MX Health MX86001 (AS-302-L) - Fingertip Pulse Oximeter Manual

Product Features

The product is easy to operate. It is small in dimensions, light in weight, convenient to carry around. Power consumption is low. Ambient light does not interfere with the performance of this device. Two AAA-batteries can give up to 12 hours of operation (not included). The battery voltage is indicated. The product is suitable for use in the following settings: Home, surgery, intensive care, medical centre, sports health facilities and the like.

Intended Use

The fingertip pulse oximeter is a portable non-invasive device intended for spot checking oxygen saturation of arterial haemoglobin SpO₂ and the pulse rate of patients in hospitals, hospital-type facilities, and the home environments.
This device is suitable for use on patients of all skin tones and is not suitable for use on infants and neonates. No special training is required to use the device but careful reading of the instructions for use is a requirement. Adults should be able to understand and read this manual with ease as it is written in layman's terms.

Principal of Measurement

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 and oxyhaemoglobin. It measures how much light sent from the light source on the one side of the sensor is transmitted through the patient tissue (such as a finger), to a receiver on the other side. The two beams of different wavelength of light (660nm red and 895nm near infrared light) can be focused onto a human nail tip through clamping the finger-type sensor. The measured signal obtained by a photo sensitive element, will be shown on the oximeters' display through a process in the electronic circuit and micro-processor of the device.
SpO₂ is a measurement of the functional oxygen saturation.
The values of SpO₂ and PR are through average processing.
The light (the red light and the infrared light which is invisible and emitted from the device is harmful to the eyes. The user and maintenance personal must not stare at the light.
The device does not have a technical specifications manual. All relevant and important information is given in this instruction for use.

Saturation %

If the SpO₂ reading of the oximeter is 94 or below, contact an appropriately qualified Healthcare Professional to seek advice and /or help.

Operating Instructions

Carefully read this user manual before use.
MX86001(AS-302-L)
The LED digitron display oximeter cannot change the direction

1. Press power switch key on the 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. If it is necessary to use another finger the ring finger, little finger or thumb may be used.
3. Read the data display on the screen after 3-4 seconds have elapsed. The bar graph height indicates the strength of the pulse.
4. The device will turn itself of automatically after 20 seconds of idle time.

The finger used must not have any pathological damage.
Do not use the fingertip pulse oximeter in a situation where an alarm is required. The device has no alarm for SpO₂ and pulse.
Operation of the fingertip oximeter may be affected by the use of an electro surgical unit.

The fingertip pulse oximeter is not suitable for continuous monitoring of the same monitoring site of the same patient. The fingertip pulse oximeter is also not suitable for use on infants and neonates. Check the finger monitoring site every 2 hours of use. If the colour of the skin changes, move the device slightly. Some patients e.g. Patients with perfusion disorder or sensitive skin may require that the device reading site be changed more often. Continuous monitoring may result in unexpected change in skin condition such as sensitivity, redness, blistering or pressure necrosis.
If the finger used for monitoring is not inserted into the oximeter thoroughly it may result in incorrect readings.
Use medicinal alcohol to clean the finger used for monitoring and the oximeter rubber touching the finger. (The oximeter rubber is made of medical silicon. The medical silicon is non-toxic, has no harmful effects to the human skin and passed the required bio-compatibility tests.)
Do not use the device in an MRI or CT environment. It may cause erroneous measurements.
Do not use the device in close proximity of flammable anaesthetic mixed with air, oxygen or nitrous oxide.
Portable and mobile RF communication equipment affects medical electrical equipment.
The materials that come into contact with the patient's skin contain medical silicon and ABS plastic enclosures. These materials have all passed the ISO 10993-5 tests for in-vitro cytotoxicity and ISO 10993-10 tests for irritation and delayed-type hypersensitivity.
The temperature of the device may increase because of use. If the temperature of the device never exceeds 41°C, no harm will come to the patient.
It is recommended that the device be used indoors and in an environment were there is no dust and strong light.
The product must be stored between -20°C and +55°C and <93% humidity.
Do not open, take apart or dismantle the product. There are no serviceable parts in this device. Should any problems arise in using this device, contact the manufacturer.
Should there be a suspicion that the readings from the device is incorrect, check the patient's vital signs by an alternative method first, and then check the oximeter. Inaccurate measurements may be because of any of the following factors:

• Ambient light radiation.
• Patient movement.
• Diagnostic tests.
• Low perfusion.
• Electromagnetic interference such as that caused by a nearby cell phone.
• Electrical equipment.
• Nail polish on fingernail.
• Artificial nails.
• Excess dirt/damage on fingers/nails.
• Skin pigmentation (like Henna, as darker pigmentation can give an over estimated SpO2 reading.
• 
  Arterial blood is to low to measure as can be caused by shock, anaemia, low temperature or use a vasoconstrictor.
• Heavy smokers may have a high CO reading causing a high haemoglobin CO reading.
• Patients with severe jaundice will have high bilirubin which affects CO which in turn causes high SpO₂.

When the pulse graph display is not normal MX86001(AS-302-L), the displayed SpO₂ or pulse rate reading may be incorrect.

Product readiness

Once the device has: The batteries correctly installed, and the display is lit; and the device silicone has been wiped with alcohol; and the device is fitted to a suitable finger, then the device is ready for use.

If the device does not give the desired results with the second attempt to get a proper reading, a different device should be used and the attending healthcare professional should be informed of the difficulty experienced with the device.

Product Accessories

• 1 x Lanyard
• 1 x Instruction Manual

Battery Installation

1. Open the battery compartment cover
2. Install 2 x AAA batteries into battery compartment to match positive and negative indicators. Slide the battery door cover horizontally along the arrow as shown in the picture.

NOTE:
The device will automatically start, and the luminous tube lights will light up if the batteries are installed correctly. If the pulse oximeter will not be used for an extended period, remove the batteries.

CAUTIONS
The battery power is displayed in the middle of the screen. When the battery sign is displayed as a blank space, replace the batteries.

The batteries must be installed according to the correct polarity indicators otherwise the device may be damaged.
When disposing this medical device, or its batteries, follow local government procedures and laws.
Keep the oximeter and its accessories out of the reach of children. Small items such as the battery door, the batteries and lanyard pose choking hazard to children.

Using the Lanyard

Thread the thin end of the lanyard through the loop which is use for the lanyard. Thread the thick end through the thin end and pull tightly. Do not hang the lanyard from the device electrical wire.

Maintenance

Cleaning:
Use medical alcohol to clean the silicon on the inside of the oximeter that touches the finger. Use a soft cloth dampened with 70% isopropyl alcohol. Clean the finger to be used, using the same alcohol before and after each test.
Do not pour or spray any liquids onto the oximeter and do not allow any liquid to enter any of the openings in the device. Allow the oximeter to dry thoroughly before re-use.
This device requires no routine calibration or maintenance other than the replacement of the batteries.

Disinfecting:
Damage may be caused by disinfecting the device. It is recommended that the device only be disinfected on the recommendation of a doctor. The device should be cleaned before disinfecting.

Maintenance:
The device should be powered up for at least three hours every three months to prevent water vapour damp.
The device should not be stored in a moist environment if it is not going to be used for a long time. Should there be a hospital maintenance plan for medical devices, this plan may be adhered to.
Clean the surfaces of the fingertip pulse oximeter every time before it is used to diagnose a patient. Do not use any caustic or abrasive detergents. Store this device in a dry environment. Extreme moisture may affect the lifetime and may cause damage to the device. The expected lifetime of the device is 5 years if it is used for 15 measurements every day with a duration of 10 minutes per measurement. When the product reaches the end of its lifetime, dispose of the device according to local government recycling and disposal regulations.

Should one of the following occur, please contact the service representative or manufacturer:

• The device display is not normal or there is no display at all.
• If new batteries inserted and the device does not power on.
• The sensor of the oximeter is damaged and causes the oximeter to function properly.
• The sensor is damaged (not the light), indicating that the sensor is damaged. Do not continue the use of the oximeter and contact the device manager.

TECHNICAL ACCURACY

A calibration tested cannot be used to assess the accuracy of a pulse oximeter. Clinical testing is used to establish the SpO₂ accuracy. The measured arterial haemoglobin saturation value (SpO₂) of the sensors is compared to arterial haemoglobin 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% to 99%. Accuracy data is calculated using the route – mean – squared (Arms value) for all subjects, as per ISO 80601-2-61: 2011, medical electrical equipment particular requirements for basic safety and essential performance of pulse oximeter equipment.
A functional tester is used to measure how accurately the fingertip pulse oximeter reproduces the specified calibration curve and the PR accuracy. The model of functional tester is the Index2 FLUKE simulator and the version is v3.00.

TECHNOLOGY

Display Type:

• LED digitron display MX86001(AS-302-L) SpO₂
• Measurement range: 36% - 99%
• Resolution: 1%
• Precision: ±2% (70% - 99%). Less than 70% no definition

Pulse rate

• Measurement range: 30bpm – 250 bpm
• Resolution: 1 bpm
• Precision: 1% or 1bpm choose the bigger one between the two on error.

Low perfusion error

• SpO₂ and pulse rate can be shown correctly when pulse-filling ration is 0.2%
• Resistance to ambient light interference ability.
• The deviation between the SpO, value measured in the condition of indoor day lighting or interior lighting and that of darkroom is less than ±1%.

Power supply

• d.c 3.0V (2 x AAA alkaline batteries)

Working current

• 20mA – 130mA

Battery life

• Not less than 12 hours

Safety type

• Interior battery: Type BF

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

Environment Requirements

Operations temperature: 5°C – 40°C
Ambient humidity: ≤80% at Atmospheric pressure: 86 106kPa
Storage, transportation condition
Operation temperature: (-20 – 55) °C
Ambient humidity: ≤93% (no condensation)
Atmosphere pressure: (50 -106) kPa

Symbol Definitions

Symbol	Definition	Symbol	Definition
	Type BF Equipment		No SpO2 Alarm
	Attention! Consult accompanying documents		Use by date
SpO%2	Oxygen saturation		CE MARK
PR BPM	Pulse rate (BPM)		Manufacturers information
IP 21	Drip proof		Follow operating instructions
SN	Serial No.		Authorized representative in the European Community
	Symbol for disposed waste electrical and electronic equipment (Follow local government 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

Documents / Resources

References

• Medinox United Kingdom
• Medinox Australia
• Medinox - Medical Supplies - Medical Distributors

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Here you can download full pdf version of manual, it may contain additional safety instructions, warranty information, FCC rules, etc.

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