Instructions to Users
Contents
1. 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 25 User Manual for Fingertip Oximeter eA 1141 Budapest Fogarasi it 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 262. B2 B3 B5 PC 60B 1 B2 B3 C C1 C2 D2 E BS C C1 C2 D2 SpO alm Lo 85 PR alm Hi 120 ea PR WIS 35 Note The Setup menu Pulse beep on screen of PC 60C1 shows Save ex 29400 the factory default limits Restore default R setting value which is Setup menu screen different from other models PC 60 C1 1 User Manual for Fingertip Oximeter 6 Instructions for Operation The finger should be put in properly and correctly Do not shake the finger Keep at ease 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 Vigorous exercise and electrosurgical device interference may affect the measuring accuracy The orientation sensor works on the basis of the gravity A small movable metal ball is built in the orientation sensor for detecting the orientation of the Oximeter When you want to change the Oximeter s display direction if you move the Oximeter too slowly the movable metal ball will also move slowly because of not enough acceleration Consequently the response of orientation detection would be delayed Please move the Oximeter with a bit of force if you want to change the display direction such as bend extend your finger quickly so an acceleration is provided to the orientation sensor for quick sensing th
3. PR measuring accuracy 2bpm or 2 whichever is greater Perfusion Index PI Display range 0 20 Preset over limits SpO gt low limit 90 Pulse Rate high limit 120bpm low limit 50bpm Over limit indication settings for PC 60C1 SpO low limit setting range 8596 9596 Default setting 85 Pulse Rate Low limit setting range 30 60bpm High limit setting range 100 240bpm Default setting high 120bpm low 50bpm 14 User Manual for Fingertip Oximeter Over limit settings for PC 60E SpO default low over limit For internal sensor 9096 For external sensor 9596 Pulse Rate For internal sensor High limit 120bpm Low limit 50bpm For external sensor High limit 160bpm Low limit 60bpm Audible amp visual alert function When measuring if SpO gt value or pulse rate value exceeds the preset limit the device will alert automatically and the value which exceeds limit will flash on the screen Power supply requirement 2x LRO3 AAA alkaline batteries Supply voltage 3 0VDC Operating current lt 40mA Environment requirement Operating Temperature 5 C 40 C Operating Humidity 30 80 Atmospheric pressure 70kPa 106kPa 15 J User Manual for Fingertip Oximeter 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 6 Resistance to interference of surrounding light The difference
4. between the SpO value measured in the condition of indoor natural light and that of darkroom is less than 1 Dimensions 66 mm L x 36 mm W x 33 mm H Net Weight 60g including batteries 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 Magnetic Compatibility Group I Class B 16 User Manual for Fingertip Oximeter 8 Accessories A lanyard Two batteries A pouch An External SpO gt Probe optional A User Manual Quality Certificate Note The accessories are subject to change Detailed items and quantity see the Packing List m m g O z gt 17 User Manual for Fingertip Oximeter 9 Repair and Maintenance 9 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 Wipe the device with alcohol first and then let it air dry 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
5. type SpO PR PI Plethysmogram Auto on Auto off XIX X X X X x X X X X X X x x x x x x x x Over limit indication Over limit setting Pulse beep Low voltage indication x x x x x x x x x x x Multi directional display User Manual for Fingertip Oximeter 2 Battery Installation Figure 3 Battery Installation 1 Refer to Figure 3 insert two AAA size batteries into the battery compartment properly 2 Replace the cover e Please make sure that the batteries are correctly installed or incorrect installation may cause the device not to work User Manual for Fingertip Oximeter 3 External SpO Probe Connection Connect the external SpO probe to SpO sensor connector in the following way Make sure the side with Arrow faces upwards Figure 4 Probe Connection Special for PC 60E Note when the external SpO probe is connected well the built in finger clip sensor will be disabled The measurement is detected from the external SpO gt probe Meanwhile the over limit setting for SpO gt and PR have changed to be SpO gt Low limit 95 Pulse Rate high limit 160bpm Low limit 60bpm 6 User Manual for Fingertip Oximeter 4 Quick Guide to Operation Operation for PC 60A PC 60B and PC 60E 1 Open the clip and put finger into the rubber cushions of the clip make sure the finger is in the correct position and then clip t
6. 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 SpO simulator or it can be done by the local third party test house High pressure sterilization cannot be used on the device 18 User Manual for Fingertip Oximeter Do not immerse the device in liquid It is recommended that the device should be kept in a dry environment Humidity may reduce the life of the device or even damage it 9 2 Cleaning and Disinfecting Instruction e Surface clean sensor with a soft cloth by wetting with a solution such as 7596 isopropyl alcohol if low level disinfection is required use a 1 10 bleach solution Then surface clean with a cloth saturated with clean water and dry with a clean soft cloth Caution Do not sterilize by irradiation steam or ethylene oxide Do not use the sensor if it is damaged 19 10 Troubleshooting Trouble Display direction doesn t change or changes insensitively Possible Reason Maybe the oximeter is not used for a long time the movable metal ball within the orientation sensor can not move freely User Manual for Fingertip Oximeter Solution Please shake the oximeter with a certain force to make the movable metal ball move freely If the prob
7. S eee 22 II COMMON KNOWLEDGE eene 23 V User Manual for Fingertip Oximeter 1 Overview 1 1 Appearance Rubber lt lt Cushions Display Key O n Display Screen D n V x J Figure 2 Rear View User Manual for Fingertip Oximeter 1 2 Name and Model Name Fingertip Oximeter Model PC 60A PC 60D2 PC 60E PC 60B PC 60B 1 PC 60B2 PC 60B3 PC 60B5 PC 60C PC 60C1 PC 60C2 1 3 Intended Use This Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation SpO gt through patient s finger It is applicable for spot checking SpO and pulse rate of adult and pediatric patients in homes and clinics 1 4 Feature List Explanation of abbreviations Mark x this function is available without this function Display type X Y Z M monochrome D dual color C full color L LCD O OLED S segment D dot matrix Note The finger clip of PC 60D2 is suitable for small fingers especially for pediatric patients Configuration of PC XXXX Fingertip Oximeters 2 User Manual for Fingertip Oximeter v v g Display type SpO PR PI Plethysmogram Auto on Auto off Over limit indication Low voltage indication x x X X x x x x x x x x X x x x x x x x x x x x x x x x x XY XY x x x x x Multi directional display User Manual for Fingertip Oximeter Display
8. User Manual for Fingertip Oximeter Instructions to User Dear Users Thank you very much for purchasing our product Please read the manual very carefully before using this device Failure to follow these instructions can cause measuring abnormality or damage to the Oximeter The manual is published in English and we have 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 We reserve the right to improve and amend it at any time without prior notice Version of the Manual Ver 1 8 Revised date January 25 2013 All rights reserved Notes e The contents contained in this manual are subject to change without notice Information furnished by our company is believed to be accurate and reliable However no responsibility is assumed by us for its use or any infringements of patients or other rights of third parties that may result from its use 3502 2290043 User Manual for Fingertip Oximeter Instructions for Safe Operations Check the device to make sure that there is no visible damage that may affect user s safety or measurement performance with regard to sensors and clips It is recommended that the device should be inspected minimally once a week When there is obvious damage stop using the device Special attention should be paid while the oximeter is used constantly under the ambient temperature ove
9. e orientation change 12 User Manual for Fingertip Oximeter Nail polish may affect the measuring accuracy and oo long fingernail may cause failure of measurement or inaccurate result Existence of high intensive light sources such as fluorescence light ruby lamb infrared heater or strong sunshine etc may cause inaccuracy of measurement result Please put an opaque cover on he sensor or change the measuring site if necessary If the first reading appears with poor waveform irregular or not smooth then the reading is unlikely tue the more stable value is expected by waiting for a while or a restart is needed when necessary Note Due to the working principle of orientation sensor used in Oximeter there is a small metal ball which is movable within its compartment of the orientation sensor Therefore you can hear a slight clatter sound when you wave or shake the oximeter It is normal and not caused by unwanted part 7 Technical Specifications A SpO Measurement Transducer dual wavelength LED sensor with wavelength Red light 663 nm Infrared light 890 nm Maximal average optical output power lt 1 5mW 13 User Manual for Fingertip Oximeter SpO measuring range 35 100 SpO measuring accuracy Arms 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 measurement PR measuring range 30bpm 240bpm
10. edge 1 Meaning of SpO SpO gt is the saturation percentage of oxygen in the blood so called O concentration in the blood it is defined by the percentage of oxyhemoglobin HbO2 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 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 293 User Manual for Fingertip Oximeter 600nm 1000nm wavelength by using these characteristics SpO2 can be determined SpO 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 me
11. he finger 2 For PC 60B Wait 2 seconds the Oximeter PC 60E will power on automatically and start to measure For PC 60A Press the display key to start the measurement For PC 60B Short time press Display Key to turn on off the backlight For PC 60B Longtime press Display Key to shift the parameter display between PR and PI For PC 60E Tilt the Oximeter to change display direction and PI value will automatically display on the device instead of PR value PR value will restore after 20 seconds 3 Remove your finger the Oximeter will power off automatically User Manual for Fingertip Oximeter Operation for PC 60B1 PC 60B2 PC 60B3 PC 60B5 PC 60C PC 60C2 and PC 60D2 1 Open the clip and put finger into the rubber cushions of the clip make sure the finger is in the correct position and then clip the finger 2 Wait 2 seconds the Oximeter will power on automatically and start to measure Short time press Display Key to change display direction Longtime press Display Key to shift the parameter display between PR and PI 3 Remove your finger the Oximeter will power off automatically User Manual for Fingertip Oximeter Step Operation for PC 60C1 Open the clip and put finger into the rubber cushions of the clip make sure the finger is in the correct position and then clip the finger Wait 2 seconds the Oximeter will power on automatically and start to
12. lem still exists maybe the orientation sensor is not working properly Please contact the local service center 20 Trouble The SpO and Pulse Rate display instable User Manual for Fingertip Oximeter Possible Reason 1 The finger is not placed far enough inside 2 The finger is shaking or the patient is moving Solution 1 Place the finger correctly inside and try again 2 Let the patient keep calm Can not turn on the device 1 The batteries are drained or almost drained 2 The batteries are not inserted properly 3 The device is malfunctioning 1 Change batteries 2 Reinstall batteries 3 Please contact the local service center No display 1 The device will power off automatically when it gets no signal for 8 seconds 2 The batteries are almost drained 1 Normal 2 Change batteries 21 User Manual for Fingertip Oximeter Appendix I Key of Symbols Symbol Description Spo Pulse oxygen saturation w BPM PR Pulse rate beats per minute PI Perfusion Index A Pulse intensity bargraph 1 Low battery voltage CE mark SN Serial number te Date of manufacture oo ul Manufacturer including address With Type BF applied part A Warning See User Manual 1 Disposal of this device according to WEEE regulations DD User Manual for Fingertip Oximeter I Common Knowl
13. measure Tilt the Oximeter to change display direction Short time press Display Key to shift the parameter display between PR and PI Longtime press Display Key to enter setup menu screen On setup menu screen Short time press Display Key to choose the setting item Longtime press Display Key to active the setting item then short time press it to modify the setting parameter Next longtime press Display Key to confirm the modification and exit from this setting item At last move the setting item to Save exit menu and long time pressing Display Key to store the modification and exit from the setup menu Remove your finger the Oximeter will power off automatically User Manual for Fingertip Oximeter 5 Display Screen For PC 60B5 Oximeter SpO gt and PR symbols are imprinted on the front panel and its corresponding value displays on display screen below the symbol see figure 5 Figure 5 Figure 6 Short time press display key display screen including values pulse intensity histogram pulse beat symbol and waveform will be flipped 180 See figure 6 Note the two figures both show that SpO value is 99 and PR value is 86 bpm 10 User Manual for Fingertip Oximeter For other type Oximeters Measuring screen PI display screen PC 60A B PC 60B SpO PI 99 14 I tha be ha be Default measuring screen SpO amp PI display screen PC 60B 1
14. r 37 C burning hurt may occur because of over heating of the sensor at this situation Necessary maintenance must be performed only by qualified service technicians Users are not permitted to maintain it by themselves The Oximeter cannot be used together with devices not specified in User Manual Cautions Explosive hazard DO NOT use the Oximeter in environment with inflammable gas such as some ignitable anesthetic agents 6 DO NOT use the Oximeter while the testee is under MRI or CT scanning Warnings II User Manual for Fingertip Oximeter 6 An uncomfortable or painful feeling may appear if using the Oximeter continuously on the same place for a long time especially for poor microcirculation patients It is recommended that the Oximeter should not be applied to the same location for longer than 2 hours If any abnormal condition is found please change the position of Oximeter 6 DO NOT clip this device on edema or tender tissue The light the infrared light is invisible emitted from the device is harmful to the eyes so service technician or testee should not stare at the light The Oximeter is not a treatment device The local law must be followed when disposing of the device Attentions a Keep the Oximeter away from dust vibration corrosive substances explosive materials high temperature and moisture a The device should be kept out of the reach of children a If the Oximeter gets wet plea
15. se stop using it and do not resume operation until it is dry When it is carried from a cold environment to a warm and humid environment please do not use it m User Manual for Fingertip Oximeter immediately DO NOT operate the button on the front panel with sharp materials a DO NOT use high temperature or high pressure steam disinfection on the Oximeter Refer to Chapter 9 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 Caution U S federal law restricts this device to sale or use by or on the order of a physician IV User Manual for Fingertip Oximeter Table of Contents VOVERVIEW nirisan 1 1 1 APPEARANCE 1 2 NAME AND MODEL 1 3 INTENDED USE IA FEATURE LISTE 2 2 BATTERY INSTALLATION 5 3 EXTERNAL SPO PROBE CONNECTION 6 4 QUICK GUIDE TO OPERATION 5 DISPLAY SCREEN 6 INSTRUCTIONS FOR OPERATION 7 TECHNICAL SPECIFICATIONS 13 8 ACCESSORIES 17 9 REPAIR AND MAINTENANCE 18 9 1 MAINTENANCE X aaa aaa qu uui ae 18 9 2 CLEANING AND DISINFECTING INSTRUCTION 10 TROUBLESHOOTING APPENDIX I KEY OF SYMBOL
16. tahemoglobin Clinical application of pulse oximeters SpO is an important physiological parameter to reflect the respiration and ventilation function so SpO monitoring used in treatment has become more popular For example such as monitoring patients with serious respiratory disease patients under anesthesia during operation and premature and neonatal infants The status of SpO gt can be determined in timely manner by measurement and will allow finding the hypoxemia patient earlier thereby preventing or reducing accidental death caused by hypoxia effectively 3 Factors affecting SpO measuring accuracy interference reason Intravascular dyes such as indocyanine green or methylene blue Exposure to excessive illumination such as surgical 24 User Manual for Fingertip Oximeter 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 Placement of a sensor 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 4 Factors causing low SpO Measuring value pathology reason lt Hypoxemia disease functional lack of HbO
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