Wellue POD-2 Fingertip Oximeter User Manual

Wellue POD-2 Fingertip Oximeter Fingertip Oximeter

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
Tel: +86-755-2643 3514
E-mail: info@creative-sz.com
Fax: +86-755-2643 0930 Website: www.creative-sz.com

Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537 Hamburg Germany Manufacture date: See the label on the product Revision Date： June 9, 2021

Download the APP software
App name: VicHealth Mobile
iOS: App Store
Android: Google Play
The ViHealth app is compatible with iOS versions
9.0+ and Android versions 5.0+.

Instructions for Safe Operation

• Make sure that there is no visible damage that may affect 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 patient 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 patients 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 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 point.
• DO NOT use high temperature or high-pressure steam disinfection on the Oximeter. Refer to instructions regarding cleaning and disinfection.
• The equipment is IP32 with protection against harmful solid foreign objects and ingress of liquid.
• Pay attention to the effects of lint, dust, light (including sunlight),etc.

Declaration of Conformity
The manufacturer hereby declares that this device complies with the following standards:

• IEC 60601-1: 2012 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance;
• ISO 80601-2-61:2017 – Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse Oximeter equipment.
• Follow the provisions of the council directive MDD 93/42/EEC.

Caution: U.S. federal law restricts this device to sale or use by or on the order of a physician.

Overview

Intended Use
This Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO2) through a patient’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 Appearance

Features

• SpO2, PR, PI, Plethysmogram, Pulse bar
• Auto On/Off
• Over-limit settings
• Pulse beep
• Wireless function
• Measuring mode: continuous
• Record list

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 a finger inside the clip (make sure the finger is in the correct position), and then release the clip. Wait for 2 seconds, the oximeter will power on and start to measure. If you connect the device to App, you can also check readings in App
2. Get the finger out, and the device will automatically power off.
3. Readings display screen The screen displays as below：
4. Recording & recall
   Recording & recall functions are available. At power-off status, pressing the Display key can bring up the record list display screen, as shown in figure 5. In record list screen, press the 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. If the batteries are removed from the device, then the records will be not kept or volatile.

Menu Setup

During measuring, 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. when the beep is on and the over-limits indication sound is activated, then the Display key will work as the ute key, and short time pressing it can mute the over-limits indication sound and pulse beep for 90 seconds.

Data transmission
The user could effectively transmit the data to App via Bluetooth.

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 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.
• 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.
• The existence of high intensive light sources, such as fluorescence light, ruby lamb, infrared heater or strong sunshine, etc. may cause inaccuracy of measurement results. 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

Wireless

The wireless icon Definition

established.
No display of “ ” icon| 1.    “Wireless” function is disabled;
2.   The device fails to setup a wireless connection with the surrounding host within 3 minutes; 3. Hardware failure of wireless transmission function while the “Wireless” function is enabled.

5.1 Connecting to the device

• Keep the device on measuring.
• Run ViHealth App on your smart device.
• Click the device icon when VicHealth finds your Pulse Oximeter.
• Follow the screen guide to start pairing.
• Once paired, you can log on to ViHealth.

Caution: Do NOT pair the device in your smart device settings.
For more details about VicHealth App, please refer to the ViHealth App user manual.

5.2 Real-time Monitoring
The ViHealth app supports monitoring SpO2 and HR in real-time on the Dashboard screen.

5.3 Syncing Data to Apple Health
To enable/disable syncing measurement data to Apple Health App, tap [Setting]-> [Apple Health]->[On/Off]. The measurement data will be transferred to Apple Health App when ViHealth App is running.
Note: Refer the ViHealth user manual for more details.

Technical Specifications

A. SpO2 Measurement
Sensor: dual-wavelength LED sensor with wavelength:
Red light: 663 nm, Infrared light: 890 nm.
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 SpO2 value or pulse rate value exceeds the preset limit, the device will alert with beep automatically and the value which exceeds limit will flash on the screen.
F. Power supply requirement
2 x LR03 (AAA) alkaline batteries Supply voltage: 3.0VDC, Operating current: ≤40mA

G. Environmental Conditions
Operating Temperature: 5°C – 40°C
Operating Humidity: 30% – 80%
Atmospheric pressure: 70kPa – 106kPa

H. Low Perfusion Performance
The accuracy of SpO2 and PR measurement still meet 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 of darkroom is less than ±1%.

J. Dimensions : 56 mm (L) × 34 mm (W) × 30 mm (H) Net Weight: approx. 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 B

Maintenance and Cleaning&Disinfection

7.1 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 lightens.

• Please clean the surface of the device before using, with 75% alcohol wipes, then let it air dry or wipe it dry. 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 ºC – 60 ºC, 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. Any SpO2 simulators should not be used to validate the accuracy of the Oximeter, they can only be used as functional testers to verify its precision. The SpO2 accuracy claimed in this manual is supported by the clinical study conducted by nducing hypoxia on healthy, non-smoking, light-to-dark skinned subjects in an independent research laboratory.
  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 environment. Humidity may reduce the life of the device, or even damage it.

Cleaning and Disinfecting Instruction

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

Caution:

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

Troubleshooting

Problem:

1. The SpO2 and Pulse Rate display instable
2. Can not turn on the device
3. No display
4. Display direction doesn’t change or changes insensitively.
5. No display of the wireless icon “ ”

Solution

1. Place the finger correctly inside and try again.
2. Changing batteries.
3. Let the patient keep calm.
4. Please shake the Oximeter with a certain force to make the movable
5. metal ball move freely. If the problem still exists, maybe the
6. orientation sensor is not working properly.
7. Hardware failure of wireless transmission function.
8. If the above problem still exists please contact the local service center

Symbols

Frequently Asked Questions

1.  Q: What’s SpO2?
   A: SpO2 means the saturation percentage of oxygen in the blood.

2.  Q: What’s the normal range of SpO2 value for healthy people?
   A: The normal range varies by individual, but usually over 95%, otherwise, please consult your physician.

3. Q: What’s the normal range of PR value for healthy people?
   A: Usually, the normal range is 60bpm~100bpm.

4. Q: Why do the display value of SpO2 and PR vary with time?
   A: The measured SpO2 and PR value changes in correspondence with the change of patient’s physiological conditions.

5. Q: What to do if there is no SpO2 and PR reading?
   A: Do not shake the finger, and keep calm during the measurement Please also avoid the Oximeter and the cuff on the same limb for blood pressure and oxygen saturation measurement simultaneously.

6. Q: How to confirm that the SpO2 reading is true or accurate?
   A: Hold breath for a while (50 seconds or more), if the SpO2 value significantly decreases, it means that the SpO2 reading truly reflects the physiological condition change.

7. Q: When to replace the batteries?
   A: The icon of low battery will appear on the screen when the battery voltages are low. By then, batteries need to be replaced.

8. Q: What to do if the Oximeter is moistened or sprayed by water?
   A: Remove the batteries immediately and dry the Oximeter completely with a hair dryer.

9. Q: What factors will affect the SpO2 accuracy?
   A: Intravascular dyes such as indocyanine green or methylene blue;

10. Exposure to excessive illumination, such as surgical lamps, bilirubin lamps, fluorescent lights, infrared heating lamps, or direct sunlight;

11. Vascular dyes or external used color-up products such as nail enamel or color skincare;

12. Excessive patient movement;

13. Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line;

14. Exposure to the chamber with High-pressure oxygen;

15. There is an arterial occlusion proximal to the sensor;

16. Blood vessel contraction caused by peripheral vessel hyperkinesias or body temperature decreasing;

17. Low perfusion condition (Perfusion Index is small). Please contact the local distributor or manufacturer if necessary.

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

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 suitable for use in all establishments, including domestic establishments and those directly network that supplies buildings used for domestic purposes.
Harmonic emissions IEC61000-3-2| N/A
Voltage fluctuations/flicker emissions IEC61000-3-3| N/A

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.

Rated maximum output power of transmitter W(Watts)| Separation distance according to frequency of transmitter M(Meters)
150kHz to 80MHz

d=1.2 P

| 80MHz to 800MHz

d=1.2 P

| 80MHz to 2,5GHz

d=2.3 P

0,01| N/A| 0.12| 0.23
0,1| N/A| 0.38| 0.73
1| N/A| 1.2| 2.3
10| N/A| 3.8| 7.3
100| N/A| 12| 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance in metres (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

• Lepu-Creative: Remote Patient Monitoring Devices Manufacturer/Company, Vital Sign Monitor Machine CO

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