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Copyright

Our company owns all rights of this unpublished work and intends to maintain it as a 
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publication is to be used solely for the purpose of reference or operation of our device. No 
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errors contained herein nor for incidental or consequential damages in connection with the 
furnishing, performance, or use of this material. The information this publication refers to is 
protected by copyrights or patents and does not convey any license under the patent rights 
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infringements of patents or other rights of third parties.
Content of the manual is subject to change without prior notice.

Model: HCSMD400
Version: Ver1.0
Revised Date: October 16, 2016

Содержание HCSMD400

Страница 1: ...r disclose the information in this work unless expressly authorized by our company All information contained in this publication is believed to be correct We shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing performance or use of this material The information this publication refers to is protected by copyrights or patents...

Страница 2: ...t 9 3 1 Probe Connection 9 3 2 Basic Operation 9 3 3 Factors that may affect the measurement 10 3 4 Alarm 11 4 Settings 13 4 1 Date Time Settings 13 4 2 User ID Setting 14 4 3 Alarm Setting 14 4 4 Data Management 15 4 5 System Setting 17 5 Data Transmission 18 6 Maintain and Repair 19 6 1 Maintenance 19 6 2 Cleaning and Disinfecting 19 6 3 Calibrating 20 6 4 Trouble Shooting 20 6 5 Warranty and Re...

Страница 3: ... of Reductive hemoglobin RHb and Oxyhemoglobin HbO2 in red and near infrared zones Operation principle of the instrument Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning and Recording Technology so that two beams of different wavelength of lights 660nm red and 905nm near infrared light can be focused onto a human nail tip through a clamping fi...

Страница 4: ...e device is not intended for sterilization Follow local ordinances and recycling instructions regarding disposal or recycling of the device and device components including batteries This equipment complies with IEC 60601 1 2 2007 for electromagnetic compatibility for medical electrical equipment and or systems However because of the proliferation of radio frequency transmitting equipment and other...

Страница 5: ...e eliminated by covering each site with opaque material Optical cross talk may adversely affect the accuracy of the SpO2 readings Obstructions or dirt on the sensor s red light or detector may cause a sensor failure Make sure there are no obstructions and the sensor is clean Any condition that restricts blood flow such as use of a blood pressure cuff or extremes in systemic vascular resistance may...

Страница 6: ...uipment and other sources of electrical noise in the health care and home environments e g cellular phones mobile two way radios electrical appliances it is possible that high levels of such interference due to close proximity or strength of a source may result in disruption of performance of this device This apparatus complies with the IEC 60601 1 2 international standard The requirements of this...

Страница 7: ...d the device and other components 1 7 Product Features High resolution 2 8 TFT screen display SpO2 PR and PI Pulse Amplitude Index waveform and pulse bar Adjustable audible and visual alarms 127 ID setup 72 hour data storage and review Medview software for data analysis 3 AA alkaline batteries or power adapter Muti language Menu English French German Spanish Italian Japanese Russian and Chinese 1 ...

Страница 8: ...or data transmission 2 SpO2 socket For connecting the SpO2 probe with the pulse oximeter 3 Alarm lamp When SpO2 or and PR alarm occurs It flashes 4 Display screen 5 Menu OK button For entering main menu or confirming the selection setting 6 Alarm silence button Press this button to silence the audible alarm 7 Navigation button Up Press this button to increase the value by one increment Or press it...

Страница 9: ...he position which is marked with and then push the cover as indicated by arrowhead as shown in 2 Install three batteries lightly as indicated by the polarity signs in battery compartment 3 Close battery cover Close the battery cover and slide the screw to the position which is marked with And the battery cover is locked Fig 2 2 Warning Make sure the polarities of the batteries are correct Battery ...

Страница 10: ... and regulations 2 2 2 AC Power Supply The device can be supplied by AC power through connecting the device to AC adapter Note Use the AC power supply make sure put the device in the safety and proper place and convenient to power off Warnings Be sure to use the adapter that specified for this device Plug and unplug the adapter cautiously to avoid injuries caused to your body If the device suddenl...

Страница 11: ...robe compatibility before use the probe should meet the ISO80601 2 61 Select the suitable probe in terms of type and dimension Attach the sensor to the appropriate site of the user s finger refer to Fig 3 2 Fig 3 2 placement of the sensor If the finger is not in the probe Finger off will be shown 3 2 Basic Operation Press and hold the power switch for 3 seconds to power the device on After several...

Страница 12: ...pO2 high alarm limit 90 SpO2 low alarm limit 4 Pulse bar 5 100 PR high alarm limit 060 PR low alarm limit 6 PRbpm PR area of display It shows the pulse rate in beats per minute during normal measurement The color of the PR value will become red when the PR is beyond the alarm limits It shows three dashes throughout probe off and finger out conditions 7 ID 001 the ID number of the current patient i...

Страница 13: ... surgical interference and defibrillators 6 Venous pulsations 7 Placement of a probe on an extremity with a blood pressure cuff arterial catheter or intravascular line 8 The patient has hypotension severe vasoconstriction severe anemia or hypothermia 9 There is arterial occlusion proximal to the probe 10 The patient is in cardiac arrest or is in shock Loss of pulse signal can occur in any of the f...

Страница 14: ...rt press the button to silence the audible alarm for 60s 120s the audible alarm indicator will be displayed as together with the countdown short press it again you can cancel alarm inhibition Warnings When an alarm occurs check patients conditions immediately Check the parameter which is alarming Check patient s condition Search for the source of the alarm Make the alarm mute if necessary Check th...

Страница 15: ...he oximeter and then press the menu button to enter the main menu refer to the Fig 4 1 Measuring 100 090 100 060 98 70 bpm Menu Data Management OK Back 12 00 Alarm Setting System Setting Date and Time SpO2 PR Fig 4 1 2 Press the Navigation button to select Date and Time item and then press the OK button to enter the time setup screen refer to Fig 4 2 Measuring 120s SpO2 100 090 100 060 98 PR 70 bp...

Страница 16: ...ncrease after 5 seconds 4 3 Alarm Setting Note Every time enter into the Alarm Setting in the main menu you should input the password From the main menu select and enter the Alarm setting screen refer to Fig 4 3 Measuring 120s SpO2 2 100 090 100 060 98 PR 70 bpm Alarm Setting Alarm High Limit Low Limit ON ON OK 100 90 60 100 PR SpO Back 12 00 Fig 4 3 You can select the Alarm on or off High limit S...

Страница 17: ...revious screen 4 4 1 Data Review Pick and enter the Data review interface as shown in Fig 4 5 By pressing the Navigation button to review the records page by page The pulse oximeter can record the alarming parameter marked with red color Press the Back button the pulse Oximeter returns to the previous interface Measuring 120s SpO2 PR Page 01 80 Time Back 12 00 98 70 1 98 70 1 98 70 1 98 70 1 90 60...

Страница 18: ... hour minute second 4 4 3 PR Trend Pick and enter the PR Trend interface as shown in Fig 4 7 By pressing the Navigation button to review the records page by page Press the Back button the pulse Oximeter returns to the previous interface Measuring 120s SpO2 100 090 100 060 98 PR PR Trend 70 bpm bpm PR 50 100 150 200 100 300 500 700 250 0 T s Page 01 80 Back 04 30 15 10 51 Fig 4 7 4 4 4 Delete all d...

Страница 19: ...ctory Default Fig 4 9 Fig 4 10 Alarm Volume you can adjust the value of alarm volume there are 7 levels and the default level is 3 Alarm Pause there are two modes 60s and 120s and the default mode is 120s The device audibly alarm upon new alarm conditions Beep Tone the level is from 0 to 7 and the default level is 3 Backlight Setting the level of brightness is from 1 to 7 and the default level is ...

Страница 20: ...nagement ID setup Factory Default 5 Data Transmission Use USB cable to transmit the measurements to PC for further review and analyze Before data transmission make sure to turn the device on and connect it with a computer by the attached USB cable The operations refer to the User Manual of the data transmission Software ...

Страница 21: ...opyl alcohol Also clean the being tested finger using alcohol before and after each test To clean your equipment follow these rules 1 Shut down the pulse oximeter and take the batteries out of the battery wharf 2 Clean the display screen using a soft clean cloth dampened with a glass cleaner 3 Clean the exterior surface of the equipment using a soft cloth dampened with the cleaner 4 Wipe off all t...

Страница 22: ...ctly c No finger alarm Please check whether the sensor is correctly connected with patient s finger 6 5 Warranty and Repair 6 5 1 Maintenance Method a Maintenance responding time 9 00am 17 30pm Monday to Friday b Service support our company offers the support by hot line e mail or spares parts Spare parts our company changes parts if it is necessary free of charge in the warranty period Because pa...

Страница 23: ...e Not our company professionals or authorized personnel disassemble oximeter and lead to oximeter failure Not carefully read manual and so wrong operation lead to oximeter damage and failure 6 5 4 User s Special Request for Guarantee Time Our guarantee constitution for oximeter complies with electronic product after sale service standard regulated by national laws We regulate the guarantee time of...

Страница 24: ...ed to be specified Specifications Display Data SpO2 PR PI pulse bar Others connection status of probe and other alarm information Equipment data update period As shown in the following figure Data update period of slower average is 8s Alarm Alarm SpO2 and pulse rate value probe off battery exhausted Alarm mode audible alarm visual alarm and information Alarm limits range SpO2 70 100 PR 30bpm 250bp...

Страница 25: ...nsation Power supply Three AA alkaline batteries rechargeable batteries or adapter Working time alkaline batteries more than 10 hours NI MH battery 6 hours Atmosphere pressure 86kPa 106kPa AC adapter optional Input Voltage AC 100 240V Input Frequency 50 60Hz Output Voltage DC 5V 5 Output Current 2A MAX Fuse Type 1206L050 I hold 0 5A I trip 1A V max 15V Store and Replay Store and replay 72 hours Sp...

Страница 26: ...cording to the methods of sterilization or disinfection Non sterile Use of Liquid surface disinfectants only According to the mode of operation Continuous operation Equipment not suitable for use in the presence of a flammable anesthetic mixture air or with oxygen or nitrous oxide Note the applied part of the device the SpO2 probe Box contents 1 Three AA alkaline batteries 2 One instruction manual...

Страница 27: ...ing probes are shown as following B 1 Clinical study details of HCSMD400 Pulse Oximeter and its supporting M 50E012CS09 Oximeter probe Table 6 1 ARMS Value Analysis Statement Item 90 100 80 90 70 80 pts 78 74 66 Bias 0 73 0 59 0 45 ARMS 1 46 1 80 1 99 Bland Altman Plot Graphic B 2 Clinical study details of HCSMD400 Pulse Oximeter and its supporting M 50B008CS09 Oximeter probe Table 6 2 ARMS Value ...

Страница 28: ...phic B 3 Clinical study details of HCSMD400 Pulse Oximeter and its supporting M 50J033CS045 Oximeter probe Table 6 3 ARMS Value Analysis Statement Item 90 100 80 90 70 80 pts 78 74 66 Bias 0 51 0 41 1 56 ARMS 1 34 1 49 2 36 Bland Altman Plot Graphic ...

Страница 29: ...itable for use in all establishments including domestic establishments and those directly connected to the public low voltage powere supply network that supplies building used for domestic purposes 6 Harmonic emissions IEC 61000 3 2 Class A 7 Voltage fluctuations IEC 61000 3 3 Complies Guidance and manufacturer s declaration Electromagnetic Immunity For all Equipment and Systems Guidance and manuf...

Страница 30: ...e that of a typical commercial or hospital environment If the user of the model HCSMD400 Pulse Oximeter requires continued operation during power main interruptions it is recommended that the model HCSMD400 Pulse Oximeter be powered from an uninterruptible power supply or a battery Power frequency 50 60Hz magnetic field IEC 61000 4 8 3A m 3A m The power frequency magnetic field should be measured ...

Страница 31: ... to 2 5GHz Where P is the maximum output power rating of the transmitter in Watts W according to the transmitter manufacture and d is the recommended separation distance in meters m 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 Interference may occur in the vicinity of equipment marked...

Страница 32: ...ess than 3V m Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM for EQIPMENT and SYSTEMS that are not LIFE SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the HCSMD400 Pulse Oximeter The model HCSMD400 Pulse Oximeter is intended for use in an electromagnetic environment in whi...

Страница 33: ...the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE1 At 80MHz and 800MHz the separation distance for the higher frequency range applies NOTE2 These guidelines may not apply in all situations Electromagnetic interference is affected by absorption and reflection from structures objects and people ...

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