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Lepu Medical TH3 Operator's Manual

Holter recorder
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Holter Recorder
(Model: TH3 / TH12)
Operator's Manual

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Summary of Contents for Lepu Medical TH3

  • Page 1 Holter Recorder (Model: TH3 / TH12) Operator’s Manual...
  • Page 3 Foreword Declaration We make no warranties of any kind, including (but not limited to) implied warranties of merchantability and fitness for a particular purpose. We shall not be liable for errors contained in this manual or incidental or consequential damages caused by the provision, actual performance and use of this manual.
  • Page 4 II Manufacturer's Liability and Warranty Liability of Manufacturer The manufacturer is responsible for the safety, reliability and performance of the device only if: Assembly operations, expansion, readjustment,  improvement and repair are performed by authorized personnel; The electrical device related to the product conforms to ...
  • Page 5  Software or Devices Software or devices installed in in the products of the manufacturer will be repaired by replacing the software or devices upon receipt of reports proving that the software or devices are defective, but the manufacturer cannot guarantee that the use of the software or devices will not be interrupted or error free.
  • Page 6 518108, Shenzhen, P.R. China Website: www.carewell.com.cn E-mail: info@carewell.com.cn Tel: +86 755 86170389 Fax: +86 755 86170478 EC Representative: Lepu Medical (Europe) Coöperatief U.A. Abe Lenstra Boulevard 36, 8448 JB, Heerenveen, Address: The Netherlands Tel: +31-515-573399 Fax: +31-515-760020 UK Responsible NPZ technology Ltd...

  • Page 7: Table Of Contents

    Content Chapter 1 Safety Guideline.............. 1 1.1 Safety Instruction ............... 1 1.2 Precautions ................ 2 Chapter 2 Overview ................. 6 2.1 Intended Use ..............6 2.2 Contraindications ............... 6 2.3 Intended Users ..............7 2.4 Structure and Composition ..........7 2.5 Product Accessories ............
  • Page 8 5.1.3 Setting Parameters ..........22 5.2 Recording Process ............22 5.3 Stop Recording ..............23 5.3.1 Stop Recording Manually ........23 5.3.2 Record Ends Automatically ........24 5.3.3 Take Off the Recorder After Record Ends ....24 5.4 Data Replay ..............25 5.5 Power On/Off ..............

  • Page 9: Chapter 1 Safety Guideline

    Chapter 1 Safety Guideline 1.1 Safety Instruction For the safe and effective usage of Holter Recorder, please read the operator’s manual carefully to avoid possible injury. Before operation, please be familiar with its performances and fully understand the correct operating methods and precautions.

  • Page 10: Precautions

    1.2 Precautions Warning Holter Recorder cannot be used for infants weighing less than 10kg. Warning It will result in explosion if Holter Recorder is operated in an environment with flammable anesthetics. Warning Do not use the device while taking a shower as it is not waterproof. Warning Do not use the device in the presence of high-voltage device or high static electricity environment.
  • Page 11 Warning Please ensure all electrode slices are connected to correct position of the subject's body. Avoid the electrode slices (including neutral electrode slices) and subject from contacting any other conductive parts or the ground. Warning Before using the device, please check if the device, lead wires and electrode slices exist any damage that may affect the safety of subjects.
  • Page 12 Caution Please read the relevant operation in this manual. Incorrect operation will result in the loss of all ECG data. Caution Please disconnect the lead wire from the subject during defibrillation. Caution When the subject is wearing a cardiac pacemaker during the recording, it may generate false positive or negative pacing recording results.
  • Page 13 Caution Please use a compatible SD card confirmed by the manufacturer. The use of a SD card unconfirmed by the manufacturer may result in abnormal record or incomplete record. Please contact the manufacturer for SD card replacement. Caution If the operator ignores the low battery alarm and continues to start recording, Holter Recorder may not record the data for 24 hours.

  • Page 14: Chapter 2 Overview

    TH3 can continuously record 8-lead ECG data for 24 hours. And TH12 can continuously record 12-lead ECG data for 24 hours. Both TH3 and TH12 Holter Recorders are powered by an AAA battery (1.5V, 700mAh), SD card is used as a memory medium,...

  • Page 15: Intended Users

    Holter Recorder is mainly composed of recorder and ECG lead wires. 2.5 Product Accessories Name Model Quantity 98ME01AC011(TH12)/ ECG lead wire (button) 1 piece 98ME01AC124(TH3) Disposable ECG 915W50 1 packet electrode slices Shoulder strap 1 piece Belt 1 piece leather case...

  • Page 16: Symbol Description

    Caution Please contact the manufacturer for more accessory information. 2.6 Symbol Description Symbol Description Symbol Description Positive pole of Negative pole of the the battery battery Symbol for "CAUTION, CONSULT SD card socket ACCOMPANYING DOCUMENTS" Type BF applied Recovery and part recycling Manufacturer...
  • Page 17 Symbol Description Symbol Description Atmospheric Temperature limit pressure limit...

  • Page 18: Chapter 3 Device Appearance

    Chapter 3 Device Appearance 3.1 Main Unit Screen Enter Down Buzzer 3.1.1 Screen The screen is a liquid crystal screen (LCD). 3.1.2 Button Description The instruction of each button and buttons combination are as follows: Button or Buttons Combination Function Change the gain.

  • Page 19: Port

    If you want to eliminate the prompt tone immediately, please reattach the dropped lead, the prompt tone will automatically disappear. 3.2 Port Lead Wire Port The lead wire port is used for connecting the ECG lead wires. 3.3 Back of Main Unit Label Battery Case...

  • Page 20: Chapter 4 Recording Preparation

    Chapter 4 Recording Preparation 4.1 Battery Selection Please install a new alkaline battery into Holter Recorder. The recording time of tested battery is as follows: Battery Type Recording Time AAA alkaline battery (1.5V, 700mAh) 24 hours Warning Incorrect replacement of batteries leads to an unacceptable risk. Caution Do not use rechargeable batteries to avoid danger.
  • Page 21 Caution Please use a compatible SD card confirmed by the manufacturer. The use of SD card unconfirmed by the manufacturer may result in abnormal record or incomplete record. Please contact the manufacturer for SD card replacement. Caution Please confirm the SD card is unlocked if it has a lock switch. Otherwise, the subject waveform information cannot be recorded.

  • Page 22: Electrode Slice Placement

    Caution When the system detects the battery level is too low to supply the Replace new battery! device for operation, the system prompts that " " (as shown in the figure below) before allowing any other operation. 4.3 Electrode Slice Placement 4.3.1 Electrode Slice Usage Fasten the disposable electrode slice into the electrode joint of lead wire.

  • Page 23: Electrode Slices Placement

     Note The correct pretreatment of the subject’s skin is essential to obtain a good ECG record. Please refer to the electrode slices manufacturer's instruction for skin pretreatment technology.  Note Please use ECG electrode slices specially used for long-distance recording Holter Recorder, and the ECG electrode slices should be equipped with a valid registration certificate for medical appliance.
  • Page 24 IEC Color Position Color Label Label The fourth intercostal Brown/ White/ space at the right edge of sternum The fourth intercostal Brown/ White/ space at the left edge of Yellow Yellow sternum Brown/ White/ The position between V2 and V4 Green Green White/...
  • Page 25  8-lead Electrode Slices (6 Lead Wires) Placement Place 6 lead wires in different colors on the human body in accordance with the corresponding position for 8-lead ECG recording. The following diagram shows the typical position of electrode slices placement. You can also refer to the position recommended by the analysis system and physician for electrode slices placement.

  • Page 26: Electrode Slice Replacement

    4.3.3 Electrode Slice Replacement Before recording, wipe the corresponding skin of human body, fasten the button between the electrode slice and lead wire. Tear down the protective plastic film and paste the electrode slice on the corresponding position of human body. After the recording ends, remove the whole electrode slice from the human body.

  • Page 27: Chapter 5 Ecg Recording

    Chapter 5 ECG Recording 5.1 Start ECG Recording Caution Every time the ECG recording is started, Holter Recorder will automatically format the SD card. Before start ECG recording, please ensure data in the SD card have been safely transferred to ECG analysis system.

  • Page 28: Waveform Interface

    Please wait for the system to complete the SD card formatting automatically. After formatting, the system will automatically access the waveform interface. Put the Holter Recorder into a leather case and wear it with the belt or shoulder strap. Caution Holter Recorder will automatically format the SD card and start ECG recording with default ID after the leads and electrodes have been correctly connected to the subject’s body for 3 minutes.
  • Page 29 Description Subject ID number Pre-set total recording time Current gain Current lead label The battery level will display the following status: ：Current remaining battery. ：The icon flashes, which means low battery. Current date Current time Current waveform Dropped lead or recording time. During the recording process, the recording time is displayed, as shown in the above diagram of normal recording interface.

  • Page 30: Setting Parameters

    5.1.3 Setting Parameters In the recording operation interface, move the cursor to the “MENU” position and press “Enter” button to access the parameters setting interface. In the parameters setting interface, you can perform the following operations: Date: The date display format is [YYYY]-[MM]-[DD]. ...

  • Page 31: Stop Recording

    Mark an Event On the waveform interface, press the Enter button mark an event. The system only records an event if the Enter button is pressed again within 8 seconds. Switch Display of ECG Waveform In the waveform interface, press the Down button switch the waveform display of each lead.

  • Page 32: Record Ends Automatically

    Then the interface displays as follows, which indicates the recording is stopped successfully. 5.3.2 Record Ends Automatically After the recording ends, the screen will display the record end interface, buttons will be invalid, the clock will stop refreshing, and the END characters will be displayed in the upper right corner.

  • Page 33: Data Replay

    Caution Do not pull the cable forcibly; otherwise, the wires inside the insulation layer will be damaged. When removing the electrode slices from the subject, please grasp the insulator at the end of the lead wire terminal to pull out the terminal. 5.4 Data Replay Perform data replay in the following steps: Access the ECG analysis system installed on the computer.

  • Page 34: Chapter 6 Cleaning, Disinfection And Maintenance

    Chapter 6 Cleaning, Disinfection and Maintenance The cleaning and disinfection introduced in this chapter only involves the main unit of the recorder. For the cleaning and disinfection of lead wires or other accessories, please refer to their corresponding instructions or follow the regulations of medical institutions.
  • Page 35 to prevent liquid from permeating into the device, which will affect the performance and safety of the device. Maintenance of Lead Wires Before use, please check the integrity of lead wire and  ensure it is in good conduction. During the use, please straighten out the lead wires as ...

  • Page 36: Chapter 7 Common Problems And Solutions

    Chapter 7 Common Problems and Solutions Problems Solutions Check the battery direction No display Install new battery Check the battery case and clean the contacting points of two poles if necessary Low battery Install new battery Please use new battery. After testing, AAA alkaline The battery battery (1.5V, 700mAh) can supply the recorder for cannot supply...

  • Page 37: Appendix A Technical Specifications

    Appendix A Technical Specifications A.1 Standards Meet the requirements of IEC 60601-1:2005+AMD1:2012+  AMD2:2020 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance Meet the requirements of IEC 60601-2-47:2012 Medical  electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems Meet the requirements of IEC 60601-1-2:2014+AMD1:2020...

  • Page 38: Environmental Specifications

    10%-95% 10%-95% (non-condensing) Humidity (non-condensing) Atmospheric 860hPa-1060hPa 860hPa-1060hPa Pressure A.4 Performance Specifications Leads TH3: 8 leads TH12:12 leads Sampling Frequency 250Hz Sampling Accuracy 24 bits Input Dynamic Range ≤ ±10% or 50µV, whichever is greater Input Impedance ≥ 40MΩ Common Mode Rejection ≥...

  • Page 39: Physical Specifications

    for 1min under stable environment System Noise ≤ 30µV (p-v) Frequency Response (0.67Hz-40Hz)（+3dB～-3dB） Time Constant ≥ 3.2s Polarization Resistance ± 300mV Voltage Storage Equipped with SD card, which can store 24 hours record. Duration of contact for t ≥1min all applied parts and accesible parts Temperature rise of the Not exceed 1℃...

  • Page 40: Appendix B Emc Information

    Appendix B EMC Information Holter Recorder conforms to the relative EMC requirements of IEC60601-2-47:2012 and IEC60601-1-2:2014. User should install and use the device according to the EMC information provided in the accompanying documents. Please see the following table for the guidance and manufacturer’s declaration.
  • Page 41 Name Length Shield or Not ECG cable Guidance and manufacturer’s declaration – electromagnetic emission – for all DEVICE AND SYSTEMS Guidance and manufacturer’s declaration – electromagnetic emission Holter Recorder is intended for use in the electromagnetic environment specified below. The customer or the user should assure that it is used in such an environment.
  • Page 42 Guidance and manufacturer’s declaration – electromagnetic immunity – for all DEVICE and SYSTEMS Guidance and manufacturer’s declaration – electromagnetic immunity Holter Recorder is intended for use in the electromagnetic environment specified below. The customer or the user should assure that it is used in such an environment. Electromagnetic IEC 60601 test Compliance...
  • Page 43 < 5 % UT (>95 % dip in for 0,5 cycle Voltage dips, 40 % UT short (60 % dip in interruptions and voltage for 5 cycles Not applicable variations on 70 % UT applicable power supply (30 % dip in input lines for 25 cycles 61000-4-11...
  • Page 44 Guidance and manufacturer’s declaration – electromagnetic immunity – for DEVICE and SYSTEM that are not LIFE-SUPPORTING Guidance and manufacturer’s declaration – electromagnetic immunity Holter Recorder is intended for use in the electromagnetic environment specified below. The customer or the user should assure that it is used in such an environment.
  • Page 45 transmitter in watts (W) 80 MHz to according to the 61000-4-3 2.7 GHz transmitter manufacturer and d is the recommended separation distance in meters (m).b Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey (a) should be less than the compliance level in each frequency range (b).
  • Page 46 measures may be necessary, such as reorienting or relocating Holter Recorder. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m. Recommended separation distances between portable and mobile RF communications device and the DEVICE or SYSTEM - for DEVICE and SYSTEMS that are not LIFE-SUPPORTING Recommended separation distances between portable and mobile RF communications device and Holter Recorder...
  • Page 47 transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
  • Page 48 Shenzhen Carewell Electronics Co., Ltd. Manufacturer address: Floor 4, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District 518108, Shenzhen, P.R. China Tel: +86-755-86170389 Fax: +86-755-86170478 Website: www.carewell.com.cn Email: info@carewell.com.cn P/N: SZ09.24310038-06 Revision: V1.5...

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Th12

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