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

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2. High intensity pulsed electromagnetic field
2.1 Mechanism
Figure 1. Cells and electromagnetic field
Every tissue in the body is made up of cells, and all the functions are based on the activity of
the cells. Each cell is surrounded by a cell membrane and protected. Since ions in a cell have
a charge, the cell membrane also has charge, which suppliesoxygen or nutrients and removes
unnecessary things in thecell. Membrane charge of healthycells ishigher than thatof diseased
or aged cells, including bacteria, viruses, and cancer cells. For example, cancer cells have a
membrane charge of about 15 mV lower than healthycells. When the cell membrane charge is
low, the cell has too little energy to perform its normal function. So, the cell needs energy, and
electromagnetic field stimulation is known to increase the energy of the cell and optimize the
function of the cell. Electromagnetic fields can pass through cells, tissues, organs and bones
without any deformation or loss, activate the electrochemistry of tissues, and improve cell and
cell membrane function. PEMF procedures can be used for the following purposes:
(1) Inflammation
The electromagnetic field reduces inflammation by recharging the cell surface. This
recharge prevents the chain of inflammation inside the cell, reducing pain and swelling
associated with inflammation. In addition, it supplies blood and oxygen to the wound area,
and it is said to help the quick recovery.
(2) Bone and Cartilage
The PEMF applied to the fractured area maximizes the electric polarity. This naturally
helps to heal fractured parts and promotes fracture recovery. Healthy bones maintain
a dynamic balance of positive and negative charges, while broken or fractured bones
show equilibrium breakdown and negative electrical environment. At this time, the

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body's natural healing begins at the fracture site, and many studies have shown that
PEMF affects this natural healing.
(3) Pain
PEMF hasbeen usedto treat pain since the late 20th century. PEMF is known toenhance
the metabolism of fibroblasts, chondrocytes, osteoblasts, and theeffectsof hormones and
neurotransmitters on the receptors of various cells. A number of studies have shown that
patients who have not had an effect on surgery, medication, or physical therapy are less
likely to have PEMF treatment. PEMF is used for the treatment of various pain such as
back pain, neck pain, shoulderdisease, knee osteoarthritis, postherpetic neuralgia, pelvic
pain, multiple sclerosis, neuropathic pain.
(4) Osteoporosis
PEMF promotes the formation of bone and helps to treat osteoporosis. Previously
published studies have shown that the bone mineral density of 20 osteoporotic patients
treated with PEMF increased by an average of 5.6% after 6 weeks of treatment.
(5) Fibromyalgia, Arthritis, Chronic Fatigue
PEMF is known to have immediate pain relief in treating pain in patients with fibromyalgia,
arthritis, and chronic fatigue. PEMF also affects the deliveryof calcium ions, promotes the
uptake of calcium in the bone, and helps in the synthesis of cartilage cells.
2.2 Objective of application
This device is a high-intensity electromagnetic field stimulation device used for the relief of
muscular pain. It is prohibited to use it for purposes other than the intended use.
2.3 Intended Use
The PERFECT is an electrically powered device intended for medical purposes that
repeatedly contracts muscles by passing electrical currents through electrodes non-
contacting the affected body area. And, in addition, the electro-magnetic stimulator 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 human.

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3. Installation
3.1 Components
Main body with transducer
Power cable
Instructions For Use
Transducer
Figure 2 Main Components
3.2 Electrical installation condition
❏Input power : 220-240 V~, 50/60 Hz
❏Power consumption : 3.6 kVA

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3.3 Environmental condition
3.3.1 Operation environment
❏Temperature : 5 –28 ℃(41 - 82.4 ℉)
❏Humidity : 30 –75 % R.H.
❏Pressure : 80- 106 kPa
3.3.2 Transport and Storage environment
❏Temperature : -10 –60 ℃(14 –140 ℉)
❏Humidity : 0–85 % R.H.
❏Pressure : 70 - 106 kPa
3.4 Installation method
3.4.1 Precautions during installation
❏Install the equipment on a flat surface.
❏Operate the PERFECT within the ambient temperature range of 5 –28 ℃, and a
humidity between 30 –75 %.
❏Install the equipment in a location with appropriate ambient temperature and
humidity, and do not install in a location where it will be exposed to dust or
flammable materials.
❏Be careful not to damage the equipment by excessive shock.
3.4.2 Connection of power
❏Confirm that power socket and power cable are grounded before operating the
machine.
❏Plug the power cable into the power terminal of the PERFECT as shown in below,
and connect the other end to a grounded power socket.
❏Confirm that the power cable is properly connected to the power terminal and power
socket. If the connection is incorrect, unexpected problems can occur.
❏Do not connect several devices to one power outlet.
❏In particular, do not use a power cable that generates connection noise.

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Figure 3. Power cable connection
Warning
To prevent the danger of electrical shock, connection shall be made to a
protected and grounded power supply.
3.4.3 Moving and fixing of equipment
❏Before moving the equipment, remove the connected power cable and the
connection cables for peripheral equipment.
❏When moving the equipment, place the transporting wheel as shown in below in the
“loose” position.
❏When the movement is completed, prevent the equipment from shaking by placing
the transporting wheel in the “locked” position.
❏If the equipment is moved while the wheel is in the “locked” position, it will damage
the wheel, so please be careful.
Figure 4. Transporting wheel in 'Loose' (Left) and in 'Locked' (right)

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3.4.4 Transducer
❏The PERFECT is equipment that generates a magnetic field by applying a strong
current to a transducer. As heat is generated from the transducer due to the strong
current used to create the magnetic field, cooling is performed by circulating the
cooling oil inside the transducer. If the transducer is used while in a tilted position,
the cooling oil will not reach all sections of the transducer, and injury or stoppage
of operation due to overheating of the transducer can result. For this reason, it is
recommended to place the transducer in a horizontal position as much as possible.
Caution
Maintaining the transducer in a horizontal position is
recommended.

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4. Product description
4.1 External view
4.1.1 Front view
Figure 5 Front view
No.
Name
Function
1
Control Panel
A display unit that operates the device using touch or displays the
device's operating status
2
CH1 Transducer
Magnetic field output transducer
3
CH2 Transducer
Magnetic field output transducer

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4.1.2 Rear view
Figure 6 Rear view
No.
Name
Function
1
Power Switch
Power ON/OFF switch
2
CH2 transducer connector
CH2 Transducer cable connector
3
CH1 transducer connector
CH1 Transducer cable connector
4
Vent
Vents for air circulation
5
Power input terminal
AC power inlet
6
Ground terminal
Equal power ground connection
7
Wheels
Wheels for transporting and moving the device

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4.2 Controls
Figure 7 Controls
No.
Name
Function
1
MODE selection button
Information of the currently selected mode
2
Select sub-MODE
Sub-MODE according to the selected MODE
3
CH1 Intensity setting window
Magnetic field strength can be set (0%~100%, 1% step)
4
START button
Generate the magnetic field
5
CH1 temperature display
The temperature of the transducer currently used is expressed as a picture.
6
SETTING button
Set the configuration
7
Setting time display window
Display set time and remaining time
8
CH2 Intensity setting window
Magnetic field strength can be set (0%~100%, 1% step)
9
STOP button
Stop magnetic field output
10
CH2 temperature display
The temperature of the transducer currently used is expressed as a picture.
11
Channel 1 selection button
Transducer Select Button
12
Synchronize
Simultaneous control of the intensity of CH1 and CH2
13
Channel 2 selection button
Transducer Select Button

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[IFU-PER(EN)]
PERFECT Instructions For Use
5. Operation instructions
5.1 Patient Preparation
For hygiene reasons, the treatment area of the patient’s body and the device are not in direct
contact. There is no need to undress when using this device.
Please prepare some fabric towelsto be placed on the treatment area of patient body for hygine
purpose. We recommend cotton towles or covering materials to be applied before treatment
starts.
5.2 Applications
The system can be used to different ares of the body for treatment purpose. (Buttocks, Thigh
etc.)