Checkme O2 Oxiband User Manual

Model: Oxiband

User’s Manual

User’s Manual

Contents

1. Introduction ................................................................... 1

3. Using the Monitor ........................................................... 4

3. Maintenance ................................................................ 12

4. Troubleshooting ........................................................ 13

5. Specifications ............................................................ 14

6. Electromagnetic Compatibility ........................................ 17

1

1. Introduction

1.1 Intended Use

This product is intended to be used for measuring, displaying
and storing of pulse oxygen saturation (SpO2) 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.

Warnings and Cautionary Advices

 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.
 Vital signs measurements, such as those taken with this device,

cannot identify all diseases. Regardless of the measurement taken

2

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.

 Use only cables, sensors and other accessories specified in this

manual.

 Prolonged continuous SpO

2

monitoring may increase the risk of
undesirable changes in skin characteristics, such as irritation,
reddening, blistering or burns.

 Check the SpO

2

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 SpO

2

sensor or a device.

3

 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

- articial nails or fingermail
polish

2

1.2 Guide to Symbols

Symbol

Description

Type BF-Applied Part

Manufacturer

European authorized representative

CE0197

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).

IP22

Protected against spraying water and

3

against access to hazardous parts with a
tool, per IEC 60529.

Follow Instructions for Use.

Warning and Caution!

SN

Serial number

No alarm system.

1.3 Unpacking

The package includes the following items:

 Main Unit × 1
 SpO

2

Sensor × 1

 Charging Cable × 1
 User’s Manual × 1

If any item on this list is missing or damaged, contact the seller.

4

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.
Press the button for five seconds to power off the device
forcedly if necessary.

2.3 Wearing the Monitor

1. Wear the monitor on the left wrist.

2. Connect the sensor cable to the device.

5

3. Slide the ring sensor into the thumb as

pictured.

4. Power on the device and choose the

proper operation mode per your
application. After a few seconds, the
device will run the mode you set and your
readings will begin appearing on the
device screen.

5. Press the button can change different screens.

Note:

 The monitor can also work as a clock and pedometer

without ring sensor, and the steps will restart counting after
the ring sensor plugged in.

 Please avoid excessive motion for the sensed finger

during recording and avoid any strong ambient light
condition.

6

2.4 Displays

Press the button can switch different displays during recording.

O2 7.5 13

MODE

ID ×××× V ×.×

MODE

Z

Z

18:45

%

97 78

SPO2

7

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

SpO2, PR, Motion

SpO2, PR, Motion, Steps

Real-time Wireless
(Dashboard)

No

Yes

Recording
Length

Max 10 hours

Max 5 hours

Drops
Detection

Yes

No

Screen

Activated by button

Always on

The Sensor
Vibrates

When SpO2 is

lower than

threshold set

When SpO2 is lower
than threshold set

Or when step goal is

met

Bluetooth

On when the screen

lights up

Always on

8

2.6 Tracking and Recording the Vital Signs

After the mode has been chosen, the SpO2 and pulse rate will
be displayed on the screen. The SpO2, pulse rate and motion
data will be automatically stored in the monitor with 2s interval.

The device can store maximum 4 records. The oldest record
will be overwritten when the 5th record is coming in.

2.7 Smart Vibration

The monitor will monitor the SpO2 level and steps during the
recording. If the vibration is ON, the vibrator in the sensor will
be activated when the SpO2 fall below the pre-set value
(Threshold) or meet steps goal. The vibration will stop when the
SpO2 reading go back to normal range, or you can press the
button to stop it.

9

2.8 Establishing Bluetooth Connection

The device Bluetooth will open automatically only when the
screen lights up.

To establish Bluetooth connection,

1. Ensure the monitor screen is on to keep the Bluetooth

enabled.

2. Run the Check O2 app and enable the phone Bluetooth

as below.

10

3. Choose the right Device ID from the device.

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 SpO2, PR and Steps.

2.10 Completing the Recording

There are two ways to complete the recording:

 Take off the sensor and it will power off later

Android iOS

11

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

detailed data plots,

 Change the settings of the monitor,
 Update the monitor,
 Manage the data in the cloud.

2.12 Using the Cloud

1. Touch the Cloud icon in the up right corner of the app,

and then create a cloud account.

2. Sign in your account in the APP.

12

3. 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

1. Connect the monitor with the APP.

2. Enter the APP, visit Device Device updateUpdate.

check the version and start an update if you want.

3.3 Battery

To keep the battery in good condition, charge the battery every
6 months when the monitor is not in use.

13

4. Troubleshooting

Problem

Possible Cause

Possible Solution

Device
does not
turn on.

Battery may be low.

Charge battery and
try again.

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.

The device
Bluetooth is off in

Sleep Mode.

Press the button,
the Bluetooth will be
turned on when the
screen lights up.

14

5. 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

15

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%

SpO2

Standards

Meet standards of ISO 80601-2­61

Measurement accuracy verification: The SpO2 accuracy
has been verified in human experiments by comparing with

16

arterial blood sample reference measured with a CO­oximeter. 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.

Pedometer

Range

0 to 99999 steps

Sleep analysis

17

Record parameters

SpO2, pulse rate, motion

Record length

Max 10 hours

Record interval

2s

Drop analysis

Yes

Mobile APP

iOS

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

 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

18

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).

Guidance and Declaration - Electromagnetic Emissions

The Health Monitor is intended for use in the electromagnetic environment specified below. The
customer or the user of the device should assure that it is used in such an environment.

Emission tests

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

19

Harmonic emissions
IEC61000-3-2

Class A

establishments, including domestic
establishments and those directly
connected to the public low-voltage
power supply network that supplies
buildings used for domestic
purposes.

Voltage Fluctuations / Flicker
Emissions IEC 61000-3-3

Complies

Guidance and Declaration - Electromagnetic Immunity

The Health Monitor is intended for use in the electromagnetic environment specified below. The
customer or the user of the Health Monitor should assure that it is used in such an environment.

Immunity test

IEC60601 test
level

Compliance level

Electromagnetic
environment ­guidance

Electrostatic
discharge (ESD) IEC
61000-4-2

± 6 kV contact
± 8 kV air

± 6 kV contact
± 8 kV air

Floors should be
wood, concrete
or ceramic tile. If
floors are
covered with
synthetic material,
the relative
humidity should
be at
least 30 %.

Electrical fast
transient/burst
IEC 61000-4-4

± 2 kV for power
supply lines
± 1 kV for
input/output lines

± 2 kV for power
supply lines
± 1 kV for
input/output lines

Mains power
quality should be
that of a typical
commercial or
hospital

Surge

± 1 kV line(s) to

± 1 kV line(s) to

20

IEC 61000-4-5

line(s)
± 2 kV line(s) to
earth

line(s)
± 2 kV line(s) to
earth

environment.

Voltage dips, short
Interruptions and
Voltage variations on
power supply input
lines
IEC 61000-4-11

<5 % UT
(>95 % dip in UT)
for 0.5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 s

<5 % UT
(>95 % dip in UT)
for 0.5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 s

Mains power
quality should be
that of a typical
commercial or
hospital
environment. If the
user of our
product requires
continued
operation during
power mains
interruptions, it is
recommended
that our product
be powered from
an uninterruptible
power supply or a
battery.

Power frequency
(50/60 HZ) magnetic
field IEC 61000-4-8

3 A/m

3 A/m

Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in
a typical
commercial or

21

hospital
environment.

Note: UT 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.

Immunity test

IEC60601
test level

Complianc
e level

Electromagnetic environment –
guidance

Conduced RF

IEC61000-4-6

3 Vrms 150
kHz to
80 MHz
outside ISM
bands

3 Vrms 150
kHz to
80 MHz
outside ISM
bands

Portable and mobile RF
communications equipment should be
used no closer to any part of the
system, including cables, than the
recommended separation distance
calculated from the equation
appropriate for the frequency of the
transmitter. Recommended
separation distances:

Pd 2.1

Radiated RF

IEC61000-4-3

3 V/m 80
MHz to

2.5 GHz

3 V/m 80
MHz to

2.5 GHz

Recommended separation distances:

80 MHz ～ 800 MHz:

Pd 2.1

800MHz-2.5GHz:

Pd 3.2

22

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
meters (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:

Note 1: At 80 MHz to 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.

a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the device is used exceeds the applicable RF compliance
level above, the device should be observed to verify normal operation. If abnormal performance
is observed, additional measures may be necessary, such as re-orienting or relocating the device.

b

Over frequency range 150kHz to 80MHz. For Resp field strength should be less than 1V/m.

23

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.

Rated max.
output power of
transmitter (W)

Separation distance according to frequency of the transmitter (m)

150 kHz - 80 MHz

80 MHz - 800
MHz

800 MHz - 2.5 GHz

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.20

1.20

2.30

10

3.80

3.80

7.30

100

12.00

12.00

23.00

For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in metres (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.

Pd 3.2

Pd 2.1

Pd 2.1

Shenzhen Viatom Technology Co., Ltd

4E,Building 3, Tingwei industrial Park,
Honglang North 2nd Road, Baoan, 518100
Shenzhen, P.R.China

www.viatomtech.com

[e-mail]

MedNet GmbH

Borkstrasse 10, 48163 Muenster, Germany

Tel:[phone] Fax:[phone]

PN：255-00917-00 Version: A
Contents of this manual are subject to changes without prior

notice.

© Copyright 2016 Shenzhen Viatom Technology Co., Ltd. All

rights reserved.