Remed PERFECT User manual

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PERFECT Instructions For Use

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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 manual 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 PERFECT. For
clinical definitions, pathological effects etc., of its functions, refer to the related medical
publications.
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 11).

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Contents
1. Information on safety ·····················································································5
1.1 Definitions of symbols····························································································································· 5
1.2 Requirements for safety·························································································································· 7
1.3 Precautions during operation ················································································································ 8
1.4 Contraindication ······································································································································· 9
1.5 Abnormal reaction···································································································································· 9
1.6 General warnings ····································································································································· 9
1.7 Label ························································································································································· 10
2. High intensity pulsed electromagnetic field ···················································· 11
2.1 Mechanism··············································································································································· 11
2.2 Objective of application ························································································································ 12
2.3 Intended Use ··········································································································································· 12
3. Installation··································································································13
3.1 Components ············································································································································ 13
3.2 Electrical installation condition ··········································································································· 13
3.3 Environmental condition······················································································································· 14
3.4 Installation method ································································································································ 14
4. Product description ·····················································································17
4.1 External view ··········································································································································· 17
4.2 Controls···················································································································································· 19
5. Operation instructions ·················································································20
5.1 Patient Preparation ································································································································ 20
5.2 Applications············································································································································· 20
5.3 Operation mode ······································································································································ 21
5.4 Environment setting······························································································································· 26
5.5 Frequently used functions···················································································································· 27
6. Messages ···································································································28
6.1 Over Temperature··································································································································· 28
6.2 Transdducer Error ·································································································································· 29
7. Technical specifications ···············································································30
7.1 Size and weight······································································································································· 30
7.2 Power························································································································································ 30
7.3 Magnetic field strength·························································································································· 30

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7.4 Modes ······················································································································································· 30
8. EMC emissions and immunity ·······································································31
9. FAQ············································································································38
10. Maintenance······························································································39
10.1 Cleaning procedure ····························································································································· 39
10.2 Routine inspection of equipment ······································································································ 39
10.3 Safety inspection·································································································································· 39
10.4 Troubleshooting ··································································································································· 40
10.5 Regular inspection for performance maintenance········································································· 41
10.6 Warranty················································································································································· 41
11. Contact information····················································································43
List of figures
Figure 1. Cells and electromagnetic field ........................................................................................................ 11
Figure 2 Main Components ................................................................................................................................ 13
Figure 3. Power cable connection ..................................................................................................................... 15
Figure 4. Transporting wheel in 'Loose' (Left) and in 'Locked' (right) ........................................................ 15
Figure 5 Front view .............................................................................................................................................. 17
Figure 6 Rear view................................................................................................................................................ 18
Figure 7 Controls.................................................................................................................................................. 19
Figure 8 PERFECT Logo ..................................................................................................................................... 21
Figure 9 PERFECT Initial screen ....................................................................................................................... 21
Figure 10 Main screen ......................................................................................................................................... 21
Figure 11 Over temperature message............................................................................................................... 28
Figure 12 Transducer error message................................................................................................................ 29
List of tables
Table 1. Self-troubleshooting ............................................................................................................................. 40

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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
Toindicate the maximum andminimum 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.
Equipotentiali
ty
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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1.2 Requirements for safety
1.2.1 Precautions for electrical safety
❏The rated power for this equipment is 220 - 240 V~.
❏Confirm that all the connecting sections (power line or peripheral equipment) are
adequately connected to the equipment.
❏Confirm that the equipment is completely grounded.
❏Repair, expansion, and installation of equipment shall not be performed by anyone
other than the specialized personnel authorized by the manufacturer. Arbitrary
disassembling/assembling of equipment by the user is absolutely prohibited.
❏Before connecting other equipment that is not specified in the Instructions For Use,
be sure to inform the menufacturer or the agency with authority over product
marketing.
❏To avoid electrical noise during use, the equipment shall be installed at a significant
distance from any generator, X-ray equipment, broadcasting device, mobile electric wire,
and so forth.
❏Needs attention due to potential electromagnetic or other interference between ME
EQUIPMENT and other devices.
❏An independent power circuit is essentially required, and sharing of power with other
electronic devices is not recommended.
❏Do not place the ME EQUIPMENT in a location where it is difficult to disconnect the
power plug or other detachable plug.
1.2.2 Classifications
❏Protection type and level for electric shock: Class I, BF Type
❏Electromagnetic compatibility (EMC) test standard: class A

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1.3 Precautions during operation
❏Installation and re-installation of equipment shall always be performed by
specialized personnel authorized by the manufacturer.
❏Installed equipment shall be subject to regular safety inspections from specialized
personnel authorized by the manufacturer.
❏Repair or installation of equipment shall only be performed by the specialized
personnel authorized by the manufacturer, and as such, all arbitrary
disassembly/assembly of equipment by the user is absolutely prohibited.
❏For electrical safety, equipment shall always be connected to a safely grounded
power supply for operation.
❏The operator and manager of equipment shall thoroughly understand the Instructions
For Use, and it must be kept in the close proximity of the equipment.
❏To prevent safety accidents and ensure adequate maintenance, place the safety
marks, guide phrases and regular inspection table provided with the equipment at
an easily visible location near the equipment.
❏As a fan is installed in the body of the equipment for air circulation, remove curtains
or any other objects which can block the flow of air from near the equipment.
❏From the surroundings of the location where equipment is installed, remove water,
alcohol, flammable materials, and so forth.
❏As a strong magnetic field is generated around the magnetic field generating section,
equipment operation technicians, assistants, and patients must not hold any items
which can be affected by the magnetic field.
❏Items such as wristwatches, mobile phones may be damaged by magnetic fields,
so please be careful and keep them separately.
❏When equipment is operated, do not use any mobile phones, radio sets, mobile
radio transmitters, wireless toys, etc. in the proximity of the equipment.
❏During the operation of the equipment, the patient shall not take drinks, water, etc.
which can influence the equipment.
Caution
“PLEASE MAKE SURE THAT PATIENT IS NOT WEARING
ANYTHING WITH METALLIC OBJECTS DURING TREATMENT
FAILURE TO DO SO MAY RESULT IN SERIOUS SKIN BURN!”

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1.4 Contraindication
❏Do not use the equipment in parallel with other electronic medical equipment.
❏Be careful to ensure that magnetic stimulation does not penetrate the heart region.
❏In general, patients in the following categories cannot be treated with this equipment.
Prior to any treatment with this equipment, permission of the doctor in charge must
be obtained.
- Patient with high fever, pregnant women and the elderly and children
- Patient with a history or status of epilepsy or seizure disability
- Patient with suspected status of epilepsy on the basis of
electroencephalography
- Patient with evidence of external wound at brain and neck
- Patient with cardiac pacemakers, drug injecting pumps or hearing aids
- Patient with cranial implants
1.5 Abnormal reaction
❏During the operation of the equipment, if the patient experiences any abnormal
symptoms, the operator must stop the treatment immediately, and contact the
doctor in charge.
1.6 General warnings
❏Be sure to use the equipment in accordance with the Instructions For Use.
❏In the Instructions For Use, the method for the correct use of the equipment is
described. Read the Instructions For Use carefully.
❏The equipment shall be operated underthe supervision of a person who has completed
specialized medical education.
❏Manufacturer is not responsible for any disadvantages / damages related to the
operation of equipment by a person without a medical education.
❏This equipment shall not be altered, remodeled, or used for any purpose other than
the intended objective.
❏Do not place objects on the device.

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1.7 Label