Wellue POD-1W Pulse Oximeter Fingertip User Manual

Wellue POD-1W Pulse Oximeter Fingertip User Manual

Notes

It is not a medical device and should not be used for any medical purposes or any 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 of 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 the ambient temperature of over 37°C, burning hurt may occur because of overheating of the sensor in 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 the 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 in the same location for a long time, especially for users 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.
• 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

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.

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.

Attention:

• 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 wet fingers 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 strong sunshine, etc. may cause inaccuracy of 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

Indications and Icons

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

Status of	Definition
Flashing in blue	The oximeter is connecting with the mobile devices.
Blue on	The connection between the oximeter and mobile devices is established.
No display of “” icon	1. The oximeter fails to set up wireless connection with mobile device within 3 minutes. 2. Hardware failure of wireless function.

Icon : low battery voltage. Flashing value: indicates the value is over the defined limits. There also accompanies the reminding sound.

Menu Setup

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

Menu operating procedures:

1. Shortly press the 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 the Display Key to confirm the modification and exit from this setting item.
4. Move the setting item to “Exit”, and long pressing 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, and the analysis result for the pulse rhythm will be displayed on the screen as well. Continuous mode: measurement will start automatically when 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)
• 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 that exceeds the 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 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 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

Maintenance
The expected service life (not a warranty) of this device is 5 years. 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, it 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.

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 as 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

Symbols

Symbol	Description
	Type BF-Applied Part
	Manufacturer
	Date of manufacture
	Authorized Representative in the European Community
	Follow Instructions for Use.
	MRI is unsafe. Presents hazards in all MR environments as the device contains strongly ferromagnetic materials.
	Protected against spraying water and against access to hazardous parts with a tool, per IEC60529.
	Serial number
	No alarm system
	Temperature limitation

Appendix EMC

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

Table 1

REFERENCE LINK