microlife OXY 200 Fingertip Oximeter Instruction Manual

microlife OXY 200 Fingertip Oximeter

Guarantee Card

• Name of Purchaser
• Serial Number
• Date of Purchase
• Specialist Dealer

PARTS DESCRIPTION

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

This product is subject to European Directive 2012/19/EU on waste elec-trical and electronic equipment and is marked accordingly. Never dispose of electronic devices with household waste. Please seek out information about the local regulations with regard to the correct disposal of elec-trical and electronic products. Correct disposal helps to protect the environment and human health.

SYMBOLS

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 Corporation!

Intended use
The Fingertip Pulse Oximeter is a non-invasive device intended for spot- checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The portable fingertip device is indicated for adult and pediatric patients, for use at home and hospital environments.

Intended user
Professional or layperson.

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 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 incorrect application.
• Precaution : Do not self diagnose or treat based on measurement results, please always consult a doctor. The product has no contraindications. The device has no side-effects if used correctly and residual risk is acceptable.
• 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 oper-ating 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 recom-mend 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 prop-erly before use.
• Do not use the device in an MRI or CT environment.
• This device is not intended for continuous monitoring.
• 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: Based on full digital technology, the fingertip pulse oximeter non-invasively measures the actual content (oxygen saturation) of oxyhemoglobin (HbO2 ) in arterial blood using the optical transmittance method. The fingertip pulse oximeter measures the blood oxygen saturation and pulse rate of a human body via finger artery. The fingertip pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 nm, which is red light; the other is 905 nm, which is infrared-red light. Skin, bone, tissue and venous vessels normally absorb a constant amount of light over time. The photodetector in finger sensor collects and converts the light into an elec-tronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases.

Directions for use

1. Insert the batteries as described in the «Inserting the batteries» 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 recom-mended 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.
8. The device will automatically switch off after approx. 10 seconds after the finger is removed from the device.

The height of the bar graph 4 is an indication of 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
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 5 appears on the display.
Always replace both batteries at the same time.

Risk reminder
If the device detects your pulse rate is lower than 50 bpm, higher than 130 bpm or the SpO2 level is lower than 94%, there will be a warning sound alert.

Using the lanyard

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 SpO2 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.

SpO2 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.

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 automatically powered off, when no signal was detected after 10 seconds.

2. The battery power is too low to operate.

| 1.   Normal.

2.   Replace the batteries.

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 non-compliance 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: Battery.

Should guarantee service 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 guarantee does not prolong or renew the guarantee period. The legal claims and rights of consumers are not limited by this guarantee.

Technical specifications

• Model: **** Pulse Oximeter JPD-510E
• Type: **** OXY 200
• Display: **** LED display
• Software version: V 2.12

SpO 2

• Measurement range: 35 ~ 100%
• Measurement **** ≤3% (70% – 100%)
• Resolution: **** 1%

Pulse rate

• Measurement range: 25 ~ 250 bpm
• Accuracy: **** ±2 bpm
• Resolution: **** 1 bpm
• Storage conditions: -10 – +50°C / 14 – 122 °F 10 – 93% relative maximum humidity
• Automatic switch-off: Automatically shut down in 10 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: **** 50 g (including batteries)
• Dimensions: **** 62 x 37 x 32 mm
• IP Class: IP22
• Operating conditions: 5 – 40 °C / 41 – 104 °F 15 – 80% relative maximum humidity
• Reference to standards: EN ISO10993-1/-5/-10; IEC 60601-1; EN 60601-1-2; ISO 80601-2-61; EN 62304; EN 60601-1-6
• Expected service life:   5 years (when used 15 times/day; 20 minutes for each measurement)

Technical alterations reserved.

Note 1: The fingertip pulse oximeter measurements are statistically distributed, only about two-thirds of pulse oximeter equipment measurements can be expected to fall within ±2% Armse (Average-root-mean-square-error) of the value measured by a co-oximeter.
Note 2 : The statistic conclusion of a controlled desaturation study which is guided by «ISO 80601-2-61, Annex EE, guidelines for evaluating and documenting SpO2 accuracy in human subjects». The statistic result displayed the accuracy distribution between the range of 70% – 100%, which is 2.83%.

Any serious incident that has occurred in relation to the device shall be reported to the manufacturer and the competent authority of the Member State in which the user and / or the patient is established.
The device is a Class IIa medical device.

Device complies with European Regulation on medical devices EU MDR 2017/745.

EMC Information-Guidance and Manufacturer’s Declaration

1. WARNING:
   Use of this equipment adjacent to or stacked with other equipment should be avoided because it may result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

2. WARNING:
   Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic
   emissions or decreased electromagnetic immunity of this equipment and may result in improper operation.

3. WARNING:
   Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the ME equipment, including cables specified by the manufacturer. Otherwise, it may result in the degradation of the performance of this equipment could result.

Declaration – Electromagnetic Immunity

Emissions test| Compliance
RF emissions CISPR 11|

Group 1

RF emissions CISPR 11|

Class B

Harmonic emissions IEC 61000-3-2|

Not applicable

Voltage fluctuations/ flicker emissions IEC 61000-3-3

|

Not applicable

Declaration – Electromagnetic Immunity

±2 kV, ±4 kV, ±8 kV,

±15 kV air

| ±8 kV contact

±2 kV, ±4 kV, ±8 kV,

±15 kV air

Electrical fast transient / burst IEC 61000-4-4

| ± 2 kV for power supply lines

± 1 kV for input / output lines

| Not applicable
Surge IEC 61000-4-5| ± 0.5kV, ± 1 kV line(s) to lines

± 0.5kV, ± 1 kV, ± 2 kV

line(s) to earth

| Not applicable
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11| 0% UT; 0.5 cycle At 0°,

45°, 90°, 135°, 180°,

225°, 270°and 315°

0% UT; 1 cycle and 70% UT; 25/30 cycles

Single phase: at 0° 0% UT; 250/300 cycles

| Not applicable
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8| 30 A/ m| 30 A/ m
NOTE: UT is the a.c. mains voltage prior to application of the test level.

Declaration – Electromagnetic Immunity

0.15 MHz to 80 MHz

6 V in ISM bands between 0.15 MHz and 80 MHz

| Not applicable
Radiated RF IEC 61000-4-3| 10V / m

80 MHz to 2.7 GHz

| 10V / m

Declaration – IMMUNITY to proximity fields from RF wireless communications equipment

Declaration – IMMUNITY to proximity fields from RF wireless communications equipment

Immunity test

| IEC60601 test level|

Compliance level

Test frequency| Modulation| Maximum power| Immunity level
 | 385 MHz| *Pulse Modulation: 18Hz| 1.8 W| 27 V/m| 27 V/m
 | 450 MHz| FM+ 5Hz deviation:|

2 W

|

28 V/m

|

28 V/m

 | 1kHz sine
 | 710 MHz, 745 MHz,|

**Pulse Modulation: 217Hz

|

0.2 W

|

9 V/m

|

9 V/m

Radiated| 780 MHz
RF IEC 61000-| 810 MHz, 870 MHz,

930 MHz

|

**Pulse Modulation: 18Hz

|

2 W

|

28 V/m

|

28 V/m

 |

**Pulse Modulation: 217Hz

|

2 W

|

28 V/m

|

28 V/m

4-3| 1720 MHz, 1845 MHz,
| 1970 MHz
| 2450 MHz| **Pulse Modulation: 217Hz| 2 W| 28 V/m| 28 V/m
|

5240 MHz, 5500 MHz,

5785 MHz

|

**Pulse Modulation: 217Hz

|

0.2 W

|

9 V/m

|

9 V/m

* _Note –_** As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.

Note** – The carrier shall be modulated using a 50 % duty cycle square wave signal.

References

• Microlife
• Support - Microlife AG
• Preventief je gezondheid managen - Microlife Nederland - Microlife AG
• Advies of hulp nodig? | Microlife - Microlife AG

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