User Manual
Contents
1. Dual Display type D O C C D SpO PR PI SpO y y J A PR pa Pulse beep pa I e e e e e e e e I e Four directions display Orientation sensor External probe connection Wireless function e e e Low voltage y indication e 2 Battery Installation Figure 3 Battery Installation 1 Refer to Figure 3 insert two AAA size batteries into the battery compartment properly and note the polarity markings 2 Replace the cover e Please make sure that the batteries are correctly installed Incorrect installation may cause the device not to work e Please remove batteries if the device is not being used for more than 7 days to prevent and avoid potential damage from the battery leaking Any such damage is not covered under the product warranty 7 3 External SpO Probe Connection Connect the external SpO probe to SpO sensor connector as shown below Ensure the Arrow faces upwards Figure 4 Probe Connection For PC 60E 60N 60NW Note When the external SpO probe is connected the built in finger clip sensor will be disabled The measurement is detected from the external SpO probe Default over limit indication settings for SpO gt and PR will change to SpO Low limit 95 Pulse Rate high limit 160bpm Low limit 60bpm 8 4 Operation 1 Open the clip and put finger inside the rubber cushions of the clip make sure the finger is in the correct positi2. high limit 120bpm low limit 50bpm Over limit indication settings for PC 60C1 N NW SpO low limit setting range 85 95 18 G Default setting 85 Pulse Rate Low limit setting range 30 60bpm High limit setting range 100 240bpm Default setting high 120bpm low 50bpm Over limit settings for PC 60E SpO default low over limit For internal sensor 90 For external sensor 95 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 value or pulse rate value exceeds the preset limit the device will alert with beep automatically and the value which exceeds limit will flash on the screen Power supply requirement 2 x LRO3 AAA alkaline batteries Supply voltage 3 0VDC Operating current lt 40mA 9 Environmental Conditions Operating Temperature 5 C 40 C Operating Humidity 30 80 Atmospheric pressure 70kPa 106kPa Low Perfusion Performance The accuracy of SpO and PR measurement still meet the precision described above when the modulation amplitude is as low as 0 6 Ambient Light Interference The difference 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 approx 60g Classification The type of protection agains
3. PIT 00 amp BAJO ueuzueugs ar Poy eds iyepueis eui ui Sey jonpoud eur VO sjeg apoyy OWEN ejeoynie Aueno CREATIVE MEDICAL Fingertip Oximeter User Manual Shenzhen Creative Industry Co Ltd II Instructions to User Dear Customers Thank you for purchasing this quality 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 ofthe Manual Ver 1 4 Revised date February 9 2015 All rights reserved Notes 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 2290065 III Instructions for Safe Operation 6 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 inspecte
4. are for detail operation Note APP software for PC and Android smart phone is also available for download from below link http www creative sz com software NOTES The two dimensional barcode QR code shown in 16 Figure 9A is for Oximeter with bluetooth V2 x and Figure 9B is for Oximeter with bluetooth V4 0 That s to say if your Oximeter is PC 60NW or PC 60B5 you need to scan at Figure 9A to download the corresponding APP software while for POD 1W you need to scan at Figure 9B 2 Please make sure the version of Android system for your smart phone should be V4 3 or higher and include the bluetooth module of V4 0 otherwise the downloaded APP software will not be compatible with the Oximeter 3 Please make sure the APP software performs successful bluetooth connection with the Oximeter Figure 9A Figure 9B OR code for Oximeter QR code for Oximeter with and bluetooth V2 0 with and bluetooth V4 0 al 7s 5 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 SpO measuring range 35 100 SpO measuring accuracy lt 2 for SpO range from 70 to 100 Pulse Rate measurement PR measuring range 30bpm 240bpm PR measuring accuracy 2bpm or 2 whichever is greater Perfusion Index PI Display range 0 20 Preset over limits SpO low limit 90 Pulse Rate
5. cted 1 4 Feature List Explanation of abbreviations this function is available 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 60D amp 60D2 are suitable for small fingers especially for pediatric patients The only without this function 2 difference between these two oximeters is battery type PC 60D installs rechargeable button cell battery which could use many times after being charged by the charger Configuration of PC XXXX Fingertip Oximeters Model POD 1a POD 2a POD 3a POD 1 POD 2 POD 3 Function I Perfusion index C TEE Autoon Autoon a MASASAMA SAKA Low voltage indication Two y J y VT S3 directions display Wireless Option function al Function Se aa a a bed NN a ES A Ed Ba J Y J Y PI Perfusion N N af y index na AS A indication Low voltage N N y N Al indication Two 4 y 4 directions displa Waterproof amp J drop resistant Big numerical display J ES Model Function 60D O C Display type D O C D SpO gt PR PI Plethysmogram Le pe ie Auto on amp off ESEBES ENEE ESA EAKA indication ERES is D O C D O Setting menu EA Low voltage J N i y indication Four directions x x 2 J J display al i ll E E External probe connection Big numerical x NI display mm 17 Q Model 60N 60NW 60NW Function Color
6. d minimally before each use If there is obvious damage stop using the device Special attention should be paid while the oximeter is used constantly under the ambient temperature over 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 service this device The Oximeter must not be used with devices and accessories not specified in User Manual Cautions 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 patient is under MRI or CT scanning This device is NOT MRI Compatible IV Warnings 6 6 6 Discomfort or pain may appear f using the Oximeter continuously on the same location for a long time especially for patient with poor microcirculation 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 DO NOT clip this device on edema or tender tissue The light the infrared light is invisible emitted from the device 1s harmful to the eyes Do not stare at the light The oximeter is not a treatment device Local laws and Regulations must be followed when disposing of the device Attentions B Keep the Oximeter away from dust vibrati
7. lamb infrared heater or strong sunshine etc may cause inaccuracy of measurement result Please put an opaque cover on the sensor or change the measuring site 1f necessary f 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 Note Due to the working principle of orientation sensor used in the Oximeters such as the model PC 60B3 there is a small metal ball which is movable within its compartment of the orientation sensor Therefore you may hear a slight clatter sound when you wave or shake the Oximeter this is normal 21152 ES ES lt gt Downloading the APP software for Android smart phone The terminal devices such as Android smart phone can be used to receive data from the Oximeter in real time and store the received data review the stored data as well You have to download the corresponding APP software on the smart phone Please follow the procedure to download 1 Scan below QR code 2 Open the link from the QR code 3 Download the software PC 60NW apk and install 4 Run the software to connect the Oximeter for real time data transfer The below QR Code is appliable to the Fingertip Oximeter with wireless function Instruction for Measurement Make sure the APP software is successful to connect with the Oximeter Refer to the manual of this APP softw
8. lay will be shifted back to PR display automatically after 20 seconds even if no button operation gt For the model PC 60B3 there is no plethysmogram display while the display direction is shifted to the right or left direction as shown in figure 8D To the opposite PC 60B1 has no plethysmogram on default measuring screen as shown in figure 8E while the display direction is shifted to left side direction there will be displayed plethysmogram please refer to figure 8F gt For the model of PC 60B2 amp 60B5 only has two change directions up and down 11 gt The model PC 60B3 may have different options for manual switching display direction by button or automatic changing display direction by orientation sensor similar to the model PC 60C1 For PC 60E PC 60N and PC 60NW when change display direction PI value will automatically display on the device instead of PR value PR value will restore after 20 seconds For PC 60E upward downward shift the Oximeter quickly can turn on off the pulse beep The default pulse beep is OFF Menu 60C1 60N 60NW Dual amp 60NWColor Spo alm La 85 Wireless on Wireless on PR alm Hi 120 SpOzalm Lo 85 SpOzalm Lo 3 mis alm Hi 12 PR alm Lo 50 PR alm Hi 120 PR alm Lo 50 Pulse beep on PR alm Lo 50 Pulse beep on save exit menu Save exit menu Save exit menu Restore default Restore default Restore default PC 60 C1 amp 60N PC 60NW Dual PC 60NW Color Long time
9. lines indicates signal intensity Data transmission The user could effectively transmit the data to computer through the wireless function Refer to the Oximeter Data Manager for detailed information Attention to the operation The finger should be put into the sensor correctly Do not shake the finger and relax 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 1 e do not use finger nail polish paints Vigorous exercise and electrosurgical device interference may affect the measuring accuracy e 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 14 because of not enough acceleration Consequently the response of orientation detection would be delayed Acceleration needs to be provided to the orientation sensor for quick sensing the orientation change e Nail polish may affect the measuring accuracy and too long fingernail may cause failure of measurement or inaccurate result Existence of high intensive light sources such as fluorescence light ruby
10. luding interference that may cause undesired operation Table of Contents OVERVIEW ana aaa 1 1 1 APPEARANCE ei 1 1 2 NAME AND MODEL eee 2 1 3 INTENDED USE erint nro ore xe nn 2 Ed FEATURE LIST usi ae 2 2 BATTERY INSTALLATION 22220000000000000000000000000 7 3 EXTERNAL SPO PROBE CONNECTION 8 ZOPERATION SEE 9 5 TECHNICAL SPECIFICATIONS eee 18 6 REPAIR AND MAINTENANTQCE eee eene een ne 21 6 1 MAINTENANCE iiie ea 21 6 2 CLEANING AND DISINFECTING INSTRUCTION 22 7 TROUBLESHOOT ING eee eene eee eene eee nu 23 8 PACKING DIS Toninas 23 9 KEY ORSYMBODS a uunnse0 en 24 VII 1 Overview 1 1 Appearance Rubber n Cushions Display Key 0 Display Screen en Figure 2 Rear View 1 2 Name and Model Name Fingertip Oximeter Model POD 1a POD 2a POD 3a POD 1 POD 2 POD 3 PC 60A POD 1W PC 60B PC 60B1 PC 60B 2 PC 60B3 PC 60B5 PC 60C PC 60C1 PC 60C2 PC 60D PC 60D2 PC 60E PC 60N PC 60NW 1 3 Intended Use This Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation SpO2 through a patient s finger It is applicable for spot checking SpO and pulse rate of adult and pediatric patients in homes and medical clinics Models with external sensor options and over limit Indication may be used for longer periods of time dependent on the suitability of the sensor sele
11. on and then clip the finger as shown in figure 5 C3 Figure 5 Put finger into the Oximeter D For PC 60A press the display key to start the measurement 2 For other modules except for PC 60A wait 2 seconds the oximeter will power on automatically and start to measure 2 Next enter into data display screen 1 POD 1 POD 2 amp POD 3 display screen are as shown in figure 6 y Im 3 3 tmm vine 8593 del Kusel Figure 6 Note the display direction of POD 1a POD 2a amp POD 3a 9 is upand down 2 PC 60A amp 60B display screen are as shown in figure TA SpO2 symbol SpO2 value Unit of PR Pulse beat symbol Pulse bar Pulse rate value Figure 7A 3 For PC 60B short time press Display Key to turn on off the backlight Longtime press Display Key to display Pl as shown in figure 7B after 8 seconds the screen will return to the screen as shown in figure T Figure 7B PI display screen for PC 60B 4 For other type oximeter PC 60B1 PC 60B2 PC 60B3 PC 60B5 PC 60C PC 60C1 PC 60C2 PC 60D and PC 60D2 short time press Display Key to change display direction Note 60C1 changes direction automatically As shown in figure 8A amp 8B Longtime press Display Key to shift the parameter display between PR and PI Please refer to figure SC 10 5 For POD 1W the display screen is as shown in figure Figure 8D Figure 8E Figure 8F Figure 8G Note gt The PI disp
12. on 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 using it and do not resume operation until it is dry and checked for correct operation When it is carried from a cold V environment to a warm and humid environment please do not use it immediately Allow at least 15 minutes for Oximeter to reach ambient temperature A DO NOT operate the button on the front panel with sharp materials or sharp point A DO NOT use high temperature or high pressure steam disinfection on the Oximeter Refer to Chapter 7 for instructions regarding cleaning and disinfection Declaration of Conformity The manufacturer hereby declares that this device complies with the following standards IEC 60601 1 2005 Medical electrical equipment Part 1 General requirements for basic safety and essential performance BS EN ISO 9919 2009 or the equivalent ISO 80601 2 61 2011 Medical electrical equipment Part 2 61 Particular requirements for basic safety and essential performance of pulse oximeter equipment And it also follows the provisions of the council directive VI FCC Rules are specifically for PC 60NW This device complies with Part 15 of the FCC Rules Operation is subject to the following two conditions 1 this device may not cause harmful interference and 2 this device must accept any interference received inc
13. pressing display key could enter the setup menu screen Wireless the wireless on off button Transmitting data to PC when it is on on and off can be optional The factory default is on Pulse beep Pulse beep option If it is set to on every pulse beat makes a beep Only for model PC 60NW the pitch tone of this beep changes according to SpO value within 90 99 219 Menu setup 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 Note if wireless connection is setup the icon M8 will be displayed on the screen 4 Wireless icon g The icon of ER de flashes The device is being to establish a wireless connection with the surrounding host gt long lights Successful wireless connection between bius the device and a host is established No display t 1 Wireless function is disabled icon 2 The device fails to setup a wireless connection with the surrounding host within 3 minutes 3 Hardware failure of wireless transmission function while the 13 Wireless function is enabled Wireless icon of POD 1W the number of
14. r or it can be done by the local third party test house Please note that the specific calibration curve so called R curve should be selected when use of SpO simulator e g for Index 2 series SpO simulator from Fluke Biomedical Corporation please set Make to DownLoadMake KRK then the user can use this particular R curve to test the oximeter If the SpO2 simulator does not contain KRK R curve please ask the manufacturer for helping to download the given R curve into the SpO2 simulator High pressure sterilization cannot be used on the device 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 6 2 Cleaning and Disinfecting Instruction Surface clean sensor with a soft cloth damped with a solution such as 75 isopropyl alcohol if low level disinfection is required use a mild bleach solution Then surface clean with a cloth damped ONLY with clean water and dry with a clean soft cloth Caution Do not sterilize by irradiation steam or ethylene oxide Do not use the Oximeter if it is damaged 2225 7 Troubleshooting Problem l The SpO and Pulse Rate display instable 2 Can not turn on the device 3 No display 4 Display direction doesn t change or changes insensitively 5 No display of the wireless icon Y Solution 1 Place the finger correctly inside and try again 2 Let the patien
15. t electric shock Internally powered equipment The degree of protection against electric shock Type BF applied parts Electro Magnetic Compatibility Group I Class B 20 6 Repair and Maintenance 6 1 Maintenance The expected 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 e Please change the batteries when the low voltage indicator lightens e Please clean the surface of the device before using with 75 alcohol wipes then let it air dry or wipe it dry Do not allow liquid to enter the device e Please take out the batteries if the oximeter will not be used any more than 7 days e The recommended storage environment of the device ambient temperature 20 C 60 C relative humidity 10 95 atmospheric pressure S0kPa 107 4kPa e The oximeter is calibrated in the factory before sale so there is no need to calibrate it during its life cycle Any SpO simulators should not be used to validate the accuracy of the oximeter they can only be used as functional testers to verify its precision The SpO accuracy claimed in this manual is supported by the clinical study conducted by inducing hypoxia on healthy non smoking light to dark skinned subjects in an independent research laboratory J If it is necessary to verify the precision of the oximeter routinely the user can do the verification by means of SpO simulato
16. t keep calm 3 Changing batteries 4 Please shake the oximeter with a certain force to make the movable metal ball move freely If the problem still exists maybe the orientation sensor is not working properly 5 Hardware failure of wireless transmission function 6 If the above problem still exists please contact the local service center 8 Packing List 1 Fingertip Oximeter 2 User Manual 3 Batteries 4 External SpO probe Optional Note the items and its quantity are subject to change please refer to your subject in hand 2086 9 Key of Symbols Description Authorised representative in the European community Follow WEEE regulations for disposal Wireless icon 24 Shenzhen Creative Industry Co Ltd Tel 86 755 2643 3514 Fax 86 755 2643 0930 E mail info creative sz com Website www creative sz com Address 2 F Block 3 Nanyou Tian an Industry Town 518054 Shenzhen GD P R China C o2 25
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