Viatom Checkme O2 User manual

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Viatom Checkme O2 Recorder
Instructions for Use
with the SleepImage System

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Viatom Checkme™ O2 Wireless Wrist Pulse Oximeter
Distributed by MyCardio LLC for use with the SleepImage System
Issued May 5, 2020
REF D-6.00283 Rev 1
[e-mail]
www.sleepimage.com
Manufactured by Shenzen Viatom Technology Co., Ltd
4E, Building 3, Tingwei Industrial Park
Honglang North 2nd Road, Baoan, 518100
Shenzen, P.R.China www.viatomtech.com
Table of Contents
Introduction ..................................................................................................................................................................3
Included in Box ............................................................................................................................................................3
Using the Recorder with the SleepImage System .......................................................................................................3
Manufacturer Warnings and Cautionary Advices........................................................................................................3
Maintenance .................................................................................................................................................................4
Cleaning the Recorder .................................................................................................................................................4
Charging the Recorder.................................................................................................................................................4
Display .........................................................................................................................................................................4
Power ON/OFF.............................................................................................................................................................4
Pairing the Recorder....................................................................................................................................................4
Performing a SleepImage Study.....................................................................................................................................5
Specifications ................................................................................................................................................................6
Electromagnetic Compatibility ....................................................................................................................................6
EMC Warnings and Cautions......................................................................................................................... 6
Troubleshooting ............................................................................................................................................................6
Symbol
Description
Type BF-applied part
Manufacturer
CE0197 CE Marking indicating conformance to EC Directive No. 93/42/EEC
MRI Unsafe. Presents hazards in all MR environments as recorder contains strongly ferromagnetic materials
Indicates separate collection for electrical and electronic equipment (WEEE)
IP22
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
Disclaimer
This document may contain technical inaccuracies or typographical errors. Changes are periodically made to the information herein; these changes will be
incorporated in future revisions of this document. MyCardio does not accept any liability for the use or misuse, direct or indirect, of this product. Users
must accept all responsibility for any results obtained by or concluded from data obtained by the products. The user must accept all responsibility for
results obtained by software from MyCardio. All clinical conclusions and decisions that are made based on the use of this product are the responsibility of
the user. MyCardio does not accept any liability or responsibility for damages arising out of the use of or inability to use this product.

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Introduction
This user manual explains how to use the Viatom Checkme O2 recorder with the SleepImage App. In order to
use the recorder, the user must have been provided with a unique Patient ID from a licensed healthcare
provider who has an account with SleepImage as well as a mobile device with Bluetooth capability and an
internet connection. Please consult with your healthcare provider to get access to the analyzed data output.
Included in Box
Checkme O2 Unit x 1
Ring Sensor x 1
USB Charging Cable x 1
Using the Recorder with the SleepImage System
This recorder is intended to be used with the SleepImage System for measuring, displaying and streaming data
from the recorder via Bluetooth to the SleepImage App (available for Android and iOS). To use with SleepImage,
fist download the App from either the iOS App Store, or the Google Play Store, then pair the recorder.
iOS: App Store
Android: Google Play
Manufacturer Warnings and Cautionary Advices
•DO NOT squeeze the sensor or apply excessive force on the sensor & cable
•Never submerge the recorder in water or other liquids.
•Do not clean the recorder with acetone or other volatile solutions.
•Do not place this recorder in pressure vessels or gas sterilization device.
•Consult your doctor immediately if you experience symptoms that could indicate acute disease.
•This recorder has no output displayed other than during recordings, it displays pulse rate (BPM) and oxygen
saturation (SpO2) as confirmation of an ongoing recording. Do not use this information for self-diagnosing a
condition or disease.
•Use only cables, sensors and other accessories specified in this manual.
•This recorder and its accessories are intended to record during sleep. Prolonged continuous use of the sensor may
increase the risk of undesirable skin irritation, reddening, blistering or burns. Patient sensitivity varies depending
on medical status or skin condition. For patients with sensitive skin or poor peripheral blood circulation, inspect
the sensor placement more frequently.
•Functional tester cannot be used to assess the accuracy of the sensor or the recorder.
•This recorder is designed to record data using a light emitting sensor. Factors that may degrade the performance of
the sensor or affect the accuracy of the recorded data include the following:
oExcess ambient light
oExcessive motion
oElectrosurgical interference
oBlood flow restrictors (arterial catheters, blood pressure cuffs, infusion lines, etc.)
oMoisture in the sensor
oImproperly applied sensor
oIncorrect sensor type or size
oPoor pulse quality
oVenous pulsations
oAnemia or low hemoglobin concentrations
oCardiogreen and other intravascular dyes
oCarboxyhemoglobin
oMethemoglobin
oDysfunctional hemoglobin

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Maintenance
Cleaning the Recorder
Use a soft cloth moistened with water or alcohol wipe to clean the device surface and sensor. The recorder display module
can be removed from the rubber wrist band which can be cleaned in warm water with mild soap. DO NOT clean the display
module with water or soap.
Charging the Recorder
Charge the recorder before using. Connect the recorder to a USB port of a computer or USB charging adapter using the
charging cable provided. While charging, a battery indicator will flash on the screen. After the recorder is fully charged, the
battery indicator will disappear. The rechargeable battery is expected to last for approximately 10 hours of continuous
recording. To keep the battery in good condition, charge the battery every 6 months when not in use.
Display
During use, the recorder displays time, remaining battery capacity, pulse rate and blood oxygen saturation (SpO2).
Power ON/OFF
To Power ON: Press and hold the button until the recorder display turns on.
To Power OFF: Recorder turns off automatically 2 minutes after the sensor is removed from finger, or if connection to the
SleepImage App is lost. It can be turned off manually by pressing the on/off button for about 2 seconds.
Pairing the Recorder
Pair the Recorder to a phone using Bluetooth that is controlled through the SleepImage App using the following steps:
•Ensure the recorder screen is on to enable the Bluetooth visibility in the SleepImage App
•Ensure the mobile device has Bluetooth enabled
•Follow instruction prompts in the SleepImage App to pair the recorder
See separate SleepImage App Instructions for Use document
Note: DO NOT PAIR the recorder with the mobile device using the ‘Settings’ on the phone.

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Performing a SleepImage Study
To begin a SleepImage Study, you will first need to have charged the recorder, and paired it with the SleepImage App
START:
Connect the sensor to the recorder, attach the strap
around the wrist and place ring sensor around thumb
or index finger.
For good signal quality, the sensor needs to be tight.
Avoid having it too tight or too loose.
Turn on the recorder with the SleepImage App open
(see separate App Instructions for Use) and press the
Play button in the App to start a recording (image 1).
Confirm that the pulse rate and SpO2display both on
the device display and the SleepImage App (image 2).
Keep the phone near your bed, then go to sleep.
1) 2)
STOP:
After waking up, open the SleepImage App, confirm
that the pulse rate and SpO2are displayed both on the
device display and the SleepImage App.
Press the Stop button in the App to stop a recording.
Press Yes to confirm (Image 1)
An Upload Succeeded message will appear at the
bottom of the App window (Image 2)
Remove the sensor from the finger and disconnect the
sensor from the recorder.
The recorded data will be automatically uploaded to
the Clinician’s SleepImage account (see separate App
Instructions for Use).
1) 2)
Successful data collection in progress is indicated by SpO2 and Pulse Rate values being displayed in the app. During this
time, the screen on the recorder will display SpO2 and Pulse Rate values as well. If you notice that the screen is off during
the recording period, click (do not hold) the power button so that the screen turns back on.

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Specifications
Classifications
EC Directive
MDD 93/42/EEC
R&TTE 1999/5/EC
ROHS 2.0 2011/65/EU
Protection against electrical shock
Type BF
Environmental
Item
Operating
Storage
Temperature
5 – 40 ℃(41 – 104 ℉)
-25 – 70 ℃(-13 – 158 ℉)
Relative humidity (noncondensing)
10% – 95%
10% – 95%
Barometric
700 – 1060 hPa
700 – 1060 hPa
Dust & Water resistance
IP22
Physical
Weight
12 g (main unit)
Display
OLED
Wireless
Bluetooth 4.0 BLE
Power Supply
Charge Input
DC 5V ± 10%
Battery type
Rechargeable lithium-polymer
Charge time
2 – 3 hours
Storage Capacity
4 records total (~10 hours each) 5th record will overwrite memory
SpO2
Standards
ISO 80601-2-61
SpO2Range
70% – 100%
SpO2Accuracy
80% – 100% ±2% | 70% – 79% ±3%
Wavelength
660 – 940nm
Output Power
Red / Infrared: 3mW max. avg.
Electromagnetic Compatibility
The recorder meets the requirements of EN 60601-1-2. EMC table information is listed on the manufacturer’s website:
https://api.viatomtech.com.cn/documents/2017/emc_en.pdf
EMC 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 recorder or its components should not be used adjacent to or stacked with other equipment.
•The recorder 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 the recorder even though they meet the requirements of CISPR.
•When the signal input is below the minimum amplitude provided in technical specifications, erroneous
measurements could result.
•Portable and mobile communication equipment may affect the performance of the recorder.
•Other devices that have RF transmitter or source may affect the recorder (e.g. mobile phones, tablets and personal
computers with wireless function).
Recorder specifications cautions and warnings have been provided by the manufacturer. For information about potential
applications of using this recorder other than with the SleepImage System please contact the manufacturer.
Troubleshooting
Problem
Possible Cause
Possible Solution
Recorder does not turn on or is not responsive
Battery may be low
Charge battery and try again
Unexpected software condition
Press & hold button for 10 seconds to reset
SleepImage App cannot connect with recorder
Bluetooth on phone is OFF
Turn on Bluetooth on phone
Recorder is OFF
Turn on the recorder
If your issue persists, please email [e-mail] with the following info: User Name, SleepImage Account Name,
Serial Number of Recorder, App version, and a description of the issue encountered. Include screenshots/pictures, if applicable.