1. Manuals
  2. Brands
  3. REMEDI Manuals
  4. Medical Equipment
  5. REMEX-KA6
  6. User manual

REMEDI REMEX-KA6 User Manual

Portable x-ray equipment
Hide thumbs
Table of Contents

Advertisement

Quick Links

Download this manual
0068
REM-IFU-KA6
User Manual
REMEX-KA6
Portable X-ray Equipment
Copyrightⓒ2020
DOC No: REM-IFU-KA6 Rev.1
REMEDI Co., Ltd.
1
48
REMEX-KA6
/
VER 1(2021.03.02.)

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the REMEX-KA6 and is the answer not in the manual?

Questions and answers

Summary of Contents for REMEDI REMEX-KA6

  • Page 1 0068 REM-IFU-KA6 User Manual REMEX-KA6 Portable X-ray Equipment Copyrightⓒ2020 DOC No: REM-IFU-KA6 Rev.1 REMEDI Co., Ltd. REMEX-KA6 VER 1(2021.03.02.)
  • Page 2 #24232, 2F, 69-14, Sakju-ro 145beon-gil, Chuncheon-si, Gangwon-do, Korea Tel: +82-2-6390-5891 Fax: +82-2-6390-5892 This User Manual may be revised for the improvement of the product, without prior notification. Images in this User Manual may differ from the actual product. REMEX-KA6 VER 1(2021.03.02.)

  • Page 3: Table Of Contents

    4.4 Storage and cleaning after use ······························ 21 4.5 Procedure allowing measurement of the radiation quantity ·················· 21 4.6 Error message ····································· 22 5. Product Warranty Policy ································· 23 6. Maintenance ······································· 26 7. Statement and tables for EMC ······························· 28 REMEX-KA6 VER 1(2021.03.02.)
  • Page 4 0068 REM-IFU-KA6 8. Product warranty policy ································· 32 REMEX-KA6 VER 1(2021.03.02.)

  • Page 5: About User Manual

    This User Manual only pertains to the REMEX-KA6 and does not serve for any other products of the company. In the event of loss of or damage to this User Manual, please contact to service center of REMEDI Co., Ltd.
  • Page 6 0068 REM-IFU-KA6 The symbols represent important cautions and advice to the user. Please read the following symbols carefully and be well informed of them for the use and storage of the product. REMEX-KA6 VER 1(2021.03.02.)
  • Page 7 * Countries other than English shall be produced in the language of the country in accordance with the translation guidelines of REMED Co., Ltd. *User manual applied Country Country Application Country Application Country Application Italy Denmark France Portugal Russia Germany Netherlands Poland Spain Swiss Ukraine Belgium Sweden Others REMEX-KA6 VER 1(2021.03.02.)

  • Page 8: Precautions

    Please read and understand the instructions carefully and then use your device. No modification of this equipment is allowed. If the product is modified or used for any purpose other than those specified in this User Manual, REMEDI will not be responsible for the safe operation of the REMEX-KA6.
  • Page 9 After laying the tube tank, the amount of oil is checked through a transparent X-ray irradiator. If air bubbles or empty spaces are identified, there is leakage, so use the device should be stopped and contact the manufacturer for repair. REMEX-KA6 VER 1(2021.03.02.)
  • Page 10 0068 REM-IFU-KA6 REMEX-KA6 VER 1(2021.03.02.)

  • Page 11: Appearance And Specifications

    3. Appearance and Specifications 3.1 Intended Use REMEX-KA6 Portable X-ray Equipment is intended to be used by a qualified and trained clinician as an x-ray source for producing diagnostic x-ray images using image receptors. Its use is intended for adult, child subjects.

  • Page 12: Specification

    - Whole body 4) Operating principle - REMEX-KA6 generates and controls X-rays using the power of the built-in battery, and irradiation is absolutely prohibited during charging. X-ray control is controlled by the designed electronic circuit and MCU, and among the conditions necessary for shooting, the tube voltage is from 40 kV to 70 kV and the tube current is from 2 mA to 6 mA.
  • Page 13 Irradiation time accuracy: less than ±(10% + 1 ms) Essential performance Tube current time accuracy: ± (10 % + 0.2 mAs) - Reproducibility of the radiation output: The coefficient of variation of measured values of air kerma: less than 0.05 REMEX-KA6 VER 1(2021.03.02.)
  • Page 14 0.009799mGy 6 mA 2.0 s 0.331055mGy - RADIATION dose delivered to the PATIENT Value Value Tube voltage 70 kV Tube current 6 mA Exposure time 0.06 s (Min.) 2.0 s (Max.) 1.22 uGyㆍm 46.12 uGyㆍm RADIATION dose REMEX-KA6 VER 1(2021.03.02.)

  • Page 15: Safety Standards

    X-ray equipment for EN 60601-2-54:2009 radiography and radioscopy IEC 62304:2006 Medical device – Software life cycle EN 62304:2008/AC:2008 IEC 62366:2008 Medical devices - Application of usability engineering to medical devices EN 62366:2008 REMEX-KA6 VER 1(2021.03.02.)

  • Page 16: Appearance

    - Hands and feet: size 12 inch X 10 inch X-ray exposure button Press this button to exposure the X-ray. Eyelet for strap Eyelet for strap Exposure status LED When the X-ray is irradiated, the yellow LED is turned on. REMEX-KA6 VER 1(2021.03.02.)
  • Page 17 Exposure status LED When the X-ray is irradiated, the yellow LED is turned on. 3.4.2 Rear view of Main body Name Description Battery cover Remove this cover to replace a rechargeable battery. Charging port Connector for charging REMEX-KA6 VER 1(2021.03.02.)
  • Page 18 Standby status LED when X-ray irradiation. Power button Turn ON/OFF Name Description Indicates the current status of the device. : “Ready” condition. Status : “Exposure” condition. After exposure the X-ray, symbol is disappeared and “READY” is remained. REMEX-KA6 VER 1(2021.03.02.)
  • Page 19 55 kV, 6 mA, 0.50s (Kid) - Head mode : 70 kV, 6 mA, 1.50s (Adult) 70 kV, 6 mA, 1.30s (Kid) - Abdomen mode : 70 kV, 6 mA, 2.00s (Adult) 70 kV, 6 mA, 1.20s (Kid) REMEX-KA6 VER 1(2021.03.02.)

  • Page 20: Dimension

    3.5.1 Main body(LED Cone and Laser cone(Option)) - size: 165.3(Length) ✕ 176(Height) ✕ 255.6(Width) mm - weight: 2.4 kg (including cone 190 g) 3.5.2 AC/DC adapter and power cord - size: 115(Length) ✕ 30(Height) ✕ 50(Width) mm - weight: 250 g REMEX-KA6 VER 1(2021.03.02.)

  • Page 21: Hand Strap

    3.5.4 Wired remote control switch(Option) : External switch for X-ray irradiation at 3m distance - size: Ø 30 ✕ 3000 mm - weight: 120 g 3.5.5 Hand strap - size: 130(Length) mm ✕ 43(Width) mm, strap length 333 mm - weight: 20 g REMEX-KA6 VER 1(2021.03.02.)

  • Page 22: Operating Condition

    - Atmospheric pressure: 80 kPa ~ 106 kPa - Altitude: Less than 2,000 m 3.7 Storage and transportation condition - Temperature: -40 ℃ ~ 70 ℃ - Related Humidity: 5 %R.H. ~ 95 %R.H. (Non-condensing) - Atmospheric pressure: 76 kPa ~ 106 kPa REMEX-KA6 VER 1(2021.03.02.)

  • Page 23: Symbols

    Follow instructions for use Product Label Note User manual General Caution, Warning (safety sign) User manual Warning: Electrical Inside of equipment General Prohibition (safety sign) User manual Alternating current Product Label Direct current Product Label Keep dry Package REMEX-KA6 VER 1(2021.03.02.)
  • Page 24 Operating Atmospheric pressure range Product Label Storage Atmospheric pressure range Package 0068 CE marking, Complies with european Package medical devices directive Product Label Package WEEE Mark Product Label Warning: Hight voltage Inside the device Product Label Radiation hazard Product enclosure REMEX-KA6 VER 1(2021.03.02.)

  • Page 25: Labels

    0068 REM-IFU-KA6 3.9 Labels of Main body Label location: on the Bottom of equipment / REMEX-KA6 3.10 Label of AC/DC adapter connector Label location: Near the AC/DC adaptor connector 3.11 Label of Cone Label location(Applied part): near the connector of the cone 3.12 Label of Radiation hazard...
  • Page 26 Label location: On the high voltage tank house(Inside the device) 3.16 Wired remote control switch Label location: On the hand grip of the switch 3.17 Laser Cone (Option) Label location(Applied part): near the connector of the cone REMEX-KA6 VER 1(2021.03.02.)
  • Page 27 0068 REM-IFU-KA6 3.18 Label of protective cover Label location: On the cover REMEX-KA6 VER 1(2021.03.02.)

  • Page 28: How To Use

    - Checking “Display LCD” - Pushing “X-ray exposure button” 4.2 Pre-procedure 1. The operator of REMEX-KA6 must be a qualified and trained clinician having received appropriate license. 2. Understand warnings, cautions and user manual. 3. Check the Charging condition of battery before use. If the battery is not charged enough, charge the battery using AC/DC adapter.

  • Page 29: Operation Procedure

    - The case thickness of water equivalent phantom is less than 10 mm, the material of it is PMMA. The size of it is 250 × 250 × 150 mm - In this area, the all performance of REMEX-KA6 can be used. - Operator Dose rate in center of the significant zone of occupancy: 20 μGy/h 4.3 Operation procedure...
  • Page 30 1. Press ON button for a few seconds (about 2s ~ 3s) (No.4 button in [Figure 2]), and turn on the REMEX-KA6. 2. Change the default setting as intended use. Tube voltage range is 40 kV ~ 70 kV, tube current range is 2 mA ~ 6 mA, exposure time range is 0.06 s ~ 2.0 s and it can be set using ↑(up), ↓(down) button.
  • Page 31 The change in SSD affects the patient's radiation dose, the shorter the SSD, the greater the patient's radiation dose, and the longer the SSD, the less the patient's radiation dose. REMEX-KA6 VER 1(2021.03.02.)

  • Page 32: Storage And Cleaning After Use

    - Place the dosimeter(μGy) on the surface of the center of the one side of the water equivalent phantom(The phantom should be filled with pure water free of bubbles.). - Place the REMEX-KA6 on the surface of the center of the opposite side of the water equivalent phantom.
  • Page 33 When user presses The device turned off after Exposure button exposure button more ERROR 5 display “Error 5” on the LCD with error than 10 seconds after the single buzzer sounds. X-ray exposure. REMEX-KA6 VER 1(2021.03.02.)
  • Page 34 5.3 X-ray tube assembly - Tube voltage range: 40 kV ~ 70 kV - Tube current range: 2 mA ~ 6 mA - Focal spot size: 0.4 mm - Inherent filtration: Min. 1.0 mmAl - Type: stationary REMEX-KA6 VER 1(2021.03.02.)
  • Page 35 - Maximum Anode Heat Dissipation Rate: 430 W - X-ray tube weight: 260 g - X-ray tube drawing - X-ray tube Characteristic curve Emission & Filament characteristics Anode Thermal characteristics Max. rating charts (Absolute Max. rating charts) REMEX-KA6 VER 1(2021.03.02.)
  • Page 36 - Size: 102(Length)✕39(Height)✕39(Width) mm 5.7 AC/DC adapter (This power supply is specified as a part of ME equipment.) - Model name: YHY-24002000 - Manufacturer: SHENZHEN YINGHUIYUAN ELECTRONICS CO., LTD - Rated input: 100-240 Va.c., 50/60 Hz, 1.5 A REMEX-KA6 VER 1(2021.03.02.)
  • Page 37 0068 REM-IFU-KA6 - Rated output: 24 Vd.c., 2.0 A REMEX-KA6 VER 1(2021.03.02.)
  • Page 38 - X-ray sensitive area: 430.08 x 430.08mm 5.11 Protection against Residual Radiation - To avoid residual radiation caused by using of REMEX-KA6, the operator should stay in the Significant zone of occupancy described in section 4.3 of this user manual and the alinement between the patient and REMEX-KA6 should be kept like [Figure 2].
  • Page 39 - Only qualified people can check this equipment. - Check items according to the Regulations of the country. - Inspection period: 1 time / 1 year - If the result is not satisfied the criteria, please contact to manufacturer. REMEX-KA6 VER 1(2021.03.02.)
  • Page 40 The device shall be disposed of in accordance with the country's specified procedures. Or It must be returned to the manufacturer for disposal. Please contact to Service center of REMEDI Co., Ltd. 6.4 Circuit diagram, component part list, etc to repair certain parts of the device The circuit diagrams, component part lists, etc required to repair the device could be provided upon request.
  • Page 41 Table 1 - ELECTROMAGNETIC EMISSIONS – for REMEX-KA6 Guidance and manufacturer’s declaration – electromagnetic emissions REMEX-KA6 is intended for use in the electromagnetic environment specified below. The customer or the user of the REMEX-KA6 should assure that it is used in such an environment.
  • Page 42 Table 2 – electromagnetic IMMUNITY – for REMEX-KA6 Guidance and manufacturer’s declaration – electromagnetic immunity The REMEX-KA6 is intended for use in the electromagnetic environment specified below. The customer or the user of the REMEX-KA6 should assure that it is used in such an environment.
  • Page 43 0068 REM-IFU-KA6 REMEX-KA6 VER 1(2021.03.02.)
  • Page 44 Table 3 electromagnetic IMMUNITY – for REMEX-KA6 that are not LIFE-SUPPORTING Guidance and manufacturer’s declaration – electromagnetic immunity The REMEX-KA6 is intended for use in the electromagnetic environment specified below. The customer or the user of the REMEX-KA6 should assure that it is used in such an environment.
  • Page 45 0068 REM-IFU-KA6 REMEX-KA6 VER 1(2021.03.02.)
  • Page 46 Recommended separation distances between portable and mobile RF communications equipment and the REMEX-KA6 The REMEX-KA6 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the REMEX-KA6 can help prevent electromagnetic interference...

  • Page 47: Product Warranty Policy

    Homepage: http://www.remedihc.com REMEDI Co., Ltd. homepage is available to you and provides a page where you can let us know if you have any complaints. If you have experienced any inconveniences during the use of our product or have any suggestions for improvement, except for product defects, please feel free to contact us and help us incorporate your ideas.
  • Page 48 0068 REM-IFU-KA6 Contact: Tel: +49 6196 4021549, Email: info@javitech.de 0068 REMEX-KA6 VER 1(2021.03.02.)

Table of Contents

Save PDF