accbiomed A403S-01 Reusable SpO2 Sensor User Manual

accbiomed A403S-01 Reusable SpO2 Sensor User Manual

Hunan Accurate Bio-Medical Technology Co., Ltd

Accurate Industrial Park, No.108, Zhixian Road，Xuelian Community， Xueshi Street of Yuelu District, 410208 Changsha, HunanProvince, PEOPLE’S REPUBLIC OF China.
Tel: +86-731-85598539
Fax: +86 731-84118539

Shanghai International Holding Corp. GmbH (Europe)

Add: Eiffestrasse 80, 20537 Hamburg Germany

• Tel: +49-40-2513175
• Fax: +49-40-255726
• Revision number: 1.1
• Release time: 2023/7/4

Intended use

SpO2 sensor is intended for monitoring of functional arterial oxygen saturation (SpO2) and pulse rate

Product usage period: 3 years

Users: adult

Product overview

Accurate reusable Sp02 sensors are classified in the following categories: adult finger(A4XX series), adult soft tip(A4XXS series)

Model
A403S-01；A410S-01；A403-01；A410-01.

Warning:

•  Accurate SpO2 sensors are for use with pulse oximeters.  Check the compatibility of the equipment, sensor and extend cable before use. Incompatible components can result in degraded accuracy and performance.

• Select appropriate sensor type to avoid inaccurate measurement or even harmful events
  which may lead to serious patient injury.

• Do not use damaged sensors and extend cables.

• Make sure the sensors are free of dirt and rust before use. Clean the sensors or replace them if necessary.

• Do not reuse the sensors and extend cables on a different patient until they have been disinfected.

• Try to keep the patient still and avoid excessive motions at the measured site, or use wrap or multi-site type sensors to reduce interference.

• Do not locate the sensors on the same arm as the blood pressure cuff, arterial catheter
  or intravascular line if using any of those devices at the same time.

• Make sure the measured site is not deeply pigmented or deeply colored, otherwise inaccurate measurement will occur.

• For long-term use, the measurement site must be changed every 4 hours to avoids in damage.

• The measurement may be inaccurate, if the perfusion is very low at the measured site.

• Avoid using sensors under the condition of strong light and irradiation field, otherwise inaccurate measurement will occur.

• Do not use the sensor inside or near a MRI equipment.

• Do not immerse the sensors in any of the cleaning solutions, disinfectants, or other liquid.

• Portable and mobile RF communication equipment can affect measurement accuracy.

• Do not place the sensors in an environment that exceed the storage range.

• Functional tester or oximetry simulator cannot be used as the assessment tool for the accuracy of sensors.

• Disposal of the sensor shall comply with local regulation.

• Don’t near active HF surgical equipment and the RF shielded room of an ME system for
  magnetic resonance imaging, where the intensity of EM disturbances is high.

• Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment
  and the other equipment should be observed to verify that they are operating normally.

• Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or
  decreased electromagnetic immunity of this equipment and result in improper operation.”

• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the equipment, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Sensor applications

Before applying sensors

Be sure to read, understand and observe all warnings listed in this manual and the manual of pulse oximeters.

Selecting appropriate sensors for different patients
Adult type sensors suit for adult patients(weight:>30 Kg).

Applying sensors

Finger and soft tip type

1. Place sensor to patient’s finger as shown below. Index finger is the best site, and other fingers except thumb can be considered either when the index finger is not available or cannot be located correctly. Be sure that the side with a finger pattern is placed on the top.
   

2. Patient fingertip should touch but not exceed the end of sensor. Trim the fingernail tocorrect the position if necessary.

3. Connect sensor to pulse oximeters (with an extend cable if needed).

4. Inspect and change the measurement site periodically.

Applying pulse oximeters

Applying pulse oximeters
Operate pulse oximeters under the instruction manuals.

Specifications

Accuracy

Note: When the SpO2 Sensor is used with the pulse oximeter, please refer to the accuracy specifications of the pulse oximeter.
| Range| Accuracy
---|---|---
Pulse rate| 20-250bpm| ±2bpm
| Wavelength range| Output power
---|---|---
Light emitting diodes| 600-1000nm| ＜18mW
| Atmospheric pressure(kPa)
---|---
Operating conditions| 70 to 106
Storage conditions| 50 to 107.4

Package and storage environment

The sensors are individually packaged and must be stored in original package under specific storage conditions to maximize their storage life. Storage conditions re as follows:

• Ambient temperature: -25 to+55℃
• Relative humidity: ≤85%

Operation environment

• Ambient temperature: 0°to+40°C
• Relative humidity:≤85%

Safety

• Degree of protection from electric shocks: type BF

Cleaning and disinfection

Cleaning

1. Clean sensors and cables with cotton or soft cloth moistened with warm soapy water.
2. Clean sensors and cables with cotton or soft cloth moistened with clean water.
3. Wipe off the water with a soft cloth.
4. Allow sensors to air dry.

Disinfection

Recommended disinfectant: 70% isopropyl alcohol.

1. Clean sensors with steps instructed above.
2. Disinfect sensors and cables with cotton or soft cloth moistened with 70% isopropyl alcohol.
3. Allow sensors to air dry.

CAUTIONS:

• Do not use any other disinfectants except 70% isopropyl alcohol.
• Never immerse or soak sensors into water or  any solution.
• Keep the pins clean and dry.

Warranty and Liability

Please refer to service announcement of Accurate. Accurate does not cover the damage or breakage due to the abusive use or negligent care of the sensors.

Symbol explanation

Caution| Production lot  number| Manufacturer| Non-sterilization| Latex free| See the instruc tions| Waste Electrical and Electronic Equipment
---|---|---|---|---|---|---
| |
| | | |
Date of manufacture e| Catalogue number| Authorized representative in the European| The product is protected against harmful effects of| This item is compliant with| Expire date| Medical devices
| | Community| dripping water perIEC| REGULATION| |
| | | 60529.| (EU) 2017/745| |
| | | | OF THE| |
| | | | EUROPEAN| |
| | | | PARLIAMENT| |
| | | | AND OF THE| |
| | | | COUNCIL.| |
| | | | | |
HUMIDITYLIMITATION| TEMPERAT| | | | |
| URE
| LIMITATIO
| N
| | | | | |

The SpO2 Sensor has completed clinical research at Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine. The study included 13 subjects -10women and 3 men. Participants are in good health and aged 22-30 years.

Guidance and manufacturer’s declaration -electromagnetic emissions and Immunity

Table 1

Guidance and manufacturer’s declaration – electromagnetic emissions

Emissions test| Compliance
RF emissions
CISPR 11| Group 1
RF emissions
CISPR 11| Class B
Harmonic emissions
IEC 61000-3-2| Not applicable
Voltage    fluctuations/               flicker emissions IEC 61000-3-3| Not applicable

Table 2 w

Guidance and manufacturer’s declaration – electromagnetic Immunity

Immunity Test| IEC 60601-1-2
Test level| Compliance level
Electrostatic (ESD)IEC 61000-4-2| discharge| ±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air| ±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
Electrical transient/burstIEC 61000-4-4| fast| ±2 kV power supply lines
±1 kV signal input/output 100 kHz repetition frequency| ±1 kV signal input/output 100 kHz repetition frequency
Surge| ± 0.5 kV, ± 1 kV differential| Not applicable
IEC 61000-4-5| mode|
| ± 0.5 kV, ± 1 kV, ± 2 kV|
| common mode|
Voltage dips, short interruptions and voltage variations on power supply input linesIEC 61000-4-11| Not applicable| Not applicable
Power  frequency magnetic fieldIEC 61000-4-8| 30 A/m
50Hz/60Hz| 30 A/m
50Hz/60Hz
Conducted RF| 3 V| 3 V
IEC61000-4-6| 0,15 MHz – 80 MHz| 0,15 MHz – 80 MHz
| 6 V in ISM and amateur radio| 6 V in ISM and amateur radio
| bands 0,15 MHz and 80 MHz80 % AM at 2 Hz| bands between 0,15 MHz and
80 MHz80 % AM at 2 Hz
Radiated RF IEC61000-4-3| 3 V/m
80 MHz – 2,7 GHz
80 % AM at 2 Hz| 3 V/m
80 MHz – 2,7 GHz
80 % AM at 2 Hz

NOTE UT is the a.c. mians voltage prior to application of the test level.

Table 3

Guidance and manufacturer’s declaration – electromagnetic Immunity

Radiated RF| Test| Band| Service| Modulation| IEC| Compliance
IEC61000-4-3| Frequency| (MHz)| | | |
(Test| (MHz)| | | | 60601-1-2| level
specifications for| | | | | Test Level| (V/m)
ENCLOSURE| | | | | (V/m)|
PORT| 385| 380| TETRA| Pulse| 27| 27
IMMUNITY to| | –390| 400| modulation| |
RF wireless| | | | 18 Hz| |
communications equipment)| | | | | |
450| 430–470| GMRS460,| FM± 5 kHz| 28| 28
| | | FRS 460| deviation| |
| | | | 1 kHz sine| |
| 710| 704 –| LTE Band| Pulse| 9| 9
| 780| | 17| 217 Hz| |
| 810| 800 –| GSM| Pulse| 28| 28
| 870| 960| 800/900,| modulation| |
| | | TETRA800,| 18 Hz| |
| 930| | | | |
| | | iDEN 820,| | |
| | | CDMA| | |
| | | 850,| | |
| | | LTE Band| | |
| | | 5| | |
| 1720| 1 700| GSM| Pulse| 28| 28
| 1845| –| 1800;| modulation| |
| | 1 990| CDMA1900;| 217 Hz| |
| 1970| | | | |
| | | GSM| | |
| | | 1900;| | |
| | | DECT;| | |
| | | LTE Band| | |
| | | 1, 3,| | |
| | | 4, 25;| | |
| | | UMTS| | |
| 2450| 2 400| Bluetooth,| Pulse| 28| 28
| | –| WLAN,| modulation| |
| | 2 570| 802.11| 217 Hz| |
| | | b/g/n,| | |
| | | RFID| | |
| | | 2450,| | |
| | | LTE Band| | |
| | | 7| | |
| 5240| 5 100| WLAN| Pulse| 9| 9
| 5500| –| 802.11| modulation| |
| | 5 800| a/n| 217 Hz| |
| 5785| | | | |
Electromagnetic environment – guidance

RF wireless communications equipment should be used no closer to any part of the device, 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 , should be less than the compliance level in each frequency rang interference may occur in the vicinity of equipment marked with the following symbol

Note 1: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people

Table 4

Guidance and manufacturer’s declaration – electromagnetic Immunity

Radiated RF| Test| Modulation| IEC 60601-1-2| Compliance level
IEC61000-4-39(Test specifications for ENCLOSURE PORT IMMUNITY to| Frequency| | Test Level (A/m)| (A/m)
30 kHz| CW| 8| 8
proximity magnetic| | | |
fields)| | | |
| 134,2 kHz| Pulse| 65| 65
| | modulation| |
| | 2.1 kHz| |
| 13,56 kHz| Pulse| 7,5| 7,5
| | modulation| |
| | 50 kHz| |

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