Viatom Checkme O2 Max User manual

Fingertip Oximeter User Manual
Checkme O2 Max
Smart Wrist Pulse Oximeter
User Manual
1. Introduction
1.1 Intended Use
This product is intended to be used for measuring, displaying and
storing of pulse oxygen level (SpO2) ， heart rate and motion of
adults. App can show the oxygen level, heart rate; get record,
display results and report.
It's not a medical device. This device is for Sports and Aviation
use only and not intended for medical use.
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 using may increase the risk of undesirable
changes in skin characteristics, such as irritation,
reddening, blistering or burns.
Check the oxygen level sensor application site every 6-8
hours to determine the positioning of the sensor and the
circulation and skin sensitivity of the user. User sensitivity
varies depending on personal status or skin condition. For
users with poor peripheral blood circulation or sensitive
skin, inspect the sensor site more frequently.
Functional tester cannot be used to assess the accuracy of
an oxygen level 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 hemoglobi
1.2 Guide to Symbols
1.3 Unpacking
Main Unit × 1
Ring Sensor × 1
Cable × 1
User Manual × 1
2. Using the Device
2.1 Overview
1. Pulse oximeter
2. Wristband
3. Sensor interface / charging interface
4. Power button
5. Oxygen level sensor
Screen display item description:
Oxygen level
Heart rate
Wear the sensor
Time
Remaining battery capacity
Reminder is on
Reminder is off
Bluetooth is connecting
2.2 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.
2.3 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.
2.4 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 device
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 saved 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.
2.5 Stop working & 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 App
You 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.
2.5.1 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.
2.6 How to synchronize the time of the device
The time of the device 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.
2.7 Reminder
When the device detects low oxygen level or abnormal heart rate, it
supports triggering reminders.
You can customize the reminder after the device power on, or use
the App to configure.
2.8 Download App
App name: ViHealth
iOS: App Store
Android: Google Play
Compatibility
The device is compatible with iOS versions 9.0+ and Android
versions 5.0+. Refer the ViHealth app manual for more details.
2.9 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.
3. PC software
3.1 Download the PC Software
PC Software: O2 Insight Pro
Download from:
https://iwearpulse.com/pages/app- download
Install the software on Windows PC or Mac.
3.2 How to connect the device 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.
3.3 How to connect the device 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
Symbol
Description
Manufacturer
Date of manufacture
SN
Serial number
MRI unsafe. Presents hazards in all MR
environments as device contains strongly
ferromagnetic materials.
Indicate 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.
Type BF-Applied Part
Warning and Caution!
No alarm system.
This product complies with the rules and
regulations of the Federal Communication
Commission.
Non-ionizing radiation
This product complies with verpackG.

Fingertip Oximeter User Manual
PDF or CSV files.
4. Maintenance
4.1 Cleaning
Use a soft cloth moistened with water or alcohol to clean the device
surface.
4.2 Battery
To keep the battery in good condition, charge the battery every 6
months when the device is not in use.
5. 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.
6. 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
Oxygen level
Standards
Meet standards of ISO 80601-2-61
Measurement accuracy verification: The oxygen level accuracy
has been verified in human experiments by comparing with
arterial blood sample reference measured with a CO-oximeter.
The heart 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.
Oxygen level range
70% to 100%
Oxygen level 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
7. FCC Statement
FCC Warning:
FCC ID: 2ADXK-1600
Any Changes or modifications not expressly approved by the party
responsible for compliance could void the user's authority to
operate the equipment.
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, and
(2) this device must accept any interference received, including
interference that may cause undesired operation.
Note: This equipment has been tested and found to comply with the
limits for a Class B digital device, pursuant to part 15 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. However,
there is no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference to
radio or television reception, which can be determined by turning
the equipment off and on, the user is encouraged to try to correct
the interference by one or more of the following measures:
-Reorient or relocate the receiving antenna.
-Increase the separation between the equipment and receiver.
-Connect the equipment into an outlet on a circuit different from that
to which the receiver is connected.
-Consult the dealer or an experienced radio/TV technician for help.
The device has been evaluated to meet general RF exposure
requirement. The device can be used in portable exposure condition
without restriction.
8. 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 amplitude
provided 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).
Table 1
Guidance and manufacturer’s declaration-electromagnetic emissions
The Pulse Oximeter is intended for use in the electromagnetic environment
specified below. The customer or the user of the Pulse Oximeter should
assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment-
guidance
RF emissions
CISPR 11
Group 1
The device uses RF energy only for its
internal function. Therefore, its RF
emissions are very low and are not
likely to cause any interference in
nearby electronic equipment.
RF emissions
CISPR 11
Class B
The device is suitable for use in all
establishments, including domestic
establishments and those directly
connected to the public low-voltage
power supply network that supplies
buildings used for domestic purposes.
Harmonic emissions
IEC61000-3-2
N/A
Voltage
fluctuations/flicker
emissions
IEC61000-3-3
N/A
Table 2
Guidance and manufacturer’s declaration – electromagnetic
immunity
The Pulse Oximeter is intended for use in the electromagnetic
environment specified below. The customer or the user of the Pulse
Oximeter should assure that it is used in such an environment.
Immunity test
IEC60601 test
level
Compliance
level
Electromagnetic
environment -
guidance
Electrostatic
discharge(ESD)
IEC61000-4-2
±8 kV contact
±15kV air
±8 kV
contact
±15kV air
Floors should be
wood, concrete or
ceramic tile. If floors
are covered with
synthetic material,
the relative humidity
should be at least
30%. If ESD
interfere with the
operation of
equipment, counter
measurements such
as wrist strap,
grounding shall be
considered.
Electrical fast
transient/
burst
IEC61000-4-4
±2kV for power
supply lines
±1 kV for
input/output lines
±2kV for
power
supply lines
±1 kV for
input/output
lines
The quality of the
power supply should
meet the
requirements of a
typical commercial
(initial power
supply).
Surge
IEC 61000-4-5
±1kV line to line
±2kV line to earth
±1kV line to
line
±2kV line to
earth
The quality of the
power supply should
meet the
requirements of a
typical commercial.
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-
11
0% UT
(100% dip in UT)
for 0.5 cycle
0% UT
(100% dip in UT)
for 1 cycle
70% UT
(30% dip in UT)
for 25/30 cycles
0% UT
(100% dip in UT)
for 250/300 cycles
0% UT
(100% dip in
UT)
for 0.5 cycle
0% UT
(100% dip in
UT)
for 1 cycle
70% UT
(30% dip in
UT)
for 25/30
cycles
0% UT
(100% dip in
UT)
for 250/300
cycles
The quality of the
power supply should
meet the
requirements of a
typical commercial.
If the user of this
product needs to
continue poerating
during power
interruption,it is
recommended to
use uninterruptible
power supply or
battery power.
Power
frequency
(50/60Hz)
magnetic field
IEC61000-4-8
30 A/m
30 A/m
Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial
or hospital
environment.
NOTE : UT is the AC mains voltage prior to application of the test level.
Table 3
Guidance and manufacturer’s declaration – electromagnetic
immunity
The Pulse Oximeter is intended for use in the electromagnetic
environment specified below. The customer or the user of The Pulse
Oximeter should assure that it is used in such an environment.
Immunity
test
IEC60601
test level
Compliance
level
Electromagnetic
environment -guidance
Conducted
RF
IEC61000-4-
6
Radiated RF
IEC61000-4-
3
3 Vrms
150 kHz to
80 MHz(6V
in ISM and
amateur
radio bands
between
0.15MHz
and
80MHz)
3 V/m
80 MHz to
2.5 GHz
N/A
10 V/m
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 from the
equation applicable to the
frequency of the transmitter.
Recommended separation
distance
d=1.2
P
d=1.2
P
80MHz to 800MHz
d=2.3
P
800MHz to 2.5GHz
Where P is the maximum
output power rating of the
transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation
distance in metres (m).
Field strengths from fixed RF
transmitters, as determined by
an electromagnetic site
survey ,a should be less than
the compliance level in each
frequency range .b
Interference may occur in the
vicinity of equipment marked
with the following symbol.
Recommended separation distances between portable and mobile
RF communications equipment and the Pulse Oximeter
The Pulse Oximeter is intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The
customer or the user of the Pulse Oximeter can help prevent
electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment
(transmitters) and the Pulse Oximeter as recommended below, according
to the maximum output power of the communications equipment.
Rated
maximum
output power
of transmitter
W(Watts)
Separation distance according to frequency of
transmitter M(Meters)
150kHz to
80MHz
d=1.16
P
80MHz to 800MHz
d=1.16
P
80MHz to
2,5GHz
d=2.33
P
0,01
0.12
0.12
0.23
0,1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in meters (m) can be estimated
using the equation applicable to the frequency of the transmitter, where p
is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for 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 and people.
Manufacturer：
Shenzhen Viatom Technology Co., Ltd.
4E, Building 3, Tingwei Industrial Park, No
6 Liufang Road, Block 67, Xin‘an Street,
Baoan District, Shenzhen, 518101,
Guangdong, P.R.China
www.iwearpulse.com
Version: A Date: Nov. 24, 2022 PN:255-05862-00
Contents of this manual are subject to changes without prior notice.
©Copyright 2020 Shenzhen Viatom Technology Co., Ltd. All rights
reserved.
Model: Oxiband