Instructions to User
Contents
1. PR Trend graph Figure 15C Trend Graph Recall Screen Press A V key to view trend graph Press gt key to return to recall list screen 4 6 2 Data Deletion Choose one record in the recall list then longtime press On key an icon gt will be displayed in the back of this record as shown in Figure 16 Oct 18 07 Oct 18 07 Oct 18 07 Figure 16 When finishing the selection of the records needed to be deleted press D key then the screen will prompt that Delete all the marked records as shown in Figure 17 at this time select Yes and press OK key to delete all the selected records 16 User Manual for Handheld Pulse Oximeter Delete all the marked records Yes No Figure 17 User Manual for Handheld Pulse Oximeter 5 Technical Specifications A Display mode dot matrix monochrome LCD B Power supply requirement 3 x LR6 AA alkaline batteries or Ni MH rechargeable batteries Supply voltage 4 5V Operating current lt SOmA Continuous working time gt 30 hours C SpO Parameter Specifications Transducer dual wavelength LED sensor Measurement wavelength Red light 660 nm Infrared light 905 nm Maximal optical output power less than 2mW maximum average Measuring range 35 99 Measuring accuracy Not greater than 3 for SpO range from 70 to 100 NOTE Accuracy defined as root mean square value of deviation according to ISO 9919 D Pulse Rate Parameter Specifi2. User Manual for Handheld Pulse Oximeter Instructions to User Dear Users Thank you very much for purchasing our product Please read the manual very carefully before using this device Please follow these instructions to operate The Manual is published by Shenzhen Creative Industry Co Ltd Creative Creative 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 Creative reserves the right to revise and amend it at any time without prior notice Version of the Manual Ver 1 8 Revised date November 12 2010 All rights reserved 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 Creative for its use or any infringements of patents or other rights of third parties that may result from its use 3502 2490001 User Manual for Handheld Pulse Oximeter Instructions for Safe Operations IZ IZ 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 service must be performed only by qualified technicians Users are not permitted to repair it by themselves The oximeter cannot be used together with the devices not specifie
3. agnetic Compatibility Group I Class B 6 Accessories A probe A holder Battery AA x3 A User Manual A Quality Certificate A data cable optional Oximeter Data Manager software optional ee A ae I Note The accessories are subject to change See the Packing List for detailed items and quantity 20 User Manual for Handheld Pulse Oximeter 7 Repair and Maintenance 7 1 Maintenance The life of this device is 5 years In order to ensure its long service life please pay attention to the maintenance e Please change the batteries when the low voltage indicator appears e Please take out the batteries if the oximeter will not be used for a long time e The recommended storage environment of the device Ambient temperature 20 C 60 C Relative humidity 10 95 Atmospheric pressure 50kPa 107 4kPa e 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 SpO2 simulator or it can be done by the local third party test house 7 2 Cleaning and Disinfecting Instruction e Surface clean sensor with a soft cloth by wetting with a solution such as 75 isopropyl alcohol if low level disinfection is required use a 1 10 bleach solution e Then surface clean by a dampened cloth and let it air dry or wipe it with a cloth A High pressure sterilization can
4. asy to carry lt High resolution LCD to display plethysmogram and measured data Monitor SpO and PR parameters simultaneously PI Perfusion Index display is available gt Real time store and recall SpO and Pulse Rate value lt Data transmission to PC for view and analysis Optional lt gt Audible amp Visual alarm function lt gt Power management function 1 5 Intended Use This Handheld Pulse Oximeter is intended for measuring and recording the pulse rate and functional oxygen saturation SpO gt It is applicable for monitoring SpO and pulse rate of adult and pediatric patients in clinical institutions and homes 1 6 Working Environment Operating temperature 5 40 C Operating humidity 30 80 Atmospheric pressure 70kPa 106kPa User Manual for Handheld Pulse Oximeter 2 Installation of Battery and Holder 1 Open the rear panel with coin or an ordinary flat screwdriver as shown in Figure 2 Figure 2 2 According to the polarity mark insert three AA batteries into battery house as shown in Figure 3 Figure 3 3 Close the battery cover and fasten it 4 User Manual for Handheld Pulse Oximeter 4 Fixing Holder Figure 4 Fixing Holder 3 SpO Probe Connection Connect the SpO probe to the right panel s connector labeled SpO After starting the monitor insert one finger into the probe index finger middle finger or ring finger with proper nail length according to
5. cations Measuring range 30bpm 240bpm Accuracy 2bpm or 2 whichever is greater 18 User Manual for Handheld Pulse Oximeter Alarm Setting SpO alarm Low limit setting range 85 99 Default alarm limit 85 Pulse Rate alarm Alarm limit setting range 25bpm 250bpm Default alarm limits High 120bpm Low 50bpm Perfusion Index Display Range 0 20 Update rate 8 beats moving average for both SpO and pulse rate readings Data Record Record data once every 1 2 4 8seconds up to 70 hour records The performance under low perfusion condition The accuracy of SpO and PR measurement still meet the precision described above when the modulation amplitude is as low as 0 5 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 The resistance to 50Hz 60Hz interference SpO and PR are precise which have been tested by BIO TEK pulse oximeter simulator 19 User Manual for Handheld Pulse Oximeter L Dimensions 145 mm L x 74 mm W x 29 mm H Net Weight 210g including batteries M Classification The type of protection against electric shock Internally powered equipment The degree of protection against electric shock Type BF applied parts The degree of protection against harmful ingress of liquids Ordinary equipment without protection against ingress of water Electro M
6. d Reserved Port Display Screen Power Back Navigation Key Mode OK Recall Backlight SpO Probe Connector Figure 1 1 Display screen display SpO plethysmogram and parameter values 2 Navigation key A Up Left Increase Press this key the default screen can be shifted to display pulse rate PR or perfusion index PI When on the system setup screen press it to move the cursor upwards or to the left and l User Manual for Handheld Pulse Oximeter adjust parameter values V Down Right Decrease Its function is similar with the key A Up Left Increase 3 EY Mode OK press this key the screen can be shifted between default screen and other screen layout longtime press this key the menu screen will be displayed when you finish parameter setting press this key to confirm 4 Data interface used for uploading data Optional function 5 Q Reserved port for future use 6 D Power Back Power on off the device by longtime pressing short time press it to back to upper level operation 7 Recall Backlight Longtime press it to enter SpO recall screen short time press it to turn on off the backlight 8 Icon SpO SpO Probe Connector 1 2 Name and Model Name Handheld Pulse Oximeter Model PC 66B 1 3 Structure It consists of the main unit and SpO probe User Manual for Handheld Pulse Oximeter 1 4 Features lt gt It is lightweight small in size and e
7. d in User Manual Cautions Ww wv 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 is under MRI or CT scanning Warnings IZ An uncomfortable or painful feeling may appear if using the sensor of this device continuously on the same place for a long time especially for the patients with poor microcirculation It is recommended that the sensor should not be applied to the same location for longer than 2 hours If any abnormal condition is found please change the position of sensor For the individual patients there should be a more prudent inspecting in the placing process The sensor can II User Manual for Handheld Pulse Oximeter not be clipped on the edema and tender tissue 6 The local law should be followed when disposing of the expired device or its accessories Attentions A A Keep the oximeter away from dust vibration corrosive substances explosive materials high temperature and moisture If the oximeter gets wet please stop operating it When it is carried from a cold environment to a warm and humid environment please do not use it immediately DO NOT operate the button on the front panel with sharp materials High temperature or high pressure steam disinfection to the oximeter is not permitted Refer to related chapter for instructions of cleaning and disinfection T
8. demonstration as shown in the following figure Figure 5 Demonstration for using SpO probe finger clip 5 User Manual for Handheld Pulse Oximeter Instructions of Operation l 2 The finger should be put in properly and correctly Do not shake the finger and keep at ease during measurement 3 Do not put wet finger directly into sensor Avoid placing the sensor 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 the sensor Vigorous exercise and electrosurgical device interference may affect the measuring accuracy Using enamel or other makeup on the nail may affect the 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 User Manual for Handheld Pulse Oximeter 4 Operation 4 1 Default Screen Press gt power key for 2 seconds to start the Oximeter then insert finger into rubber cushions of the probe the screen will display the default screen as shown in Figure 6 SpO2 10 12 45 PR aA 99 65 Figure 6 Default Screen Screen Description SpO 99 SpO value 99 is a percentage value 10 12 45 Current time PR 65 Pulse rate value 6Sbpm OME Battery indication fh Data memory ico
9. he intended use of this device is not for therapy purpose Caution U S federal law restricts this device to sale or use by or on the order of a physician MI User Manual for Handheld Pulse Oximeter Table of Contents DAD V OR VICW N E E O E E NTE 1 BLADH INCO osis en a a l LANM and Mode lereier 2 Ds Ss UIC WING Sua ss es N E E E A T 2 KE Poat ES yeeros tweak fel ees 3 S Intended Se aust as te acca eae teres aa eee let cca ecan 3 1 6 Working Environment esens nar 3 2 Installation of Battery and Holdet cccccccssssssssssseees 4 3 SpO Probe CONnNectiOn ccsssccccorrrssssssssssssssssssssscccceseeccees 5 A ODO AION E E E E E 7 4A Defaalt Seienn ER E ee ees J 4 2 Display Screen with PI Value mandioa iania 8 ABO ner Serec Layos ities an ee ates nae lane e a 9 4 4 Indication for No Signal cccccccccccccecceeeeeeeeeeeeeeees 9 AYO Meni SC RUD e e a A 10 AOD ala RECA Eea Aa 14 5 Technical Specifications ssssseceeccccocccossssssecececccocosssssssee 18 O ACCESSOTIES soasisso daosine noana eaae EEan na aaa 20 7 Repair and Maintenance eeeeececooecocssssssssseccececeooccsssssssee 21 PEM amMenaNe Ea eee vet eeccentceels 21 7 2 Cleaning and Disinfecting Instruction cc eeeeees 21 8 Troubleshooting sieses coves cccccnsvececevsesincevewsis cosaecaness savsevieigusessece 22 PAID OMI oosina A EAEE EE NA 23 User Manual for Handheld Pulse Oximeter 1 Overview 1 1 Appearance Data Interface an
10. n when the data on screen becomes stable the device will start to store data automatically No icon means the current data will not be stored If the memory is full or the total number of the records is 256 pieces the earliest records will be overwritten and the icon will appear on the screen for prompt as shown in the figure 7 User Manual for Handheld Pulse Oximeter below SpO 10 12 45 PI 99 14 Full memory icon Note It is suggested that the data shall be uploaded to computer for saving or the earliest records will be overwritten Lr Alarm Icon Pulse strength bar graph Lower part displays plethysmogram 4 2 Display Screen with PI Value On the default screen press A V Navigation key to shift screens between default screen and display screen with PI value The display screen with PI value is shown below Figure 7 Display Screen with PI Value 8 User Manual for Handheld Pulse Oximeter 4 3 Other Screen Layouts On default screen press BY Mode OK key to enter into other screen layouts as shown in Figure 8A Operation A Y Navigation key shift screens between PR observation screen Figure 8A and PI observation screen Figure 8B EY Mode OK key shift screens among four screens as shown in Figure 6 Figure 7 Figure 8A and Figure 8B 10 12 45 PR Figure 8B PI Observation Screen 4 4 Indication for No Signal If No Signal prompts on screen as
11. ng dysfunctional hemoglobin such as carboxyhemoglobin or metahemoglobin Clinical application of pulse oximeters SpO is an important physiological parameter to reflect the respiration and ventilation function so SpO 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 can be determined in time by measurement and find the hypoxemia patient earlier thereby preventing or reducing accidental death caused by hypoxia effectively 3 Normal SpO Range and Default Low Alarm Limit In Campagna area healthy people s SpO gt value is greater than 94 so the values below 94 are determined as hypoxia SpO lt 90 is considered as the default threshold for determining anoxia by most researchers so SpO low alarm limit of the oximeter is set as 90 generally 4 Factors affecting SpO measuring accuracy interference reason lt 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 26 lt gt lt gt lt gt 5 Factors reason gt User Manual for Handheld Pulse Oximeter Vascular dyes or external used color up product such as nail enamel or color skin care Excessive patient movement Placement of a sensor
12. not be used on the device Do not immerse the device in liquid 21 User Manual for Handheld Pulse Oximeter 8 Troubleshooting Trouble Possible Reason Solution 1 The finger is not placed far enough inside The SpO and Pulse 1 Place the finger correctly inside and try male 2 The finger is i shaking or the patient is moving 2 Let the patient keep calm display instable 1 The batteries are drained or almost drained 1 Change batteries 2 The batteries are 2 Reinstall batteries turn on f i not inserted 3 Please contact the the device properly local service center 3 The device is malfunctioning 1 The device will power off automatically when there is no signal 1 Normal Display and no operation for 2 Change batteries 1 minute 2 The batteries are almost drained 22 User Manual for Handheld Pulse Oximeter Appendix Key of Symbols Symbol YoSpO The pulse oxygen saturation Pl Perfusion Index Symbols ebpm Pulse rate Unit beats per minute oOo Low battery voltage on the screen CA reme 23 User Manual for Handheld Pulse Oximeter SpO probe connector Power Back Key OA rainy S EC e sw Seria number oe eee European community al ance nang ae O A A With Type BF applied part O A Warning See User Manual IV N REP i Disposal of this device according _ to WEEE regulatio
13. ns 24 User Manual for Handheld Pulse Oximeter Common Knowledge 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 is an important physiological parameter to reflect the respiration function it is calculated by the following method SpO HbO 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 passes Due to that oxygenated hemoglobin HbO and deoxygenated hemoglobin Hb have different absorption character in the spectrum range from red to infrared light 600nm 1000nm wavelength by using these characteristics SpO can be determined SpO measured by this oximeter is the functional oxygen saturation a percentage of the hemoglobin that can transport oxygen In 25 User Manual for Handheld Pulse Oximeter contrast hemoximeters report fractional oxygen saturation a percentage of all measured hemoglobin includi
14. on an extremity with a blood pressure cuff arterial catheter or intravascular line Exposure to the chamber with High pressure oxygen There is an arterial occlusion proximal to the sensor Blood vessel contraction caused by peripheral vessel hyperkinesias or body temperature decreasing causing low SpO Measuring value pathology Hypoxemia disease functional lack of HbO Pigmentation or abnormal oxyhemoglobin level Abnormal oxyhemoglobin variation Methemoglobin disease Sulfhemoglobinemia or arterial occlusion exists near sensor Obvious venous pulsations Peripheral arterial pulsation becomes weak Peripheral blood supply is not enough 27
15. shown in Figure 9 please 9 User Manual for Handheld Pulse Oximeter check whether the probe connects well and whether the finger is in appropriate position P No Signal Figure 9 Probe Off Screen 4 5 Menu Setup On the above mentioned screens longtime press EY key for entering into menu screen as shown in Figure 10 UPLOAD DATA VERSION Figure 10 Menu Screen Screen Description SETUP set parameter values refer to Chapter 4 5 1 for details UPLOAD DATA enter into uploading status refer to Chapter 4 5 2 for details VERSION for viewing version number of the software 10 User Manual for Handheld Pulse Oximeter refer to Chapter 4 5 3 for details 4 5 1 Setup On the menu screen select SETUP and then press LY key for entering into system setup screen The setup screen is as shown in the following figures SETUP DATE eA 18 07 TIME 10 12 45 CONTRAST 4 Figure 11 System Setup Screen A ALAR M SOUND ALARM 5p0 ALARM PR HI ALARM PR LO Figure 11 System Setup Screen B ALARM PR HI ALARM PR LO PULSE SOUND REC INTERVAL Figure 11 System Setup Screen C 11 User Manual for Handheld Pulse Oximeter Operation Instructions 1 DATE Date setting 1 When cursor stays on the Month of the date press AY Mode OK key to active Month option the cursor flashes on the Month of the date 2 Press A V Navigation key to adjust month 3 Pre
16. ss D Power back key or E Mode OK key to confirm and exit from date setting 4 The procedures of adjusting Day value and year value are the same with Month adjustment Date Format MM dd yy Note The setting operations of other parameters such as TIME CONTRAST ALARM SOUND etc are the same with date setting 2 TIME Time setting 3 CONTRAST LCD contrast setting 4 ALARM SOUND The factory default value is ON When the set is ON the device stays in alarm status and the alarm icon displays on the upper right display screen 5 ALARM SpO SpO alarm setting the factory default value 85 6 ALARM PR HI LO Pulse rate High Low limit setting the factory default value High limit 120 Low limit 50 12 User Manual for Handheld Pulse Oximeter 7 PULSE SOUND Pulse beep sound switch 8 REC INTERVAL Record interval setting five options 1s 2s 4s 8s and OFF When the option is OFF the device will not record real time measurement data Note The length of data record is limited to 30 seconds at least and the maximal length for one record is also limited to one hour for one second interval 2hours for 2 seconds interval 4 hours for 4 seconds interval or 8 hours for 8 seconds interval 4 5 2 Upload Data a menu screen select UPLOAD DATA and then press S Figure 12 When you transmit data SpO and PR values to key for entering into connecting s
17. tatus as shown in your computer please let the oximeter stay in connecting status Do the following operation by the instruction in Oximeter Data Manager User Manual The data uploading will be activated Connecting Figure 12 Connecting Status Screen 13 User Manual for Handheld Pulse Oximeter 4 5 3 Version On the menu screen select VERSION and then press LY key for entering into version screen as shown in Figure 13 VERSION Version V2 2 Figure 13 4 6 Data Recall On the default display screen longtime press 0 i Recall backlight key to enter into recall list screen Oct 18 07 Oct 18 07 Oct 18 07 Figure 14 Recall List 14 User Manual for Handheld Pulse Oximeter 4 6 1 Data Recall Choose one record in the recall list then press LY key the display screen will display trend graph as shown in Figure 15A SPO 9PO Trend graph PR Trend graph Figure 15A Trend Graph Recall Screen Screen description SpO The left ordinate value is SpO gt value 12 50 35 Measuring time 2s Record interval is 2 seconds PR The right ordinate value is pulse rate value Operation Instructions press E key to shift trend recall screens as shown in Figure 15A Figure 15B and Figure 15C S pO 12 50 35 2s 100 SpO Trend graph Figure 15B Trend Graph Recall Screen 15 User Manual for Handheld Pulse Oximeter 12 50 35
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