Zimmer Z Wave Pro User manual

Instructions for Use
ZWave
Pro
USA

Illustrations
Front of the Device
Fig.1
Selection and control
elements
1 Control unit
2 Pulse energy controller
3 Display
4 Frequency controller
5 Slot for SD card
6 Power switch
Handpiece
7 Handpiece
8 Air vents, front
9 Air vents with fan, rear
10 Holder for handpiece
Footswitch
11 Footswitch
Accessories optional
12 Swivelling base
2
5
7
8
4
3
10
11
1
9
12
6

Illustrations
Rear of the Device
Fig.2
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
16
15
17
13
18
14

Illustrations
Screens / Displays
Fig 3.
Display / Application
screen
19 Status bar
20 Buttons on the screen
21 Navigation bar
Fig 4.
Navigation bar
Description of the
functions
(A) Back
Move back one step
(B) Menu
Move to the selected menu
B
A
21
20
19

Illustrations
Applicator Head and Accessories
Fig.5
Applicator head
22 39 mm applicator head
Accessories
23 Silicone cap
22
23

Explanation of the Symbols
In this instructions for use, this symbol stands for “Danger”.
Caution!
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
Illustrations
Front of the Device
Rear of the Device
Screens / Displays
Applicator Head and Accessories
Explanation of the Symbols
Page
1
Indications / Contraindications
1
2
Application Information
2
3
Warnings
3
4
ZWavePro –in brief
4
5
Set-up Device
Installation of Cables
5
6
Settings
6
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
10
11
13
15
16
8
Technical Information
8.1 Info-Chart, Duration of Application
19
20
9
Cleaning / Disinfection
21
10
Scope of Delivery / Accessories
22

Table of Contents
Page
11
Safety and Maintenance
11.1 Safety
11.2 Maintenance
23
24
12
Function Test
25
13
Error Messages / Troubleshooting / Disposal
26
14
Manufacturer’s declaration of Electromagnetic Compatibility
29
Valid for the device ZWavePro.
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.

Indications /
Contraindications
1
Page 1
Indications
The application is recommended for the temporary reduction in the appearance of
cellulite.
Contraindications
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.

Application Information
2
Page 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.
Caution!
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.
Caution!
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.
ZWave 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.
Caution!
Only use accessories from Zimmer MedizinSysteme GmbH.
Caution!
The handpiece of the device is not designed for continuous operation. After a max.
6000 strokes, a treatment pause of 15 min is required.
Caution!
If ZWave Pro is not mounted on a designated wagon, ensure that the ZWavePro is
placed on a stable surface.
Caution!
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).

Warnings
3
Page 3
Users of ZWave 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.

ZWavePro –in brief
4
Page 4
What is ZWave Pro?
A state of the art innovative therapeutic massager.
Pulse application
High energy radial pulse application is a procedure for the temporary reduction in
the appearance of cellulite.
What does
ZWavePro do?
Creation of pulses using an ergonomic handpiece and transmission of pulses via a
special applicator.
ZWavePro has a maximum penetration depth of about 35 mm in human tissue.
How are pulses
generated with
ZWavePro?
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.
What are the
advantages of
ZWavePro?
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.
Note:
ZWave Pro has been constructed and designed solely for the application on
superficial skin problems in humans.

Set-up Device
Installation of Cables
5
Page 5
Note:
If the ZWave Pro is not mounted on the designated system trolley, please make sure
that it is standing on a stable surface. .
Note:
Make sure that the power switch of the device is set to “0”.
Connect the power
cable
Connect the power cable to the appropriate socket (13) in the device, and connect
the cable to the power supply.
Note:
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.
Caution!
All cables must be protected against clamping or other mechanical damage.

Operation Instructions
7.1 Device Description
7
Page 6
Note:
Changes in the basic settings are only possible from the start-up screen.
Start-up screen
After switching on the device and performing the self-test, the start-up screen opens.
Note:
Activation of the “Protocols” button (2) immediately switches to the
application screen.
Settings menu
In the settings menu, the factory settings can be individually changed and adjusted.
Settings select
Activating the “Settings” button (1) opens the settings screen.
1
2

Operation Instructions
7.1 Device Description
7
Page 7
The default settings are pre-programmed as shown in the screen.
(1) Start settings
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.
(2) Language
Choose language.
The selection is made directly in the corresponding line.
(3) Welcome text
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.
(4) Volume
(5) Brightness
(6) Maintenance
(7) Version
(8) Load default
(9) Color scheme
(10) Handpiece
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.
5
6
7
2
1
8
9
10
3
4

Operation Instructions
7.1 Device Description
7
Page 8
Handpiece
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).
Note:
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.
Interval operation
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.
Note:
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.
Recommendation:
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.
Note:
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.

Operation Instructions
7.1 Device Description
7
Page 9
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 ZWave 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.
Meanwhile the application can be continued with the second handpiece.
Application head
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
applicator head counter clockwise from the handpiece with the other hand.
Then screw in the new applicator clockwise to the stop position.
Note
The applicator is a wear part and needs to be replaced after a certain period of use
(see chapter 11 Maintenance).
Footswitch
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.

Operation Instructions
7.2 Notes on Operation
7
Page 10
Application
Please hold the handpiece as shown below.
The ZWave 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).
Caution!
When using the provided lotion or other lubricants, the applicator must be covered
with the silicone cap.
Note:
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
Note:
The patient should be carefully monitored during use.

Operation Instructions
7.3 Performing the Application
7
Page 11
Note:
All buttons, menus, and sub-menus can be directly activated on the screen by
touching with your finger.
Program start
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.