Instructions to User
Contents
1. electromagnetic immunity for all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic immunity The CAZSS0QPB Pulse Oximeter is intended for use in the electromagnetic environment specified below The customer or the user of C1ZS50QB Pulse Oximeter should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Eiectronagaene eI guidance Electrostatic t6 kV contact t6 kV contact Floors should be wood concrete discharge ESD t8 kV air 8 kV air or ceramic tile If floor are IEC 61000 4 2 covered with synthetic material the relative humidity should be at least 30 Power frequency 3A m 3A m Power frequency magnetic fields 50 60Hz magnetic Should be at levels characteristic field of a typical location in a typical IEC61000 4 8 commercial or hospital environment NOTE Uris the a c mains voltage prior to application of the test level Guidance and manufacturer s declaration electromagnetic immunity for EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING Guidance and manufacturer s declaration electromagnetic immunity The CAZ 50QP Pulse Oximeter is intended for use in the electromagnetic environment specified below The customer or the user of CMSS0QB Pulse Oximeter should assure that it is used in such an environment i Compliance l Immunity test TEC 60601 test level level Electrom2. i 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 69 3 69 7 38 100 11 67 11 67 23 33 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 13
3. 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 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 A the problem of overrating would emerge when the patient is suffering from toxicosis which is 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 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 clamp finger type sensor Then measured signal can be obt
4. 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 amp 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 A When cleaning the device with water the temperature should be lower than 60 C amp 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 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 ma The device has pulse sound indication function Please check the chapter 6 1 as reference amp 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 amp The device has the alarm function this function can be suspended Please check the chapter 6 1 as reference
5. A The device may be not fit for all patients If you are unable to receive approving measure discontinue use A A flexible circuit connects the two parts of the device Do not twist or pull on the connection 2 Overview The pulse oxygen saturation is the percentage of HbO in 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 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 is small in volume low in power consumption convenient in operation and portable It is only necessary for patient to put one finger into probe for diagnosis and the display screen will directly show the SpO value with the high veracity and repetition 2 Features A Novel appearance more fit for children B Small in volume light in weight and convenient in carrying C Low power consumption
6. 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 Manual We would sincerely regret for that This product is medical device which can be use
7. agnetic environment guidance eve Portable and mobile RF communications equipment should be used no closer to any part of the CAZ 500Q2 Pulse Oximeter including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 3 5 d WP LA J Radiated RF 3 V m 3 V m IEC 61000 4 3 80 MHz to 2 5 GHz d VJP 80 MHz to 800 MHz 1 7 d WP 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 should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol 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 absorption 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 ele
8. ained 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 Yo Glow and Infrared ray Receipt Tube Figure 1 Work elements 4 Technical specifications 4 1 Main performance SpO value display Pulse rate value display Bar graph display Pulse waveform display Pulse sound indication Low power indication when the battery is low in power the symbol will blink With alarm function With screen overturn function 4 0 Main parameters A Measurement of SpO Measuring range 0 100 Accuracy 70 100 4 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 Ibpm D Measurement performance in weak filling condition SpO and pulse rate can be detected correctly when pulse filling ratio is 0 4 SpOz 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 5 Installation 5 1 View of the front panel Power indication Alarm sound indication Pulse sound indication spO value Pulse waveform 4 Pulse rate value Pulse
9. bar graph Button Figure 2 Front View 5 2 Battery installation Figure 3 Battery installation A Refer to the polarity and put the edge of the battery on the mouth of the battery box along the bottom of the battery box gently push the battery into the box until the whole battery has been in place Refer to Figure 3 B Replace the cover A Please take care of the polarity when you insert the battery for the improper insertion may damage the device 5 3 Accessories A One rechargeable buttony battery Type LiR2450 B Charge accessories One power adapter Type CMS0105 one charger Type LiCh 10 one data line Type USB AM To USB miniBM C Oneuser manual D Onelanyard 6 Operating Guide 6 1 Application method 6 1 1 Basic operation a Open the battery cover and put the buttony battery in the battery box then replace the cover Insert one finger into the probe of the device Long press the button to turn the device on and the measure interface appears after the device self test d Do not shake the finger and try to keep the patient still during the process e The data can be read directly from the display screen in the measuring interface Figure 4 Finger placement 3 AN Pinserit and the luminescent tube should be in the same side 6 1 2 Pulse sound setting After turning the device on the pulse sound is open Long press the button can close the pulse sound and the pulse sound indication icon di
10. ctromagnetic site survey should be considered If the measured field strength in the location in which the CAZ 50Q7 Pulse Oximeter is used exceeds the applicable RF compliance level above the CMS50OB Pulse Oximeter should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the CAZS50OB Pulse Oximeter b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 12 Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM for EQUIPMENT or SYSTEM that are not LIFE SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the C5 500B PULSE OXIMETER The CAZ 50Q2 Pulse Oximeter is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the CAZ 50Q7 Pulse Oximeter can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the CMS50OB Pulse Oximeter as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated maximum output m power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz W 4 33 Jp gis d L WP A
11. d mixed with toxic harmful corrosive materials 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 Trouble Possible Reason Solution The SpO and Pulse The finger is not properly positioned Place the finger properly and try Rate can not be again displayed normally The patients 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 Rate are not enough again displayed stably The finger is shaking or the patient is Let the patient keep still moving The device can not be turned on The battery is drained away or almost drained away Please charge battery The battery installation is incorrect Install the battery over again The malfunction of the device Please contact the local service center The display is off suddenly The battery is almost drained away Please charge battery shut down automatically in 5 seconds when there is The device is set to no signal Normal The device can not be used for full time The battery is not full charged Please recharge the battery The battery is damaged Please contact the local service after charge cent
12. d repeatedly WARNING 67 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 6 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 6 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 6 Testee can not use enamel or other makeup 6 Testee s fingernail can not be too long 6 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 Ur M AI 1 1 Instructions for safe operations eee ennemi nnne nennen nnne 1 IEN E dC ITUR ERAT E ME HM MIHI T EEE 1 IE ATS M e e aget e E scenes E ASE o A e Ne E Aak 1 jn DA Features ete eee eR E IU BE qui BE gne D gei aU gm 2 2 2 Major applications and scope of application ssssssssssssssseseeeeeeeeeeenne 3 2 3 Environment requirements esssssssessseeeeeeee eene enne nne nnne nenn eerie r nre n eren inneren nns 3 3 Principle t 4 Technical spec
13. es 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 6 Prevent children from swallowing the product or its accessories For children users please use the product under the condition of adult guardianship 6 When installing or removing the battery do not wear electric articles on hands to prevent from short circuit and burning the skin Itisnotrecommended to use the device in high frequency environment 6 Inthe area where the blast is easy to happen because of potential factor don t take out install or charge the battery in order to avoid blast or fire Please charge the battery in the room temperature environment In addition the overall check of monitorincluding the safety check such as the leakage current should be performed only by qualified personnel once every 12 months 1 33 Attention amp Keep the oximeter away from dust vibration corrosive substances tinder high temperature and moisture amp 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 amp High temperature
14. et The battery can not The battery is damaged Please contact the local service be full charged even center after 10 hours charging time 9 Key of symbols Signal Description A Warning See User Manual SpO2 The pulse oxygen saturation 96 PRbpm Pulse rate bpm Low power indication The alarm sound indication od The pulse sound indication Type BF IPXI Ingress of liguids rank REPI EUROPEAN REPRESENTATIVE WEEE 2002 96 EC m This item is compliant with Medical Device Directive 93 42 EEC of 0123 June 14 1993 a directive of the European Economic Community battery positive electrode battery cathode electrode 10 Function specification Information Display Mode The Pulse Oxygen Saturation SpO2 2 digit digital OLED display 3 digit digital OLED display bar graph Waveform 09 100 the resolution is 1 70 100 2 Below 70 unspecified 30bpm 250bpm the resolution is 1bpm Accuracy 2 bpm or 2 select larger Interior Battery BF Type Pulse Intensity Continuous bar graph display the higher display indicates the stronger pulse Battery Requirement Voltage 3 6 rechargeable buttony battery x 1 Battery working life Charge and discharge not less than 300 times 46 L x 40 W x 29 H mm i About 35g with a rechargeable buttony battery Appendix A Guidance and manufacture s declaration
15. ifications cccccccccccsrssrscescescescsesceccessesscescescesceesceccescscssescescessessoescessesseescescesseeS 4 1 Main performante reszesei el ener ener etre nene nnne nnne nte nnne nere resin t elk 3 4 2 M in parameters os ano ee to REIR tado v ne See EO 4 M EU2 2 AA A 51 View of the front panl semer aa a a tet oai RN 4 52 Battery installations 35 e Ret tede eb tdt 5 3 3 ACCESSOLIES e cune ox Ten DID p MD PCR be 5 6 Operating Guide essesessssesssoesesoesosoosessssssssoesssossesossssssssssosossssesosoesossososoosossosesssoesossosossesossesesse D 6 1 Application method isssz sisse ERU EEE EER ACTEUR TRUE ERE Est 5 6 2 Attention for OPCTatiON cceccceccccessccsssecssecesecestecesseeesseecsseeeseeeceeeeeseeesseeeseseeseseeseeeseees 6 6 3 Clinical restrictions once type ef etg Pe E eret tene Pn 7 7 Maintain transportation and storage cccccccccccscsscsssscsccccsccscsccsccscscsscsscscsssscssesscscscssesee 7 7 l Cleaning and disinfectig esos senem ore dee ee D RePnRHSIUSEGPN BD 7 7 2 Maint ti uoi oro n ARIERIROUPU ERE EARU HR HDI HE 7 7 3 Transportation and storage enne nnne nne ennr entrent innen nnne 7 LEM DOE M LEM COMOMDJL10 TTTT oe 10 Function specification eere eese reete eee eroe en
16. 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 of figure 4 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 and pulse rate 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 Asthe measure is taken on the basis of arteriole pulse substantial pulsating blood flow of subject 1s required For a subject with weak pulse due to shock low ambient body temperature major bleeding or use of vascular contracting drug the SpO2 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
17. sappears Long press button again the pulse sound is turned on and pulse sound indication icon appears 6 1 3 Alarm setting a Alarm includes the alarm of measure data s going beyond the limits When the SpO2 is below 90 or the pulse rate is not between 50bpm and 120bpm the alarm occurs the alarm of low power b In the open state of alarm when the measure data is beyond the the normal measure range the device would give alarm sound and the corresponding value glitter Alarm could be suspended by short pressing button and the alarm icon disappears but the value still glitter Alarm function will be renewed in 30 seconds A If low power alarm occurs please charge the battery and if the battery has been out of normal life please replace it by a new one 6 1 4 Display mode switch In the normal measure or alarm pause state short press the button can switch the display mode of the screen 6 1 5 Charge Put the rechargeable buttony battery properly according to the polarity direction in the charger Connect one end of the adapter to the power supply socket and connect another end of the adapter to charger by data line A The power adapter of the device accords with the requirements of IEC 60601 1 A The charger accords with the requirements of IEC 60601 1 A In charging state the red indication light of the charger will shine the green indication light of the charger shining means the charge has been accomplished 6 2 Attention for
18. seasons snos essen seno senses sen senoenssensensenoseseesseseesses P L II Appendix A T IH 1 Safety 11 Instructions for safe operations lt 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 lt Necessary maintenance must be performed by qualified service engineers ONLY Users are not permitted to maintain it by themselves lt The oximeter cannot be used together with devices not specified in User s Manual Only the accessory that is appointed or recommendatory by manufacture can be used with this device lt 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 DO NOT use the oximeter while the patient is being scanned by MRI or CT Theperson who is allergic to rubber can not use this device 6 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 6 Please check the packing before use to make sure the device and accessori
19. 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 SpO2 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 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 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 transporte
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