YONGKANG YK-80A - User Manual

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Summary

User Manual Overview

General Description

Explains haemoglobin saturation and the oximeter's importance.

Intended Use and User Group

Details who can use the device and for what purpose.

Contraindications and Notes

Lists conditions where the device should not be used and important notes.

Measurement Principle and Precautions

Operation Principle Diagram

Illustrates the operational concept of the pulse oximeter.

Safety and Environmental Precautions

Covers MRI/CT, explosion hazard, sensor site checks, and ambient light.

Operational and Interference Warnings

Details adhesive tape, long-term use, dyes, and signal interference factors.

Additional Precautions and Features

Usage Conditions and Material Warnings

Includes warnings on modifications, RF interference, placement, and material allergies.

Performance and Maintenance Warnings

Covers sensor degradation, service life, EMI, and calibration advice.

Product Features Overview

Highlights key features like OLED display and gravity sensing.

Operation and Installation

Operation Instructions

Step-by-step guide for using the oximeter.

Battery and Lanyard Installation

Instructions for installing batteries and attaching the lanyard.

Front Panel and Parameter Setup

Brief Description of Front Panel

Identifies key components of the oximeter's front panel.

Parameter Setup Guide

Details how to access and configure device settings.

Detailed Product Functions

Display Type and SpO2 Specifications

Describes the OLED display and SpO2 measurement range and accuracy.

Pulse Rate and LED Probe Parameters

Details pulse rate specifications and LED probe characteristics.

PI Index, Power, and Standby

Covers PI index, battery power, and automatic standby function.

Specifications and Classification

Use Specification

Defines expected medical instructions, patient population, and environment.

Product Classification

Details management class, shock protection, and pollution degree.

Maintenance, Disposal, and Accessories

Maintenance and Preservation

Provides guidelines for battery replacement, cleaning, and storage.

Waste Disposal and Product Accessories

Outlines proper waste disposal and lists included accessories.

Electromagnetic Compatibility Declarations

Electromagnetic Emission Guidance

Manufacturer's declaration on electromagnetic emissions for equipment.

Electromagnetic Immunity Guidance

Manufacturer's declaration on electromagnetic immunity for equipment.

Electromagnetic Immunity Test Levels

Electrostatic Discharge and Burst Immunity

Specifies test levels for ESD and transient/burst immunity.

Surge and Voltage Variation Immunity

Details test levels for surge and voltage variations on power supply.

Further Immunity and Test Specifications

Power Frequency and Magnetic Field Immunity

Covers immunity to power frequency magnetic fields.

RF Wireless Communications Immunity

Provides test specifications for immunity to RF wireless communications.

Problem Solving and Definitions

Possible Problems and Resolutions

Lists common issues and their corresponding solutions for the oximeter.

Symbols and Definitions

Explains key symbols and terms used in the manual.

Statements and After-Sales Service

Manufacturers Declaration and Statements

Includes manufacturer statements and environmental use advice.

After-Sales Service Information

Details warranty, maintenance, and contact information.

This document describes the Fingertip Pulse Oximeter, a portable medical device designed for non-invasive detection of arterial SpO2 (oxygen saturation) and PR (pulse rate). It provides quick and precise measurements, making it suitable for use in hospitals, families, schools, and medical centers.

Function Description

The Fingertip Pulse Oximeter operates based on the principle of spectrum absorption characteristics of reductive hemoglobin and oxyhemoglobin (HbO2) in red and infrared light zones. It utilizes photoelectric oxyhemoglobin inspection technology combined with capacity pulse scanning and recording technology. Two lights with different wavelengths (660nm red light and 940nm infrared light) are focused onto the human nail through a clamp finger-type sensor. A photosensitive element then obtains the measured signal, which is processed by electronic circuits and a microprocessor and displayed on two groups of diodes.

Haemoglobin Saturation (SpO2) is the percentage of oxyhemoglobin (HbO2) compounded with oxygen relative to all combinable hemoglobin (Hb) in the blood. It is a critical physiological parameter for respiratory and circulatory systems. Reduced hemoglobin saturation, often caused by respiratory diseases, anesthesia, trauma, or medical examinations affecting oxygen supply, can lead to symptoms like megrim, vomiting, and asthenia. Timely monitoring of hemoglobin saturation is therefore clinically significant.

The device is designed for ease of use, requiring the patient to simply insert a finger into the photoelectric sensor for diagnosis. The measured hemoglobin saturation value is then directly displayed. Clinical experiments have demonstrated its high precision and repeatability.

Important Technical Specifications

Display Type: OLED display, double color, with six different display modes. If equipped with gravity induction, the interface can rotate through four directions.

SpO2 Measurement:

Measurement range: 70%~100%
Accuracy:
- 80%~100%: ±2% (including 80%)
- 70%~79%: ±3%
- Below 70%: No requirement
Resolution: 1%

PR Measurement:

Measurement range: 30BPM~254BPM
Accuracy:
- ≤100BPM: ±1BPM
- 100BPM: ±2BPM

LED Probe Parameters:

RED: Wavelength 660±5nm, Radiation power 1.8mW
IR: Wavelength 940±10nm, Radiation power 2.0mW
- These parameters are particularly useful for clinicians.

PI Index: Measurement scope: 0~20 (optional)

Power: Two AAA 1.5V batteries.

Low-power consumption allows for continuous operation for more than six hours.
Low voltage indicator.

Automatic Standby: The product shuts off automatically after 8 seconds of no signal.

Automatic Start-up: If equipped with this function, the instrument automatically detects the signal after 5 seconds when a finger is inserted, and boots up automatically.

Gravity Sensing Function: If equipped, the screen display changes with finger movement due to gravity sensing.

Dimension: Approximately 58mm × 36mm × 33mm

Operation Environment:

Temperature: 5 °C ~ 40 °C
Humidity: 15% ~ 80%, non-condensing
Atmospheric pressure: 70kPa ~ 106kPa

Transport, Storage Environment:

Temperature: -10 °C ~ 40 °C
Humidity: 10% ~ 95%, non-condensing
Atmospheric pressure: 70kPa ~ 106kPa, non-corrosive gas and well-ventilated

EMC Compliance: Complies with IEC60601-1-2 standard.

Alarm Function: This equipment has no alarm function and is not intended for continuous monitoring.

Data Averaging and Signal Processing Delay: The display and transmission of SpO2 data have a date update period of <12S.

Warm-up/Cool-down Time: Approximately 30 minutes are required for the oximeter to warm up from minimum storage temperature or cool down from maximum storage temperature before intended use.

Applied Parts: Probe and its circuit.

Classification:

Management Class for Medical Devices: II equipment
Anti-electric Shock Type: Internally powered equipment
Anti-electric Shock Degree: Type BF equipment
Overvoltage category classification: Class II
Pollution degree: Pollution degree 2: Micro-environment with non-conductive pollution, occasional conductivity caused by condensation.

Usage Features

User Group: Individuals who need blood oxygen measurement, including patients, doctors, and medical staff.

Contraindication: None found.

Operation Steps:

Install two AAA batteries into the battery cassette.
Plug one finger thoroughly into the rubber hole of the oximeter with the nail upwards.
Press the button on the front panel (unless equipped with automatic startup).
Avoid trembling the finger or moving the body during measurement.
Press the button to change the display direction (unless equipped with gravity sensing).
Read the data from the display screen.
The instrument enters sleep mode after 8 seconds of no signal.
Replace batteries when the OLED indicates low power.

Parameter Setup:

Access parameter setup by pressing the start button (>3s).
In Menu ① ("Alm Setup"), press the button (>3s) to enter Menu ②.
Use the button (<1s) to select items (e.g., prompt, beep, demo, screen brightness).
Press the button (>3s) to set the selected item.
To restore factory settings, press the button (>3s) when "*" is shown on "Restore".
In Menu ② ("Sounds Setup"), press the button (>3s) to enter Menu ②.
Use the button (<1s) to select items and press (>3s) to adjust data using "+" or "-" for plus or minus values.

Screen Brightness Adjustment:

Adjust screen brightness to a higher level for outdoor use or strong light conditions.
Choose a lower brightness to conserve battery power.

Cleaning and Disinfection:

Clean the rubber with medical alcohol before and after each test.
Clean the tested finger with alcohol before and after the test.
The rubber inside the oximeter is medical grade, non-toxic, and non-allergenic.

Precautions:

Do not use with MRI or CT equipment.
Do not use in explosive atmospheres.
Intended as an adjunct in patient assessment; diagnosis should be made in conjunction with clinical manifestations and symptoms.
Frequently check the sensor application site for circulation and skin integrity.
Avoid contact between the sensor and adhesive tape to prevent measurement errors or skin blisters.
The device has no SpO2 alarm and is not for continuous monitoring.
Change test sites periodically (at least every 2 hours) to prevent discomfort or tenderness, especially for patients with microcirculation disorders.
Inaccurate measurements may result from autoclaving, ethylene oxide sterilizing, or immersing sensors in liquid.
Significant levels of dysfunctional hemoglobins (e.g., carboxyl-hemoglobin, methemoglobin) or intravascular dyes (e.g., indocyanine green, methylene blue) may cause inaccurate readings.
High ambient light can adversely affect SpO2 measurements; shield the sensor area if necessary.
Unexpected actions may cause inaccurate readings.
Medical signals or interference from defibrillators may lead to inaccurate readings.
Venous pulsations may cause inaccurate readings.
Inaccurate readings may occur if the sensor and blood pressure cuff are on the same arterial catheter or intravascular line.
Hypotension, severe vasoconstriction, severe anemia, or hypothermia may cause inaccurate readings.
Cardiotonic use after cardiac arrest or patient shivering may cause inaccurate readings.
Bright or painted nails may cause inaccurate SpO2 readings.
Do not use if allergic to ABS, black silicone pad, or other materials.
If performance is inconsistent with the description, stop use and contact the manufacturer.
Do not use the measuring function to evaluate oximeter accuracy.
Degraded or loosened sensors/electrodes can cause performance issues.
Keep out of reach of children and pets to prevent falling, biting, or affecting performance.
The oximeter's height should not exceed two meters.
Do not use beyond the product's service life, as accuracy will be affected.
No modification of this equipment is allowed.
Portable RF communications equipment (including peripherals) should be used no closer than 30cm (12 inches) to any part of the oximeter to prevent performance degradation.
Avoid places with poor ventilation, high dust, and lint content.
Avoid direct sunlight and strong light sources.
The oximeter cannot be serviced or maintained during use.
Internal magnetic rings, magnetic beads, and conductive cloth are used to avoid electromagnetic interference.
Regularly change the oximeter's placement position (every 2 hours) and check its impact on the skin.

Maintenance Features

Battery Replacement: Replace batteries promptly when the low battery indicator flashes. Remove batteries if the oximeter will not be used for an extended period to prevent leakage.

Cleaning Frequency:

Home use: Clean the enclosure and silicone pad after each use if dirty. If not dirty, simply clean the black silicone pad before and after each use. Wipe and disinfect with 75% alcohol, then dry naturally or with a dry cloth, at least twice a week.
Medical institutions: Clean after each use. Clean the tested finger with 75% alcohol before use. After each measurement, wipe and disinfect the contact part between the black silicone and enclosure with 75% alcohol.

Calibration: The oximeter can display functional arterial oxygen saturation and pulse rate after calibration. The Blood oxygen simulator is calibrated to display functional oxygen saturation.

Storage: Store in -10~40°C (14-104°F) and 10%-95% humidity. Keep the product dry at all times, as a wet environment can affect its lifetime and cause damage.

Calibration and Maintenance Schedule: The Fingertip Pulse Oximeter can be maintained and calibrated once every two years.

Waste Disposal: Follow local laws and recycling instructions for disposing of waste scrap, the device, components, and used batteries.

Product Accessories:

The host: 1 set
Lanyard: 1 pcs
One user manual: 1 pcs
AAA battery (optional): 2 pcs

Manufacturer's Declaration:

The Fingertip Pulse Oximeter should be used in the specified electromagnetic environment to prevent abnormal operation.
The company can provide users with random files in email or other electronic formats if needed.

After-sales Service:

Users must read the manual before use and ensure operation and daily maintenance comply with instructions and environmental requirements.
Free maintenance is provided within the product's warranty scope, with a warranty card. Paid services are available for issues outside the warranty scope.
The main machine has a one-year warranty, and accessories have a three-month warranty from the date of purchase.
Warranty does not cover faults caused by human factors, damage due to inconsistent use with provided conditions, or damage from unauthorized disassembly or repair.
For problems, contact customer service at 400-828-6667 during business hours (Monday to Friday, 9:00 am to 5:30 pm, except national holidays).

Company Information:

Using life: 5 years
TEL: +86-516-87892766-601
FAX: +86-516-87892755-606
Web site: www.yonker.cn
Address: Xuzhou Yongkang Electronic Science Technology Co., Ltd, 1st&2nd Floor, 6#01, 6#02, No.6 Building 1st Phase Economic Development Manufacturing Zone, LIANDO U Valley, No.6 Leye Road, Xuzhou ETDZ, 221000 Xuzhou, PEOPLE'S REPUBLIC OF CHINA.
Authorized Representative of European Union: Prolinx GmbH, Brehmstr. 56, 40239 Düsseldorf, Germany.

YONGKANG YK-80A Specifications

General

Brand	YONGKANG
Model	YK-80A
Category	Medical Equipment
Language	English