microlife OXY 300 Fingertip Pulse Oximeter Instruction Manual

OXY 300

Fingertip Oximeter

IB OXY N-V9 4720- Revision Date: 2020-10-30

Guarantee Card

Name of Purchaser ——————————————————

Serial Number ————————————————————

Date of Purchase ——————————————————–

Specialist Dealer ———————————————————

Beijing Choice Electronic Technology Co., Ltd.
2nd Floor, 3rd Floor and Room 410-412 4th Floor,
No. 2 Building, No. 9 Shuangyuan Road,
Shijingshan District, 100041 Beijing, People’s Republic of China

Shanghai International Holding Corp. GmbH (EUROPE)
Eiffestrasse 80, 20537 Hamburg / Germany

Pulse Oximeter

1. ON/OFF button
2. Oxygen saturation (value as a percentage)
3. Pulse rate (value in beats per minute)
4. Pulse wave (plethysmographic wave)
5. Pulse bar
6. Low battery indicator
7. Inserting the batteries
8.  Attaching the lanyard
9.  Display modes
10.  Operation principle

Dear Customer,
This Microlife fingertip pulse oximeter is a portable non-invasive device intended for spot-checking of the oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of
adults and pediatric patients. It is suitable for private use (at home, or on the go) as well as for use in the medical sector (hospitals, hospital-type facilities). It has been clinically proven to be of high precision during repeatability.

If you have any questions, problems, or want to order spare parts please contact your local Microlife-Customer Service. Your dealer or pharmacy will be able to give you the address of the Microlife dealer in your country. Alternatively, visit the internet at www.microlife.com where you will find a wealth of invaluable information on our products.

Retain instructions in a  safe place for future reference.
Stay healthy – Microlife AG!

Explanation of Symbols

| Batteries and electronic devices must be disposed of in accordance with the locally applicable regulations, not
with domestic waste.
---|---
| Read the instructions carefully before using this device.
| Type BF applied part
| Keep dry
| Manufacturer
| Date of manufacture
| No SpO2 alarm
| Low battery indicator
| Serial number
| Protected against dripping water
| Authorized Representative in the European community
| Oxygen saturation (value as a percentage)
| Pulse rate (value in beats per minute)
| Operating conditions: 5 – 40 °C / 41 – 104 °F
| Storage conditions: -20 – +55 °C / -4 – +131 °F
| CE Marking of Conformity

Important Safety Instructions

• Follow instructions for use. This document provides important product operation and safety information regarding this device. Please read this document thoroughly before using the device and keep it for future reference.

• This device may only be used for the purposes described in these instructions. The manufacturer cannot be held liable for damage caused by the incorrect application.

• Never immerse this device in water or other liquids. For cleaning please follow the instructions in the «Cleaning and Disinfecting» section.

• Do not use this device if you think it is damaged or notice anything unusual.

• Never open this device.

•  This device comprises sensitive components and must be treated with caution. Observe the storage and operating conditions described in the «Technical Specifications» section.

• Protect it from:
  – water and moisture
  – extreme temperatures
  -impact and dropping
  – contamination and dust
  – direct sunlight
  – heat and cold

•  The function of this device may be compromised when used close to strong electromagnetic fields such as mobile phones or radio installations and we recommend a distance of at least 1 m (according to 60601-1-2 table 5). In cases where you suspect this to be unavoidable, please verify if the device is working properly before use.

• Do not use the device in an MRI or CT environment.

• This device is not intended for continuous monitoring.

•  This device does not have an alarm function and is therefore not suitable for evaluating medical results.

• Do not use this device in situations where alarms are required.

• Do not sterilize this device using autoclaving or ethylene oxide sterilizing. This device is not intended for sterilization.

• If the device is not going to be used for a prolonged period the batteries should be removed.
  Ensure that children do not use this device unsupervised; some parts are small enough to be swallowed.  Be aware of the risk of strangulation in case this device is supplied with cables or tubes.
  **** Use of this device is not intended as a substitute for a consultation with your doctor.

 General Description

Oxygen saturation indicates the percentage of hemoglobin in arterial blood that is loaded with oxygen. This is a very important parameter for the respiratory circulation system.
Many respiratory diseases can result in lower oxygen saturation within human blood.

Following factors can reduce oxygen saturation: Automatic regulation of organ dysfunction caused by anesthesia, intensive postoperative trauma, injuries caused by some medical examinations. These situations may result in light-headedness, asthenia, and vomiting. Therefore, it is very important to know the oxygen saturation of a patient so that
doctors can detect problems in a timely manner.

Measurement Principles

Principle of this fingertip pulse oximeter: A mathematical formula is established making use of Lambert-Beer Law according to spectrum absorption characteristics of
deoxygenated hemoglobin (Hb) and oxyhemoglobin (HbO2) in red and near-infrared zones.

Operation principle of this device: Photoelectric oxyhemoglobin inspection technology is adopted in accordance with capacity pulse scanning and recording technology so that two beams of different wavelengths of lights (660 nm red and 905 nm near-infrared light) can be focused onto a human nail tip through a clamping finger-type sensor. A
the measured signal obtained by a photosensitive element will be shown on the display through the process in electronic circuits and microprocessors.

Diagram of Operation Principle 10 :

1. Red and infrared-ray emission tube.
2. Red and infrared-ray receipt tube.

Directions for Use

1. Insert the batteries as described in the «Inserting the batteries 7» section.
2. Insert one finger (nail side up; index or middle finger is recommended) into the finger opening of the device. Be sure to fully insert the finger so that the sensors are completely covered by the finger.
3. Release the device allowing it to clamp down on the finger.
4. Press the ON/OFF button 1 to turn the device on.
5. Do not shake your finger during the test. It is recommended that you do not move your body whilst taking a reading.
6.  Your measurement values will appear on the screen after a few seconds.
7.  Remove your finger from the device. The display will indicate «Finger Out».
8.  The device will automatically switch off after approx.
   8 seconds after the finger is removed from the device.
   The height of bar graph 5 is an indication of the pulse and signal strength. The bar should be greater than 30 % for a proper reading.
   The device must be able to measure the pulse properly to obtain an accurate SpO2 measurement.
   Verify that nothing is hindering the pulse measurement before relying on the SpO2 measurement.
   The maximum application time at a single site should be less than 30 minutes, in order to ensure correct sensor alignment and skin integrity.

Inaccurate measurements may occur if:

•  The patient suffers from significant levels of dysfunctional hemoglobin (such as carboxyhemoglobin or methemoglobin).
• Intravascular dyes such as indocyanine green or methylene blue have been injected into the patient.
•  Used in the presence of high ambient light (e.g. direct sunlight). Shield the sensor area with a surgical towel if necessary.
•  There is excessive patient movement.
•  The patient experiences venous pulsations.
•  The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia.
•  The patient is in cardiac arrest or is in shock.
•  Fingernail polish or false fingernails are applied.

Inserting the batteries 7

After you have unpacked your device, first insert the batteries. The battery compartment is on the bottom of the device. Remove the battery cover by sliding it in the direction
shown. Insert the batteries (2 x 1.5 V, size AAA),  thereby observing the indicated polarity.

Replace the batteries when the low power indicator 6 appears on the display.
Always replace both batteries at the same time.

Adjusting Display Mode and Brightness

Display Mode
When the device is switched on, shortly press the ON/OFF button 1 to switch to another display mode to select your desired display mode 9. There are 6 different display
modes. The default setting is mode 1.

Brightness
Press and hold the ON/OFF button 1 for longer than one second to adjust the brightness of the device. The display will show «Br 1-10». There are 10 levels of brightness. The default setting is level 4.

Using the Lanyard 8

1. Thread the thinner end of the lanyard through the hanging hole at the rear end of the device.
2. Thread the thicker end of the lanyard through the threaded end before pulling it tightly.

 Malfunctions and Actions to take

correctly.

2.  Patient Sp02 value is too low to be measured.

3.  There is excessive illumination.

| 1.    Retry inserting the finger.

2.    & 3. Measure more times. If you determine the product is working correctly, consult your doctor.

Sp02 or pulse rate is shown unstable.| 1.      Finger might not be inserted deep enough.

2.      Excessive patient movement.

| 1.    Retry inserting the finger.

2.    Sit calmly and retry.

The device cannot be powered on.| 1.  No batteries or low battery power.

2.  Batteries are not installed correctly.

3.  The device may be damaged.

| 1.      Replace the batteries.

2.      Remove and reinstall the batteries.

3.      Contact your local Microlife-Customer Service.

The display suddenly switches off.| 1.  The device is auto- matically powered off when no signal was detected after 8 seconds.
2.  The battery power is too low to operate.| 1.    Normal.

2.    Replace the batteries.

«Error 3»| The red emission LED is damaged.| Check the red emission LED.
«Error 4»| The infrared emission LED is damaged.| Check the infrared emission LED.
«Error 6»| The screen has failed.| Contact your local Micro- life-Customer Service.
«Error 7»| The emission LED or reception diode is damaged.| Contact your local Micro- life-Customer Service.

Cleaning and Disinfecting

Use an alcohol swab or cotton tissue moistened with alcohol (70% Isopropyl) to clean the silicone that touches the finger inside of the device. Also, clean the finger being tested using alcohol before and after each test. Allow the device to dry thoroughly before use.

**** Never use abrasive cleaning agents, thinners, or benzene for cleaning, and never immerse the device in water or other cleaning liquids.

 Guarantee

This device is covered by a 2-year guarantee from the date of purchase. During this guarantee period, at our discretion, Microlife will repair or replace the defective product free of charge.

Opening or altering the device invalidates the guarantee.
The following items are excluded from the guarantee:

•  Transport costs and risks of transport.
•  Damage caused by incorrect application or noncompliance with the instructions for use.
• Damage caused by leaking batteries.
•  Damage caused by accident or misuse.
•  Packaging/storage material and instructions for use.
•  Regular checks and maintenance (calibration).
•  Accessories and wearing parts: Batteries.

Should guarantee service to be required, please contact the dealer from where the product was purchased or your local Microlife service. You may contact your local Microlife service through our website: www.microlife.com/support

Compensation is limited to the value of the product. The guarantee will be granted if the complete product is returned with the original invoice. Repair or replacement within the guarantee does not prolong or renew the guarantee period. The legal claims and rights of consumers are not limited by this guarantee.

Technical Specifications

30 ~ 99 bpm: ±2 bpm;
100 ~ 250 bpm: ±2 %
Resolution:| 1 bpm
Operating conditions:| 5 – 40 °C /  41 – 104 °F ≤ 80 % relative maximum humidity
Storage conditions:| -20 – +55 °C / -4 – +131 °F ≤ 93 % relative maximum humidity
Automatic switch-off:| Automatically shut down in 8 seconds, when no or low signal is detected.
Battery:| 2 x 1.5 V alkaline batteries; size AAA
Battery lifetime:| approx. 30 hours (using new batteries)
Weight:| 56 g (including batteries)
Dimensions:| 58 x 32 x 34 mm
IP Class:| IPX1
Reference to standards:| EN ISO10993-1/-5/-10; IEC 60601-1;
EN 60601-1-2; EN ISO9919;
EN 62304; EN 60601-1-6; CE0123
Expected service life:| 5 years (when used 15 times/day; 20 minutes for each measurement)

Technical alterations reserved.

Distributor
Microlife AG
Espenstrasse 139
9443 Widnau / Switzerland
www.microlife.com

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