PC – 68B
Contents
1. trend curve of SpO2 and PR 1 Your finger is out of proper location in the probe 2 Blood flowin the finger blocked 3 Extreme movement User Manual for Wrist Oximeter Possible Reason M 1 The finger is not placed far enough inside 1 The batteries are drained or almost drained 2 The batteries are not inserted properly 3 The device is malfunctioning 39 Solution 1 Place the finger correctly inside and try again 1 Change batteries 2 Reinstall batteries 3 Please contact the local service center location properly 2 Make sure there ig no object may occlude the blood flow 3 Extreme Movement may cause invalid measuring result Trouble 1 The probe is not connected to the oximeter properly 2 The finger is not placed well 3 The probe connector or the probe sensor is broken User Manual for Wrist Oximeter M Possible Reason M Solution 1 Connect the probe to the oximeter properly and try again 2 Place the finger properly and try again 3 Please contact the local service center 2 User Manual for Wrist Oximeter 9 Appendix A Common Knowledge for SpO Measurement 1 Meaning of SpO2 SpO is the saturation percentage of oxygen in the blood so called O gt concentration in the blood it is defined by the per2. Wrist Oximeter A High temperature or high pressure steam disinfection to the oximeter is not permitted Refer to related chapter for instructions of cleaning and disinfection Declaration of Conformity The manufacturer hereby declares that this device complies with the following standards IEC 60601 1 ISO 9919 and follows the provisions of the council directive MDD93 42 EEC User Manual for Wrist Oximeter Contents OVERVIEW nassen 1 Dl AADC ATA CC sy eek i 1 2 Name and Model ana eetrns 2 l 3 511 1K ya an 7 1nL0 KESSEONEPRSPRERNRHIIRES AR ESHEEREFPEFEURRNIR SERRSRERERPLEREN 3 54 Features une ee 3 LS Intended Use nennen im 4 1 6 Key of Symbole ee ee 5 2 BATTERY INSTALLATION cussscosssossssossssossesonssnonene 6 3 OPERATION 7 3 1 Taking Measurement ann 7 3 2 Menu Operation ee 16 SAL TEREND REMTEW ae es 17 3 22 DELETE DATA a es 18 3 2 3 OVER LIMIT INDICATION SETTINGS 18 3 2 4 TIME SET TINGS u ee 20 3 2 5 WIRELESS SETTING OPTIONAL 21 3 2 6 RECORD INTERVAL SETTINGS 22 3 3 Upload D ta soe chicane nn ee ee 24 User Manual for Wrist Oximeter 3 4 Low Battery Indication cece ecceseeessneeeeeeeeees 24 4 ADDITIONAL ADVICE FOR OPERATION 25 5 TECHNICAL SPECIFICATION SG csessssesseees 26 GACCEHSSOR IEG wa aus inikenaknn 29 7 REPAIR AND MAINTENANCE ssssssossssossssossssonee 30 J L Malntenance os eee cause nunetoe asiiaes cata
3. finger The probe should be oriented in such a way that the sensor side with a finger tip icon is positioned on the top Figure 6 Figure 6 Placement Illustration 4 Next insert your index finger into the probe until the fingernail tip rests against the stop at the end of the probe 8 User Manual for Wrist Oximeter Figure 7 Adjust the finger to be placed evenly on the middle base of the sensor make sure the finger is in the right position If the index finger cannot be positioned correctly or is not available other finger can be used Figure 7 Wrong Placement of the Probe Finger out Not deep enough Figure 8 5 The oximeter will automatically start measurement in 2 seconds Then the default screen will be displayed Figure 9A User can read the values and view the waveform from the display screen 9 User Manual for Wrist Oximeter Figure 9 Default Screen Display gt SpO SpO gt label 99 SpO value PR Pulse rate label 65 Pulse rate value lt A Pulse beat icon Mme Battery indicator P Pulsation bar graph gt The displayed waveform is plethysmogram Key Operations sc e Short press circularly display screen will be switched among the m key to switch display modes three measure screens displays as shown in Figure 9A Figure 9C and Figure 9D e Long press 4 key choose display always on or not which will be effective dur
4. in Figure 11 Full memoryicon Wireless icon SpO amp PI m 99 14 j ANIAN Figure 11 When Memory is Full 86 gt Wireless icon If the wireless bluetooth communication function is enabled the icon will be 13 User Manual for Wrist Oximeter displayed on screen Please refer to chapter 3 2 5 Wireless Setting Note It is suggested that the data shall be uploaded to computer when memory is full or the earliest record will be overwritten Working Mode e The measurement will start automatically when the finger is inserted into the SpOz probe so the data recording SpOz and PR value starts simultaneously as well The display is as shown in Figure 9A e During measurement if the icon for display always on is not shown on screen and no key button operation for 30 seconds the screen display will be blank for power saving even when the measurement and data recording are still undergoing but short pressing any key will activate the display for viewing the current measuring information again e If there is no signal and no key press to be detected e g finger off for 20 seconds the device will be at standby status i e blank screen and standby for measurement e When the device is at standby status short pressing 14 User Manual for Wrist Oximeter any key will activate the screen to default display screen or once the finger is inserted in the SpO2 probe the measuremen
5. measure SpO2 and Pulse Rate PR Real time clock display and setting Over limit alert by audible beep visible display and vibration of the oximeter the over limits can be adjustable It is convenient for you to measure SpO and pulse rate in long term while sleeping or at other daily activity 33 User Manual for Wrist Oximeter e Recording interval can be selected up to 480 hours data memory e Applicable for longtime continuous measurement e PR trend curve and SpO gt trend curve view e Data storage and transmission to PC for view and analysis Optional 1 5 Intended Use This Wrist Oximeter is intended for measuring the pulse rate and functional oxygen saturation SpO2 It is applicable for long term measurement of adult s SpO2 and pulse rate in home and clinics 4 User Manual for Wrist Oximeter 1 6 Key of Symbols Description Authorized representative in the European community Disposal of this device according to WEEE regulations User Manual for Wrist Oximeter 2 Battery Installation Figure 4 Battery Installation 1 Lift up the cloth covered on the battery cover Then use your index finger and middle finger to press against the battery cover Meanwhile slide it towards the side with SpO probe as shown in Figure 4 2 Refer to Figure 4 insert two AAA size batteries into the battery compartment properly in the right direction 3 Replace th
6. measurement used in clinical becomes more popularly such as monitoring the patient with serious respiratory disease the patient under anesthesia during operation premature and neonate The status of SpO2 can be determined in time by measurement and find the hypoxemia patient earlier thereby preventing or reducing accidental death caused by hypoxia effectively 235 User Manual for Wrist Oximeter 3 Factors affecting SpO measuring accuracy interference reason gt Intravascular dyes such as indocyanine green or methylene blue lt Exposure to excessive illumination such as surgical lamps bilirubin lamps fluorescent lights infrared heating lamps or direct sunlight Vascular dyes or external used color up product such as nail enamel or color skin care Excessive patient movement gt Placement of a sensor on an extremity with a blood pressure cuff arterial catheter or intravascular line gt Exposure to the chamber with High pressure oxygen gt There is an arterial occlusion proximal to the sensor lt Blood vessel contraction caused by peripheral vessel hyperkinesias or body temperature decreasing 36 User Manual for Wrist Oximeter 4 Factors causing low SpQO2 Measuring value pathology reason gt Hypoxemia disease functional lack of HbO gt Pigmentation or abnormal oxyhemoglobin level lt Abnormal oxyhemoglobin variation gt Methemoglobin disease gt Sulfhemoglobinemia or arterial occ
7. measuring accuracy If the first reading appears with poor waveform irregular or not smooth then the reading is unlikely true the more stable value is expected by waiting for a while or a restart is needed when necessary 25 User Manual for Wrist Oximeter 5 Technical Specifications A B Display mode Color OLED Display Power supply requirement 2 x LRO3 AAA alkaline batteries or Ni MH rechargeable batteries Supply voltage 3 0VDC Continues working time display is off 70hours Operating current lt 40mA SpO Parameter Specifications Transducer dual wavelength LED Measurement wavelength Red light 663 nm Infrared light 890 nm Maximal optical output power less than 1 5mW maximum average Measuring range 35 100 Measuring accuracy Not greater than 3 for SpO range from 70 to 100 NOTE Arms is defined as root mean square value of deviation according to ISO 9919 Pulse Rate Parameter Specifications Measuring range 30bpm 240bpm Accuracy 2bpm or 2 whichever is greater 26 User Manual for Wrist Oximeter Preset limits SpO Low limit setting 85 Pulse Rate limit setting range Upper limit 120bpm Lower limit 50bpm Update rate 6 seconds moving average for SpO2 and 8 beats average for Pulse Rate readings Perfusion Index Display Range 0 2 20 Performance under low perfusion condition The accuracy of SpO gt and PR measurement still meets the specification described above w
8. the surface of the device before using Use cloth with alcohol to wipe the device first and then let it dry in air or wipe it dry Please take out the batteries if the oximeter will not be used for a long time The recommended storage environment of the device ambient temperature 20 C 60 C relative humidity 10 95 atmospheric pressure S0kPa 107 4kPa The oximeter is calibrated in the factory before sale there is no need to calibrate it during its life cycle However if it is necessary to verify its accuracy routinely the user can do the verification by means of SpO simulator or it can be done by the local third party test house High pressure sterilization cannot be used on the device A Do not immerse the device in liquid 30 User Manual for Wrist Oximeter 7 2 Cleaning and Disinfecting Instruction e Surface clean sensor with a soft gauze by wetting with a solution such as 75 isopropyl alcohol if low level disinfection is required use a 1 10 bleach solution Then surface clean with a damp cloth and dry with a piece of cloth e Clean the wristband with soapy water Please detach the wristband from the oximeter firstly Refer to Appendix for detailed disassembly method Caution Do not sterilize by irradiation steam or ethylene oxide Do not use the sensor if it is damaged 31 8 Troubleshooting Trouble The SpO2 and Pulse Rate display instable turn on the device Fragmental
9. User Manual Wrist Oximeter User Manual for Wrist Oximeter a49 UsYZUSYS sh EPuey s ayy YIM E Pnpolg Sul B EOWISD AIeND User Manual for Wrist Oximeter Instructions to User PC 68B Wrist Oximeter is a precision measuring device please read the manual very carefully before using this device Failure to follow these instructions may cause measuring abnormality or damage to the oximeter The Manual is published in English and Shenzhen Creative Industry Co Ltd has the ultimate right to explain the Manual No part of this manual may be photocopied reproduced or translated into another language without the prior written consent Shenzhen Creative Industry Co Ltd reserves the right to improve and amend it at any time without prior notice Version of This Manual Ver 1 1 Revised date February 9 2015 Product service life 5 years no warranty Manufacturing date See Label Copyright Shenzhen Creative Industry Co Ltd All rights reserved 3502 2290068 Il User Manual for Wrist Oximeter Notes The contents contained in this manual are subject to change without prior notice Information furnished by Creative is believed to be accurate and reliable However no responsibility is assumed by us for its use or any infringements of patents or other rights of third parties that may result from its use Instructions for Safe Operations 6 6 Check the device to make sure that there is no
10. centage of oxyhemoglobin HbO2 in the total hemoglobin of the arterial blood SpOz is an important physiological parameter to reflect the respiration function it is calculated by the following method SpO2 HbOy HbO Hb x100 HbO are the oxyhemoglobins oxygenized hemoglobin Hb are those hemoglobins which release oxygen 2 Principle of Measurement Based on Lamber Beer law the light absorbance of a given substance is directly proportional with its density or concentration When the light with certain wavelength emits on human tissue the measured intensity of light after absorption reflecting and attenuation in tissue can reflect 339 User Manual for Wrist Oximeter the structure character of the tissue by which the light passes Due to that oxygenated hemoglobin HbO2z and deoxygenated hemoglobin Hb have different absorption character in the spectrum range from red to infrared light 600nm 1000nm wavelength by using these characteristics SpOz2 can be determined SpO2 measured by this oximeter is the functional oxygen saturation a percentage of the hemoglobin that can transport oxygen In contrast hemoximeters report fractional oxygen saturation a percentage of all measured hemoglobin including dysfunctional hemoglobin such as carboxyhemoglobin or metahemoglobin Clinical application of pulse oximeters SpO gt is an important physiological parameter to reflect the respiration and ventilation function so SpOz
11. e cover Remark After finishing battery installation the oximeter will automatically power on and display software version number firstly Please take care when you insert the batteries as the improper insertion may make the device not work 6 User Manual for Wrist Oximeter 3 Operation NOTE for key button operation Long pressing press a key down more than 1 second Short pressing press a key down then let it go immediately less than 1 second The following methods can activate the device while it is in standby status 1 Short press Set Key m to activate the screen display 2 Insert finger into the probe to activate the measurement and screen display automatically 3 When USB data cable is connected between the device and PC it will enter data uploading mode NOTE If the calendar clock time has not been set the device will enter the Time Settings screen while it powers up The device will enter standby status automatically if there is no key press and no measuring signal in 20 seconds That is the only way to turn it off i e at standby status 3 1 Taking Measurement 1 Insert the SpOz probe connector into the SpOz probe receptacle on the device properly 7 User Manual for Wrist Oximeter iW a un er pO probe connector Figure 5 SpO2 Probe Connection 2 Fix the oximeter on your left wrist Figure 6 3 Then hold the probe with its opening towards your index
12. ent 11 20 35 start time of trend graph displayed on this screen m A Page scroll backward forward button Curves in the middle area Green curve indicate pulse rate trend curve Orange curve indicate SpO gt trend curve Operation Instructions o gt e Short press A key Page scroll forward e Short press W key Page scroll backward 17 User Manual for Wrist Oximeter e Long press m key go back to the menu screen Note when the display screen is menu screen or its submenu screen the measurement will be interrupted 3 2 2 Delete Data On menu screen select Delete Data and press W key to enter into Deletion Confirmation screen Then select Yes with A key short time press after short pressing W key all the records will be deleted Delete Yes Figure 14Delete Records 3 2 3 Over limit indication Settings On menu screen select Alert and press ll key to enter Alert Limit Settings screen as shown in Figure 15 18 User Manual for Wrist Oximeter Alert SpO2 Lo 85 PR Hi 120 PR Lo 50 Alert On Figure 15 Over limit indication Settings SpO Lo set SpO2 low limit Setting range 85 95 default setting 85 PR Lo set pulse rate low limit Setting range 25bpm 99bpm default setting 50bpm PR Hi set pulse rate high limit Setting range 100bpm 250bpm default setting 120bpm l
13. hen the modulation amplitude is as low as 0 6 Resistance to interference of surrounding light The difference between the SpO2 value measured in the condition of indoor natural light and that of darkroom is less than 1 Resistance to 50Hz 60Hz interference SpO2 and PR are precise which have been tested by Fluke Biomedical Index 2 series SpOz simulator 27 User Manual for Wrist Oximeter Dimensions W 59mmxD 49mmxH 22mm Net Weight about 60g not including batteries Classification The type of protection against electric shock Internally powered equipment The degree of protection against electric shock Type BF applied part The degree of protection against harmful ingress of liquids Ordinary equipment without protection against ingress of water Electro Magnetic Compatibility Group I Class B 28 User Manual for Wrist Oximeter 6 Accessories e A data cable optional e Oximeter Data Manager software optional e A Wristband e A SpO gt Probe e Two batteries AAA e A User Manual Note The accessories are subject to change See the items and quantity in your hand for detailed 29 User Manual for Wrist Oximeter 7 Repair and Maintenance 7 1 Maintenance The service life not a warranty of this device is 5 years In order to ensure its long service life please pay attention to the maintenance Please change the batteries when the low voltage indicator lightens Please clean
14. ing measurement If you choose display always on the icon for display always on will appear on the screen as 10 User Manual for Wrist Oximeter shown in Figure 9B e Short press A key during measurement the screen display direction can flip 180 Icon for display always on it indicates that the screen display is always on during measurement If the icon is disappeared it indicates that the screen display will be off after a period of displaying time during measurement for power saving SpOz Pleo 99 14 i MANN Figure 9C 11 User Manual for Wrist Oximeter PI Perfusion index label Figure 9D Real Time Clock 20 30 the current time Key Operations e Long press EM key menu screen will be displayed refer to section 3 2 for details 6 Prompt information e During measurement if you haven t inserted your finger into the probe or the probe is off Finger out will be prompted on the screen e During measurement if the probe is not connected to the oximeter No Signal will be prompted on the screen as shown in Figure 10 19 User Manual for Wrist Oximeter No Signal Figure 10 No Signal Indication e During measurement if the memory is full or the total number of the records reaches to 1024 pieces the earliest record will be overwritten and the icon lt A gt will appear on the screen for prompt as shown
15. lusion exists near sensor gt Obvious venous pulsations gt Peripheral arterial pulsation becomes weak gt Peripheral blood supply is not enough SI User Manual for Wrist Oximeter B Wristband Installation and Disassembly Step 1 Fix the wristband on your left wrist Fig A Fig B Wristband underlay Step 2 Put the oximeter on the proper site of the wristband Then press the oximeter to make the wristband underlay Fig B stick to the wristband firmly Next follow the Fig C to fix the oximeter well Step 3 The process of wristband disassembly is similar to the installation method but with reverse procedure IN Note Please detach the wristband from the oximeter before cleaning the wristband 38 0123 Shenzhen Creative Industry Co Ltd 2 F Block 3 Nanyou Tian an Industry Town Shenzhen GD 518054 P R China Tel 86 755 2643 3514 Fax 86 755 2643 0930 E mail info creative sz com Website www creactive sz com
16. nd press EM key to enter Wireless Setting screen as shown in Figure 17 Wireless ON OFF Figure 17 Wireless Setting Screen select ON or OFF with A key short press then short press W key to confirm the selection If you select ON bluetooth communication will be enabled and the wireless icon displays on the screen Meanwhile the oximeter can communicate with the bluetooth enabled host device such as a smart phone which is running specific application software APP to receive 21 User Manual for Wrist Oximeter the measured data SpO2 PR values and plethysmogram etc Please refer to the user manual of relative application software NOTE Only the bluetooth protocol version 4 0 or later is supported 3 2 6 Record Interval Settings On menu screen select Rec Interval and press lM key to enter Record Interval Setting screen as shown in Figure 18 li A Interval ls Figure 18 Record Interval Setting Operation Instructions e Short press W key active the option e Short press A key select record interval three options 1s 4s and 8s e Short press Wm key confirm the selection 22 User Manual for Wrist Oximeter e long press W key go back to the menu screen Note The length of data record is constrained to at least 30 seconds and the maximal length for one record is also limited to 60 hour
17. s for 1 second interval 240 hours for 4 second interval or 480 hours for 8 second interval respectively 293 User Manual for Wrist Oximeter 3 3 Upload Data Before uploading the data to PC please quit from the menu screen if you are doing the setup or trend view operation Before uploading connect the USB data cable between the oximeter and PC e Do the following operations by the instruction in Oximeter Data Manager User Manual then the data uploading will be activated e Copy the data from the oximeter to PC or other host device as the oximeter will be mapped as a removable disk when it is connected to PC by USB data cable 3 4 Low Battery Indication If 11 appears on the screen it indicates that battery power is not enough please change batteries If you keep on using it after a while the batteries are exhausted and the oximeter will be off 24 User Manual for Wrist Oximeter 4 Additional Advice for Operation The finger should be put properly and correctly Avoid shaking finger as possible as you can during measurement Do not put wet finger directly into sensor Avoid placing the device on the same limb which is wrapped with a cuff for blood pressure measurement or during venous infusion Do not let anything block the emitting light from device Electrosurgical device interference may affect the measuring accuracy Using enamel or other makeup on the nail may affect the
18. seea ts 30 7 2 Cleaning and Disinfecting Instruction 31 8 TROUBLESHOOTING 2000s00000000000000000000000000000 32 9 APPENDIX ee Balsam 34 A Common Knowledge for SpO2 Measurement 34 B Wristband Installation and Disassembly 38 VII User Manual for Wrist Oximeter 1 Overview 1 1 Appearance _ Pr mz Figure 1 Front View 1 LCD screen 2 Set Key W shift display modes confirm the operation etc 3 Scroll Key A Short Press to move display cursor modify parameter values etc Long Press to choose display always on or not which will be effective during measurement User Manual for Wrist Oximeter 6 Figure 2 Frontal Side View 4 Buzzer 5 Data interface 6 Wristband Underlay il Nii MM za zu JA Figure 3 Right Side View 7 SpO2 probe receptacle 1 2 Name and Model Name Wrist Oximeter Model PC 68B User Manual for Wrist Oximeter 1 3 Conformation It comprises the main unit and SpO2 probe 1 4 Features Wrist Oximeter can be used to measure and record the functional oxygen saturation SpOz and pulse rate accurately Simply put your finger into sensor SpO2 value and pulse rate value will be displayed on screen and stored in the device It is light weight small in size and easy to carry Color OLED display Perfusion index PI display is available Automatic starts to
19. t Alert enable disable the function of over limit alert by audible beeping visual display and vibration of the oximeter If select ON when SpO value or and PR value exceeds its their preset limits during measurement the oximeter will beep and vibrate and the numerical value exceeded limit will flash Operation Instructions e Short press A key shift cursor circularly e Short press W key active the option 19 User Manual for Wrist Oximeter e Short press 4 key increase numerical value one time e long press A key increase numerical values continuously e Short press W key confirm the selection e long press m key go back to the menu screen 3 2 4 Time Settings On menu screen select Time and press ll key to enter Time Settings screen as shown in Figure 16 Tine MM DD YYYY 10 28 2007 12 30 10 Figure 16 Date and Time Settings Date format MM DD YY YYY Time format hh mm ss Operation Instructions e Short press A key shift cursor circularly e Short press W key active the option e Short press 4 key increase numerical value one 20 User Manual for Wrist Oximeter time e long press A key increase numerical value continuously e Short press W key confirm the modification e long press W key go back to the menu screen 3 2 5 Wireless Setting Optional On menu screen select Wireless a
20. t will start and screen display will be activated as well Note During measurement there is a green dot flashing on the screen for indicating the measurement and data recording are undergoing when the display screen is blank and if SpO2 or and PR values exceed the preset limit it will activate the display and the value exceeded limit will flash 15 User Manual for Wrist Oximeter 3 2 Menu Operation On display screen long press ll key menu screen will be displayed on the screen as shown in Figure 12 gt gt gt gt Menu Review Delete Data Alert Time Wireless Rec Interval Figure 12 Menu Screen Review view SpO and pulse rate trend graph Delete Data delete all the records Alert set SpOz low limit and pulse rate high low limit Time set current date and time Wireless set or unset wireless function Rec Interval set the time interval to record SpO2 and pulse rate data Operation Instructions e Short press A key shift cursor circularly 16 User Manual for Wrist Oximeter e Short press W key confirm the selection and enter into the corresponding screen e long press EM key go back to the default screen display 3 2 1Trend Review On menu screen select Review and press EM key to enter Trend Review screen as shown in Figure 13 E 11 20 35 Figure 13 Trend Review Screen 03 06 2008 date of the measurem
21. visible damage that may affect user s safety and measurement performance When there is obvious damage stop using the device Necessary servicing must be performed by qualified service engineers ONLY Users are not permitted to maintain it by themselves The oximeter cannot be used together with the devices not specified in User Manual Cautions 6 Explosive hazard DO NOT use the oximeter in environment with inflammable gas such as some ignitable anesthetic agents DO NOT use the oximeter while the testee s under MRI or CT scanning III User Manual for Wrist Oximeter Warnings 6 6 For individual patients there should be a more prudent inspecting in the placing process The device can not be clipped on the edema and tender tissue The light the infrared light is invisible emitted from the sensor is harmful to the eyes so the user or even the service engineer should not stare at the light emitting components To dispose the device the local law should be followed Attentions A Keep the oximeter away from dust vibration corrosive substances explosive materials high temperature and moisture The device should be kept out of the reach of children If the oximeter gets wet please stop operating it When it is carried from cold environment to warm and humid environment please do not use it immediately DO NOT operate the button on front panel with sharp materials IV User Manual for
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