Introduction Intended Use The Oxiband Pulse Oximeter is a wrist pulse oximeter indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate for adult patients. It is intended for spot-check and/or continuous data collection, and not continuous monitoring.
Page 4
do not play with it. Sources of electromagnetic disturbance may affect this device (e.g. microwave cookers, diathermy, lithotripsy, electrocautery, RFID, electromagnetic anti-theft systems, and metal detectors), please try to stay away from them when using. This equipment complies with International IEC 60601-1- ...
Page 5
or locations that are subject to strong electromagnetic influences. Do not use the device in a combustible environment (i.e., oxygen-enriched environment). Never submerge the device in water or other liquids. Do not clean the device with acetone or other volatile solutions.
Page 6
before reuse. Do not place the SpO2 probe on a finger with edema or fragile tissue. Check the SpO2 sensor and cable before use. Do not use a damaged SpO2 sensor. Prolonged continuous SpO2 measuring may increase the ...
Page 7
- Moisture in the sensor - Improperly applied sensor - Incorrect sensor type - Poor pulse quality - Venous pulsations - Anemia or low hemoglobin –concentrations - Cardiogreen and other -intravascular dyes - Carboxyhemoglobin - Methemoglobin - Dysfunctional hemoglobin Guide to Symbols Symbol Description Type BF-Applied Part...
Protected against spraying water and against IP22 access to hazardous parts with a tool, per IEC 60529. Follow Instructions for Use. Warning and Caution! Serial number No alarm system. Prescription use Using the Device Product information Name: Pulse Oximeter Model: Oxiband...
Page 9
Overview 1. Main unit 2. Wristband 3. Multi-function Connector for External SpO2 Cable and Charging Cable 4. Power button 5. Clasp 6. SpO2 sensor Screen display item description: SpO2 Pulse rate Wear the sensor Time...
Remaining battery capacity Bluetooth is connecting Charging Battery must be charged before using. To charge the device battery, connect one end of the charging cable to sensor/charging interface on the device, and the other end to either a USB charging adapter for a wall outlet or the USB port of a computer.
Bluetooth connection SMARTPHONE REQUIRED This device requires you to have an Apple or Android smart phone or tablet and connection to the internet. INSTALL APP Download the ViHealth app from the Apple App store or Google Play. A p p N a m e : ViHealth IMPORTANT: Enable Bluetooth on your smartphone and grant Bluetooth access to the ViHealth App.
Page 12
Start recording 1. Connect the sensor cable to the device. 2. Wear the device on your wrist and the ring sensor on your thumb or index finger. 3. Press and hold the power button for 1 second to power on the device.
Page 13
Stop recording Take off the sensor, the countdown will begin. During the countdown, if you wear the sensor again, the record will be resumed. After the countdown, the data will be ready for uploading. Note: The device can store maximum 4 records. The oldest record will be overwritten when the 5 record is coming in.
2 ) Flip the main unit over, the device ID is printed on the label of the product. Note: The device ID is on the back of the device. 2.10 Bluetooth Connection The device Bluetooth will be enabled automatically when the device is on.
contain any sterile components. Shelf life is 3 years based on our testing reports and battery specification documentations Battery To keep the battery in good condition, charge the battery every 6 months when the device is not in use. Troubleshooting Problem Possible Cause Possible Solution...
response. condition reset Device might be Please contact your local damaged. distributor. The app The Bluetooth Turn on the Bluetooth in does not on your smart your smart device detect the device is off. settings. device. Specifications Classifications Protection against Internally powered equipment electric shock Degree protection...
Page 17
Degree of dust & IP22 water resistance Physical Weight 12 g (main unit) Display OLED Wireless Bluetooth 4.0 BLE Power Supply Charge input: DC 5V ±10% Rechargeable lithium-polymer Battery type battery (3.7Vdc, 130mAh) Battery run time 72 hours Charge time 2 hours Meet standards of ISO 80601-2- Standards...
Page 18
Accuracy Display Range (Arms) ±2% 70% to 100% (Arms:1.88) SpO2 Accuracy (Arms) 90-100% ±2% 80-90% ±2% 70-80% ±3% 0%-69% not defined PR range 30 to 250 bpm ±2 bpm or ±2%,whichever is PR accuracy greater Wavelength / Max 660nm/940nm, 0.8mW/1.2mW emission power Bluetooth RF 2.402-2.480 GHz...
Page 19
The device is not intended to be used during motion and therefore testing in accordance with Clause 201.12.1.102 of ISO 80601-2-61:2011 was not conducted. Viatom does not make any claims about the accuracy of SpO2 measurements under conditions of low perfusion, and therefore testing in accordance with Clause 201.12.1.103 of ISO 80601-2-...
The Oxiband device uses the same SpO2 measurement technology provided in the Checkme Pro health monitor. So the graph can also reflect the clinical study condition of the Oxiband pulse oximeter. FCC Statement FCC ID: 2ADXK-1600 This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference.
of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.
Page 22
decreased electromagnetic immunity of the equipment. The device or its components should not be used adjacent to or stacked with 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.
Page 23
RF emissions Class B The device is suitable for use in all CISPR 11 establishments, including domestic establishments and Harmonic those directly connected to the emissions IEC public low-voltage power supply 61000-3-2 network that supplies buildings used for domestic purposes. Voltage fluctuations/ flicker emissions...
Page 24
IEC 61000-4-5 line ±2 kV line to earth 0% U (100% dip in for 0.5 cycle Voltage dips, 0% U short (100% dip in interruptions and voltage for 1 cycle variations on 70% U power supply (30% dip in U input lines for 25/30 IEC 61000-4-...
Page 25
Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated 150kHz to from the equation applicable to 80MHz Conducted the frequency of the transmitter. (6V in ISM Recommended separation IEC61000- distance:...
Page 26
customer or the user of the Pulse Oximeter can help prevent electromagnetic interference by maintaining a minimum distance between portable mobile communications equipment (transmitters) and the Pulse Oximeter as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of Rated transmitter (m)
Need help?
Do you have a question about the Checkme O2 Max and is the answer not in the manual?
Questions and answers