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Comen SCD600 User Manual

Sequential compression system
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User's Manual for Sequential Compression System SCD600
Copyright
Version: B00
No.: 046-001737-00
Revision date: 2021/04
Product name: Sequential Compression System
Model No.: SCD600
Statement
Shenzhen Comen Medical Instruments Co., Ltd. (hereinafter referred to as ―Comen‖
or ―Comen Company‖) holds the copyright of this unpublished manual and has the
right to treat this manual as a confidential document. This manual is provided for the
operation, repair and maintenance of Comen Sequential Compression System only. Its
content shall not be disclosed to any other person.
This manual contains the proprietary information protected by the Copyright Law. No
individual or organization is allowed to duplicate, photocopy or translate any part of
this manual without the prior written permission of Comen.
Comen Company shall not be responsible for errors in the manualor accidental or
indirect damages caused by the provision, actual performance and use of the
instruction. Comen Company does not provide concessions granted by the Patent Law
to other parties. Comen shall not take the legal responsibility for the legal
consequences caused by violation of the patent law and the rights of the third party.
The contents contained in the manual may be changed without notice.
Warranty
Comen will be responsible for the safety, reliability and performance of the product if
all of the following conditions are satisfied:
I

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Summary of Contents for Comen SCD600

  • Page 1 The contents contained in the manual may be changed without notice. Warranty Comen will be responsible for the safety, reliability and performance of the product if all of the following conditions are satisfied:...
  • Page 2 (including customs fees) should be on the customer’s account. Return Policy Please observe the following steps if it is necessary to return your product to Comen: Make your return request: tell the After-sales Service Department of Comen your product number (indicated on the product nameplate; if the product number is illegible, your return request will be rejected), product manufacturing date and reasons for return.
  • Page 3 User’s Manual for Sequential Compression System SCD600 After-sales Service Department Name: After-sales Service Department of Shenzhen Comen Medical Instruments Co., Address: Floor 10 of Building 1A, FIYTA Timepiece Building, Nanhuan Avenue, Matian Sub-district, Guangming District, Shenzhen, Guangdong, 518106, P.R. China Tel.: 0086-755-26431236, 0086-755-86545386, 0086-755-26074134...
  • Page 4 User’s Manual for Sequential Compression System SCD600 Preface This manual provides detailed descriptions of the performance, operation methods and other safety information about Sequential Compression System. It is the best start guide for new users of the Sequential Compression System.

  • Page 5: Table Of Contents

    User’s Manual for Sequential Compression System SCD600 Contents Chapter 1 Safety ...................... 1-1 1.1 Safety Information ................... 1-1 1.2 Contraindications ..................... 1-5 1.3 Side effect ......................1-6 1.4 Device Symbols ....................1-6 Chapter 2 Overview ....................2-1 2.1 Product introduction ..................2-1 2.1.1 Product Composition ................
  • Page 6 User’s Manual for Sequential Compression System SCD600 Chapter 4 Basic Operations ..................4-1 4.1 Therapy Modes ....................4-1 4.2 System Set ....................... 4-1 4.2.1 Brightness ....................4-1 4.2.2 System Time ..................... 4-2 4.2.3 Fault Prompt Volume ................4-2 4.2.4 Unit Set ..................... 4-2 4.2.5 Language ....................
  • Page 7 User’s Manual for Sequential Compression System SCD600 6.3 Screen Calibration ................... 6-3 6.4 Pressure Calibration ..................6-3 6.5 Fault Detection ....................6-4 Chapter 7 Cleaning and Maintenance ..............7-1 7.1 Overview ......................7-1 7.2 Cleaning of device and accessories ..............7-2 7.3 Disinfection of device and accessories ............
  • Page 8 User’s Manual for Sequential Compression System SCD600 Blank Page VIII...

  • Page 9: Chapter 1 Safety

    Chapter 1 Safety 1.1 Safety Information Warning  Alerts you to situations that may result in serious consequences or adverse events or endanger personal safety. Failure to observe the warning information may cause severe injury or even death of user or patient. Caution ...
  • Page 10 Safety Warning  The device can be used only by trained, qualified doctors and nurses.  For patient with diabetes or vascular disease, skin check must be performed frequently.  Prior to use, user must check the device and its accessories to ensure their normal and safe operation.
  • Page 11 Safety having been trained and authorized by Comen.  Please observe the local laws and regulations or the waste disposal rules of the hospital when disposing of packaging materials. Keep the packaging materials out of the reach of children. ...
  • Page 12 Safety Caution  To avoid damage to the device and ensure the patient’s safety, please use accessories specified in this manual.  Please properly install or carry the device to avoid damage caused by drop, collision, strong oscillation or other external mechanical forces. ...

  • Page 13: Contraindications

    4. Extreme deformity of the leg. 5. Suspected pre-existing deep venous thrombosis. Foot Compression The SCD600 may not be recommended for use with Foot Cuffs on patients with the following: 1. Conditions where an increase of fluid to the heart may be detrimental.

  • Page 14: Side Effect

    Safety 1.3 Side effect  During the treatment, pain or numbness may appear in the treatment area 1.4 Device Symbols  Device Symbols WEEE classified Note! collection Start/Pause key Manufacturer IPX1 Ingress rating Main menu Battery operating Power on/off key indicator AC indicator Serial number mark...
  • Page 15 Safety years. Complies with medical European community device directive representative 93/42/EEC Protective earth (ground) Manufacturing date contain natural Not contain PVC rubber latex. This Side Up Stacking Layer Limit Fragile Keep dry Transport and Storage Transport and Storage atmospheric pressure of environment humidity 70kPa~106kPa 15%~93%...

  • Page 16: Chapter 2 Overview

    Chapter 2 Overview This Sequential Compression System is designed to increase the flow rate of the patient's venous blood during intermittent pneumatic compression, thereby helping prevent the occurrence of deep vein thrombosis and pulmonary embolism. The system consists of the main unit, connecting tubes (supplied with the main unit) and cuffs for a single patient (to be purchased separately).The cuff can increase the venous blood flow by compressing the limbs.

  • Page 17: Appearance

    Overview 2.2 Appearance The left view and front view of the product are not presented here, because no main functional component is contained therein. 2.2.1 Panel Power ON/OFF key Battery indicator AC power indicator Start/Pause key 2.2.2 Right View Auxiliary handle Main handle Grounding jack AC power jack...

  • Page 18: Rear View

    2.2.3 Rear View Channel L and R This Sequential Compression System (SCD600) provides two output channels (channel L and channel R), each containing 4 sub-channels. The two channels are independent of each other and can be used independently or simultaneously.

  • Page 19: Osd (On-Screen Display)

    Overview 2.3 OSD (On-screen Display) Main Menu Human body under treatment Feet Select channel L and channel R respectively, select up to two circles on either foot or leg (not on both) as the areas to be treated. The areas selected for treatment are indicated dynamically: ...

  • Page 20: Chapter 3 Installation

    Chapter 3 Installation 3.1 Unpacking and Checking Carefully take the Sequential Compression System and its accessories out of the packing box; properly keep the packaging materials for use in future transportation or storage. Check the accessories according to the Packing List. Check to see if there is any mechanical damage.

  • Page 21: Environmental Requirements

    Installation transported or stored. Direct startup without connection to AC power supply may result in failure to work normally due to low battery level. When AC power supply is connected, the battery can be charged no matter whether the device is turned on or not. 3.3 Environmental Requirements Please observe the following instructions to ensure absolute safety of electrical installation.

  • Page 22: Equipotential Earthing

    Installation into a matching 3-prong outlet, the device will be earthed via the earth lead (protective earth) of the power cord. If no 3-prong outlet is available, please contact the electrical management personnel of your hospital. Warning  It is forbidden to insert the tri-lead cable plug of the device into a 2-prong socket.

  • Page 23: Startup

    Installation Warning  If the protective earthing (protective earth) system is not stable, the internal power supply should be used to supply voltage to the device. Note  If the equipotential earthing affects the functioning of the device, contact our Customer Service Department or agent. 3.6 Startup Press the Power ON/OFF key to start the power-on self-test, at the end of which, the boot LOGO will appear.
  • Page 24 Installation a cold surface. The lower the temperature is, the faster the condensation will be.

  • Page 25: Chapter 4 Basic Operations

    Chapter 4 Basic Operations Click the Main Menu icon ― ‖ to go to the main menu interface, where you can select [System Set], [Param Set] and [Maintance] to go to the corresponding interfaces. Click [Prev] or [Next] to go to the previous or next page when necessary. Note ...

  • Page 26: System Time

    Basic Operations 4.2.2 System Time Click [System Set], and then set the Year, Mth, Day and Time (hour, minute and second). 4.2.3 Fault Prompt Volume Fault prompts refer to the system error messages or sounds triggered upon failure of any function of the system caused by improper operation/use or system failure. When any fault occurs, the system will trigger a ―Ding-Ding-Ding‖...

  • Page 27: Param Set

    Basic Operations 4.3 Param Set No settings completed here will take effect unless you click [Enter] to enable them. 4.3.1 Inflation Speed Select [Param Set], and then click ―+‖ or ―-‖ to adjust the value of [Inflat Spd]. 4.3.2 Venous Fill Time [Param Set], and then click ―+‖...

  • Page 28: Stop Treatment

    Basic Operations Note  The device provides two independent output channels, supporting simultaneous use of up to 6 cuffs.  The cuff should be secured in such manner that no insertion of two fingers is allowed. 4.5 Stop Treatment During the normal treatment, you can press the Start/Pause key to stop the treatment. Note ...

  • Page 29: View Device Information

    Basic Operations 4.6.2 View Device Information Select [Maintance], enter the password and then enter maintenance screen. Click [Check] beside [Device Info] to view the [Software Version], [Compile Time] and [NK Version]. Such information is provided to help the manufacturer maintain and trace the device. 4.6.3 Fault Review In [Fault Review], you can view up to 200 latest fault events.

  • Page 30: Chapter 5 Battery

    Chapter 5 Battery 5.1 Overview The device is equipped with a built-in rechargeable battery. When AC power supply is connected, the battery can be charged automatically till full no matter whether the device is turned on or not. In the event of unexpected power outage, the system will automatically use the battery to supply voltage, thus to avoid interruption of device operation.

  • Page 31: Install Battery

    Battery Note  If the battery is to be left unused for a long period of time, please remove the battery and keep it properly.  If the device is provided with a built-in battery, the battery must be charged after each use to ensure sufficient battery reserve.

  • Page 32: Optimize And Check Battery Performance

    Battery Place the device with its back facing upward. Remove the screws with a screwdriver, and take out the old battery. Install the new battery into the battery case according the anode and cathode symbols Tighten the screws, and place the monitor straight. Warning ...
  • Page 33 Battery Check Battery Performance The battery life varies with the storage and operation environments, frequency of battery discharging and use time. The battery performance will degrade gradually even if the battery is not used. Here are the steps for checking the battery: First, determine whether the battery is damaged.

  • Page 34: Battery Recycling

    Battery 5.4 Battery Recycling If the battery is obviously damaged or runs out, it should be replaced. Waste batteries should be properly recycled in accordance with applicable laws and regulations or the rules of the hospital. Warning  Do not disassemble or short-circuit the battery or place it in fire; otherwise battery fire, explosion, leakage of hazardous gas or other hazards may be caused.

  • Page 35: Chapter 6 Maintenance

    Chapter 6 Maintenance 6.1 Maintenance Checks Before use of the device, or every 6-12 months or after each maintenance or upgrade, a comprehensive check, including functional safety check, of the device should be carried out by qualified technical maintenance personnel having received training. Items for checking should include: Check to see if the operating environment and the power supply for the device conform to relevant requirements.

  • Page 36: Reusable Accessory Service Life

    Maintenance endanger personal safety. Upon request by the user, Comen will conditionally provide relevant circuit diagrams to help the user to repair user-serviceable components of the device by appropriate and qualified technicians. Warning  The hospital or organization using this device should establish a sound maintenance plan;...

  • Page 37: Screen Calibration

    Maintenance 6.3 Screen Calibration Select [Maintance], and then click [Start] beside [Calibrate Screen] or press and hold the Start/Pause key on the panel to go to the screen calibration interface. Follow the instructions to click the marks on the screen. The system will exit the screen calibration interface automatically at the end of calibration.

  • Page 38: Fault Detection

    Maintenance 6.5 Fault Detection This function is designed to test whether the gas circuits have leakage faults. Connect cuffs to the device and click [Start] beside [Fault Detect] to start the inflation process, in order to test the air tightness of gas circuits. If the gas circuits pass this test, no message will appear.
  • Page 39 Maintenance Fault Detect Gas circ #1 leak: check ext tubing for connect #2 Test Cancel Warning  This leakage test is different from that specified in EN 1060-1 standards. It is designed to help the user test the existence of leakage faults occurring in the course of inflation.

  • Page 40: Chapter 7 Cleaning And Maintenance

    Please keep the device and its accessories dustless. After cleaning, please check the device carefully. If there is any evidence of ageing or damage, please stop using it immediately. If it is necessary to send back the device to Comen for repair, first clean it. Please observe the following precautions: Warning ...

  • Page 41: Cleaning Of Device And Accessories

    Cleaning and Maintenance  Never allow any liquid to flow into the housing.  Do not dry clean the instruments and accessories.  Do not let the fluid enter into the device and remove any residual fluid when cleaning and disinfecting accessories and the device. ...

  • Page 42: Disinfection Of Device And Accessories

    Cleaning and Maintenance tough conditions or very windy and dusty places, the cleaning frequency should be increased. Prior to cleaning, please first consult or understand relevant rules of your hospital on device cleaning. You are advised to use water, neutral soap,70% alcohol to clean the device.
  • Page 43 Cleaning and Maintenance for accessories). Disinfecting steps: Power the device off, and unplug the power cord. Use a soft cloth dipped with an appropriate amount of disinfector to wipe the housing of the device and the surface of accessories. Use a soft cloth dipped with an appropriate amount of disinfector to wipe the display screen of the device.

  • Page 44: Appendix I Accessories

    Appendix I Accessories Standard Accessories Type Materials Shape Inner cuff: TPU Reusable 3-cavity leg cuff FM-01 3-section Outer fabric: Nylon Reusable left-foot cuff FM-03 1-section Inner cuff: TPU Reusable right-foot cuff FM-04 Outer fabric: Nylon 1-section Optional Accessories Type Materials Shape Inner cuff: TPU Reusable 3-cavity calf cuff...

  • Page 45: Appendix Ii Product Specifications

    Appendix II Product Specifications Product Classification Electric shock protection class Class I, with internal power supply Electric shock protection level BF applied part, anti-defibrillation device with internal power supply. Balloon are of Type BF Working mode Continuous operation Explosion protection level Ordinary device, no explosion protection, not safe to work with inflammable respirator...
  • Page 46 Product Specifications Environmental Specifications Name Description Working conditions Ambient temperature 0℃~40℃ 15%~80% Barometric pressure 70kPa~106kPa Transportation/storage Suitable for land, air and sea transportation; to be protected against violent impact, shock, rain and snow during transportation Storage conditions (in packaged state): to be stored in a well-ventilated room free of corrosive gas (ambient temperature: -40 ℃...
  • Page 47 Product Specifications Frequency 50/60Hz Power Battery Name Description Battery type 11.1V 2200mAh Charging time In power-on state: ≤8h; in power-off state: ≤4h. fully charged) Powered by fully charged 2,200mAh battery and working under normal conditions (room temperature of 5℃± 5℃): working time ≥ Working time Treatment Parameters Name...
  • Page 48 Product Specifications normal operating position. Pressure indication error: ± 5mmHg. Adjustable range and errorof Therapy pressure: foot: 130 mmHg; leg: 45 mmHg therapy pressure Error: 5mmHg Ultimate pressure in cuffs: ≤300mmHg (holding Ultimate pressure time at >15mmHg(2kPa): ≤3min) Over-pressure protection The device has double over-pressure protection measures of software and hardware in place.
  • Page 49 Product Specifications device will relieve the patient pressure automatically (time of reducing patient pressure from the highest level to 15mmHg: ≤10s). Manual relief of pressure Time of reducing patient pressure from the highest level to 15mmHg: ≤10s Venous fill time Adjustable range:20s~60s Error: ±...
  • Page 50 Product Specifications deflate Resolution of 1mmHg pressure sensor Pressure error ± 5mmHg of cuffs <2mmHg in 1s Maximum leakage rate of gas circuits Cuff Description Name Description Airtightness of The cuff and connecting pipeline should have good airtightness, cuff keep it under 300mmHg pressure for 1min, and the pressure drop should not exceed 10% Cuff pressure...
  • Page 51 Product Specifications requirements. 10) OtherDescription Name Description Event 200 times of storage The noise during normal operation of the equipment should be no Working noise more than 60dB(A) II-7...

  • Page 52: Appendix Iii Fault Prompt Messages

    Appendix III Fault Prompt Messages When a system fault occurs, the correspondent fault messagewill pop up. Select [Enter] to move and save such fault message to the FaultReview page, or select [Cancel] to remove such fault message without saving it to the Fault Review page. The ―Power Low‖...
  • Page 53 Fault Prompt Messages placed correctly each part or replace a cuff. If cuff pressure is 10mmHg connected the fault still exists, contact reliably, or the us for repair service. more) higher gas circuit has a than leakage fault. predetermined therapy pressure in 2 consecutive cycles.
  • Page 54 Fault Prompt Messages battery –About to battery power power to charge the battery. battery power: shutdown If the fault still exists after shut down 6h charging, contact us for time starts to repair service. count down. Before pressing Select desired limb limb After...
  • Page 55 Fault Prompt Messages is interrupted. the device. If the fault error- Shut down!" appears persists, please contact the manufacturer for repair. external Check the X gas circuit, During the fault Gas circ #X leak- pipeline of X whether the external pipeline detection, Check ext tubing message "...

  • Page 56: Appendix Iv Default Settings

    Appendix IV Default Settings Treatment Parameters Name Description Therapy time 30min Venous fill time Therapy mode Mode 1 General Settings Name Description Level 6 Brightness Fault prompt volume Level 8 Pressure unit mmHg IV-1...

  • Page 57: Appendix V Emc

    Appendix V EMC Note  The device complies with the applicable EMC requirements in IEC60601-1-2.  Please follow the EMC instructions in the User’s manual to install and use the device.  Portable and mobile RF communication devices may affect the performance of the device.
  • Page 58 Grounding wire 2.5M Guide and Manufacturer’s Statement – Electromagnetic Emission The device is intended to work in the following electromagnetic environment. Please use it in such electromagnetic environment. – Electromagnetic Environment Emission Test IEC60601-1-2 YY0505 Guide RF emission Group 1 The device uses RF energy for its CISPR 11 internal functions only.
  • Page 59 GB 17625.2 Guide and Manufacturer’s Statement – Electromagnetic Immunity The device is intended to work in the following electromagnetic environment. Please use it in such electromagnetic environment. Immunity Electromagnetic IEC60601-1-2 – Test YY 0505 Environment Guide ± 8 kV Contact discharge; wooden, IEC61000-4- concrete or tile...
  • Page 60 GB/T 17626.5 <5% UT, duration = 0.5 Voltage sag, 0%UT;0.5 cycle The mains power cycle short supply should be At0° ,45° , 90° ,135° , interruption (UT sag >95%) of typical quality 180° ,225° , 270° and voltage commercial 315° change or hospital use.
  • Page 61 hospitals. Conduction 3Vrms 3Vrms150kHz~80MHz( Portable 2Hz) mobile 150kHz~80MHz(1K communication 61000-4-6 devices must be GB/T 6 V in ISM bands used 17626.6 between specified 0.15MHz~80 MHz distance from component this device and/or system (including cables). Such isolation distance calculated using appropriate equation selected based transmitter...
  • Page 62 immunity 80MHz~2.7GHz(1K 80MHz~2.5GHz(2Hz) recommended isolation 20V/m distance: 61000-4-3 6V in ISM bands 80MHz~2.5GHz GB/T between MHz~800 0601-2009, 17626.3 80MHz~2.7GHz MHz: YY0784-2010) d=1.2; 800MHz-2.5GHz d=2.3. above formula: – transmitter’s maximum rated output power (W) learnt from transmitter manufacturer; – recommended isolation distance (m).
  • Page 63 transmitters is measured by surveying electromagnetic field and should be lower than the coincidence level either frequency range This product cause interference nearby devices marked with following symbol:...
  • Page 64 Appendix VI Consideration for Environmentally Conscious Design Instructions for Minimizing Environmental Impact during Normal Use This part is compiled based on the requirements of Clause 4 Protection of Environment, 4.5.2 Instructions for minimizing environmental impact during normal use of IEC 60601-1-9. According to the requirements of this clause, manufacturer shall provide instructions for minimizing the environmental impact of the ME equipment during normal use in the accompanying documents.

  • Page 65: Appendix Vi Consideration For Environmentally Conscious Design

    Consideration for Environmentally Conscious Design with it in a collective way and put into the specified location where complying with the rules and regulations of the Local and the Hospital. If not specified, please follow the rules and regulations of the Local and the Hospital.
  • Page 66 Consideration for Environmentally Conscious Design and machine, the water and ethanol or isopropanol will be used and the waste liquid shall be thrown following the rules. During normal use, it is expected there Emissions during NORMAL USE will be some consumption of the medical (e.g.
  • Page 67 Consideration for Environmentally Conscious Design responsible organization with information for the proper disposal of the ME equipment at End of Life (EOL). And the manufacturer shall make available information to waste treatment facilities necessary for the environmentally responsible management of end of life ME equipment. The information shall contain the following items (Table 2).
  • Page 68 Consideration for Environmentally Conscious Design Do not place the battery in an environment whose temperature is above 60℃ （140℉） . Store the battery in the -20℃ （-4℉） to 60℃ (140 ℉ ) environment. Use the specified charger only. Read instructions for use. Maximum Recommended Ambient is 45℃...

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