Zimmer ZTone non-medical User manual

Instructions for Use
ZTone non-medical
EN

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Copyright
This Instructions For Use is protected by the Copyright REMED.
Transferring or storing all or part of the contents of the Instructions For Use to another media through translation,
copying, scanning, photography, etc. is prohibited without the prior written approval of REMED.
The Instructions For Use may include editing errors. In addition, technical changes to improve performance may be
made to this device after this Instruction For Use has been published, without any prior notice.
The user of this device must sufficiently understand its functions and the
precautions that must be observed for its safe use and stable performance.
For the safe use and post management of the device, be sure to thoroughly
understand the details of the Instructions For Use before using the device. This
is essential to guaranteeing the safe use and stable performance of the device.
The Instructions For Use provides a guide to the efficient use of the ZTone.
As the Instructions For Use has been arranged in independent chapters, some
of the descriptions have been duplicated.
If you encounter any problems during operation of the equipment, stop its use
immediately, and contact the customer service center of REMED (Refer to
chapter 12).

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Contents
1. Information on safety ·····················································································6
1.1 Definitions of symbols····························································································································· 6
1.2 Requirements for safety·························································································································· 9
1.3 Safety device ··········································································································································· 12
1.4 Applicable person ·································································································································· 12
1.5 Contraindications ··································································································································· 12
2. High intensity pulsed electromagnetic field ···················································· 13
2.1 Principle ··················································································································································· 13
2.2 Device description ································································································································· 13
3. Installation·································································································· 14
3.1 Components ············································································································································ 14
3.2 Electrical installation condition ··········································································································· 14
3.3 Environmental condition······················································································································· 15
3.4 Installation method ································································································································ 15
4. Product description ····················································································· 18
4.1 External view ··········································································································································· 18
4.2 Controls···················································································································································· 20
4.3 Component ·············································································································································· 24
5. Operation instructions ················································································· 25
5.1 Preparation ·············································································································································· 25
5.2 How to Use··············································································································································· 25
5.3 Environment setting······························································································································· 28
5.4 Frequently used functions···················································································································· 29
6. How to store and care for after use································································ 30
7. Messages ··································································································· 31
7.1 Over Temperature··································································································································· 31
7.2 Transdducer Error ·································································································································· 32
7.3 Warning ···················································································································································· 32
8. Technical specifications ··············································································· 33
8.1 Size and weight······································································································································· 33
8.2 Magnetic field strength·························································································································· 33
8.3 Protocol provided (electromagnetic field) ·························································································33
8.4 Stimulation frequency ··························································································································· 33

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8.5 Stimulation Pulse Width························································································································ 33
8.6 Expected life time ··································································································································· 33
9. EMC emissions and immunity ·······························Fehler! Textmarke nicht definiert.
10. FAQ ·········································································································· 34
11. Maintenance ······························································································ 35
11.1 Cleaning procedure······························································································································ 35
11.2 Routine inspection of equipment ······································································································ 35
11.3 Safety inspection ·································································································································· 36
11.4 Troubleshooting···································································································································· 37
11.5 Regular inspection for performance maintenance·········································································38
11.6 Warranty ················································································································································· 38
12. Contact information ··················································································· 40

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List of figures
Figure 1. Main Components ............................................................................................................................... 14
Figure 2. Power cable connection..................................................................................................................... 16
Figure 3. Transporting wheel in 'Loose' (Left) and in 'Locked' (right) ........................................................16
Figure 4. Transducer connection....................................................................................................................... 17
Figure 5. Front view ............................................................................................................................................. 18
Figure 6. Rear view............................................................................................................................................... 19
Figure 7. Initial screen ......................................................................................................................................... 20
Figure 8. Level selection screen........................................................................................................................ 21
Figure 9. Intensity setting screen...................................................................................................................... 22
Figure 10. Configuration ..................................................................................................................................... 23
Figure 11. Transducer .......................................................................................................................................... 24
Figure 12. Power Cable ....................................................................................................................................... 24
Figure 13. ZTone Logo......................................................................................................................................... 25
Figure 14. ZTone Initial screen........................................................................................................................... 25
Figure 15. Over temperature message ............................................................................................................. 31
Figure 16. Transducer error message............................................................................................................... 32
Figure 17. Warning message.............................................................................................................................. 32
List of tables
Table 1. Definitions of Symbols........................................................................................................................... 8
Table 2. Self-troubleshooting ............................................................................................................................. 37

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1. Information on safety
1.1 Definitions of symbols
❏When there is specific information in the Instructions For Use that needs to be emphasized
for safety, the following terms and symbols are indicated. All warnings and precautions
shall always be observed.
❏The manufacturer or agent of the product is not responsible for any personal/material
damage caused by erroneous use, operation for purposes other than its intended
objective and negligence of product maintenance.
Warning
“Warning” symbol is used to indicate a life-
threatening risk to the operator if the warning is
disregarded.
Caution
“Caution” symbol is used to indicate that injury or
damage can be caused if the caution is
disregarded.
No pushing To prohibit pushing against an object
BF Type Applied part BF type
instructions for
use Follow instructions for use.
Serial number Serial number
Manufacturer Manufacturer
Date of
manufacture Date of manufacture
Do not stack
To indicate that the items shall not be vertically
stacked, either because of the nature of the transport
packaging or because of the
nature of the items
themselves.
Keep away
from rain
To indicate that the transport package shall be kept
away from rain and in dry conditions.

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Fragile
To indicate that the contents of the transport package
are fragile and the package shall be handled with
care.
This way up To indicate correct upright position of the transport
package.
Recycling To indicate the location of a recycling bin or container.
“OFF” (Power)
To indicate disconnection from the mains, at least for
mains switches or their positions, and all those cases
where safety is involved.
“ON” (Power)
To indicate connection to the mains, at least for mains
switches or their positions, and all those cases where
safety is involved.
Alternating
current
To indicate on the rating plate that the equipment is
suitable for alternating current only to identify relevant
terminals.
WEEE
Indicates that when the end-user wishes to discard
this product,m it must be sent to separate collection
facilities for recovery and recycling.
Temperature
limitation
To indicate the maximum and minimum temperature
limits at which the item shall be stord, transported or
used.
Humidity
Limitation
To indicate the acceptable upper and lower limits of
relative humidity for transport and storage.
Atmospheric
pressure
limitation
To indicate the acceptable upper and lower limits of
atmospheric pressure for transport and storage.
Dangerous
Voltage To indicate hazards arising form dangerous voltages.
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. lacal bonding.

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Keep away from
sunlight
To indicate that transport package shall not be exposed to
sunlight
Unique Device
Identifier
Indicates a carrier that contains Unique Device Identifier
information
Table 1. Definitions of Symbols

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1.2 Requirements for safety
1.2.1 Warning
❏This equipment is not applicable to the following persons.
- Person with high blood pressure
- Person with high fever
- Pregnant, newborns, infants, and children
- Person with Heart disease (especially those with pacemakers)
- Person with acute illness
- A Person who has implanted implants in the body, such as an artificial hip joint
- Person wearing artificial pacemakers, drug injection pumps, and hearing aids
- Person with a history or status of epilepsy or seizure disability
- Person with conductive, ferromagnetic or other magnetically sensitive metals in
the vicinity of the head or treatment coil. (e.g. cochlear implants, implanted
electrodes/stimulators, aneurysmal clips or coils, stents, deep brain stimulators,
vagus nerve stimulators, bullet shards, jewelry or hairpins, etc.)
❏This device should be used for person who can accurately express and communicate
pain during stimulation. (Can be used for men and women aged 13 to 60 years old.
Older people over that age can be used according to doctor's prescription)
1.2.2 Precautions for adverse reactions that may occur as a result of the use of devices,
fatal side effects due to negligence in use, and accidents
❏Pain may occur in the application area.
❏If any abnormalities other than the intended phenomena are found during use.
❏Serious accidents occurring during the use of the equipment must be reported to the
manufacturer and user and/or to the competent authority.
1.2.3 General precautions
❏The device must be used according to the Instructions For Use.
❏Do not place the ME equipment in a location where it is difficult to remove the power plug
or other removable plug.
❏For safety accident prevention and proper maintenance, keep safety signs and
information provided with the equipment, and regular checklists in a well-visible place
around the equipment.

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❏Keep the area where the equipment is installed free of water, alcohol, and flammable
substances.
❏For electrical safety, the device must be connected to a safety grounded power source.
❏To prevent unintended phenomena, keep the device away from direct sunlight or strong
electromagnetic fields.
❏When the equipment is in operation, do not use cell phones, walkie-talkies, portable
wireless transmitters, and wireless toys in the vicinity.
❏Since the main body is equipped with a fan for internal air circulation, remove curtains or
other objects that may block airflow from around the machine.
❏A strong magnetic field is generated around the magnetic field generator, so when
operating the equipment, the operator, assistant, and person should not carry any
belongings that may be affected by the magnetic field.
❏No other than the professional personnel authorized by the supplier cannot repair or install
the equipment, so it is absolutely forbidden for the user to arbitrarily disassemble and
assemble the equipment.
❏Equipment in installation and operation must be regularly inspected for safety by qualified
personnel authorized by the supplier.
❏Check whether the power supply at the installation site meets the input conditions of the
device.
❏The equipment is only operated indoors where temperature: 5 – 28 ℃, humidity: 30 –
75 % R.H. are maintained.
1.2.4 Interaction
❏Do not use in combination with other electronic devices.
❏Components other than those provided may not be used.
1.2.5 Use for pregnant women, lactating women, women of childbearing potential, newborns,
infants, children and the elderly
❏Pregnant, newborns, infants, and children are prohibited.
❏Do not use on menstruating women
❏For female persons, do not stimulate the lower part of the abdomen where the ovaries