A&D UP-200 Instruction Manual Download Page 25

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installed and used in accordance with these guidelines.

●

When the device is disturbed, the data measured may fluctuate, please measure

repeatedly or in another environment to ensure its accuracy.

Manufactured by:

Contec Medical Systems Co., Ltd

Address:No.112 Qinhuang West Street, Economic ＆ Technical Development Zone,

Qinhuangdao, Hebei Province, PEOPLE’S REPUBLIC OF CHINA

EC REPRESENTATIVE

Shanghai International Holding Corp. GmbH(Europe)

Address: Eiffestrasse 80, 20537, Hamburg, Germany

Manufacturered for:

A&D Instruments Limited

European Head Office

24-26 Blacklands Way

Abingdon Business Park

Abingdon

Oxfordshire,

OX14 1DY

United Kingdom

Summary of Contents for UP-200

Page 1: ...PULSE OXIMETER UP 200 Instruction Manual ...

Page 2: ...protect both the user and device Refer to the respective chapters for details Please read the User Manual carefully before using this device The User Manual which describes the operating procedures should be followed strictly Failure to follow the User Manual may cause measuring abnormality device damage and human injury The manufacturer is NOT responsible for the safety reliability and performanc...

Page 3: ...r if using the device ceaselessly especially for the microcirculation disturbance users It is not recommended that the sensor is used on the same finger for more than 2 hours M For some special users who need a more careful inspection on the test site please don t place the device on the edema or tender tissue M Please do not stare at the red and infrared light emitter the infrared light is invisi...

Page 4: ...nd device performance When there is obvious damage please replace the damaged parts before use M Functional testers can not be used to assess the accuracy of the Pulse Oximeter M Some functional testers or patient simulators can be used to verify whether the device works normally for example INDEX 2LFE Simulator software version 3 00 please refer to the Manual for the detailed operation steps M So...

Page 5: ...n several products are used on the same patient simultaneously danger may occur which is arisen from the overlap of leakage current M CO poisoning will appear excessive estimation so it is not recommended to use the device M This device is not intended for treatment M The intended operator of the device may be a user M Avoid maintaining the device during using M Users should read the product manua...

Page 6: ... etc Serious symptoms might bring danger to human s life Therefore prompt information of patients SpO2 is of great help for the doctor to discover the po tential danger and is of great importance in the clinical medical field Insert the finger when measuring the device will directly display the SpO2 value mea sured it has a higher accuracy and repeatability 1 1 Features A Easy to use B Small in vo...

Page 7: ...hat it locates in normal working state and operat ing environment In order to get a more accurate measurement it should be used in a quiet and com fortable environment When it is carried from cold or hot environment to warm or humid environment please do not use it immediately wait four hours at least is recommended If the device is splashed or coagulated by water please stop operating DO NOT oper...

Page 8: ...ly shows the low voltage please change the battery when the battery voltage is used up The maximum temperature at the SpO2 probe tissue interface should be less than 41 which is measured by the temperature tester During measuring when abnormal conditions appear on the screen please pull out your finger and reinsert it to measure again If some unknown error appears during measuring remove the batte...

Page 9: ...e when measuring The finger should be placed correctly see Attached figure 5 as improper installation or improper contact position for sensor will influence the measurement The light between the photoelectric receiving tube and the light emitting tube of the device must pass through the subject s arteriole Make sure the optical path is free from any optical obstacles like rubberized fabric to avoi...

Page 10: ...ing drug the SpO2 waveform PLETH will decrease In this case the measurement will be more sensitive to interference B The measurement will be influenced by intravascular staining agents such as indocy anine green or methylene blue skin pigmentation C The measured value may be normal seemingly for the tester who has anemia or dys functional hemoglobin such as carboxyhaemoglobin COHb methaemoglobin M...

Page 11: ...an be used in measuring the pulse oxygen saturation and pulse rate through finger 2 Principle Figure 1 Operating principle Principle of the Oximeter is as follows An experience formula of data process is estab lished taking use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive Hemoglobin Hb and Oxyhemoglobin HbO2 in glow near infrared zones Operation principle of th...

Page 12: ...sitive element information acquired through which will be shown on screen through treatment in electronic circuits and microprocessor 3 Functions A SpO2 value display B PR value and bar graph display C Pulse waveform display D Low battery indication low battery indication appears when the battery voltage is too low to work E Automatic standby function F Display mode can be changed G Adjustable scr...

Page 13: ...ion 4 1 View of the Front Panel Figure 2 Front view 4 2 Battery Step 1 Refer to Figure 3 and insert the two AAA size batteries properly in the right direc tion Step 2 Replace the cover Figure 3 Batteries installation ...

Page 14: ...ep 1 Put the end of the rope through the hole refer to Figure 4 Step 2 Put another end of the rope through the first one and then tighten it 4 4 Structure accessories A Structure main unit B Accessories one User Manual One hanging rope Two batteries optional Please check the device and accessories according to the list to avoid that the device can not work normally ...

Page 15: ...ger and keep the patient at ease during the process Meanwhile human body is not recommended in movement status 6 Get the information directly from screen display When the device is in operation status the display mode can be changed 7 When the device is in standby mode pressing the button can exit it When the device is in operation status pressing the button long can change brightness of the scree...

Page 16: ...t may affect patient s safety and monitoring performance It is recommend ed that the device should be inspected weekly at least When there is obvious damage stop using it B Please clean and disinfect the device before after using it according to the User Manual 6 1 C Please replace the batteries in time when low battery appears D Please take out the batteries if the device is not used for a long t...

Page 17: ...mally 1 Please insert the finger properly and measure again 2 Let the patient keep calm 3 Please use the device in normal environment 4 Please contact the af ter sales The device can not be turned on 1 The battery is drained away or almost drained away 2 The battery is installed incor rectly 3 The device s malfunction 1 Please change batteries 2 Please Install the battery again 3 Please contact th...

Page 18: ... inhibit IP22 International Protection WEEE 2012 19 EU Symbol Description European Representative Manufacture Date Manufacturer Storage and Transport Temperature limitation Storage and Transport Humidity lim itation Storage and Transport Atmospheric pressure limitation This side up Fragile handle with care Keep dry This item is compliant with Directive 93 42 EEC of 14 june 1993 concerning medical ...

Page 19: ...sion see note 4 Low perfusion 0 4 SpO2 4 PR 2 bpm during the pulse rate range of 30 bpm 99 bpm and 2 during the pulse rate range of 100 bpm 250 bpm Light interference Under normal and ambient light conditions the SpO2 deviation 1 Pulse intensity Continuous bar graph display the higher display indicates the stronger pulse Optical sensor see note 5 Red light Wavelength about 660 nm optical output po...

Page 20: ...ime to form paired data which are used for the accuracy analysis There are 12 healthy volunteers male 6 female 6 age 18 50 skin color black 2 light 8 white 2 data in the clinical report Note 2 Because pulse oximeter equipment measurements are statistically distrib uted only about two thirds of pulse oximeter equipment measurements can be expected to fall within Arms of the value measured by a CO O...

Page 21: ... environment specified below The purchaser or the user of the device should assure that it is used in such environment Emission test Compliance RF emissions CISPR 11 Group 1 RF emissions CISPR 11 Class B Table 2 Guidance and manufacturer s declaration electromagnetic immunity The Pulse Oximeter is intended for use in the electromagnetic environment specified below The purchaser or the user of the ...

Page 22: ...es 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 st...

Page 23: ...n b W Distance m IMMUNITY TEST LEVEL V m 385 380 390 TETRA 400 Pulse modulation b 18 Hz 1 8 0 3 27 450 430 470 GMRS 460 FRS 460 FM c 5 kHz deviation 1 kHz sine 2 0 3 28 710 704 787 LTE Band 13 17 Pulse modulation b 217 Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modulation b 18 Hz 2 0 3 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Ban...

Page 24: ...n m and E is the IMMUNITY TEST LEVEL in V m Warning 1 Don t near active HF SURGICAL EQUIPMENT and the RF shielded room of an ME SYSTEM for magnetic resonance imaging where the intensity of EM DISTURBANCES is high 2 Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation If such use is necessary this equipment and the other e...

Page 25: ...ec Medical Systems Co Ltd Address No 112 Qinhuang West Street Economic Technical Development Zone Qinhuangdao Hebei Province PEOPLE S REPUBLIC OF CHINA EC REPRESENTATIVE Shanghai International Holding Corp GmbH Europe Address Eiffestrasse 80 20537 Hamburg Germany Manufacturered for A D Instruments Limited European Head Office 24 26 Blacklands Way Abingdon Business Park Abingdon Oxfordshire OX14 1D...

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