Zimmer emFieldPro User manual

Instructions for Use
emFieldPro
EN

Illustrations
Front of the Device
Fig. 1 Front of the device
1Applicator (large)
2Applicator quick-connector
3Applicator arm
4Applicator (medium)
5Display
6Central control knob
7Control unit
8Swiveling wheels
1
2
3
4
5
7
8
6

Illustrations
Rear of the Device
Fig. 2 Rear of the device
9Connectors for applicator tube
10 Cooling
11 Power connector
12 Power switch
13 Serial no / Identification plate
9
10
11
12
13

Illustrations
Screens and Displays
Fig. 3 Screens and displays
14 Time remaining
15 Total operation time
16 Configuration icon
17 Intensity in %
18 Start/Stop
19 Channel selector (CH1 Large or CH2 Medium)
20 Applied program
21 Mode selector (Programs / Favourites / Expert mode)
22 Program information screen
14
15
16
17
18
19
20
21
22

Illustrations
Accessories
23 Mains cable
24 Hex key

Explanation of Symbols
This symbol indicates “Danger” with regard to possible risks to people.
This symbol indicates “Caution” with regard to possible material damage.
Applied part BF type emFieldPro
Operation instructions
Follow instructions for use
No access for people with pacemakers
Serial number
Article number
Manufacturer
Date of manufacture
Disposal of electrical and electronic equipment as well as used batteries and
accumulators.
This product must not be disposed of with household waste.

Explanation of Symbols
Do not push
No sitting on device
The device emits energy in the form of non-ionizing electromagnetic radiation
Warning, magnetic field
Warning, electricity
Protective earth
Equipotentiality, to identify the terminals which, when connected together, bring the
various parts of an equipment or of a system to the same potential, not necessarily
being the earth (ground) potential, e.g. for local bonding.
Keep dry
Disposable packaging materials
Fragile, handle with care
This way up
Temperature limit

Explanation of Symbols
Do not stack
CE marking with the number of the notified body

Contents
Illustrations
Front of the Device
Rear of the Device
Screens and Displays
Accessories
Explanation of Symbols
Page
1.
Indications / Contraindications 1
2.
Side Effects 2
3.
Application Information
3
4.
Warnings 4
5.
emFieldPro - in brief
Intended use 5
6.
Device set up 6 - 7
7.
Settings 8 - 9
8.
Operation Instructions 10 - 18

Contents
9.
Technical Information 19
10.
Cleaning Disinfection 20
11.
CE-Mark 21
12.
Scope of Delivery and Accessories 22
13.
Device Combinations 23
14.
Safety and Maintenance 24
15.
Functional Test 25 - 26
16.
Legal notice 27
17.
Error Messages / Troubleshooting
Disposal
28 - 30
18.
Manufacturer’s EMC declaration 31 - 34

Contents
Valid for emField Pro devices.
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 December 2021.
If the instructions for use have become illegible, damaged, or are not accessible for the user
for other reasons, a replacement is to be requested from the manufacturer for the safe use
of emField Pro and made available to the user. This also includes the information on the
labels on the device. The instructions for use can also be downloaded from our website.
We reserve the right to revise this document at any time or change product specifications
described. There is no obligation to provide information about the changes to the customer.

Indications / Contraindications
1
Page 1
Indications
•Stimulation of muscular tissue
•Nerve regeneration
•General pain control
•Improvement blood circulation
•Urinary incontinence
Contraindications Absolute contraindications for use of the emFieldPro are placing an active applicator
over metal or electronic implants like cardiac pacemakers, cochlear implants,
intrathecal pumps, hearing aids etc.
Be ensured that magnetic stimulation doesn’t penetrate the heart region.
The emFieldPro should be used with caution in persons with Grave’s disease, active
bleeding disorders or seizure disorders.
Patients in the following categories cannot be treated, prior to permission of the doctor
in charge:
•Fever
•Application over menstruating uterus
•Pregnancy
•Application over areas of the skin with sensitivity disorder
•Elderly and childrenPatients with suspected status of epilepsy on the basis of
electroencephalograph
•Patients with evidence of external wound at brain and neck
•Patients with cranial implants
•Implanted defibrillators
•Implanted neurostimulators
•Malignant tumor
•Hemorrhagic conditions
•Epilepsy
•Recent surgical procedure
•Pulmonary insufficiency

Side Effects
2
Page 2
Side effects
Common side effects reported after treatment generally mild in nature. They may
include but are not limited to:
• Skin damage, for instance:
o Local erythema
o Skin redness
• Abdominal discomfort, such as
o Menstrual irregularities and abdominal cramping
o Constipation, diarrhea, or abdominal bloating
• Aches and pain, such as
o Muscular pain, myalgia
o Temporary pain, e.g in back, extremities, joints, tendons
• Systemic symptoms, such as
o Lightheadedness, nausea, headache or migraine
o Muscle weakness, asthenia, malaise, or somnolence
Adverse events that are seldom seen are
• Dyspigmentation (hyper / hypopigmentation)
• Hair growth
• Infection
• Scarring
• Nerve pain, pinching
If the patient experiences any symptoms, the operator must stop treatment
immediately and contact the appropriate physician.
Residual risks
If the device is used within its intended purpose, no other unacceptable residual risks
are known besides the side effects and the warnings already mentioned.

Application Information
3
Page 3
Before using the emFieldPro on a patient, the user should become acquainted with
the operating instructions and individual treatment methods as well as the indications
/ contraindications, warnings and application information. Additional sources of
information about types of therapy should be consulted.
Before use, ensure that the device is powered via a properly earthed plug with a
grounded outlet (electrical installation according to DIN VDE 0100 Part 710). The
device must only be operated with the supplied power cord. The power cord must be
protected against mechanical stress.
Operation of this equipment in the vicinity of strong electromagnetic fields (e.g.
tomographs, x-ray or diathermy equipment) may interfere with the operation of the
device. Please keep a safe distance of several meters.
During use, the device is to be located in a position allowing direct access to the
device´s central mains supply so that it can be disconnected for the mains at any
time.
To avoid the risk of electric shock; the device´s main plug must be disconnected
from the mains supply before performing any maintenance or cleaning activities.
The emFieldPro is not suitable for use in areas with an explosive, flammable or
combustive environment.
Inspect the device before to use. If there is any damage, it must not be used.
Only accessories provided by Zimmer MedizinSysteme GmbH must be used.
This therapy may only be performed on undamaged skin.

Warnings
4
Page 4
emFieldPro is intended to be used exclusively for medical professionals, such
as authorised physicians, therapists, and medical paraprofessionals.
Magnetic therapy devices are not intended for use by laypersons or in home
care
The patient must not be left unattended during therapy.
The device is intended to be used exclusively by medical professionals.
Any treatment instructions regarding treatment location, duration and intensity
require medical knowledge and should be given by authorised physicians, therapists
and health paraprofessionals. It is imperative that these instructions are followed.
The use in wet areas is not permitted and may in case of non-compliance lead to
considerable damage to the device and endanger both the patient and the user.
Dispose packaging materials properly. Make sure that it is not accessible to children.
It is forbidden to push the device if castors are not in transport position.
Sitting on the device prohibited.

emField Pro - in brief / Intended use
5
Page 5
What is the
emFieldPro?
emFieldPro is a most reliable and powerful pulsed inductive therapy device.
What does the
emFieldPro do?
emFieldPro generates max. 3 Tesla electromagnetic field to treat acute and chronic
pains.
What are the
advantages of
emFieldPro?
Non-invasive treatment
Deep penetrating by 3 Tesla pulsed electromagnetic field
Unique oil circulation cooling transducer
Touch screen display for easy operation
Wide range of applications
What are other
advantages of
emFieldPro?
Two types of transducer for wider application
Intended use
The emFieldPro is an electrically powered device intended for medical purposes
that repeatedly contracts muscle tissue by passing electrical currents through
electrodes non-contacting the affected body area. In addition, the device is intended
to provide entirely non-invasive electromagnetic stimulation of pelvic floor
musculature for the purpose of rehabilitation of weak pelvic muscles and restoration
of neuromuscular control for the treatment of urinary incontinence in humans.
Patient Population
Patients with acute / chronic pain (aged over 18 recommended). No limitations
regarding gender or anatomy difference.
Note:
The device is intended to be used exclusively by medical professionals (e.g.
physicians, therapists, medical paraprofessionals).

Device Set Up
6
Page 6
Note:
After the transport and before switching on the device, make sure that the swiveling
wheels are in the ‘locked’ position.
Make sure that the emFieldPro is placed on a stable and flat surface
Connect mains cable
Connect the mains cable (23) to the socket on the device (11) and connect it to the
mains.
The device may only be connected to earthed sockets
Switching the device
on
Switch on the device with the power switch (12)
Be aware that connecting the power cable with the power switch turned on may
cause malfunction.
If the transducer is used while in a tilted position, the cooling oil will not reach all
sections of the transducer and damage the transducer due to overheating. For this
reason, it is recommended to place the transducer in a horizontal position as much
as possible.
When separating the transducer from the transducer arm supporter, the pressure of
the gas spring may cause the arm to jump up and the transducer may fall off. Be
sure to hold the transducer with one hand while holding the arm supporter vertically.
When replacing the transducer, be sure to mount the arm support vertically as well.

Device Set Up
6
Page 7
Switching the device
off
After using the emFieldPro for a long time, the transducer arm may be stuck down or
up. In this case, the position of the transducer arm can be changed by adjusting the
gas spring pressure. To lower the arm supporter, turn the hexagonal wrench bolt in
the (−) direction as shown in the figure below, and turn it in the (+) direction to lift it
upwards.
To adjust the transducer arm use only the supplied hex key (24).
The device is switched off using the power switch (12).
In order to completely disconnect the device (all-phase) from the mains, remove the
mains cable.

Settings
7
Page 8
Start-up screen
Once the device has been switched on and the self-test performed, the start-up
screen opens.
Standard screen
After the self-test has been performed, the emFieldPro goes automatically in the
standard screen.
Selecting configuration
Pressing the Configuration button (A) immediately switches to the configuration
menu.
A

Settings
7
Page 9
Configuration menu
(B) Brightness
Adjust the brightness by using the left and right arrows.
(C) Volume
Adjust the volume by using left and right arrows.
(D) Language
Selection of the language by using the left and right arrows.
(E) Admin
Only for service partners
(F) Version
Shows information about the current software version
(G) Close
Closes and stores the configuration menu
F
G
B
C
D
E