Table of Contents
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Table of Contents
Summary of Contents for Checkme O2 Oxiband
- Page 1 Model: Oxiband User’s Manual...
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Page 2: Table Of Contents
User’s Manual Contents Introduction ..............1 Using the Monitor ............4 Maintenance ..............12 Troubleshooting ............13 Specifications ............14 Electromagnetic Compatibility ........17... -
Page 3: Introduction
1. Introduction 1.1 Intended Use This product is intended to be used for measuring, displaying and storing of pulse oxygen saturation (SpO ) and pulse rate in home or healthcare facilities environment. The data and results provided by this device are for pre-check screening purpose only and cannot be directly used for diagnostic or treatment. - Page 4 using this device, you should consult your doctor immediately if you experience symptoms that could indicate acute disease. Do not self-diagnose or self-medicate on the basis of this device without consulting your doctor. In particular, do not start taking any new medication or change the type and/or dosage of any existing medication without prior approval.
- Page 5 This device is designed to determine the arterial oxygen saturation percentage of functional hemoglobin. Factors that may degrade pulse oximeter performance or affect the accuracy of the measurement include the following: - excess ambient light - poor pulse quality - excessive motion - venous pulsations - electrosurgical...
- Page 6 1.2 Guide to Symbols Symbol Description Type BF-Applied Part Manufacturer European authorized representative CE Marking indicating conformance to EC CE0197 directive No. 93/42/EEC concerning medical devices. MRI unsafe. Presents hazards in all MR environments as device contains strongly ferromagnetic materials. Indicate separate collection for electrical and electronic equipment (WEEE).
- Page 7 against access to hazardous parts with a tool, per IEC 60529. Follow Instructions for Use. Warning and Caution! Serial number No alarm system. 1.3 Unpacking The package includes the following items: Main Unit × 1 Sensor × 1 ...
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Page 8: Using The Monitor
3. Using the Monitor 2.1 Charging Connect the device to a standard USB charging port with the provided charging cable. Charge the battery fully before using to get an overnight recording. 2.2 Power On/Off Press the button to power on the device. Press the button for three seconds to power off the device normally. - Page 9 Slide the ring sensor into the thumb as pictured. Power on the device and choose the proper operation mode your application. After a few seconds, the device will run the mode you set and your readings will begin appearing on the device screen.
- Page 10 2.4 Displays Press the button can switch different displays during recording. 97 78 SPO2 18:45 MODE MODE ID ×××× V ×.× O2 7.5...
- Page 11 2.5 Operation Mode Navigation The monitor has two operation modes: Sleep Mode and Monitor Mode. Press the button during the icon flashing to switch between two modes. Sleep Mode Monitor Mode Parameters , PR, Motion , PR, Motion, Steps Real-time Wireless (Dashboard) Recording Max 10 hours...
- Page 12 2.6 Tracking and Recording the Vital Signs After the mode has been chosen, the SpO and pulse rate will be displayed on the screen. The SpO , pulse rate and motion data will be automatically stored in the monitor with 2s interval. The device can store maximum 4 records.
- Page 13 2.8 Establishing Bluetooth Connection The device Bluetooth will open automatically only when the screen lights up. To establish Bluetooth connection, Ensure the monitor screen is on to keep the Bluetooth enabled. Run the Check O2 app and enable the phone Bluetooth as below.
- Page 14 Choose the right Device ID from the device. Android 2.9 Using Real-time Wireless Dashboard After Bluetooth connection established in Monitor Mode, touch the Dashboard icon in the app, then your phone / tablet will show real-time SpO , PR and Steps. 2.10 Completing the Recording There are two ways to complete the recording: ...
- Page 15 automatically, or Press the button for 3s to power off the monitor. 2.11 View Results and Settings on Mobile App Download the Check O2 app from the Apple APP Store or Google Play Store and then install it. With the APP, you can: Review all measurement and analysis results with ...
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Page 16: Maintenance
Data will be updated to the cloud automatically or manually based on your setting. 3. Maintenance 3.1 Care and Cleaning Clean the device by carefully swabbing the device surface with a soft cloth swab with water or alcohol. 3.2 Firmware Update Connect the monitor with the APP. -
Page 17: Troubleshooting
4. Troubleshooting Problem Possible Cause Possible Solution Device Battery may be low. Charge battery and does not try again. turn on. Device might be Please contact your damaged. local distributor. The app The Bluetooth of Turn on the cannot your phone is off. Bluetooth in the find the phone. -
Page 18: Specifications
5. Specifications Classifications MDD, 93/42/EEC EC Directive R&TTE, 1999/5/EC ROHS 2.0, 2011/65/EU Degree protection Type BF against electrical shock Environmental Item Operating Storage Temperature 5 to 40° C -25 to 70° C Relative humidity 10% to 95% 10% to 95% (noncondensing) 700 to 1060 700 to 1060... - Page 19 Physical Weight 35 g (main unit) Display OLED Wireless Bluetooth 4.0 BLE Vibrator Built in Power Supply Charge input: DC 5V ± 10% Battery type Rechargeable lithium-polymer battery Battery run time Sleep Mode: > 10 hours Monitor Mode: > 5 hours Charge time Less than 2 hours to 90% Meet standards of ISO 80601-2-...
- Page 20 arterial blood sample reference measured with a CO- oximeter. The pulse rate accuracy has been verified by Emulator. Pulse oximeter measurement are statistically distributed and about two-thirds of the measurements are expected to come within the specified accuracy range compared to CO-oximeter measurements. range 70% to 100% Accuracy...
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Page 21: Electromagnetic Compatibility
Record parameters , pulse rate, motion Record length Max 10 hours Record interval Drop analysis Mobile APP iOS 9.0 or above, iPhone 4s/iPad 3 or above Android Android 4.4 or above, with Bluetooth 4.0 BLE 6. Electromagnetic Compatibility The device meets the requirements of EN 60601-1-2. Warnings and Cautions ... - Page 22 other equipment. The device needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided below. Other devices may interfere with this device even though they meet the requirements of CISPR. ...
- Page 23 Harmonic emissions Class A establishments, including domestic IEC61000-3-2 establishments and those directly connected to the public low-voltage Voltage Fluctuations / Flicker Complies power supply network that supplies Emissions IEC 61000-3-3 buildings used domestic purposes. Guidance and Declaration - Electromagnetic Immunity The Health Monitor is intended for use in the electromagnetic environment specified below.
- Page 24 IEC 61000-4-5 line(s) line(s) environment. ± 2 kV line(s) to ± 2 kV line(s) to earth earth Voltage dips, short <5 % UT <5 % UT Mains power Interruptions (>95 % dip in UT) (>95 % dip in UT) quality should be Voltage variations on for 0.5 cycle for 0.5 cycle...
- Page 25 hospital environment. Note: U is the AC mains voltage prior to application of the test level. Guidance and Declaration - Electromagnetic Immunity The Health Monitor is intended for use in the specified electromagnetic environment. The customer or the user of the Health Monitor should assure that it is used in such an environment as described below.
- Page 26 Where, P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer recommended separation distance in meters (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...
- Page 27 Recommended separation distances between portable and mobile RF communications equipment and the device The Health Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Health Monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the monitor as recommended below, according to the maximum output power of the communications equipment.
- Page 28 Shenzhen Viatom Technology Co., Ltd 4E,Building 3, Tingwei industrial Park, Honglang North 2 Road, Baoan, 518100 Shenzhen, P.R.China www.viatomtech.com info@viatomtech.com MedNet GmbH Borkstrasse 10, 48163 Muenster, Germany Tel:+49 251 32266-0 Fax:+49 251 32266-22 PN：255-00917-00 Version: A Contents of this manual are subject to changes without prior notice.