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27

Electromagnetic field effects, such as nuclear magnetic

resonance device

Electrosurgical devices

Concentration of non-functional hemoglobin, such as carboxyhemoglobin (COHb)

and methemoglobin (MetHb)

Presence of certain dyes, such as methylene blue and indigo rouge, inappropriate

placement of oxygen probe or incorrect use of oxygen probe

Shock, anemia, low temperature or application of vasoconstrictor drugs leads to

reduced pulse blood flow in the water that can not be measured

Chapter VII of temperature (TEMP) (optional)

7.1 Temperature Monitoring Operation Steps (Optional)

Oximeter temperature probe can be used to measure the body temperature
data.
1. If you are using a disposable temperature probe, insert the cable’s right side
into socket and connect the other side with probe. For reusable temperature
probe, you can plug it directly into the socket.
2. The temperature probe firmly attached to the patient.
3. Connect the oximeter and temperature cable.

Содержание B-820 mini

Страница 1: ...Mini Handheld Pulse Oximeter User s Manual ...

Страница 2: ...otice Before using the product please read the contents of this manual carefully for proper use of the product Please keep this manual after reading it so as to access at any time when needed Foreword This manual describes in detail the purpose function and operational use of the product Before using this product please carefully read and understand the contents of this manual to ensure proper use...

Страница 3: ... by under the following circumstances including but not limited to Component disassembly stretching and re commissioning replacement of accessories without permission of the company or the machine repair by non authorized personnel of the company Return of goods Return process The company is really necessary to be returned follow these steps 1 The acquired right of return Contact our customer serv...

Страница 4: ...ameter area 12 Chapter III Preparation before Use 13 3 1 Unpacking and Inspection 13 3 2 Power On 13 3 3Shutdown 14 Chapter Ⅳ Menu Settings 14 4 1 Alarm 14 4 1 1 SPO2 Alarm 13 4 1 2 Temp Alarm 13 4 2Setup 13 4 3System Setup 16 4 3 1 Screen Brightness 15 4 3 2 Default Setup 19 4 3 3 Manufacturer Maintenance 19 Chapter V Alarm 21 5 1 Alarm Type 21 5 2 Alarm Status Icon 21 5 3 Alarm Pause 22 5 4 Set ...

Страница 5: ...Setting The Temperature Unit 29 Chapter VIII Battery 30 8 1 Overview 30 8 2 Installing The Batteries 30 8 3 Battery Recycling 31 9 1 Inspection 32 9 2 Cleaning 33 9 3 Disinfection 33 9 4 Scrap 34 Chapter Ⅹ Accessories 35 A Product Specification 36 B Default factory settings 40 C Alarm Information 41 C 1 Physiological alarm information 42 C 2 Technical alarm information 42 D Manufacturer s Declarat...

Страница 6: ...3 ...

Страница 7: ...s and if they are not avoided it could result in slight personal injury product failure damage or property loss Attention Highlight important considerations and provide instructions or explanations to make better use of this product This product is not involved in the information on danger level 1 1 1 Warning Warning Users before using this Palm Pulse Oximeter should follow the instructions set ou...

Страница 8: ...h an electrosurgical device the user doctor or nurse should ensure the safety of the patient under intensive care During defibrillation do not touch patients or else it may cause serious injury and death To prevent delays in treatment make full alarm settings for each patient while alarm sound should also be able to be ensured when alarming The physiological waveforms physiological parameters and ...

Страница 9: ...rements specified on the device label or in this manual Please properly install or carry the device to prevent the device falling or being damaged due to collision receiving strong shock or other mechanical force 1 1 3 Attention Attention Mount the device at the place where it is easy to observe operate and maintain Place this manual near the device so as to be able to easily and timely access whe...

Страница 10: ...nufacturer Date of manufacture Serial number Recycled separately from other household waste under the WEEE directive Keep dry Keep away from sunlight Chapter II Product Overview 2 1 Introduction 2 1 1 Intended use The oximeter is suitable for both home care and hospital use to monitor patients vital sign parameters including blood oxygen saturation pulse rate and body temperature body temperature ...

Страница 11: ... specification in this manual When the device is moved from one scene to another one due to differences temperature or humidity which may cause the device condensation At this point you must keep waiting until the condensation condition disappears to use the device Warning Please ensure that the device is operated under specified environmental conditions otherwise it will not meet the technical sp...

Страница 12: ...erent situations the key has different functions Start After the battery is installed short press the button to turn on the monitor Shutdown in the startup state long press the button for 2 seconds to turn off the monitor 3 Menu key Press this key to enter the menu screen or select an option 4 Alarm Indicator light 1 2 4 3 5 6 7 8 9 10 ...

Страница 13: ... functions Press this key to move the cursor upward to reduce the value of a menu option or to decrease the pulse volume and to complete other operations 7 Micro USB interface Connect the adapter 8 Oxygen sensor socket connects with the oxygen saturation probes to achieve oxygen detection 9 Temperature sensor interface Connected to the temperature probes to achieve temperature measurement 10 Power...

Страница 14: ...alue display area 3 PR value display area 4 Physiological and technical alarms area Display alarm information tips and information on the operating mode Circle display when coming with multiple messages 5 Alarm status area indicates the alarm sound turned off 6 Battery status icon 7 PI bar diagram 8 Time area 2 3 1 SpO2 value display Area 1 2 3 5 6 8 4 7 1 6 5 4 2 3 ...

Страница 15: ...12 1 Value Name 2 SpO2 value 3 PI bar graph 4 Low alarm limit 5 High alarm limit 6 Unit 2 3 2 PR parameter area 1 Value Name 2 Unit 3 High alarm limit 4 Low alarm limit 5 PR value 2 3 4 1 5 ...

Страница 16: ... department or agency immediately Warning Keep packaging material out of children s reach Concerning Disposal packaging materials waste disposal system must comply with relevant local regulations or hospital s claim 3 2 Power On 1 Before starting check whether the oximeter is mechanically damaged 2 Make sure the battery has enough capacity 3 Insert the oximeter cable into interface jack 4 Press th...

Страница 17: ... that the work of monitoring patient comes to an end 2 Disconnect the oximeter and oximeter cable 3 Press the power switch and hold for two seconds to turn off the oximeter Chapter Ⅳ Menu Settings The oximeter is designed with a flexible configuration Both monitoring and alarm setting could be free performed by user Press the Menu key to bring up the main menu shown in Figure 4 1 Figure 4 1 4 1 Al...

Страница 18: ...em as your need then press M Increase or decrease via pressing After your adjustment pressing M to ensure it 4 1 2 PR Alarm Choose PR in Alarm menu PR adjustable range Max 254 Min 0 SPO2 Alarm On Off Adjustment method same as 4 1 1 4 1 2 Temp Alarm optional Choose Temp in Alarm menu Temp adjustable range Max 50 Min 20 SPO2 Alarm On Off Adjustment method same as 4 1 1 ...

Страница 19: ...tup menu select the alarm vol Press to select the level of the alarm volume The options have five levels as 1 2 3 4 5 In the Setup menu select the TEMP unit Press to modify TEMP unit The options include and Attention If used outdoors or ambient light please increase the screen brightness for observation Use Alarm Off button if you need to turn off the Alarm function 4 3 System Setup Select SYSTEM ...

Страница 20: ...17 Figure 4 4 4 3 1 Review Choose Review in SYSTEM you will see menu as Figure 4 5 You can setup record Open or Close and the recording period Time in Review menu 图4 5 历史回顾 ...

Страница 21: ...ll see menu as Figure 4 6 图4 6 Trend This device can review 500groups history data Choose Previous Page in Trend you will see menu as Figure 4 7 图4 7 Review You can choose SPO2 PR TEMP in Review Open read PRE to read the previous page ...

Страница 22: ...Select No to quit the current operation and the system remains unchanged original configuration 4 3 3 Manufacturer Maintenance In the System Setup select the Maintenance item and pop out a dialog box as shown in Figure 4 9 Users can input specific user password to active advanced settings in user maintenance menu Factory Maintenance function only opens to the company s designated maintenance perso...

Страница 23: ...20 Figure 4 9 4 4 Time Setup Choose Time Set in SETUP menu as Figure 4 10 Figure 4 10 Attention ...

Страница 24: ...ies cannot be attribute to one single physiological parameter beyond the range it can be referred to as physiological alarm when the alarm is from the machine itself namely when there are technical barriers existed in the alarm or the machine itself breaks down as a result the patient cannot be observed accurately it is referred to as technical alarm Patient or machine Alarm category Heart rate of...

Страница 25: ...ot change Warning When the alarm volume is adjusted to 0 the alarm sound is off Patients cannot be monitored and cared only by the sound alarm system When the alarm sound is adjust to a relatively small volume patients can be in a dangerous condition Users should pay close attention to the actual clinical condition of patients 5 5 Countermeasures to The Alarm In case that the oximeter sends out an...

Страница 26: ...ed for SpO2 measurement It measures the specific wavelength of light from the light source of oxygen saturation probes and after it is absorbed by oxyhemoglobin in the patient s tissue and reaches the luminous flux of photodetector end thus to get oxygen saturation and pulse rate The oximeter has been calibrated and is used to display functional oxygen saturation The interface is as shown in Figur...

Страница 27: ...pulse 3 Pulse rate PR the number of pulse detected per minute obtained from plethysmography waveform 4 Plethysmography Pleth waveform the strength of the patient s pulse signal does not affect the amplitude of Pleth waveform 6 2 Safety Information Warning Influence from carboxyhemoglobin methemoglobin or dye dilution chemicals will cause biased SPO2 value Do not use any other SpO2 probe except the...

Страница 28: ... occurred to patient s skin Continuous long term monitoring may increase risk of patient s unpredictable skin changes such as allergies reddening blistering or oppression necrosis The cables of electrosurgical devices cannot be entwined with oximeter cable Do not mount and place the oxygen probe on the limbs with arterial ducts or intravenous tubes Do not place the oxygen probe and blood pressure ...

Страница 29: ...above the high alarm limit a physiological alarm of too high parameters will be triggered 3 Set the Low Limit of SpO2 or PR When the measured parameter value is below the low alarm limit a physiological alarm of too low parameters will be triggered In case that a parameter alarm occurs the measured value of the parameter will flash and the appropriate alarm light will be triggered 6 6 Measuring In...

Страница 30: ...cation of vasoconstrictor drugs leads to reduced pulse blood flow in the water that can not be measured Chapter VII of temperature TEMP optional 7 1 Temperature Monitoring Operation Steps Optional Oximeter temperature probe can be used to measure the body temperature data 1 If you are using a disposable temperature probe insert the cable s right side into socket and connect the other side with pro...

Страница 31: ...f and an alarm sounds Similar to other channels Place carefully temperature probe and cable when not in use probe and cable should be rolled into a loose ring If the inside of the wire pull too tight it will cause mechanical damage Must biennial temperature measuring instrument calibration or according to hospital protocol indicates the time Note Disposable temperature probe can only be used once ...

Страница 32: ...arm sounds alarm lights and alarms are turned off the display Temp parameter shows icon 7 4 Set the Alarm Limit 1 Select Menu Alarm Alarm temperature alarm 2 Set Temp The High Limit When the measured parameter value is above the high alarm limit an alarm will be triggered physiological parameters too high 3 Set Temp the Lower limit When the measured value is below the low alarm limit parameters lo...

Страница 33: ... Note Remove the batteries before shipping oximeter or not use for a long time AC adapter power supply is available simultaneous use when you are using batteries Warning Keep out of the reach of children Use only the battery specified by the manufacturer 8 2 Installing The Batteries 1 Hold the battery cover push it down remove the battery cover 2 Install the batteries 1 Press the batteries correct...

Страница 34: ...ompany does not bear any responsibility for the effectiveness of the chemicals or methods listed as a means of infection control About the method for infection control please consult the hospital s infection prevention department or epidemiologist Please keep your devices and its accessories free of dust To prevent damage to the device be sure to observe the following Please dilute the cleaning ag...

Страница 35: ...least every two years a comprehensive inspection on it should be conducted by qualified maintenance personnel to ensure the normal operation and work of the oximeter Inspection items should include The environment and power supply meet the requirements The device and accessories are not mechanically damaged The power line is not worn with good insulation properties Use the specified accessories Th...

Страница 36: ...urn off the oximeter 2 Use a soft cotton ball and adsorb the right amount of cleaning agent and wipe the display screen 3 Use a soft cloth ball and adsorb the right amount of cleaning agent and wipe the surface of the device 4 Use a dry cloth to remove excessive cleaning agent when necessary 5 The device is placed in the ventilated shade and dry environment 9 3 Disinfection Disinfection operation ...

Страница 37: ...contamination or infection to others environment or other devices before scrapping the oximeter follow the state relevant laws or regulations for its disinfection and purification For the oxygen probe please follow the relevant provisions of the local hospital on waste scrap ...

Страница 38: ...ry packages or accessories are damaged do not use the accessories The blood oxygen saturation probe in the chapter complies with biocompatibility requirements and meets the standards ISO 10993 1 and ISO 10993 5 and ISO 10993 10 Blood oxygen saturation probe Model Applicabl e object Wavelength DB9 adult finger clip Adult 660nm 940nm DB9 newborn wrap Newborn 660 nm 905 nm Others Name Model Body temp...

Страница 39: ...luding internal power supply Protection class of electric shock BF anti defibrillator Explosion protection class Ordinary device explosion protection not provided Protection class of inlet liquid IPX2 Movement grade Handheld Working mode Continuous Environmental specification Work Storage Temperature 0 40 20 60 Relative humidity non condensing 15 95 10 95 Atmospheric pressure mmHg or kPa 425 809 m...

Страница 40: ... Hardware specification Display screen Color TFT 2 4 inch dot matrix 240 320 Speaker 1 alarm sound 45 85dB multi level volume function alarm sound in line with the requirements of IEC 60601 1 8 standard Alarm indicator light 1 yellow Power indicator light 1 green Blood oxygen probe interface 1 D 9 pin socket Temperature probe interface 1 optional Micro USB interface 1 connect adapter Measurement s...

Страница 41: ...ion 1 Precision 70 100 2 adults in the non moving state 3 in the moving state 0 69 not defined Update cycle 1 s PR Measuring range 18 300 bpm Resolution 1 bpm Precision 3 bpm in the non moving state 5 bpm in the moving state Update cycle 1 s Alarm limit specification Alarm limit Range Step length SpO2 high limit low limit 1 100 1 SpO2 low limit 50 high limit 1 Alarm limit Range bpm Step length bpm...

Страница 42: ...39 TEMP Measuring range 0 50 Resolution 0 1 Precision 0 1 Alarm limit specification Alarm limit Range Step length TEMP high limit low limit 1 50 1 TEMP low limit 0 high limit 1 ...

Страница 43: ...he factory settings but when needed the default factory settings of the oximeter can be restored B 1 Alarm Alarm setting Default factory settings Alarm volume 1 Pause time for alarm tone 120 s Alarm switch open Probe off low SPO2 alarm open PR alarm limit open B 2 SpO2 SpO2 Settings Adults SpO2 high alarm limit 100 SpO2 PR low alarm limit 90 ...

Страница 44: ...ological and technical alarm information but some alarm information is not necessarily listed For each alarm information appropriate countermeasures are given out If the problem persists after operations following the countermeasures contact the maintenance personnel Alarm information Reasons and countermeasures SpO2 too high Check the physiological condition of the patient and confirm whether the...

Страница 45: ...on are correct and whether the oxygen probe is damaged Reconnect the oxygen probe or use a new oxygen probe patient type and alarm limit settings are applied to the patient PR too high PR too low No pulse found If the patient s pulse signal is too weak the system can not analyze Check the patient s condition oxygen probe and measurement site Temp too high Check the physiological condition of the p...

Страница 46: ... customer or the user of Palm Pulse Oximeter should assure that it is used in such an environment 3 Emissions test Compliance Electromagnetic environment guidance 4 RF emissions CISPR 11 Group 1 The Palm Pulse Oximeter uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment 5 RF emissions CISP...

Страница 47: ... environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode N A Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec N A Mains power ...

Страница 48: ...ed separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance P V d 5 3 1 P E d 5 3 1 80 MHz to 800 MHz P E d 7 1 800 MHz to 2 5 GHz where p is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m b Field strengths from fix...

Страница 49: ...n an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Palm Pulse Oximeter can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Palm Pulse Oximeter as recommended below according to the maximum output power of the communications equipmen...

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