Zimmer Z Wave Med User manual

Instructions for Use
ZWave
Med
EN

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
(C) Scrollbar
Scroll forward or backward in the list
B
A
C
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 instructions for use
Products marked with the adjacent symbol must not be disposed of with household
waste.
Serial number
Applied part type BF
Article number
Manufacturer
Date of manufacture
Value of accessible fuses
Interval operation –note the instructions for use

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
Side Effects
2
3
Application Information
3
4
Warnings
4
5
ZWaveMed –in brief
5
6
Set-up Device
6
7
Settings
7
8
Operation Instructions
8.1 Device Description
8.2 Notes on Operation
8.3 Performing the Treatment
8.4 Display and Buttons
8.5 Treatment of Hamstring Tendinopathy
8.6 SD-Card
8.7 Favourites Lists –Retrieving Programs and Editing List
9
11
12
16
18
19
20
9
Technical Information
9.1 Info-chart Duration of Treatment
23
24
10
Cleaning/ Disinfection
25

Table of Contents
Page
11
CE-mark
26
12
Scope of Delivery / Accessories
27
13
Device Combination
28
14
Safety and Maintenance
14.1 Safety
14.2 Maintenance
29
30
15
Function Test
31
16
Safety Check / Metrological Control
32
17
Error Messages / Troubleshooting / Disposal
33
18
Manufacturer’s EMC Declaration
36
Valid for the device ZWaveMed.
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 May 2021.

Indications / Contraindications
1
Page 1
Indications
● hamstring tendinopathy
Contraindications /
restrictions of use
•Vascular disorders at or in the vicinity of the treatment area
•Open wounds at or in the vicinity of the treatment area
•Local infections in the treatment area
•Application in the area of malignant / benign tumors
•Application directly on cartilage surfaces or in the area of the small
•facet joints of the spine
•Application directly over implanted electronic devices, such as a pacemaker, pain
pump etc.
•In areas where mechanical energy in the form of vibration could results in damage to
tissue, e.g. metal implants
•Following a fracture, in cases of muscle fibre tears or muscle tears
It is generally recommended to avoid treatment
•In cases of blood coagulation disorders or treatments that result in a change in blood
coagulation
•During pregnancy
•In cases of diseases affecting the vasomotor system in the treatment area
•Over air-filled cavities, e.g. treatment of the thoracic spine etc.
•Generalized pain syndromes, e.g. fibromyalgia
Caution should be exercised in the case of individuals
•with sensory disorders
•with severe autonomic disorders
•who are under the influence of drugs and / or alcohol
as in such cases high levels of circulatory strain and unsuitable treatment responses
cannot be excluded.

Side Effects
2
Page 2
Side Effects Treatments with ZWaveMed may occasionally cause irritation, petechiae, bruising,
swelling or pain.

Application Information
3
Page 3
Before using the device on patients, users should be come familiar with the operating
instructions and individual treatment methods to be used as well as
warnings/instructions for use. In addition, other sources of information regarding the
treatment should also be observed.
Caution!
Before use, ensure that the device is operated via a properly grounded
socket (electrical installation in accordance with DIN VDE 0100 Part 710). The device
may only be operated with the supplied power cable. The power cable must be
protected against mechanical stress.
Caution!
The operation of devices with strong electromagnetic fields (e.g. tomography, x-ray, or
diathermy equipment) may interfere with the operation of the device. Please maintain a
safe distance of several meters.
ZWaveMed 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 ZWaveMed is not mounted on a designated wagon, ensure that the ZWaveMed 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
4
Page 4
Users of ZWaveMed 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.
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 shock wave in these individuals.
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.

The ZWaveMed –in brief
5
Page 5
What is the ZWaveMed?
A modern and innovative shock wave device.
Shock wave therapy
Radial, ballistic shock wave therapy is a versatile method for the improvement of
hamstring tendinopathy.
What does the
ZWaveMed do?
It generates shock waves by means of an ergonomic handpiece and emits them
through a special applicator.
With the ZWaveMed, a maximum penetration depth of about 35 mm can be achieved
in human tissue.
How are shock
waves created in
ZWaveMed?
An electromagnetic field is generated via a coil in the rear end of the handpiece.
A projectile is accelerated through the field, bounces against the applicator head in
the front of the handpiece, and generates shock waves that spread radially in the
tissue.
What are the
advantages of
ZWaveMed?
This innovative technology allows for a compact design with no compressor.
The modern clear-colour display that presents all relevant application parameters,
the modern touch operation, and the simultaneous connection option of two
handpieces provide for an enjoyable and motivating application.
Individual programme start-up settings and clear and simple menu
navigation provide maximum comfort to the user.
Different, continuously adjustable frequencies allow an application that is suited to
the particular condition of the patient.
Intended Use
ZWaveMed is a therapy system for the generation and application of radial shock
waves in orthopaedics, physiotherapy and aesthetics.
Note:
The use of the device for orthopaedic and physiotherapeutic purposes is intended
for healthcare professionals (e.g. physicians, therapists and trained medical
assistants) only.
Note:
ZWaveMed is exclusively designed and intended for the application of hamstring
tendinopathy in humans.

Set-up Device
Installation of Cables
6
Page 6
Note:
If the ZWave Med is not mounted on the designated system trolley, please make sure
that it is standing on a stable surface. We recommend using the optional swivelling
base (see Accessories, chapter 12).
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 grounding 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.

Settings
7
Page 7
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.
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.
The settings options are described below.
The default settings are pre-programmed as shown in the screen.
1
2
3
4
5
6
7
2
1
8
9
10

Settings
7
Page 8
(1) Start settings
Start menu:
Individual options of the start menu. If you select the “Favourites” setting, the start
menu will consist of the favourites list. If you select “Individual 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) Colour 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 “Colour scheme” button changes the display colour 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.

Operation Instructions
8.1 Device Description
8
Page 9
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 17.
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 maximum values for the treatment in the figure in Chapter 9.1.
After reaching the specific values, the treatment must be interrupted and can only be
resumed once the applicator head has cooled down to room temperature.
Note:
Please note that the temperature control of the handpiece described on page 10 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 case of 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 shocks remain unchanged. The pulse energy returns to 0 and
must be reset.

Operation Instructions
8.1 Device Description
8
Page 10
Handpiece
temperature
monitoring /
regulation
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 Med 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 automatically stops 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.
Changing the
applicator heads
To change the applicator head, hold the handpiece with one hand and unscrew the
applicator head from the handpiece with the other hand, turning in an anti-clockwise
direction. Then screw in the desired head by turning clockwise until it stops.
Note:
The applicator head is a wear part and needs to be replaced after a certain period of
use (see chapter 14.2 Maintenance).
Footswitch
Place the corresponding foot switch in such a way that it can be easily reached 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
8.2 Notes on Operation
8
Page 11
Therapy
Please hold the handpiece as shown below.
The ZWave Med 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 applying pulses, 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 tissue, 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 following pages).
Caution!
When using the provided lotion or other lubricants, the applicator must be
covered with the silicone protective 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
8.3 Performing the Treatment
8
Page 12
Note:
All buttons, menus, and sub-menus can be directly activated on the screen with a
touch of your finger.
Select application
programme
Activation of the “Application”button opens the application screen with the
appropriate programme. All relevant application recommendations are pre-set, but
the pulse energy must be individually stepped up for each application.
Place the handpiece /
applicator
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.
Caution!
When using lubricants, the applicator must be covered with the silicone protective
cap.
Setting the pulse energy
Set the pulse energy using the controller on the left side.
Start of treatment
By activating the foot switch, the application starts.
Note:
The shock wave should be activated by the foot after placing the handpiece on the
patient.
End of treatment
By deactivating the foot switch, the application is interrupted or terminated.
Note:
During use, the patient must be monitored carefully, and the application must be
adjusted if necessary or terminated if problems arise.