BRAUN Pulse Oximeter 1 User Manual

Pulse oximeter 1

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Questions or comments?
Call: 1-800-327-7226
Email: ConsumerRelations@HelenofTroy.com
Visit: www.BraunHealthcare.com
Certain trademarks used under license from Procter & Gamble
Company or its affiliates.

© 2021 All Rights Reserved.
Distributed by:
Kaz USA, Inc., a Helen of Troy Company
400 Donald Lynch Blvd., Suite 300
Marlborough, MA 01752

Made in China
Xuzhou Yongkang Electronic Science Technology CO., Ltd Manufacture Address: 4F C8 Building, No. 40 Jingshan Road
Economic Development District, Xuzhou, Jiangsu, China

|

Hecho en China
A005486R0
30OCT20

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Product description

1. OLED display
2. Finger clip
3. Power/Menu button
4. Lanyard

OLED display modes

Thank you for purchasing the Braun Pulse oximeter, BPX800. This pulse oximeter is a high-quality product tested in accordance with international ISO safety and performance standards. This device uses red and infrared light at set wavelengths along with a photodetector to measure oxygen saturation in the blood and the associated pulse rate.
The Braun Pulse oximeter is intended to be used by consumers in a home-use setting (such as a home setting or places of business).
Please read these instructions carefully before using this product and keep the instructions and the pulse oximeter in a safe place.

Indications for use

The Braun Pulse oximeter (BPX800) is a non-sterile, reusable device intended for spot-checking or intermittent determination of oxygen saturation in arterial blood, as well as the associated pulse rate by using the tip of the finger as the measurement site. The device is intended for people 12 years of age or older, in a home-use environment (such as a home setting or places of business). The pulse oximeter displays the %SpO2, pulse rate, as well as pulse amplitude using a vertical bar graph.

WARNINGS AND PRECAUTIONS

Please read the manual carefully before use. The device isn’t suitable for continuous monitoring. Pulse oximeters are sensitive to motion. Keep hands still while taking a reading. Pulse oximeters require sufficient blood flow to obtain proper readings. Poor blood circulation can result in inaccurate readings. If your hands are cold or if you have poor circulation, warm your hands by rubbing them together or use another warming method before attempting to obtain a reading. A tourniquet, blood pressure cuff, other devices, or clothing that cause blood flow restrictions may also result in inaccurate readings. Fingernail polish or acrylic nails obstruct the light transmission through the fingertip and may also result in inaccurate readings. Your finger must be clean for a proper reading. The Pulse oximeter should be clean in order to get a proper reading. Please ensure the finger clip area is cleaned, following the cleaning instruction in the manual. If reading is difficult to obtain, switch to another finger or to the other hand. The index or middle finger is recommended for taking measurements. There are a number of other conditions which may lead to an inaccurate reading; including but not limited to, recent medical tests that included an injection of dyes, use of arterial catheters, a weak pulse, low levels of hemoglobin in the blood, low perfusion (the quality of your pulse), elevated levels of dysfunctional hemoglobin, the strength and type of light that you are in while using the pulse oximeter, and the existence of cell phones, radios, and fixed transmitters within certain ranges of the pulse oximeter during use. This device does not provide a low SpO2 alarm.

DO NOT use on the same finger continuously for over 2 hours. The device is not appropriate for the constant monitoring
of the user. Prolonged and continuous monitoring may increase the potential of unexpected changes of dermal conditions such as putrescence, etc. A feeling of discomfort or pain may occur if using the device continuously, especially for those users who experience poor perfusion or immature dermographia by light collimation. In addition to the items described in the Warnings and precautions section, inaccurate measurements may be caused by factors including but not limited to:

• Immersing the device in liquid.
• Significant levels of dysfunctional hemoglobin (such as carboxyhemoglobin or methemoglobin).
• Intravascular dyes such as indocyanine green or methylene blue.
• Measurements may be adversely affected in the presence of high ambient light such as direct sunlight. In bright light conditions, cover the sensor area if necessary.
• Excessive user movement.
• High-frequency electrosurgical interference and defibrillators.
• Venous pulsations.
• Hypotension, severe vasoconstriction, severe anemia, or hypothermia.
  DO NOT modify this equipment without the authorization of the manufacturer.

Fingertip pulse oximetry General description

Oxygen mixes with blood in the lungs and is transported in blood mainly by hemoglobin. Chemically the oxygen molecule combines loosely and reversibly with the heme portion of the hemoglobin. The amount of oxygen that combines with hemoglobin is determined by the partial pressure of oxygen. The amount of oxygen in the blood expressed as a percentage of hemoglobin saturation is a measure of oxygen (SaO2) in the artery and is estimated by a pulse oximeter as a SpO2 reading.

The amount of oxygen in the blood (as measured by the pulse oximeter SpO2 reading) is a very important physiological parameter in respiratory and circulatory systems. Many respiratory diseases reduce the oxygen-hemoglobin saturation in human blood. Moreover, factors such as Automatic Organic Regulation Malfunction caused by anesthesia, trauma resulting from major surgery or medical examination, or other diseases due to virus or bacteria can also cause a reduction in oxygen hemoglobin saturation in arterial blood which can be detected by the pulse oximeter through a low SpO2 reading. This can result in symptoms such as depression, vomiting, and asthenia in patients.

The fingertip pulse oximeter is a compact, low-power consumption, portable device. When the index finger is inserted into the fingertip photoelectric sensor, the display screen of the Braun Pulse oximeter will show the measured value of %SpO2 and pulse rate as well as a vertical bar graph showing the pulse amplitude.

Measurement principle

Pulse oximetry is based on the difference in the selective absorption of red light by oxygenated blood or oxyhemoglobin (HbO2, which is bright red) as compared to deoxyhemoglobin (Hb, which is dull red) or deoxygenated blood. This selective absorption is based on the Beer-Lambert Law. A red (660nm) and infrared LED (940nm) on the top portion of the prospective clamp finger-type sensor emits light at these two frequencies. The red light transmitted through the finger is selectively absorbed by the oxygenated arterial blood and the remaining light is detected by a photodetector on the lower portion of the clamp finger. The infrared light then passes through the finger without any selective absorption and is detected by the photodetector on the lower side of the clamp. The transmitted light captured by the photodetector is converted into a voltage or current signal and then passed through signal conditioning and filtering circuits using a microprocessor. %SpO2 is then derived by analyzing the changes in the amplitude of these pulsatile signals derived from the photodetector and calibrating them using pulse scanning and recording technology. The pulse rate is then derived from these associated waveforms.

How to use your Braun Pulse oximeter Installing and replacing batteries (initial set up)

Push down on the battery cover to remove it from the device.

Install 2 AAA batteries.

Replace the battery cover.

Taking a measurement

Press on top and bottom housing to open the rubber finger clip.

Insert finger with nail facing up into rubber finger clip.
It is recommended that you use the oximeter on your index finger.

Make sure your finger is fully inserted into the device and not pressed hard into a surface.
Press the Power/Menu button on the top of the device.

Keep your finger steady while taking measurements.

Rotating the display
If you want to change the display direction, press and release (approx. 1 second) the Power/Menu button on the front panel. The display can be viewed in 6 different orientations.

Care and cleaning

Use 70% alcohol to clean the pulse oximeter finger insert area and your finger, before and after each test.
Parameter set up

Press the Power/Menu button to turn on the device. With the device turned on, press and hold the Power/Menu button to change the display mode.

Press and hold the Power/Menu button (approx. > 3seconds) until you enter the parameter setup menu 1 and hold down again (approx. 3 seconds) to enter screen 2.

1. In menu 1 or 2 press the Power/Menu button to cycle through the various parameters. You will see the * move to each parameter as you cycle through. When you are at the parameter you wish to change, press the Power/Menu button for 3 seconds to change the parameter setting.
2. If you wish to restore to factory settings, move the * to the restore selection on menu 1 and hold the Power/ Menu button down for approximately 3 seconds.
3. To exit the menus and return to the measurement screen, move the * to the exit selection on menu 1 or 2 and hold the Power/Menu button for 3 seconds, or simply wait 10-12 seconds without interacting with the device and it will return to the measurement screen.

Attention
If using the device outdoors or under strong light, please increase the screen brightness to improve legibility. Choose a lower screen brightness to conserve battery power.

Limited 1-year warranty

A. This 1-year limited warranty applies to repair or replacement of products found to be defective in material or workmanship. This warranty does not apply to damage resulting from commercial, abusive, unreasonable use, or supplemental damage. Defects that are the result of normal wear and tear will not be considered manufacturing defects under this warranty. KAZ IS NOT LIABLE FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY NATURE, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE ON THIS PRODUCT IS LIMITED IN DURATION TO THE DURATION OF THIS WARRANTY. Some jurisdictions do not allow the exclusion or limitation of incidental or consequential damages or limitations on how long an implied warranty lasts, so the above limitations or exclusions may not apply to you.

This warranty gives you specific legal rights and you may also have other rights which vary from jurisdiction to jurisdiction. This warranty applies only to the original purchaser of this product from the original date of purchase. B. At its option, Kaz will repair or replace this product if it is found to be defective in material or workmanship. C. This warranty does not cover damage resulting from any unauthorized attempts to repair or from any use not in accordance with the instruction manual. Call us toll-free at 1-800-327-7226 or e-mail: consumerrelations@helenoftroy.com. Please be sure to specify a model number.

NOTE : IF YOU EXPERIENCE A PROBLEM, PLEASE CONTACT CONSUMER RELATIONS FIRST OR SEE YOUR WARRANTY. DO NOT RETURN THE PRODUCT TO THE ORIGINAL PLACE OF PURCHASE. DO NOT ATTEMPT TO OPEN THE DEVICE HOUSING YOURSELF, DOING SO MAY VOID YOUR WARRANTY AND CAUSE DAMAGE TO THE PRODUCT OR PERSONAL INJURY.

Errors and troubleshooting

inserting the finger Try a few more times

If you can make sure that there is no problem with the product, please go to the hospital in a timely manner for an exact diagnosis

Sp02 or PR reading is unsteady| Anger is not fully inserted into the device
User is moving or finger is shaking| Retry by correctly inserting the finger
Remain as still as possible
The oximeter can not be turned on| Inadequate power or power off Batteries are installed incorrectly
The oximeter might be damaged| Replace the batteries
Please reinstall the batteries
Please contact the customer service center
Unit turned off| The product automatically shuts off when no signal can be detected within 8 seconds
Inadequate power| Normal
Replace the batteries
Low battery displayed| Batteries need to be replaced| Replace the batteries

Product specifications

Type:
Display Type:
SpO2 Measurement range:
Accuracy:Resolution: PR Measurement range:
Accuracy:Resolution:
Power Supply:
Power Consumption:
Automatically Power-off:Dimension:
Operation Environment:
Operation Temperature:
Storage Temperature:
Operation Humidity:
Storage Humidity:
Air Pressure:| Braun Pulse oximeter, BPX800US
OLED display
70% – 100%
80% – 100% ±2%
70% – 79% ±3%
±1%
30BPM~254 BPM
≤ 100 ±1 BPM

100 ±2 BPM
±1 BPM
two AAA 1.5V alkaline batteries
below 30mAh
The product automatically shuts off
when no signal can be detected
within 8 seconds
Approx. 58mm×35mm×30mm
41 ºF ~ 104 ºF (5 ºC~40 ºC)
14 ºF ~ 104 ºF (-10 ºC~40 ºC)
15%~80%
10%~95%
70kPa~106kPa
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This device conforms to the following standards:

IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety, and essential performance.

IEC 60601-1-2: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests.

IEC 60601-1-11: Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.

ISO 80601-2-61: Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.

ISO 10993-1  biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process.

ISO 10993-5: Biological evaluation of medical devices – Part 5: Tests for In Vitro cytotoxicity.

ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.

ISO 15223-1: Medical devices – Symbols to be used with medical device labels, labeling and information to be supplied – Part 1: General requirements.

ISO 14971 – Medical Devices – Application Of Risk Management To Medical Devices

IEC 62366 – Medical devices – Part 1: Application of usability engineering to medical devices

Maintenance and storage

1. Replace the batteries when the low voltage symbol is lit.
2. Clean the surface of the oximeter before it is used to take a measurement.
3. Remove the batteries if you will not use the oximeter for an extended amount of time.
4. For product preservation store the device in 14-104 ºF (-10~40 ºC) and 10%-95% humidity.
5. It is recommended that the product should be kept dry at all times. Excessive humidity might affect its lifetime and even damage the product.

To protect the environment, dispose of empty batteries at appropriate collection sites according to national or local regulations.

Product accessories

One lanyard
One user manual
2 AAA 1.5V alkaline batteries

Manufacturer’s Declaration—Electromagnetic Radiation—To Other Equipment and Systems

The pulse oximeter I designed to be used in specified electromagnetic eivirorrnent. Users of the pulse oximeter must use it in the to bowing erwirorrnents.

Radiation Test| Compliance| Electromagnetic Environment- Guidance
PS interference CtSPR 11| Group 1| RE signal of the pulse oximeter is simply created by its internal function. Therefore. its RP interference is very low and is not likely to cause any interference to nearby electronic equipment.
RP interference OISF’R 11| Pass B| Thaulse oximeter is applicable to all including in one. including communities and domestic buildings which are directly corrected to the public low-voltage power supply network.

Symbols and definitions

Type BF Applied Part| Operating Humidity

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Operating temperature
| Consult Instructions for Use

IP22

Guidance and manufacturer’s declaration – electromagnetic immunity

The BPX800 is intended for use in the electromagnetic environment specified below.
The customer or the user of the BPX800 should ensure that it is used in such an environment.

Phenomenon| Basic standard or test method| IMMUNITY TEST LEVELS
HOME HEALTHCARE ENVIRONMENT
ELECTROSTATIC| IEC 6100-4-3| ± 8 kV Contact
± 2 kV, ± 8kV, ± kV, ± 15kV air
Radiated RFEM fetas “| IEC 61000-4-3| 10 V/m f)

80 MHz – 2.7 GHz b)
80% AM at kH c)

Proximity fields from RF wireless communications equipment| IEC 6100-4-3| See RF wireless communication equipment immunity table below
RATED power frequency magnetic fiets”)| IEC 61000-4-8| ’30 A/m g)
50 Hz or 60 Hz

a) The interface between the PATIENT physiological signal simulation. if used. and the ME EQUIPMENT or

ME SYSTEM shall be located within 0.1 m of the vertical plane of the uniform field area in one orientation of the ME EQUIPMENT Of ME SYSTEM.

b) ME EQUIPMENT and ME SYSTEMS that intentionally receive RF electromagnetic energy for the purpose of their operation shall be tested at the frequency of reception. Testing may be performed at other modulation frequencies identified by the RISK MANAGEMENT PROCESS. This test assesses the BASIC SAFETY and ESSENTIAL PERFORMANCE of an intentional receiver when an ambient signal Is In the passband. It Is understood that the receiver might not achieve normal reception during the test.

c) Testing may be performed at other modulation frequencies Identified by the RISK MANAGEMENT PROCESS.

d) Applies only BP ME EQUIPMENT and ME SYSTEMS with magnetically sensitive components Or Circuitry.

e ) During the test, the ME EQUIPMENT or ME SYSTEM may be powered at any NOMINAL input voltage, but with the same frequency as the test signal (see Table 1).

f ) Before modulation is applied.

g ) This test level assumes a minimum distance between the ME EQUIPMENT Or fa SYSTEM and sources of the power-frequency magnetic field of at least 15 cm. If the RISK ANALYSIS shows that the ME EQUIPMENT Or ME SYSTEM will be used closer than 15 cm to sources of the power-frequency magnetic field, the IMMUNITY TEST LEVEL shall be adjusted es appropriate for the minimum expected distance.

Guidance and manufacturer’s declaration – electromagnetic emissions

The BPX800 equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the BPX800 should ensure that it is used in such an environment.
Emissions Test| Compliance| Electromagnetic environment – guidance
RF Emissions
CISPR 11| Group 1| The ME equipment uses RF energy only for Its internal function.
Therefore, its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
RF Emissions
CISPR 11| Class 8| Compiles
Harmonic emissions
IEC 61000-3-2| Not
Applicable| The ME equipment Is solely battery powered. Not
Voltage fluctuations/
flicker emissions| Applicable

References

• Braun Healthcare US | Accurately. Confidently. Braun.

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