indiamart AF543-01 Disposable Spo2 Velcro Sensor Probe User Manual

: June 12, 2024
: indiamart

Table of Contents

Intended use
Users:
Warning:
Sensor applications
Specifications
Warranty and Liability
Symbol explanation
Clinical summary
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Disposable SpO2 Sensor
User’ s Manual
Product Information
Product Name: Disposable SpO2 Sensor

Intended use

SpO2 sensor is intended for monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.
1.1 Product usage period: Disposable
1.2 Product storage period: 3 years

Users:

adult；neonate；
2.1 Model：
AF543-01，AF543-01X
2.2 Product overview
Accurate disposable Sp02 sensors are classified in the following categories: adult&neonate foam adhesive(AF543 series)type.

Warning:

Accurate disposable 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.
In the event of the packaging being damaged, do not use the sensor.
Disposable SpO2 sensor is intended for single patient use, and has been cleaned before delivery. Do not attempt to clean or sterilize it, otherwise it may result in product failure.
Try to keep the patient still and avoid excessive motions at the measured site.
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 avoid skin damage.
The measurement may be inaccurate with very low perfusion at the measured site.
Prevent the sensors from being 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 communications 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

4.1 Before applying sensors
Be sure to read, understand and observe all warnings listed in this manual and the manual of pulse oximeters.
4.2 Selecting appropriate sensors for different patients
Adult type sensors suit for adult patients(weight:>30 Kg);neonatal type sensors suit for neonatal patients(weight:<3 Kg).
4.3 Applying sensors
Neonate/Adult Foam Adhesive

Place sensor to patient as shown below.

Neonate:
Place sensor to patient’s toe or finger as shown below with optical components opposite each other.

Adult:

Place sensor to patient’s finger as shown below with optical components opposite each other. Be sure that the side with LED is above the nail. 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.
Holding sensor and stretch strap slightly.
Connect sensor to pulse oximeters (with an extend cable if needed).
Inspect and change the measurement site periodically.

4.1 Applying pulse oximeters
Operate pulse oximeters under the instruction manuals.

Specifications

5.1 Accuracy

Sp02 Range	Sp02 accuracy
70%-100%	±2%
＜70%	not specified

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

5.2 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 are as follows:

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

5.3 Operation environment

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

5.4 Safety
Degree of protection from electric shocks: type BF

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 instructions
| WasteElectrical and Electronic Equipment
| Medical devices
| Date of manufact ure
| Catalogue number
**| Authorized Representative In The European Community
| Do not re-use
| Expiry date
IPX2| The product is protected against harmful effects of dripping water perIEC 60529.
0 1 2 3**| This item is compliant with REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL.
| TEMPERAT URE LIMITATION
| HUMIDITY LIMITATION

Clinical summary

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 -10 women 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

Table 2

Guidance and manufacturer’s declaration – electromagnetic Immunity

Immunity Test| IEC 60601-1-2
Test level| Compliance level
Electrostatic (ESD) discharge 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
Electrical fast transient/burst IEC 61000-4-4| ±2 kV power supply lines
±1 kV signal input/output 100 kHz repetition frequency| Not applicable
Surge
IEC 61000-4-5| ± 0.5 kV, ± 1 kV differential mode
± 0.5 kV, ± 1 kV, ± 2 kV common mode| Not applicable
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11| Not applicable| Not applicable
Power frequency magnetic field
IEC 61000-4-8| 30 A/m
50Hz/60Hz| 30 A/m
50Hz/60Hz
Conducted RF
IEC61000-4-6| 3 V
0,15 MHz – 80 MHz
6 V in ISM and amateur radio
bands 0,15 MHz and 80 MHz
80 % AM at 2 Hz| 3 V
0,15 MHz – 80 MHz
6 V in ISM and amateur radio
bands between 0,15 MHz and
80 MHz
80 % 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 IEC61000-4-3
(Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment)| Test Frequency (MHz)| Band (MHz)| Service| Modulation| IEC 60601-1-2
Test Level (V/m)| Compliance level (V/m)
385| 380 –390| TETRA 400| Pulse modulation 18 Hz| 27| 27
450| 430 –470| GMRS 460, FRS 460| FM ± 5 kHz deviation
1 kHz sine| 28| 28
710| 704 – 787| LTE Band 13, 17| Pulse modulation 217 Hz| 9| 9
745
780
810| 800 – 960| GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5| Pulse modulation 18 Hz| 28| 28
870
930
1720| 1 700 – 1 990| GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band
1, 3, 4, 25;
UMTS| Pulse modulation 217 Hz| 28| 28
1845
1970
2450| 2 400 – 2 570| Bluetooth, WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7| Pulse modulation 217 Hz| 28| 28
5240| 5 100 – 5 800| WLAN 802.11 a/n| Pulse modulation 217 Hz| 9| 9
5500
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 b.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 IEC61000-4-39
(Test specifications for ENCLOSURE PORT IMMUNITY to proximity magnetic fields)| Test Frequency| Modulation| IEC 60601-1-2 Test Level (A/m)| Compliance level (A/m)
30 kHz| CW| 8| 8
134,2 kHz| Pulse modulation 2.1 kHz| 65| 65
13,56 kHz| Pulse modulation 50 kHz| 7,5| 7,5

Hunan Accurate Bio-Medical Technology Co., Ltd.
Accurate Industrial Park, No.108, Zhixian Road，
Xuelian Community, Xueshi Street of Yuelu District, 410208 Changsha, Hunan
Province, 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