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CE
0120
Hingmed
Ambulatory Blood Pressure Monitor
User Manual
(Apply to:ABP-03)
Shenzhen Hingmed Medical Instrument Co., Ltd.
VER:A/0
Date: May 15, 2014
1

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Summary of Contents for HINGMED ABP-03

  • Page 1 0120 Hingmed Ambulatory Blood Pressure Monitor User Manual (Apply to:ABP-03) Shenzhen Hingmed Medical Instrument Co., Ltd. VER:A/0 Date: May 15, 2014...
  • Page 2 Fax: +353(1)6864856 Web: www.CE-marking.com Email: AuthRep@CE-marking.eu Version Information This manual may upgrade due to software upgrading. User will not be notified further. ■ Version: A/0 ■ Issue date: May 2014 Shenzhen Hingmed Medical Instruments Co., Ltd. owns and reserves the copyright.
  • Page 3: Table Of Contents

    4.1 Battery installation ....................11 4.2 Installing System ....................12 4.3 Conduct Ambulatory Blood Pressure Study ............13 4.3.1 Communication with Hingmed ABPM ............13 4.3.2 Connect monitor to computer ..............13 4.3.3 Continuous measurement programming ........... 13 4.3.4 Cuff selection and connection ..............14 4.3.5 Ready for use and patient training .............
  • Page 4: Chapter 1 Preface

    Chapter 1 Preface Brief Introduction to Ambulatory Blood Pressure Monitoring Ambulatory blood pressure monitoring is an instrument for monitoring human’s blood pressure continuously during certain period (normally 1-2 days) with certain interval that is based on actual situation. Blood pressure readings in different periods and under different life conditions can be judged according to the measuring results, thus blood pressure diagnosis would be given.
  • Page 5 For the following hypertension types, it is only ambulatory blood pressure monitoring that could diagnose easily. 1. White-coat hypertension White-coat hypertension is the blood pressure that is high when measured at health care site but normal in daily activity. The high pressue at health care site is repeatable in different days.
  • Page 6: Chapter 2 Safety Requirements

    Chapter 2 Safety Requirements 2.1 Intended use Blood pressure monitor of ABP-03 is mainly used to measure blood pressures, which include systolic pressure, diastolic pressure and pulse rate, of patients in different setting intervals within 24 hours (not applicable to children under 3 years), and the measurement data can be transmitted by USB data wire for medical personnel’s reference and analysis...
  • Page 7: Contraindication

    Product composition: Main unit, Noninvasive blood pressure cuff, USB data wire and Hingmed PC software. The device is inner power source with 2 AA alkaline batteries; Electric shock protection degree: CF type applied part; Operation mode: continuous mode. The service life of this product is five years.
  • Page 8: Notice

    ● Be careful to regarding the effect of blood flow interference and resulting harmful injury to the patient caused by continuous cuff pressure due to connection tubing kinking ● When using this device, please pay attention to the following situation which may interrupt blood flow and influence blood circulation of the patient, thus cause harmful injury to the patient: connection tubing kinking too frequent and consecutive multiple measurements.
  • Page 9: Energy Conservation And Environment Protection

    ● Please properly handle the scrapped batteries, cuff, data wires and main units in compliance with local environmental regulations. 2.4.5 Maintenance ● Please use the accessories supplied by Hingmed, otherwise it may cause measuring errors. ● Maintenance should be conducted only by trained personnel or personnel authorized by Hingmed.
  • Page 10: Name And Function Of Each Component

    Optional accessories Small adult cuff(18-26cm) Middle adult cuff(22-32cm) Plus-Large adult cuff(33-43cm) Waistband 3.2 Name and Function of Each Component 3.2.1 Host Introduction 1 LCD screen; 2 Start/stop button; 3 Upper cover; 4 USB port; 5 Lower cover. 1 Host unit; 2 Rubber tubing; 3 Blood pressure cuff 3.2.2 LCD screen displays and icon implication Measuring times of instrument after loading batteries...
  • Page 11: Symbols

    Night or sleeping period Automatic measurement Systolic pressure Diastolic and systolic pressure values indicated after measuring Unit of diastolic and systolic pressure Heart rate value indicated after measuring Heart rate unit (times per minute) Indicate current time when not measuring, after powering on.
  • Page 12: Installing System

    If the CD cannot run automatically, operate as following steps: a) Open “My computer” or “Computer”; b) Click CD to drive and find HingMed installation software of server version or stand-alone version by your demand. “” c) Double-click the installation program and operate by following instructions →“Next”...
  • Page 13: Conduct Ambulatory Blood Pressure Study

    ABPM. 4.3.3 Continuous measurement programming After successful connection, start Hingmed ABPM software to program. 1. Click the “Program”; 2. Input the related information in the programming interface as the following Figure: 3. Click “OK” to program;...
  • Page 14: Cuff Selection And Connection

    Standard / Fixed 4.3.4 Cuff selection and connection Wear Hingmed ABPM and cuff for patient: After successfully programming by Hingmed ABPM software, then wear ABPM and cuff for patient, either arm can be wore. a) Select cuff of suitable size Select cuff of suitable size and wrap it on the upper arm of patient against slipping.
  • Page 15: Ready For Use And Patient Training

    partition like cloth or film before wrapping the cuff, to avoid cross-infection. b) Wear cuff correctly Wear cuff correctly, the cuff should be 2-3 cm above the fossa cubitalia. Make sure that the artery sign is against the artery brachialis and points to fossa cubitalis, cuff tube should be upwards, and wrap on the upper arm of patient.
  • Page 16: Derive Data

    4.3.6 Derive data 1. Connect Hingmed ABPM to computer through USB port; 2. Open Hingmed ABPM software; 3. Click “Search” to transmit the data, click “Blood pressure data” to view these data, and analyze the data in software.
  • Page 17 The monitoring data could be stored in disk of comptuter and an independent file will be created include patient name, ID etc. A PDF format file could be also created and pages needed could be also printed, see the following Figure a to Figure c. Figure a: Historical data curves of ambulatory blood pressure Figure b: Statistics of historical data of ambulatory blood pressure...
  • Page 18 Figure c: Ambulatory blood pressure history data analysis summary map Note: 1. Operation details of PC software of Hingmed Ambulatory Blood Pressure Monitor, please refer to <User Guide of PC software>; 2 In the programming of monitor every time, an interface will pop up to notice that the history data will be overwritten, so please make sure that the history data has been derived and stored;...
  • Page 19: Troubleshooting And Maintenance

    Troubleshooting and Maintenance 5.1 Troubleshooting Error Description Resolution Code Cuff is too loose, maybe loose winding or Retighten cuff or keep proper arm EC01 disconnected cuff position when inflation Tighten metal connector and check Air leakage, maybe valve leakage or gas EC02 the cuff.
  • Page 20: Maintenance

    EC48 Memory is full, can no longer measure Upload and empty the data * If the errors can be revised, please call agent or after-sale department of Hingmed for help. 5.2 Maintenance 5.2.1 Maintenance inspection and safety management Visually inspect the broken or damages on tube connecters, pressure air tube and the enclosure of monitor.
  • Page 21: Chapter 7 Emc Information

    Systolic blood pressure 40-260 mmHg measurement range Diastolic blood pressure 20-210 mmHg measurement range Pulse rate measurement 40-200 bpm range Resolution Blood pressure: 1mmHg or 0.1Kpa; pulse rate: 1BPM The difference of repeated readings of each point is within Repeatability 4mmHg in the statically continuous low-pressure mode Accuracy Static Accuracy: ±3 mmHg;...
  • Page 22 Guidance and manufacture’s declaration – electromagnetic emission is intended for use in the electromagnetic environment specified below. The customer of the ABP-03 user of the should assure that it is used in such an environment.
  • Page 23 Guidance and manufacture’s declaration – electromagnetic immunity The ABP-03 is intended for use in the electromagnetic environment specified below. The customer or the user of ABP-03 should assure that it is used in such an environment. Electromagnetic environment - Immunity test...
  • Page 24 Portable and mobile RF communications equipment should be used no closer to any part of the ABP-03, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance...
  • Page 25 If the measured field strength in the location in which the ABP-03 is used exceeds the applicable RF compliance level above, the ABP-03 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the ABP-03.
  • Page 26: Chapter 8 Warranty Card

    Hingmed. This limited warranty contains the entire obligations of Hingmed, exclude other expressed, implied or regulated warranties. Representatives or employees without authorized by Hingmed will assume any further liability or grant any further warranties except as set herein.

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