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Disposable SPO2 Sensor User Manual

Intended Use & Indications for Use

The disposable SpO2 sensors are indicated for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin(SpO2) and pulse rate(PR).

They are fully compatible replacement sensors intended for use with major brands of pulse oximeter. The SpO2 sensors are designed to match the specifications of the original equipment manufacturer, therefore ensure the appropriative sensor model number is selected for a particular pulse oximeter technology.

The models of disposable sensors suit for the following patients size:

Adult (weight greater than 40 kg)
Pediatric (10-50 kg weight)
Infant (3-20 kg weight)
Neonate (weight less than 3 kg)

Principle of Operation

The sensors shall be connected with its corresponding monitor. Oxygenation of blood is measured by detecting the infrared and red light absorption characteristics of deoxygenated hemoglobin and oxygenated hemoglobin, which consists of a probe attached to the patient's finger. The sensor is connected to a data acquisition system which is used to calculate and display oxygen saturation levels and heart rate conditions.

Installation/Utilization/maintenance

Connect the sensor cable to the adaptor cable that fits your oximeter. Then turn on the oximeter and verify proper operation
Select the sensor site on the patient. The preferred sensor sites are the index finger for adult and children, the great toe for infants, and on the foot below the toes for neonate.
Apply the sensor on the patient:

Position the emitter and detector directly opposite each other.
Apply the sensor firmly but not too tightly.

Visually monitor the sensor site to ensure the integrity of the skin.

Performance/Reliability/Safety/Compatibility/ Mechanical Integrity

Performance/Reliability:
The SpO2 sensor with its compatible pulse oximeter has been validated and tested for compliance with ISO 80601-2-61:2011

Comparative value measurement in % saturation:
SpO2 range (70%-100%) -------------------------- Accuracy ±3 %
SpO2 range (<70%) -------------------------------- No specified
Pulse rate range: 35-240bpm --------------------- Accuracy ±2 bpm
Low perfusion：SpO2 range (70%-100%) ------- Accuracy ±3 %
Pulse rate range: 35-240bpm --- Accuracy ±3 bpm

Peak Wavelength and Maximum Output Power

LED Type	RED Peak Wavelength	RED Maximum Output Power	IR Peak Wavelength	IR Maximum Output Power
2-Leads	663nm	1.2mW	890nm	1.0mW
3-Leads	661nm	1.2mW	940nm	1.2mW
4-Leads	660nm	1.2mW	905/940nm	1.0mW

Safety:
Degree of protection from electric shocks: type BF
Classification is in accordance with MDD 93/42/EEC: Class IIb
Degree of Protection against the Ingress of Water: IPX2
Compatibility:

In order to ensure compatibility and claimed accuracy of the devices,The SpO2 sensors are only to be used with the specified equipment for which they have been designed and labeled use for.
Mechanical Integrity:

The sensors of we designed to be extremely durable. We use only the highest quality materials to ensure the sensors stand up to the rough hospital environment.
The solid connectors are fitted with flexible sleeves, minimizing the risk of the cable parting. They have no accessible metallic parts.

Operating conditions

Ambient temperature: 0 til +40 ° C
Relative humidity: 15 til 85%
Atmospheric pressure: 86kpa ~ 106kpa

Storage/Packaging

The sensors are individually packaged.
The sensors must be stored in its original packaging and within the storage conditions to maximize the storage life of the sensors.
Storage conditions are as follows:

Ambient temperature: -10 to +40 ° C
Relative humidity: 15 to 85%
Atmospheric pressure: 86kpa ~ 106kpa

Shelf-life

2 years

Warning

The sensors should not be fixed in the tissue injury site, not for hyperactivity of blood oxygen monitoring.
The sensors are designed for use with specific monitors.
The operator is responsible for checking the compatibility of the monitor,sensor and cable before use it.
Incompatible components can result in degraded accuracy and performance.
Consult the operation instructions for the equipment concerned and the related accessories before operating equipment to ensure their compatibility.
Portable and mobile RF communications equipment can be affect equipment.
Do not immerse connector ends in cleaning solution(s).
Do not allow service or maintenance the sensor while used in patient.
No modification of this equipment is allowed.
The sensors are tested by biocompatibility,there are not any risk to the human body.

Warning: MR-unsafe!
Do not expose the device to a magnetic resonance (MR) environment.

The device may present a risk of projectile injury due to the presence of ferromagnetic materials that can be attracted by the MR magnet core.
Thermal injury and burns may occur due to the metal components of the device that can heat during MR scanning.
The device may generate artifacts in the MR image.
The device may not function properly due to the strong magnetic and radiofrequency fields generated by the MR scanner.

CAUTION:
Federal (U.S.) Law restricts this device to sale by or on the order of a physician.
Waste disposal:
According to local laws and regulations to deal with waste SpO2 sensors.

Symbol explanation

	Manufacturer
	Catalogue number
	Batch code
	Series number
	Single patient use
	Use by
	Latex free
	Non sterile
	See the instructions
	Caution
	Date of manufacture
	Crossed out wheelie bin indicates separate treatment from general waste at end of life. Waste of Electrical and Electronic Equipment Directive (WEEE)
	Protection against moisture
	Federal (U.S.) Law restricts this device to sale by or on the order of a physician.
	European Authorized Representative
	CE Mark
	Type BF Equipment

Appendix EMC Declaration

Guidance and manufacturer´s declaration - electromagnetic emission - for all EQUIPMENT AND SYSTEMS

1	Guidance and manufacturer´s declaration – electromagnetic emission
2	The Disposable SpO2 Sensor is intended for use in the electromagnetic environment specified below. The customer or the user of Disposable SpO2 Sensor should assure that it is used in such an environment.
3	Emissions test	Compliance	Electromagnetic environment - guidance
4	RF emissions CISPR 11	Group 1	The Disposable SpO2 Sensor uses RF energy only for its internal function. There for, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
5	RF emissions CISPR 11	Class A	The Disposable SpO2 Sensor is suitable for use in all establishments other than domestic, and may be used in domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded: Warning: This equipment/system is intended for use by healthcare professionals only. This equipment/ system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the Disposable SpO2 Sensor or shielding the location.
6	Harmonic emissions IEC 61000-3-2	Not Complies
7	Voltage fluctuations flicker emissions IEC 61000-3-3	Not Complies

Guidance and manufacturer's declaration – electromagnetic immunity –
for all EQUIPMENT and SYSTEMS

Guidance and manufacturer´s declaration – electromagnetic immunity
The Disposable SpO2 Sensor is intended for use in the electromagnetic environment specified below. The customer or the user of the Disposable SpO2 Sensor 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 %.
Electrostatic transient / burst IEC 61000-4-4	± 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 hospital environment.
Surge IEC 61000-4-5	± 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 % UT; 0,5 cycle g) At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° 0 % UT; 1 cycle and 70 % UT; 25/30 cycles Single phase: at 0° 0 % UT; 250/300 cycle		Mains power quality should be that of a typical commercial or hospital environment. If the user of the Disposable SpO2 Sensor requires continued operation during power mains interruptions, it is recommended that the Disposable SpO2 Sensor 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.
NOTE UT is the a. c. mains voltage prior to application of the test level.

Guidance and manufacturer´s declaration - electromagnetic immunity -
for EQUIPMENT and SYSTEM

Guidance and manufacturer´s declaration – electromagnetic immunity
The Disposable SpO2 Sensor is intended for use in the electromagnetic environment specified below. The customer or the user of the Disposable SpO2 Sensor 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 Radiated RF IEC 61000-4-3	3 Vrms 150 kHz to 80 MHz 6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz 10 V/m 80 MHz to 2.7 GHz 385MHz-5785MHz Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communication equipment (Refer to table 9 of IEC 60601-1-2:2014)	3V 150 kHz to 80 MHz 6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz 10 V/m 80 MHz to 2.7 GHz 385MHz-5785MHz Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communication equipment (Refer to table 9 of IEC 60601-1-2:2014)	Portable and mobile RF communications equipment should be used no closer to any part of the Disposable SpO2 Sensor, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance 80 MHz til 800 MHz 800 MHz til 2,7 GHz 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 is affected by absorption and reflection from structures, objects and people. The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz. 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, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Disposable SpO2 Sensor is used exceeds the applicable RF compliance level above, the Disposable SpO2 Sensor should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Disposable SpO2 Sensor. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

Recommended separation distances between portable and mobileRF communications equipment and the EQUIPMENT or SYSTEM -
for EQUIPMENT and SYSTEMS

Recommended separation distances between portable and mobile RF communications equipment and the W-T2008-B Haemodialysis machine
The Disposable SpO2 Sensor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Disposable SpO2 Sensor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Disposable SpO2 Sensor as recommended below, according to the maximum output power of the communications equipment
Rated maximum output of transmitter W	Separation distance according to frequency of transmitter
Rated maximum output of transmitter W	150 kHz to 80 MHz outside ISM and amateur radio bands	150 kHz to 80 MHz in ISM and amateur radio bands	80 MHz to 800 MHz	800 MHz to 2.7 GHz
0.01	0.12	0.20	0.035	0.07
0.1	0.38	0.63	0.11	0.22
1	1.2	2.00	0.35	0.70
10	3.8	6.32	1.10	2.21
100	12	20.00	35	70
For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres (m) can be estimated 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.