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EcoNet meX+20BT User Manual

Battery powered portable x-ray system
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  • Page 2 / For Human Battery Powered Portable X-ray Product Manual (Operation & Service) Version 2.1 2021-04-15 Im Erlengrund 20 D-46149 Oberhausen Handelsregister / Trade Register: Duisburg HRB 25273 Tel.: +49 (0) 208 377 890 – 23 E-Mail: info@medical-econet.com...
  • Page 3 TABLE OF CONTENTS PART 1: OPERATION MANUAL ......................4 1. General Description ......................... 4 2. Operational Safety ........................... 9 3. Operating Environment ........................16 4. Radiation Safety ..........................17 5. System Configuration ........................17 6. Basic Functions ..........................19 7. Specifications ..........................20 8.
  • Page 4 (1) Introduction Thank you for purchasing the meX+20BT, BATTERY POWERED portable x-ray system. The meX+20BT is the lightest weight, most compact sized high frequency x-ray machine on the market today. All medical ECONET Portable series x-ray units are equipped with ripple free, high frequency generators that produce up to 40~50% stronger power output efficiency when compared to conventional x-ray systems.
  • Page 5 SAFETY SYMBOLS The following safety symbols will be used in the equipment. Their meaning is described below. Protective earth (ground) Alternating current Caution ON (power) Non-ionizing radiaion OFF (power) General prohibition sign Ionizing radiation Type B Applied Part General warning sign Warning, electricity Refer to instruction manual Date of manufacture...
  • Page 6 Indication: The medical ECONET Battery Type Portable X-ray Unit is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts.
  • Page 7 ECONET certifies that each system complies with the Radiation Control for Health Safety Act in Title 21, Chapter I, subchapter J of the Code of Federal Regulation in the USA and EN 60601, general requirements for radiation protection in diagnostic X-ray equipment for IEC 601-1-3 in European Nations.
  • Page 8 (5) The coefficient of variation of measured values of air kerma shall not be greater than 0.05 for any combination of loading factors. Note: The device fundamental performance shall be tested once a year contacting medical ECONET service or a qualified agent.
  • Page 9 2. Operational Safety 1) Safe Use Expected service-life of medical ECONET X-ray units is 7 years if the device is handled in compliance with this manual. Please see the manufacture date on the device label. 2) General Rules for Safe Use The user’s safety, ease of operation and product reliability are our major concerns in the design of...
  • Page 10 electromagnetic disturbances was performed. The device may be susceptible at levels below Refer to ‘1.7 Essential Performances’ of the X-ray IEC60601-1-2 immunity test levels. units. One of Error Codes among #10 to #19 shown in ‘4. Error Codes and Countermeasures’ will appear, if the Essential Performance is lost or degraded due to EM disturbances.
  • Page 11 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The meX+20BT is intended for use in the electromagnetic environment specified below. The customer or the user of the meX+20BT should assure that it is used in such an environment. Emission test Compliance...
  • Page 12 Mains power quality should be for 0,5 cycle for 0,5 cycle that of a typical commercial or hospital environment. If the user of the meX+20BT (60% dip in (60% dip in requires continued operation Voltage dips, short for 5 cycles...
  • Page 13 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the meX+20BT is used exceeds the applicable RF compliance level above, the meX+20BT should be observed to verify normal operation. If abnormal performance is observed, additional measurements may not necessary such as reorienting or relocation the meX+20BT.
  • Page 14 The meX+20BT is intended for use in the electromagnetic environment controlled Radio Frequency (RF) interference below. The user of the meX+20BT should prevent electromagnetic interference between the products and portable and mobile RF communications equipment (such as transmitter).You should follow below indications according to maximum output of communication equipment.
  • Page 15 Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure. (1) The laser beam is emitted from the front of meX+20BT (2) Do not place the laser pointer for direct eye exposure.
  • Page 16 3. Operating Environment 1) For proper operation and the longevity of your system, please avoid exposing this equipment to the following conditions: (1) Exposure to water vapor. (2) Direct exposure to sunlight for prolonged periods of time. (3) Exposure to heavy air contaminants and/or dust. (4) Exposure to high humidity conditions.
  • Page 17 This device consists of the following components: Portable X-ray Unit (include Hand-switch) These components are only provided by the manufacturer (medical ECONET). The unit is for generating accurate X-ray source for diagnosis only, and X-ray cassette or FPD for receiving X-ray images can be provided on the request of purchase.
  • Page 18 The following items should be firmly fixed and connected for proper functionality: 1) meX+20BT components A. Operation Panel B. Ultra Capacitor C. DRV BOARD (INVERTER) D. Capacitor Charger Board E. HV Tank including X-ray Tube F.
  • Page 19 6. Basic Functions 1) kV and mAs Settings A. Select the kV and mAs values using the kV & mAs up/down switchs. B. APR (Anatomical Programming Radiography) Mode: Users can select kV and mAs values and save them into 4 pre-set memory locations. 2) Parameter selection by the operator (kV/mA).
  • Page 20 7. Specifications 1) ELECTRONIC SPECIFICATION Contents Specification Input Power Equipment power supply DC16.8 V±0.1 V / 1.5 A Charger power supply 100~240 VAC, 50/60 Hz MODEL PK-LCH-AD22 Output Power Max. Output 1.6 kW Max. kV / mA 100 kV / 20 mA Tube Voltage Range [kV] 40 ~ 100 kV in 1kV steps mAs Range [mAs]...
  • Page 21 2) Main Body and Carrying Case (1) Main Body (2) Carrying Case...
  • Page 22 3) X-ray Tube Specifications (1) General details A. Model name (manufacturer): D-124 (Canon) B. Tube Voltage Range: 40 ~ 100kV C. Focus size: 1.2×1.2mm D. Input power (per second): 2400W E. Anode heat index: 14kJ(20kHU) F. Maximum Anode Heat runout rate: 180W (250 HU/s) (2) Filament characteristic curve (3) Maximum Output Graph...
  • Page 23 (4) Anode Heat characteristic curve (5) Dimension...
  • Page 24 8. Parts Description 1) Part Names ( 1 ) ( 8 ) Measuring Tape Collimator Operation panel Battery charge connector Handle bumper Handle Hand switch connector Collimator knob...
  • Page 25 2) OP Console and Panel Display [13] [11] [10] [12] [14] Ready Lamp APR Switch (1~5) X-ray Lamp APR Storage Switch Wait Lamp [10] Collimator Lamp/Laser Switch kV Display [11] Reverse Display Switch kV Up/down Switch [12] Power Switch mAs Display [13] Battery Leftover Indicator mAs Up/down Switch...
  • Page 26 [4] kV Display Displays the kV value for X-ray exposures (refer to Table 1, unit specifications for usable kV scopes). [5] kV Up/Down Button Allows the user to input the kV value for x-ray exposures. The kV value will decrease/increase by -/+1 with every push of the button (refer to Table 1, unit specifications for usable kV scopes).
  • Page 27 The [4] kV and [6] mAs values can be displayed in reverse for when using this unit in an upside down position. [12] Power Button Powers the unit on and off. [13] Battery Residual Indicator It displays battery charge level with 5 steps. When battery charge drops to an insufficient level, the [4] kV Display and [6] mAs display will show, “bt_Lo.”...
  • Page 28 3) Label Attachment Location (1) Main Body Label Warning: This X-ray unit may be dangerous to patient and operator unless safe exposure factors and operation instruction are observed...
  • Page 29 Please check the connection between the power cable and the other cables before operating the equipment and producing exposures. WARNING In case of any trouble, power down the unit immediately and contact medical ECONET or an authorized distributor. 2) Collimator & Laser point check list...
  • Page 30 (1) Place the loaded cassette on the patient’s backside. (2) Arrange the SID (Focal Spot to Image Receptor Distance) using a scale located on the side of the collimator. (3) Turn on the collimator lamp and laser pointer by pressing collimator/laser on switch. (4) Arrange the X-ray beam size in accordance with the film size using the X-ray collimator handle.
  • Page 31 10. Standard Operating Procedures 1) General Mode A. Connect the hand switch to meX+20BT’ main body via the provided hand switch cord. CAUTION Only use accessories provided by medical ECONET. 3rd party accessories are not compatible and may cause serious damage to your unit.
  • Page 32 B-v) after showing battery remains, X-ray exposure Display Mode will be shown. C. The “Wait LED” will be lit while the Ultra Capacitor is charging. Initial charge time: 1 minute 10 seconds. Post-exposure recharge time: 35 seconds. (under 50mAs exposure conditions) D.
  • Page 33 2) APR Mode A. After turning your unit on, the below display will appear: B. Select 1-5 APR switch. (15 APR switches are available) Switch Combinations : 1, 1+2, 1+3, 1+4, 1+5, 1+6, 2, 2+3, 2+4, 2+5, 2+6 3, 3+4, 3+5, 3+6, 4, 4+5, 4+6, 5, 5+6, 6 C.
  • Page 34 REFERENCE When selecting an APR Mode, the latest memory setting will be recalled and displayed automatically. 11. Remote Control 1) Introduction The remote control hand switch is capable of controlling all technical parameters, collimator lamp and laser pointer functions. The hand switch is designed with two stages or steps. The first stage of the hand switch preps and readies your unit while the second stage of the hand switch controls the exposure.
  • Page 35 3) kV Selection Rapidly click the hand switch 3 times to the “Ready Step” position. The APR selection LED, kV and mAs display will begin to flash. Press the “Ready Step” of hand switch one time while the APR switch is flashing and you are ready to enter the kV setting mode. Click the hand switch once to move the kV value by one.
  • Page 36 Wireless RF devices (main & sub-modules) are optional accessories (e.g. DR flat panels) to be integrated with the meX+20BT generator and a DR controller computer. RF mode setup is only applicable with compatible DR systems. The RF Mode should be set to the “OFF”...
  • Page 37 Down button = RF OFF E. After making your selection, press and hold the LAMP button for 3 seconds and wait for 2 audible beeps that will confirm your selection has been successfully saved into the meX+20BT PROM Memory. 8) DAP Display...
  • Page 38 (EMC) 1) General meX+20BT X-ray Units fulfill the requirements on electromagnetic compatibility according to EN 60601-1- 2:2015 (Ed. 4). The equipment is built so that the generation and emission of electromagnetic interference is limited to the extent that other devices are not disturbed in their use in accordance with the regulations and so that the equipment itself is suitably immune to electromagnetic interference in hospitals, transports and home healthcare use environment.
  • Page 39 Electromagnetic environment – guidelines Emissions test Compliance The medical ECONET Portable X-ray Unit uses RF energy RF emissions only for its internal function. Therefore, its RF emissions are CISPR 11.
  • Page 40 13. Cleaning and Disinfection The following cleaning solutions will not harm the models meX+20 lite , meX+20BT, meX+20BT lite, meX+40, meX+40BT, and meX+60 X-ray Units. • Gentle dish soap and water • Dry microfiber cleaning cloth or a chamois (static-free cloth without oil) •...
  • Page 41 Only within the term of the warranty is the customer entitled to warranty services and only on condition that he or she informs medical ECONET of the defect in writing within two months after the date the defect was discovered.
  • Page 42 - Swelling caused by a variety of non-ideal chemical reactions including: overcharge, elevated temperature aging, and moisture intrusion, and - air cargo incidents are caused by mechanical damage or external short circuiting of cells Standards and regulations that apply to the transport of medical ECONET Battery Type X-ray Unit Air Freight...
  • Page 43 In the following cases the manufacturer declines all liability: If you have any questions, contact your dealer or medical ECONET. • Use of medical ECONET Portable X-ray Unit for purposes and applications that differ from the specific requirements made in this User Manual.
  • Page 44 17. Disposal of the Product Comply with your national regulations, guidelines and requirements for the disposal of end-of-life electrical equipment and batteries. Specialist Medical Device dealers will be pleased to provide you with country-specific information concerning disposal. Make sure the product or battery is not mixed with other types of waste when it is being disposed of. Prior to disassembly and disposal your device must not be contaminated and must have been completely reprocessed (Cleaning/Disinfection).
  • Page 45 Ionized radiation may be dangerous to patients and operators unless the following safety regulations are strictly observed. 1.2. This manual is designed to ensure correct use and operation of the meX+20BT. Please read this manual entirely before using this equipment.
  • Page 46 2. Regular Maintenance 2.1. Overview This device should be inspected regularly in accordance with the instructions described in this manual. 2.2. Periodical Inspections 1) Every 6 Month: A. Check all visual displays: display readout windows (FNDs), LEDs and other indicators. B.
  • Page 47 3. Block Diagram...
  • Page 48 4. Calibration * Preparation Following tools and instruments are required for technical calibration. 1) Tools: Screwdrivers (No.1 & 2), Straight slot screwdriver 2) Instruments: DVM, oscilloscope (Tektronix TDS 3032 or equivalent device) 4.1 Power Supply 1) The device should be turned off before beginning. 2) Turn on the device.
  • Page 49 - Set kV to 40kV and mAs to 1.2mAs (20mA), then check the mA waveform of Oscilloscope Channel 2. - If Oscilloscope Channel 2 is not at 2V (40kV), adjust the kV output via the Calibration Mode. - Turn SW1 dip s/w pin 1 to the ON position (found on the soldered side of the OP board). - kV indicator FND is displayed as “CX”.
  • Page 50 B. Tube current confirmation and calibration - Turn power OFF. - Uncover the upper section where the OP board is attached. - Check to see that OP Board SW1 DIP switch is OFF. (Note: This is the standard DIP switch position.) - Channel 1: Connect oscilloscope prove to TP15 (IP F/B) and GND (TP10).
  • Page 51 - Push the kV up switch. (Refer to the “OP sheet”). You will see the following display: Calibration code Calibration data C1 is the calibration code of the tube current. (15mA at 81kV~90kV). 150 is the calibration value of the tube current. (15mA at 81kV~90kV). - You can adjust the value by pressing the “mAs up/down”...
  • Page 52 - If the waveform is over or under the intended value, you will need to re-set the calibration value. Push the kV up switch. (Refer to “OP sheet”). The following display will be seen: Calibration data Calibration code P1 is the Filament Preheat Calibration Code. (Preheat Calibration Code of 15mA). 144 is the Filament Preheat Calibration Value.
  • Page 53 E. VR Info Direction Adjusted VR Number LEFT RIGHT REMARK Values (Anticlockwise) (Clockwise) Preheat Increase Decrease...
  • Page 54 61~70kV 0 ~ 249 71~80kV 0 ~ 249 81~90kV 0 ~ 249 91~100kV 0 ~ 249 CAUTION When encountering continuous “Err” messages, discontinue use of your device immediately and contact medical ECONET or one of its authorized distributors for help.
  • Page 55 6. Error Code 6.1 When the hand switch is non-operational, check to see if the hardware values are more than EP=10kV, IP=5mA, FIL=0.1V F/B, Code No. Description Resolution Err. 10 Filament feedback over Calibration or change OP B/D Err. 11 kV feedback over Calibration or change OP B/D Err.
  • Page 56 - Change OP B/D...
  • Page 57 Document No.: PMH-PXM20BTP-1436 Revision No.: 4 Date of Issue: 2019-06-04 7. How To Replace Battery 7.1 Loosen the bolt located on the bottom of the unit as seen below. 7.2 Move the grip towards the rear of the unit as shown by the arrow in the picture below. The battery cover will slide off easily.
  • Page 58 Document No.: PMH-PXM20BTP-1436 Revision No.: 4 Date of Issue: 2019-06-04 Grab a hold of the handle and gently pull upwards until the battery is separated from main body of the unit. 7.4 Replace the new battery into the body of the unit and follow the above steps in reverse order to reassemble your unit.
  • Page 59 Revision No.: 4 Date of Issue: 2019-09-04 8. Maintenance Instruction 1. medical ECONET will provide free maintenance if failure happens under normal usage by obeying the operation manual during the warranty period. 2. No free maintenance will be provided in the following condition.
  • Page 60 Document No.: PMH-PXM20BTP-1436 Revision No.: 4 Date of Issue: 2019-09-04 Service Request Form This form must be completed fully and submitted with any medical ECONET x-ray products returned for warranty considerations or repair services. General Information Product name : Serial number : C.
  • Page 61 Document No.: PMH-PXM20BTP-1436 Revision No.: 4 Date of Issue: 2019-09-04 medical ECONET GmbH Im Erlengrund 20 D-46149 Oberhausen, Deutschland Tel: +49 (0) 208 377 890-0 Fax: +49 (0) 208 377 890-55...