BIOS Medical 110PO Diagnostics Portable Oximeter User Manual

BIOS Medical 110PO Diagnostics Portable Oximeter

Product Information

The Fingertip Pulse Oximeter is a handheld non-invasive device used for spot- checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent, and child patients in hospitals, hospital-type facilities, and homecare. The product features dual-color OLED displays SpO2, PR, PI (Perfusion Index), Pulse bar, and waveform. It has low power consumption, real-time battery status indication, and automatically powers off after 8 seconds when no signal or low signal is detected. The product comes with one lanyard, two AAA batteries, one carrying case, and one user’s manual.

Product Usage Instructions

1. Slide the battery door cover horizontally along the arrow as shown in the picture.
2. Install two AAA batteries into the battery compartment. Match the plus (+) and minus (-) signs in the compartment. If the polarities are not matched, damage may be caused to the oximeter.
3. Close the battery door. Please remove the batteries if the pulse oximeter will not be used for long periods of time. Please replace the battery when the power indicator starts flickering.
4. Place clamp over finger nail as shown in the right diagram.
5. Insert one finger into rubber hole of the oximeter fully.
6. Press the switch on the front panel.
7. Try to keep still while measuring.
8. Read corresponding data from display screen.
9. After turning on the oximeter, each time you press the power switch, the oximeter will switch to another display mode. There are 7 display modes shown as follows:

• SpO2 value and pulse rate value
• Waveform and bar graph for pulse rate
• Waveform and bar graph for SpO2
• PI (Perfusion Index) value and pulse rate value
• Waveform and bar graph for PI (Perfusion Index)
• Waveform and bar graph for pulse rate, SpO2, and PI (Perfusion Index)
• Display mode with battery status icon

Note: The Fingertip Pulse Oximeter is not for continuous monitoring. For troubleshooting assistance, please contact Consumer Support at 1 866-517-2970. Our representatives are trained to provide you assistance over the phone and may be able to resolve your problem without returning. For the best possible assistance, please have your unit available when calling us.

General Description

Oxygen binds to hemoglobin in red blood cells when moving through the lungs. It is transported throughout the body as arterial blood. A pulse oximeter uses two frequencies of light (red and infrared) to determine the percentage (%) of hemoglobin in the blood that is saturated with oxygen. The percentage is called blood oxygen saturation, or SpO2. A pulse oximeter also measures and displays the pulse rate at the same time it measures the SpO2 level. Diagram of Operation Principle

1. Red and Infrared-ray Emission Tube
2. Red and Infrared-ray Receipt Tube

Precautions For Use

1. Before use, carefully read the manual.
2. Operation of the fingertip pulse oximeter may be affected by the use of an electrosurgical unit (ESU).
3. The fingertip pulse oximeter 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.
4. Do not use the fingertip pulse oximeter in an MRI or CT environment.
5. Do not use the fingertip pulse oximeter in situations where alarms are required. The device has no alarms. It is not for continuous monitoring.
6. Do not use the fingertip pulse oximeter in an explosive atmosphere.
7. The fingertip pulse oximeter is intended only as an adjunct in patient assessment. It must be used in conjunction with other methods of assessing clinical signs and symptoms.
8. In order to ensure correct sensor alignment and skin integrity, the maximum application time at a single site for our device should be less than half an hour.
9. Do not sterilize the device using autoclaving, ethylene oxide sterilizing, or immersing the device in liquid. The device is not intended for sterilization.
10. Follow local ordinances and recycling instructions regarding disposal or recycling of the device and device components, including batteries.
11. This equipment complies with IEC 60601-1-2:2014 for electromagnetic compatibility for medical electrical equipment and/or systems. However, because of the proliferation of radio-frequency transmitting equipment and other sources of electrical noise in healthcare and other environments, it is possible that high levels of such interference due to close proximity or strength of a source might disrupt the performance of this device.
12. Portable and mobile RF communications equipment can affect medical electrical equipment.
13. This equipment is not intended for use during patient transport outside the healthcare facility
14. This equipment should not be used adjacent to or stacked with other equipment.
15. It may be unsafe to:
    • use accessories, detachable parts and materials not described in the instructions for use
    • interconnect this equipment with other equipment not described in the instructions for use
    • disassemble, repair or modify the equipment
16. The materials that contact the patient’s skin contain medical silicone and ABS plastic enclosure. They all pass the ISO10993-5 Tests for invitro cytotoxicity and ISO10993-10 Tests for irritation and delayed-type hypersensitivity.
17. When the signal is not stable, the reading may be inaccurate. Please do not reference.

Inaccurate measurements may be caused by

1. 1. Significant levels of dysfunctional hemoglobin (such as carbonyl – hemoglobin or methemoglobin).
   2. Intravascular dyes such as indocyanine green or methylene blue.
   3. High ambient light. Shield the sensor area if necessary.
   4. Excessive patient movement.
   5. High-frequency electrosurgical interference and defibrillators.
   6. Venous pulsations.
   7. Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line.
   8. The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia.
   9. The patient is in cardiac arrest or is in shock.
   10. Fingernail polish or false fingernails.
   11. Weak pulse quality (low perfusion).
   12. Low hemoglobin.

Product Features

1. Dual colour OLED displays SpO2, PR, PI (Perfusion Index), Pulse bar, and waveform.
2. Low power consumption; real-time battery status indication.
3. Automatically power off; 2 AAA alkaline batteries
4. When no signal or low signal is detected, the pulse oximeter will power off automatically in 8 seconds.

Contraindication
It is not for continuous monitoring

Intended Use
The Fingertip Pulse Oximeter is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent and child patients in hospitals, hospital-type facilities and homecare.

Operation Instructions

1. Install two AAA batteries into battery compartment correctly.
2. Place clamp over finger nail as in the right diagram.
3. Insert one finger into rubber hole of the oximeter fully.
4. Press the switch on the front panel.
5. Try to keep still while measuring.
6. Read corresponding data from display screen.
7. Seven display modes After turning on the oximeter, each time you press the power switch, the oximeter will switch to another display mode. There are 7 display modes shown as follows:

When you press the power switch for more than one second, the brightness of the oximeter will be changed by degrees. The default level is set to 4. There are 10 levels of brightness that are shown as BR1, BR2, BR3, up to BR10. The setting is shown on the display as the numbers cycle through all levels while the power button is held.
NOTE: Please use medical alcohol to clean the rubber inside the oximeter, and clean the test finger using alcohol before and after each test. (The rubber inside of the oximeter is a medical rubber, which has no toxins and is not harmful to the skin of a person).

Product Accessories

1. One lanyard
2. Two AAA batteries
3. One user’s manual
4. One carrying case

Battery Installation

1. Slide the battery door cover horizontally along the arrow as shown in the picture.
2. Install two AAA batteries into the battery compartment. Match the plus (+) and minus (-) signs in the compartment. If the polarities are not matched, damage may be caused to the oximeter.
3. Close the battery door.

Notes:

1. Please remove the batteries if the pulse oximeter will not be used for long periods of time.
2. Please replace the battery when the power indicator starts flickering.

Maintenance and Storage

1. Replace the batteries in a timely manner when low voltage lamp is lighted.
2. Clean surface of the fingertip oximeter before it is used in diagnosis for patients.
3. Remove the batteries if the oximeter is not operated for a long time.
4. It is best to store the product in -25°C ~+70°C and ≤93% humidity.
5. Keep in a dry place. Extreme moisture may affect oximeter lifetime and may cause damage.
6. Dispose of battery properly; follow any applicable local battery disposal laws.

Cleaning the fingertip pulse oximeter
Please use a soft cloth dampened with 70% isopropyl alcohol to clean the silicone touching the finger inside of the oximeter. Also clean the finger being tested with alcohol before and after each measurement. Do not pour or spray liquids onto the oximeter, and do not allow any liquid to enter any openings in the device. Allow the oximeter to dry thoroughly before reuse.
The fingertip pulse oximeter requires no routine calibration or maintenance other than replacement of batteries.
The use life of the device is five years when it is used for 15 measurement per day (10 minutes per measurement). Stop using and contact local service center if one of the following cases occurs:

• An error in the Possible Problems and Solutions is displayed on screen.
• The oximeter cannot be powered on in any case not due to low/depleated battery.
• There is a crack on the oximeter or damage on the display causing readings to not be identified; the spring is invalid; or the key is unresponsive or unavailable.

Disinfecting
The applied parts touching the patients’ body are required to be disinfected once after each use. The recommended disinfectants include: ethanol 70%, isopropanol 70%, glutaraldehyde-type 2% liquid disinfectants. Disinfection may cause damage to the equipment and is therefore not recommended for this pulse oximeter unless otherwise indicated in your hospital’s servicing schedule. Clean the pulse oximeter before disinfecting it.
CAUTION: Never use EtO or formaldehyde for disinfection.

Specifications

1. Display Type: OLED display

2. SpO2

   • Display range: 0%~100%
   • Measurement range: 70%-100%
   • Accuracy: 70%~100%: ±2%; 0%~69% no definition
   • Resolution: 1%
     A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or sensor. Clinical testing is used to establish the SpO2 accuracy.
     The measured arterial hemoglobin saturation value (SpO2) of the sensors is compared to arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a laboratory CO-oximeter. The accuracy of the sensors in comparison to the CO-oximeter samples measured over the SpO2 range of 70%– 100%. Accuracy data is calculated using the root-mean-squared (Arms value) for all subjects, per ISO 9919:2005, Medical Electrical Equipment–
     Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use.
     A functional tester is used to measure how accurately Fingertip Pulse Oximeter is reproducing the specified calibration curve and the PR accuracy.
     The model of functional tester is Index II FLUKE simulator and the version is 2.1.3.

3. Pulse Rate

   • Display range: 30bpm~250bpm
   • Measure range: 30bpm~250bpm
   • Accuracy: 30bpm~99bpm, ±2bpm; 100bpm~250bpm, ±2%
   • Resolution: 1bpm

4. PI

   • Display range: 0.1%~20%
   • Measure range: 0.3%~20.0%
   • Resolution: 0.1%

5. Probe LED Specifications**
    | Wavelength| Radiant Power**
   ---|---|---
   RED| 660±3nm| 3.2mW
   IR| 905±10nm| 2.4mW

NOTE: The information about wavelength range can be especially useful to clinicians.

6. Power Requirements

7. Two AAA alkaline Batteries

   • Power consumption: Less than 40mA
   • Battery Life: Two AAA 1.5V, 1200mAh alkaline batteries could be continuously operated as long as 18 hours.

8. Environment Requirements

   • Operation Temperature: 5°C ~ 40°C
   • Storage Temperature: -25°C ~ +70°C
   • Ambient Humidity: 15%~ 93% no condensation in operation; ≤93% no condensation in storage/transport
   • Atmosphere pressure: 70kPa~106kPa

9. Equipment Response Time
   As shown in the following figure.(Figure 1) Response time of slower average is 8s.

10. Classification

    • According to the type of protection against electric shock: INTERNALLY POWERED EQUIPMENT;
    • According to the degree of protection against electric shock: TYPE BF APPLIED
    • PART (applied part: the rubber hole of the device);
    • According to the degree of protection against ingress of water: IP22;
    • According to the mode of operation: CONTINUOUS OPERATION.

Clinical Study Summary

The following details are provided to disclose actual performance observed in the clinical validation study of healthy adult volunteers. The ARMS value analysis statement and Bland-Altman plot of data is shown as following:
ARMS Value Analysis Statement

Possible Problems and Solutions

2. Patient’s SpO2 value is too low to be measured

| 1. Retry by inserting the finger

2. There is excessive illumination

3. Try measuring again. If you are sure no problem

exists with the product, please go to a hospital for timely diagnosis.

SpO2 or PR is shown unstably| 1. Finger might not be inserted deep enough.

2. Excessive patient movement

| 1. Retry by inserting the finger

2. Refrain from moving during measurement

The oximeter can not be powered on| 1. No battery or low power of battery

2. Batteries might be installed incorrectly

3. The oximeter might be damaged

| 1. Please replace batteries

2. Please reinstall the batteries

3. Please contact your local customer service centre

Indication lamps are suddenly off| 1. The product is automatically powered off when no signal is detected for longer than 8 seconds

2. The battery power is too low to work

| 1. Normal

2. Replace the batteries

“Err7” is displayed on screen| Err 7 means all the emission LED or reception diodes are damaged| Please contact your local customer service centre

Symbol Definitions

Notes:

1. The illustrations used in this manual may differ slightly from the appearance of the actual product.
2. The specifications are subject to change without prior notice.

Declaration

LIMITED WARRANTY

The Fingertip Pulse Oximeter has a 2 year warranty to be free of manufacturing defects in materials and workmanship under normal applications for 2 years of the original owner. If this product becomes inoperable due to defect and requires repair, return the product with all component pieces and proof of purchase to the address listed below. This warranty does not cover any shipping/transport costs. This warranty does not apply if the product is subject to misuse, neglect, rough handling or damage.

Ship the unit prepaid and insured (at owner’s option) to: Thermor Ltd.
Attn: Repair Department
16975 Leslie Street
Newmarket, ON L3Y 9A1
www.biosmedical.com
Email: support@biosmedical.com

Limitations
This warranty covers all defects encountered in normal use of the equipment and does not apply in the following cases.

1. If the equipment has been serviced by other than a certified center.
2. Damage to the equipment due to mishandling, abuse, accident or not following operating instructions.
3. INSTRUMENTS: Warranty does not extend to display face, batteries, carrying case or lanyard.

For troubleshooting assistance please contact Consumer Support. Our representatives are trained to provide you assistance over the phone and may be able to resolve your problem without returning. For the best possible assistance please have your unit available when calling us.
Service Phone: 1 866-517-2970
www.biosmedical.com

Manufactured by:
Thermor Ltd.
16975 Leslie Street
Newmarket, ON L3Y 9A1
WWW.BIOSMEDICAL.COM
2020 Thermor Ltd. ALL RIGHTS RESERVED

Project Type

Instructions

| Date: December 16 2022 Customer: Thermor Ltd Job Number: TH6644| Revision: D|
---|---|---|---
 | Item Number: 110PO

Designer: Alex Vranjesevic

|  | Contact: Graphic’s Department graphics@thermor- ins.com
UPC (For Reference Only)
| Reason For Project: New Item:

New Branding: Design Update: X

N/A:

| Artwork is not to be amended or scaled. If any changes are required please send through Thermor office with instructions, and we will amend here and resend artwork through. PLEASE RETURN WITH SIGNATURE| Colour Breakdown

References

• BIOS Medical | Leading Medical Equipment Manufacturers in Canada

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