CMS-50I Instruction Manual
Contents
1. 2 Zev CTT 2 2 2 Major applications and scope Of 116 2222 6666 2 ann T 11 80 3 7 7 1 3 A i 3 AI MAMMA TOTALING gi brite di 2 23 2 3 232 23 333 11113131 1 baook 3 AD Mam Parame Ler 3 23 3 3 311 771111 7 650 4 0 7 1 11111111115 0 4 3 37 11 1 3 4 5 2 Probe cg 5 1 2 2 2 313131110 30 00 5 1 0 0 5 6L Applicaton 2532. 1550 USER MANUAL CONTEC MEDI FA f a aly 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 correct 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 des
3. 3 0 5 02 Atenon LOL 22 2 2 11 1 11 1 11111111111 10 6 2 11 10 7 Maintain transportation and Storage 22222 2 11 AE 1 110 11 T 82 ence crise uci 0 11 72 gt 3 3 110 0 11 S 7 7 0 0 0 11 11 9 351111 1 110 12 2 2 2 2 3 81 1 9 13 MI 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 monitoring performance It is recommended that the device should be inspected weekly at least When there is obvious damage stop using the device Necessary maintenance must be performed by qualified service engineers ONLY Users are not permitted to maintain it by themselves The oximeter cannot be used together with devices not specified in User s Manual Only the accessory that is appointed or recommendatory by manuf
4. 4 The user can adjust the settings through the main menu such as backlight alarm data storage system setting pulse sound setting demo The specific operation methods are as follows A Brightness adjustment In the main menu interface short press menu button to move the choice bar to the Brightness item then long press menu button to adjust the brightness of screen 4 levels adjustable Figure 4 Main Menu Interface B Alarm setting In the main menu interface short press menu button to move the choice bar to Alarm item then long press menu button to enter the alarm setting menu as Figure 5 Figure 5 Alarm Setting Menu a The high low limit of alarm setting In alarm setting menu short press menu button to move the choice bar to Dir item long press menu button to choose Up or Down Short press menu button to adjust alarm item SpO high limit SpO ALM HD SpO low limit SpO ALM LO Pulse rate high limit PR ALM HI Pulse rate low limit PR ALM LO Long press menu button to change the value Long press menu button once and the value raise or descend once The low limit can t be above high limit and the high limit can t be below the low limit Air the alarm function is on the device will provide medium priority alarm signal when the data of SpO or pulse rate is beyond the limit Intermittent alarm will occur and the values show in yellow Medium priority indicating that prompt operator response is required b The
5. Weak Filling Condition SpO and pulse rate can be shown correctly when pulse filling ratio is 0 4 SpO gt error is 4 pulse rate error is 2 bpm or 2 select larger F 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 G Power supply requirement 3 6 V DC 4 2V DC H Optical Sensor Red light wavelength is 660nm 6 65mW Infrared wavelength is 880nm 6 75mW Adjustable alarm range SpO 0 100 Pulse Rate Obpm 254bpm 5 Installation 5 1 View of the front panel Alarm setting Power button Time Power indication Pulse sound Probe Pulse rate value Perfusion Index SpO gt value X Menu button 5 alarm low limit Pulse bar graph Pulse waveform Wristban Figure 2 Front View 5 2 Probe installation A Open the USB cover inserting the probe into the USB port of the pulse oximeter and the red light of probe will flicker B Insert the finger into the probe the side with finger sign and the nail should be in the same side The connected probe could work normally when the luminescent tube in the device emit red light sostenuto A In order to ensure device life and measure accuracy external probe is limited to the matching model and can t be replaced by other model Or else the device will be damaged or usage 1s affected 5 3 Accessories A User Manual A power
6. acture can be used with this device This product is calibrated before leaving factory 1 2 Warning Explosive hazard DO NOT use the oximeter in the environment with tinder such as anesthetic DONOT use the oximeter while the patient is being scanned by MRI or CT The person who is allergic to rubber can not use this device The disposal of scrap instrument and its accessories and packing 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 totally in accordance with the packing list or else the device may have the possibility of working abnormally Please choose the accessories which are appointed or recommended by the manufacturer for avoiding device damage Please don t measure this device with functional tester for the device s related information 1 3 Attention A Keep the oximeter away from dust vibration corrosive substances tinder high temperature and moisture A If the oximeter gets wet please stop operation A When it is carried from cold environment to warm or humid environment please do not use it immediately A DO NOT operate button on front panel with sharp things A High temperature or high pressure steam disinfection for the oximeter is not permitted Refer to User Manual in the relative chapter 7 1 for cleaning and disinfection A Do not have the oximeter imme
7. adapter optional A data line A disk PC software A adult fingertip SpO2 probe 0 3m and two One off adhesive SpO2 probe 0 3m 2 eS 6 Operating Guide 6 1 Application method 6 1 1 Measurement Insert the finger into the probe of the device Long press power button to turn the device on Do not shake the finger and keep the patient 1 a stable state during the process ao SP The data can be read directly from the display screen in the measuring interface 6 1 2 Lay finger The right method of laying finger is as Figure 3 Figure 3 A Fingernails and the luminescent tube should be in the same side 6 1 3 Pause alarm a Alarm includes the alarm of measure data s going beyond the limits SpO2 and pulse rate value alarm of low power and the alarm of finger out b In the measuring interface if the alarm function is on during the period of alarming alarm can be suspended by short pressing menu button and the screen will appear pause alarm symbol but the function will be renewed in about 30 seconds c If you want to turn off the alarm you should enter the menu for operation Please refer to chapter Alarm setting for detail 6 1 4 Change display direction The device could change display direction by manual mode In the measuring interface short press menu button to change display direction 6 1 5 Menu operations In the measuring interface long press menu button to enter the main menu interface as Figure
8. alarm state setting alarm setting menu short press menu button to move the choice bar to the Alarm item then long press menu button to turn on or turn off the alarm sound Choose on to turn on the alarm and choose off to turn off the alarm Exit operation In alarm setting menu short press menu button to move the choice bar to Exit item then long press button to exit alarm setting menu and return to the main menu C Data record setting In the main menu interface short press menu button to move the choice bar to the Record item then long press menu button to enter the record setting menu as Figure 6 Figure 6 Record setting Menu a Record segments Display the number of the data segments which have been recorded b Record setting In the Record Menu interface short press menu button to move the choice bar to the Record off item then long press menu button to begin to record data here enter the Record menu again in Record on menu long press menu button to stop recording and the on will become off c Delete all In the Record Menu interface short press menu button to move the choice bar to the Delete all item then long press menu button to delete all recorded data d Exit In the Record Menu interface short press menu button to move the choice bar to Exit item then long press button to exit record menu and return to the main menu D System setting In the main menu inter
9. cription of this User Manual We would sincerely regret for that This product is medical device which can be used repeatedly WARNING Discomfort or pain may appear if using the device ceaselessly especially for the microcirculation barrier patients It is recommended that the pulse oximeter should not be used on the same finger for more than 2 hours For the special 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 is invisible emitted from the device is harmful to the eyes so the user and the maintenance man should not look at the light source Testee can not use enamel or other makeup Testee s fingernail can not be too long Please refer to the correlative literature about the clinical restrictions and caution This device is not intended for treatment The User Manual is published by our company All rights reserved II Contents 1 7 0 1 1 1 5 6 Tor 1 2 51111 1 01 1 7 1 11 71 1 2
10. e a year or according to the calibrating program of hospital It also can be performed at the state appointed agent or just contact us for calibration 7 3 Transportation and storage A The packed device can be transported by ordinary conveyance or according to transport contract The device can not be transported mixed with toxic harmful corrosive material B The packed device should be stored in room with no corrosive gases and good ventilation Temperature 40 C 60 C Relative Humidity lt 95 8 Troubleshooting The SpO and Pulse The finger is not properly positioned Place the finger properly and try Rate can not be again displayed normally The patient s SpO is too low to be Try again Go to a hospital for a detected diagnosis if you are sure the device works all right The SpO and Pulse The finger is not placed inside deep Place the finger properly and try displayed stably The finger is shaking or the patient is Let the patient keep calm 7 The device can not The battery is drained away or almost Please charge up battery The malfunction of the device Please contact the local service yes 11 The display is off The malfunction of the device Please contact the local service suddenly center The battery is drained away or almost Please charge up battery The device can not The battery is not full charged Please recharge the battery be used for full time The batter
11. e data saved data Connect the device to computer with data line then open the PC software Please refer to lt 5 0 Assistant user manual gt for detailed operation method of uploading data The software symbol is as Figure 9 9 Hgd apis Assistant Figure 9 Software symbol 6 2 Attention for operation A Please check the device before using and confirm that it can work normally B The finger should be in a proper position see the attached illustration as Figure 3 for reference or else it may result in inaccurate measure C The ray between luminescent tube and photoelectric receiving tube must get across subject s arteriole D The oximeter should not be used at a location or limb tied with arterial canal or blood pressure cuff or receiving intravenous injection E Ensure nothing such as a plaster can impede the light passage or else it may result in inaccurate measure of SpO pulse rate and PI F Excessive ambient light may affect measurement accuracy It includes fluorescent lamp dual ruby light infrared heater direct sunlight and etc G Intense activity of the subject or extreme electrosurgical interference may also affect the accuracy H Testee can not use enamel or other makeup I Please clean and disinfect the device after operating according to the User Manual 7 1 6 3 Clinical restrictions A As the measure is taken on the basis of arteriole pulse substantial pulsating blood flow of subject
12. easy to view E Perfusion Index measure 2 2 Major applications and scope of application The Pulse Oximeter can be used in measuring the pulse oxygen saturation pulse rate and perfusion index through finger The product is fit for family hospital oxygen bar community healthcare physical care in sports It can be used before or after doing sports and it is not recommended to use the device during the process of having sport and etc Z N the problem of overrating would emerge when the patient is suffering from toxicosis which caused by carbon monoxide the device is not recommended to be used under this circumstance 2 3 Environment requirements Storage Environment a Temperature 40 C 60 C b Relative humidity 5 95 c Atmospheric pressure SOOhPa 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 An experience formula of data process is established taking use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive Hemoglobin Hb and Oxyhemoglobin HbO 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 c
13. face short press menu button to move the choice bar to the System item then long press menu button to enter the system setting menu as Figure 7 Figure 7 System Menu a Hard Ver The version number of hardware for the device b Soft Ver The version number of software for the device Sound Volume the System Menu interface short press menu button to move the choice bar to Sound Volume item then long press button to change sound volume step by step 3 levels adjustable d Device ID The user can set device ID by PC software Please refer to lt SpO gt Assistant user manual gt for details e Exit In the System Menu interface short press menu button to move the choice bar to Exit item then long press button to exit System Menu and return to the main menu E Pulse sound indication setting In the main menu interface short press menu button to move the choice bar to the Pulse Sound item then long press menu button to turn on or turn off the pulse sound Choose on to turn on pulse sound and choose off to turn off pulse sound F Demo setting In the main menu interface short press menu button to move the choice bar to the Demo item then long press menu button to turn on or turn off Demo Choose on to turn on Demo and the demo interface will appear when returning to measure interface Choose off to turn off Demo G Exit main menu In the main Menu interface short press menu but
14. ght About 45g with a lithium battery 14
15. is required For a subject with weak pulse due to shock low ambient body temperature major bleeding or use of vascular contracting drug the SpO waveform PLETH will decrease In this case the measurement will be more sensitive to interference 10 B For those with a substantial amount of staining dilution drug such as methylene blue indigo green and acid indigo blue or carbon monoxide hemoglobin COHb or methionine Me Hb or thiosalicylic hemoglobin and some with icterus problem the SpO determination by this device may be inaccurate C The drugs like dopamine procaine prilocaine lidocaine and butacaine may also be a major factor resulted in serious error of SpO measure D The SpO value serves as a reference value for judgment of anemic anoxia and toxic anoxia for some patients with serious anemia may also report good SpO measurement 7 Maintain transportation and storage 7 1 Cleaning and Disinfecting Using medical alcohol to wipe the device for disinfecting nature dry or clean it with clean soft cloth 7 2 Maintain A Please clean and disinfect the device before using according to the User Manual 7 1 B Please recharge the battery when the screen shows low power the battery power is Lb C Recharge the battery soon after the over discharge The device should be recharged every six months when it is not regular used It can extend the battery life following this guidance D The device needs to be calibrated onc
16. lamp finger type sensor Then measured signal can be obtained by a photosensitive element information acquired through which will be shown on screen through treatment in electronic circuits and microprocessor Glow and Infrared ray Emission Tube Glow and Infrared ray Receipt Tube Figure 1 Work elements 4 Technical specifications 4 1 Main performance SpO gt value display Pulse rate value display bar graph display Pulse waveform display Perfusion Index value display Charge function Lithium battery is the power supply and can be charged up time and again Low power indication low power indication symbol appears before working abnormally which is due to low power Power off long press power button to turn off the device The display direction can be changed Short press menu button to change display direction Screen brightness can be adjusted Pulse sound indication With alarm function With SpO gt value and pulse rate value record function The record data can be uploaded to the computer be connected with oximeter probe 4 2 Main Parameters A Measurement of SpO Measuring range 35 100 Accuracy 70 100 42 Below 70 unspecified B Measurement of pulse rate Measuring range 30bpm 250bpm Accuracy 30bpm 100bpm 2bpm 101bpm 250bpm 2 C Perfusion Index Range 0 20 D Resolution SpO 1 Pulse rate 1bpm Perfusion Index 0 1 E Measurement Performance in
17. rged in liquid When it needs cleaning please wipe its surface with medical alcohol by soft material Do not spray any liquid on the device directly A When cleaning the device with water the temperature should be lower than 60 C A The fingers which are too thin or too cold may affect the measure accuracy please clip the thicker finger such as thumb and middle finger deeply enough into the probe A The oximeter probe which is optional can be used to children The update period of data is less than 5 seconds which is changeable according to different individual pulse rate A Please read the measure value when the waveform on screen is equably and steady going This measure value is optimal value and the waveform at the moment is the standard one A If some abnormal conditions appear on the screen during test process pull the finger out and reinsert to restore normal use A The device has normal life for three years since the first electrified use A The device has alarm function this function can either be paused or closed default setting for good Please check the chapter 6 1 as reference A The device has the function of beyond limit alarm When the measure data is beyond the highest or lowest limit the device would start alarm automatically on the premise of the alarming function is on A The device may be not fit for all patients If you are unable to receive approving measure discontinue use A Do not contort or drag the
18. ton to move the choice bar to Exit item then long press button to exit main Menu and return to the measure interface H Clock setting In the measure interface Short press power button to enter to the clock interface and long press button to set time up means to adjust time upwards down means to adjust time downwards and long press button for switching Short press menu button to change setting item including hour minute year month day week save Exit up down and long press menu button to set time which has been chosen Figure 8 Click setting interface 6 1 6 Charge There are two kinds of charge method a Connect the device to computer with data line then the device should be in charge state b Connect the device to power supply with power adaptor then the device should be in charge State A When charging in power off state short press power button and the device will display green dynamic state bar It means that the device is charging When the state bar is full the charging is finished When charging in power on state dynamic Power indication symbol displays It means that the device is charging When the state bar is full the charging is finished Air the alarm function is on the device will provide high priority alarm signal when the battery is in low power status Intermittent alarm sound will occur High priority indicating requires that operator responds immediately 6 1 6 Uploading the data real tim
19. wire of the device 2 Overview The pulse oxygen saturation is the percentage of HbOz 1 the total Hb in the blood so called the O2 concentration in the blood It is an important bio parameter for the respiration A number of diseases relating to respiratory system may cause the decrease of SpOz in the blood furthermore some other causes such as the malfunction of human body s self adjustment damages during surgery and the injuries caused by some medical checkup would also lead to the difficulty of oxygen supply in human body and the corresponding symptoms would appear as a consequence such as vertigo impotence vomit etc Serious symptoms might bring danger to human s life Therefore prompt information of patients SpO is of great help for the doctor to discover the potential danger and is of great importance in the clinical medical field The Pulse Oximeter is small in volume low in power consumption convenient 1 operation and portable With high definition display screen the device is concise and fashion It is only necessary for patient to put one finger into probe for diagnosis and the display screen will directly show the SpO2 value pulse rate value Perfusion Index value and pulse waveform with the high veracity and repetition 2 1 Features Ultra thin wrist design concise and fashion Small in volume light in weight and convenient in carrying Low power consumption STO SP Display direction can be changed automatically
20. y is broken Please contact the local service after charge center The battery can not The battery is broken Please contact the local service be full charged even center after 10 hours charging time 9 Key of Symbols Signal Description Ca 00 0 ee emee Ton er Tm nano TT 12 10 Function Specification Information Display Mode The Pulse Oxygen Saturation SpO 2 digit digital OLED display Pulse Intensity bar graph bar graph OLED display SpO Parameter Specification 0 100 the resolution is 1 Measuring range Accuracy 70 100 2 Below 70 unspecified Pulse Parameter Specification Measuring range 30bpm 250bpm the resolution is 1 bpm 30bpm 100bpm 2bpm A ccuracy 101bpm 250bpm 2 Perfusion Index Specification er Range 0 20 the resolution is 0 1 Accuracy O 1 40 2 1 20 1 Safety Type Interior Battery Type BF application part Pulse Intensity Continuous bar graph display the higher display indicates the stronger pulse Battery Requirement Voltage 3 7 rechargeable lithium battery x 1 The red wire on the battery denotes anode the black wire on the battery denotes cathode Battery working life Charge and discharge no less than 500 times Power Adapter selected Output voltage DC 5V Oo Output current Dimensions and Weight Dimensions 63 L x 55 W x 15 H mm Wei
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