DAESUNG MAREF CTC-7 User manual

This device is a medical device, designed to be used under a doctor’s instruction.
This user manual is intended to keep user safety and prevent property damage.
Please keep this manual at a place where a user can find it whenever he/she needs.
USER MANUAL
www.dsmaref.com ISO 9001
EN ISO 13485 0068

CONTENTS
Device Information
1-1. CTC-7 Introduction … 041-2. Intended use … 041-3. Target Patient … 04
1-4. Contraindications … 051-5. Side effect … 06General warnings and Cautions
2-1. Electrical safety cautions … 072-2. Cautions prior to use … 082-3. Cautions during use … 102-4. Cautions after use … 122-5. Cleaning … 142-6. Operating / Storage conditions … 152-7. WEEE … 16
Device Composition
3-1. Basic set … 173-2. Accessories … 18Device Description
4-1. Device specifications / Characteristics … 194-2. Parts name /function … 20Installation… 22How to use … 246-1. Cold & Heat Therapy setting … 256-2. RCT Therapy setting… 28
Cleaning and Draining … 317-1. Cleaning… 317-2. Draining … 32Storage … 341
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System setting… 359-1. How to set the Backlight time… 359-2. How to set the Beep sound… 369-3. How to set the RTC initial… 369-4.How to set the Temp unit… 379-5. F-Reset (Factory-Reset)… 37Troubleshooting
10-1. Matters to be checked prior to submitting a request for service… 3810-2. Error code occurrence… 39Labels Information… 41Information on EMC12-1. Guidance and Manufacturer's Declaration
– Electromagnetic Immunity… 4212-2. Guidance and Manufacturer's Declaration
– Electromagnetic Emissions… 43Symbols information… 449
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Device Information
1-1. CTC-7 Introduction
Thanks for purchasing CTC-7.
DAESUNG MAREF, we pledge to provide the highest quality device with excellent support
and service.
This user manual specifies the procedures required for properly using, storing and repairing
this device. In addition, this user manual specifies the instructions that must be followed to
not only prevent causing property damages to users and other people, but also safely use the
purchased device. Since it is important that you learn to control and connect the equipment
in order to properly use this device, make sure to read and follow the instructions specified in
this user manual prior to safely using this device.
Please always keep this manual with the device.
You must carefully read it before first use and as many times as needed.
※ The IFU can be distributed in English / Korean.
If users request, we can provide IFU in the requested language.
1-2. Intended use
The purpose of this system is to treat post-operative injuries and acute injuries to reduce
swelling, edema and pain. and It is to treat symptoms requiring medically or surgically local
thermal therapy (Cold, Heat, RCT) after post-traumatic or post-operative.
1-3. Target Patient
a) Age : No restrictions
b) Body weight : No restrictions
c) Nationality : Plural (not relevant)
d) Intended patient population : 1 person
e) Patient condition : 'Patients who need cooling, heating therapy after acute injury, trauma,
surgery (Not specified)
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USER MANUAL
* The patient must not use to CTC-7 system if the patient is suspected the following.
Heat Therapy
and/or
Contrast Therapy
- Vascular dysregulation
- Vascular ischemic disease
- Venous or Arterial Occlusive Disease
- Acute inflammations of the Veins
- Local malignancy
- Acute inflammatory skin disease or infection
- Venous or Lymphatic return is not desirable
- Local or systemic active infection
- Incapacitated patients
- A pregnancy
- Acute unstable fracture- Cutaneous insensitivity
- Acute trauma
- Bleeding diathesis
- Large scar
1-4. Contraindications
Cold therapy
and/or
Contrast Therapy
- Vascular dysregulation
- Vascular ischemic disease
- Venous or Arterial Occlusive Disease
- Acute inflammations of the Veins
- Decompensated Hypertonia
- Cerebral infraction
- Venous or Lymphatic return is not desirable
- Endocarditis
- Atheromatous embolic plaque
- Lymphedema after breast cancer
- Cold urticarial
- Atrial fibrillation
- Cutaneous insensitivity
* The following patients must use the device for temperature contact therapy under the
supervision of a physician.
Thermotherapy
(Heat and Cold)
and / or
Contrast Therapy
- Diabetes mellitus
- Decompensated Cardiac Insufficiency
- Hypertension, Cardiac failure
- Extreme low pressure
- Multiple sclerosis- Spinal cord injuries
- Rheumatoid arthritis
- Poor circulation
- Extremities not sensitive to pain
- Raynaud's Disease
- Hypersensitive to cold
- Children
- Incapacitated patients
- Recent skin graft
- Unstable angina
- Uncontrolled blood pressure
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1-5. Side effect
Heat Therapy
- Burns
- Skin discoloration
- Increased pain
- Increased inflammation
Cold Therapy
- Frostbite
- Cardiovascular effects (bradycardia)
- Raynaud’s phenomenon
- Cold urticarial
- Nerve and tissue damage
- Slowed wound healing
Contrast Therapy
- Burns
- Frostbite
- Cold urticarial
- Raynaud’s phenomenon
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USER MANUAL
2-1. Electrical safety cautions
- When this device is not in use, disconnect the power cord.
- When you connect or disconnect the power cord to or from the socket,
make sure to grab the plug instead of the line.
- When thunder and lightning cause a sudden blackout, turn off this device
and disconnect the power plug.
(There is a risk of device failure or electric shock.)
- Accurately connect the power cord so that it is rigidly plugged in.
(When the power cord is not stably connected, there is a risk of malfunction
and fire.)
- Make sure to untie the power cord prior to use.
(There is a risk of heat generation and fire.)
- When you move this device, use the handle instead of pulling the power
cord line.
(When the power cord is damaged, there is a risk of fire and electric shock.)
- Do not use this device near any equipment that creates electromagnetic
waves such as X-ray equipment and MRI equipment.
(When influenced by electromagnetic waves, this device may not function
properly.)
(There is a risk of malfunction which may cause injury.)
- When this device is dropped and damaged, do not operate this device.
- When the power cord is damaged, do not operate this device.
- When adding or draining distilled water, make sure to be careful.
(There is a risk of fire or electric shock which may cause injury.)
- Operators should not touch the patient while touching the SD card, USB port
of the device.
Caution for safety
2
※Make sure that you follow all the specified cautions and warnings prior to using this device.
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- Do not use this device for any purposes other than the intended use.
- The device cannot be used in home health care environment.
- When the intended user is wearing a life support system, make sure that
the intended user consults one’s doctor.
(Ex; heart assist device)
- When the intended user’s skin is sensitive to high or low temperature, make sure
that the intended user consults one’s doctor prior to use.
(There is a risk of low temperature burn and frostbite (on the spot where this
device is worn) which may cause injury.)
- When this device is not used for a long time, clean this device and check
whether or not this device functions properly prior to use.
- Do not install this system in an environment exposed to heating devices and
direct light.
(There is a risk of deformation and failure which may cause malfunction.)
2-2. Cautions prior to use
- Use a power cord in compliance with the standard in the involved country.
(There is a risk of fire and electric shock.)
- To avoid causing electric shock, use this device by connecting it with
a main-power supply unit with a protective ground.
(There is a risk of fire and electric shock.)
- Do not use a damaged power cord/plug or a loose socket.
(When the connection is unstable, there is a risk of fire and electric shock
which may cause injury.)
- When you smell something abnormal while this device is in use, immediately
stop using this device. In this case, immediately turn off the power switch,
disconnect the power cord from the socket, and contact the manufacturer or
the seller.
- Do not use wet hands or other wet body parts to touch this device, the
power cord, plug and socket.
(There is a risk of electric shock which may cause injury.)
- Do not damage, bend, twist, or heat up the power cord.
(When the cord is damaged, there is a risk of fire and electric shock.)
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USER MANUAL
- Check whether or not the tubing is damaged.
(When the tubing is damaged, there is a risk of oil leak and water leak which
may cause fire and electric shock.)
- Prior to use, check the status of this device as well as the status of the accessories.
(When this device or the exterior of the accessories is/are damaged, contact the
seller or the service center. When you intend to use the damaged device and
accessories, there is a risk of electric shock or current leakage which may cause
fire and injury.)
- Do not install this device on a desk or a table to which vibration or impact is
frequently applied.
(There is a risk of fall caused by vibration or impact which may cause failure
and injury.)
- Make sure to install this device in a place where the power plug can be connected
and disconnected without any interfering obstacles and where the power plug can
be removed without any interfering obstacles.
- Do not use a separate coolant for this device.
- When installing this device, make sure that the vent is not blocked.
- The SD card and USB cable can only be used as a firmware update.
- Prior to use, make sure that the water tank cover is locked.
- Do not paint this device or attach stickers and other foreign substances to
this device.
(When any foreign substance is inserted into the air socket or the connection
port, there is a risk of malfunction.)
(Depending on the physical constitution of the intended user, there is a risk
that the paint or the stickers may cause allergy and eczema. In this case,
stop using this device consult your doctor.)
- Do not cover the power cord with a carpet or other objects.
(As you walk, your feet may be caught in the power cord, making this
device fall.)
(There is a risk of fall which may cause failure and injury.)
- Make sure to install this device on a flat and stable surface.
(When this device is installed on a tilted or unstable surface, there is a risk
of noise, fall, failure and malfunction.)
- Use the wrap with wearing thin cloths.
(It can cause an allergy to a person with sensitive skin.)
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- Do not remodel, disassemble, or repair this device at your own discretion.
(When this device is remodeled, disassembled, or repaired at your own
discretion, you will not be able to receive our free repair service. Make sure
to submit a request to our service center to repair this device.)
- Do not install this device on a foldable, portable, or lightweight table.
(When the weight leans towards one side, there is a risk of table fall which
may cause failure and injury.)
- When installing this device, make sure that no liquid or foreign substance is
inserted into any part of this device other than the inlet of the water container.
(When any foreign substance is inserted into any part of this device,
there is a risk of failure, fire and malfunction which may cause injury.)
- When this device is transferred at a temperature below 0℃, make sure
to completely dry this device at room temperature for approximately 1~2hours
until the dew condensation disappears.
(Any moisture and liquid ingredients may damage the parts and circuits of
this device.)
- The wrap is intended to be connected with the device manufactured
by DAESUNG MAREF only. Do not connect the wrap with other devices
manufactured by other companies.
- The accessories and parts to be used in CTC-7 must be of those provided or
approved by DAESUNG MAREF.
(When any accessories and parts not approved by DAESUNG MAREF are
used, there is a risk of malfunction which may not guarantee user safety.)
- When it comes to determining how the temperature, mode and time of this
device should be set, follow the instructions given by your doctor.
- Use this device indoor where the temperature is above 10℃and below 25℃.
(When the service environment conditions are not satisfied, there is a risk
that the cooling/heating performance of this produce may be degraded.)
- CTC-7 Warp is not sterilized. Make sure that no wounded site is directly
touching the cooling/heating pad.
- Do not apply extreme impact by dropping this device.
- Do not use this device while it is inside the recovery bag.
(When this device is used while the vent is blocked, the device may not
function properly.)
2-3. Cautions during use
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USER MANUAL
- Do not operate this device while the tubing is facing your eyes, nose and lips.
(The water and air released from the tubing may cause injury.)
- Make sure that no heat is applied to the gonad and developing embryo.
(If you are a pregnant woman, be aware when you wear the back wrap.)
- When this device is used in the Cold, Heat, or RCT mode, do not use this
device with other heat sources.
(Doing so may result in an outcome different from the purpose of the
intended treatment.)
- Do not insert your finger into the water container or the vent.
- Make sure that the front, side, or rear vent of this device is not blocked
while this device is in operation.
- Make sure not to touch the side vent of this device while this device is in
use or immediately after this device is used.
- When connecting the tubing, make sure not to bend it.
- When moving this device, make sure to turn off this device prior to moving it.
(While this device is in operation, do not move this device.)
- Do not use a safety pin on the wrap to fix it.
(The wrap may be torn by the sharp part of a safety pin.)
- Prior to wearing the wrap, remove all accessories from the part of your body where
the wrap will be worn.
* When accessories are worn, there is a risk that the wrap may be damaged or that
the part of your body where the wrap is worn may be injured.
* When the wrap is to be worn on your leg: your belongings within trouser pockets,
ankle bracelet, etc.
* When the wrap is to be worn on your waist: your waist belt, belongings within
trouser pockets, key chain, mobile phone, etc.
* When the wrap is to be worn on your arm and hand: your watch, bracelet, ring, etc..
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2-4. Cautions after use
- When disconnecting the power cord from the device, disconnect the power cord
from the socket prior to removing it from this device.
- Check whether or not this device is damaged and whether or not this device
functions properly at least once per year.
(When this device is used without conducting maintenance, there is a risk
of malfunction and injury.)
- Prior to cleaning this device, disconnect the power cord from the socket,
and then disconnect the power cord from this device.
(When you get caught in the power cord line as you clean this device,
there is a risk of fall injury, damage and electric shock.)
- Make sure that no liquid is inserted into the socket, AC inlet and vent located
on the side of this device.
(When any liquid is inserted, the influenced internal parts may cause
malfunction, electric shock and fire.)
- Do not directly apply the liquid detergent to this device or use benzene,
thinner, or alcohol to clean this device. Make sure to apply the liquid
detergent to a cloth to be used for cleaning this device.
(There is a risk of discoloration, damage, electric shock and fire.)
- After operating this device, always wait until this device reaches room
temperature prior to storage.
- When the case of this device is damaged, immediately submit a request
for repair to the supplier or the customer center.
- Store this device and the accessories in a dry place free from water and
moisture.
(Moisture and liquid ingredients may damage the parts and circuits of this
device.)
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USER MANUAL
- Do not store this device in a dirty place full of dust.
(Dust and foreign materials may result in failure, fire, or electric shock which
may cause injury.)
- When this device and the accessories are to be stored for a long time,
make sure to completely remove the distilled water inside this systems.
(Unless the distilled water inside this device is completely drained, there is
a risk of contamination(microorganism inside this device) which may
cause failure.)
- The adequate temperature range for storing this device is from 1℃to 50℃.
Make sure that the temperature is within that range while this device is stored.
- Do not play any objects on this device.
(When this device is operated or moved while any liquid container(vase, water
bottle, cup, cosmetic device and chemical), volatile substance, chemical, or
sharp object(scissor and knife) is placed on this device, there is a risk of fall
which may cause fire and injury.)
- Do not disassemble or remodel this device at your own discretion for repair.
This device can only be disassembled and repaired by the approved personnel.
(When you disassemble and repair this device at your own discretion, there is a
risk of malfunction and injury.)
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2-5. Cleaning
2-5-1. Device cleaning - When any foreign substance(ex: filth, dust, blood) is attached to this device, turn off this
device, apply a bit of water or neutral detergent to a cloth, and use the cloth to gently
remove the foreign substance.
(There is a risk of discoloration, damage and malfunction.)
(When this device is cleaned, make sure to dry this device completely prior to use.)
- Please be careful to prevent any liquid from going into the air socket or AC inlet on the back
of device. If liquid does get in operation errors, electric shock, and fire could occur due to
do an affect of internal parts.
- Do not wipe the device with benzene, thinner, alcohol, etc or spray water directly on the
device.
(It may cause discoloration, damage, electric shock or fire.)
* Use neutral detergent or the alkalescence for cleaning.
Dilute in water if it is Alkali undiluted state.
Drug use: be careful not to enter into the skin or eyes.
2-5-2. Wrap cleaning - When necessary apply a bit of neutral/mild detergent or water to a soft cloth, use the cloth
to clean the wrap, and completely dry the wrap prior to use.
- Close the tubing hole at the bottom with a rubber stopper before cleaning.
(If you do not close the tubing hole with a rubber stopper, there is a risk of contamination
which may cause failure.)
* Do not use a dryer to dry the wrap.
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USER MANUAL
2-6. Operating / Storage conditions
2-6-1. Operating condition
Temperature (oC) Relative Humidity (%) Atmospheric Pressure(hPa)
10℃
25℃
Temperature (oC) Relative Humidity (%) Atmospheric Pressure(hPa)
5
1℃
50℃
2-6-2. Storage condition
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Consumers have to actively contribute to the success of such collection and should be
encouraged to return WEEE.
The Producer have to provide the information of re-usable, recyclable and recoverable rate.
75% shall be recovered, and 55% shall be prepared for re-use and recycled within category
5 (Small equipment) in DIRECTIVE 2012/19/EU ANNEX III.
CTC-7 is a recoverability rate of 74.4% and a recyclability rate of 81.8%.
Information for treatment facilities shall be made available to centres which prepare for
re-use and treatment and recycling facilities by producers of EEE.
DAESUNG MAREF, whenever, is prepared to provide.
2-7. WEEE
This symbol indicating separate collection for EEE is based on
DIRECTIVE 2012/19/EU.
The purpose of this Directive is to contribute to sustainable production
and consumption by, as a first priority, the prevention of WEEE and, in
addition, by the re-use, recycling and other forms of recovery of such
wastes so as to reduce the disposal of waste and to contribute to the
efficient use of resources and the retrieval of valuable secondary raw
materials.
This Directive cover all EEE used by consumers and EEE intended for
professional use.
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USER MANUAL
3-1. Basic set
Device Composition
3
Device
Tubing (Air + Water)
Ref. CTC7210
Tubing (Drain) Assistant Strap
Power Cord
User Manual
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3-2. Accessories
- The wrap is a consumable device.
- The wrap is defined as the mounting part in IEC 60601-1.
2. Shoulder Wrap
1. Knee Wrap
3. Elbow Wrap
4. Ankle Wrap 5. Back Wrap 6. Universal Wrap
NO Name Size Ref.No (Reusable Wrap) Ref.No (Disposable Wrap)
1 Knee Wrap Free CTCKF00 CTCKFD0
2 Shoulder Wrap M CTCSM00 CTCSMD0
3 Elbow Wrap Free CTCEF00 CTCEFD0
4 Ankle Wrap Free CTCAF00 CTCAFD0
5 Back Wrap Free CTCBF00 CTCBFD0
6 Universal Wrap
M CTCUM00 CTCUMD0
L CTCUL00 CTCULD0
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USER MANUAL
Device Description
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4-1. Device specifications/Characteristics
The exterior and specifications of this device may be changed without notice for performance
improvements.
You can purchase the accessories through the official website of DAESUNG MAREF.
You must purchase the official parts provided by DAESUNG MAREF. When accessories produced
by other companies are used, this device may not function properly. In this case, our free as will not
be applicable.
The time it takes for this device to reach the set temperature may vary depending on the ambient
temperature. This device may fail to reach the set temperature depending on the case.
Device name Circulating-fluid thermal/compression therapy system control unit
Model CTC-7
Dimension 272(W) x 180(D) x 239(H) mm
Weight 3.7kg (empty water container)
3.9kg (full water container)
Power source AC 100 – 240V, 50/60Hz
Power consumption 270VA
Mode Cold Therapy, Heat Therapy, RCT Therapy
Therapy Temperature
Range
Cold Therapy : 6 - 15℃± 3℃(43 - 59℉±5.4℉)
Heat Therapy : 35 - 45℃± 3℃(95 - 113℉±5.4℉)
Time Range
Manual (Cold Therapy) : 5 - 60 min
Manual (Heat Therapy) : 5 - 30 min
PRESET (Run/Rest) : 20/20, 20/40, 30/30, 30/60 min
Pressure Range
Cold Therapy :0 - 4 Level / Heat Therapy : 0 - 1 Level
0 Level : 0mmHg
1 Level : 15mmHg ±5mmHg
2 Level : 30mmHg ±5mmHg
3 Level : 50mmHg ±5mmHg
4 Level : 75mmHg ±5mmHg
Coolant Distilled water
Refrigerant None
Fluid Capacity 250mL
Ambient Operating Range 10 – 25℃Type of protection IP IPX0
Class / type of protection Class I
* Setting value
should be operated
under doctor's
instructions.
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4-2. Parts name/function
No Parts Name Function
1 LCD display It is a screen that displays the GUI and operating status of
CTC-7
2 Back button When the back button is shortly pressed, the previous
screen will appear.
3 Knob wheel
When the knob wheel is rotated or pressed, the temperature,
time and pressure level of this device can be controlled.
* While this device is in operation, press the knob wheel to stop
this device from operating.
4 Alarm LED
- Standby status : Green
- In operation : Blue and Green flickering
- Error : Orange flickering
5 Start / Stop button
When the button is shortly pressed, this device will operate
based on the set values.
While this device is in operation, press the button shortly to stop
this device from operating.
6 Air vent This is a fan-operated air vent, an air-circulated vent that allows
internal air to circulate during operation.
7 Water socket It is a water socket used to connect the tubing with this device.
8 Air socket It is an air socket used to connect the tubing with this device.
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