SEOIL PACIFIC COMFORTCOUGH II User Manual
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SEOIL PACIFIC COMFORTCOUGH II User Manual

Mechanical in-exsufflator
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2195
C
C
II
®
OMFORT
OUGH
Mechanical In-Exsufflator [CC20]
USER MANUAL

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Summary of Contents for SEOIL PACIFIC COMFORTCOUGH II

  • Page 1 2195 ® OMFORT OUGH Mechanical In-Exsufflator [CC20] USER MANUAL...

  • Page 2: Table Of Contents

    Contents 1. Device Introduction �������������������������� 2 1.1 Device Name ����������������������������� 2 1.2 Intended Purpose ��������������������������� 2 1.3 Overview �������������������������������� 2 1.4 Applicable Disease ��������������������������� 2 1.5 Patient Interface ���������������������������� 2 1.6 Use Environment ���������������������������� 2 2. Important Safeguards ������������������������ 3 2.1 Warning ��������������������������������...

  • Page 3: Device Introduction

    1. Device Introduction 1.1 Device Name ● Device Name : COMFORTCOUGH II (Mechanical In-Exsufflator) ® ● Model Name : CC20 ● Medical Grade : Class II 1.2 Intended Purpose Caution : Federal law restricts this device is to sale by or on the order of a licensed healthcare practitioner.

  • Page 4: Important Safeguards

    ● The device is recommended to use the AC power cord provided with the device. Inappropriate power cable can cause overheat and damage. ● If any parts are replaced with inappropriate parts which are not provided by Seoil Pacific, it can lead Electromagnetic Interference or malfunction of the device.

  • Page 5: Caution

    ● Do not disassemble, open, drop, bend, transform or thirl a detachable battery pack. ● If you dropped or misused a detachable battery, stop using it and contact to Seoil Pacific or local sales manager. ● Do not remodel or re-manufacture the battery. Do not insert foreign material into the battery.

  • Page 6: General Description

    3. General Description 3.1 Front View On the front side of the device, there are Screen Panel, Control Panel and Patient Port. Screen Panel Control Panel Patient Port Part Function Screen Panel Shows all the set value/parameters and operating status. Control Panel Sets in-exhale pressure and time duration.

  • Page 7: Rear View

    3.2 Rear View On the backside of the device, there are Patient Air Inlet, Air Vent, Power Switch, etc. Handle Patient Hose Holder Patient SD Card Air Inlet Open to hold the patient hose Air Vent Battery Pack Air Vent POWER 100-240VAC SPO2...

  • Page 8: Package Contents

    4. Package Contents ® II provides the replaceable accessories as below. OMFORT OUGH All components are for single-patient use and must not be re-used for other patients to avoid the risk of cross-contamination. In case of repeated use for single patient, these parts must be completely washed and dried before re-use.

  • Page 9: Accessories (Optional)

    Pouch 1A6054 1A6053 European type Power Cable 1A6100 UL/CSA Type 4.2 Accessories (optional) 4.2.1 Foot Switch Foot Switch is optionally available for manual therapy. Foot Switch can be connected with the Foot Switch Connector on the back side of the device. If the Foot Switch is activated, the Manual Control Lever on front panel is deactivated.

  • Page 10: Operating Instruction

    5. Operating Instruction 5.1 LCD Screen (with Pressure Bar) The LCD screen displays the various parameters and operation status. To assist you in adjusting the device, the LCD is equipped with a backlight. The LCD backlight lights up when the device is turned on and goes out when the device is not in use more than 5 minutes.

  • Page 11: Lcd Screen (With Pressure Graph)

    5.2 LCD Screen (with Pressure Graph) The LCD screen displays the various parameters and operation status. To assist you in adjusting the device, the LCD is equipped with a backlight. The LCD backlight lights up when the device is turned on and goes out when the device is not in use more than 5 minutes.

  • Page 12: Lcd Screen (Automatic Mode/With Pressure Bar)

    5.3 LCD SCREEN (Automatic Mode/with Pressure Bar) The LCD screen displays the various parameters and operation status. To assist you in adjusting the device, the LCD is equipped with a backlight. The LCD backlight lights up when the device is turned on and goes out when the device is not in use more than 5 minutes.

  • Page 13: Lcd Screen (Manual Mode/With Pressure Graph)

    5.4 LCD Screen (Manual Mode/with Pressure Graph) The LCD screen displays the various parameters and operation status. To assist you in adjusting the device, the LCD is equipped with a backlight. The LCD backlight lights up when the device is turned on and goes out when the device is not in use more than 5 minutes.

  • Page 14: Lcd Screen (Percussor Mode)

    5.5 LCD Screen (Percussor Mode) The LCD screen displays the various parameters and operation status. To assist you in adjusting the device, the LCD is equipped with a backlight. The LCD backlight lights up when the device is turned on and goes out when the device is not in use more than 5 minutes.

  • Page 15: Lcd Screen(No Setting Mode)

    5.6 LCD Screen(No Setting Mode) The LCD screen displays the various parameters and operation status. To assist you in adjusting the device, the LCD is equipped with a backlight. The LCD backlight lights up when the device is turned on and goes out when the device is not in use more than 5 minutes.

  • Page 16: Control Panel

    5.7 Control Panel ⑤ ① ② ③ ④ Button Funtion Description START/ To start and stop the device. STOP Increase/ To increase and decrease the parameter. Decrease Control Lock is activated/deactivated by pushing Value ‘Up’ and ‘Down’ keys simultaneously in stop mode. Manual To manually change inhale to exhale phase or Control...

  • Page 17: How To Use The Device

    1. Please read this User Manual carefully before operating. 2. Use the provided power cable only. 3. Combined use with other devices without prior approval of Seoil Pacific Corp. can cause malfunction or unexpected results. Please pay attention when you use the device.
  • Page 18 6.1.2 Patient Circuit Assembly Place the device on a stable and flat area within operator’s easy reach. Make sure not to block the patient air inlet and air vent. 1. Attach the patient interface to the patient hose. 2. The patient interface are such as an connector and face mask, mouthpiece, endotracheal tube or tracheostomy tube.
  • Page 19 6.1.4 Install and Use a Detachable Battery 1. Put a detachable battery on the backside of the device. Insert the battery softly until “click” sounds in order to lock it. 2. The battery provides power in case AC Power isn’t available. 3.

  • Page 20: Initial Setting

    6.1.6 Disuse of a Battery A battery has to be discarded in accordance with local regulations. 6.1.7 Battery Specification 1. Voltage : 14.8VDC 2. Capacity : 84Wh(Standard) 3. Battery type : Lithium-ion 4. Operating temperature : 5℃~40℃ 5. Storage temperature : -20℃~60℃ 6.

  • Page 21: Change A Menu Setting

    6.3 Change a Menu Setting Menu Settings Options Data Clear Patient Data Remove SD Card Patient data to SD Card Format SD Card ※ The above screen shows various menu settings. It will be displayed when you stop the device and press MENU button. If you choose a menu item and press ENTER button, the device will show relevant setting values.
  • Page 22 4. Cough-Sync: Select Cough-Sync menu and press ENTER button. Set the Cough-Sync by pressing ‘▲(UP)/▼(DOWN)’ button and then ENTER button. 5. Inhale Pressure : Select Inhale Pressure menu and press ENTER button. Set the inhale pressure from 0 to 70cmH2O by pressing ‘▲(UP)/▼(DOWN)’ button and then ENTER button. 6.
  • Page 23 ※ Note: - The graph below is an example of Oscillation setting. - Oscillation : Inhale pressure : 40cmH20, Exhale pressure : 40cmH2O, Amplitude : 10cmH2O, Frequency : 10Hz. - Red line shows a pressure curve when the oscillation is not applied. - Blue line shows a vibration and pressure waveform when the oscillation is applied.
  • Page 24 Settings Preset Mode Percussor Inhale Pressure 70 cmH2O Percussor Frequency 780 CPM Percussor Time Minute 5 min Percussor Time Sec 30 sec I/E Ratio 14. Inhale Pressure : Select Inhale Pressure menu and press ENTER button. Set the inhale pressure from 0 to 70cmH2O by pressing ‘▲(UP)/▼(DOWN)’button and then ENTER button.
  • Page 25 page 2/2 Options Hour Minute Therapy Hours 0 hour 59 min 1. Language : Select Language menu and press ENTER button. Set the language among English, Chinese, Japanese, German, Spanish and Portuguese, Slovenian, and others by pressing ‘▲(UP)/▼(DOWN)’ button and then ENTER button. 2.
  • Page 26 ③ Data page 1/2 Data SD Card Capacity 7.26GB free of 7.27GB Serial Number 1705A6122 Software Version 1.05 Model Number CC20 Therapy Hours 0 hour 20 min Calibration Date 2017-05-11 Detachable Battery SN 1705E1100 page 2/2 Data Detachable Battery Cycles 1.
  • Page 27 ④ Clear Patient Data Clear Patient Data? - Clear Patient Data : Clear the data of the patient recorded in the device. ⑤ Remove SD Card Remove SD Card? - Remove SD Card : Remove SD Card from the device safely.
  • Page 28 ⑥ Patinet data to SD Card Patient data to SD Card? - Patient data to SD Card : Patient data copy to the SD card ⑦ Format SD Card Format SD Card? - Format SD Card : Format the SD Card. Do not remove the SD card during formatting.

  • Page 29: Setting & Using The Automatic Mode

    6.4 Setting & Using the Automatic Mode * The above screen displays pressure as graph. The pressure can be displayed as bar. Please refer to the 6.3 Change a Menu Setting for changing the setting. 1. Connect the patient circuit to the device. 2.

  • Page 30: Setting & Using The Manual Mode

    6.5 Setting & Using the Manual Mode *The above screen displays pressure as graph. The pressure can be displayed as bar. Please refer to the 6.3 Change a Menu Setting for changing the setting. 1. Connect the patient circuit to the device. 2.

  • Page 31: Setting & Using The Percussor Mode

    6.6 Setting & Using the Percussor Mode *Only pressure bar can be displayed in Percussor Mode. When using Percussor Mode, at the pressure range of 50~70cmH2O, we highly recommend to use the device within 5 minutes. If you use the device more than 5 minutes, it may lead to get “Temp.”...

  • Page 32: Operation Verification

    6.7 Operation Verification It is recommended that the device is to be periodically tested to ensure that the cycling valve returns to the pause position after either the inhale or exhale phase. To determine this, follow these steps. 1. Turn on the device. 2.

  • Page 33: Cleaning & Disinfection

    4. Wash the filter with a mild detergent and water and rinse it thoroughly. 5. Dry the filter completely and re-insert it to the device. If the filter is damaged, replace it. Only use the filter provided by Seoil Pacific. 7.4 Preventive Maintenance The device doesn’t need a preventive maintenance service.

  • Page 34: Storaging

    8. Storaging 8.1 How to store 1. If not in use for more than a year, the device must be checked by trained personnel per year. 2. Be sure to store the device away from water source. 3. Be sure to store the device to prevent dust from outside. 4.

  • Page 35: Specifications

    9. Specifications 9.1 Information Device Name ® Ⅱ OMFORT OUGH Model Name CC20 Mechanical In-Exsufflator(MI-E) helps to clear bronchial secretions when Intended Purpose patients can’t cough by themselves. How to Use Refer to the manual Rated Voltage 100-240V~ Rated Frequency 50/60Hz Rated Power 120VA...

  • Page 36: Emc Information

    10. EMC Information 10.1 Guidance and manufacturer’s declaration – electromagnetic emissions Guidance and manufacturer’s declaration – electromagnetic emissions The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance...
  • Page 37 Guidance and manufacturer’s declaration – electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. IEC60601 test Immunity test Compliance level Electromagnetic environment - guidance level...
  • Page 38 Recommended separation distances between portable and mobile RF communications equipment and this device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are con- trolled. The customer or the user of this device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and this device as recommended below, according to the maximum output power of the communications equipment.

  • Page 39: Symbols

    11. Symbols The labels or labeling for this device may have the following symbols which have the meaning described below. Symbol Description Read the accompanying manuals “ON” for part of equipment “OFF” for part of equipment Attention, consult instruction manual Type BF Equipment Manufacturer Date of Manufacture...
  • Page 40 Symbol Description IP22 Protected against finger sized objects protection against vertically falling water drops. Foot Switch Foot Switch remote control USB connector Oximeter connector SpO2 Alternating current Direct current Lithium Ion battery Li-Ion Catalogue number Serial Number Compliant with the waste electrical and electronic equipment and restriction of the use of certain hazardous substances in electrical and electronic equipment (WEEE/RoHS) recycling directives.

  • Page 41: Trouble Shooting

    90 days from the purchasing date from the authorized dealer. If the device fails under conditions of normal use, Seoil Pacific Corp. will repair or replace, at its option, the defective device or any of its components.

  • Page 42: Quality Warranty Certifications

    ※ This certificate promises free repairs based on mentioned period and terms. Therefore, this certificate does not limit customer’s legal rights. If you have any questions about service and repairs after the warranty period, please contact Seoil Pacific Service Center or your sales manager.
  • Page 43 MEMO...
  • Page 44 DOC NO. : CC20E-R6 PRINTED DATE : 2020.03 Advena Ltd. SEOIL PACIFIC CORP. Rm.515,516 Ace high-end tower, 5, Digital-ro 26-gil, Tower Business Center, 2nd. Flr., Tower Street, Swatar, BKR 4013 Malta. Guro-Gu, Seoul 08389, KOREA T: +44 1926 800153 TEL: +82 2 325 2106 FAX: +82 2 325 2107...

This manual is also suitable for:

Cc20

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