viatom PO6B Pulse Oximeter Instruction Manual
- June 6, 2024
- Viatom
Table of Contents
Work In progress
PO6B Pulse Oximeter
Pulse Oximeter
Instruction for Use
1. Introduction
1.1 Intended use This Pulse Oximeter is intended to be used for measuring,
displaying and storing adult ‘ s pulse oxygen saturation (SpO2), pulse rate of
adults in home or healthcare facilities environment.
1.2 Contraindications No contraindications.
1.3 Warnings and Cautions DO NOT squeeze the sensor part or apply excessive
force on it. Do not use this device during MRI examination. Do not use this
device with a defibrillator. Do not store the device in the following
locations:
locations in which the device is exposed to direct sunlight, lint,dust,high
temperatures or levels of moisture, or heavy contamination; locations near to
sources of water or fire; 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. Do not drop this device or subject it to strong impact. The device
and accessories are provided non-sterile. Do not place this device in pressure
vessels or gas sterilization device. Do not dismantle the device, as this
could cause damage or malfunctions or impede the operation of the 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 monitoring may increase the
risk of undesirable changes in skin characteristics, such as irritation,
reddening, blistering or burns. Do not open the device cover without
authorization.
The cover should only be opened by a qualified service personnel. The
biocompatibility testing has been performed on the materials in contact with
the person in accordance with ISO10993. 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. 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. The
functional tester cannot be used to assess the accuracy of the SpO2 sensor or
a device. The device has no alarm system. Continuous use for a long time may
cause allergies, redness, blistering or burns. Check the wearing position
every 6-8 hours. The local laws and regulations should be followed when
disposing of the device and accessories. Do not maintain the device while it
is charging. Please keep the cable away from children. It can cause
strangulation. Keep the device out of reach of pets, pests and children. The
PULSE OXIMETER EQUIPMENT is calibrated to display FUNCTIONAL OXYGEN
SATURATION. The product is for prescription use. 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
Caution: Federal law restricts this device to sale by or on the order of a physician.
1.4 Guide to Symbols Symbol Description Type BF-Applied Part
Manufacturer
Date of manufacture
Authorized Representative in the European Community
Follow Instructions for Use.
MRI unsafe. Presents hazards in all MR environmentsas devicecontainsstrongly
ferromagnetic materials.
Protectedagainst spraying water and IP22 against access to hazardous parts
with a
tool, per IEC60529.
SN
Serial number
No alarm system
Temperature limitation
Humidity limitation
Atmospheric pressure limitation
RX only
Indicate separate collection for electrical and electronic equipment (WEEE).
Prescription Use
2.1 Appearance
3 Using the Device 3.1 Battery Installation
1.5 Unpacking Device User Manual Batteries Pouch Lanyard
2 Overview
Name:Pulse Oximeter Model: PO6BPO6C
Model and Configuration see the table below.
Model
PO6B PO6C
Bluetooth
×
Note: `’ means standard configuration,
`×’ means no such configuration.
Figure 3 Battery Installation
- Refer to Figure 3, insert two AAA size batteries into the battery
compartment properly, and note the polarity markings. 2) Replace the cover.
Please make sure that the batteries are correctly
installed. Incorrect installation may cause the device not to work. Please remove batteries if the device is not being used for more than 7 days to prevent and avoid potential damage from the battery leaking. Any such damage is not covered under the product warranty.
3.2 Operation
- Start Open the clip and put finger inside the rubber cushions of the clip (make sure the finger is in the correct position), and then clip the finger, as shown in figure 4.
Menu
When finger is in oximeter, long time pressing display key can enter the setup
menu screen.
Figure 4 Put finger into the Oximeter
Wait 2 seconds, the Oximeter will power on automatically and start to measure;
2) END. When finger is out, the Oximeter shuts down automatically. 3) Readings
display screen:
Figure 5
The display direction is remembered at each startup, that is, the screen
layout (display direction) of the last time will be used as the initial screen
layout when powering on the Oximeter next time.
Figure 6
Recording & recall functions are available. At power off status, pressing
Display key can bring up record list display screen, as shown in figure 6. In
record list screen, press Display key to shift the records page. If the time
from displaying valid readings to the end of measurement is less than 5
seconds, then no recording will be done. Up to 12 groups of records can be
stored in the record list, the newest record is marked as M1, and the oldest
record is marked as M12. The new record will override the previous record.
Menu setup: Short time press Display Key to choose the setting item; Longtime
press Display Key to active the setting item, then short time press it to
modify the setting parameter; Next, longtime press Display Key to confirm the
modification and exit from this setting item. At last, move the setting item
to “Save, exit menu”, and long time pressing Display Key to store the
modification and exit from the setup menu.
“Pulse beep” / “Beep” Pulse beep option. If it is set to on, every pulse beat
makes a beep.
When beep is on and over-limits indication sound is activated, then Display
key will work as the Mute key, and short time pressing it can mute the over-
limits indication sound and pulse beep for 90 seconds.
Note: Not all the product models have the features described in this chapter,
please be subject to the actual products.
Attention to the operation
The finger should be put into the sensor correctly.
Do not shake the finger and relax during measurement.
Do not put wet finger directly into sensor.
Avoid placing the device on the same limb which is wrapped with a cuff for
blood pressure measurement or during venous infusion.
Do not let anything block the emitting light from device, i.e. do not use
finger nail polish/paints.
Vigorous exercise and electrosurgical device interference may affect the
measuring accuracy.
Nail polish may affect the measuring accuracy, and too long fingernail may
cause failure of measurement or inaccurate result.
Existence of high intensive light sources, such as fluorescence light, ruby
lamp, infrared heater or strong sunshine, etc. May cause inaccuracy of
measurement result.
Please put an opaque cover on the sensor or change the measuring site if
necessary.
If the first reading appears with poor waveform (irregular or not smooth),
then the reading is unlikely true, the more stable value is expected by
waiting for a while, or a restart is needed when necessary.
SpO2 measurement principle:
The Pulse Oxiemter is a lightweight, portable health oximeter for use in the
home or in healthcare facilities. SpO2 measurement technology is based on
developed photoelectron method, the circuit design and calculation software
was developed by Shenzhen Viatom Technology Co., Ltd. The SpO2 sensor receives
the optical signal from the red light and infra-red light through the finger.
Insert the finger into the oximeter, there are two emitting tube (red light
diodes and infrared diodes) located on the inner upside of the sensor and they
can emit red light and infrared; There is the receiving end located on the
inner downside of the sensor, and it can transmit the red light and infrared
into the pulse signal through finger. The MCU receives the pulse signal, gets
the frequency signal by counting, processes its digital signal, and finally
gets the measured SpO2 value. The PR is averagely calculated by above peak
intervals of PR waveform.
4 Maintenance 4.1 Cleaning The device can be repeatedly used. Please clean
before reuse as follow:
· Clean the device with a soft, dry cloth with 70% alcohol and then let it air
dry. · Do not use petrol, thinners or similar solvent. · Clean the SpO2 sensor
carefully with cloth soaked 70% alcohol and then let it air dry.
Note: The device is a non-sterile medical device and does not contain any
sterile or degradable component thus the device is not subject to the shelf
life requirements.
4.2 Battery To keep the device in good condition,when the battery is dead, it
should be replaced immediately.
5 Troubleshooting
Problem
Possible Solution
Can not turn on the device
Charge battery and try again. Please contact your local distributor.
The SpO2 and Pulse Rate display unsteadily
Place the finger correctly inside and try again.
No display Let the patient keep calm down
3.2 Stop working & Upload data
Take off the device, the countdown will begin. (If the working time is less
than 2 minute, there will be no countdown)
During the countdown, if you wear the device again, the record will be
resumed. After the countdown, the data will be ready for uploading.
Note: If the above problem still exists please contact the local service center.
Notice: The built-in memory can store 1 records. The oldest will be overwritten by the 2th. Please upload data to your phone in time.
6 Specifications
Environmental
Temperature Relative humidity (noncondensing) Barometric
Protection against electric shock Degree protection against electrical shock
Electro-magnetic compatibility Degree of dust & water resistance Weight Size
Battery
SpO2 display range SpO2 Accuracy (Arms)
Operating 5 to 40°C
10% to 95%
Storage -25 to 70°C
10% to 95%
700 to 1060hPa 700 to 1060hPa
Internally powered equipment
Type BF
Group I, Class B
IP22
60g 56 mm (L) × 34 mm (W) × 30 mm (H) DC 3.0V 2 x LR03 (AAA) alkaline
batteries
35% to 100%
70%-100%: ±2% (Arms:1.88) 70%-80%: ±3%
80%-90%: ±2%
90%-100%: ±2%
0%-69%: not defined
Pulse Rate range
30 to 240 bpm
Pulse Rate accuracy ±2 bpm or ±2%, whichever is greater
A functional tester or SpO2 simulator can be used to determine the pulse rate accuracy.
Wavelength / Max emission power
663nm/890nm, 2mW
Vibration source
Low SpO2
Recorded parameters Record interval
Data storage
Wireless
Bluetooth RF Frequency range
SpO2 ,Pulse rate 5s 12 groups of records Bluetooth 4.2 BLE 2.402 2.480 GHz
GFSK Modulation
Wireless Quality of Service (QoS)
Adaptive Frequency Hopping (AFH) Transmission Distance: 1.5m Transmission Time: 10s
Data integrity: 100%
7 SpO2 test summary
This graph shows plots of the error (SpO2-SaO2) by SaO2 using the Checkme Pro
health monitor with a linear regression fit and upper 95% and lower 95% limits
of agreement. Subject from a clinical study in nonmotion conditions identifies
each sample data point. Clinical study was performed using healthy adult
subjects. 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 80601-2-61:2011 was not conducted.
The 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.
8 Electromagnetic Compatibility
The device meets the requirements of IEC 606011-2.
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
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
Compliance Electromagnetic environment
test
guidance
RF emissions Group 1
The device uses RF energy only
CISPR 11
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 Class B
The device is suitable for use in all
CISPR 11
establishments, including
domestic establishments and
Harmonic
N/A
emissions IEC
61000-3-2
those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Voltage
N/A
fluctuations/
flicker
emissions
IEC 61000-3-3
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 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
IEC 60601 test level
Compliance level
Electromagnetic environment guidance
Electrostatic discharge (ESD) IEC 61000-4-2
± 8 kV contact ± 15 kV air
± 8 kV contact ± 15 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%. If ESD interfere with the operation of equipment, counter measurements such as wrist strap, grounding shall be considered.
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
The quality of the power supply should meet the requirements of a typical commercial (initial power supply) or medical environment.
Surge IEC 61000-4-5
Voltage dips, short interruptions and voltage variations on power supply input
lines IEC 61000-4-11
± 1 kV line to line ±2 kV line to earth
± 1 kV line to line ±2 kV line to earth
0% UT 0% UT
(100% dip in UT) (100% dip in UT)
for 0.5 cycle for 0.5 cycle
0% UT 0% UT
(100% dip in UT) (100% dip in UT)
for 1 cycle for 1 cycle
70% UT 70% UT
(30% dip in UT) (30% dip in UT)
for 25/30 cycles for 25/30 cycles
0% UT 0% UT
(100% dip in UT) (100% dip in UT)
for 250/300 for 250/300 cycles
cycles
The quality of the power supply should meet the requirements of a typical
commercial or medical environment.
The quality of the power supply should meet the requirements of a typical
commercial or medical environment.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 (50/60 Hz) magnetic field IEC 61000-4-8
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.
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
IEC 60601 test level
Compliance level
Electromagnetic environment guidance
Conducted RF IEC61000- 3Vrms
150kHz to 80MHz
4-6
(6V in ISM and amateur
N/A
radio bands between
0.15MHz and 80MHz)
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
Radiated RF IEC61000-43
3V/m 80MHz to 2.7GHz
10V/m
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)
0.01 0.1 1 10 100
Separation distance according to frequency of transmitter (m)
150kHz to 80MHz
d = 1.16 P
0.12 0.38 1.2 3.8 12
80MHz to 800MHz
d = 1.16 P
0.12 0.38 1.2 3.8 12
800MHz to 2.5GHz
d = 2.33 P
0.23 0.73 2.3 7.3 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 ddress: 4E, 3#, Tingwei
Industrial Park, Honglang North 2nd Road, Baoan District, Shenzhen, China
Weibsite: www.welluehealth.com
MedNet EC-REP GmbH Borkstrasse 10, 48163 Muenster, Germany
0197
Model: PO6BPO6C Version: A ©Copyright 2019 Shenzhen Viatom Technology Co.,
Ltd. All rights reserved.
FCC Warnning: 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.