Shenzhen Smallsignal Technology 07010012 Fingertip Pulse Oximeter User Manual

Smallsignal Technology
Fingertip Pulse Oximeter
User Manual

07010012 Fingertip Pulse Oximeter

Please read the user manual before use!
The contents of this manual and the specifications of this product are subject to change without notice!

Declaration

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

Overview

1. Features
   Blood oxygen saturation is the percentage of the capacity of hemoglobin (oxyhemoglobin Hb02) combined with oxygen molecules in the blood to the total capacity of bindable hemoglobin (oxyhemoglobin Hb02 and reduced hemoglobin Hb). Blood oxygen saturation is used to evaluate the ability of human blood to carry and transport oxygen. It is a very important physiological parameter in the respiratory system and cardiovascular system. Knowing the blood oxygen saturation of the body in time will help users make correct judgments.
   The fingertip pulse oximeter (hereinafter referred to as the oximeter) has the advantages of small size, low power consumption, simple operation and convenient carrying. During the measurement, as long as the finger is inserted into the device correctly, the blood oxygen and pulse rate information of the body can be quickly obtained. The device collects the human body signal through a photosensitive detector. After the signal is processed by the internal circuit, the measurement result will be displayed on the front panel display. The clinically proven oximeter has high accuracy and repeatability.

2. Main purpose and scope of application
   The finger clip pulse oximeter is mainly used to measure the users blood oxygen saturation and pulse rate. It is suitable for families, hospitals, oxygen bars, community medical places and other environments.

3. Environmental requirements
   a) Working environment: temperature: 5 C -40 C , relative humidity: 15% – 80%, atmospheric pressure: 86kPa 106kPa.
   — Transportation and storage environment: temperature: -10 C -40 C, relative humidity: 15%- 95%, atmospheric pressure: 50kPa 106kPa.

4. Power supply : DC3V (two 1.5VAAA batteries).

5. Disposal of waste: Products should be disposed of as electronic waste or in accordance with local regulations after end of life.

6. Safety classification : This equipment is a type BF equipment powered by an internal power supply .

7. Mass: 33±3g (without battery).

8. Dimensions (unit: mm): Dimensions of Alpine20/ 20L series : 61 x37x33; Dimensions of Alpine30/ 30L series : 61 x34x32.

9. Continuous use for 24 hours with 2 AAA1.5 V alkaline batteries.

10. Emission light information

| wavelength|

Maximum optical output power

---|---|---

RED

| 660 ±3 nm| 1.2mW
IR| 905 ±10 nm|

1.2mW

11. The device has been calibrated when it is out of the field, and does not need to be calibrated by the user.
12. The data update cycle of the device is 15 seconds.

Safety Information

1. Be sure to read this manual carefully before use.
2. Using this device , make sure that the oximeter is in normal working condition and operating environment.
3. This device is suitable for children and adults over the age of 4 (should weigh between 15kg and 110kg). This device contains small parts and should be used by children under adult supervision.
4. Function of this instrument when monitoring patients, which must be verified regularly. The most reliable monitoring method is the close monitoring and proper use of the oximeter by the medical staff.
5. When using the oximeter, please stay away from devices that generate strong electric and magnetic fields (such as MR equipment). Using it in an inappropriate environment may affect the work of the oximeter.
6. When several devices are used on the same patient at the same time, it may bring additional danger. It is recommended to consult the manufacturer for the correct use method to ensure that the leakage current is within the safe allowable range and will not cause harm to the patient, operator and surrounding environment.
7. Do not use this device in the presence of flammable gases, such as certain flammable anesthetics.
8. Keep the oximeter away from dust, corrosive substances, flammable and explosive materials, and away from high temperature and humid environments.
9. Do not use this device under strong light or high-frequency magnetic fields.
10. Do not use this device during MRI or CT.
11. If the user has severe hypotension, vasoconstriction, severe anemia or hypothermia, the measurement may be erroneous.
12. This device is not intended for users in a state of carbon monoxide poisoning or other abnormal hemoglobin conditions and will result in erroneous results.
13. The temperature should not exceed 40°C when in contact with the patient. The maximum time of use on the same part should not exceed 2 hours.
14. Do not repair the device by yourself, if necessary, please contact the after-sales personnel for repair.
15. If the device is to be stored for more than a month, remove the battery or the battery may leak.
16. Interference from medical high-frequency signals or defibrillators can cause erroneous degrees.
17. False readings can be caused by the patient after the heart has stopped beating or on inotropes or when the patient is shaking.
18. It is not recommended that users use this device while exercising.
19. The cleaning of this device should follow the instructions in this manual, and this device is prohibited for those who are allergic to medical silicone.
20. Do not use the information displayed by the oximeter as the sole basis for clinical diagnosis. The oximeter is only used as an aid in diagnosis. The clinical manifestations and symptoms must be combined with the doctors diagnosis.
21. When the ambient temperature is 20°C, take the device out of the environment with the highest or lowest storage temperature and wait for 20 minutes before it can be used normally.
22. Do not mix new and old batteries .
23. Do not look directly at the light-emitting tube to avoid damage to the eyes.
24. Functional testers cannot be used to identify or verify the true accuracy of a pulse oximeter.
25. This device shows where the pulse wave is normalized.

This device does not have an alarm function! Do not use this device on infants or newborns! This device is not suitable for continuous monitoring!
No modification of this equipment is allowed.

Structural features and working principle

1. Product structure: This device is a single host device.

2. Measurement principle
   The measurement principle of this equipment is based on the spectral characteristics of reduced hemoglobin (Hb) and oxyhemoglobin (Hb02) with different absorption rates of red light with a wavelength of 660 nm and infrared light with a wavelength of 905 nm. Law) established a data empirical formula to calculate blood oxygen saturation.

3. Red light infrared light emitting tube

4. Photoelectric receiving sensor

System settings

1. System default settings.
   LED version default settings
   a) Low blood oxygen saturation prompt threshold 94
   b) Low pulse rate prompt threshold 50
   c) High pulse rate prompt threshold 130
   d) Default beep on
   e) Default flashing character prompt
   f) Default pulse tone off

2. manual setting
   Long press the power button for 3 seconds to enter the setting interface. After entering the setting interface, long press the power button to execute the operation, short press the power button to select the operation , and long press the Exit or no operation for 40 seconds to automatically exit the setting interface.

Setting interface description:

1. Remind Setup : Remind Setup
2. Limit Setup : Threshold setting
3. Sp02 Hi: High blood oxygen prompt tone setting
4. Sp02 Lo: low blood oxygen tone setting
5. PR Hi: high pulse rate beep sound setting
6. PR Lo: low pulse rate beep setting
7. +/-: Addition and subtraction settings
8. Sound Reminder : Reminder sound switch
9. Beep: Pulse rate tone switch
10. Demo: demo mode switch
11. Restore: restore factory settings
12. Brightness: Brightness setting
13. Exit : Exit the setting interface

User guides

1. battery installation
   1) Open the battery compartment door
   2) Correctly insert the battery according to the positive and negative symbols in the battery compartment
   3) Install the battery compartment door

2. Measurement
   Keep your fingers and the device clean. When the device is turned on, insert your finger in the direction shown in the picture (nails are facing the light- emitting direction) . Do not move during measurement. After the measurement is completed, the device will automatically shut down if no operation is performed for 10 seconds.

3. Display interpretation
   1) oxygen saturation symbol
   2) bluetooth symbol
   3) battery level symbol
   4) blood oxygen saturation
   5) stick figure
   6) pulse rate
   7) pulse rate symbol
   CAUTION!: If the measurement result shows that the blood oxygen saturation or pulse rate is abnormal, please ensure that the correct measurement method is used to measure again . If it Is determined that the oximeter Is normal, please go to the hospital for confirmation In time.

4. Accuracy Statement
   project| Measuring range| Resolution| Accuracy
   ---|---|---|---
   blood oxygen saturation| 35-100%| 1%| 70-100%, ± 2%; 69% and below undefined
   pulse rate| 25-250bpm| 1bpm| ±2bpm

Cleaning and Maintenance

1. Equipment cleaning: Do not allow any liquid to enter the inside of the equipment.
   If you need to clean or sterilize the equipment, you can wipe the surface of the equipment with 75% alcohol at room temperature and soft materials with the battery removed, and let it dry before use.

2. Storage: If not in use for a long time, please remove the battery and store it in a cool and dry place.

3. Equipment maintenance: This equipment can only be repaired by professionals from the factory.

4. Long-term placement in a humid environment will shorten the service life of the device.

Troubleshdog

2. fingers too thin
3. Ambient light is too strong| 1. Refer to the instruction manual to insert the finger correctly
2. Try several times, if you confirm that the machine is normal, please go to the hospital for diagnosis in time
3. Use thumb or middle finger to measure
4. Take measurements after leaving the strong light environment
unstable blood| 1. fingers or body in motion| 1. Keep your fingers and body relaxed
oxygen or pulse rate| 2. Finger not inserted correctly| 2. Refer to the instruction manual to insert the finger correctly
Can not boot| 1. battery not installed correctly
2. battery is low
3. Equipment damage| 1. Install the battery correctly according to the instruction manual
2. Replacement battery
3. Please contact the after-sales staff for processing
Screen suddenly turns off| 1. The device automatically turns off without detecting a finger for a long time
2. battery is low
3. Equipment damage| 1. The machine is normal
2. Replacement battery
3. Please contact the after-sales staff for processing

Electromagnetic Compatibility

NOTICE:

• The finger clip pulse oximeter meets the relevant requirements of 9706.102-2021 and YY0784-2010 standards for electromagnetic compatibility.
• Users should install and use according to the electromagnetic compatibility information provided in this manual.
• Portable and mobile RF communication equipment may affect the performance of the finger clip pulse oximeter, avoid strong electromagnetic interference when using, such as near mobile phones, microwave ovens, etc.;
• Guidelines and manufacturer’s declarations are detailed in the appendix.

WARNING:

• The finger clip pulse oximeter should not be used close to or stacked with other equipment.
  If it must be used close to or stacked, it should be observed and verified that it can operate normally in the configuration it is used in;

• finger-clip pulse oximeter below the minimum amplitude or minimum values above may result in inaccuracy;

• The finger clip pulse oximeter uses Bluetooth technology, the sending and receiving frequency is 2400-2483.5MHz, the modulation type is: GFSK, and the effective radiation power is -2.4dBm;

• Even if other devices meet the emission requirements of the corresponding national standards, the finger clip pulse oximeter may still be interfered by other devices.

Guidance and manufacturers declaration-Electromagnetic emission

Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of the Model AOJ-70B should assure that it is used in such an environment.
Emissions| 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 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
I EC61000-3-2| N.A.| N.A.
VoltageFluctuations /flicker emissions
I EC61000-3-3| N.A.

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 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 IEC 61000-4-4| Not applicable| Not applicable|
Surge IEC 61000-4-5| Not applicable| Not applicable|
Voltage dips, short interruptions and voltage variations on power supply input lines
IEC 610004-11| Not applicable| Not applicable|
Power frequency magnetic field IEC 61000-4-8| 30 A/m 50Hz/60Hz| 30 Alm 50Hz/60Hz| Power frequency magneticfields should be at levels characteristic of a typicallocation in a
typicalcommercial or hospital environment.
Conducted RF IEC61000-4-6| Not applicable| Not applicable
Radiated RF IEC61000-4-3| 10 V/m 80 MHz — 2 7, GIlz
80% AM at 1 kHz| 10 V/m
80 MHz — 2,7 GHz
80 % AM at 1 kHz
NOTE: UT is the a.c. mains voltage prior to application of the test level

Symbol Description

| Type BF applied part| | Read the manual before use
---|---|---|---
| Garbage sorting| | Anti-dust&Anti-water class
| Alarm inhibit| | warn
| power switch| | afraid of rain
| Non-ionizing electromagnetic radialior| | Fragil
| Low battery alert| | This way up
| Manufacturer| | European representative
| CE mark| | RoHS mark
| Medical device| | Serial Number

IP22 : IP22 means shcll of this product can withstand the water dropping to the surface when the shelldeviate 15 degree from horizontal surface

Warranty Regulations

This product has quality problems that are not caused by human factors within one week from the date of sale, and the company is responsible for the return, replacement and repair. The company will provide free maintenance; if the product has quality problems one year after the date of leaving the factory, the user can go to the company’s after-sales service department, office or dealer according to the invoice and warranty card. The company provides spare parts for maintenance, and only charges The cost of fees.
The following situations are not covered by the warranty:

1. The failure caused by the user’s disassembly, repair and modification of the product;
2. Failure caused by accidental falling during use, handling, etc.;
3. Damage caused by improper use by the user;
4. Failure caused by the user not operating in the correct way in accordance with the instruction manual;
5. Damage caused by unforeseen natural disasters (such as fire, earthquake, flood, etc.).

Boxing List

serial number| project| quantity
1| Finger clip pulse oximeter host| 1
2| 1.5V MA battery| 2
3| Manual, Warranty Card, Certificate of Conformity , Packing List| 1
4| certificate| 1
Warranty Card
Product number|
Serial number|
dealer (stamp)|
Invoice number|
username|
contact number|
Maintenance records
date| | Maintenance staff
| |
| |
| |
| |

Corporate Information

Shenzhen Small Signal Technology Co., Ltd.
Room 901-7, Building 1, No. 9, Jinxiu Middle Road, Laokeng Community, Longtian
Street, Pingshan District, Shenzhen
Email: service@smallsignal.cn
Website: https://www.smallsignal.cn
Tel : +86-0755-23010489

Share Info GmbH
Address: Heerdter Lohweg 83, 40549 Dusseldorf, Germany
FCC Warning
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 this device must accept any interference received, including interference that may cause u ndesired operation. Any changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. 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 a gainst 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 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 co rrect 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.

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.

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