Kinetik Wellbeing Finger Pulse Oximeter - User Manual

Instructions to User

Thank you for purchasing the Kinetik Wellbeing Finger Pulse Oximeter. This manual is compiled in accordance with medical device directives and harmonized standards. Information is subject to change without notice.

This manual describes the product's structure, functions, specifications, transportation, installation, usage, operation, repair, maintenance, storage, and safety procedures. Please read it carefully before use.

⚠️ WARNING:

• Prolonged use may cause discomfort or pain, especially for patients with microcirculation barriers. It is recommended not to apply the sensor to the same finger for over 2 hours.
• For special patients, inspect the placement process carefully. Do not clip the device on edema or tender tissue.
• The emitted light (infrared is invisible) can be harmful to eyes; do not stare at it.
• Users should not use enamel or other makeup on their fingernails.
• Fingernails should not be too long.
• Refer to correlative literature for clinical restrictions and cautions.
• This device is not intended for treatment.

1 Safety

1.1 Instructions for Safe Operations

• Periodically check the main unit and accessories for visible damage that may affect patient safety or monitoring performance. Inspect the device at least weekly. Stop use if obvious damage is present.
• Necessary maintenance must be performed by qualified service engineers only.
• Do not use the oximeter with devices not specified in this manual. Only use accessories appointed or recommended by the manufacturer.
• The product is calibrated during production.

1.2 Warnings

• Explosive hazard: DO NOT use in environments with inflammable gas, such as ignitable anesthetic agents.
• DO NOT use during MRI or CT scans.
• If allergic to rubber, do not use this device.
• Dispose of scrap instruments and accessories according to local laws and regulations.
• Check the packing before use to ensure all items are present and correct, otherwise the device may work abnormally.
• Do not test this device with function test paper for device-related information.

1.3 Attentions

• Keep the oximeter away from dust, vibration, corrosive substances, explosive materials, high temperature, and moisture.
• If the oximeter gets wet, stop operating it.
• Do not use immediately after moving from a cold to a warm or humid environment.
• DO NOT operate front panel keys with sharp materials.
• High temperature or high-pressure steam disinfection is not permitted. Refer to the manual for cleaning and disinfection instructions.
• Do not immerse the oximeter in liquid. Wipe the surface with medical alcohol using a soft material for cleaning. Do not spray liquid directly onto the device.
• When cleaning with water, the temperature should be below 60℃.
• If fingers are too thin or cold, they may affect SpO2 and pulse rate measurements. Use a thicker finger (e.g., thumb or middle finger) and insert it deeply into the probe.
• Do not use on infant or neonatal patients.
• The product is suitable for children above four years old and adults (Weight between 15kg to 110kg).
• The device may not work for all patients. Discontinue use if stable readings cannot be achieved.
• Data update period is less than 5 seconds, variable by pulse rate.
• If abnormal conditions appear on the screen, remove and reinsert the finger to restore normal use.
• The device has a normal useful life of three years from the first electrified use.
• The hanging rope is made from non-allergic material. If sensitive, stop using it. Avoid wearing the hanging rope around the neck to prevent harm.
• The instrument does not have a low-voltage alarm function; it only shows a low-voltage indicator. Change batteries when they run out.
• The instrument does not have an alarm function. Do not use in situations requiring alarms.
• Remove batteries if the device is stored for over one month to prevent leakage.
• A flexible circuit connects the two parts of the device; do not twist or pull the connection.

1.4 Indication for Use

The Fingertip Pulse Oximeter is a non-invasive device intended for spot-checking of arterial hemoglobin oxygen saturation (SpO2) and pulse rate in adult and pediatric patients in home and hospital environments (including clinical use in internal medicine/surgery, anesthesia, intensive care, etc.). This device is not intended for continuous monitoring.

2 Overview

Pulse oxygen saturation (SpO2) is the percentage of oxyhemoglobin (HbO2) in total hemoglobin (Hb) in the blood, representing blood oxygen concentration. It is an important bio-parameter for respiration. Kinetik Wellbeing developed this Pulse Oximeter for easier and more accurate SpO2 measurement, which also measures pulse rate simultaneously.

Features include low power consumption, convenient operation, small size, and portability. Users place a finger into the sensor, and the display shows the measured Hemoglobin Saturation value.

2.1 Classification

• Class II b (MDD93/42/EEC IX Rule 10)
• Class II (U.S.FDA)

2.2 Features

• Simple and convenient operation.
• Small, lightweight (approx. 50g with batteries), and portable.
• Low power consumption; two AAA batteries provide approx. 24 hours of continuous operation.
• Automatic power-off when no signal is detected for 5 seconds.
• Low-battery indicator flashes the battery icon.

2.3 Major Applications and Scope of Application

The Pulse Oximeter measures human Hemoglobin Saturation and pulse rate via the finger, indicating pulse intensity by a bar display. It is suitable for home use, oxygen bars, social medical organizations, and general saturation oxygen and pulse rate measurement.

The product is not suitable for continuous patient supervision.

The device is not recommended for use in cases of carbon monoxide poisoning, as it may lead to overrating.

2.4 Environment Requirements

Storage Environment:

• Temperature: -40℃ to +60℃
• Relative humidity: ≤95%
• Atmospheric pressure: 500 hPa to 1060 hPa

Operating Environment:

• Temperature: 10℃ to 40℃
• Relative humidity: ≤75%
• Atmospheric pressure: 700 hPa to 1060 hPa

3 Principle and Caution

3.1 Principle of Measurement

The Oximeter uses Lambert-Beer Law to establish a data process formula based on the spectrum absorption characteristics of reductive hemoglobin (Hb) and oxyhemoglobin (HbO2) in glow & near-infrared zones. The instrument employs Photoelectric Oxyhemoglobin Inspection Technology and Capacity Pulse Scanning & Recording Technology. Two beams of different wavelength lights are focused onto the fingertip through a sensor. A photosensitive element obtains the measured signal, which is then processed by electronic circuits and a microprocessor for display.

[Diagram Description: Figure 1 illustrates the operating principle, showing light sources transmitting through a finger and a sensor detecting the transmitted light.]

3.2 Caution

1. Ensure proper finger placement (refer to Figure 5) for accurate measurement.
2. The SpO2 sensor and photoelectric receiving tube must be correctly positioned relative to the subject's arteriole.
3. Do not use the SpO2 sensor on a location or limb with an arterial canal, blood pressure cuff, or receiving intravenous injection.
4. Ensure the optical path is free from obstacles like rubberized fabric.
5. Excessive ambient light (e.g., fluorescent lamps, direct sunlight) can affect measurement results.
6. Strenuous subject actions or extreme electrosurgical interference may also affect accuracy.
7. Users cannot use enamel or other makeup.

3.3 Clinical Restrictions

1. Measurement relies on arteriole pulse; substantial pulsating blood flow is required. Weak pulse (due to shock, low temperature, bleeding, or vasoconstrictive drugs) can decrease the SpO2 waveform (PLETH) and increase susceptibility to interference.
2. Inaccurate SpO2 readings may occur in individuals with significant amounts of staining dilution drugs (e.g., methylene blue, indigo green, acid indigo blue), carbon monoxide hemoglobin (COHb), methionine (Me+Hb), thiosalicylic hemoglobin, or certain icterus conditions.
3. Drugs like dopamine, procaine, prilocaine, lidocaine, and butacaine can cause serious errors in SpO2 measurement.
4. While SpO2 serves as a reference for anemic anoxia and toxic anoxia, some patients with severe anemia may still report good SpO2 measurements.

4 Technical Specifications

• Display Format: Digital tube Display.
• SpO2 Measuring Range: 0% - 100%.
• Pulse Rate Measuring Range: 30 bpm - 250 bpm.
• Pulse Intensity Display: Columniation display.
• Power Requirements: 2 × 1.5V AAA alkaline batteries (adaptable range: 2.6V~3.6V).
• Power Consumption: Less than 25 mA.
• Resolution: 1% for SpO2 and 1 bpm for Pulse Rate.
• Measurement Accuracy: ±2% for 70%-100% SpO2; meaningless below 70%. ±2 bpm or ±2% (select larger) for Pulse Rate.
• Measurement Performance in Weak Filling Condition: Correctly shown when pulse-filling ratio is 0.4%. SpO2 error is ±4%, pulse rate error is ±2 bpm or ±2% (select larger).
• Resistance to Surrounding Light: Deviation less than ±1% in artificial light or indoor natural light compared to a darkroom.
• Function Switch: Equipped with a switch; powers off when no finger is detected for 5 seconds.
• Optical Sensor: Red light (wavelength 660nm, 6.65mW), Infrared (wavelength 880nm, 6.75mW).

5 Accessories

• One hanging rope.
• Two batteries.
• One User Manual.

6 Installation

6.1 View of the Front Panel

[Diagram Description: Figure 2 shows the front view of the pulse oximeter, indicating the display screen and the power/function switch button.]

6.2 Battery Installation

[Diagram Description: Figure 3 illustrates the process of installing two AAA batteries into the device, showing the correct orientation for positive and negative terminals.]

1. Refer to Figure 3 and insert the two AAA size batteries properly in the correct direction.
2. Replace the cover.

Take care when inserting batteries to avoid damaging the device.

6.3 Mounting the Hanging Rope

[Diagram Description: Figure 4 shows how to attach the hanging rope to the device by threading one end through the loop and then through the first loop to secure it.]

1. Put one end of the rope through the hole on the device.
2. Put the same end of the rope through the first loop and tighten it.

7 Operating Guide

1. Insert the two batteries correctly and replace the cover.
2. Open the clip as shown in Figure 5.
3. Place the patient's finger into the rubber cushions of the clip, ensuring it is in the correct position, and then clip the finger.
4. Press the switch button once on the front panel.
5. Keep the patient at ease and avoid shaking the finger during measurement. Measurement is not recommended if the patient is moving.
6. Read the information directly from the screen display.
7. In the boot-strap state, pressing the button resets the device.

Fingernails and the luminescent tube should be on the same side of the finger within the sensor.

[Diagram Description: Figure 5 shows a finger correctly inserted into the pulse oximeter clip, with the nail and sensor alignment indicated.]

8 Repairing and Maintenance

• Change batteries when the low-voltage symbol [low-voltage indicator] is displayed.
• Clean the device surface before use by wiping with medical alcohol and allowing it to air dry or cleaning with a dry fabric.
• Use medical alcohol to disinfect the product after use to prevent cross-infection.
• Remove batteries if the oximeter is not in use for a long time.
• The optimal storage environment is -40℃ to 60℃ ambient temperature and not higher than 95% relative humidity.
• It is advised to calibrate the device periodically or according to the hospital's calibration program. Calibration can also be performed by an appointed agent or by contacting Kinetik Wellbeing.

High-pressure sterilization cannot be used on the device.

Do not immerse the device in liquid. It is recommended to keep the device in a dry environment, as humidity may reduce its useful life or damage it.

9 Troubleshooting

10 Key of Symbols

11 Function Specification

Display Information

SpO2 Parameter Specification

• Measuring range: 0%~100% (resolution is 1%).
• Accuracy: 70%~100%: ±2%, Below 70% unspecified.
• Optical Sensor: Red light (wavelength 660nm), Infrared (wavelength 880nm).

Pulse Parameter Specification

• Measuring range: 30bpm~250bpm (resolution is 1 bpm).
• Accuracy: ±2bpm or ±2% (select larger).

Pulse Intensity

• Range: Continuous bar-graph display, stronger display indicates a stronger pulse.

Battery Requirement

• 1.5V (AAA size) alkaline batteries × 2.

Battery Useful Life

• Two batteries can work continuously for 24 hours.

Dimensions and Weight

• Dimensions: 57(L) × 31(W) × 32(H) mm.
• Weight: About 50g (with batteries).

Appendix: Electromagnetism Compatibility

Guidance and manufacturer’s declaration – electromagnetic emissions for all EQUIPMENT and SYSTEMS

Guidance and manufacturer’s declaration – electromagnetic emission

The PO6L is intended for use in the electromagnetic environment specified below. The customer or user of the PO6L should assure that it is used in such an environment.

Guidance and manufacturer’s declaration – electromagnetic immunity – for all EQUIPMENT and SYSTEMS

Guidance and manufacturer’s declaration – electromagnetic immunity

The PO6L is intended for use in the electromagnetic environment specified below. The customer or the user of PO6L should assure that it is used in such an environment.

NOTE: U_T is the a.c. mains voltage prior to application of the test level.

Guidance and manufacturer’s declaration – electromagnetic immunity – for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING

Guidance and manufacturer’s declaration – electromagnetic immunity

The PO6L is intended for use in the electromagnetic environment specified below. The customer or the user of PO6L should assure that it is used in such an environment.

Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM – for EQUIPMENT or SYSTEM that are not LIFE-SUPPORTING

Recommended separation distances between portable and mobile RF communications equipment and the PO6L

The PO6L is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the PO6L can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the PO6L as recommended below, according to the maximum output power of the communications equipment.

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.