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Easi-PulseTM

1. Figure 5 SpO2 program Figure 5 SpO2 Review program 11 12 On the measuring interface the display direction can be changed by pressing the power button quickly There are six modes of data display that can be viewed a Adjusting the high and low limits of alarms On the alarm setting interface Click the power button to select Dir then Press and hold the power button 1 erin second to enter the Settings Menu etungs Interface see Figure 7 be Alarm The user can setup the following parameters in the Settings Menu Record off Turn on alarm turn on pulse sound Exit alarm high low limits data storage recording Figure 7 Please note in the Settings Menu CLICK short press of power button and PRESS prolonged push of power button 1sec a Alarm setting On the main menu interface click the power button to select Alarm Press the power button 1sec to enter the alarm setting interface as shown in Figure 8 Figure 8 Press the button 1sec to enter the alarm direction setting interface as shown in Figure 9 Direction On the alarm direction setting interface Click the power button to select SpO2 Alm or PR Alm then gt Sp02 Alm Press the button 1 sec to enter the PR Alm SpO2 or PR direction setting interface as shown in Figure 10 Exit Click the power button to select Dir then Press the button to choose Up Figure 9 or Down this will b
2. Warranty amp Support This product is provided with a one year warranty for problems found during normal usage Mistreating the Easi Pulse or opening the unit will invalidate this warranty Any data stored on the unit and any consequential loss is not covered by this warranty The battery is not user replaceable Technical Support Please visit www tts group co uk for the latest product information Email feedback tts group co uk for technical support TTS Group Ltd Park Lane Business Park Kirkby in Ashfield Nottinghamshire NG17 9GU UK Freephone 0800 318686 Freefax 0800 137525 TTS Product Code ELOO145 Easi Pulse WARNING Do not dispose of this product in household waste Hand it over to a collection point for recycling electronic appliances WARNING Not suitable for children under 36 months due to small parts choking hazard Made in China on behalf of the TTS Group Ltd CEXO N448 USER GUIDE Instructions to User Dear users thank you very much for purchasing the Pulse Oximeter This Manual is written and compiled in accordance with the council directive MDD93 42 EEC for medical devices and harmonized standards In case of modifications and software upgrades the information contained in this document is subject to change without notice The Manual describes in accordance with the Pulse Oximeter s features and requirements main structure functions specifications corr
3. When cleaning the device with water the temperature should be lower than 60 C The update period of data is less than 5 seconds Please read the measured value when the waveform on screen is equal and steady This measured value is optimal value If some abnormal symbols appear on the screen during use pull out the finger and reinsert to restore normal use This device has an alarm users can check on this function according to chapter 6 2 as a reference A flexible circuit connects the halves of the device Do not twist or pull on the connection 2 Overview The pulse oxygen saturation is the percentage of HbO2 in the total Hb in the blood so called the O2 concentration in the blood It is an important bio parameter for respiration A number of diseases relating to respiratory system may cause a decrease of SpO2 in the blood 2 1 Features A Operation of the product is simple and convenient B The product is compact light in weight and convenient to carry C Low power consumption 2 2 Major applications and scope of application The Pulse Oximeter can be used in measuring the pulse oxygen saturation and pulse rate through finger The product is suitable for being used at home in the hospital at an oxygen bar in community healthcare and for physical care in sports it can be used before or after sports it is not recommended to use the device during sport and etc 2 3 Environment requirements Storage Environment a
4. 800 MHz to 2 5 GHz Ee a f h For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 23
5. press the 14 button to exit the main menu F Power off The device will power off automatically when it gets no signal for 5 seconds The device cannot power off when it is storing data 6 2 Attention for operation A Please check the device before use B The finger should be in a proper position see the attached illustration of Figure 4 for reference or else it may result in an inaccurate measurement C The SpO2 sensor should not be used at a location or with a limb with an arterial canal or blood pressure cuff or whilst receiving intravenous Injection D Do not fix the SpO2 sensor with adhesive E Excessive ambient light may affect the measuring result F Strenuous action of the subject or extreme electrosurgical interference may also affect the accuracy G Please clean and disinfect the device after operating according to the User Manual 7 1 6 3 Clinical restrictions A Some medical conditions will affect the SpO2 reading by this monitor and may be inaccurate 7 Maintenance transportation and storage 7 1 Cleaning and Disinfecting Use medical alcohol to disinfect the device nature dry or clean it with clean soft cloth 7 2 Maintenance A Please clean and disinfect the device before using according to the User Manual 7 1 B Please change the battery when the screen shows C Remove the battery from the device for long periods of storage 15 7 3 Transportation and storage A There are not speci
6. s Manual Only the accessory that appointed or recommendatory by manufacture can be used with this device This product is calibrated before leaving factory 1 2 Warning Explosive hazard DO NOT use the oximeter in an environment with inflammable gas such as some ignitable anesthetic agents Ensure that the environment in which the device is operated is not subject to any sources of strong electromagnetic interference such as radio transmitters mobile telephones etc DO NOT use the oximeter during MRI and CT scans Plastics contain rubber that some users may be allergic to The disposal of the instrument and Its accessories and packaging including battery plastic bags foams and paper boxes should follow the local laws and regulations Please check the packing before use to make sure the device and accessories are in accordance with the packing list Please choose the accessories and probe which are approved or manufactured by the manufacturer other devices or accessories may damage the device 1 3 Attention Keep the oximeter away from dust vibration corrosive substances explosive materials high temperature and moisture If the oximeter gets wet stop use The Oximeter should be left to acclimatize to different environments DO NOT the operate keys on front panel with sharp materials High temperature or high pressure steam disinfection of the oximeter is not recommended Do not expose the Oximeter to liquids
7. the previous Menu b Data storage setting This instrument has the ability to store 24 hours worth of data It can store the measured pulse rate and SpO2 values transfer the data to a computer display the data and print reports with the included SpO2 Software Green Heart a On the main menu interface as shown in Figure 7 Click the button to select Record then press the button to choose whether to store the data or not choose on to allow storing choose off to prevent storing b If the data storage is turned on the main user interface will show a flashing yellow dot c Whilst recording the screen will be automatically shut down with only the flashing yellow dot to indicate that the device is recording d Data is automatically written over if not uploaded e When the storage space is full the device will display Memory is full on the screen and then shut down after 3 seconds c Uploading the data to the PC after recording a Connect the device to a computer via the USB lead supplied with the device then double click SpO2 Review icon to launch the software Click the New Session Icon in the software enter the patient data and then click ok The Software will then display device connected waiting for data b On the main menu interface on the device recording mode must be off d Exit the main menu On the main menu interface Click the button to select Exit then
8. Operating Guide 6 1 Application method A a Insert the two batteries ensuring the correct polarity and then replace the cover b Open the clip as shown in Figure 4 c Insert the finger into the foam rubber cushions of the clip make sure the finger is in the right position and then 4 release the clip onto the finger Figure 4 Put finger in position d The data can be read directly from the screen on the measuring interface B Change display direction On the measuring interface press the button to change the display C Pause alarm a Alarm including can be set to sound for data going beyond the predetermined limits low battery and finger removed c To turn off the alarm setting can be changed in the operation menu D Data transmission setting Firstly please install the affiliated software onto the computer two icons will appear on the desktop after installation SoO2 is a program for receiving real time data which is shown as Figure 5 the icon of SpO2 Review is a program for receiving stored data which is shown as Figure 6 a Please connect the device to the computer with the USB lead then double click the SpO2 icon to start the program b When you unplug the USB lead from the computer a dialog box will appear Save data at view on the desktop at this point you will be prompted to input basic user information if required E Menu operations oy Spuz SpUCMRevilew
9. Temperature 40 C 60 C b Relative humidity 5 95 c Atmospheric pressure 500hPa 1060hPa Operating Environment a Temperature 10 C 40 C b Relative Humidity 30 75 c Atmospheric pressure 700hPa 1060hPa 3 Principle Principle of the Oximeter is as follows using Lambert Beer Law and according to Spectrum Absorption Characteristics of Reductive Hemoglobin Hb and Oxyhemoglobin HbO2 in glow amp near infrared zones Operation principle of the device is Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning amp Recording Technology so that two beams of different wavelength of lights can be focused onto human nail tip through perspective clamp finger type sensor Then the measured signal can be obtained by a photosensitive element information acquired through which will be shown on screen Glow and Infrared ray Emission tube Glow and Infrared ray Receit tube 4 Technical specifications 4 1 Main performance A SpO2 value display B Pulse rate value display bar graph display C Pulse waveform display D Low voltage indication E Automatically power off it will automatically power off within 5 seconds if the finger falls out of probe F The display mode can be changed G A pulse rate sound indication H Alarm function With SpO2 value and pulse rate data storage the stored data can be uploaded to computers J Data can be transmitted to computers 4 2 M
10. ain Parameters A Measurement of SpO2 Measuring range 0 100 Accuracy When the SpO2 measuring range is 70 100 the permission of absolute error is 2 below 70 unspecified B Measurement of pulse rate Measuring range 30bpm 250bpm Accuracy 2 bpm or 2 select larger C Resolution SpO2 1 Pulse rate 1bpm D Measurement Performance in Weak Filling Condition SpO2 and pulse rate can be shown correctly when pulse filling ratio is 0 4 SpO2 error is 4 pulse rate error is 2 bpm or 2 select larger E Resistance to surrounding light The deviation between the value measured in the condition of man made light or indoor natural light and that of darkroom is less than 1 F Power supply requirement 2 6 V DC 3 6V DC G Optical Sensor Red light wavelength is 660nm 6 65mW Infrared wavelength is 880nm 6 75mW H Adjustable alarm range SpO2 0 100 Pulse Rate Obpm 250bpm 5 Installation 5 1 View of the front panel pulse sound indication 50 low battery indication pU2 O alarm indication pO020PRbpm pulse rate E 98 070 3 i gt m 7 e button FingertipOximeter pulse bar graph graph pulse waveform 5 2 Battery installation A Refer to Figure 3 and insert the two AAA size batteries with the correct polarity B Replace the cover Figure 3 5 3 Accessories A Lanyard C User manual B Two dry batteries AAA D USB lead optional E CD PC software 6
11. al transportation requirements B The packed device should be stored in room with Temperature 40 C 60 C Humidity lt 95 Troubleshooting The SpO2 and Pulse Rate cannot be read The SpO2 and Pulse Rate are not displayed stably The device will not turn on The display switches off suddenly 1 The finger is not properly positioned 2 The patient s SpO2 is too low to be detected 1 The finger is not placed inside deep enough 2 The finger is shaking or the patient is moving 1 The battery is flat 2 The battery is installed incorrectly 3 The device is faulty 1 This device is set to automatically power off after 5 seconds when it cannot detect any signal 2 The battery is flat 1 Place the finger properly and try again 2 Try again Go toa hospital for a diagnosis if you are sure the device works all right 1 Place the finger properly and try again 2 Let the patient keep calm 1 Please change batteries 2 Please Install the battery again 3 Please contact distributer 1 Ensure finger is correctly inserted 2 Please change batteries 9 Key of Symbols A SpO2 PRbpm IPXI mix Warning See User Manual The pulse oxygen saturation Pulse rate bpm Low voltage Open the alarm sound indication Open the pulse sound indication menu button power button function button Type BF Serial number 1 the finger clip falls off no finger i
12. e the direction the value of the high low limits of SpO2 e gt Dir and pulse rate will be adjusted down To raise the SpO2 and pulse rate limit High 099 choose Dir as Up then Click the power button to select high limit High or low limit Low Press the power button and hold to adjust the Low 085 Exit Figure 10 selected limit to the desired higher value and release the power button once the higher limit has been reached To lower the SpO2 and pulse rate limit choose Dir as Down then Click the power button to select high limit High or low limit Low Press the power button and hold to adjust the selected limit to the desired lower value and release the power button once the lower limit has been reached b Pulse sound indication setting On the alarm setting interface as shown in Figure 8 Click the power button to select Psound then Press the power button to choose to have the Pulse Sound heart beat alarm on or off 13 c The alarm state setting On the alarm setting interface as shown in Figure 8 Click the power button to select Alarm then Press the power button to choose alarm on or off press on to turn on the alarm and off to turn off the alarm d Exit the Alarm settings the alarm direction setting the SpO2 or PR direction setting Click the power button to select Exit then Press the power button to exit the Menu and return to
13. ect methods for transportation installation usage operation repair maintenance and storage etc as well as the safety procedures to protect both the user and equipment Refer to the respective chapters for details Please read the User Manual carefully before using this product The User Manual which describes the operating procedures should be followed Strictly Failure to follow the User Manual may cause measuring abnormality equipment damage and human injury The manufacturer is NOT responsible for the safety reliability and performance issues and any monitoring abnormality human injury and equipment damage due to users negligence of the operation instructions The manufacturer s warranty service does not cover such faults Owing to the forthcoming renovation the specific products you received may not be totally in accordance with the description of this User Manual We would sincerely regret for that This product is medical device which can be used repeatedly Easi Pulse WARNING E Uncomfortable or painful feeling may occur if using the device continuously especially for microcirculation barrier patients It is recommended that the sensor is applied for no longer than 2 hours E The device cannot be clipped on the edema or tender tissue E Do not attempt to look directly at the infra red light emitter E Remove all cosmetics from the finger nail before use E Please refer to literature about the clinical restr
14. ictions and caution E This device is not intended for medical treatment The User Manual is published by Contec Medical Systems Co LTD All rights reserved CONTENTS 1 Safety 1 1 Instructions for safe operation 1 2 Warnings 1 3 Attention 2 Overview 2 1 Features 2 2 Major applications and scope of application 2 3 Environment requirements 3 Principle 4 Technical specifications 4 1 Main performance 4 2 Main Parameters 5 Installation 5 1 View of the front panel 5 2 Battery installation 5 3 Accessories 6 Operating Guide 6 1 Application method 6 2 Operation 6 3 Clinical restrictions 7 Maintain transportation and storage 7 1 Cleaning 7 2 Maintainance 7 3 Transportation and storage 8 Troubleshooting 9 Key of Symbols 10 Function Specification Appendix O CO WON NN DD WD WH UW WI S oe ss es se se se ss sls CO WO O N ADwWwWununnn UWOd Od Oo O 1 Safety 1 1 Instructions for safe operations Check the main unit and all accessories periodically to make sure that there is no visible damage that may affect patient s safety and check cables It is recommended that the device should be inspected once a week When there is obvious damage stop using the device Necessary maintenance must be performed by qualified service engineers ONLY There are no user serviceable parts and users are not permitted to maintain it by themselves The oximeter cannot be used together with devices not specified in User
15. nserted 2 Probe error 3 Signal inadequacy indicator battery positive battery negative USB Ingress of liquids rank WEEE 2002 96 EC This item is compliant with Medical Device Directive 93 42 EEC of June 14 1993 a directive of the European Economic Community ie The Pulse Oxygen Saturation SpO2 Pulse Rate PR Pulse Intensity bar graph SpO2 Parameter Specification Measuring range Accuracy Average value Pulse Parameter Specification Measuring range Accuracy Average pulse rate Safety Type Pulse Intensity Range Battery Requirement Battery working life 18 2 digit digital OLED display 3 digit digital OLED display bar graph OLED display 0 100 the resolution is 1 70 100 2 Below 70 unspecified Calculate the Average value in every 4 measure value The deviation between average value and true value does not exceed 1 30bpm 250bpm the resolution is 1 bpm 2bpm or 2 select larger Moving calculate the Average pulse rate every 4 cardio beats cycle The deviation between average value and true value does not exceed 1 Interior Battery BF Type Continuous bar graph display the higher display indicates the stronger pulse 1 5V AAA size alkaline batteries x 2 Two 1 5V AAA size 600mAh alkaline batteries can work continually for 24 hours Dimensions and Weight Dimensions 58 5 L x 31 W x 32 H mm Weight About 52g with the batteries Ap
16. nvironment guidance Floors should be wood concrete or ceramic tile If floor are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the test level 20 Immunity IEC 60601 Compliance test test level level Radiated RF IEC 61000 4 3 Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the CMS50D including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 3 5 d V ve d vp 80 MHz to 800 MHz E 7 d ve 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment Q marked with the following symbol 22 NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absor
17. pendix Guidance and manufacturer s declaration electromagnetic emissions for all Equipment and Systems Guidance and manufacturer s declaration electromagnetic emission The CMS50D is intended for use in the electromagnetic environment specified below The customer of the user of the CMS50D should assure that it is used in such and environment Emission test Compliance Electromagnetic environment guidance RF emissions Group 1 The CMS50D uses RF energy only CISPR 11 for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment De eaaresiory dass B The CMS50D is suitable for use in all CISPR 11 establishments other than domestic and those directly connected to a low voltage power supply network which supplies buildings used for domestic purposes Guidance and manufacturer s declaration electromagnetic immunity for all Equipment and Systems Guidance and manufacturer s declaration electromagnetic immunity The CMS50D is intended for use in the electromagnetic environment specified below The customer or the user of CMS50D should assure that it is used in such an environment Immunity test Electrostatic discharge ESD IEC 61000 4 2 Power frequency 50 60Hz magnetic field IEC 61000 4 8 IEC 60601 test level 6 kV contact 8 kV air Compliance level 6 kV contact 8 kV air Electromagnetic e
18. ption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the CMS50D is used exceeds the applicable RF compliance level above the CMS50D should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the CMS50D b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended separation distances between portable and mobile RF communications equipment and the CMS50D The CMS50D is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the CMS50D can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the CMS50D as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to output power of frequency of transmitter m transmitter W 80 MHz to 800 MHz

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