AS-301 AILE Pulse Oximeter Oxygen Meter User Manual

AS-301 AILE Pulse Oximeter Oxygen Meter

Product Features

The product is easy to operation, small in volume, light in weight, convenient in carrying, and adopted the low consumption design, with strong resistance to ambient light interference ability. 2pcs AAA batteries can be continuously used for 12 hours, and battery voltage can be indicated. The product is suitable for use in home healthcare, hospital (including internal medicine, surgery, anesthetic, intensive care and etc.), oxygen bar, community medical centre, sports healthcare and etc.

Intended Use

The fingertip pulse oximeter is a portable non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult in hospitals, hospital-type facilities, 2 and home environments.
It applies to persons of all colors except infants and neonates. No special training in the use of the product, but requires the user to read the instructions before use. Readers are adults, and would be able to read and understand the operation manual; there are no reading and understanding barriers.

Measurement Principle

Arterial oxygen saturation is measured by a method called pulse oximetry. It is a continuous, non-invasive method based on the different spectra absorption of hemoglobin and oxyhemoglobin. It measures how much light, sent from light sources on one side of the sensor, is transmitted through patient tissue (such as a finger), to a receiver on the other side. Two beams of different wavelength of lights (660nm red and 895nm near infrared light) can be focused onto a human nail tip through c clamping finger-type sensor. A measured signal obtained by a photosensitive element, will be shown on the oximeter’s display through process in electronic circuits and microprocessor.

SpO2 is a measurement of the functional oxygen saturation. 2
The value of SpO2  and PR were through average processing. 2
The light (the red light and the infrared light which is invisible) emitted from the device is harmful to the eyes, so the user and the maintenance personnel cannot stare at the light.
The device don’t have Technical specifications manual, the product specified see the instructions.

Operation Instruction

Before use, carefully read the user manual.

The LED digitron display oximeter can not change direction and no waveform display.

1. Press the “power switch” key on front panel to turn the pulse oximeter power on.
2.  Place your one finger (forefinger or middle finger) into the cavity of the pulse oximeter. It is also available to measure if using your other fingers, such as thumb, ring finger or litter finger
3.  Read the data display on the screen ( about 3~4s). The bar graph height indicates the pulse strength.
4.  The device will turn itself off automatically after 8 s idling.

The finger measured has no pathological change.
Do not use the fingertip pulse oximeter in situations where alarms are required. The device has no alarms of the SpO2 and pulse.
Operation of the fingertip pulse oximeter may be affected by the use of an electrosurgical unit.
This fingertip pulse oximeter is neither suitable for continuous monitoring the same site of the same patient nor suitable for measuring neonate and infant. Check the finger touching site for every two hours. The finger measured should move or shift part if the finger skin changes. Some patients, such as the one with perfusion disorder or sensitive skin, may need frequent measurement. Long time continuous monitoring could increase the unexpected change in skin, such as sensitive, red, blister or pressure necrosis , etc.

The results may be wrong if you did not insert the finger thoroughly in the oximeter
Please use the medical alcohol to clean the finger and the oximeter rubber touched by finger. (The oximeter rubber is medical silicon, which has no toxin, no harmful to human skin and has passed biocompatibility test.)
Do not use the device in an MRI or CT environment. It may cause errors of measurement data.
Do not use the device in the presence of flammable anesthetic mixed with air, oxygen or nitrous oxide.
Portable and mobile RF communications equipment can affect medical electrical equipment.
These materials that contact with the patient’s skin contain medical silicone and ABS plastic enclosure are all pass the ISO 10993-5 tests for invitro cytotoxicity and ISO 10993-10 Tests for irritation and delayed-type hypersensitivity.
Temperature may rise in the process of product use, but the temperature may not exceed 41 degrees and no harm will be caused to the user.
It is suggested that the device be used indoors or in the environment where there are no strong light and too much dust.
It is best to store the product in-20℃-+55℃ and ≦93% humidity.
Do not dismount, take apart or maintain the product by self.
Please contact the service provider if there is any problem of the product.
If the accuracy of the measurement by the device is uncertain, check the patient’s vital signs by alternative means first.
Then check the oximeter. Inaccurate measurement may be caused by the following factors.

1. Ambient light radiation
2. Patient movement
3. Diagnosis test
4. Low perfusion
5. Electromagnetic, such as using the cell phone nearby
6. Electrical equipment
7. The fingernail polish
8. Artery blood is too low to measure, which is caused by shock, anemia, low-temperature or vasoconstrictor.
9. Heavy smoking patient may appear instantaneous high CO, causing the increase of the hemoglobin CO.
10. Patients with severe jaundice will have high bilirubin, which metabolizes CO that shapes significant lever carboxyhemoglobin. Thus causes high SpO2

When the waveform display is not the law (AS-301, AS-302, AS-303,AS-304) or pulse bar graph does not bounce (AS-3 01-L, AS-302-L,AS-304-L)，the displayed SpO2 or pulse rate value is potentially incorrect. Because the waveform is under-normalized, so the signal waveform when the irregular or display line, the value of SpO2 and PR displayed may be incorrect.

Product Accessories

One lanyard
One instruction manual

Battery Installation

1. Open up the battery compartment cover
2. Install two AAA batteries into the battery compartment correctly to match the positive and negative. Slide the battery door cover horizontally along the arrow

NOTE:
The device will automatically star and the luminous tube lights when the batteries installed correctly.
Please remove the batteries if the pulse oximeter will not be used for long periods of time.

Cautions:

The battery power is showed in the middle of the screen. Please replace the Batteries when battery sign shows blank space.
Caution: Batteries polarities must be installed correctly, otherwise damage might be caused to the device.
Please remove the batteries from the battery compartment if the pulse oximeter will not be used for a long periods of time.
Follow local governing ordinance and recycling instructions regarding disposal of batteries, other electron devices and outer packing.
Keep the oximeter away from young children, Small items such as the battery door, battery and lanyard are choking hazards.

Using the Lanyard

Thread the thinner end of the lanyard through the loop which is used for lanyard. Thread the thicker end of the lanyard through the thinner end of it, and then pull it tightly.
Keep the pulse oximeter away from young children. Small items such as the battery door, battery, and lanyard are choking hazards.
Do not hang the lanyard from the device’s electrical wire

Maintenance

Cleaning:
Please use medical alcohol to clean the silicone touching the finger inside of oximeter with a soft cloth dampened with 70% isopropyl alcohol. Also clean the being tested finger using alcohol before and after each test.

Do not pour or spray liquids onto the oximeter, and do not allow any liquid to enter any openings in the device. Allow the oximeter to dry thoroughly before reuse. The device requires no routine calibration or maintenance other than replacement of batteries.

Disinfecting: Damage may be caused by disinfecting. It is recommended that the device should be disinfected when doctors think it is necessary. The device should be cleaned before disinfecting. Maintenance: Please power up three hours per three months to prevent the damage of the water vapor, if the device does not work for a long time or is stored in a moisture environment. Additional consideration for the maintenance, please follow the hospital maintenance plan.

Clean surface of the fingertips pulse oximeter before it is used to diagnosis for patient.

Do not use the caustic or abrasive detergent. It is recommended to keep the device in dry environment. Extreme moisture may affect product lifetime and cause damage.
Do not pour and spray liquids onto the fingertips pulse oximeter, accessories, connectors, switch, or do not allow any liquid to enter openings of the oximeter to prevent the damage of the oximeter.
The use life of the device is five years when it is used for 15 measurements every day and 10 minutes per one measurement. Please stop to use the product and follow local governing ordinance and recycling instructions regarding disposal waste.

The oximeter requires no routine calibration or maintenance during its life time. Please contact the service representative if one of the following cases occurs.
The oximeter is calibrated by simulation fingertip pulse oximeter before it leaves the factory, which can display the hemoglobin saturation.

• The device cannot show normally or do not display at all.
• The device cannot be powered on (New batteries have been changed.)
• The sensor of the oximeter was damaged seriously and causes the oximeter stop working properly

 If the sensor is damaged (not light), indicating that the sensor
has been damaged. Please do not continue to use the oximeter. And contact your local dealer for processing.

NOTE:
A functional tester cannot be used to assess the accuracy of a pulse oximeter. Clinical testing is used to establish the SpO2 accuracy. The measured arterial hemoglobin saturation value (SpO2 ) of the sensors is compared arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a laboratory CO-oximeter. The accuracy of the sensors in comparison to the CO- oximeter samples measured over the SpO2 range of 70% – 99%. Accuracy data is calculated using the root-mean-squared (Arms value) for all subject, per ISO 80601-2-61 : 2011, Medical electrical equipment

• Part 2-6 1: Particular requirements for basic safety and essential performance of pulse oximeter equipment. A functional tester is used to measure how accurately Fingertip Pulse Oximeter is reproducing the specified calibration curve and the PR accuracy.
  The model of functional tester is Index2 FLUKE simulator and the version is v3.00.

Technology

Display Type
LED digitron display

SpO 2
Measurement range： 36% ~ 99%
Resolution: 1%
Precision: ±2%（70% ~ 99%).Less than 70% no definition

Pulse Rate
Measurement range: 30bpm ~ 250bpm
Resolution: 1bpm
Precision: 1% or 1bpm choose the bigger one between the two

Low perfusion error
SpO2 and pulse rate can be shown correctly when pulse-filling 2 ratio is 0.2%.

Resistance to Ambient light interference ability
The deviation between the SpO2 value measured in the condition of indoor day lighting or interior lights lighting, and that of darkroom is less than ±1%.

Power supply
d.c. 3.0V (2 × AAA alkaline batteries)

Working current
20mA ~ 130mA

Battery life
Not less than 12 hours

Safety type
Interior battery, Type BF

Direction sensor
Four directions 4（optional）

Light sensor
Red light (wavelength 660nm ~ 666nm 7mW）
Infrared light (wavelength 890nm ~ 904nm 5.5mW）

Date update cycle
Not more than 12s

Degrees of protection
IP21
NOTE: The information about wavelength range can be especially useful to clinicians.

Dimensions

Length: 58.5mm Width: 32mm
Height： 32mm Weight：30g

Environment Requirements

Operation temperature : 5-40℃
Ambient humidity: ≤80%
Atmosphere pressure: 86-106 kPa

Storage, transportation condition

Operation temperature: （ -20~55）℃
Ambient humidity: ≤93%（no condensation）
Atmosphere pressure: （ 50~106）kPa

Troubleshooting

again after reinserting you finger
SpO2 or Pulse rate is erratic|

1. Finger might not be in the correct position
2. Finger trembling or patient motion

|

1. Reinsert the finger
2. Patient must remain still

The oximeter does not turn on|

1. Batteries week or batteries not installed
2. Batteries incorrectly installed
3. Damaged oximeter

|

1. Replace the batteries
2. Ensure the batteries are installed correctly
3. Contact service representative

The screen suddenly shuts down|

1. The oximeter is powered off automatically when no signal of the finger is detected for long time
2. Inadequate power of the batteries

|

1. Normal
2. Replace the new batteries

The oximeter blackout| The oximeter probe failure| The device failure, contact customer service
AS -301, AS-302 orAS-303,AS-304 displays waveform with no SpO2 and pulse rate| The signal of SpO2 is not integrity or not correct| Replace a finger and measure again
The device failure, contact customer service
AS-301-L,AS-302-L ,AS 304 L displays bar graph with no SpO2 and pulse rate| The signal of SpO2 is not integrity or not correct|

1. Replace a finger and measure again
2. **** The device failure, contact customer service

Symbol Definitions

date

SpO 2 %

| Oxygen saturation| ****| CE MARK

PR BPM

| Pulse rate(BPM)| ****| Manufacture’s information

IP21

| Drip proof| | Follow operating instructions
| Serial No.| | Authorized representative in the European Community
****| Symbol for disposed waste electrical and electronic equipment (Follow local governing ordinance and recycling instructions\ regarding disposal of batteries)

Equipment Response Time

As shown in the following figure.
Response time of normal average is 10.4s

Electromagnetic compatibility

Note: Fingertip pulse oximeter AS-302-L，comply with the requirement of Electromagnetic Compatibility in YY 0505-2012. And IEC 60601-1-2:2007
The user needs to install and use according to electromagnetism compatibility information which is attached with it.
Portable and mobile RF communication devices may influence fingertip pulse oximeter AS-302-L、performance. So fingertip pulse oximeter AS-302-Lhould be kept away from the strong electromagnetic interference, such as adjacent to cellular phone, microwave oven etc, during using. Guidance and manufacturer’s declaration stated in the appendix.

Warning: AS-302-L should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, AS-302-L should be observed to verify normal operation in the configuration in which it will be used.

Appendix：

**Guidance and Manufacture’s declaration – Electromagnetic emission**

The AS-302-L Fingertip Pulse Oximeter is intended for use in the Electromagnetic environment specified below. The customer or the user of AS-302-L should assure they are used in such an environment.
Emission test| Complian ce| Electromagnetic Environment- Guidance
FR emissions CISPR 11| Group 1| The AS-302-L Fingertip Pulse oximeter use RF energy only for their internal function. Therefore, their RF emissions are very low and are not likely to cause any interference in nearly electronic equipment
FR emissions CISPR 11| Class B| The AS-302-L fingertip pulse oximeter are suitable for use in all establishments other than domestic 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| Not Applicable
Voltage fluctuations/flicker emissions IEC 61000 -3-3| Not Applicable
**Guidance and Manufacturer’s declaration – electromagnetic immunity
The AS-302-L Fingertip Pulse Oximeter is intended for use in the Electromagnetic environment specified below. The customer or the user of AS-302-L should assure they are used in such an environment.
Immunity test| IEC60601 test level| Compliance level| Electromagnetic
Environment-Guidance
---|---|---|---
Electrostatic Discharge
（ESD）
IEC
61000-4-2| ±6 kV contact
±8 kV air| ±6 kV contact
±8 kV air| Floors should be wood,
concrete, or tile. If the
floor is covered with
synthetic material, the
relative humility should
be at least 30%.
Electrical fast transient /burst IEC 61000-4-4| ±2Kv Power supply lines
±1kV Input/output line| Not Applicable| Main power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5| ±1 kV Line(s) to line(s)
±2 kV Line(s) to ground| Not Applicable| Main 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| <5 % UT, for 0.5 cycle （>95% dip in UT） 40 % UT, for 5 cycles （60% dip in UT） 70 % UT，for 25 cycles (30% dip in UT） <5 % UT, for 5s （>95% dip in UT）| Not Applicable| Main power quality should be that of a typical commercial or hospital environment. If the user of the AS-302-L requires continued operation during power mains interruptions, it is recommended that the AS-302-L and be powered from an uninterruptible power supply or a battery
Power frequency magnetic field (50/60Hz) IEC 61000-4-8| 3A/m| 3A/m| Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Note : UTis the a.c. mains voltage prior to application of the test level
Guidance and Manufacture’s declaration – electromagnetic immunity**

The AS-302-L Fingertip
Pulse Oximeter is intended for use in the Electromagnetic environment specified below. The customer or the user of AS-302-L should assure they are used in such an environment.
Immunity test| IEC60601 test level| Compliance| Electromagnetic Environment- Guidance
Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

| 3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to 2.5 GHz

| level Not
Applicable3 V/m| Portable and mobile RF communications equipment should be used no closer to any part of the
AS-302-L including cables, than the
recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance
d = 1 .2 √p
d = 1 .2 √p 80 MHz to 800 MHz
d = 2 . 3 √p 800 MHz to 2.5 GHz
Where：
P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer
D is the recommended separation
distance in meters (m)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 following symbol.
Note 1： Between 80MHz and 800MHz, 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 human bodies.

aField 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 AS-302-L is used exceeds the applicable RF compliance level above, the AS-302-L should be observed to verify normal operation. If ab If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the AS-302-L
b The frequency range between 150KHz～80MHz，fields strengths should be less than 3 V/m.
Recommended distance between portable and mobile RF equipment and fingertip pulse oximeter AS-302-L

The AS-302-L are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user o the of AS-302-L can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the AS-302-L as recommended below, according to the maximum output power of the communications equipment.
Maximum rated output power of transmitter W| Separation distance according to frequency of transmitter (m)
150 kHz ～ 80 M
Hz
d = 1 . 2√ p| 80 MHz ～ 800
MHz
d =1 .2√ p| 800 MHz～ 2.5
GHz
d = 2 .3√p
0.01| Not Applicable| 0.12| 0.23
0.1| Not Applicable| 0.38| 0.73
1| Not Applicable| 1.2| 2.3
10| Not Applicable| 3.8| 7.3
100| Not Applicable| 12| 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (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 ：Between 80 MHz 800 MHz， the higher frequency range applies.
Note 2 ：These guidelines may not apply in all situations. Electromagnetic transmission is affected by absorption and reflection of structures, objects and human bodies.

Customer Support

MedNet GmbH
Add: Borkstrasse 10, 48163 Munster, Germany

SHENZHEN ACURIO INSTRUMENT CO., LTD.
Add: 502G Part B, Donglian Building, Chuangye 2nd Road, 23rd Subdistrict, Baoan District, Shenzhen

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