醫(yī)療器械質量體系H10說明書 打印

1、PAGE 3第PAGE 45頁All Rights reserved, No Spreading abroad without Permission of ZTEHomecare Muti-parameter RecorderUsers Manual Version:1.0Product Name:Homecare multi-parameter RecorderProduct Model:H10Company Name:ZTEICT(QHD) Technology Co., Ltd.Address:Suite 612,ShuGu Building, No.2 Shu-Gu Road, Eco

2、nomic&Technological Development Zone, Qinhuangdao, Hebei, P.R. ChinaVersion record sheet:REVISIONDATEDESCRIPTIONEDITORA02015-10-20Initial issueContentTOC o 1-7 h u HYPERLINK l _Toc27675 Content PAGEREF _Toc27675 2 HYPERLINK l _Toc4930 Preface PAGEREF _Toc4930 3 HYPERLINK l _Toc17159 Chapter 1 Safety

3、 information PAGEREF _Toc17159 5 HYPERLINK l _Toc7231 1.1 Signs in this manual PAGEREF _Toc7231 5 HYPERLINK l _Toc3696 1.2 Important Notes for Safety PAGEREF _Toc3696 7 HYPERLINK l _Toc22525 1.3 Safe Operation Conditions PAGEREF _Toc22525 9 HYPERLINK l _Toc3560 Chapter 2 Product Description PAGEREF

4、_Toc3560 10 HYPERLINK l _Toc7079 2.1 General Introduction PAGEREF _Toc7079 10 HYPERLINK l _Toc28249 2.2 Main Unit PAGEREF _Toc28249 10 HYPERLINK l _Toc8994 2.3 Basic Operation PAGEREF _Toc8994 13 HYPERLINK l _Toc23578 2.4 Instruction of App PAGEREF _Toc23578 13 HYPERLINK l _Toc20839 Chapter 3 ECG PA

5、GEREF _Toc20839 21 HYPERLINK l _Toc24147 3.1 Introduction PAGEREF _Toc24147 21 HYPERLINK l _Toc18633 3.2 Safety Information PAGEREF _Toc18633 21 HYPERLINK l _Toc3753 3.3 Measurement Procedure PAGEREF _Toc3753 22 HYPERLINK l _Toc17006 3.4 ECG Display PAGEREF _Toc17006 23 HYPERLINK l _Toc5982 Chapter

6、4 SpO2 PAGEREF _Toc5982 24 HYPERLINK l _Toc1663 4.1 Introduction PAGEREF _Toc1663 24 HYPERLINK l _Toc29501 4.2 Safety Information PAGEREF _Toc29501 24 HYPERLINK l _Toc13014 4.3 Measurement Procedure PAGEREF _Toc13014 25 HYPERLINK l _Toc1540 4.4 SpO2 Display PAGEREF _Toc1540 25 HYPERLINK l _Toc11323

7、Chapter 5 NIBP PAGEREF _Toc11323 27 HYPERLINK l _Toc6462 5.1 Introduction PAGEREF _Toc6462 27 HYPERLINK l _Toc13937 5.2 Safety Information PAGEREF _Toc13937 27 HYPERLINK l _Toc26776 5.3 Measurement Limitations PAGEREF _Toc26776 27 HYPERLINK l _Toc20884 5.4 Measurement Procedure PAGEREF _Toc20884 28

8、HYPERLINK l _Toc571 5.5 NIBP Display PAGEREF _Toc571 28 HYPERLINK l _Toc12196 Chapter 6 Guidance and Manufacturers Declaration of EMC PAGEREF _Toc12196 30 HYPERLINK l _Toc8892 Chapter 7 Maintenance and Cleaning PAGEREF _Toc8892 34 HYPERLINK l _Toc27440 7.1 Equipment Maintenance PAGEREF _Toc27440 34

9、HYPERLINK l _Toc12685 7.2 Equipment Cleaning PAGEREF _Toc12685 34 HYPERLINK l _Toc12408 7.3 Cleaning and Sterilizing of Accessories PAGEREF _Toc12408 35 HYPERLINK l _Toc27173 Chapter 8 Labeling and Language PAGEREF _Toc27173 37 HYPERLINK l _Toc21632 8.1 Machine Label PAGEREF _Toc21632 37 HYPERLINK l

10、 _Toc24375 8.2 Language PAGEREF _Toc24375 37 HYPERLINK l _Toc29166 Chapter 9 Troubleshooting PAGEREF _Toc29166 38 HYPERLINK l _Toc12451 Appendix A Specification PAGEREF _Toc12451 40 HYPERLINK l _Toc8618 A.1.Environmental Specifications PAGEREF _Toc8618 40 HYPERLINK l _Toc21009 A.2.Physical Specifica

11、tions PAGEREF _Toc21009 40 HYPERLINK l _Toc21907 A.3.Measurement Specifications PAGEREF _Toc21907 42 HYPERLINK l _Toc28507 Appendix B Product and accessories List PAGEREF _Toc28507 43 HYPERLINK l _Toc19911 Appendix C Abbreviations PAGEREF _Toc19911 44PrefaceProduct InformationProduct Model: H10Produ

12、ct Name: Homecare multi-parameter RecorderManufacturer Name:ZTEICT(QHD) Technology Co., Ltd.After Service Contact Information:Address: Suite 612,ShuGu Building, No.2 Shu-Gu Road, Economic&Technological Development Zone, Qinhuangdao, Hebei, P.R. ChinaFax: +86ost code: 006004Toll-free co

13、nsultation hot line: +86evision HistoryThis manual has a revision number. This revision number changes whenever the manual is updated due to software or technical specification change. Contents of this manual are subject to change without prior notice.Document No.: ZTEHMPR0012015Revisi

14、on number:A0Release time: Oct. 2015Copyright 2015 ZTEICT(QHD) Technology Co., Ltd.All rights reserved.CE markEC Representative Name: MEQUIPEX E.U.EC Representative Address:Feldstrasse 39/1/3, 4813 Altmuenster AustriaStatementManufacturer holds the copyright of this manual, and we are also entitled t

15、o deal with this manual as confidential files. This manual is only used for operation, maintenance and service of product, someone else can not publish the manual.This manual contains exclusive information protected by copyright laws and we reserve its copyright. Without written approval of manufact

16、urer no parts of this manual shall be photocopied, Xeroxed or translated into other languages.The contents contained in this manual are subject to amendments without notification.Manufacturers ResponsibilityOnly under the following circumstances will manufacturer be responsible for the safety, relia

17、bility and performance of the instrument:All the installation, expansion, readjustment, renovation or repairs are conducted by the personnel certified by manufacturer.The storage condition, operation condition and electrical status of the instrument conform to the product specification.The instrumen

18、t is used in accordance with the users manual.About this manualThis manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use. Observance of this manual is a prerequisite for proper product performance and correct operation and ensu

19、res patient and operator safety. This manual is based on the maximum configuration and therefore some contents may not apply to your product. If you have any question, please contact us. This manual is an integral part of the product. It should always be kept close to the equipment so that it can be

20、 obtained conveniently when needed.The manual is geared for adult who are expected to have a basic knowledge of medical procedures, practiced and terminology as required for running this recorder All illustrations in this manual serve as examples only. They may not necessarily reflect the setup or d

21、ata displayed on your product.Chapter 1 Safety information1.1 Signs in this manual Warning: Indicates a potential hazard or unsafe practice that, if not avoided, will result in death or serious injury. SymbolSymbol NoteSymbolSymbol NoteBefore putting the recorder into operation,carefully read the op

22、erating instructions. Pay special attention to the instructions labeled Caution and Warning.Attention: Consult accompanying documents (this manual).ECGShort for “ “Electrocardiogram” Dangerous voltageSpO2Short for “Pulse Oxygen Saturation”Equipotentiality Alternating currentOutput NIBPShort for “Non

23、-invasive Blood Pressure”VGA display connectorUSB socket Keep dryManufacture dateManufacturerDefibrillator synchronization output connectorSNSerial numberAuxiliary plug-in box connectorLOTBatch codeIPX1Degree of protection against ingress of liquidDo not re-useREFCatalog numberTemperature limitation

24、Use by date YYYY-MM-DDHumidity limitationPressure limitationCE markSymbol for the marking of electrical and electronics devices according to Directive 2002/96/EC.Warning:Before putting the system into operation, verify that the recorder, connecting cables and accessories are in correct working order

25、 and operating condition. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earthWhere the integrity of the external protective conductor in the installation or its arrangement is in doubt, equipment shall be operated from its internal elect

26、rical power source To avoid explosion hazard, do not use the recorder in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide.Do not open the recorder housings; electric shock hazard may exist. All servicing and fu

27、ture upgrades must be carried out by the personnel trained and authorized by manufacturer only.When using the recorder with electrosurgical units (ESU), make sure the patient is safe.Caution：To ensure patient safety, use only parts and accessories specified in this manual.At the end of its service l

28、ife, the recorder, as well as its accessories, must be disposed of in compliance with the guidelines regulating the disposal of such products. If you have any questions concerning disposal of the recorder, please contact us.Magnetic and electrical fields are capable of interfering with the proper pe

29、rformance of the recorder. For this reason make sure that all external devices operated in the vicinity of the recorder comply with the relevant EMC requirements. Mobile phone, X-ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radi

30、ation.Before connecting the recorder to the power line, check that the voltage and frequency ratings of the power line are the same as those indicated on the recorders label or in this manual.Always install or carry the recorder properly to avoid damage caused by drop, impact, strong vibration or ot

31、her mechanical force.1.2 Important Notes for SafetyPatient NumberThe recorder can only be applied to one patient at one time.InterferenceDo not use mobile phone in the vicinity of the recorder . High level of electromagnetic radiation emitted from such devices may result in strong interference with

32、the recorder performance.Protection against ingress of liquidTo avoid electric shock or device malfunction, liquids must not be allowed to enter the device. If liquids have entered the device, take it out of service and have it checked by a service technician before it is used again.AccuracyIf the a

33、ccuracy of any value displayed or printed on a printout paper is questionable, determine the patients vital signs by alternative means. Verify that the equipment is working correctly.Before UseBefore putting the system into operation, please visually inspect all connecting cables for signs of damage

34、. Damaged cables and connectors must be replaced immediately.Before using the system, the operator must verify that it is in correct working order and operating condition.Periodically, and whenever the integrity of the product is in doubt, test all functions.CablesRoute all cables away from patients

35、 throat to avoid possible strangulation.Disposal of packageDispose of the packaging materials, please observe the applicable waste control regulations and keeping it out of children. Explosion hazardDo not use this equipment in the presence of flammable anesthetics, vapors or liquids.Operating tempe

36、rature Please use the recorder under 40situation,applied part may exceed 41,take care to use it.Leakage current testWhen interfacing with other equipment, a test for leakage current must be performed by qualified biomedical engineering personnel before using with patients.BatteryThe device is equipp

37、ed with a battery. The battery discharges even when the device is not in use. Store the device with a fully charged battery and take out the battery, so that the service life of the battery will not be shortened. Functional Testa functional tester cannot be used to assess the accuracy of this produc

38、t,a functional tester maybe used to verify operation of product,for example make sure if the recorder can measure three-parameter ,Spo2,ECG and blood pressure.CautionThe recorder will display a notice when the battery in an enough low situation which can not support normally work.Disposal of accesso

39、ries and deviceDisposable accessories are intended for single use only. They should not be reused as performance could degrade or contamination could occur.The service life of this recorder is 5 years. At the end of its service life, the recorder, as well as its accessories, must be disposed of in c

40、ompliance with the guidelines regulating the disposal of such products. If you have questions concerning disposal of products, please contact manufacturer or its representatives.EMCMagnetic and electrical fields are capable of interfering with the proper performance of the device. For this reason, m

41、ake sure that all external devices operated in the vicinity of the recorder comply with the relevant EMC requirements. X-ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation. Also, keep mobile phones or other telecommunication

42、 equipment away from the recorder.Instruction for useFor continuous safe use of the recorder, it is necessary that listed instructions were followed. However, instructions listed in this manual in no way can supersede established medical practices concerning patient care.1.3 Safe Operation Condition

43、sMethods of sterilization or disinfection recommended by the manufacturerSterilization: not applicableDisinfection: Refer to Maintenance and Cleaning ChapterElectromagnetic interferenceNo mobile telephone nearbyElectrosurgical interference damageNo damageDiathermy instruments influenceDisplayed valu

44、es and prints may be disturbed or erroneous during diathermyAuxiliary outputsThe recorder must fulfill the requirements of standard IEC 60601-1-1Operating ConditionTemperature: +5 to +40CRelative Humidity: 15%85%（non condensing）Atmospheric Pressure ：700hPa1060hPaTransportation and StorageTemperature

45、: -20 to +55CRelative Humidity: 10%93%（non condensing）Atmospheric Pressure ：500hPa1060hPaAdapterc.100-240V 50/60Hz d.c.5V / 1A output HYPERLINK C:/Users/lanboss/AppData/Local/Yodao/DeskDict/frame/20150803194832/javascript:void(0); lithium HYPERLINK C:/Users/lanboss/AppData/Local/Yodao/DeskDict/frame

46、/20150803194832/javascript:void(0); battery2000mAh,3.7VChapter 2 Product Description2.1 General IntroductionZTE homecare multi-parameter recorder is mainly composed of recorder(H10), intelligent home control center(IHCC,D10), single-lead ECG cable, blood pressure cuff and SPO2 probe which for monito

47、ring the physiological data of ECG,SPO2 and NIBP at home. It can realize data transmission between the H10 and the D10 through Bluetooth. Moreover, The recorder equipped with USB, SD card, and HDMI data transmission and realize users registration and users historical data records. The equipment oper

48、ating system customized for android 4.4.2 system, elaborate design is easy to operate and carry.Intended useThis recorder is mainly used in household mode, intended use for measuring the physiological data of elder people, provide a convenient measurement of electrocardiogram (ECG),SPO2 and non-inva

49、sive blood pressure. Provide reference data for the doctor and clinical diagnosed.CautionThis product cant be used for pregnant women and whose arm burn.Classification:According to 93/42/EEC Annex IX, Rule 10,to diagnose or monitor other vital physiological processes parameters, our recorder belong

50、to class IIa2.2 Main Unit2.2.1 Main ViewPower on/offStart/StopPower Indicator/RedBluetooth Indicator/BlueCharging Lamp/GreenPower Jack (Connect to 5v 1A Adapter)Heart Rate Socket (Micro-USB pin)Blood Pressure Socket (Connect to cuff )SPO2 Socket(Mini-USB pin)CuffSPO2 Sensor ECG Cable , ECG Electrode

51、sAdapterCharge Cable2.2.2 Intelligent home control center(IHCC,D10)1. Main viewH10 and D10 connect diagram2.3 Basic OperationBattery charging: connect the adapter line and the recorder, the charging lamp will keep twinkling on the process and turn off when the battery chargedPress “Power On” and the

52、 recorder will connect to D10 automatic. Turn on the recorder first Turn on the Bluetooth of D10 D10 scan Bluetooth automatically and make connection with recorder .Default match code is:1234 Open the App after match successfully, start to measurement after the indicator of recorder turns off. Press

53、 “power on/off” key and open App only to come to measurement state from the second time use.Press the “power on/off” key to turn off the recorder after complete measurement. The device will come to power off state in 5 minutes.2.4 Instruction of AppClick and open the APP, the Bluetooth will scan aut

54、omatically and display pairing request.Click the “people” icon and enter the log-in screen. if there are user name and password, you can log-in directly(default user is “User”)If you do not have an account, please click “+”and create a new account. You need to register according to your own situatio

55、n for correct measurement result.Now, we log in main interface. Click blood pressure,SPO2, or ECG to start measurement. The measurement data display on the right screen.2.4.1Blood Pressure MeasurementClick the blood pressure icon and enter instruction for measurement, please operate according to ins

56、truction. RESTINGESSURE CIRCULATIOMODE MODEWhen you make the cuff ready, click “start”, youre supposed to be calm and quiet when measuring. If you make force to stop in the process, there are no measurement result.The measurement will complete automatically and display HYPERLINK C:/Users/lanboss/App

57、Data/Local/Yodao/DeskDict/frame/20150803194832/javascript:void(0); systolic HYPERLINK C:/Users/lanboss/AppData/Local/Yodao/DeskDict/frame/20150803194832/javascript:void(0); pressure(SBP), HYPERLINK C:/Users/lanboss/AppData/Local/Yodao/DeskDict/frame/20150803194832/javascript:void(0); diastolic HYPER

58、LINK C:/Users/lanboss/AppData/Local/Yodao/DeskDict/frame/20150803194832/javascript:void(0); pressure(DBP) and PR Value on the result screen.2.3.2 SPO2 MeasurementClick SPO2 icon and enter the instruction for measurementWhen you make your finger clap ready, click “Start”. Youre supposed to be clam an

59、d quiet and you can stop measurement in the process or wait for display result automatically.When measurement complete, you can see SPO2 and PR value on the screen. If you want to measure more than once, you can click “Try Again”, or click” Back” to back to homepage to make other measurement.2.4.3 E

60、CG MeasurementClick “ECG” icon and enter the instruction for measurementWhen you make cable ready then click “Start”. You supposed to be clam and quiet and you can stop measurement in the process or wait for display result automatically.When measurement complete, you can see ECG and HR on the screen