Vibeat S5 Pulse Oximeter User Manual

Pulse Oximeter
User Manual
( Model: S5,S5W)

S5 Pulse Oximeter

Shenzhen Creative Industry Co., Ltd.
Floor 5, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District, 518110 Shenzhen, P. R. China
Manufacture date: See the label on the product Revision Date: August 3, 2023
Manual Version: V1.1
PN: 3502-2290146

Download the APP software (Only for S5W)

http://app.appurl.me/79816540314

App name: ViHealth
iOS: App Store
Android: Google Play

1. Sign up or log in to your App
2. Enable Bluetooth on your phone, and insert the finger into the device to turn it on.
3. Tap the searched device icon on the App.

Notes

• It’s not a medical device. This device is for Sports and Aviation use only and not intended for medical use.
• The Oximeter is not intended for medical
• The Oximeter is not an apnea monitor and should not be used for arrhythmia analysis.
• Do not self-diagnose or self-medicate on the basis of the measurements. Always consult your doctor.
• It is intended for spot-check use
• Please read the manual very carefully before using this Failure to follow these instructions can cause measuring abnormality or damage to the Oximeter.
• The contents contained in this manual are subject to change without notice.
• Information furnished by our company is believed to be accurate and However, no responsibility is assumed by us for its use, or any infringements of users or other rights of third parties that may result from its use.

Instructions for Safe Operation

Make sure that there is no visible damage that may affect user’s safety or measurement performance with regard to sensors and clips.
It is recommended that the device should be inspected minimally before each use. If there is obvious damage, stop using the device.
Special attention should be paid while the oximeter is used constantly under the ambient temperature over 37°C, burning hurt may occur because of over- heating of the sensor at this situation.
Necessary maintenance must be performed only by qualified service technicians. Users are not permitted to service this device.
The oximeter must not be used with devices and accessories not specified in User Manual.

Warnings and Cautions

Explosive hazard—DO NOT use the Oximeter in environment with inflammable gas such as some ignitable anesthetic agents.
DO NOT use the Oximeter while the user is under MRI or CT scanning. This device is NOT MRI Compatible.
Discomfort or pain may appear if using the Oximeter continuously on the same location for a long time, especially for user with poor microcirculation. It is recommended that the Oximeter should not be applied to the same location for longer than 2 hours. If any abnormal condition is found, please change the position of Oximeter.
The light (the infrared light is invisible) emitted from the device is harmful to the eyes. Do not stare at the light.
The Oximeter is not a treatment device.
Local laws and regulations must be followed when disposing of the device.
Keep the Oximeter away from dust, vibration, corrosive substances, explosive materials, high temperature and moisture.
The device should be kept out of the reach of children.
If the oximeter gets wet, please stop using it and do not resume operation until it is dry and checked for correct operation. When it is carried from a cold environment to a warm and humid environment, please do not use it immediately. Allow at least 15 minutes for Oximeter to reach ambient temperature.
DO NOT operate the button on the front panel with sharp materials or sharp point.
DO NOT use high temperature or high-pressure steam disinfection on the Oximeter. Refer to Chapter 8 for instructions regarding cleaning and disinfection.
Pay attention to the effects of lint, dust, light (including sunlight), etc.

Overview

1.1 Intended Use
This Pulse Oximeter is intended for measuring the pulse rate and oxygen level (SpO2) through a user’s finger.
1.2 Views

Battery Installation

1. Refer to Figure 2, insert two AAA size batteries into the battery compartment properly, and note the polarity markings.
2. Replace the cover.

Attentions:

• Make sure that the batteries are correctly installed. Incorrect installation may cause the device not to work.
• Remove batteries if the device is not being used for more than 7 days to prevent and avoid potential damage from the battery leaking. Any such damage is not covered under the product warranty.

Start/Stop Measuring

1. Open the clip and put finger inside the clip (make sure the finger is in the correct position), and then release the clip.
2. Wait for 2 seconds, the oximeter will power on and start to measure.
3. The display screen shows the measurement.
4. Get the finger out, and the device will automatically power off.

Attentions for measuring:
Do not shake the finger and relax during measurement.
Do not put wet finger directly into sensor.
Avoid placing the device on the same limb which is wrapped with a cuff for blood pressure measurement or during venous infusion.
Do not let anything block the emitting light from device, i.e. do not use finger nail polish/paints.
Existence of high intensive light sources, such as fluorescence light, ruby lamb, infrared heater or strong sunshine, etc. may cause inaccuracy of measurement result. Please put an opaque cover on the sensor or change the measuring site if necessary.
Vigorous exercise and electrosurgical device interference may affect the measuring accuracy.
Nail polish may affect the measuring accuracy, and too long fingernail may cause failure of measurement or inaccurate result.
lf the first reading appears with poor waveform (irregular or not smooth), then the reading is unlikely true, the more stable value is expected by waiting for a while, or a restart is needed when necessary.

Screen

4.1 Indications and Icons

• Icon : indicates the wireless connection is set up between the mobile device and oximeter. Only SSW has this function.
  Status of| Definition
  ---|---
  Flashing in blue| The oximeter is connecting with the mobile devices.
  Blue on| The connection between the oximeter and mobile devices is established.
  No display of “ ” icon| 1.  The oximeter fails to set up wireless connection with mobile device within 3 minutes.
  2.  Hardware failure of wireless function.
• Icon : low battery voltage.
• Flashing value: indicates the value is over the defined limits. There also accompanies the reminding sound.

Menu Setup

During measuring, long pressing Display key can enter the setup menu screen.

Menu operating procedures:

1. Shortly press Display Key to choose the setting item;
2. Long press Display Key to active the setting item, then shortly press it to modify the setting parameter;
3. Long press Display Key to confirm the modification and exit from this setting item.
4. Move the setting item to “Exit”, and long pressing Display Key to store the modification and exit from the setup menu.

“Beep”: Pulse beep option. If it is set to on, every pulse beat makes a beep.

Record List

• Asingle group of stable readings will be recorded in the record list each time when the oximeter shuts down regardless of spot-check or continuous mode. However, if the time from displaying valid readings to the end of measurement is less than 5 seconds, then no recording will be done.
• Up to 12 groups of records can be stored in the record list, the newest record is marked as M1, and the oldest record is marked as M12. The new record will override the previous record.
• When batteries are removed from the device all readings will be deleted.
• On power off status, long pressing the Display key shows the record list screen. On record list screen, a short pressing on the Display key can shift the records display, and if there is no key operation for 6 seconds, then the oximeter will power off automatically again.

Technical Specifications

A. Oxygen level Measurement
Sensor: dual-wavelength LED sensor with wavelength: Red light: 663 mm, Infrared light: 890 mm.
Maximal average optical output power: <2mW
Oxygen level display range: 35% – 100%
Oxygen level measuring accuracy: < 2% for oxygen level range from 70% to 100%
B. Pulse Rate measurement
PR display range: 30 bpm — 250 bpm
PR measuring accuracy: +2bpm or +2% (whichever is greater)
C. Perfusion Index (Pl) Display range 0% – 20%
D. Over-limit settings
Oxygen level:
Low limit setting range: 85% – 99%, step: 1%
Default setting: 90%
Pulse Rate:
Low limit setting range: 30 – 60 bpm, step: 1bpm;
High limit setting range: 100 – 240 bpm, step: Sbpm;
Default setting: high: 120bpm; low: SObpm
E. Power supply requirement
2 x LRO3 (AAA) alkaline batteries
Supply voltage: 3.0VDC, Operating current: <40mA
F. Environmental Conditions
Operating Temperature: 5°C- 40°C
Operating Humidity: 30% – 80%
Atmospheric pressure: 70kPa – 106kPa
G. Low Perfusion Performance
The accuracy of oxygen level and PR measurement still meet the precision described above when the modulation amplitude is as low as 0.6%.
H. Ambient Light Interference
The difference between the oxygen level value measured in the condition of indoor natural light and that of darkroom is less than +1%.
I. Dimensions: 56 mm (L) x 34 mm (W) x 30 mm (H)
Net Weight: approx. 60g (including batteries)
J. Classification
The type of protection against electric shock: Internally powered equipment.
The degree of protection against electric shock: Type
BF applied parts.
The degree of protection against harmful solid foreign objects and ingress of liquid:
The equipment is IP22 with protection against harmful solid foreign objects and ingress of liquid.
Electro-Magnetic Compatibility: Group |, Class B

Maintenance and Cleaning & Disinfection

8.1 Maintenance
The expected service life (not a warranty) of this device is 5 years. In order to ensure its long service life, please pay attention to the maintenance.

• Please change the batteries when the low-voltage indicator lightens.
• Please clean the surface of the device before using, with 75% alcohol wipes, then let it air dry or wipe it dry. Do not allow liquid to enter the device.
• Please take out the batteries if the Oximeter will not be used any more than 7 days.
• The recommended storage environment of the device: ambient temperature: -20 2C – 60 9C, relative humidity 10% – 95%, atmospheric pressure: 50 kPa – 107.4 kPa.
• The Oximeter is calibrated in the factory before sale, so there is no need to calibrate it during its life cycle.

Caution:

• High-pressure sterilization cannot be used on the device.
• Do not immerse the device in liquid.
• It is recommended that the device should be kept in a dry environment. Humidity may reduce the life of the device, or even damage it.

8.2 Cleaning and Disinfecting Instruction

• Surface-clean sensor with a soft cloth damped with a solution such as 75% isopropyl alcohol, if low-level disinfection is required, use a mild bleach solution.
• Then surface-clean with a cloth damped ONLY with clean water and dry with a clean, soft cloth.

Caution:

• Do not sterilize by irradiation steam, or ethylene oxide.
• Do not use the Oximeter if it is damaged.

Troubleshooting

correctly inside and try again. Keep calm.
Cannot turn on the device.| Change or re-install the batteries.
No display| Change the battery.

Symbols

| Manufacturer

| Date of manufacture

| Serial number
| Indicates a device that is not to be disposed of as unsorted municipal waste.
| Follow Instructions for Use.
| Type BF Applied Part
| No alarm system
****| MRI unsafe. Presents hazards in all MR environments as device contains strongly ferromagnetic materials.

IP22

| Resistant to liquid ingress
| This product complies with the rules and regulations of the Federal Communication Commission.
| Non-ionizing radiation

| This product complies with verpackG.

FCC Statement

FCC Warning:
FCC ID: A49POD-1W
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 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 ina 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.

The device has been evaluated to meet general RF exposure requirement. The device can be used in portable exposure condition without restriction.

Appendix EMC

The equipment meets the requirements of IEC 60601-1-2:2014.
Table 1

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 test| Compliance| Electromagnetic environment-guidance
RF emissions CISPR 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.
RF emissions CISPR 11| Class B| The Pulse Oximeter suitable for use in all establishments, including domestic establishments and those directly network that supplies buildings used for domestic purposes.
Harmonic emissions IEC61000-3-2| N/A
Voltage fluctuations/flicker emissions IEC61000-3-3| N/A

Table 2

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.
Immunity test| IEC60601 test level| Compliance level| Electromagnetic environment -guidance
Electrostatic discharge(ESD)
IEC61000-4-2| ±8 kV contact
±15kV air| ±8 kV contact
±15kV 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/ burst
IEC61000-4-4| ±2kV for power Supply lines
±1 kV for
input/output lines| N/A| N/A
Surge
IEC 61000-4-5| ±1kV line (s) to line(s)
±2kV line(s) to earth| N/A| N/A
Voltage dips, short interruptions and voltage variations on power supply input lines IEC61000-4-11| <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 s| N/A| N/A
Power frequency (50Hz/60Hz) magnetic field IEC61000-4-8| 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.

Table 3

Guidance and manufacturer’s declaration – electromagnetic immunity

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 electromagnetic environment.
Immunity test| IEC60601 test level| Compliance level| Electromagnetic environment -guidance
Conducted RF
IEC61000-4-6
Radiated RF IEC61000-4-3| 3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz| N/A
3 V/m| Portable and mobile RF communications equipment should be used no closer to any part of The Pulse Oximeter, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
d=1.2 P
d=1.2 P 80MHz to 800MHz d=2.3 P 800MHz to 2.5GHz
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 metres (m). b 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, and electromagnetic site survey should be considered. If the measured field strength in the location in which The Pulse Oximeter is used exceeds the applicable RF compliance level above, The Pulse Oximeter should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating The Pulse Oximeter. b: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

Table 4

Recommended separation distances between portable and mobile
RF communication the equipment

The Pulse Oximeter is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of The Pulse Oximeter can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Pulse Oximeter as recommended below, according to the maximum output power of the communications equipment.
Rated| Separation distance according to frequency of
maximum| transmitter M(Meters)
output power| 150kHz to| 80MHz to| 80MHz to
of transmitter| 80MHz| 800MHz| 2,5GHz
W(Watts)| d=1.2 P| d=1.2 P| d=2.3 P
0,01| N/A| 0.12| 0.23
0,1| N/A| 0.38| 0.73
1| N/A| 1.2| 2.3
10| N/A| 3.8| 7.3
100| N/A| 12| 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance in metres (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for 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.

Quality Certificate
Name: Pulse Oximeter
Model:………………………..
Date:………………………..
QA:………………………..
This product has been inspected in accordance with the standards specified in the User Manual.
Shenzhen Creative Industry Co., Ltd]

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