DAESUNG MAREF CTC-7 User Manual
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DAESUNG MAREF CTC-7 User Manual

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www.dsmaref.com
ISO 9001
EN ISO 13485
0068
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.

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Summary of Contents for DAESUNG MAREF CTC-7

  • Page 1 www.dsmaref.com ISO 9001 EN ISO 13485 0068 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.

  • Page 2: Table Of Contents

    CONTENTS Device Information … 04 1-1. CTC-7 Introduction … 04 1-2. Intended use 1-3. Target Patient … 04 … 05 1-4. Contraindications … 06 1-5. Side effect General warnings and Cautions … 07 2-1. Electrical safety cautions … 08 2-2. Cautions prior to use …...
  • Page 3 … 35 System setting 9-1. How to set the Backlight time … 35 9-2. How to set the Beep sound … 36 9-3. How to set the RTC initial … 36 9-4.How to set the Temp unit … 37 9-5. F-Reset (Factory-Reset) …...

  • Page 4: Device Information Contents

    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.

  • Page 5: Contraindications

    1-4. Contraindications * The patient must not use to CTC-7 system if the patient is suspected the following. - Vascular dysregulation - Incapacitated patients - Vascular ischemic disease - A pregnancy - Venous or Arterial Occlusive Disease - Acute unstable fracture...

  • Page 6: Side Effect

    1-5. Side effect - Burns - Skin discoloration Heat Therapy - Increased pain - Increased inflammation - Frostbite - Nerve and tissue damage - Cardiovascular effects (bradycardia) - Slowed wound healing Cold Therapy - Raynaud’s phenomenon - Cold urticarial - Burns - Frostbite Contrast Therapy - Cold urticarial...

  • Page 7: Electrical Safety Cautions

    Caution for safety ※ Make sure that you follow all the specified cautions and warnings prior to using this device. 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.

  • Page 8: 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.
  • Page 9 - 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.

  • Page 10: Cautions During Use

    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.)
  • Page 11 - 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.

  • Page 12: Cautions After Use

    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.
  • Page 13 - 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.

  • Page 14: Cleaning

    2-5. Cleaning Device cleaning 2-5-1. - 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...

  • Page 15: Operating / Storage Conditions

    2-6. Operating / Storage conditions Operating condition 2-6-1. Temperature ( Relative Humidity (%) Atmospheric Pressure(hPa) 25 ℃ 10 ℃ 2-6-2. Storage condition Temperature ( Relative Humidity (%) Atmospheric Pressure(hPa) 50 ℃ 1 ℃ USER MANUAL...

  • Page 16: Weee

    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.

  • Page 17: Device Composition

    Device Composition 3-1. Basic set User Manual Device Power Cord Tubing (Air + Water) Tubing (Drain) Assistant Strap Ref. CTC7210 USER MANUAL...

  • Page 18: Accessories

    3-2. Accessories - The wrap is a consumable device. - The wrap is defined as the mounting part in IEC 60601-1. 1. Knee Wrap 2. Shoulder Wrap 3. Elbow Wrap 6. Universal Wrap 4. Ankle Wrap 5. Back Wrap Name Size Ref.No (Reusable Wrap) Ref.No (Disposable Wrap) Knee Wrap...

  • Page 19: Device Description

    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.

  • Page 20: Parts Name/Function

    Parts Name Function It is a screen that displays the GUI and operating status of LCD display CTC-7 When the back button is shortly pressed, the previous Back button screen will appear. When the knob wheel is rotated or pressed, the temperature, time and pressure level of this device can be controlled.
  • Page 21 Memory card / It is a port in which the memory card and USB cable can be USB port inserted for device firmware updates. Power on/off switch It is a switch used for turning on/off this device. Power cord socket It is a socket used for connecting the AC cord with this device.

  • Page 22: Installation

    Installation 1) When you open the package and take out this device, proceed with caution to avoid causing damages. After you take out this device, check whether or not this device and the parts are damaged. 2) Install this device on a flat and stable surface. * To avoid the air flow of this device from being interrupted, install this device in a place, where the obstacles are at least 30cm away from the vent of this device.
  • Page 23 5) After you connect the water socket of the tubing with this device, connect the air socket by pushing it until you hear a “click” sound. * When this device is used without properly connecting the tubing with this device, there is a risk of oil leakage.

  • Page 24: How To Use

    How to use ※ Use “Clause 5. Installation” as your reference to install CTC-7 in your intended environment. 1) When you turn on the power switch located on the side of this device, the mode selection screen will appear. 2) On the mode selection screen, rotate the knob wheel counterclockwise or clockwise to select the most to be used.

  • Page 25: Cold & Heat Therapy Setting

    6-1. Cold & Heat Therapy setting 1) On the mode selection screen, rotate the knob wheel to select Cold or Heat Therapy, and press the knob wheel to move to the standby screen. 2) On the standby screen, press the knob wheel to move to the setting screen. * On the mode setting screen, you can set the time, temperature and pressure level.
  • Page 26 4) On the Time setting screen, rotate the knob wheel to select Manual or Preset. On the Manual Time setting screen, you can set the run time. * Manual Time range Cold Therapy : 5 - 60min / Heat Therapy : 5 - 30min On the Preset Time setting screen, you can choose the time which is continuously moving for run and rest setting.
  • Page 27 * Cold Therapy setting range Manual 5 - 60 min Cold Therapy mode Time range Preset Run/Rest : 20/20, 20/40, 30/30, 30/60 min Cold Therapy mode 6 - 15℃ ± 3℃ (43 - 59℉ ± 5.4℉) Temperature range 0 Level 0 mmHg 1 Level 15 mmHg ±...

  • Page 28: Rct Therapy Setting

    6-2. RCT Therapy setting 1) On the mode selection screen, rotate the knob wheel to select ‘RCT Therapy’, and press the knob wheel to move to the RCT therapy standby screen. 2) On the RCT therapy standby screen, press the knob wheel to move to the RCT setting screen. * On the RCT setting screen, you can set the temperature, pressure level and treatment cycle for Cold therapy and Heat therapy.
  • Page 29 3-1) On the Cold setting screen, rotate the knob wheel counterclockwise or clockwise to select from ’Temperature’ and ‘Pressure Level’. Select the item (‘Temperature’, ‘Pressure Level’) to be set and press the knob wheel, and a pop-up screen will appear. Rotate the knob wheel counterclockwise or clockwise to adjust the levels.
  • Page 30 3-3) On the Cycle setting screen, rotate the knob wheel counterclockwise or clockwise to adjust the levels. Press the knob wheel to save the settings, and press the Back button to return to the RCT therapy standby screen without saving the settings. * RCT Therapy setting range Cold Therapy mode 20 min...

  • Page 31: Cleaning And Draining

    7-1. Cleaning 1) Fill CTC-7 with distilled water and check whether or not the tubing and wrap are all connected. * Check whether or not the pipe attached to the wrap is rotated. When the pipe is rotated, the water will leak during cleaning.

  • Page 32: Draining

    7-2. Draining 1) Check whether or not the cap of the water container located on the rear side of this device is completely closed. 2) Check whether or not the tubing and wraps are connected to CTC-7.
  • Page 33 * When the water level remains the same during the Draining process, a failure will occur. * When a failure occurs, check whether or not the tubing and wrap are all connected to CTC-7, and check whether or not the pipe is open. USER MANUAL...

  • Page 34: Storage

    ※ To prevent causing problems while moving and storing this device, make sure to use the packaging that this device was initially covered in. ※ For long term storage refer to section 7-2 Drain Methods of CTC-7 to remove distilled water from the device and accessories.

  • Page 35: System Setting

    System setting When this device is in the standby mode, press and hold the ‘Back button’ and ‘knob wheel’ at the same time to go to the System set screen. * On the system set screen, you can set 5 items : Backlight, Beep sound, RTC initial, Temp unit, and Factory reset.

  • Page 36: How To Set The Beep Sound

    9-2. How to set the Beep sound 1) On the System set screen, rotate the knob wheel, select ‘Beep sound’, and press the knob wheel to turn on/off the beep sound of this device. 2) On the Beep sound set screen, rotate the knob wheel, set the beep sound, and press the knob wheel to return to the system set screen.

  • Page 37: 9-4.How To Set The Temp Unit

    9-4. How to set the Temp unit 1) On the System set screen, rotate the knob wheel, select ‘Temp unit’, and press the knob wheel to change how the temperature is displayed on the device. 2) On the Temp unit set screen, rotate the knob wheel, select either (℃) or (℉), and press the knob wheel to return to the system set screen.

  • Page 38: Troubleshooting

    Troubleshooting The user is encouraged to receive a device quality test from the manufacturer every 1 year. 10-1. Matters to be checked prior to submitting a request for service. * When this device does not function properly, make sure to read the user manual and follow the instructions to take adequate actions against the following symptoms prior to contacting the customer center.

  • Page 39: Error Code Occurrence

    While using this device, I got a message saying that the temperature of this device is high. Turn off this device and let it cool down for approximately 1 hour prior to turning it back on for use. When the ambient temperature is high or this device is continuously used for a long time, take a break from using this device.
  • Page 40 Error Code Symptom Solution Occurs when the temperature cannot be adjusted due to failure of the cooling system Occurs when the temperature cannot be - Contact the service center and local person in charge. adjusted due to failure of the water pump Occurs when the air sensor has no load while this device is in operation...

  • Page 41: Labels Information

    Labels Information Label Position Label Design Caution Before use the product, please read the manual and follow every precautions and warnings. Please turn off the power when you fill up distilled water in the product. Please be careful not to spill distilled water on the product when you fill it up.
  • Page 42 Guidance and Manufacturer's Declaration – Electromagnetic Immunity The CTC-7 is intended for use in the electromagnetic environment specified below. The customer or the user of the CTC-7- should assure that it is used in such an environment. IEC 60601 Compliance...
  • Page 43 Guidance and Manufacturer's Declaration – Electromagnetic Emissions The CTC-7 is intended for use in the electromagnetic environment specified below. The customer or the user of the CTC-7- should assure that it is used in such an environment. Emission test Compliance...
  • Page 44 Symbols Information Symbol Description Reference EN ISO 15223-1 Manufactured Date 5.1.3 EN ISO 15223-1 Manufacturer 5.1.1 Symbol that indicates electrical and electronic components which must be EN 50419 collected separately. EN ISO 15223-1 Serial Number 5.1.7 EN ISO 15223-1 Batch code 5.1.5 IEC 60878 Type of applied part...
  • Page 45 Symbol Description Reference ISO 7000 Convenience 0622 ISO 7000 Load Limitation 2403 IEC 60878 "ON" (power) button 5007 IEC 60878 "OFF" (power) button 5008 The official mark of Europe Certificate CE logo 0068 EN ISO 15223-1 European Representative 5.1.2 Temperature limitation EN ISO 15223-1 (Operating: 10℃~25℃...
  • Page 46 Custom Description Symbol Cold therapy Heat therapy (Rapid Contrast Therapy) Air compression Synergy No moisture Convenience Back button Start/Stop button Memory card port icon USB port icon No leakage Manual Time Preset Time...
  • Page 47 Warranty Much appreciated on using our device. We, DAESUNG MAREF are doing our best to improve the quality of our products. ※ We can not be responsible for any defect occured from user's careless use or in case of followings, even though warranty period : 1.
  • Page 48 - Established DAESUNG Machinery Company - Awarded the Governor's Citation for Day of Commerce and Industry by 1994 Gyeonggi province - Conversion to DAESUNG MAREF CO.,LTD. 2011 1999 President Award - Registered DOCTOR LIFE - Gold Listed at the Korea Precision...

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