Instructions to Users
Contents
1. 65 Pulse rate value Pulse beat symbol MEN Battery indicator P Pulse intensity bargraph The waveform displayed in the lower area is SpO gt plethysmogram o gt ood 9 User Manual for Wrist Oximeter Key Operations e Short time press ll key to switch display modes circularly display screen will be switched among the screens as shown in Figure 9A Figure 9C and Figure 9D e Longtime press A key choose display always on or not which will be effective during measuring If you choose display always on the symbol for display always on will appear on the screen as shown in Figure 9B Short time press A key the display screen can shift 180 SpO PR vu 99 65 KAP Pa Figure 9B lt gt 9 Symbol for display always on it indicates that the LCD screen is always on during measuring If the symbol is disappeared it indicates that the LCD screen will be off after a period of display time during measuring for power saving 10 User Manual for Wrist Oximeter 5pQ PI m 99 14 AMMAR Figure 9C lt PI Perfusion index symbol 12 30 Figure 9D Real Time Clock lt 12 30 the current time Key Operations e Longtime press W key menu screen will be displayed refer to section 3 2 for details 11 User Manual for Wrist Oximeter 6 Prompt information e During monitoring if you haven t inserted your finger into the2. Overview 1 1 Appearance Figure 1 Front View 1 LCD screen 2 Set key shift display modes confirm the operation etc 3 Scroll key short press move display cursor modify parameter values etc Longtime press choose display always on or not which will be effective during measuring 1 User Manual for Wrist Oximeter 4 5 6 Figure 2 Frontal Side View 4 Buzzer 5 Data interface 6 Wristband Underlay f fa AN TEEN Figure 3 Right Side View 7 SpO gt 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 SpO gt 2 probe 1 4 Features Wrist Oximeter can be used to monitor pulse oxygen saturation SpO gt 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 lightweight small in size and easy to carry Color OLED display Perfusion index PI display is available Automatic starts to measure SpO gt and Pulse Rate PR Real time clock display and set Audible amp visible over limit indication high amp low limits are adjustable It is convenient for you to monitor SpO gt in long term while sleeping or at other daily activity Record interval can be selected up to 480 hours data memory Applicable for longtime continuous monitoring Be User Manual for Wrist Oxi
3. enamel or color skin care lt gt Excessive patient movement lt Placement of a sensor on an extremity with a blood pressure cuff arterial catheter or intravascular line lt gt Exposure to the chamber with High pressure oxygen lt gt There is an arterial occlusion proximal to the sensor lt gt Blood vessel contraction caused by peripheral vessel hyperkinesias or body temperature decreasing BAL User Manual for Wrist Oximeter 4 Factors causing low SpO Measuring value pathology reason lt gt Hypoxemia disease functional lack of HbO lt Pigmentation or abnormal oxyhemoglobin level lt gt Abnormal oxyhemoglobin variation lt Methemoglobin disease lt gt Sulfhemoglobinemia or arterial occlusion exists near sensor lt gt Obvious venous pulsations lt gt Peripheral arterial pulsation becomes weak lt gt Peripheral blood supply is not enough 35 User Manual for Wrist Oximeter B Wristband Installation and Disassembly Step 1 Fix the wristband on your left wrist Fig A Fig B Wristband eF underlay C A ay Wristband Fig A Fig C Step 2 Put the oximeter on the propriate 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 AN Note Please detach the wr
4. hemoglobin HbO gt and deoxygenated hemoglobin Hb have different absorption character in the spectrum range from red to infrared light 600nm 1000nm wavelength by using these characteristics SpO2 can be determined SpO gt 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 SpO gt monitoring 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 SpO gt can be determined in time by measurement and find the hypoxemia patient earlier thereby preventing or reducing accidental death caused by hypoxia effectively 33 User Manual for Wrist Oximeter 3 Factors affecting SpO2 measuring accuracy interference reason lt Intravascular dyes such as indocyanine green or methylene blue lt gt Exposure to excessive illumination such as surgical lamps bilirubin lamps fluorescent lights infrared heating lamps or direct sunlight lt gt Vascular dyes or external used color up product such as nail
5. movement may movement cause invalid measuring result 30 User Manual for Wrist Oximeter 1 Connect the probe to the oximeter properly 1 The probe is not connected to the Always oximeter properly and try again display eigne 2 Place the finger No placed well 3 The probe properly and try again 3 Please contact the local service center Signal connector or the probe sensor is broken ae User Manual for Wrist Oximeter 9 Appendix A Common Knowledge for SpO Measurement 1 Meaning of SpO SpO is the saturation percentage of oxygen in the blood so called O concentration in the blood it is defined by the percentage of oxyhemoglobin HbO in the total hemoglobin of the arterial blood SpO gt is an important physiological parameter to reflect the respiration function it is calculated by the following method SpO HbO3 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 the structure character of the tissue by which the light 3 User Manual for Wrist Oximeter passes Due to that oxygenated
6. probe Finger out will be prompted on the screen During monitoring if the probe is not connected to the oximeter or the probe is off No Signal will be prompted on the screen as shown in Figure 10 SpO Piss a No Signal Figure 10 No Signal During measuring if the memory is full or the total number of the records is 1024 pieces the earliest records will be overwritten and the icon will appear on the screen for prompt as shown in Figure 11 12 User Manual for Wrist Oximeter SpO amp PR am 9 9 65 ETON Figure 11 Memory Full Note It is suggested that the data shall be uploaded to computer for saving or the earliest records will be overwritten Working Mode The measurement will start automatically when the finger is inserted into the soft rubber of the sensor so the data recording SpO gt and PR values starts simultaneously as well The display is as shown in Figure 9A During measuring if the display mode is not display always on the symbol for display always on is not shown on screen and no key button operation for 1 minute the LCD display will be blank for power saving even when the measurement and data recording are still undergoing but long time pressing a User Manual for Wrist Oximeter any key will activate the display for viewing the current measuring information again If there is no signal to be detected e g finger off f
7. ED 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 gt 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 24 User Manual for Wrist Oximeter Preset limits SpO2 Low limit setting 85 Pulse Rate limit setting range Upper limit 120bpm Lower limit 50bpm Update rate 6 seconds moving average for SpO gt and 8 beats average for Pulse Rate readings Perfusion Index Display Range 0 2 20 Performance under low perfusion condition The accuracy of SpO and PR measurement still meets the specification described above when the modulation amplitude is as low as 0 6 Resistance to interference of surrounding light The difference between the SpO value measured in the condition of indoor natural light and that of darkroom is less than 1 Resistance to 50Hz 60Hz interference SpO and PR are precise which have been tested by BIO TEK pulse oximeter simulator 25 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 protec
8. Oz simulator or it can be done by the local third party test house High pressure sterilization cannot be used on the device Do not immerse the device in liquid 28 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 29 User Manual for Wrist Oximeter 8 Troubleshooting The SpO and Pulse 1 The finger is not 1 Place the finger Rate placed far enough correctly inside and display inside try again instable 1 The batteries are drained or almost 1 Change batteries Can not en 2 Reinstall turn on the Eg S DALENE Se batteries devi not inserted i evice 3 Please contact the properly i heder local service center malfunctioning 1 Adjust your finge 1 Your finger is location properly out of proper 2 Make sure there is Fragmental location in the no object may trend curve probe occlude the blood of SpO 2 Blood flow in flow and PR the finger blocked 3 Extreme 3 Extreme
9. 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 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 4 Revised date July 26 2012 All rights reserved 3502 2290033 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 Check the device to make sure that there is no 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 Explosive hazard DO NOT use the oximeter in environmen
10. er 3 4 Low Battery Indication If 1 occurs on the screen it indicates battery power is not enough please change batteries If you keep on using after a while when the batteries are exhausted Low Battery indication will be displayed and the oximeter will be off in 5 seconds 99 User Manual for Wrist Oximeter 4 Additional Advice for Operation e The finger should be put properly and correctly e Avoid shaking finger as possible as you can during measuring e Do not put wet finger directly into sensor e Avoid placing the device on the same limb which is wrapped with a cuff for blood pressure measurement or during venous infusion e Do not let anything block the emitting light from device e Electrosurgical device interference may affect the measuring accuracy e Using enamel or other makeup on the nail may affect the measuring accuracy e 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 D 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 L
11. eter Table of Contents TOVERVIEN i cssccciccasccisecsestaceseccnssesasscccioasasescccioasanennches 1 1 1 Appearance vvvvveee ene 1 1 2 Name and Model oororrrrororrnnnnnnnrrnnnvnnvrrrrnnnnnnnnnnne 2 1 3 Conformation visser 3 1 4 FealureSLunumevp 3 LS Intended SE vvs 4 1 6 Key of Symbols rrrrrrrrrrrrrrnnnnnnrrrrrrrrrrrrnrrnnnnnnnnnnnnn 5 2 BATTERY INSTALLATION esveessrvvsessvsvsessvsesesseseseene 6 SD OPERATION i ccscicdssccecsdiccraddccccsceusecanseneessecenseuseeseeassveees 7 3 1 Measuring Operation orrrrrrrrrrrrrrrsonnnnnnrrrrrnrnrrnrr 7 3 2 Menu Operation onnonrrrnrrrrrrrrrrrrrrnnnnnnnvrrvnnnrnnnnr 15 3 3 Upload Data rrrrrrrroorooororooororrorrrrrrrrrrrrrrrrrrrnrrnnnrr 21 3 4 Low Battery Indication orrrrrrrrronrorrronrnrrrrnnnnnr 22 4 ADDITIONAL ADVICE FOR OPERATION 23 5 TECHNICAL SPECIFICATIONS cscssccsssseees 24 6ACCESSORIES ssssssissscccsssssssccccastecsnsseacesacssssssseseccasseees 27 7 REPAIR AND MAINTENANCE sccccsssssssseesees 28 7 1 Mamtenancesussusne 833th sheecaatieeataaeae sate 28 7 2 Cleaning and Disinfecting Instruction 29 8 TROUBLESHOOTING seesooecsssoocsessssocsessssocsessssoe 30 SAPPENDER iccecntrccescscccsserereteccssscocsescinseosccmionccscereoites 32 A Common Knowledge for SpO gt Measurement 32 B Wristband Installation and Disassembly 36 V User Manual for Wrist Oximeter 1
12. ew and press ll key to enter Trend Review screen as shown in Figure 16 120 03 06 2008 Figure 16 Trend Review Screen 03 06 2008 date of the measurement 11 20 35 initial time of trend graph displayed on this screen nm A Page scroll left right symbol Curves in the middle area Green curve indicate pulse rate trend curve Orange curve indicate SpO gt trend curve Operation Instructions o gt 4 Short time press A key Page scroll right e Short time press W key Page scroll left Longtime press W key back to the menu screen Note when the display screen is menu screen or its submenu screen the measurement will be interrupted 20 User Manual for Wrist Oximeter 3 2 5 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 time pressing W key all the records will be deleted Delete Yes No Figure 17 Delete Records 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 When start uploading connect the data cable between the device and PC do the following operation by the instruction in Oximeter Data Manager User Manual then the data uploading will be activated 21 User Manual for Wrist Oximet
13. istband from the oximeter before cleaning the wristband 36 User Manual for Wrist Oximeter LD 1141 Budapest Fogarasi ut 77 1095 Budapest Mester u 34 Tel 220 7940 220 8881 220 7959 Tel 218 5542 215 9771 215 7550 220 7814 364 3428 Fax 220 7940 216 7017 216 7018 Fax 218 5542 Mobil 30 531 5454 30 939 9989 Mobil 30 940 1970 20 949 2688 E mail delton delton hu Web www delton hu www medipek hu Er
14. it indication function If SpO gt value or and PR value exceeds its their preset limits during measuring the oximeter will beep and the numerical value exceeded limit will flash Pressing lm key can suspend the current beep sound 7 User Manual for Wrist Oximeter Operation Instructions Short time press A key shift cursor circularly Short time press W key active the option Short time press A key increase numerical value one time Longtime press A key increase numerical values continuously Short time press W key confirm the selection Longtime press W key back to the menu screen 18 User Manual for Wrist Oximeter 3 2 3 Time Settings On menu screen select Time and press ll key to enter Time Settings screen as shown in Figure 15 Time MM DD YYYY 10 28 2007 12 30 10 Figure 15 Time Settings Date format MM DD YYYY lt Time format hh mm ss Operation Instructions Short time press A key shift cursor circularly Short time press W key active the option Short time press A key increase numerical value one time Longtime press A key increase numerical value continuously Short time press W key confirm the modification Longtime press W key back to the menu screen 19 User Manual for Wrist Oximeter 3 2 4 Trend Review On menu screen select Trend Revi
15. k to the default screen 15 User Manual for Wrist Oximeter 3 2 1 Record Interval Settings On menu screen select Rec Interval and press m key to enter Record Interval Setting screen as shown in Figure 13 Interval Figure 13 Record Interval Setting Operation Instructions e Short time press W key active the option Short time press A key select record interval three options 1s 4s and 8s e Short time press W key confirm the selection Longtime press W key back to the menu screen Note The length of data record is limited to 30 seconds at least and the maximal length for one record is also limited to 60 hours for 1 second interval 240 hours for 4 second interval or 480 hours for 8 second interval 16 User Manual for Wrist Oximeter 3 2 2 Over limit indication Settings On menu screen select Alarm Limit and press ll key to enter Alarm Limit Settings screen as shown in Figure 14 Alarm SpO2 Lo 85 PR Hi 120 PR Lo 50 Alarm On Figure 14 Over limit indication Settings lt SpO Lo set SpO gt low limit Setting range 85 95 default setting 85 PR Lo set pulse rate low limit Setting range 25bpm 99bpm default setting 50bpm lt PR Hi set pulse rate high limit Setting range 100bpm 250bpm default setting 120bpm lt Alarm enable disable the audible amp visual lim
16. meter PR trend curve and SpO trend curve view Data storage and transmission to PC for view and analysis Optional Smart battery power management with low battery indication 1 5 Intended Use This Wrist Oximeter is intended for measuring the pulse rate and functional oxygen saturation SpOz It is applicable for long term measurement of adult s SpO gt and pulse rate in home and clinics User Manual for Wrist Oximeter 1 6 Key of Symbols Symbol Pulse Oxygen Saturation PI Perfusion Index PR Puserae O OY Pulse rate symbol OO Low battery voltage Oe Symbol for display always on MB Memory full EC REP Authorised representative in the European community mr aa Manufacturer including address With Type BF applied part OA Warning See User Manual 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 the cover Remark After finishing battery installation the oximeter will automatically power on and display software version number firstly A Please take care when
17. or 20 seconds the device will be at idle state i e blank screen and standby for measurement When the device is at idle state long time pressing any key will activate the LCD display for measuring default screen or once the finger is inserted in the soft rubber of the sensor the measurement will start and LCD display will be activated as well Note During measuring 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 SpO gt or and PR values exceed the preset limit it will active the display and the value exceeded limit will flash 14 User Manual for Wrist Oximeter 3 2 Menu Operation On display screen longtime press m key menu screen will be displayed on the screen as shown in Figure 12 lt gt lt gt lt gt lt gt lt gt Menu Rec Interval Alarm Time Trend Review Delete Data Figure 12 Menu Screen Rec Interval set the interval to record SpO gt and pulse rate data Alarm set SpO gt low limit and pulse rate high low limit Time set current time Trend Review view SpO and pulse rate trend graph Delete Data delete all the records Operation Instructions Short time press A key shift cursor circularly Short time press W key confirm the selection and enter into the corresponding screen Longtime press W key bac
18. t with inflammable gas such as some ignitable anesthetic agents DO NOT use the oximeter while the testee is under MRI or CT scanning I User Manual for Wrist Oximeter Warnings PS 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 M User Manual for 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 IV User Manual for Wrist Oxim
19. tion 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 26 User Manual for Wrist Oximeter 6 Accessories e A data cable optional Oximeter Data Manager software optional e A Wristband e A SpO Probe Two batteries AAA e A User Manual Quality Certificate Note The accessories are subject to change See the Packing List for detailed items and quantity De 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 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 50kPa 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 Sp
20. you insert the batteries as the improper insertion may make the device not work 6 User Manual for Wrist Oximeter 3 Operation 3 1 Measuring Operation 1 Insert the external SpO gt probe connector into SpO gt probe receptacle properly ry SEU AT ae SpO probe connector Figure 5 Sp0 Probe Connection 2 Fix the oximeter on your left wrist Figure 6 3 Then hold the probe with its opening towards your index finger The probe should be oriented in such a way that the sensor side with a finger tip sign is positioned on the top Figure 6 User Manual for Wrist Oximeter Figure 6 Placement Demonstration 4 Next insert your index finger into the probe until the fingernail tip rests against the stop at the end of the probe 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 User Manual for Wrist Oximeter Wrong Placement of the Probe amp eS Finger out i 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 SpO PR vo 99 651 AMAMN Figure 9A Default Screen SpOr SpO gt symbol 99 SpO value PR Pulse rate icon
Download Pdf Manuals
Related Search