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Homecare Multi-parameter Recorder

- 37 -

www.ehealthcareinc.com

[email protected]

250 East Gish Road, San Jose
CA, 95112 USA

Chapter 8 Labeling and Language

8.1 Machine Label

The sample of label only for reference. The label contents will be changed accordingly depends on
manufacture side.

8.2 Language

English is used to all the machines with the CE certificate, which includes the product document
sent to the user-end

、

label

、

mark of package and software interface, etc..

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Summary of Contents for H100

Page 1: ...m 250 East Gish Road San Jose CA 95112 USA H100 Homecare Multi Parameter Recorder User Manual Version A1 4 Product Name Homecare Multi parameter Recorder Product Model H100 Company Name eHealthcare Address 250 East Gish Road San Jose CA 95112 USA ...

Page 2: ...ntroduction 24 4 2 Safety Information 24 4 3 Measurement Procedure 25 4 4 SpO2 Display 26 Chapter 5 NIBP 27 5 1 Introduction 27 5 2 Safety Information 27 5 3 Measurement Limitations 28 5 4 Measurement Procedure 28 5 5 NIBP Display 28 Chapter 6 Guidance and Manufacturer s Declaration of EMC 30 Chapter 7 Maintenance and Cleaning 34 7 1 Equipment Maintenance 34 7 2 Equipment Cleaning 34 7 3 Cleaning ...

Page 3: ...nufacturer 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 Manufacturer s Responsibility Only under the following circumstances will manufacturer be responsible for the safety reliability and performance of the instrument All the installation expansion readjustment renovatio...

Page 4: ...y 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 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...

Page 5: ...ns Pay special attention to the instructions labeled Caution and Warning Attention Consult accompanying documents this manual ECG Short for Electrocardiogram Dangerous voltage SpO2 Short for Pulse Oxygen Saturation Equipotentiality Alternating current Output NIBP Short for Non invasive Blood Pressure VGA display connector USB socket Keep dry Manufacture date Manufacturer Defibrillator synchronizat...

Page 6: ...nt is in doubt equipment shall be operated from its internal electrical 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 future upgrades must be carried out by th...

Page 7: ...r can only be applied to one patient at one time Interference Do 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 the recorder performance Protection against ingress of liquid To avoid electric shock or device malfunction liquids must not be allowed to enter the device If liquids have enter...

Page 8: ...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 Test A functional tester cannot be used to assess the accuracy of this product 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 ...

Page 9: ...ctions listed in this manual in no way can supersede established medical practices concerning patient care 1 3 Safe Operation Conditions Methods of sterilization or disinfection recommended by the manufacturer Sterilization not applicable Disinfection Refer to Maintenance and Cleaning Chapter Electromagnetic interference No mobile telephone nearby Electrosurgical interference damage No damage Diat...

Page 10: ...realize user s registration and user s historical data records The equipment operating system customized for android 4 4 2 system elaborate design is easy to operate and carry Intended use This 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 invasive blood pressure Pro...

Page 11: ...East Gish Road San Jose CA 95112 USA IIa Open the cover and insert the pad when you need to use the recorder Accessories pad storage box Open the box cover and you can see a Spo2 sensor and cable b Pad c Adapter d Blood pressure cuff e ECG cable and electrode 2 2 2 Side view BP cuff socket ...

Page 12: ...ry charging connect the adapter line and the recorder the charging lamp will keep twinkling on the process and turn off when the battery charged 2 Open the android pad support frame insert the pad 3 Open the App 2 4 Instruction of App 1 Power on H100 and APK will automatically run Please connect the WIFI as required After WIFI connected successfully click NEXT to continue the operations ...

Page 13: ...lthcareinc com info ehealthcareinc com 250 East Gish Road San Jose CA 95112 USA 2 Follow the APK guide to insert the Pad into basement And it will pair with the basement automatically NOTE Please use the same packaged Pad and Basement to be paired ...

Page 14: ...are Multi parameter Recorder 13 www ehealthcareinc com info ehealthcareinc com 250 East Gish Road San Jose CA 95112 USA 3 The Prompt will be displayed and Click Accept to accept the Service Privacy Agreement ...

Page 15: ... info ehealthcareinc com 250 East Gish Road San Jose CA 95112 USA 4 Now we log in main interface As the user account we have three types A Visitor If you use Visitor to do the tests the results will be not saved on Pad you cannot find the history data interface ...

Page 16: ...hcareinc com info ehealthcareinc com 250 East Gish Road San Jose CA 95112 USA B On line User For On line user Click User Management option and click on line user to register the on line user The accounts info should be supplied by your service team ...

Page 17: ...lthcareinc com 250 East Gish Road San Jose CA 95112 USA C Off line User You can also register the off line user the test data can be saved on Pad but cannot be uploaded to the back end platform 5 Click BP Blood Pressure SpO2 Blood Oxygen or ECG icon to start measurements ...

Page 18: ...info ehealthcareinc com 250 East Gish Road San Jose CA 95112 USA NOTE You should select the correct account for testing 2 4 1Blood Pressure Measurement 1 Click the blood pressure icon and enter instruction for measurement please operate according to instructions ...

Page 19: ...e the cuff ready click start and the recorder will start to measure twice automatically you re supposed to be calm and quiet when measuring If you make fore to stop in the process there are no measurement results 3 The measurement will complete automatically and display systolic pressure SBP and diastolic pressure DBP on the result screen ...

Page 20: ...rement 1 Click SPO2 icon and enter the instruction for measurement 2 When you make your finger clap ready You re supposed to be calm and quiet and you can stop measurement in the process or wait for display result automatically in 30 seconds without click Start When measurement complete you can see SPO2 and PR Pulse Rate value on the screen ...

Page 21: ...2 4 3 ECG Measurement 1 Click ECG icon and enter the instruction for measurement 2 When you make cable ready you re supposed to be calm and quiet and you can stop measurement in the process or wait for display result automatically in 2 minutes without click Start When measurement complete you can see ECG and PR on the screen ...

Page 22: ...n Warning It is imperative to only use the ECG electrodes and cables provided by manufacturer or specified in this manual Users shall use the electrode which has little polarization voltage and little contact resistance Before connecting the ECG cables to the recorder please check if the lead wires and cables have been worn out or cracked If so they should be replaced When you are connecting the e...

Page 23: ...trodes are clean and free of damage 3 Place the electrodes on the body of patient Before attaching smear some conducting cream on the electrodes if the electrodes are not electrolyte self supplied 4 Connect the cable leads to the electrodes through the buttons of the electrodes Note For patients who tremble a lot or patients with especially weak ECG signals it might be difficult to extract the ECG...

Page 24: ...SA and should not be in parallel 7 3 3 Connecting ECG Cable Plug the ECG cable into the ECG connector An ECG waveform and numeric appears on the recorder display 3 4 ECG Display The following figure shows the ECG display screen the display on your Recorder may be looked slightly different Waveform Display Parameter Display ...

Page 25: ...O2 sensor s instructions for use and adhere to all warnings and cautions When a trend toward patient deoxygenation is indicated blood samples should be analyzed by a laboratory co oximeter to completely understand the patient s conditions Do not use the recorder and the SpO2 sensor during magnetic resonance imaging MRI Induced current could cause burns Prolonged continuous measurement may increase...

Page 26: ...the cable of sensor should not be pulled with force 4 3 Measurement Procedure 1 Selecting SpO2 Sensor Depending on the patient category weight and application site you can select the SpO2 sensor as required 2 Connecting SpO2 Sensor Plug the SpO2 sensor cable into the SpO2 connector on the measurement module 3 Applying SpO2 Sensor Clean the application site such as colored nail polish and apply the...

Page 27: ...Homecare Multi parameter Recorder 26 www ehealthcareinc com info ehealthcareinc com 250 East Gish Road San Jose CA 95112 USA 4 4 SpO2 Display 4 4 1 Waveform Display 4 4 2 Parameter Display ...

Page 28: ...for patient safety Do not measure NIBP on patients with sickle cell disease or any condition where skin damage has occurred or is expected Use clinical judgement to decide whether to perform frequent Auto BP measurements on patients with severe blood clotting disorders because of the risk of hematoma in the limb fitted with the cuff Use clinical judgement to decide whether to perform Auto BP measu...

Page 29: ...rs before pulling it out 3 Tie the cuff to the upper arm or thigh of the patient 4 Connect the cuff with the air inflating pipe and ensure the pipe connecting cuff is not knotted or tangled while placing pipe naturally without any press or force Note While measuring blood pressure the patient must keep calm without any talk The cuff tied on the limb shall be on the same level as the patient s hear...

Page 30: ...Homecare Multi parameter Recorder 29 www ehealthcareinc com info ehealthcareinc com 250 East Gish Road San Jose CA 95112 USA display screen the display on your recorder may be looked slightly different ...

Page 31: ...c purposes Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Guidance and manufacture s declaration electromagnetic immunity The recorder is intended for use in the electromagnetic environment specified below The customer or the user of recorder should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance le...

Page 32: ...wer quality should be that of a typical commercial or hospital environment If the user of the recorder requires continued operation during power mains interruptions it is recommended that the recorder be powered from an uninterruptible power supply or a battery Power frequency 50Hz magnetic field IEC 61000 4 8 3A m 3A m If image distortion occurs it may be necessary to position the recorder furthe...

Page 33: ...on distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance P V d 1 5 3 P E d 1 5 3 80 MHz to 800 MHz P E d 1 7 800 MHz to 2 5 GHz Where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmit...

Page 34: ...ment in which radiated RF disturbances are controlled The customer or the user of the recorder can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the recorder as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Sepa...

Page 35: ... by a qualified person who has adequate training knowledge and practical experience to perform these tests 7 2 Equipment Cleaning Keep your equipment and accessories free of dust and dirt To avoid damage to the equipment follow these rules 1 Always dilute according the manufacturer s instructions or use lowest possible concentration 2 Do not immerse part of the equipment in the liquid 3 Do not pou...

Page 36: ...ng time harm to cable it is suggested that sterilization to the product be conducted only when necessary according to the regulation of your hospital Do not clean and reuse disposable electrode SpO2 Sensor The recommended disinfector include isopropyl alcohol 70 10 decolourant solution can be used for sterilization at lower standard Don t use undiluted decolourant 5 5 25 sodium hypochlorite or oth...

Page 37: ...rom the submerged gauze then wipe airbag and pipe d Wash the cuff sheath in the clean neutral soapy water e After the sheath and airbag intensive drying enclose airbag with cuff sheath and put into operation Attention Excessive or frequent cleaning may damage airbag so don t clean airbag unless necessary Do not dry airbag and sheath in high temperature If higher sterilization level is required ple...

Page 38: ...8 Labeling and Language 8 1 Machine Label The sample of label only for reference The label contents will be changed accordingly depends on manufacture side 8 2 Language English is used to all the machines with the CE certificate which includes the product document sent to the user end label mark of package and software interface etc ...

Page 39: ...e skin Check the user manual and repeat measurement Your body is too tense Relax and repeat the measurement Your skin is dry Moisten your skin with a damp towel The electrodes have been applied over clothing Apply the electrodes to bare skin The ECG signal is too weak Make sure that the electrodes are applied correctly However for some individuals measurement may not be possible Lead wires not ful...

Page 40: ...ectrodes are inaccuracy Check the user manual and repeat measurement The SD memory card in the unit but the unit cannot recognize it The SD memory card cannot be recognized Replace a new SD memory card The SD memory card cannot be used The SD memory card may be damaged Format the SD memory card or use a new SD memory card ECG data has disappeared Device error Please contact ZTE customer service Ot...

Page 41: ... 15 to 85 non condensing 6 Operating atmospheric pressure 700hPa to 1060hPa Transportation and storage temperature 20 to 50 Transportation and storage humidity 10 to 93 non condensing Transportation and storage atmospheric pressure 500hPa to 1060hPa size 260mm 210mm 60mm length width height mm weigh 2 0kg type Table model System Android 5 1 Bluetooth support 2 4GHz WiFi support 2G 3G 4G support SD...

Page 42: ... 0mmHg 0kPa 300mmHg 40kPa Static Pressure Accuracy 0 4kPa 3mmHg ABP Range ambulatory blood pressure 30mmHg 4kPa 200mmHg 26 6kPa ABP Accuracy ambulatory blood pressure Error 0 7KPa 5mmHg Accuracy A 5mmHg δ 8mmHg maximum standard deviation Measure interval 5min HR Range 40 240bpm Blood Pressure Range SBP 40 270mmHg Adult DBP 10 215mmHg Adult Pmean 20 235mmHg Adult Lead type single lead Accuracy 1 or...

Page 43: ... for arm 3 Important 5 Finger clap SPO2 Sensor Sensor for SPO2 measurement 1 Important 6 Blood pressure cuff and air tube connector Cuff for Blood Pressure measurement 1 Important 7 Power Adapter Adapt to lithium battery inside 1 Important 8 User Manual Instruction For User 1 Important 9 Certification of Approval Certification of conformity 1 Important 10 Warranty Card Card for Product Warranty 1 ...

Page 44: ...h Ampere hour kg kilogram nm nanometer bpm Beat per minute kPa kilopascal rpm Breaths per minute bps Bit per second L litre s second ºC centigrade lb pound W watt cc Cubic centimeter m meter mmHg Millimeters of mercury cm centimeter mAh Milliampere hour cmH2O Centimeters of water dB decibel Mb Mega byte ms millisecond DS Dyne second mcg microgram V volt ºF fahrenheit mEq milli equivalents VA Volt ...

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