AOJ-70B Fingertip Pulse Oximeter User Manual

Pulse Oximeter

Software version: V1.1 Manual Ver: 1.4 Issuing Date: 2021/04,7
The pulse oximeter has two types of screen for option.
(1) LED screen
(2) OLED screen

General Description

Sp02 stands for peripheral capillary oxygen saturation. Oxygen saturation is defined as the ratio of oxyhemoglobin (Hb02) to the total concentration of hemoglobin (i.e. Oxyhernoglobin + reduced hemoglobin) present in the blood. It is an important physiological parameter involved in respiration and circulation. The Pulse Oximeter features herein are small, portable, non- invasive, and easy to use. The user only needs to insert a finger into the chamber to measure his/her Sp02 and pulse rate.

Measurement Principle

Oxygenated blood absorbs light preferentially at 905nrn (near-infrared light), whereas deoxygenated blood absorbs light preferentially at 660nm (red light). A pulse oximeter works by passing a beam of red and infrared light through a pulsating capillary bed and then measuring the amount of red and infrared light emerging from the tissues via a sensor. To improve accuracy, the iP900AP uses a proprietary algorithm to collect data from pulsatile arterial blood and excludes local noise from the tissues. The relative absorption of light by oxyhemoglobin (HBO) and deoxyhemoglobin is then calculated according to Beer- Lambert’s law and quantitative measurement of the users’ oxyhemoglobin status i.e. Oxygen saturation level (Sp02) is derived. Due to the sensitivity of the pulse oximeter, the finger should be kept stationary during measurement. It is recommended that you use this device for measurement before or after sports. Do not use it for continuous monitoring.

Precautions For Use

1. Do not use the pulse oximeter in an MRI or CT environment.
2. Explosion hazard: Do not use the pulse oximeter in an explosive atmosphere.
3. The pulse oximeter is intended only as an adjunct in user assessment. It must be used in conjunction with other methods of assessing clinical signs and symptoms.
4. Check the pulse oximeter sensor application site frequently to determine the positioning of the sensor and circulation and skin sensitivity of the user.
5. Do not stretch the adhesive tape while applying the pulse oximeter sensor. This may cause inaccurate readings or skin blisters.
6. Before use, carefully read the manual.
7. The pulse oximeter has Sp02 alarms; it is not for continuous monitoring.
8. Prolonged use or the user’s condition may require changing the sensor site periodically. Change sensor site and check skin integrity, circulatory status, and correct alignment at least every 4 hours.
9. Inaccurate measurements may be caused by autoclaving, ethylene oxide sterilizing or immersing the sensors in liquid.
10. Significant levels of dysfunctional hemoglobins (such as carboxyhemoglobin or methemoglobin) may cause inaccurate readings.
11. Intravascular dyes such as indocyanine green or methylene blue.
12. Sp02 measurements may be adversely affected in the presence of high ambient light. Shield the sensor area (with a surgical towel, or direct sunlight, for example) if necessary.
13. Excessive user movement may cause inaccurate readings.
14. Venous pulsations may cause inaccurate readings.
15. High-frequency electrosurgical interference may cause inaccurate readings.
16. Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line.
17. The user has hypotension, severe vasoconstriction, severe anemia, or hypothermia.
18. The user is in cardiac arrest or is in shock.
19. Fingernail polish or false fingernails may cause inaccurate Sp02 readings.
20. This pulse oximeter is not a medical device and is not intended to diagnose and/or treat any medical condition or disease. It is intended for non-medical use by healthy people to monitor their pulse rate and blood oxygen levels. It is for sports and/or aviation use. People who need Sp02 and pulse rate measurements because of a medical condition should consult with their physician.

Follow local ordinances and recycling instructions regarding disposal or recycling of the device and device components, including batteries.

Product Features

• Lightweight, portable, and easy to use.
• Dual-color OLED screen shows pulse rate, Sp02, plethysmograph, bar graph, and perfusion index; While LED screen shows pulse rate & Sp02.
• Large font display.
• Alarm function.
• Low battery indicator.
• Auto shut down if no signal is detected within15 seconds.
• Low power consumption.

Intended Use

The pulse oximeter is a reusable device intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients in healthcare environments.

Operation Instructions

1. Install two AAA batteries into battery compartment correctly.

2. Insert one of your fingers into the finger chamber of the pulse oximeter.
   Note: The fingernail should be facing the top chamber (which contains the sensor). Finger should also be inserted completely into the chamber. Otherwise, the measurement will be inaccurate.

3. Press the power-on button to turn on the pulse oximeter.

4. Finger and body should not tremble during the measuring.

5. Read correct data from the displayed screen.
   The following operation is only for OLED screen: Keep pressing the power on button for a second to enter the setting interface.

Press the power on the button once to switch among the settings, keep pressing the button for a second to change the current settings of sounds on or off and other parameters.

Notes:

• When your finger is inserted into the oximeter, your nail surface must be upward.
• The results may be wrong if you do not place your finger thoroughly in the oximeter.
• Please use medical alcohol to clean the silicon touching the finger inside of the oximeter, and clean the test finger using alcohol before and after each test. (The silicon inside of the oximeter belongs to medical silicon, which has no .n and is not harmful to the skin).

Brief Description of Front Panel

(1) LED screen

(2) OLED screen

The pulse bar graph displays the corresponding with the user’s pulse beat. The height of the bar graph shows the user’s pulse strength.

Product Accessories

1. Pulse oxirneter.1 pc
2. User manual, pc
3. Lanyard, pc

Battery Installation

1. Put the two AAA batteries into the battery compartment with incorrect polarities.

Notes:

Battery polarities should be correctly installed. Otherwise, damage may be caused to the device.
Please remove the batteries if the Oxirneter will not be used for a long time.

Installing the Lanyard

Thread the thin end of the lanyard through the lanyard hole, thread the coarse end of the lanyard through the thin end of the lanyard, and tighten the lanyard.

Cleaning and Disinfection

1. To clean the instrument, power off and remove the batteries first. Then clean the outer surface of the instrument (including the screen) using a piece of dry soft cloth dipped. with 75% medical alcohol. Do not immerse the unit in alcohol!
   Attention: Do not use any strong dissolving agent such as acetone.
   Attention: Do not rub the body of the instrument using materials such as steel wire balls or polished metal objects.
   Attention: Ensure that there is no washing liquid on the surface of the instrument.
   Caution: Do not allow liquid to flow into the instrument during cleaning.
   Caution: Do not immerse any part of the instrument into any liquid.

2. Disinfection Before measurement with the instrument, wipe the silicon finger pad using a piece of dry soft cloth dipped with 75% medical alcohol. Clean the finger to be measured using the medical alcohol for disinfection purposes before and after use.
   **** Do not disinfect the instrument by using high-temperature/high-pressure disinfecting gas.

Maintenance and Storage

1. Replace the batteries in time when a low voltage lamp is lighted.
2. Clean the surface of the fingertip oximeter before it is used in diagnosis for users.
3. Remove the batteries inside the battery cassette if the oximeter will not be operated for a long time.
4. It is best to preserve the product in a place where ambient temperatures are -20°C-70°C ( -4°F-158°F ) and relative humidity is 10%-95%.
5. It is recommended that the product should be kept in a dry environment anytime. A wet ambient might affect its lifetime and even might damage the product
6. Avoid exposure to direct sunlight.
7. Avoid excessive radioactive infrared rays or ultraviolet rays.
   Please follow the law of the local government to deal with used batteries.

Technical Specification

1. Display Type: LED screen OLED screen

2. Sp02: Measurement range: 35%-100%
   Resolution: 1%
   Accuracy: 70%-100%, ±2%; < 70% no definition.

3. Pulse Rate: Measurement range: 25bpm -250bpm
   Resolution: 1bpm
   Accuracy : ± 3bpm
   Pulse Intensity: Bargraph Indicator (only for OLED screen)

4. Perfusion Index (only for OLED screen): Measurement range: 0%-50% Resolution: 1% Accuracy : 0.1% ( O%-1% ) ; 1% ( 1%-20% ) ; >20%no definition.

5. Power Requirements:
   Two AAA alkaline Batteries
   Power consumption: 30mA(Normal)
   Low power indication: Battery Life: Two AAA 1.5V, 600mAh alkaline batteries could be continuously operated as long as 24 hours.

6. Dimension: Length:
   63mm Width: 36mm Height: 39mm
   Weight: 43g (without battery)

7. Environment Requirements:
   Operation Temperature: 0°C-50°C ( 32°F —122°F )
   Storage Temperature: -20°C-70°C ( -4°F — 158°F )
   Ambient Humidity:580%RH, no condensation in operation.
   ≤ 93%RH, no condensation in storage

8. Measurement Performance in Low Perfusion Condition:0.3%.

Declaration

EMC of this product complies with IEC60601-1-2 standard. The materials with which the user can come into contact have no toxicity and no action on tissues comply with 15010993-1, 1S010993-5, and 1S010993-10.

Guidance and manufacturer’s declaration-electromagnetic emissions-for all EQUIPMENT and SYSTEMS

Guidance and manufacturer’s declaration —electromagnetic emission

The Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of the Pulse Oximeter should assure that it is used in such an environment.
Emissions on test| Compliance| Electromagnetic environment guidance.
RF emissions CLSPR 11| Group 1| The Pulse Oximeter 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.

Possible Problems and Resolutions

Problems

| Possible reason|

Solution

---|---|---
The| 1. The finger is not| 1. Make sure that
Oximeter| placed between| the finger is
fails to| the sensor and| placed right in
display| the Light Emitting Diode.| between the sensor and the
the blood| 2. The user’s blood| Light Emitting
oxygen| perfusion is too| Diode.
saturation| low to be| 2. Make sure
levels| detected.| nothing is
and/or| | restricting your
pulse rate.| | blood flow.
Sp02 or| 1. The finger is not| 1. Make sure that
PR is| placed between| the finger is
shown| the sensor and| placed right in
unstably| the Light| between the
| Emitting Diode.| sensor and the
| 2. The user is| Light Emitting
| moving his/her| Diode.
| finger and/or| 2. Try to stay still
| body.| during measurement.
The| 1. The batteries are| 1. Replace the
Oximeter| drained.| batteries.
can not be| 2. The batteries are| 2. Please refer to
powered| incorrectly| section 2.8.1 on
on| installed.| how to install
| 3. The Oximeter is| the battery
| defective and/or| correctly.
| damaged.| 3. Contact the distributor.
The screen| 1. If the Oximeter| 1. This is normal.
are| does not detect| Just turn on the
suddenly| any signal within| pulse oximeter
off| 15 seconds, it| again.
| will| 2. Replace the
| automatically power off.| batteries.
| 2. The batteries are drained.|

correctly. Do not spray, pour, or spill any liquid on the oximeter, its accessories, connectors, switches, or openings in the enclosure as this may damage the oximeter.

Symbol Definitions

Symbol for the marking of electrical and electronic devices according to Directive 200296/EC. The device, accessories, and packaging have to be disposed of waste correctly at the end of the usage. Please follow Local Ordinances or Regulations for disposal.
Note: The Oximeter is applied to this regulation.
Note: The frustration used in this manual may differ slightly from the appearance of the actual product.

FCC STATEMENT
Any changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference. and (2) this device must accept any interference received. including interference that may cause undesired operation.

Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy. if not installed and used in accordance with the instructions. may cause harmful interference to radio communications. However. there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception. which can be determined by turning the equipment off and on. the user is encouraged to try to correct the interference by one or more of the following measures:
– Reorient or relocate the receiving antenna.
– Increase the separation between the equipment and receiver.
– Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radial/ technician for help.
FCC Radiation Exposure Statement.
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment.
This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.

Use your mobile phone to test the Bluetooth function, download -nRF Connect-1 on an Android phone, as shown in Figure 3, download it on an iPhone

1. “LightBlue”, As shown in Figure 4;
   

2. Take nRF Connect as an example. After entering the APP, open Bluetooth and fill in the filter Bluetooth name “AOJ-20A”, as shown in Figure 5. Pull down to refresh and you will only see the name “AOJ-20A”. If there are more than one, select For the device with the strongest signal, you can also enhance the RSSI to -60dBm filtering, click CONNECT to connect, as shown in Figure 6;
   Turn on the Bluetooth receiving service, as shown in Figure 7; perform a normal measurement and check the received Bluetooth data, as shown in Figure 8;
   

3. For LightBlue, after entering the APP, turn on Bluetooth, pull down to refresh and find the device with the name “AOJ-20A”. If there are more than one, select the device with the strongest signal. You can also adjust the Filter to -60dBm and click connect, as shown in Figure 9. Show; turn on the Bluetooth receiving service, as shown in Figure 10;
   Turn on the Notify data monitoring switch Listen for notifications, as shown in Figure 11; take a normal measurement and check the received Bluetooth data, as shown in Figure 12;
   

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