MOBI 700030 Smart Bluetooth Pulse Oximeter Blood Oxygen Monitor User Manual

Smart Bluetooth Pulse Oximeter Blood
Oxygen Monitor
Item #700030
Date of Issue: 7/18/22, Version: V1.1

FCC Statement

This device complies with Part 15 of the FCC Rules Operation is subject to the following two conditions:

• this device may not cause harmful interference.
• 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 resid ential installation. This equipment generates, uses and can radiate radio frequency energy and, 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 radio/TV technician for help.

Warning: Changes or modifications to this unit not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.

Precautions

• Do not attempt to maintain the Oximeter unless you are professional engineers. Only professionals with maintenance qualification are allowed to perform interior maintenance as necessary.
• Periodically change the contact position between the Oximeter probe and the finger for a measurement that lasts a long time. Adjust the position of the probe before the measurement lasts two hours, and check the integrity of skin, the blood circulation condition of the finger as well as the position of the finger.
• This product is not applicable to the examination of newborn babies.
• Seek for medical care in time if the measured value goes beyond the normal range while you are sure that the instrument does not malfunction.
• Do not directly expose your eyes to light-emitting components of the Oximeter, as that could cause harm to your eyes.
• For details about clinical limitations and contraindications, please carefully consult relevant medical literatures.

The following factors may cause disturbance to or affect the accuracy of examination:
◆ This product is used in an environment involving high-frequency devices, such as high-frequency electric knives and CT apparatuses.
◆ The probe of the Oximeter is placed on the same body part or limb as with blood pressure cuff arterial duct or intravenous injection.
◆ The user suffers from hypotension, severe vascular atrophy, severe anemia, or low oxygen.
◆ The user is in sudden cardiac arrest or shock state.
◆ The finger with nail polish or a fake fingernail may cause wrong readings of pulse oxygen saturation.

Warnings
Warning: Do not use the Oximeter in an environment with any inflammable gases, inflammable anesthetic, or other inflammable substances.
Warning: Do not attempt to charge any common dry battery, as that could cause leakage, fire disaster, or even explosion. Dispose of exhausted batteries in accordance with
environment protection regulations.
Warning: Do not use the Oximeter in an MRI or CT environment.
Warning: Do not operate the Oximeter when it is damp with overflow or water vapor condensation. Avoid moving the Oximeter from an excessively cold environment to a
high-temperature moist environment.
Warning: Do Not Mix Alkaline, Standard, or Rechargeable Batteries.

Product Accessories

1. One hanging rope.
2. Storage bag.
3. Two AAA batteries
4. One user manual

Symbol Conventions

| Applied Apart of Type BF (The applied apart is the probe tip)
| Caution: Please see this manual.
**%SpO2| ** Symbol of oxygen saturation
**bpmPR| ** Symbol of pulse rate

| No SPO2 alarms.
| Refer to Operating Instructions
**IP22**| IP22: The first number 2: Protected against solid foreign objects to 12.5mm Φ and greater. The second number: Protected against

| Bluetooth symbol
| **** Compliance with WEEE Standard

Overview

Oxygen saturation is the percentage of oxyhemoglobin (HbO2) that is combined with oxygen against all combinable hemoglobin (Hb). It is an important physiological parameter involved in respiration and circulation. The oxygen saturation of arterial blood in a normal human body is 98%. Oxygen saturation is an important indicator of the oxygen condition in the human body. In general, the normal values of oxygen saturation shall not be lower than 94%. If the measured value of oxygen saturation is lower than 94%, an insufficient supply of oxygen is considered.
The pulse rate is the number of pulse beats per minute. Normally, the pulse rate is consistent with the heart rate. In general, the pulse rate of every people is 60 to 90 beats per minute.
The Perfusion Index (PI) usually reflects the limb perfusion status of an examined patient and shows the detection precision of the instrument as well; that is, examination can still be performed even in the low or weak perfusion condition. The PI of a normal human body is 0.3% or greater.

Working Principles, Expected Usage, and Applicable Scope
Based on full digital technology, the Finger Pulse Oximeter non-invasively measures the actual content (oxygen saturation) of oxyhemoglobin (HbO2) in arterial blood using the optical transmittance method.
The Finger Pulse Oximeter measures the blood oxygen saturation and pulse rate of a human body via finger artery. It is applicable to a wide range of fields, such as families,
clinics. Use this instrument for measurement before or after sports. You are not advised to use this instrument during sports activities. Do not use it for continuous care for patients.

Appearance of Structure

Screen Display
The following figure shows the information display on the OLED screen of the Oximeter in normal measurement state:

Note: Battery power indication and Bluetooth symbol will alternately display.

Power-On Button/Functional Button Operations
After powering on the Oximeter, hold the power-on Button/functional button for about one second. The Oximeter shows a parameter setting interface. Press or hold the power-on/functional button to perform corresponding operations. Hold it to set an item or press it to switch an option. Press means no more than 0.5 seconds, while hold means more than 0.5 seconds.

Alert Sound Setting
Hold the power-on button/functional button while the Oximeter is in powered-on state.
Parameter setting interface 1 is displayed, as shown in the following figure. Move “” to the corresponding option and hold the functional button to set Alm to on and set Beep to off. When Alm is set to on and the measured values of the blood oxygen saturation and pulse rate go beyond the upper limit or lower limit, the Oximeter gives off an alert sound.
When Alm is set to off and the measured values go beyond the limit, the Oximeter will notgive any alert sound. When Beep is set to on, a tick will be heard along with pulse beats during pulse rate measurement. When Beep is set to off, no sound will be output along with pulse beats during pulse rate measurement. While the “” symbol stays on the Restore option, hold the functional button to restore factory settings.

Brightness Setting
On parameter interface 1, press the functional button to select the Brightness option and then hold the functional button to set the brightness to a value ranging from 1 to 5. The greater the value, the greater the brightness of the screen.

Alert Range Setting
On parameter interface 2, press the functional button to switch between options. On this interface, you can set the upper limit and lower limit of SpO2 Alm and PR Alm. While the “” symbol stays on the +/- option, hold the functional button to set the option to + or -. In + mode, select the corresponding option and hold the functional button increment the upper or lower limit; in – mode, hold the functional button to discrete the upper or lower limit. Move “” to the Exit option and hold the functional button to return to the monitoring interface.

Operation Guide

Stick one finger completely into the measurement parts of the Oximeter, keep the fingernail surface upward, and release the clip. Then press the power button to power on the Oximeter.

If you do not yet completely insert your finger into the cavity, the measurement result may be inaccurate.
Do not vibrate your finger during measurement. Preferably, ensure that your body does not move. After the readings become stable, read the measured values of oxygen
saturation and the pulse rate on the screen.
The Oximeter will automatically shut down 10 seconds later after your finger leaves away.
Connecting the Instrument to a Mobile Phone via Bluetooth
Note: For details on specific operations, see software operation instructions for the mobile phone.
Replace the batteries when the battery capacity is insufficient along with the symbol flickers on the screen.
Cleaning
Power off the instrument and remove the batteries before cleaning. Ensure that the appearance of the instrument is neat, dust-free, and dirt-free. Clean the outer surface of the instrument (including the OLED screen) using 75% medical alcohol and a piece of dry soft cloth.
Caution: Avoid liquid flowing into the instrument during cleaning.
Caution: Do not immerse any part of the instrument into any liquid.

Disinfection

Before measurement with the instrument, wipe the rubber 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 means of high-temperature/high- pressure or gas disinfection.

Maintenance

• Remove the batteries from the battery slot and properly store them if you do not plan to use the Oximeter for a long period of time.
• Store the Oximeter between 14°F and 122°F (–10 °C to +50°C) and at humidity levels 10%-93%.
• Periodically check the Oximeter for damage.
• Avoid using the Oximeter in an environment with inflammable gases or using it in an environment where the temperature or humidity is excessively high or low.
• Check the accuracy of the oxygen saturation and pulse rate readings by using an appropriate calibration apparatus.

Technical Specifications

1. Dimensions: 62.0 mm (Width) × 37.0 mm (Depth) × 32.0 mm (Height)
   Weight: 42.5 g (including the height of the two AAA dry batteries)

2. Peak wavelength range of the light emitted from the probe: red light 660 nm ± 3; infrared light 905 nm ± 5.

3. Maximum optical output power of the probe: 1.2 mw for infrared light (905 nm).

4. Bluetooth module: 5.0 (single mode)

5. Manufacturing date: see the label

6. Normal working condition
   Working Temperature| 5°C to 40°C (41°F to 104°F)
   ---|---
   Relative Humidity| 15% to 80%, non-condensing
   Atmospheric Pressure| 70 kPa to 106 kPa
   Rated Voltage| DC 3.0 V

7. Default values and conditions of alert
   Parameter| Value
   ---|---
   Oxygen saturation| Upper limit: 100     Lower limit: 94
   Pulse rate| Upper limit: 130     Lower limit: 50
   Alert condition| When the alert switch is on and the actual measured value goes beyond the preset alert parameter range, the Oximeter gives an alert sound.

8. Technical parameters
   Parameter| Value
   ---|---
   Display range| Oxygen saturation| 35% to 100%
   Pulse rate| 25 bpm to 250 bpm
   Resolution| Oxygen saturation| 1%
   Pulse rate| 1 bpm
   Measureme nt precision| Oxygen saturation| ±2% (70% to 100%)
   No requirement (≤ 69%)
   Pulse rate| ±2 bpm
   Alert range| Oxygen saturation| Upper limit: 50% to 100%
   Lower limit: 50% to 100%
   Pulse rate| Upper limit: 25 bpm to 250 bpm Lower limit: 25 bpm to 250 bpm
   Alert error| Oxygen saturation| ± 1% of the preset value
   Pulse rate| The greater of ±10% of the preset value and ±5 bpm

Safety Type

Anti-electric-shock type: internal power supply device
Anti-electric-shock degree: BF-type application part
Running mode: continuous working
Waterproof grade: IP22

Storage and Transportation

Packaged products should be stored in well-ventilated rooms without corrosive gas and with an ambient temperature of –10°C to +50°C, a relative humidity 10%- 93% (without condensation), and an atmospheric pressure of 50–106 kPa.

ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES

Guidance and manufacturer’s declaration – electromagnetic emissions

The device is intended for use in the electromagnetic environment specified below. The customer or the user assure that it is used in such an environment.
Emissions test| Compliance| Electromagnetic environment – guidance
RF emissions CISPR11| Group 1| The device use 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 CISPR11| Class B| The device is suitable for use in all establishments other than domestic and those directly connected to the public
Harmonic emissions| Not
lEC61000-3-2| applicable| low-voltage power supply network that supplies buildings used for domestic purposes
---|---|---
Voltage fluctuations/ Flicker emissionslEC61000- 3-3| Not applicable
Guidance and manufacturer’s declaration — electromagnetic immunity

The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.
Immunity test| IEC 60601 Test level| Compliance level| Electromagnetic environment-guidance
Electrostatic discharge (ESD) lEC61000-4-2| ±6kV contact
±8kV air| ±6kV contact
±8kV air| Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%
Electrical fast transient/bur st IEC 61000-4-4| ±2 kV for power supply lines ± 1 kV Input/ output line| not applicable| not applicable (For INTERNALLY POWERED ME EQUIPMENT)
Surge IEC 61000-4-5| ± 1 kV Differential mode voltage
± 2 kV Common mode voltage| not applicable| not applicable (For INTERNALLY POWERED ME EQUIPMENT)
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11| <5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec| not applicable| not applicable (For INTERNALLY POWERED ME EQUIPMENT
Power frequency (50Hz/60Hz)  agnetic field IEC 61000-4-8| 3A/m| 3A/m| Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
customer or the user of device should assure that it is used in such an environment.

Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment – guidance
Radiated RF IEC 61000-4-3| 3 V/m80 MHz to 2.5 GHz| 3 V/m| Portable and mobile RF communications equipment should be used no closer to any part of the Blood Pressure Monitor, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey(a), should be less than the compliance level in each frequency range. (b)
Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2  These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
(a)  Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Blood Pressure Monitor is used exceeds the applicable RF compliance level above, the Blood Pressure Monitor should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Blood Pressure Monitor.
(b)    Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [Vi] V/m.

Recommended separation distances between portable and mobile RF communications equipment and the device.
The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended
below, according to the maximum output power of the communications equipment.

Maximum output
power of transmitter
(v v)| Separation distance according to frequency of transmitter(m)
---|---
80 MHz to 800M Hz
| 800 MHz to 2.5GHz
| 800 MHz to 2.5GHz

0.01| I| 0.12| 0.23
0.1| /| 0.38| 0.73
I| /| 1.| 2.
10| /| 4.| 7.
100| /| 12| 23
For transmitters rated at a maximum output power not listed above, there commended separation distance d in meters(m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts(W) accordable to the transmitter manufacturer.
NOTEI At 80 MHz and 800 MHz the separation distance for the higher frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and refection from structures, objects and people.

Limited Product Warranty

MOBI® warrants its products to be free from defects in material and workmanship for period of (1 Year) from the date of purchase. Should the product prove to be defective at any time during the warranty period, we would either replace or repair the product at our option without charge. After the warranty period, a service charge will apply for replacement of parts and labor costs. To obtain warranty service, you must return the product complete with its original parts & accessories along with a copy of the original purchase, gift, or registry receipt to us. This warranty does not cover damage caused by any tampering, accident, misuse, abuse, improper maintenance, unauthorized modification, or connection to an improper power supply. There will be a charge for repair caused for such damage. This warranty becomes void upon purchase from an unauthorized, third-party seller. This warranty excludes all incidental or consequential damages and any liability other than stated above.

Questions?
Please visit: www.getmobi.com
Support portal: https://mobisupport.zendesk.com
Support ticket: https://www.getmobi.com/gethelp
For detailed instructional manual please follow this link: https://ww.getmobi.com
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All Rights Reserved

References

• Home Health Technology - Remote Health Monitoring - Mobi USA

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