DS Maref MEDIRENT CTC-7 User manual

Indicaons for safety use
CTC-7
User Manual
Indicaons for safe use
This is a medical device. Please read this manual
carefully and follow instructions at all times.

1. Introducon .........................................3
2. Warnings ..............................................4
3. Cleaning, Operang and Storage
Condions ............................................. 10
4. Product Descripon ...................... 12
5. Installaon ........................................ 18
6. How to Use ...................................... 20
7. Cleaning and Draining ................. 27
7. Storage ............................................. 30
8. Troubleshoong ............................. 31
9. Informaon on EMC .................... 34
10. Symbols informaon .................. 37
11. Warranty ....................................... 39
Contents
This user manual species the procedures required for properly using, storing and
repairing this device. In addition, it species the instructions that must be followed to not
only prevent injury to users and other people, but also to avoid damage to the device. Read
and follow the instructions specied in this user manual prior to safely using the device.
1. Introducon
Introducon
Intended Use
The purpose of the CTC-7 system is to provide local thermal therapy of cold, heat, and
rapid contrast therapy (RCT). It is intended to be used for acute injury post-operatively or
post-trauma to reduce swelling, oedema, and pain.
This device is suitable for people 12 years and over.
Side Eects
Heat Therapy • Burns
• Skin discolouration or irritation
• Increased pain
• Increased inammation
• Increased swelling
• Increased redness
Cold Therapy • Cold burns
• Cardiovascular effects (bradycardia)
• Nerve and tissue damage
• Slowed wound healing
Contrast Therapy • Heat or cold burns
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2. Warnings
Contraindicaons Precauons
Heat Therapy
and/or Contrast
Therapy
• Vascular dysregulation
• Vascular ischaemic disease
• Venous or arterial occlusive disease
• Acute inammation of the veins
• Local malignancy
• Acute inammatory skin disease or infection
• Conditions where venous or lymphatic return is not desirable
• Local or systemic active infection
• Acute unstable fractures
• Hypoesthesia, sensation impairment, numbness
• Acute trauma
• Bleeding diathesis
Cold therapy
and/or Contrast
Therapy
• Vascular dysregulation
• Vascular ischaemic disease
• Venous or arterial occlusive disease
• Acute inammation of the veins
• Decompensated hypertonia
• Cerebral infarction
• Conditions where venous or lymphatic return is not desirable
• Endocarditis
• Atheromatous embolic plaque
• Hypoesthesia, sensation impairment, numbness
• Atrial brillation
The following conditions are contraindicated for CTC-7 use.
Thermotherapy
(Heat and Cold
and / or Contrast
Therapy
• Pregnancy
• Rheumatoid arthritis
• Conditions where sensation is compromised leading to increased
or decreased sensitivity to cold/heat/injury e.g. General poor
circulation, Diabetes mellitus, multiple sclerosis, spinal cord
injuries
• Decompensated cardiac insufciency
• Hypertension, Cardiac failure
• Buerger’s disease
• Peripheral vascular disease
• Medication that may negatively affect peripheral vascular
circulation (ex: beta-adrenergic blockers, epinephrine, local
anaesthetics, etc.)
• Insensitivity to pain
• Children under 12 years old
• Recent skin graft
• Unstable angina
• Uncontrolled blood pressure
• Sickle cell anaemia
• Vasospastic disorder
• Implanted life support system
* If you have any of the following conditions you must use the device under the supervision
of a physician.
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• Unwind the power cord prior to use.
• When you connect or disconnect the power cord to or from the
socket, make sure to hold the plug instead of the cord.
• During a storm or blackout, turn off the device and disconnect the
power plug.
• Connect the power cord so that it is rmly plugged in.
• Use the handle to lift and move the device. Do not drag by the power
cord.
• Do not use the device near any equipment that creates
electromagnetic waves such as X-ray and MRI equipment.
• Do not operate the device if it has been dropped and damaged.
• Do not operate the device if the power cord is damaged.
• When adding or draining distilled water, do not to spill water over
the device electronics.
• When the device is not in use, disconnect the power cord.
• Use a power cord in compliance with the country’s electrical
standards.
• Use the device by connecting it with a main-power supply unit with
a protective ground.
• Do not use a damaged power cord/plug or a loose socket.
• If you notice an abnormal smell whilst the device is in use,
immediately stop using the device. In this case, immediately turn off
the power switch, disconnect the power cord from the socket, and
contact Medi-Rent.
• Do not use wet hands or other wet body parts to touch this device,
the power cord, plug and socket.
• Do not damage, bend, twist, or heat up the power cord.
prohibited
caution
• Do not use the device for any purposes other than the intended use.
• Use with care if the user has an underlying condition that impairs
skin sensitivity to temperature or pain.
• If the device has not been used for a long time, clean the device and
check the function prior to applying the garment to the body.
• Do not install this system in an environment exposed to heating
devices and direct light.
• Check if the tubing is damaged.
• Prior to use, check the device and the accessories are in good
condition and undamaged.
• Set up the device on a at and stable surface.
• Do not set up the device on a desk or a table to which vibration or
impact is frequently applied.
• Set up the device in a place where the power plug can be connected
and disconnected without any obstruction.
• Do not use coolant in the device.
• When setting up the device, make sure that the vent is not blocked.
• The SD card and USB cable can only be used as a rmware update.
• Prior to use, make sure that the water tank cover is screwed on
tightly.
• Do not paint the device or attach stickers and other foreign
substances to it.
• Do not cover the power cord with a carpet or other objects.
• Wear thin fabric between your skin and the CTC-7 garment.
prohibited
caution
Electrical Safety Cauons prior to use
Make sure that you follow all the specied cautions and warnings prior to using this device.
• Do not remodel, disassemble, or repair this device as this will void
warranty.
• Do not set up the device on a foldable, portable, or lightweight table.
• Make sure that no liquid or foreign substance enters any part of the
device other than the inlet of the water container.
• Allow the device 1-2 hours to reach room temperature operating
conditions between 10 and 25ºC prior to use. If condensation has
occurred, dry with a soft cloth before turning the device on.
• The wrap is intended to be connected with the CTC-7 only. Do not
connect the wrap with devices manufactured by other companies.
• The accessories and parts to be used inthe CTC-7 must be of those
provided or approved by DAESUNG MAREF.
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Cauons during use
• When determining the temperature, mode and time settings of this
device, follow the instructions given by your clincian.
• Use the device indoors where the temperature is 10−25ºC.
• CTC-7 wraps are not sterilised. Avoid direct contact of the wrap to
the skin. Wear a thin layer of fabric between the skin surface and
the wrap.
• Keep the treatment area dry and check frequently.
• Do not drop the device.
• Do not use the device while it is inside the carry bag.
• Do not apply heat to the abdomen if you are pregnant, or to the
genitals.
• When this device is used in the Cold, Heat, or RCT mode, do not use
the device with other heat sources.
• Do not insert your nger into the water container or the vent.
• Make sure that the front, side, or rear vent of the device is not
blocked while the device is in operation.
• Do not to touch the side vent of the device while it is in use or
immediately after the device has been used.
• Do not forcefully bend the tubing when connecting to the device.
• Turn off the device prior to moving it
• Remove all jewellery on the affected limb prior to wearing the wrap.
caution
Cauons aer use
• Disconnect the power cord from the socket prior to removing it
from the device, particularly before cleaning.
• Check whether or not the device is damaged and whether or not it
functions properly at least once per year.
• Make sure that no liquid is inserted into the socket, AC inlet or vent
located on the side of this device.
• Do not directly apply liquid detergent to the device or use benzene,
thinner, or alcohol to clean this device. Clinell wipes are the
preferred method to clean the device and can be purchased from
Medi-Rent or other outlets.
• After operating the device, always wait until the device reaches
room temperature prior to storage.
• If the device case is damaged, immediately submit a request for
repair to Medi-Rent.
• Store this device and the accessories in a dry place free from water
and moisture.
• Dust and foreign materials may result in failure, re, or electric
shock.
• When the device and the accessories are to be stored for a long
time, make sure to completely remove the distilled water inside the
system.
• The adequate temperature range for storing this device is 1−50ºC.
caution
prohibited
• To prevent voiding warranty, do not disassemble or remodel the
device at your own discretion for repair.
• This device can only be disassembled and repaired by Medi-Rent.
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Cleaning; Operang and Storage Condions WEEE Marking
• When any foreign substance (e.g. dirt, dust, blood) contaminates the device, turn off,
apply a damp cloth or Clinell wipe to gently remove the foreign substance.
• Do not wipe the device with benzene, thinner, alcohol, etc or spray water directly on the
device.
• Use pH neutral detergent or Clinell wipes (available from Medi-Rent) to clean.
• Dilute in water if it is alkali undiluted state.
• Take necessary care when using cleaning detergents. Use appropriate skin and eye
protection.
Device cleaning
• When necessary apply pH 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.
• Do not use a dryer to dry the wrap.
Wrap cleaning
Operang condions
Storage condions
This marking shown on the product or its literature, indicates that
it should not be disposed with other household wastes at the end
of its working life. To prevent possible harm to the environment or
human health from uncontrolled waste disposal, please separate
this from other types of waste and recycle it responsibly to promote
the sustainable reuse of material resources.
Household users should contact Local Council about how and
where they can dispose of this item for environmentally safe
recycling.
Business users should contact their supplier and check the items
and conditions of the purchase contract. This product should not be
mixed with other commercial waste for disposal.
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Product Descripon
Basic kit
The wrap is dened as the mounting part in IEC 60601-1.
Accessories
These wraps come in both re-usable or single patient-use options.
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Device specicaons
Name Product code
Re-usable wrap
Knee wrap CTC-KNEE-R
Shoulder wrap CTC-SHOULDER-R
Elbow wrap CTC-ELBOW-R
Ankle wrap CTC-ANKLE-R
Back wrap CTC-BACK-R
Universal wrap CTC-UNIVERSAL-M-R size medium
CTC-UNIVERSAL-L-R size large
Single
patient-use wrap
Knee wrap CTC-KNEE-D
Shoulder wrap CTC-SHOULDER-D
Elbow wrap CTC-ELBOW-D
Ankle wrap CTC-ANKLE-D
Back wrap CTC-BACK-D
Universal wrap CTC-UNIVERSAL-M-D size medium
CTC-UNIVERSAL-L-D size large
Class / type of
protection
Class I, BF-Type
Device name Circulating-uid 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 Temperature
Range
Cold Therapy : 6 - 15ºC ± 3ºC
Heat Therapy : 35 - 45ºC± 3ºC
Time Range Cold Therapy : 5 - 60 min
Heat Therapy : 5 - 30 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
Type of protection IP IPX0
Rx only
Setting value
should be operated
under clinician’s
instructions.
The exterior and specications of this device may be changed without notice for performance
improvements. You can purchase accessories through Medi-Rent. Only CTC-7 accessories must be used
with the device otherwise the warranty will be void.
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No Parts Funcon
1LCD display The screen displays the operating status of CTC-7
2Back button When the back button is pressed, the previous screen will
appear.
3Dial
When the dial is rotated or pressed, the temperature, time
and pressure level of this device can be controlled. While the
device is in operation, press the dial to pause operation.
4Alarm LED
Standby status : Green
In operation : Blue and green ashing
Error : Orange ashing
5Start / Stop button
When the button is pressed, the device will operate based
on the set values. While the device is in operation, press the
button to stop operation.
6Air vent The fan-operated air vent allows internal air to circulate
during operation.
7Water socket Connection point for the water tubing of the device.
8Air socket Connection point for the air tubing of the device.
No Parts Funcon
9Memory card /
USB port Memory card and USB port for device rmware updates.
10 Power on/off
switch Turns device on/off
11 Power cord socket To connect the AC cord with the device.
12 Water level
indicator
Indicator used for checking the amount of distilled water
contained in the water container.
13 Water tank cover Cover used for preventing the distilled water from spilling.
14 Handle Convenient carry handle when moving the device.
Part numbers
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Installaon
1. Open the package with care to avoid damage to the product. Check the device, tubing,
and garment are in good condition and undamaged prior to use.
2. Install the device on a at and stable surface.
* To avoid the air ow of the CTC-7 from being interrupted, place the device in an
area with 30cm clearance around it.
3. Open the water bottle cap located on the rear side of
the device, ll the water bottle with distilled water,
and screw the cap back on rmly.
• When adding distilled water, use a jug with a sharp
spout.
• Check the water level indicator located on the rear
side of the device.
• The maximum volume of distilled water is 250mL.
Once operang, the device needs to be topped
up with water as the inial water moves from the
device to the garment.
4. Find the water socket located on the side of the
device and connect the garment water tubing to
this until you hear a “click” sound.
• When the device is used without properly
connecting the tubing there is a risk of water
leakage.
5. After you connect the water socket, connect the air
socket by pushing the tubing until you hear a “click”
sound.
6. Check whether or not the pipe attached to the wrap
is twisted. (The pipe is only in the re-usable wrap.
Disposable wrap do not have drain pipes.)
• When the pipe is twisted 90 degrees, the distilled
water will spill.
7. Find the power cord socket located on the side of
the device, and connect the cord. Then, connect the
device to a power outlet.
• Install this device in an environment where
the power cord can be easily connected and
disconnected.
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