Kinetik Wellbeing JPD-500E - Pulse Oximeter Manual

Instructions to User

This Manual is written and compiled in accordance with the council directive MDD 93/42/EEC for medical devices and harmonized standards. In case of modifications and software upgrades, the information contained in this document is subject to change without notice.
Please read the User Manual carefully before using this product.

• Discomfort or pain may occur if using the device for long periods of time, especially for microcirculation barrier patients. It is recommended that the sensor is not applied to the same finger for over 2 hours.
• The light (infrared is invisible) emitted from the device is harmful to the eyes, so the user and all maintenance should not stare at the light.
• Enamel or acrylic nail polish or other nail applications may distort and/or produce inaccurate readings.
• Please refer to the correlative literature about any clinical restrictions or cautions.
• This device is not intended for treatment.

Safety

Instructions for Safe Operation

• Check the main unit and all accessories periodically to make sure that there is no visible damage that may affect patient's safety and monitoring performance about cable and transducers. It is recommended that the device is inspected once a week at least. When there is obvious damage, stop using the monitor.
• Necessary maintenance must be performed by qualified service engineers ONLY. Users are not permitted to maintain it by themselves.
• The oximeter cannot be used together with devices not specified in the User Manual. Only accessories appointed or recommended by the manufacture can be used with this device.
• This product is calibrated before leaving factory.

Warnings

• Explosive hazard: DO NOT use the oximeter in an environment with inflammable gas such as ignitable anaesthetic agents.
• DO NOT use the oximeter if the user is being measured by an MRI or CT scan.
• DO NOT use the device if allergic to rubber.
• The disposal of scrap material, the device's accessories and packaging (including batteries, plastic, foam and paper) should follow the local laws and regulations.
• Please check the pack's contents before use to make sure the device and accessories are in accordance with the packing list, otherwise the device may work abnormally.

Attentions

• Keep the oximeter away from dust, vibration, corrosive substances, explosive materials, high temperature and moisture.
• If the oximeter gets wet, stop operation.
• If the device is moved from a cold environment to a warm or humid environment, please do not use it immediately.
• High temperature or high pressure steam disinfection of the oximeter is not permitted. Refer to section 7 of the User Manual for instructions on cleaning and disinfection.
• Do not immerge the oximeter in liquid. To clean, wipe its surface with alcoholic wipes. Do not spray any liquid on the device directly.
• Do not use the device on small children and babies.
• The product is suitable for 4+ years old and for those who weigh between 15kg – 110kg.
• The device may not work for all patients. If you are unable to achieve stable readings, discontinue use.
• The update period of data is less than 5 seconds, which may change according to the individual's pulse rate.
• The device has a normal lifespan of five years since the first electrified use.
• The device shows low-voltage but does not have a low-voltage alarm function. Please change the battery when the battery dies.
• Batteries must be removed if the device is going to be stored for more than a month in case batteries leak.

Indication for use

The Finger Pulse Oximeter is a non-invasive device intended for the spot-check of oxygen saturation of arterial haemoglobin (SpO2) and the pulse rate of adult and paediatric patients in home and hospital environments (including clinical use in internist/surgery, anaesthesia, intensive care etc.) This device is not intended for continuous monitoring.

Overview

The pulse oxygen saturation is the percentage of HbO2 in the total Hb in the blood, also known as the O2 concentration in the blood. It is an important bio-parameter for respiration. For the purpose of measuring the SpO2 more easily and accurately, our company developed the Finger Pulse Oximeter. The device can also measure pulse rate simultaneously.
The Pulse Oximeter features a convenient operation, low power consumption, small size and portability.
small volume, low power consumption, convenient operation and portability. A patient needs to put just one finger onto the photoelectric sensor for diagnosis, and a display screen will directly show the measured value of Haemoglobin Saturation.

Classification

Class II b (MDD 93/42/EEC IX Rule 10)

Features

• Simple and convenient operation
• Small size, lightweight and portable (total weight is 50g est. including batteries)
• Low power consumption
• The product will automatically turn off when out of use for over 16 seconds

Major Applications and Scope of Application

The Pulse Oximeter can be used to measure Haemoglobin Saturation and pulse rate through the finger, and indicate the pulse intensity by the bar-display. The product is suitable for use at home, in hospital, oxygen bar, social medical organisations and to measure oxygen saturation and pulse rate.
The product is not suitable for continuous supervision of patients.
The product is not suitable for use in continuous supervision for patients.

Environment Requirements

Operation Temperature: 5ºC-40ºC
Storage Temperature: -10ºC-50ºC
Ambient Humidity: 15%-80% RH, no condensation in operation
10%-93% RH, no condensation in storage
Atmospheric Pressure: 70 kPa to 106 kPa, in operation 50kPa–106 kPa, in storage

Principle and Caution

Principle of Measurement

Principle of Oximeter: An experienced formula of data processing is established using Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive Haemoglobin (Hb) and Oxyhaemoglobin (HbO2) in glow & near-infrared zones.
Operation of Oximeter: Photoelectric Oxyhaemoglobin inspection
Technology is adopted in accordance with Capacity Pulse Scanning & Recording Technology, so that two beams of different wavelength of lights can be focused onto the fingertip through a perspective clamp finger-type sensor. The measured signal can be obtained by a photosensitive element, information acquired through which will be shown on screen through treatment in electronic circuits and a microprocessor.

Caution

1. Place the finger properly (see Figure 5) to avoid inaccurate measurement.
2. The SpO2 sensor and photoelectric receiving tube should be arranged with the subject's arteriole in between.
3. Excessive ambient light may affect the measuring result. This includes fluorescent lamps, dual ruby lights, infrared heaters direct sunlight and etc.
4. Strenuous action or extreme electrosurgical interference may also affect the accuracy.

Accessories

Installation

View of the Front panel

Battery

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

Please take care when you insert the batteries as improper insertion may damage the device.

Attaching the Lanyard

1. Put one end of the lanyard through the hole.
2. Put the other end of the lanyard through the first one and tighten.

Operating Guide

1. Insert the two batteries properly to the direction, and then replace the cover.
2. Open the clip as shown in Figure 5.
   
   
3. Place finger into the clip with the fingertip over the sensor, and then clip the finger.
4. Press the button once on the front panel.
5. Do not shake the finger and remain still during the process.
6. Read the information on the screen display.
7. In boot-strap state press the button and the device will reset.

Fingernails and the luminescent tube should be on the same side.

Repairing and Maintenance & cleaning and disinfection

Troubleshooting

Key of Symbols

Symbol	Description
	Type BF applied part
	Warning, see User manual.
	The pulse oxygen saturation (%)
	Pulse rate (bpm)
	The battery voltage indication is deficient (change the battery in time avoiding the inexact measure)
	No finger inserted An indicator of signal inadequacy
	When end users abandon this product, they must send the product to the collection place for recycling.
IP22	Ingress of liquids rank

Technical Specification

Electromagnetism Compatibility

Guidance and manufacture's declaration – electromagnetic emissions-for all EQUIPMENT and SYSTEMS

Warranty

Your product is warranted to be free of defects in materials and workmanship for one year from the original purchase date. The device was built to exacting standards and carefully inspected prior to shipment. In the event of a defect covered by this warranty there is the option to repair or replace the device. This warranty does not cover device failure due to owner misuse or negligence, or normal wear and tear. If you have questions about your device or the warranty, please contact the local distributor.

	WellKang Ltd Suite B, 29 Harley Street, London W1G 9QR, UK
	Shenzhen Jumper Medical Equipment Co., Ltd Address: Building D, No. 71, Xintian Road, Fuyong Street, Baoan, Shenzhen, Guangdong, P. R. China, 518103