece and foot switch are connected properly to the device.

Check to see whether the power cable is connected properly to the device and whether it is connected to the network.

Switch the device on.

Briefly press the foot switch – the fan and pulse generator start immediately. The pulse generator must work at the frequency on the display (10 Hz as standard value).

Upon completion of the function test, switch off the Z Wave Pro .

If an application is to be carried out directly afterwards, set the desired application parameters and proceed further as described in section 7.

Page 25

Loss of function of handpiece

Error Messages

Troubleshooting

Disposal

Malfunction of handpiece

13

In the status bar, the message “Ready” appears, and despite activating the foot switch, no pulse is triggered.

Possible cause 1

Handpiece / foot switch is not properly connected, or defective.

Fix for cause 1

Make sure that the foot switch and handpiece are connected correctly. The plug must be snapped in properly.

Check the cable of the foot switch for damage or kinks.

Check whether the gearshift dome of the foot switch can be moved or is blocked.

Possible cause 2

Program settings incorrect.

Fix for cause 2

Check whether the pulse energy is set.

Irregular emission of the pulses / excessive heating of the handpiece

Possible cause 1

Wear of applicator head / stiffness through abrasion

Fix for cause 1

The applicator head is a wear part and must be replaced after a certain number of pulses.

Removal of parts rubbed off:

Remove the applicator head from the handpiece, and clean thoroughly the rear dome.

Then hold the handpiece without applicator head with the opening facing downwards and produce some pulses (maximum 10) with 2 or 5 Hz frequency at the lowest energy level. Then re-insert the applicator head.

If the error persists, the applicator head must be changed.

Possible cause 2

Wear of pulse generator

Fix for cause 2

The pulse generator is a wear part, and it should be replaced after two million pulses.

Check the total pulse count of the handpieces in the settings menu.

If a total of two million pulses is reached or exceeded for each handpiece, the pulse generator must be replaced.

To replace the pulse generator, please contact your sales representative or the head office in Irvine, CA. USA.

Page 26

Error Messages

Troubleshooting

Disposal

13

Applicator not found In the status bar, the message “No applicator found” appears.

Functional failure of device

Possible cause

Handpiece not connected or incorrectly connected.

Fix for cause

Make sure the handpiece is properly connected. The plug must be properly snapped in.

No response to the main switch / display remains dark

Possible cause 1

Mains power connection

Fix for cause 1

Check whether the power cord is plugged properly into the electrical outlet and whether the plug is firmly inserted into the socket of the device.

Check the power cord for damage.

Check the power supply and mains socket.

Possible cause 2

Fuse

Fix for cause 2

In the power input socket of the device, there are micro-fuses that disconnect the power supply in the event of an electrical problem. Open the cover and check the fuses. If necessary, replace the faulty fuse.

Replace the fuse only with fuses of exact the same name or equivalent.

First, check the power supply completely for possible errors.

If the error occurs again, inform the customer service department.

Page 27

Error message SD card

Overtemperature warning

Error Messages

Troubleshooting

Disposal

13

If the SD card is not inserted, the following message appears upon activation of the “Favorites” button:

“SD card not found”.

The use of “Favorites” requires a SD card.

Insert the card and restart the device.

If you lose your card, please contact the customer service department.

If the temperature reaches a critical level, a cooling phase is initiated. This is indicated in the display by the following message:

“Over temperature in handpiece. Please allow the handpiece to cool down.”

After receiving this message, no more pulse input is possible.

After confirming the message with “OK”, the application screen appears and indicates when the handpiece will reach the operating temperature again.

In the case of other malfunctions, switch the device off and then switch it on after waiting for 5 seconds. If the problem persists, please contact the customer service department in Irvine.

Zimmer MedizinSystems

3 Goodyear, Suite B

Irvine, CA. 92618

Phone (800) 327-3576

Fax (949) 727-2154 www.zimmerusa.com

[email protected]

Disposal Please observe the national regulations regarding disposal. Contact your distributor if necessary.

Page 28

Manufacturer’s declaration of

Electromagnetic Compatibility

14

The Zwave Pro is developed according to the recognized standards of technology; the information on the intended use of the components is taken into account.

The Zwave Pro must not be operated near active HF surgery devices or magnetic resonance tomography that can cause high levels of electromagnetic interference.

The Zwave Pro is exclusively for professional health care facilities such as hospitals provided and tested.

The Zwave Pro has no essential performance features that could be caused by electromagnetic interference.

WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

The electromagnetic compatibility of the Zwave Pro device has been tested on the original device with handpiece

WARNING: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emission or decreased electromagnetic immunity of this equipment and result in improper operation.

The device Zwave Pro contains no interchangeable components, cables or other that leads to a deterioration of the EMC.

WARNING: Portable RF communication equipment (including peripherals such as antennas) should be used no closer than 30 cm (12 inches) to any part of the device Zwave Pro including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

The device was tested for RF immunity only at selected frequencies. Nearby transients at other frequencies may result in degraded operation. The frequencies tested are listed in Table 4.

The Zwave Pro is developed according to the recognized standards of technology; the information on the intended use of the components is taken into account.

The device Zwave Pro does not contain any components which age over the course of the device life time and could lead to a deterioration of the electromagnetic compatibility. Thus, no maintenance is required during the life of the device to ensure basic safety. All tests according to standard IEC 60601-1-2 Ed. 4.0 were performed. No other standards and regulations for electromagnetic compatibility have been applied.

Page 29

Manufacturer’s declaration of

Electromagnetic Compatibility

14

Table 1

Guidance and Manufacturing Declaration- Electromagnetic Emissions

The device of the device

Zwave Pro is intended for use in the electromagnetic environment specified below. The customer or user

Zwave Pro should ensure that it is used in such environment.

Emission Measurement Compliance Electromagnetic Environment-Guidelines

RF Emissions in accordance with

CISPR 11

Group 1 The device ZWave Pro must emit electromagnetic energy in order to ensure its intended function.

Nearby electronic equipment may be affected.

RF Emissions in accordance with

CISPR 11

Emissions of Harmonics in accordance with IEC 61000-3-2

Class A

Class A

Emissions of voltage fluctuations/ flickers in accordance with IEC

61000-3-3

Table 2

Compliant

Guidance and Manufacturing Declaration- Electromagnetic Immunity

The device ZWave Pro is suitable for use in all establishments, including domestic establishments and those directly connected to the public supply network that also supplies buildings used for domestic purpose.

The device of the device

Zwave Pro is intended for use in the electromagnetic environment specified below. The customer or user

Zwave Pro should ensure that it is used in such environment.

Immunity

Tests

IEC 60601- Test Level Compliance Level Electromagnetic Environment -

Guidelines

Electrostatic

Discharge

(ESD) in accordance with IEC

61000-4-2

± 8 kV Contact Discharge

± 2 kV, ± 4 kV, ± 8 kV,

± 15 kV Air Discharge

± 8 kV Contact Discharge

± 2 kV, ± 4 kV, ± 8 kV,

± 15 kV Air Discharge

Floors should be made from wood, concrete or ceramic tiles. If floors are covered with synthetic material, the relative humidity must be at least 30 %

Electrical fast transient/ burst in accordance with IEC

61000-4-4

± 2 kV

100 kHz repetition frequency

± 2 kV

100 kHz repetition frequency

The supply voltage quality must correspond to that of a typical commercial or hospital environment.

± 0,5 kV, ± 1 kV Surges in accordance with IEC

61000-4-5

-Line-to-

Line-

± 0,5 kV, ± 1 kV

Surges in accordance with IEC

61000-4-5

-Line-to-

Earth-

± 0,5 kV, ± 1 kV, ± 2 kV ± 0,5 kV, ± 1 kV, ± 2 kV

Page 30

Manufacturer’s declaration of

Electromagnetic Compatibility

14

Guidance and Manufacturing Declaration- Electromagnetic Immunity

The device of the device

Zwave Pro is intended for use in the electromagnetic environment specified below. The customer or user

Zwave Pro should ensure that it is used in such environment.

Immunity

Tests

IEC 60601- Test Level Compliance Level Electromagnetic Environment -

Guidelines

Voltage dips in accordance with IEC

61000-4-11

0 % U

T;

0,5 cycle

At 0°, 45°, 90°, 135°, 180°,

225°, 270° and 315°

0 % U

T;

1 cycle and 70%

U

T;

25/30 cycles

Single phase: at 0°

0 % U

T;

0,5 cycle

At 0°, 45°, 90°, 135°, 180°,

225°, 270° and 315°

0 % U

T;

1 cycle and 70% U

T;

25/30 cycles

Single phase: at 0°

The supply voltage quality must correspond to that of a typical commercial or hospital environment. If the user of the device

Zwave

Pro requires continued operation, even in the case of interruptions in the power supply, it is recommended that the device

Zwave

Pro be powered from an uninterrupted power supply or a battery.

Voltage interruptions accordance with IEC

61000-4-11

0% U

T;

250/300 cycle

30 A/m

50 Hz oder 60 Hz

Magnetic field of supply frequency

(50/60 Hz) in accordance with IEC

61000-4-8

0% U

50 Hz

T;

30 A/m

250/300 cycle

Note: U

T

is the mains AC Voltage before application of the test level

Magnetic fields at mains frequency should have the typical values found in a business or hospital environment.

Page 31

Manufacturer’s declaration of

Electromagnetic Compatibility

14

Table 3

Guidance and Manufacturing Declaration- Electromagnetic Immunity

The device of the device

Zwave Pro is intended for use in the electromagnetic environment specified below. The customer or user

Zwave Pro should ensure that it is used in such environment.

Immunity Test IEC 60601-Test

Level

Compliance Level Electromagnetic Environment -

Guideline

Conducted

Disturbances induced by RF fields according IEC 61000-

4-6

3 V

0,15 MHz to 80

MHz

6 V in ISM Band between 0,15 MHz and 80 MHz

80% AM at 1 kHz

3 V

0,15 MHz to 80 MHz

6 V in ISM Band between 0,15

MHz and 80 MHz

80% AM at 1 kHz

In the vicinity of devices, bearing the following symbol, interference is possible:

Radiated RF EM fields according IEC 61000-

4-3

3 V/m

80 MHz-2,7 GHz

80% AM to 1 kHz

3 V/m

80 MHz-2,7 GHz

80% AM to 1 kHz

870

930

1720

1845

1970

710

745

780

810

Table 4

Electromagnetic immunity to HF radio communication equipment

Test

Frequency

(MHz)

385

Band

(MHz)

Service

380-390 TETRA 400

Modulation

450 430-470 GMRS 460,

FRS 460

Pulse

Modulation

18 Hz

FM

± 5kHz

Derivation

1kHz Sine

2450

704-787 LTE Band 13, 17

800-960 GSM 800/900,

TETRA 800, iDEN 820, CDMA

850, LTE Band 5

1700-

1990

2400-

2570

Pulse

Modulation

217Hz

Pulse

Modulation

18Hz

GSM 1800;

CDMA 1900;

GSM 1900; DECT;

LTE Band 1,3, 4, 25;

UMTS

Bluetooth, WLAN, 802.11 b/g/n,

RFID 2450, LTE Band 7

Pulse

Modulation

217 Hz

Pulse

Modulation

217 Hz

Maximum

Energy

(W)

1,8

2

0,2

2

2

2

Distance

(m)

Immunity Test

Level

(V/m)

0,3 27

0,3

0,3

0,3

0,3

0,3

28

9

28

28

28

Page 32

Manufacturer’s declaration of

Electromagnetic Compatibility

5240

5500

5785

Electromagnetic immunity to HF radio communication equipment

Test

Frequency

(MHz)

Band

(MHz)

Service Modulation

5100-

5800

WLAN 802.11 a/n Pulse

Modulation

217 Hz

Maximum

Energy

(W)

0,2

14

Distance

(m)

Immunity Test

Level

(V/m)

0,3 9

Page 33

Instructions for Use

Zimmer MedizinSystems

3 Goodyear, Suite B

Irvine, CA. 92618

800 327 3576

949 727 2154 fax www.zimmerusa.com

[email protected]