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Summary of Contents for A&D UP-200
- Page 1 PULSE OXIMETER UP-200 Instruction Manual...
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Page 2: Instructions To User
Instructions to User Dear users, thank you very much for purchasing the Pulse Oximeter (hereinafter referred to as device). 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 no- tice. - Page 3 Warnings Remind that it may cause serious consequences to tester, user or environment. M Explosive hazard—DO NOT use the device in environment with inflammable gas such as anesthetic. M DO NOT use the device while examining by MRI or CT, as the induced current may cause burn.
- Page 4 insensitive material. Please do not use it if any person is allergic to lanyard. Do not wrap the lanyard around neck to avoid an accident. M The disposal of scrap device, its accessories and packaging should follow the local laws and regulations, to avoid polluting to the local environment. And the packaging materials must be placed in the region where the children are out of reaching.
- Page 5 M Do not place the device in places exposed to direct sunlight, high temperature, humidity, dust, cotton wool or easy to splash water, to avoid affecting its performance. M The measured accuracy will be affected by the interference of electrosurgical equipment.
- Page 6 1. Overview The oxygen saturation is the percentage of HbO in the total Hb in the blood, so-called the concentration in the blood, it is an important physiological parameter for the respirato- ry and circulatory system. A number of diseases related to respiratory system may cause the decrease of SpO in the blood, furthermore, some other causes such as the malfunc- tion of human body’s self-adjustment, damages during surgery, and the injuries caused...
- Page 7 1.3 Environment requirements Storage Environment a) Temperature: -40 ℃ ~ + 60 ℃ b) Relative humidity: ≤ 95% c) Atmospheric pressure: 500 hPa ~ 1060 hPa Operating Environment a) Temperature: +10 ℃ ~ + 40 ℃ b) Relative Humidity: ≤ 75% c) Atmospheric pressure: 700 hPa ~ 1060 hPa 1.4 Precautions 1.4.1 Attention...
- Page 8 and disinfection..Please take out the internal battery before cleaning and disinfection. % The product is suitable for adults. % The device may not be suitable for all users, if you can’t get a satisfactory result, please stop using it. % Data averaging and signal processing have a delay in the upgrade of SpO data values.
- Page 9 parts will pose risks on the parameters and technical parameters of the equipment known to the manufacturer. % If necessary, our company can provide some information (such as circuit diagrams, component lists, illustrations, etc.), so that the qualified technical personnel of the user can repair the device components designated by our company.
- Page 10 rial ductus or intraluminal tube. % The measured value may be inaccurate during defibrillation and in a short period af- ter defibrillation, as it has not defibrillation function. % The device has been calibrated before leaving factory. % The device is calibrated to display functional oxygen saturation. % The equipment connected with the Oximeter interface should comply with the re- quirements of IEC 60601-1.
- Page 11 c. During cardiopulmonary resuscitation. d. When the patient is hypovolemic. e. For assessing the adequacy of ventilatory support. f. For detecting worsening lung function in patients on a high concentration of oxygen. 1.5 Clinical indications The Pulse Oximeter can be used in measuring the pulse oxygen saturation and pulse rate through finger.
- Page 12 is adopted in accordance with Capacity Pulse Scanning & 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 photo- sensitive element, information acquired through which will be shown on screen through treatment in electronic circuits and microprocessor.
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Page 13: Installation
4. Installation 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 Figure 4 Mounting the hanging rope Please take care when you insert the batteries for the improper insertion may damage the device. 4.3 Mounting the Hanging Rope Step 1. Put the end of the rope through the hole refer to Figure 4 . Step 2.
- Page 15 5. Operating Guide Insert the two batteries properly to the direction, and then replace the cover. Open the clip as shown in Figure 5. Figure 5 Put finger in position Let the patient’s finger put into the rubber cushions of the clip (make sure the fin- ger is in the right position), and then clip the finger.
- Page 16 6. Maintain, Transport and Storage 6.1 Cleaning and disinfection The device must be turned off before cleaning, and it should not be immersed into liquid. Please take out the internal battery before cleaning, do not immerse it into liquid. Use 75% alcohol to wipe the device enclosure, nature dry or clean it with clean and soft cloth.
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Page 17: Troubleshooting
B. The packed device should be stored in room with no corrosive gases and good ventila- tion. Temperature: -40° C~+60° C; Relative humidity: ≤ 95%. 7. Troubleshooting Trouble Possible Reason Solution 1) The finger is not properly 1) Please insert the finger inserted. -
Page 18: Key Of Symbols
8. Key of Symbols Symbol Description Symbol Description Type BF European Representative Refer to instruction manual/booklet Manufacture Date The pulse oxygen saturation(%) Manufacturer %SpO Storage and Transport Temperature PRbpm Pulse rate (bpm) limitation Storage and Transport Humidity lim- Recyclable itation 1.No finger inserted Storage and Transport Atmospheric 2.An indicator of signal inadequacy... -
Page 19: Function Specification
9. Function Specification [see note 1] Display range 0% ~ 99% Measured range 0% ~ 100% 70%~100%: ±2%; Accuracy [see note 2] 0%~69%: unspecified. Resolution Display range 30 bpm ~ 250 bpm Measured range 30 bpm ~ 250 bpm Accuracy ±2 bpm during the pulse rate range of 30 bpm ~ 99 bpm and ±2% during [see note 3] the pulse rate range of 100 bpm ~ 250 bpm. - Page 20 Working voltage DC 2.6 V ~ 3.6 V Working current ≤ 30 mA Power supply 1.5 V (AAA size) alkaline batteries × 2 The device can continuously work for 20 hours when it was powered by two Operation time new batteries within the warranty period. Dimension and Weight 57(L) ×...
- Page 21 compare them with the known SpO and PR values of input signal. Note 5: Optical sensors as the light-emitting components, will affect other medi- cal devices applied the wavelength range. The information may be useful for the clinicians who carry out the optical treatment.For example, photodynamic therapy operated by clinician.
- Page 22 Table 3: Guidance and manufacturer’s declaration – electromagnetic immunity The Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer the user of the Pulse Oximeter should assure that it is used in such environment. Immunity test IEC 60601 test level Compliance level Radiated RF...
- Page 23 Table 4： Guidance and manufacturer’s declaration - electromagnetic Immunity The [Code SI] is intended for use in the electromagnetic environment specified below. The customer or the user of the Pulse Oximeter should assure that it is used in such an environment Test IMMUNITY Band a)
- Page 24 NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3. a) For some services, only the uplink frequencies are included. b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
- Page 25 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.
- Page 26 © 2022 A&D Medical. All rights reserved. Specifications subject to change without notice.
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