Wellue POD-1W Fingertip Oximeter User Manual

POD-1W Fingertip Oximeter
User Manual
(Model: POD-1, POD-1W)

Website: getwellue.com
Contact us: service@getwellue.com
Shenzhen Creative Industry Co., Ltd.
Floor 5, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road,
Xili Street, Nanshan District, 518110 Shenzhen, P. R. China
Manufacture date: See the label on the product
Revision Date: Jan, 2021
Manual Version: V1.1
PN：3502-1290221

Notes
It is not a medical device and should not be used for any medical purposes or medical conditions. It is intended only for general wellness use.

• Please read the manual very carefully before using this device. Failure to follow these instructions can cause measuring abnormality or damage to the Oximeter.
• The contents contained in this manual are subject to change without notice.
• Information furnished by our company is believed to be accurate and reliable. However, no responsibility is assumed by us for its use or any infringements of users or other rights of third parties that may result from its use.

Instructions for Safe Operation

• Make sure that there is no visible damage that may affect the user’s safety or measurement performance with regard to sensors and clips. It is recommended that the device should be inspected minimally before each use. If there is obvious damage, stop using the device.
• Special attention should be paid while the oximeter is used constantly under an ambient temperature over 37°C, burning hurt may occur because of over-heating of the sensor at this situation.
• Necessary maintenance must be performed only by qualified service technicians. Users are not permitted to service this device.
• The oximeter must not be used with devices and accessories not specified in User Manual.

Warnings and Cautions

• Explosive hazard—DO NOT use the Oximeter in an environment with inflammable gas such as some ignitable anesthetic agents.
• DO NOT use the Oximeter while the user is under MRI or CT scanning. This device is NOT MRI Compatible.
• Discomfort or pain may appear if using the Oximeter continuously on the same location for a long time, especially for user with poor microcirculation. It is recommended that the Oximeter should not be applied to the same location for longer than 2 hours. If any abnormal condition is found, please change the position of the Oximeter.
• The light (the infrared light is invisible) emitted from the device is harmful to the eyes. Do not stare at the light.
• The Oximeter is not a treatment device.
• Local laws and regulations must be followed when disposing of the device.
• Keep the Oximeter away from dust, vibration, corrosive substances, explosive materials, high temperature, and moisture.
• The device should be kept out of the reach of children.
• If the oximeter gets wet, please stop using it and do not resume operation until it is dry and checked for correct operation. When it is carried from a cold environment to a warm and humid environment, please do not use it immediately. Allow at least 15 minutes for Oximeter to reach ambient temperature.
• DO NOT operate the button on the front panel with sharp materials or sharp points.
• DO NOT use high temperature or high-pressure steam disinfection on the Oximeter. Refer to Chapter 8 for instructions regarding cleaning and disinfection.
• Pay attention to the effects of lint, dust, light (including sunlight), etc.

Overview

1.1 Intended Use
This Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO2) through a user’s finger. It is intended for sports or aviation use only. It should not be used to diagnose or treat any medical condition.

1.2 Views

Battery Installation

1.  Refer to Figure 2, insert two AAA size batteries into the battery compartment properly, and note the polarity markings.
2. Replace the cover.

Attentions:

• Make sure that the batteries are correctly installed. Incorrect installation may cause the device not to work.
• 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.

Start/Stop Measuring

1. Open the clip and put your finger inside the clip (make sure the finger is in the correct position), and then release the clip.

2. Wait for 2 seconds, the oximeter will power on and start to measure.

3. The display screen shows the measurement.

4. Get the finger out, and the device will automatically power off.

Attentions for measuring:

• Do not shake the finger and relax during measurement.
• Do not put a wet finger directly into the 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 the device, i.e. do not use fingernail polish/paints.
• The existence of high intensive light sources, such as fluorescence light, ruby lamb, infrared heater, or strong sunshine, etc. may cause inaccuracy in measurement results. Please put an opaque cover on the sensor or change the measuring site if necessary.
• Vigorous exercise and electrosurgical device interference may affect the measuring accuracy.
• Nail polish may affect the measuring accuracy, and too long fingernails may cause the failure of measurement or inaccurate results.
• 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.
• If the measurements are over the limits, there is a reminder sound. You can press the Display key to mute it, or wait for 10 seconds till the sound disappears by itself.

Screen

4.1 Indications and Icons

Icon: indicates the wireless connection is set up between the mobile device and oximeter. Only POD-1W has this function.

established.
No display of “ ” icon| 1. The oximeter fails to set up a wireless connection with a mobile device within 3 minutes.
2. Hardware failure of wireless function.

• Icon: 25 indicates the counting-down time if the oximeter works at Spot check mode. The total measuring time for Spot check mode is 30 seconds.
• Icon / : low battery voltage.
• Flashing value: indicates the value is over the defined limits. There also accompanies the reminding sound.

Menu Setup

During measuring, the long-pressing Display key can enter the setup menu screen.

Menu operating procedures:

1. Shortly press Display Key to choose the setting item;
2. Long press Display Key to active the setting item, then shortly press it to modify the setting parameter;
3. Long press Display Key to confirm the modification and exit from this setting item.
4. Move the setting item to “Exit”, and long-press Display Key to store the modification and exit from the setup menu.

“Beep”： Pulse beep option. If it is set to on, every pulse beat makes a beep.
“Mode”: Set the measuring mode. “Continuous” and “Spot check” for optional, the default is “Spot check”.
Spot check mode: the measuring time lasts 30 seconds with a counting-down indication. The SpO2 and PR readings will freeze at the end of 30 seconds, the analysis result for the pulse rhythm will be displayed on the screen as well.
Continuous mode: measurement will start automatically when the finger is inserted into the oximeter, SpO2 and PR readings will be displayed until the finger is removed from the oximeter.

Record List

• A single group of stable readings will be recorded in the record list each time when the oximeter shuts down regardless of spot-check or continuous mode. However, 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.
• When batteries are removed from the device all readings will be deleted.
•  On power off status, long-pressing the Display key shows the record list screen. On the record list screen, a short pressing on the Display key can shift the records display, and if there is no key operation for 6 seconds, then the oximeter will power off automatically again.

Technical Specifications

A. SpO2 Measurement
Sensor : dual-wavelength LED sensor with wavelength:
Red light: 663 mm, Infrared light: 890 mm.
Maximal average optical output power: ≤2mW
SpO2 display range: 35% – 100%
SpO2 measuring accuracy: ≤ 2% for SpO2 range from 70% to 100%
B. Pulse Rate measurement
PR display range: 30 bpm – 240 bpm
PR measuring accuracy : ±2bpm or ±2% (whichever is greater)
C. Perfusion Index (PI) Display range 0% – 20%
D. Over-limit settings
SpO2:
Low limit setting range: 85% – 99%, step: 1%
Default setting: 90%
Pulse Rate:
Low limit setting range: 30 – 60 bpm, step: 1bpm;
High limit setting range: 100 – 240 bpm, step: 5bpm;
Default setting: high: 120bpm; low: 50bpm
E. Audible & visual alert function
When measuring, if the SpO2 value or pulse rate value exceeds the preset limit, the device will alert with a beep automatically and the value which exceeds limit will flash on the screen.
F Power supply requirement 2 x 1R03 (AAA) alkaline batteries Supply voltage: 3.OVDC, Operating current: 540mA
G Environmental Conditions
Operating Temperature: St – 40°C
Operating Humidity:             30% – 80%
Atmospheric pressure:          70kPa – 106kPa
H Low Perfusion Performance
The accuracy of 502 and PR measurement still meets the precision described above when the modulation amplitude is as low as 0.6%.
I Ambient Light Interference
The difference between the SpO2 value measured in the condition of indoor natural light and that in the darkroom is less than ±1%.
J Dimensions: 56 mm (1) x 34 mm (W) x 30 mm (H) Net Weight: 60g (including batteries)
K Classification
The type of protection against electric shock: Internally powered equipment.
The degree of protection against electric shock: Type BF applied parts.
The degree of protection against harmful solid foreign objects and ingress of liquid:
The equipment is IP22 with protection against harmful solid foreign objects and ingress of liquid.
Electro-Magnetic Compatibility: Group I, Class 8

Maintenance and Cleaning &Disinfection

8.1 Maintenance
The expected service life (not a warranty) of this device is 5 years. In order to ensure its long service life, please pay attention to the maintenance.

• Please change the batteries when the low-voltage indicator
• Please clean the surface of the device before using, it with 75% alcohol wipes, then let it air dry or wipe it Do not allow liquid to enter the device.
• Please take out the batteries if the Oximeter will not be used any more than 7 days.
• The recommended storage environment of the device: ambient temperature: -20 QC – 60 2C, relative humidity 10% – 95%, atmospheric pressure: 50 kPa – 107.4 kPa.
• The Oximeter is calibrated in the factory before sale, so there is no need to calibrate it during its life cycle.

Caution:

• High-pressure sterilization cannot be used on the device.
• Do not immerse the device in liquid.
• It is recommended that the device should be kept in a dry Humidity may reduce the life of the device, or even damage it.

8.2 Cleaning and Disinfecting Instruction

• Surface-clean sensor with a soft cloth damped with a solution such as 75% isopropyl alcohol, if low-level disinfection is required, use a mild bleach
• Then surface-clean with a cloth damped ONLY with clean water and dry with a clean, soft

Caution:

• Do not sterilize by irradiation steam or ethylene oxide.
• Do not use the Oximeter if it Is damaged.

Troubleshooting

Problem|

Solution

---|---
The SpO2 and Pulse Rate values are unstable| Place the finger correctly inside and try again. Keep calm.
Cannot turn on the

device

| Change or re-install the batteries.
No display| Change the battery.

Symbols

Symbol

| Description| Symbol|

Description

---|---|---|---

0123

| CE mark| | Authorized representative in the
European community

SN

| Serial number| | Manufacturer (including address)
| Date of manufacture| | BF type applied part
| Attention ─ refer to User Manual| | Follow WEEE regulations for disposal

UK- RP

| UK Responsible Person| |

Appendix EMC
The equipment meets the requirements of IEC 60601-1-2:2014.
Table 1

Guidance and manufacturer’s declaration-electromagnetic emission

The Fingertip Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of the Fingertip Oximeter should assure that it is used in such an environment.
Emissions test| Compliance| Electromagnetic environment- guidance
RF emissions CISPR 11| Group 1| The Fingertip Oximeter 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 Fingertip Oximeter is suitable for use in all establishments, including domestic establishments and that direct 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 emission

The Fingertip Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of the Fingertip 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%
Electrical fast transient/
burst IEC61000-4-4| ±2kV for power
Supply lines
±1 kV for input/output lines| N/A| N/A
Surge
IEC 61000-4-5| ±1kV line (s) to line(s) ±2kV line(s) to earth| N/A| N/A
Voltage dips, short
interruptions and volts e
g
variations on power supply input lines IEC61000-4-11| <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| N/A| N/A
Power frequency (50Hz/60Hz) magnetic field IEC61000-4-8| 3A/m| 3A/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 a.c. mains voltage prior to application of the test level.

Table 3

Guidance and manufacturer’s declaration – electromagnetic immunity

The Fingertip Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of The Fingertip Oximeter should assure that it is used in such an electromagnetic environment.
Immunity test| IEC60601 test level| Compliance level| Electromagnetic environment -guidance
Conducted RF IEC61000-4-6Radiated RF IEC61000-4-3| 3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz| N/A 3 V/m|

Portable and mobile RF communications equipment should be used no closer to any part of The Fingertip Oximeter, 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 meters (m). b Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, 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 and 800 MHz, 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 broadcasts and TV broadcasts 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 Fingertip Oximeter is used exceeds the applicable RF compliance level above, The Fingertip Oximeter should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating The Fingertip Oximeter. b: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

Table 4

Recommended separation distances between portable and mobile RF communication the equipment
The Fingertip Oximeter is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of The
Fingertip Oximeter can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Fingertip Oximeter as recommended below, according to the maximum output power of the communications equipment.

The rated maximum output power of
transmitter W(Watts)| Separation distance according to the frequency of transmitter M(Meters)
---|---
150kHz to 80MHz| 80MHz to 800MHz| 80MHz to 2,5GHz
d=1.2 V p| d=1.2 V p| d=2.3 Al p
0,01| N/A| 0.12| 0.23
0,1| N/A| 0.38| 0.73
1| N/A| 1.| 2.
10| N/A| 4.| 7.
100| N/A| 12| 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance in meters (m) can be determined 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.

References

• Wellue - Innovative Technology Powers Your Health

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