viatom Checkme O2 Max Smart Wrist Pulse Oximeter User Manual

viatom Checkme O2 Max Smart Wrist Pulse Oximeter User Manual

Introduction

Intended Use

This product is intended to be used for measuring, displaying and storing of pulse oxygen saturation (SpO2), pulse rate and motion in home or healthcare facilities environment. App can show real-time SpO2, pulse rate; get record, display results and report.

Note:

The data and results provided by this device are for pre-check screening purpose only and cannot be directly used for diagnostic or treatment. The data provided by the APP and PC software (optional) is not intended for diagnosis or treatment purpose, always consult your doctor for any health condition.

Warnings and  Cautionary Advices

• DO NOT squeeze the sensor or apply excessive force on the sensor & cable.
• Do not use this device during MRI examination.
• Never submerge the device in water or other liquids.
• Do not clean the device with acetone or other volatile solutions.
• Do not place this device in pressure vessels or gas sterilization device.
• 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.
• Use only cables, sensors and other accessories specified in this manual.
• Prolonged continuous SpO2 monitoring may increase the risk of undesirable changes in skin characteristics, such as irritation, reddening, blistering or burns.
• Check the SpO2 sensor application site every 6-8 hours to determine the positioning of the sensor and the circulation and skin sensitivity of the patient. Patient sensitivity varies depending on medical status or skin condition. For patients with poor peripheral blood circulation or sensitive skin, inspect the sensor site more frequently.
• Functional tester cannot be used to assess the accuracy of a SpO2 sensor or a device.
• 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 – excessive motion
  • electrosurgical interference
  • blood flow restrictors(arterial catheters, blood pressure cuffs, infusion lines, etc.)
  • 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
	Manufacturer
	European authorized representative
	CE Marking indicating conformance to EC 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).
	Protected against spraying water and against access to hazardous parts with a tool, per IEC 60529.
	Follow Instructions for Use.
	Warning and Caution!
SN	Serial number
	No alarm system.

Unpacking

• Main Unit × 1
• Ring Sensor × 1
• Cable × 1
• User Manual × 1

Using the Monitor

Overview

1. Pulse oximeter
2. Wristband
3. Sensor interface / charging interface
4. Power button
5. SpO2 sensor

Screen display item description:

	SpO2
	Pulse rate
	Wear the sensor
	Time
	Remaining battery capacity
	Alert is on
	Alert is off
	Bluetooth is connecting

Charging

Charge the battery before using. Use the charge cable to charge the battery of device in the USB Port of the computer or with USB charging adapter. After being fully charged, the device will power off automatically.

POWER ON/OFF

POWER ON:Press the button for 1 second to turn on the device.

POWER OFF: Automatically power off: The device will turn off automatically in 2 minutes if no measurement, no operation or without App connection. Manually power off: You can press the button for about 2 seconds to turn off.

TAKE THE FIRST RECORDING START.

Wear the device and the Ring Sensor, press the button to power on. And keep yourself in the quiet environment. (For the sake of clarity, recommended the user wear the monitor watch on their left wrist and put the ring sensor on the thumb. If it is too tight, try another finger. Avoid being loose.)

STOP. After the record, take off the Ring Sensor (and the device), the recording will be save after the countdown. (If the working time is less than 1 minute, the data will not be saved.)

Note:

• Please avoid excessive motion for the sensed finger during recording and avoid any strong ambient light condition.

Stop monitoring & sync data

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 sync.

Note: The duration of the recording is 1mins~10 hours. And the device can collect and store maximum 4 recording, when the 5th recording coming, the first recording will be will covered.

Sync data to the ViHealth AppYou can Sync the data to your app after the countdown or next time after you turn on the device.Note: Refer the ViHealth app manual for more details.

How to find the Serial Number?

1. Detach the main unit from wristband.
2. Flip the main unit over, the series number is printed on the label of product.

Note: The serial number is on the back of the device

How to synchronize the time of the device

The time of the monitor will be automatically synchronized with the network time on your smart device after connected with the app.Note: Refer the ViHealth app manual for more details.

Alert

When the monitor detects low blood oxygen or abnormal pulse rate, it supports triggering vibration reminders or sound reminders.You can customize the vibration reminder after the monitor power on, or use the App to configure the vibration intensity.The sound reminder only can be configured on the App.

Download App

App name: ViHealthiOS: App StoreAndroid: Google Play

CompatibilityThe device is compatible with iOS versions 9.0+ and Android versions 5.0+. Refer the ViHealth app manual for more details.

Bluetooth Connection

The device Bluetooth will be enabled automatically when the device is on.

Note: DO NOT PAIR in the settings of your smart device.

PC software

Download the PC Software

PC Software: O2 Insight ProDownload from: www.viatomtech.com/supportInstall the software on Windows PC or Mac.

How to connect the monitor to PC

1. Turn on device, connect the device to PC USB port with the supplied Cable of data.
2. Open the PC software, download data from the device.
3. With the optional PC software, You can view and print report, which can also be exported as PDF or CSV files.

How to connect the monitor to Mac

1. Turn on device, and turn on the Bluetooth of the Mac.
2. Open the “O2 Insight Pro” software and click the “Connect” on the screen. Choose your device to connect.
3. Then click the “download” on the screen. Then the data will sync with your Mac.
4. You can view and print report, which can also be exported as PDF or CSV files.

Maintenance

Cleaning

Use a soft cloth moistened with water or alcohol to clean the device surface.

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
Device does not turn on or no response.	Battery may be low.	Charge battery and try again.
Unexpected software condition	Press the button for about 10 seconds to reset
Device might be damaged.	Please contact your local distributor.
The app cannot find the device.	The Bluetooth of your phone is off.	Turn on the Bluetooth in the phone.

Specifications

Classifications
EC Directive	MDD, 93/42/EEC
R&TTE, 1999/5/EC
ROHS 2.0, 2011/65/EU
Degree protection against electrical shock	Type BF
Environmental
Item	Operating	Storage
Temperature	5 to 40°C	-25 to 70°C
Relative humidity (noncondensing)	10% to 95%	10% to 95%
Barometric	700 to 1060 hPa	700 to 1060 hPa
Degree of dust & water resistance	IP22
Physical
Weight	18 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	72 hours
Charge time	2.5 hours
SpO2
Standards	Meet standards of ISO 80601-2-61
Measurement accuracy verification: The SpO2 accuracy has been verified in human experiments by comparing with 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.

SpO2 range	70% to 100%
SpO2 Accuracy (Arms)	80-100%:±2%, 70-79%:±3%
PR range	30 to 250 bpm
PR accuracy	±2 bpm or ±2%，whichever is greater
Wave length	660-940nm
Output power	Red/Infrared: 3mW max. avg.
Storage
Capacity	4 records,10 hours for each
Mobile APP
iOS	iOS 9.0 or above, iPhone 4s/iPad 3 or above
Android	Android 5.0 or above, with Bluetooth 4.0 BLE

Electromagnetic Compatibility

The device meets the requirements of EN 60601-1-2.

Warnings and Cautions

• Using accessories other than those specified in this manual may result in increased electromagnetic emission or 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.
• Other devices may interfere with this device even though they meet the requirements of CISPR.
• When the inputted signal is below the minimum amplitudeprovided in technical specifications, erroneous measurements could result.
• Portable and mobile communication equipment may affect the performance of this device.
• Other devices that have RF transmitter or source may affect this device (e.g. cell phones, PDAs, and PCs with wireless function).

EMC table information is listed on our website: https://api.viatomtech.com.cn/documents/2017/emc_en.pdf

Support

Shenzhen Viatom Technology Co., Ltd4E,Building 3, Tingwei industrial Park, Honglang North 2 nd Road, Baoan, 518100Shenzhen, P.R.Chinawww.viatomtech.com

MedNet GmbHBorkstrasse 10, 48163 Muenster, GermanyTel:+49 251 32266-0Fax:+49 251 32266-22

2020.11 Version: AContents of this manual are subject to changes without prior notice.

©Copyright 2020 Shenzhen Viatom Technology Co., Ltd. All rights reserved.

Model: Oxiband

 

References

• 
  Support – Service And Download Center | Viatom arrow&v
• 
  Home Wearable Medical Devices: Pulse Oximeter Manufacturer | Viatom