This Manual is written and compiled in accordance with the council
Contents
1. About 175 g with the lithium battery 1 19 gt CONTEC Southeastern Medical Supply Inc Address 1024 Wildwood Centre Dr Columbia SC 29229 Tel 803 233 3691 Fax 803 233 6140 Website http www semedical com File No CMS2 782 129ESS 1 1 File Ver 1 1 20 Release Date April 20102. 6 1 as a reference A The device has the function of limits alarming when the measured data is beyond the highest or lowest limit the device would start alarming automatically on the premise of the alarming function is on 3 The device has the function of alarming this function can either be paused or closed default setting for good This function could be turned on through menu operation if you need Please check the chapter 6 1 as a reference A The device may not work for all patients If you are unable to achieve stable readings discontinue use 2 Overview The pulse oxygen saturation is the percentage of HbO in the total Hb in the blood so called the O 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 SpO 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 features in small volume low power consumpt
3. from the probe figure 5 please accept the actual probe with the device B Change display direction On the measuring interface press the screen change button can change the display direction C Pause alarm a Alarm including the alarm of measure data s going beyond the limits the alarm of low voltage the alarm of probe or finger s out of position b When alarm is on press the alarm pause button can pause the alarm it can renew alarm in about 60s and if pressing the alarm pause button again within 60s it can renew alarm c If you want to turn off the alarm for good you should enter the menu for operation D Menu operations On the measuring interface press the menu button can enter the menu of figure 6 Users can adjust the setting through the main menu such as alarm pulse sound indication backlight data storage turn on off Bluetooth the specific method is as follows Figure 6 Main Menu Interface a Alarm setting On the main menu interface press the up button or down button move the menu choice bar to Alarm then press the menu button to enter the alarm setting menu of figure 7 Figure 7 Alarm Setting Menu a The highest lowest alarm limit setting Press the up button or down button to choose the parameter to be adjusted then press the menu button again to enter the similar dialog box shown as figure 8 then press the up button or down button to change data Each press of the up button or down button the da
4. CMS 60CW Pulse Oximeter User Manual SOUTHEASTERN MEDICAL SUPPLY INC 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 description of this User
5. Manual We would sincerely regret for that This product is medical device which can be used repeatedly WARNING Uncomfortable or painful feeling may appear if using the device ceaselessly especially for the microcirculation barrier patients It is recommended that the sensor should not be applied to the same finger for over 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 stare at the light 6 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 Contents A RT 4 1 1 Instructions OF sale OPCEAU ONS anotaron 4 A shud aed eaee taro pecsasuands 4 AAA nO II IO O O II eden 4 sr MIVOL VICW cidad nidad 5 Dl RR 5 2 2 Major applications and scope Of application cccccccccccnnnnonnononnnnnnnnnnnnnnnnnonononononnnnnnnnnnnnnnnnnnnnnnonnnnnnos 5 2 3 Environment regure INCHES araeir A A E 6 gy MN MUNCH PNG ar RO 6 v Technical SPECINCATIONS A A EN 6 Al VE ATSC LOLI ANIC Cassie isteach os 6 ANAM SS A o NI II II O anadncattanees 7 In
6. a or charge the lithium battery via a data line 5 3 Rear View LI POLYMER Figure 4 Refer to Figure 4 and insert the lithium battery properly in the right direction 5 4 Accessories A A lithium battery B A User Manual C A power adapter D Adata line E A disk PC software F An adult oximeter probe Model CMS03 An infant oximeter probe May purchase selectively 6 Operating Guide 6 1 Application method A a Open the lid of battery box and put the battery inside then close b Put the suitable probe into the jack on the right side of the oximeter The probe is limited to be produced by our company never replace 1t with the similar ones by other manufacturers c Put the finger into the probe d Press the power on off button long about a few seconds the power 1s on and the device will start to self inspect The device displays the measuring interface after self inspecting e Do not shake the finger and keep the patient in a stable state during the process f The data can be read directly from the screen on the measuring interface A Fingernails and the luminescent tube should be on the same side Air the alarm function is on the device will provide medium priority alarm signal when probe or finger is out Intermittent alarm will occur and the user interface presents FINGER OUT Medium priority indicating that prompts operator response is required Figure 5 Actual probe may be different
7. he menu button then press the up button or down button to choose setting then press the menu button to confirm setting Figure 10 d If the data storage function 1s being turned on when return to the measuring interface a red REC sign and a flashing red dot would appear on screen which means the device is in a state of storing e In the state of storing whatever interface the device 1s on measuring interface menu interface the sign Recording would appear on the screen in 30 seconds and then the screen will be automatically shut down If pressing any button power on off excluded at this moment the sign Recording would appear on the screen and then the screen will be automatically shut down again if pressing the power on off button the device would return to the former interface f If turning on the data storage function the former stored data will be automatically removed g In the state of data storing after the screen is automatically shut down the pulse sound indication would be off for saving power h When the storage space is full it displays Memory is full on the screen and then shut down in a few seconds But it will still display Memory is full by the next time you turn on the device on the purpose of warning the user if press any button power on off excluded again it will enter the measuring interface e Set Bluetooth state In the main menu interface press the up button or down button to m
8. ice lt gt This product is calibrated before leaving factory 1 2 Warning 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 measured by MRI and 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 and probe which are approved or manufactured by the manufacturer or else it may damage the device Please choose the battery chargers which should be ensured compliance with the requirements of IEC 60601 1 or else it may damage the device The device can only be matched with the compatible probe 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 explosive materials high temperature and moisture A Ifthe oximeter gets wet please stop operating it A When it is carried from cold environment to warm or humid environment please do not use it immediately A DO NOT ope
9. ion convenient operation and being portable It is only necessary for patient to put one of his fingers into a probe for diagnosis and a display screen will directly show the measured value of pulse oxygen saturation with the high veracity and repetition 2 1 Features A Operation of the product is simple and convenient B The product is small in volume light in weight and convenient in carrying 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 in 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 5 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 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 An experience formula of data process is established taking use of Lambert Beer Law according to Spect
10. it may result in inaccurate measure C The SpO sensor and photoelectric receiving tube should be arranged in a way with the subject s arteriole in a position there between D The SpO sensor should not be used at a location or limb tied with arterial canal or blood pressure cuff or receiving intravenous injection E Do not fix the SpO sensor with barrier such as adhesive or else it may result in inaccurate measure of SpO and pulse rate F Excessive ambient light may affect the measuring result It includes fluorescent lamp dual ruby light infrared heater direct sunlight and etc G Strenuous action of the subject or extreme electrosurgical interference may also affect the accuracy H Testee can not use enamel or other makeup L 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 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 B For those with a substantial amount of staining dilution drug such as ethylene blue indigo green and acid indigo blue or carbon monoxide hemoglobin COHb or methionine Me Hb or 14 thiosalicylic hemoglobin and some with icter
11. lute error is 2 below 70 unspecified B Measurement of pulse rate Measuring range 30bpm 250bpm Accuracy 2 bpm or 2 select larger C Resolution SpO 1 Pulse rate 1bpm D Measurement Performance in Weak Filling Condition SpO and pulse rate can be shown correctly when pulse filling ratio is 0 4 SpO 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 3 6 V DC 4 2V DC G Optical Sensor Red light wavelength is 660nm 6 65mW Infrared wavelength is 880nm 6 75mW H Adjustable alarm range SpO 0 100 Pulse Rate Obpm 254bpm 5 Installation 5 1 View of the front panel pulse sound indication Bluetooth indication alarm indication SpOz pulse rate battery status indication alarm pulse button up button pulse bar graph meno button power anjot button pulee waweto rm screen change button 4 O L gt probe jack L gt 5p02 ALN LO Sp ALM His Figure 2 Front View 5 2 Underside View and Left View Figure 3 Underside View and Left View 1 Probe jack It is used to connect a SpO gt sensor to measure the oxygen saturation and pulse rate 2 USB port It is used to connect a personal computer to export the trend data or real time dat
12. ntilation Temperature 40 C 60 C Humidity 5 95 15 8 Troubleshooting The SpO and Pulse Rate can not be displayed normally The SpO and Pulse Rate displayed stably are not The device can not be turned on The display is off suddenly The device can not be used for full time after charge The battery can not be full charged even after 10 charging time hours 1 The finger 1s not properly positioned 2 The patient s SpO 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 drained away or almost drained away 2 The battery is installed incorrectly 3 The malfunction of the device The battery is drained away or almost drained away 1 The battery is not full charged 2 The battery is broken The battery is broken 16 1 Place the finger properly and try again 2 Try again Go to a 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 recharge the battery 2 Please install the battery again 3 Please contact the local service center Please recharge the battery 1 Please recharge the battery 2 Please contact the local service center Please contact the local service center 9 Key of Symbols Signal Description Alarm pause button up button Menu b
13. ove the menu choice bar to Bluetooth then press the menu button to turn on off Bluetooth Choose on to turn on Bluetooth and choose off to turn off Bluetooth as figure 11 12 A It is recommended to use the Bluetooth adapter which use CSR as main chip Please don t to pull out the USB data line or Bluetooth adapter when the data is being transmitted between device and computer when the data is being transmitted between device and computer the user can t set Bluetooth If the user can t set Bluetooth after cutting connecting please try again after waiting 30 seconds Figure 11 f Device ID The user could modify device ID by software SpO Assistant g Exit the main menu On the main menu interface press the up button or down button in order to move the menu choice bar to Exit then press the menu button to exit the main menu E PC software operation Please connect the device with computer by the USB data line or Bluetooth adapter please ensure the Bluetooth is on if the data is transmitted by Bluetooth then double click SpO2 Assistant icon to run the PC software The functions such as uploading data and change device ID could be carried out by the software Please refer to lt SpO Assistant user manual gt for detail Ar the users choose to turn on the synchronizing display function on computer it would probably take several seconds for the data to appear on the computer screen If there is no data on
14. rate keys on front panel with sharp materials A High temperature or high pressure steam disinfection of the oximeter is not permitted Refer to User Manual in the relative chapter 7 1 for instructions of cleaning and disinfection A Do not have the oximeter immerged 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 When cleaning the device with water the temperature should be lower than 60 C A As to the fingers which are too thin or too cold it would probably affect the normal measure of the patients SpO and pulse rate please clip the thick finger such as thumb and middle finger deeply enough into the probe A The pulse oximeter can be used to adult or infant Whether the device is used to adult or infant 1t depends on the probe selected 5 The update period of data is less than 5 seconds which is changeable according to different individual pulse rate A Please read the measured value when the waveform on screen is equably and steady going this measured 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 out the finger and reinsert to restore normal use A The device has normal useful life for three years since the first electrified use A This device has the function of alarming users can check on this function according to chapter
15. rum 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 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 ay Emission Tube gt Glow and Infrarebray gt Receipt Tube Figure 1 4 Technical specifications 4 1 Main performance A SpO value display B Pulse rate value display bar graph display C Pulse waveform display D Low voltage indication low voltage indicator appears before working abnormally which is due to low voltage E The display mode can be changed F Screen brightness can be changed G A pulse sound indication H With alarm function I With storage function of SpO value and pulse rate value the stored data can be uploaded to computer J It can be connected with an external oximeter probe K Data can be transmitted to computers 4 2 Main Parameters A Measurement of SpO Measuring range 0 100 Accuracy When the SpO measuring range is 70 100 the permission of abso
16. stala iiciri ds 8 Sel VIEW Os Hie MONG PANE sitio tl oia 8 J 2 Underside View and Well NIC ii A a a 8 De INCI VIEWS a a A E A 8 MAAC COSSOLIC iia 9 Operatie GuUldE csoro aaa aaa Ea aaa SE aaa aasia 9 01 Applicanonmetidd si ia 9 02 Alttention OF Opera iii ii 14 609 Cinca esta COS hse a a A asadas 14 Maintain transportation and Storage ccccccccccssssssssccccscsssssssccccscsssssssscccccccssssssscccsssssssssscoess 15 lle amie and TOI SIME CUNO eaaa EEA 15 FDA NGM AUN o loo oooO 15 ds Ban portaton and Strada oda added iaa 15 TroUblesho00IME A A ae eas aoe 16 Key 0f Symbols aci aa a E a sde caa nio 17 10 FUnchiOn SPECIFIC CIO iiss ssdisctasnscciscesosscadicacsiccandeccuevesiunseusssscedsssssisaseceisboveunceedssesisscsssscbesestescsesesncncess 18 1 Safety 1 1 Instructions for safe operations lt gt 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 about cables and transducers It is recommended that the device should be inspected once a week at least When there is obvious damage stop using the device lt gt Necessary maintenance must be performed by qualified service engineers ONLY Users are not permitted to maintain it by themselves lt gt The oximeter cannot be used together with devices not specified in User s Manual Only the accessory that appointed or recommendatory by manufacture can be used with this dev
17. storage setting This device has the function of 24 hours data storage it has the capability of accurately storing pulse rate and SpO data then transmit the data to computer by the data line or wireless method for replay and analysis a On the main menu interface press the up button or down button move the menu choice bar to Record thenpress the menu button again to enter the dialog box of figure 9 if it is in recording state the Stop 1s displayed on menu if it is not in recording state the Start is displayed on menu APCOFO 8 8 STarp Figure 9 b When the Start 1s displayed on the menu if the memory still have the former data in storage the Do you really want to recover the memory dialog box will be displayed when pressing the menu button then press the up button or down button to choose setting then press the menu button to confirm setting the dialog box will be displayed as figure 10 It needs to set the starting time for data storage by users users can change the setting value by pressing the up button or down button and confirm the setting value by pressing the menu button the black cursor will move to next place after setting When the black cursor move to Yes store or No dont store press the up button or down button to choose setting then press the menu button to confirm setting c When the Stop is displayed on menu the Do you really want to stop recording dialog box will be displayed when pressing t
18. ta will raise or descend for one time accordingly until it gets to the required number then press the menu button for another time to end the setting 10 Mu 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 measurement shows in yellow Medium priority indicating that prompts operator response is required When operating at the beginning the operator inserts his finger and set up the Spo2 ALM HI lower than the current measured value then the machine will start alarm The pulse rate alarm test is the same with the above Figure 8 b The alarm state setting Press the up button or down button move the menu choice bar to Alarm then choose the alarm state on off by pressing the menu button choose on to start the alarm function and choose off to close 1t for good b Pulse sound indication setting On the main menu interface press the up button or down button move the menu choice bar to Pulse Sound then choose the pulse sound indication state on off by pressing the menu button press on to start the function and press off to close it c Backlight adjustment On the main menu interface press the up button or down button move the menu choice bar to Brightness then press the menu button to change the number in order to adjust the brightness of screen d Data
19. the computer screen unplug USB data line or Bluetooth adapter then repeat step E again F Charge There are two kinds of charging methods a Connect the device with computer by data line and then the device should be under charging state b Connect the device with power supply by power adaptor and then the device should be under charging state c The five status of battery power are shown as follows 13 Power supply by battery only and battery status 1s full Battery status is not full Battery status is draining away Low power alarm indication Please charge the battery Battery is under charging the four status above shows dynamically in turn d When charging the battery in the state of power off the sign of battery status still exists on the screen but it will disappear in about 60 seconds for saving power However the sign will appear again if you press any button power on off excluded at this moment Aun the alarm function is on the device will provide high priority alarm signal when the battery is in low power status Intermittent alarm will occur and the battery icon turns red in the state of flashing High priority indicating requires that operator responds immediately 6 2 Attention for operation A Please check the device before using and confirm that 1t can work normally B The finger should be in a proper position see the attached illustration of figure 5 for reference or else
20. us problem the SpO determination by this monitor 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 As the SpO value serves as a reference value for judgment of anemic anoxia and toxic anoxia 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 disinfect the device nature dry or clean 1t 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 EHH 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 Please take out the batteries if the oximeter is not in use for a long time E The device needs to be calibrated once 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 ve
21. utton Screen change button down button Type BF Ingress of liquids rank 1 the finger clip falls off no finger inserted 2 Probe error 3 Signal inadequacy indicator WEEE 2002 96 EC Anode of battery Cathode of battery 10 Function Specification The Pulse Oxygen Saturation SpO 2 digit digital TFT display Pulse Rate PR 3 digit digital TFT display Pulse Intensity bar graph bar graph TFT display SpO Parameter Specification Measuring range 0 100 the resolution is 1 Accuracy 70 100 2 Below 70 unspecified Calculate the Average value in every 4 measure value Average value The deviation between average value and true value does not exceed 1 Pulse Parameter Specification Measuring range 30bpm 250bpm the resolution is 1 bpm Accuracy 2bpm or 2 select larger Moving calculate the Average pulse rate every 4 cardio beat s cycle Average pulse rate The deviation between average value and true value does not exceed 1 Safety Type Interior Battery B F Type Pulse Intensity 18 Continuous bar graph display the higher display indicate the stronger pulse Battery Requirement Voltage 3 7 rechargeable lithium battery x 1 Battery working life Charge and discharge no less than 500 times Power Adapter Input Voltage 100 to 240 VAC 50 60 Hz Output voltage 5 VDC Output current 250mA Output power 1 25 W Dimensions 87 L x 45 W x 22 H mm
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