Zimmer Z Field Dual User manual

Instructions for use
ZField Dual (MFG-03)
EN

Illustrations
Front of the device
Fig. 1 Front of the device
1Applicator, left side
2Applicator, right side
3Display
4Central control knob
5Control unit
6Swiveling castors
1
2
3
4
5
6

Illustrations
Rear of the device
Fig. 2 Rear of the device
7Connections for applicator hose
8Ventilation grid
9Mains connection
10 On/off switch
11 Identification plate
10
11
7
8
9

Illustrations
Screens and displays
Fig. 3 Screen and displays
12 Remaining time
13 Total operating time
14 Configuration icon
15 Intensity in %
16 Start/stop
17 Channel selection (channel 1 and/or channel 2)
18 Applied program
19 Mode selection (Programs/Region/Manual Mode)
20 Program information screen
12
13
14
15
16
17
17
18
20
19

Illustrations
Accessories
21 Mains cable
22 Fixingbelt

Explanation of symbols
In the instructions for use, this symbol indicates "Danger".
Caution
!
In the instructions for use, this symbol warns of "caution" regarding possible damage to the
device.
Applied part of type BF
Consult instructions for use
Follow the instructions for use
No access for people with pacemakers
Do not push the device
Do not sit on the device
Warning, magnetic field
Protective earth
Serial number
Catalogue number
Manufacturer
Date of manufacture

Explanation of symbols
Disposal of electrical and electronic equipment as well as used batteries and accumulators.
This product must not be disposed of with household waste.
Washing, maximum 40°C
Do not bleach
Do not dry clean
Do not tumble dry
Do not iron
Do not stack
Keep dry
Fragile; handle with care
Temperature limit
This way up
Danger or Warning - Systemic health hazards

Contents
Illustrations
Front of the device
Rear of the device
Screens and displays
Accessories
Explanation of symbols
Page
1.
Indications / Contraindications / Side Effects 1
2.
Warnings 3
3.
Z Field Dual – overview
Intended purpose 5
4.
Setting up thedevice 6
5.
Settings 7
6.
Operating instructions 9
7.
Technical information 15
8.
Cleaning and disinfection 16
9.
CE marking 18
10.
Scope of delivery and accessories 19

Contents
11.
Device combinations
Safety 20
12.
Function check 21
13.
Legal Notice 22
14.
Error messages/troubleshooting
Disposal 23
15.
Manufacturer's Declaration on Electromagnetic Compatibility (EMC) 26
16.
Material Safety Data Sheet 30
Valid for Z Field Dual (MFG-03) devices.
These operating instructions form part of the device. They must be stored together with the
device and kept accessible at all times to all personswho are authorised to operate this
device.
Information as of August 2019.

Indications /
Contraindications /
Side Effects
1
Page 1
Indication
Muscular atrophy
Recommended application
To strengthen and tighten the abdominal, gluteal and thigh muscles.
Operating environment
Z Field Dual is only to be used in medical facilities. The device is intended for indoor use.
Contraindications
•Placing an active applicator over implanted electricaldevices like pacemakers,
cochlear implants, intrathecal pumps, hearing aids etc.
•Be ensured that magnetic stimulation doesn’t penetrate the heart region.
•Z Field Dual should be used with caution in persons with Grave’s disease, active
bleeding disorders or seizure disorders.
•Women who are close to menstruation may find that it comes sooner or cramping is
increased / intensified with Z Field Dual treatments, therefore we recommend not
undergoing treatment during this time of the month.
Other contraindications to treatment include the following:
•Fever
•Application over menstruating uterus
•Application over areas of the skin that lack normal sensation
•Metal or electronic implants in the treatment area
•Cardiac pacemakers
•Implanted defibrillators
•Implanted neurostimulators
•Drug pumps
•Malignant tumor
•Hemorrhagic conditions
•Epilepsy
•Recent surgical procedure
•Application in the area of growth plate
•Pulmonary insufficiency
•Application in the head area
•Pregnancy
•Sensitivity or allergy to latex
In persons with Graves' disease, active bleeding disorders or seizure disorders, the
Z Field
Dual
should be used with caution.
Intended patient group
Age: 18+
Gender: Male and female, diverse
Nationality: no restriction
Ethnic affiliation: no restriction
Skin colour: Light and dark-skinned
Weight: All weight classes

Indications /
Contraindications /
Side Effects
1
Page 2
Side effects
There are no reports of side effects. However, if the patient experiences abnormal
symptoms, the operator must stop treatment immediately and contact the appropriate
physician.
The adverse effects may include, but are not limited to:
•Muscular pain
•Temporary muscle spasm
•Temporary joint or tendon pain
•Local erythema or skin redness
•Premature menstruation and/or lower abdominal cramps

Warnings
2
Page 3
The users of the Z Field Dual must have read the instructions for use prior to the first use of
the device, including the treatment methods, indications, contraindications, warnings and
application information.
Do not place any ferromagnetic or metallic materials, data carriers (credit or debit cards, USB
sticks, etc.) or electronic devices (mobile phones, tablets, watches, PCs, etc.) and other
device applicators or accessories in the vicinity (less than 1 meter) of the applicators. Do not
place the device near other devices that generate a strong electromagnetic field (diathermia,
X-rays, mobile phones, high frequencies), in order to prevent mutual interference to
functionality. If this happens, place the unit further away from the source of interference or
contact an authorised member of service staff.
Make sure that people with pacemakers are not near the device when it is in use.
It is forbidden to push the deviceif castors are not in transport position.
Sitting on the device is prohibited.
Before use, make sure that the device is supplied with power via a properly earthed plug with
a safety plug (electrical installation in accordance with DIN VDE 0100 Part 710). The device
must only be operated with the supplied mains cable. The mains cable must be protected
against mechanical stress.
Use of this device in the presence of strong electromagnetic fields (e.g., tomographs, X-ray
or diathermia devices) may impair the operation of the device.
During use, the device should be placed so that directaccess to the central power supply of
the device is possible, so that it can be disconnected from the mains at any time.
To avoid the risk of electric shock, the mains plug of the device must be disconnected from
the mains before maintenance and cleaning work.
The Z Field Dual is not suitable for use in explosive, inflammable or combustible environments.
Check the device before use. If damage can be seen on it, it must not be used.
Only accessories from Zimmer MedizinSysteme GmbH may be used.
The patient should not be left unattended during treatment.

Warnings
2
Page 4
The device is intended for use by medical professionalsonly.
All treatment instructions regarding treatment location, duration, and intensity require medical
knowledge and should be issued by authorised physicians, therapists, and medical
assistants. It is imperative that these instructionsare followed.
Please refer to chapter 16, Material Safety Data Sheet, in case of leaking oil or contact your
service engineer.
In case of leaking oil, please wear gloves providing adequate chemical resistance,
specifically to aromatic hydrocarbons, while cleaning.
Ventilate the room in case of leaking oil.
Disposal of the gloves and the oil-soaked cloth according to local regulations. Do not dispose
of in domestic waste.
It is not permitted to use the device in a wet area; if this is disregarded, this may result in
considerable damage to the device and endanger both the patient and the user.
Packaging materials must be disposed of properly. It is important to ensure that these are not
accessible to children.

Z Field Dual – overview
Intended purpose
3
Page 5
Intended Use
Z Field
Dual
is an electrically operated medical device and provides electromagnetic
impulses. Z Field Dual generates an electromagnetic field and is able to contract/stimulate
the muscles.
Intended Purpose
An electromagnetic field is generated by electricity. These impulses are delivered to the
muscle tissue via the applicators.
The muscles respond to the non-invasive, pulsed electromagnetic impulses and cause
repeated contractions of the muscle tissue. Based on the frequencies and intensities
used, these contractions can be adjusted to different strengths. The effect is based on
the principle that repeated contractions of muscles leads to muscle growth through
multiplication of muscle fibres.
What are the advantages of
the Z Field Dual?
•Non-invasive treatment
•Deep penetration of a pulsed electromagnetic field of 1.0 Tesla per applicator
•Touch screen display for easy operation
•Broad range of possible applications
What other advantages does
the Z Field Dual offer?
•Safe application
•No downtime
•Virtually painless
•Short treatment times.
•Easy to operate
Note:
The device is intended solely for use by specialist healthcare professionals (e.g.,
doctors, therapists, medical assistants).

Setting up the device
4
Page 6
Caution
!
After transport and before switching on the device, make sure that the swivelwheels are in
the "locked" position.
Note:
Make sure the Z Field
Dual
is on a stable and level surface.
Connecting the mains
cable
Plug the mains cable (21) into the socket on the device (9) as shown below and connect it to
the mains.
The device may only be connected to earthed sockets.
Switching on the device
Switch on the device using the on/off switch (10).
Caution
!
Note that connecting the mains cable while the on/off switch is on may cause malfunctions.
Caution
!
If the applicator is used in a slanting position, the cooling oil does not reach all areas of the
applicator and damage is caused due to overheating. For this reason, it is recommended to
place the applicator in a horizontal position if possible.
Switching the device off
The device is switched off using the on/off switch (10).
In order to completely disconnect the device (all-phase) from the mains, remove the mains
cable.

Settings
5
Page 7
Home screen
When the device is switched on, a self-test is carried out and the home screen opens.
Default screen
After performing the self-test, the Z Field
Dual
will automatically switch to the default screen.
Selecting the
configuration
By pressing the configuration button (A), you will immediately switch to the configuration
menu.
A

Settings
5
Page 8
Configuration menu
(B) Brightness
Adjust the brightness using the arrow keys to the left and right.
(C) Volume
Adjust the volume using thearrow keys to the left and right.
(D) Language
Select the language using thearrow keys to the left and right.
(E) Administrator
Only for service partners
(F) Version
Displays information about the current software version.
(G) Close
Closes the configuration menu and saves changes.
F
G
B
C
D
E

Operating instructions
6
Page 9
Description of the device
Z Field Dual consists of a main body and two equally sized applicators that are connected to it.
The input power for this device is 230 V AC.
The repair, enhancement and installation of the device may only be carried out by specialists
who have been authorised by the manufacturer. Unauthorised disassembly/assembly of
devices by the user is strictly prohibited.
Since a strong magnetic field is generated around the area of magnetic field generation,
device operators, assistants and patients must not carry any objects on them that may be
affected by the magnetic field.
Note:
When operating the device, do not use objects such as wristwatches, mobile phones, radios,
transmitters, or wireless toys asthey can be damaged by magnetic fields. Please therefore
be careful and keep these devices separated from one other.
Note:
While the device is in operation, the patient should not consume any drinks, water, etc., that
may affect the device.
Z Field Dual monitors the temperature of the applicator. In addition, the device checks the
connection between the applicator and the main unit at regular intervals. If an error message
appears, please refer to chapter 14.

Operating instructions
6
Page 10
Placing the applicator
Place the applicators onto the treatment area so that the connection cables face the foot end.
Secure the applicators using the fixingbelt supplied with the device.
The fixingbelt is available in S and Mversions. The larger one is for the abdomen and
buttocks area and the small one is for the legs.
The fixingbelt serves to fix the applicators and helpsto minimize the movements of the
applicators during the treatment.
The applicators should be placed into the pocket of the fixingbelt. The underside of the
applicators should be in complete contact with the fixingbelt.
Before applying the fixingbelt, always check the VelcroTM closures are working!
It should be applied by an expert.
In case the fixingbelt has not been put on correctly, do not try to move the fixingbelt by
tugging, as the elastic material might be damaged. So open the fixingbelt again and put on
once more.