AND UP-200BLE Manual

Fingertip pulse oximeter

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FINGERTIP PULSE

OXIMETER

UP-200BLE

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Summary of Contents for AND UP-200BLE

Page 1 FINGERTIP PULSE OXIMETER UP-200BLE...
Page 2: Instructions To User
Dear Users, thank you for purchasing the UP-200BLE Pulse Oximeter. The manual describes the Pulse Oximeter’s requirements, features, functions, specifications, and the safety procedures to protect both the user and the oximeter. It also states the correct methods for transportation, use, repair, maintenance and storage.
Page 3 • Don’t place the oximeter on the edema or tender tissue. • Do not stare at the red and infrared light emitter (the infrared light is invisible) after turning on the oximeter, as it may be harmful to the eyes.
Page 4 1. SAFETY 1.1 Instructions for Safe Operations • Inspect the main unit and all accessories periodically to make sure that there is no visible damage that may affect user’s safety and monitoring performance. It is recommended that the oximeter should be inspected weekly at least.
Page 5 • DO NOT use the measured values as the sole basis for clinical diagnosis. Please consult with your physician. • The oximeter contains silicone, PVC, TPU, TPE and ABS materials and has passed biocompatibility testing in accordance to ISO 10993-1. An individual who is allergic to silicone, PVC, TPU, TPE or ABS cannot use this oximeter.
Page 6 • A flexible circuit connects the two parts of the oximeter. Do not twist or pull on the connection. • Before using the oximeter, ensure it is in a normal working state and the operating conditions are met.
Page 7 2. OVERVIEW The Pulse Oximeter features a compact design, low power consumption, and convenient operation. It is only necessary for user to put one finger into a fingertip photoelectric sensor for measurement, and a display screen will directly show measured value of Hemoglobin Saturation.
Page 8 2.2 Major Applications and Scope of Application The Pulse Oximeter can be used in measuring pulse oxygen saturation and pulse rate through finger. The product is suitable for family use. The oximeter can be used before or after doing sports, but it is not recommended to be used during sports activity.
Page 9 Please take care when you insert the batteries for the improper insertion may damage the oximeter. 3.3 Attaching the lanyard Step 1. Put the thin loop through the hole on the oximeter. Step 2. Put the lanyard strap through the thin loop and tighten.
Page 10 2. Choose “Add Bluetooth Devices.” 3. Click on the “+” icon in the lower right corner. Choose “Pulse Oximeter.” 4. Choose UP-200BLE. 5. Follow the onscreen instructions to complete the pairing. 4.3 Taking Measurement 1. Open the “A&D Heart Track” application.
Page 11 6. Place finger into the rubber cushions (make sure the finger is in the right position), then clip the finger. 7. Do not shake the finger and keep the user in a stable state during the process. 8. Press “Button” to exit from the standby mode.
Page 12 After replacing the batteries, take a measurement in the app to synchronize the date and time.
Page 13 5.2 Maintenance • There is no need to calibrate the oximeter. • Clean and disinfect the oximeter before/after using it according to the User Manual. • Replace the batteries when low-battery appears. • Remove the batteries if the oximeter is not used for a long time.
Page 14: Principle And Caution
During transportation, avoid strong shock, vibration and getting wet. It can not be transported mixed with toxic, harmful, corrosive material. • The packed oximeter should be stored in room with no corrosive gases and good ventilation. 6. PRINCIPLE AND CAUTION 6.1 Principle of Measurement...
Page 15 1. The finger should be placed properly, or else it may cause inaccurate measurement. 2. The SpO sensor and photoelectric receiving tube should be arranged in a way with the subject’s arteriole in a position there between. 3. The SpO sensor should not be used at a location or limb tied with arterial canal or blood pressure cuff or receiving intravenous injection.
Page 16 8. Defibrillation and the short period after defibrillation may affect the measured accuracy as it does not have a defibrillation function. 6.3 Clinical Restrictions 1. Since the measurement 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 SpO2 waveform (PLETH) will decrease.
Page 17: Technical Specifications
±4%, pulse rate error is ±2 bpm or ±2% (select larger). 4. Resistance to surrounding light: The deviation between the value measured in the condition of man-made light, indoor natural light and darkroom is less than ±1%. 5. It is equipped with a switch function: The product will enter standby mode when no signal is in the product within 5 seconds.
Page 18 regression plot Bland–Altman plot...
Page 19: Troubleshooting
Operating frequency: 2.4 GHz ISM band Modulation: GFSK(Gaussian Frequency Shift Keying) Transmitting power: 0 dBm, -6 dBm, -23 dBm Sensitivity: ≤-84 dBm @ 0.1% BER Transfer rate: 1 Mbps Safety features: Authentication and encryption Support Services: Bluetooth Data Transfer ® 8. FCC ID:2ABOGCMS50D-BT 9.
Page 20 The Sp0 1. The finger is not placed 1. Place the finger properly Pulse Rate are inside deep enough. and try again. not displayed 2. The finger is shaking or the 2. Remain still while taking stably user is moving...
Page 21: Key Of Symbols
Ingress of liquids rank manual The pulse oxygen %SpO Manufacturer saturation (%) PRbpm Pulse rate (bpm) Manufacture Date Storage and Transport Alarm inhibit Temperature limitation The battery voltage indication is deficient Storage and (change the battery Transport Humidity in time avoiding the...
Page 22 Symbol Description Symbol Description 1. No finger inserted Storage and Transport 2. An indicator of Atmospheric pressure signal inadequacy limitation 3. Probe error Battery positive This side UP electrode Battery negative Fragile, handle with electrode care Bluetooth icon Keep dry ®...
Page 23: Function Specification
±2 bpm or ±2%, whichever is greater. Resolution 1 bpm Accuracy under low Low perfusion 0.4%: perfusion (see note 4) SpO2: ±4%; PR: ±2 bpm or ±2%, whichever is greater Light interference Under normal and ambient light conditions, the SpO2 deviation ≤ 1%...
Page 24 Pulse intensity Continuous bar-graph display, the higher display indicate the stronger pulse. Upper and lower limit of measured values Sp02 0% ~ 100% Pulse Rate 0 bpm ~ 254 bpm Optical sensor (see note 5) Red light Wavelength: about 660 nm, optical output power: <...
Page 25 70 % to 100 % SaO2, compare the SpO2 values collected by the secondary standard pulse oximeter equipment and the tested equipment at the same time, to form paired data, which are used for the accuracy analysis.
Page 26 NOTE 4: percentage modulation of infrared signal as the indication of pulsating signal strength, patient simulator has been used to verify its accuracy under conditions of low perfusion. SpO2 and PR values are different due to low signal conditions, compare them with the known SpO2 and PR values of input signal.
Page 27 EQUIPMENT and SYSTEMS Guidance and Manufacture’s Declaration – Electromagnetic Emission The UP-200BLE Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of the UP-200BLE Pulse Oximeter should assure that it is used in such and environment.
Page 28 EQUIPMENT and SYSTEMS Guidance and Manufacture’s Declaration – Electromagnetic Immunity The UP-200BLE Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of UP-200BLE Pulse Oximeter should assure that it is used in such an environment.
Page 29 0,15 MHz and 80 MHz 0,15 MHz and 80 MHz 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...
Page 30 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the UP-200BLE Pulse Oximeter is used exceeds the applicable RF compliance level above, the UP-200BLE Pulse Oximeter should be observed to verify normal operation.
Page 31 Test Band Service Modula- Modu- Dis- Immunity Frequency tion b) lation tance Test Level (MHz) (MHz) b) (W) (V/m) Radiated Pulse modu- TETRA IEC61000- lation (Test 18 Hz specifica- tions for FM c) ENCLO- ± 5 SURE GMRS PORT 460, devia- IMMUNITY FRS 460...
Page 32 Radiated Test Band Service Modula- Modu- Dis- Immunity Frequency tion b) lation tance Test Level (MHz) (MHz) b) (W) (V/m) IEC61000- (Test specifica- tions for 800/ ENCLO- 900, SURE TETRA Pulse PORT 800, modu- IMMUNITY iDEN lation to RF 820, wireless CDMA 18 Hz...
Page 33 Radiated Test Band Service Modula- Modu- Dis- Immunity Frequency tion b) lation tance Test Level (MHz) (MHz) b) (W) (V/m) IEC61000- (Test specifica- 1720 1800; tions for CDMA ENCLO- 1900; SURE Pulse PORT 1700 modu- 1900; 1845 IMMUNITY lation DECT; to RF 1990 217 Hz...
Page 34 Radiated Test Band Service Modula- Modu- Dis- Immunity Frequency tion b) lation tance Test Level (MHz) (MHz) b) (W) (V/m) IEC61000- (Test Bluetooth, specifica- WLAN, tions for 802.11 Pulse 2400 ENCLO- b/g/n, modula- 2450 SURE RFID tion b) 2570 PORT 2450, 217 Hz IMMUNITY...
Page 35 Minimum separation distances for higher IMMUNITY TEST LEVELS shall be calculated using the following equation: Where P is the maximum power in W, d is the minimum separation distance in m, and E is the IMMUNITY TEST LEVEL in V/m.
Page 36 (12 inches) to any part of the oximeter including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. 5. Active oximeters are subject to special EMC precautions and they must be installed and used in accordance with these guidelines.
Page 37: Warranty
You purchased the Product under normal use. This Limited Warranty is personal to You and is not transferable. If the Product is defective, then You return the Product to A&D in accordance with the procedure set forth below.
Page 38: Contact Information
CONTACT INFORMATION Manufactured for: Distributed in Canada A&D Engineering, Inc. by: Auto Control Médical 4622 Runway Boulevard an A&D Company Ann Arbor, MI 48108 6695 Millcreek Drive, Unit 6, Mississauga, andmedical.com Ontario L5N 5R8 1-888-726-9966 Canada lifesourcecanada.com 1-800-461-0991...