AVITA SP62B Pulse Oximeter Instruction Manual

Pulse Oximeter
SP62B

INSTRUCTION MANUAL
Please read this instruction manual carefully  Before using the device

SP62B Pulse Oximeter

RoHs REACH

****| MDSS GmbH
Schiffgraben 41
30175 Hannover Germany
AViTA Corporation
---|---
| 9F., No. 78, Sec. 1, Kwang Fu Rd.,
San Chung Dist., New Taipei City 24158, Taiwan
| Importer
| Distributor

INTENDEDE USE

SP62B is intended for measuring functional oxygen saturation of arterial hemoglobin (SpO2) and  pulse rate for both adults and adolescent as non‐invasive spot checking in home and professional  caring environment. It is designed for fingers between 0.8cm and 2.3cm (0.3 inches ~0.9 inches)  and for patients during no‐motion condition.  Contraindications:

1.  Presence of an ongoing need for measurement of pH, PaCO2, total hemoglobin, and abnormal  hemoglobins may be a relative contraindication to pulse oximetry
2. A pulse oximeter cannot distinguish the differences and the reading will show the total  saturation level of oxygen and carbon monoxide. Carbon monoxide molecules, even in a small  mount, can attach to the patient’s hemoglobin replacing oxygen  molecules.
3. Irregular heartbeats or by patient’s movements can post irregular signal.
4. A high level of methaemoglobin would cause a pulse oximeter to have a eading of around 85%  regardless of the actual oxygen saturation level. The higher percentage of methaemoglobin can be genetic or caused by exposure to certain chemicals and medications.

PRINCIPLE OF OPERATION

Physiological Principle
SP62B determines SpO2 by measuring the absorption of red & infrared light passing through  perfused tissue. Changes in absorption caused by the pulsation of blood in the vascular bed are  used to determine SpO2 reading and pulse rate.
Date Update and Signal Processing
SP62B in the algorithms automatically extends the amount of data required for measuring SpO2 and pulse rate depending on the measuring conditions. During normal measurement conditions, the averaging time is three to six heart beats. SP62B automatically adjusts the signal processing  during degraded conditions, such as finger motion, ambient light, electromagnetic interference,  and patient motion, which results in an increase in the dynamic averaging beyond 10 heart  beats or may reach 40 heart beats.
Pulse Indicator
The Pulse Indicator displays a loading bar when detect a pulse. When the pulse rate is detected,  the bar will continue to show to indicate the connection of reading, but it does not mean it is  the signal strength, nor will it affect the strength of signal.
Pulse Waveform Display
The display provides the pulse waveform to detect the real‐time sensor signal. The relative  pulsation rate of the input signal can be observed.

CONTENT OF PACKAGE

SP62B includes the following items:
A. Fingertip Pulse Oximeter, 1 unit
B. User Manual, 1 sheet
C. AAA‐Size Alkaline Battery, 1 piece
Please make sure all items are packed. All items are non‐sterile. If any item is missing or  damaged, contact your distributor.

WARNINGS (general)

• Do not use the oximeter in an explosive atmosphere to avoid explosion  hazard.
• Do not use the oximeter when applied part temperature is over 41°C  (105.8°F).
• The oximeter has to measure the pulse properly to obtain accurate SpO2  reading. Blood flow restrictors (e.g., blood pressure cuffs) may hinder pulse  measurements. Remove any objects that may hinder the performance of the  oximeter.
• SP62B is a no SpO2 alarm device. Please do not use SP62B under  alarm‐required situation.
• Exposure to strong external light while taking measurement may result in  inaccurate readings. Shield the sensors from bright lights. Strong  electro‐magnetic fields may also affect readings.
• Nail polish and pressed‐on nails may interfere with readings.
• Intravenous dyes (such as methylene blue, indigo carmine, and indocyanine  green) can cause inaccurate readings.
• Seek professional advice if measured irregular reading. SP62B is designed to  monitor user health condition, not diagnosis or interpretation of health  condition.

WARNINGS   (for health professionals)

• Do not use the oximeter in an MRI or CT environment.
• The oximeter is intended as an adjunct in subject assessment. It must be used in conjunction with other methods to assess clinical signals and symptoms.
• When replace a battery of the device, a user shall not to touch the battery  contact or battery and the patient simultaneously.

WARNINGS (for patients)

• If the monitoring sites have trauma, disability or other medical conditions, users  should consult doctors before use.
• Please do not leave the device to a child and always keep the battery cover in  attach to avoid swallowing by a child.

DEVICE FEATURES

Two color OLED display
Press the   key to rotate the screen
Lanyard Hole
Battery Cover

 SYMBOLS AND TERMINOLOGY

**CAUTION**

• This oximeter is not an apnea monitor.
• Significant levels of dysfunctional hemoglobin such as carbonxyhemoglobin or  methemoglobin may affect the accuracy of the measurement.
• Cardio green and intravascular dyes may affect the accuracy of SP62B.
• The performance of the oximeter might be affected by the presence of a  defibrillator.
• The oximeter may not work on all subjects. If you are unable to achieve stable  readings, please discontinue use.
• The oximeter has motion tolerant algorism to minimize the possible motion  artifact. However, the oximeter may be still interpreted by motion. Please  minimize subject motion as much as possible.
• All the materials of the oximeter in contact with a patient or a user have passed  ISO 10993 Biological Evaluation of Medical Devices accordingly. It shall be no  toxicity harm to children, pregnant or nursing women.

BEFORE USE

First Time Use
For the first time use, a protective plastic membrane is attached to the front panel of the  oximeter. Please remove the plastic membrane to allow the OLED display to show its best  performance.
The oximeter is calibrated in the factory before deliveried, there is no need to calibrate it  during its life cycle.
Battery Replacement
Before start any measurement, please make sure the battery power is sufficient and the  setting is correct. If not, please refer to the following procedures. Make sure the oximeter is  off when replacing the battery. The device is powered by one AAA‐ size alkaline battery. Please  press the   mark on the battery cover to open it up and installing a new battery

CAUTION

• Please use alkaline battery to ensure the best performance of  device.
• Please dispose the battery according the proper procedure.

  CAUTION

• SP62B can be operated by either a patient or trained personnel. Consult healthcare professionals before use.
• The oximeter might not work on cold extremities due to poor  circulation. Please warm or rub the finger, or reposition the device to  improve it.
• Check the applied site of a patient frequently to evaluate body  circulation and skin sensitivity. The recommended maximum applied  time at a single spot is 30 minutes. Misapplication of the oximeter on  applied site with excessive pressure for prolonged periods can  introduce pressure injury.

OPERATION

STEP1. Open up the oximeter and put one of your fingers into the opening.
Please make sure that your finger face up and touch the bottom (Inner Base) of the  opening before releasing the clamp.
STEP2. The device will turn on automatically after finger is inserted.
STEP3. Reference to Data Transferring, for Bluetooth setup.
STEP4. After detecting the pulse signal, the oximeter shows SpO2 and pulse rate on the display.  The readings will be updated based on the signal received with each pulse.
STEP5. During the operation, if you press the   key, the screen will rotate in different  direction to allow users in desired view angle.
STEP6. If the finger is not detected or removed, the oximeter will show “Finger Out”. As the  finger keeps being undetectable, the device will turn off automatically in about 8  seconds.
STEP7. After finish use, follow the cleaning instruction to clean the device thoroughly.

Data Transferring

This product is a Pulse Oximeter. Design without entering personal information. If the device has a  transmission function, the transmission measurement data is designed to be encrypted and  transmitted, and will not be tampered with or retrieve user‐ elated information during the  transmission process. The firmware and software of the product have been programmed in the production process, and the programming interface is different from the data transmission  interface. When programming to the microcontroller, use an encrypted programmer, so there is no  need to worry about the software being tampered with during transmission.
Bluetooth function requirement:
‐  An Android device with Android version 4.3 or above and hardware support for Bluetooth 4.2.
‐  An iOS device with iOS version 5 or above and hardware support for Bluetooth 4.2.
How to activate the Bluetooth function:
Please refer to the instruction manual of your mobile phone or computer for how to activate the
Bluetooth function.

Set Up Process

1.  Please check if your mobile phone or computer has BLE4.2.
2. Turn on the SP62B (put your finger into the pulse oximeter), when the Bluetooth icon shows on  the device, it means SP62B is under broadcast condition.
3. Enable Bluetooth function from your mobile phone or computer. Check for available Bluetooth  connection, the device name should be “SP62B”.
4. It require manual Bluetooth connection for every time, once the connection is connected the  measure reading will automatically transfer to your mobile phone or computer.

TROUBLE SHOOTING

align the finger inward at vertical-middle of the device.
Display lockup or blank. If the device is on a finger, changes do not appear at wave form or pulse indicator.| The measuring function is malfunction.| The reading might not be reliable; discontinue using the device.
Electromagnetic interference (EMI).| Remove the surrounding electronic devices away. eg. MRI, CT at hospital, or microwave at home environment.
Finger might be trembling or place incorrectly.| Keep the finger steady or align the finger inward at vertical-middle of the device.
No reading of Sp02 or pulse rate and shows dash-line.| Low finger pulse quality.| Please try the following.
1.   Reposition the finger
2.   Warm the finger by rubbing.
3.   Select another finger.
Sp02 or pulse rate warning/indicator appears| A patient’s condition is abnormal.| Provide immediately medical attention to this patient.
Low battery “ ” appears on display.| The battery power is low.| Replace with a new battery.

If you have followed the actions recommended above but the problem keeps unresolved, please  call your agent for assistance.

FEDERAL COMMUNICATIONS COMMISSION INTERFERENCE STATEMENT

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.   his  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    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.
CAUTION:
Any changes or modifications not expressly approved by the grantee of this device 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.
RF exposure warning
The equipment complies with FCC RF exposure limits set forth for an uncontrolled environment.
The equipment must not be co‐located or operating in conjunction with any other antenna or transmitter.

MAINTENANCE AND STORAGE

• Remove the batteries inside the battery compartment if the oximeter will not be operated for  more than one month.
• It is best to preserve the product in a place where ambient temperature range is from ‐30°C ~  70 °C (‐22 °F ~ 158 °F), humidity range from 10% to 90%, and atmospheric pressure range from  700hPa to 1060 hPa.
• The commercially available bench top functional testers and patient simulators may only be  suitable to validate the pulse rate, but may not be able to verify the proper oximetry of this  pulse oximeter. Please consultant with your distributor or the manufacturer proper model and  the usage of functional testers and patients simulator for this oximeter.
• Furthermore, after a long term operation, the light sensor within the device may degrade with  time. The testers and simulators may be useful for verifying that the pulse oximeter are working  normally A functional tester cannot be used to assess the accuracy of pulse oximeter device.
• During the warranty period, if the evident shows that the device is misused or the device has  been opened or tampered with the components within the casing by non‐authorized service  personnel, the warranty will be invalidated and a charge for repair will be assessed.

**CAUTION**

• Do not spray, pour, or spill any liquid on the oximeter, accessories, switches  or openings.
• Do not use caustic or abrasive cleaning agents on the oximeter.
• This is a precision medical instrument and must be repaired by qualified  personnel from manufacturer only.
• Please follow local governing ordinances and recycling instructions regards  disposal or recycling of the device and components.

Clean and Disinfection

‐ For home use device disinfection, use 75% alcohol (available in the pharmacy) with damp  cloth for cleaning and disinfection, the device can be clean up to 1000 times. Clean it  thoroughly the body and the finger groove.
‐ Never use abrasive cleaning agents, thinners or benzene for cleaning. Do not scratch the  surface of the lens or the display. Do not expose the oximeter to extreme temperatures,  humidity, direct sunlight, or shock.
‐ Do not immerse the pulse oximeter into water, as the liquid can penetrate and damage the  device nor ever place any heavy objects on the device.

Technical Specification

Dimension & Weight| L68mm (2.68”) x W37.8mm (1.49”) x H30.2mm (1.19”);without battery: approx. 26g (0,92 ounces)
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Display| Two color OLED
Auto on/off| Whenever user inserts a finger, the device will turn on automatically. Vise versa, the device will turn off automatically when the finger is removed from it.
Input key| key for screen rotate
Measurement Method| Dual wavelength LED (660 nanometers @ 3.2mW and 905
nanometers @ 2.4mW; both as max average
SpO2 Range & Resolution| Range: 0% to 100%; resolution: 1%
SpO2 Accuracy| Range 70% to 100% range ± 2%,
less than 70% are unspecified
Pulse Rate Range &
Resolution| Range: 30 to 250 bpm; resolution: 1 bpm
Pulse Rate Accuracy| ±2 bpm or ±2%, whichever is greater
Water‐resistance| Against water splash (IP22 Approved)
Battery Type| 1 AAA‐size Alkaline battery
Usage Life| > 18 hrs typical operation under default setting
Ambient Temperature| Operation: 5 °C ‐ 40 °C ( 41 °F ‐ 104 °F);
Storage: ‐30°C ~ 70 °C ( ‐22 °F ~ 158 °F)
Atmospheric Pressure| Operation & storage are both 700 hPa ‐ 1060 hPa
Humidity| Operation & storage are both 10% ‐ 90%, non‐condensing
Degree of Electrical Protection| Type BF
Bluetooth Frequency|   2402~2480GHz
Bluetooth Output|   <=4dBm
Power Range|

This device has been tested under compliance with IEC 60601‐1, IEC 60601‐1‐2, ISO 80601‐2‐61,  and ISO 10993 requirements.

EMC Tables

The oximeter is intended for use in the electromagnetic environment specified as below. The  customer or the user should assure that it is used under such an environment.

Recommended separation distances between portable and mobile RF communications equipment and the ME equipment

Fingertip Pulse Oximeter is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of Fingertip Pulse Oximeter can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and Fingertip Pulse Oximeter as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of transmitter W| Separation distance according to frequency of transmitter m
150 kHz to 80 MHz d=1.17 √ P| 80 MHz to 800 MHz d=1.17 √ P| 800 MHz to 2.5 GHz d=2.33 √ P
0.01| 0.12| 0.12| 0.23
0.1| 0.37| 0.37| 0.74
1| 1.17| 1.17| 2.33
10| 3.70| 3.70| 7.37
100| 11.70| 11.70| 23.30
Declaration ‐ electromagnetic emissions

Fingertip Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of Fingertip Pulse Oximeter should assure that it is used in such an environment.
Emissions test| Compliance| Electromagnetic environment ‐ guidance
RF emissions CISPR 11| Group 1| Fingertip 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| Fingertip Pulse Oximeter is suitable for use in all establishments, including domestic establishments and those directly connected to the public low‐voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions
IEC 61000‐3‐2| N/A
Voltage fluctuations / Flicker emissions
IEC 61000‐3‐3| N/A
Fingertip Pulse Oximeter declaration – electromagnetic immunity

Fingertip Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of Fingertip Pulse Oximeter should assure that it is used in such an environment.
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment ‐ guidance
Conducted RF
IEC 61000‐4‐6| 3 Vrms ; 6 Vrms
150 kHz to 80 MHz| N/A| Portable and mobile RF communications equipment should be used no closer to any part of the EQUIPMENT or SYSTEM including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Interference may occur in the vicinity of equipment marked with the following symbol.

Radiated RF IEC 61000‐4‐3| 3 V/m ; 10V/m
80 MHz – 2.7 GHz 80%| 10 V/m
80 MHz – 2.7 GHz 80%
Proximity fields from RF wireless communications equipment IEC 61000‐4‐3| 27 V/m| 385 MHz| 27 V/m| 385 MHz
28 V/m| 450 MHz| 28 V/m| 450 MHz
9 V/m| 710 MHz| 9 V/m| 710 MHz
745 MHz| 745 MHz
780 MHz| 780 MHz
28 V/m| 810 MHz| 28 V/m| 810 MHz
870 MHz| 870 MHz
930 MHz| 930 MHz
28 V/m| 1720 MHz| 28 V/m| 1720 MHz
1845 MHz| 1845 MHz
1970 MHz| 1970 MHz
28 V/m| 2450 MHz| 28 V/m| 2450 MHz
9 V/m| 5240 MHz| 9 V/m| 5240 MHz
5500 MHz| 5500 MHz
5785 MHz| 5785 MHz
Declaration – electromagnetic immunity

Fingertip Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of Fingertip Pulse Oximeter should assure that it is used in such an environment.
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment ‐ guidance
Electrostatic discharge (ESD) IEC 61000‐4‐2| ±8 kV contact
±2 kV , ±4 kV , ±8 kV , ±15 kV air| ±8 kV contact
±2 kV , ±4 kV , ±8 kV , ±15 kV 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| ±2 kV for power supply lines
±1 kV for input/output lines| N/A| Mains power quality should be that of a typical commercial or
IEC 61000‐4‐4| | | hospital environment.
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Surge
IEC 61000‐4‐5| ±0.5 kV
±1 kV differential mode
±2 kV common mode| N/A| Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines
IEC 61000‐4‐11| 0 % U T ; 0 , 5 cycle
At 0°, 45°, 90°, 135°, 180°,
225°, 270° and 315°
0 % U T ; 1 cycle and 70 %
U T ; 25/30 cycle Single phase: at 0°| N/A| Mains power quality should be that of a typical commercial or hospital environment. If the user of the EQUIPMENT or SYSTEM requires continued operation during power mains interruptions, it is recommended that the EQUIPMENT or SYSTEM be powered from an uninterruptible power supply or a battery.
Power frequency (50/60 Hz)
magnetic field IEC 61000‐4‐8| 30 A/m| 30 A/m| Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

ESSENTIAL PERFORMANCE

The essential performance of SP62B Fingertip Pulse Oximeter is defined as Spo2 accuracy and  pulse rate accuracy. The specification of SP62B Fingertip Pulse Oximeter in non‐motion conditions is ±2 which is in compliance with the specified oxygen saturation, Arms of 2. The essential  performance will not be affected under the electromagnetic environment specified as above.

Explanation of Symbols

| The CE marking with the Registration Number of the Notified Body. This denotes the compliance of European Medical Device Directive 93/42/EEC

| ** Medical Device

| ** Manufacturer

| Authorized representative in the European Community

| Batch code
LOT WWWXXXXX
LOT: Lot Number; WWW: working sheet; XXXXX: serial no.

| Serial number
SN YYMWWWXXXXX
YY: year; M:month; WWW: working sheet; XXXXX: serial no.

| ** Keep dry

| ** Temperature limit

| ** Humidity limitation

| ** Atmospheric pressure limitation

| ** Caution

| ** Consult the instruction for use
****| Disposal information: Should you wish to dispose of the article, do so in accordance with current regulations. Details are available from your local authority. WEEE 2012/19/EU Directives

RoHS

| **** This product fulfilling the requirements of the RoHS Directive 2011/65/EU.

REACH

| This product fulfilling the requirements of the REACH Directive EC 1907/2006 and its amendments, do not contain Substances of Very High Concern in concentration above the limit of 0.1 %. No substance(s) is/are present in the parts of the product above the concentration of 0.1 % weight by weight.
| Device classification type BF
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****| This product meets the basic safety and essential performance requirements indicated in the IP22 conditioning test (protection against solid foreign objects of 12.5mm ∅ and greater and against vertically falling water drops when enclosure tiled up to 15°)
| The empty, completely flat batteries must be disposed of through specially designated collection boxes, recycling points or electronics retailers. You are legally required to dispose of the batteries.
| Importer
| Distributor
| Model Number
| Country of Manufacturer
| Unique Device Identifier
| Keep away from sunlight
****| No alarm

SP62BP‐22420AV
2022.12.08

Documents / Resources

| AVITA SP62B Pulse Oximeter [pdf] Instruction Manual
PW-62B, UV3SPW-62B, V3SPW62B, spw 62b, SP62B Pulse Oximeter, SP62B, Pulse Oximeter, Oximeter
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