MX HEALTH MX86001 User 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.
Caution: 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 nger. Use a soft cloth dampened with 70% isopropyl alcohol.
Clean the nger 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 ngertip 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:
lThe device display is not normal or there is no display at all.
lIf new batteries inserted and the device does not power on.
lThe sensor of the oximeter is damaged and causes the oximeter to
function properly.
lThe 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.
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 ngertip pulse oximeter is a portable non-invasive device intended
for spot checking oxygen saturation of arterial haemoglobin SpO2and 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 nger), 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 nger-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.
SpO2is a measurement of the functional oxygen saturation.
The values of SpO2and 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 specications manual. All
relevant and important information is given in this instruction for use.
Saturation %
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 nger (forenger or middle nger) into the cavity of the pulse oximeter. If
it is necessary to use another nger the ring nger, little nger 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 nger used must not have any pathological damage.
Do not use the ngertip pulse oximeter in a situation where an alarm is
required. The device has no alarm for SpO2and pulse.
Operation of the ngertip oximeter may be affected by the use of an electro
surgical unit.
Product Model:
MX86001(AS-302-L)
The ngertip pulse oximeter is not suitable for continuous monitoring of
the same monitoring site of the same patient. The ngertip pulse oximeter
is also not suitable for use on infants and neonates. Check the nger
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 nger used for monitoring is not inserted into the oximeter thoroughly
it may result in incorrect readings.
Use medicinal alcohol to clean the nger used for monitoring and the
oximeter rubber touching the nger. (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 rst, and then check
the oximeter. Inaccurate measurements may be because of any of the
following factors:
lAmbient light radiation.
lPatient movement.
lDiagnostic tests.
l Low perfusion.
lElectromagnetic interference such as that caused by a nearby cell phone.
lElectrical equipment.
l Nail polish on ngernail.
l Articial nails.
l Excess dirt/damage on ngers/nails.
lSkin pigmentation (like Henna, as darker pigmentation can give an over
estimated SpO2 reading.
lArterial blood is to low to measure as can be caused by shock, anaemia,
low temperature or use a vasoconstrictor.
lHeavy smokers may have a high CO reading causing a high haemoglobin
CO reading.
lPatients 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 SpO2or 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 tted
to a suitable nger, then the device is ready for use.
Warning: 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 difculty
experienced with the device.
Product Accessories
l 1 x Lanyard
l1 x Instruction Manual
TECHNICAL ACCURACY
A calibration tested cannot be used to assess the accuracy of a pulse
oximeter. Clinical testing is used to establish the SpO2accuracy. 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 ngertip pulse
oximeter reproduces the specied 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:
l LED digitron display MX86001(AS-302-L)
SpO2
l Measurement range: 36% - 99%
l Resolution: 1%
l Precision: ±2% (70% - 99%). Less than 70% no denition
Pulse rate
l Measurement range: 30bpm – 250 bpm
lResolution: 1 bpm
l Precision: 1% or 1bpm choose the bigger one between the two on error.
Low perfusion error
lSpO2 and pulse rate can be shown correctly when pulse-lling ration is 0.2%
lResistance to ambient light interference ability.
lThe 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
l d.c 3.0V (2 x AAA alkaline batteries)
Working current
l 20mA – 130mA
Battery life
lNot less than 12 hours
Safety type
lInterior battery : Type BF
Light sensor
l Red light (wavelength 660nm – 666nm 7mW)
l Infrared light (wavelength 890nm – 904nm 5.5mW)
Date update cycle
lNot more than 12s
Degrees of protection
lIP21
NOTE: The information about wavelength range can be especially useful to
clinicians.
DIMENSIONS:
Model Length Width Height Weight (incl batteries)
MX86001
(AS-302-L)
58mm 35mm 32mm 50g
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
Problems Possible Cause Corrective Action
SpO2or pulse rate is
incorrect
Insert the nger
incorrect position
Measure again after
reinserting your
nger
SpO2or Pulse rate is
erratic
1. Finger might not
be in the correct
position
2. Finger trembling
or patient motion
1. Reinsert the nger
2. Patient must
remain still
FINGERTIP
PULSE OXIMETER
™
USER MANUAL
GOOD NOT GOOD SEEK MEDICAL HELP
100 - 95 95 - 90 90 - 85
If the SpO2 reading of the oximeter is 94 or below, contact an appropriately
qualied Healthcare Professional to seek advice and /or help.
oximeter_Instruction Manual_SA.indd 1oximeter_Instruction Manual_SA.indd 1 2020/08/09 18:492020/08/09 18:49
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.
Caution: 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 nger. Use a soft cloth dampened with 70% isopropyl alcohol.
Clean the nger 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 ngertip 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:
lThe device display is not normal or there is no display at all.
lIf new batteries inserted and the device does not power on.
lThe sensor of the oximeter is damaged and causes the oximeter to
function properly.
lThe 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.
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 ngertip pulse oximeter is a portable non-invasive device intended
for spot checking oxygen saturation of arterial haemoglobin SpO2and 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 nger), 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 nger-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.
SpO2is a measurement of the functional oxygen saturation.
The values of SpO2and 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 specications manual. All
relevant and important information is given in this instruction for use.
Saturation %
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 nger (forenger or middle nger) into the cavity of the pulse oximeter. If
it is necessary to use another nger the ring nger, little nger 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 nger used must not have any pathological damage.
Do not use the ngertip pulse oximeter in a situation where an alarm is
required. The device has no alarm for SpO2and pulse.
Operation of the ngertip oximeter may be affected by the use of an electro
surgical unit.
Product Model:
MX86001(AS-302-L)
The ngertip pulse oximeter is not suitable for continuous monitoring of
the same monitoring site of the same patient. The ngertip pulse oximeter
is also not suitable for use on infants and neonates. Check the nger
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 nger used for monitoring is not inserted into the oximeter thoroughly
it may result in incorrect readings.
Use medicinal alcohol to clean the nger used for monitoring and the
oximeter rubber touching the nger. (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 rst, and then check
the oximeter. Inaccurate measurements may be because of any of the
following factors:
lAmbient light radiation.
lPatient movement.
lDiagnostic tests.
l Low perfusion.
lElectromagnetic interference such as that caused by a nearby cell phone.
lElectrical equipment.
l Nail polish on ngernail.
l Articial nails.
l Excess dirt/damage on ngers/nails.
lSkin pigmentation (like Henna, as darker pigmentation can give an over
estimated SpO2 reading.
lArterial blood is to low to measure as can be caused by shock, anaemia,
low temperature or use a vasoconstrictor.
lHeavy smokers may have a high CO reading causing a high haemoglobin
CO reading.
lPatients 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 SpO2or 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 tted
to a suitable nger, then the device is ready for use.
Warning: 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 difculty
experienced with the device.
Product Accessories
l 1 x Lanyard
l1 x Instruction Manual
TECHNICAL ACCURACY
A calibration tested cannot be used to assess the accuracy of a pulse
oximeter. Clinical testing is used to establish the SpO2accuracy. 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 ngertip pulse
oximeter reproduces the specied 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:
l LED digitron display MX86001(AS-302-L)
SpO2
l Measurement range: 36% - 99%
l Resolution: 1%
l Precision: ±2% (70% - 99%). Less than 70% no denition
Pulse rate
l Measurement range: 30bpm – 250 bpm
lResolution: 1 bpm
l Precision: 1% or 1bpm choose the bigger one between the two on error.
Low perfusion error
lSpO2 and pulse rate can be shown correctly when pulse-lling ration is 0.2%
lResistance to ambient light interference ability.
lThe 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
l d.c 3.0V (2 x AAA alkaline batteries)
Working current
l 20mA – 130mA
Battery life
lNot less than 12 hours
Safety type
lInterior battery : Type BF
Light sensor
l Red light (wavelength 660nm – 666nm 7mW)
l Infrared light (wavelength 890nm – 904nm 5.5mW)
Date update cycle
lNot more than 12s
Degrees of protection
lIP21
NOTE: The information about wavelength range can be especially useful to
clinicians.
DIMENSIONS:
Model Length Width Height Weight (incl batteries)
MX86001
(AS-302-L)
58mm 35mm 32mm 50g
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
Problems Possible Cause Corrective Action
SpO2or pulse rate is
incorrect
Insert the nger
incorrect position
Measure again after
reinserting your
nger
SpO2or Pulse rate is
erratic
1. Finger might not
be in the correct
position
2. Finger trembling
or patient motion
1. Reinsert the nger
2. Patient must
remain still
FINGERTIP
PULSE OXIMETER
™
USER MANUAL
GOOD NOT GOOD SEEK MEDICAL HELP
100 - 95 95 - 90 90 - 85
If the SpO2 reading of the oximeter is 94 or below, contact an appropriately
qualied Healthcare Professional to seek advice and /or help.
oximeter_Instruction Manual_SA.indd 1oximeter_Instruction Manual_SA.indd 1 2020/08/09 18:492020/08/09 18:49
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.
Caution: 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 nger. Use a soft cloth dampened with 70% isopropyl alcohol.
Clean the nger 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 ngertip 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:
lThe device display is not normal or there is no display at all.
lIf new batteries inserted and the device does not power on.
lThe sensor of the oximeter is damaged and causes the oximeter to
function properly.
lThe 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.
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 ngertip pulse oximeter is a portable non-invasive device intended
for spot checking oxygen saturation of arterial haemoglobin SpO2and 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 nger), 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 nger-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.
SpO2is a measurement of the functional oxygen saturation.
The values of SpO2and 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 specications manual. All
relevant and important information is given in this instruction for use.
Saturation %
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 nger (forenger or middle nger) into the cavity of the pulse oximeter. If
it is necessary to use another nger the ring nger, little nger 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 nger used must not have any pathological damage.
Do not use the ngertip pulse oximeter in a situation where an alarm is
required. The device has no alarm for SpO2and pulse.
Operation of the ngertip oximeter may be affected by the use of an electro
surgical unit.
Product Model:
MX86001(AS-302-L)
The ngertip pulse oximeter is not suitable for continuous monitoring of
the same monitoring site of the same patient. The ngertip pulse oximeter
is also not suitable for use on infants and neonates. Check the nger
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 nger used for monitoring is not inserted into the oximeter thoroughly
it may result in incorrect readings.
Use medicinal alcohol to clean the nger used for monitoring and the
oximeter rubber touching the nger. (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 rst, and then check
the oximeter. Inaccurate measurements may be because of any of the
following factors:
lAmbient light radiation.
lPatient movement.
lDiagnostic tests.
l Low perfusion.
lElectromagnetic interference such as that caused by a nearby cell phone.
lElectrical equipment.
l Nail polish on ngernail.
l Articial nails.
l Excess dirt/damage on ngers/nails.
lSkin pigmentation (like Henna, as darker pigmentation can give an over
estimated SpO2 reading.
lArterial blood is to low to measure as can be caused by shock, anaemia,
low temperature or use a vasoconstrictor.
lHeavy smokers may have a high CO reading causing a high haemoglobin
CO reading.
lPatients 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 SpO2or 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 tted
to a suitable nger, then the device is ready for use.
Warning: 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 difculty
experienced with the device.
Product Accessories
l 1 x Lanyard
l1 x Instruction Manual
TECHNICAL ACCURACY
A calibration tested cannot be used to assess the accuracy of a pulse
oximeter. Clinical testing is used to establish the SpO2accuracy. 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 ngertip pulse
oximeter reproduces the specied 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:
l LED digitron display MX86001(AS-302-L)
SpO2
l Measurement range: 36% - 99%
l Resolution: 1%
l Precision: ±2% (70% - 99%). Less than 70% no denition
Pulse rate
l Measurement range: 30bpm – 250 bpm
lResolution: 1 bpm
l Precision: 1% or 1bpm choose the bigger one between the two on error.
Low perfusion error
lSpO2 and pulse rate can be shown correctly when pulse-lling ration is 0.2%
lResistance to ambient light interference ability.
lThe 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
l d.c 3.0V (2 x AAA alkaline batteries)
Working current
l 20mA – 130mA
Battery life
lNot less than 12 hours
Safety type
lInterior battery : Type BF
Light sensor
l Red light (wavelength 660nm – 666nm 7mW)
l Infrared light (wavelength 890nm – 904nm 5.5mW)
Date update cycle
lNot more than 12s
Degrees of protection
lIP21
NOTE: The information about wavelength range can be especially useful to
clinicians.
DIMENSIONS:
Model Length Width Height Weight (incl batteries)
MX86001
(AS-302-L)
58mm 35mm 32mm 50g
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
Problems Possible Cause Corrective Action
SpO2or pulse rate is
incorrect
Insert the nger
incorrect position
Measure again after
reinserting your
nger
SpO2or Pulse rate is
erratic
1. Finger might not
be in the correct
position
2. Finger trembling
or patient motion
1. Reinsert the nger
2. Patient must
remain still
FINGERTIP
PULSE OXIMETER
™
USER MANUAL
GOOD NOT GOOD SEEK MEDICAL HELP
100 - 95 95 - 90 90 - 85
If the SpO2 reading of the oximeter is 94 or below, contact an appropriately
qualied Healthcare Professional to seek advice and /or help.
oximeter_Instruction Manual_SA.indd 1oximeter_Instruction Manual_SA.indd 1 2020/08/09 18:492020/08/09 18:49
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.
Caution: 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 nger. Use a soft cloth dampened with 70% isopropyl alcohol.
Clean the nger 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 ngertip 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:
lThe device display is not normal or there is no display at all.
lIf new batteries inserted and the device does not power on.
lThe sensor of the oximeter is damaged and causes the oximeter to
function properly.
lThe 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.
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 ngertip pulse oximeter is a portable non-invasive device intended
for spot checking oxygen saturation of arterial haemoglobin SpO2and 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 nger), 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 nger-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.
SpO2is a measurement of the functional oxygen saturation.
The values of SpO2and 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 specications manual. All
relevant and important information is given in this instruction for use.
Saturation %
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 nger (forenger or middle nger) into the cavity of the pulse oximeter. If
it is necessary to use another nger the ring nger, little nger 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 nger used must not have any pathological damage.
Do not use the ngertip pulse oximeter in a situation where an alarm is
required. The device has no alarm for SpO2and pulse.
Operation of the ngertip oximeter may be affected by the use of an electro
surgical unit.
Product Model:
MX86001(AS-302-L)
The ngertip pulse oximeter is not suitable for continuous monitoring of
the same monitoring site of the same patient. The ngertip pulse oximeter
is also not suitable for use on infants and neonates. Check the nger
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 nger used for monitoring is not inserted into the oximeter thoroughly
it may result in incorrect readings.
Use medicinal alcohol to clean the nger used for monitoring and the
oximeter rubber touching the nger. (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 rst, and then check
the oximeter. Inaccurate measurements may be because of any of the
following factors:
lAmbient light radiation.
lPatient movement.
lDiagnostic tests.
l Low perfusion.
lElectromagnetic interference such as that caused by a nearby cell phone.
lElectrical equipment.
l Nail polish on ngernail.
l Articial nails.
l Excess dirt/damage on ngers/nails.
lSkin pigmentation (like Henna, as darker pigmentation can give an over
estimated SpO2 reading.
lArterial blood is to low to measure as can be caused by shock, anaemia,
low temperature or use a vasoconstrictor.
lHeavy smokers may have a high CO reading causing a high haemoglobin
CO reading.
lPatients 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 SpO2or 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 tted
to a suitable nger, then the device is ready for use.
Warning: 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 difculty
experienced with the device.
Product Accessories
l 1 x Lanyard
l1 x Instruction Manual
TECHNICAL ACCURACY
A calibration tested cannot be used to assess the accuracy of a pulse
oximeter. Clinical testing is used to establish the SpO2accuracy. 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 ngertip pulse
oximeter reproduces the specied 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:
l LED digitron display MX86001(AS-302-L)
SpO2
l Measurement range: 36% - 99%
l Resolution: 1%
l Precision: ±2% (70% - 99%). Less than 70% no denition
Pulse rate
l Measurement range: 30bpm – 250 bpm
lResolution: 1 bpm
l Precision: 1% or 1bpm choose the bigger one between the two on error.
Low perfusion error
lSpO2 and pulse rate can be shown correctly when pulse-lling ration is 0.2%
lResistance to ambient light interference ability.
lThe 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
l d.c 3.0V (2 x AAA alkaline batteries)
Working current
l 20mA – 130mA
Battery life
lNot less than 12 hours
Safety type
lInterior battery : Type BF
Light sensor
l Red light (wavelength 660nm – 666nm 7mW)
l Infrared light (wavelength 890nm – 904nm 5.5mW)
Date update cycle
lNot more than 12s
Degrees of protection
lIP21
NOTE: The information about wavelength range can be especially useful to
clinicians.
DIMENSIONS:
Model Length Width Height Weight (incl batteries)
MX86001
(AS-302-L)
58mm 35mm 32mm 50g
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
Problems Possible Cause Corrective Action
SpO2or pulse rate is
incorrect
Insert the nger
incorrect position
Measure again after
reinserting your
nger
SpO2or Pulse rate is
erratic
1. Finger might not
be in the correct
position
2. Finger trembling
or patient motion
1. Reinsert the nger
2. Patient must
remain still
FINGERTIP
PULSE OXIMETER
™
USER MANUAL
GOOD NOT GOOD SEEK MEDICAL HELP
100 - 95 95 - 90 90 - 85
If the SpO2 reading of the oximeter is 94 or below, contact an appropriately
qualied Healthcare Professional to seek advice and /or help.
oximeter_Instruction Manual_SA.indd 1oximeter_Instruction Manual_SA.indd 1 2020/08/09 18:492020/08/09 18:49
The oximeter does not
turn on
1. Batteries weak
or batteries not
installed
2. Batteries
incorrectly installed
3. Damaged
oximeter
3. Replace the
batteries
2. Ensure the
batteries are
installed correctly
3. Contact the
manufacturer
The screen suddenly
shuts down
1. The oximeter
is powered off
automatically when
no signal of the
nger is detected for
a long time
2. Inadequate power
of the batteries
1. Normal
2. Replace the
batteries
The oximeter blackout The oximeter probe
failure
The device is
faulty. Contact the
manufacturer.
MX86001(AS-302-L)
displays bar graph with
no SpO2 and pulse rate
The signal of SpO2
source is suspect or
incorrect
Use a different nger
and measure again.
The device is
faulty. Contact the
manufacturer
Symbol Denitions
Symbol Denition Symbol Denition
Type BF Equipment No SpO2 Alarm
Attention! Consult
accompanying
documents
Use by date
Oxygen saturation CE MARK
Pulse rate (BPM)Manufacturers
information
Drip proof Follow operating
instructions
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 gure.
Response time of normal average is 10.4s
Electromagnetic compatibility
Note: Fingertip pulse oximeter MX86001(AS-302-L) comply with the
requirement of the Electromagnetic Compatibility in YY 0505-2012. And IEC
60601-1-2:2007
The user needs to install and use according electromagnetism compatibility
information which is attached to it.
Portable and mobile RF communication devices may influence the
Fingertip Pulse Oximeter MX86001(AS-302-L) performance. So ngertip
pulse oximeter MX86001(AS-302-L) should be kept away from strong
electromagnetic interference such as cell phone in close proximity,
microwave oven and the like during operation. Guidance and manufacturer’s
declaration are stated in the appendix.
Warning: MX86001(AS-302-L) should not be used adjacent to or stacked
with other equipment. If MX86001(AS-302-L) is used with or stacked
with other equipment it should be observed to ensure and verify normal
operation in this conguration.
Appendix:
Guidance and Manufacturer’s declaration – Electromagnetic emission
The MX86001(AS-302-L) Fingertip Oximeter is intended for use in the Electromagnetic
environment specied below. The customer or the user of MX86001(AS-302-L) should
assure they are used to work in such an environment.
Emission Test Compliance Electromagnetic Environment
Guidance
FR emissions GB48424 Group 1 The MX86001(AS-302-L)
Fingertip 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 nearby
electronic equipment.
FR emissions GB48424 Class B The MX86001(AS-302-L)
Fingertip Pulse Oximeters
are suitable for use in all
environments other than
domestic and those directly
connected to the public low
voltage power supply network
that supplies buildings used for
domestic purposes.
Harmonic emissions
GB17625.1
Not applicable.
Voltage fluctuations/flicker
emissions GB17625.2
Not applicable.
Guidance and manufacturers declaration – electromagnetic immunity
The MX86001(AS-302-L) Fingertip Oximeter is intended for use in the Electromagnetic
environment specied below. The customer or the user of MX86001(AS-302-L) should
assure they are used to work in such an environment.
Immunity test IEC60601 test
level
Compliance level Electromagnetic
Environment - Guidance
Electrostatic
discharge
(ESD) GB/T
17626.2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood,
concrete and tile. If the
floor is covered with
synthetic material, the
relative humidity should
be 30%.
Electrical fast
transient/burst
GB/T17626.4
±2 kV power
supply lines
±1 kV input/
output line
Not applicable Main power quality
should be that of a
typical commercial or
hospital environment.
Surge GB/T
17626.5
±1 kV lines to
lines
±2 kV lines 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
GB/T 17626.11
<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 5 s
(>95% dip in UT)
Not applicable Main power quality
should be that of a
typical commercial or
hospital environment.
If the user of
MX86001(AS-302-L)
requires continued
operation during power
mains interruptions, it
is recommended that
the MX86001(AS-302-L)
be powered from an
uninterruptable power
supply or battery.
Power
frequency
magnetic eld
(50/60 Hz )
GB/T 17626.8
3 A/m 3A/m/50Hz Power frequency
magnetic elds
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
The MX86001(AS-302-L) Fingertip Pulse Oximeter is intended for use in the
electromagnetic environment specied below. The customer or the user of
MX86001(AS-302-L) should assure they are used in such an environment.
Immunity test IEC 60601 test level Compliance
Conducted RF
GB/T 17626.6
Radiated RF
GB/T 17626.3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5GHz
Level not applicable.
3 V/m
Electromagnetic environment - Guidance
Portable and mobile RF communication equipment should be used no closer to any
part of the MX86001(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√F)
d=(1.2√F)80MHz to 800 MHz
d=(1.2√F) 80 MHz to 2.5 GHz
Where:
P is the maximum output power of the transmitter in watts (W) according to the
transmitter manufacturer.
D is the recommended separation distance in meters (m).
Field strengths from xed RF transmitters, as determined by an electromagnetic site
survey, should be less than the compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked with the following symbol.
Note 1: Between 80 MHz and 800 MHz 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.
Field strengths from xed 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 xed RF transmitters, and electromagnetic
site survey should be considered. If the measured eld strength in the location in which
the MX86001(AS-302-L) is used exceeds the applicable RF compliance level above,
the MX86001(AS-302-L) should be observed to verify normal operation. If normal
performance is observed, additional measures may be necessary, such as reorienting
the MX86001(AS-302-L). The frequency range between 150 KHz to 80 MHz, eld
strengths be less than 3 V/m.
Recommended distance between portable and mobile RF equipment and Fingertip
Pulse Oximeter MX86001(AS-302-L)
SpO%
2
PR BPM
SN
SpO 2
The MX86001(AS-302-L) are intended for use in electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the MX86001(AS-
302-L) can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters)
and the MX86001(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 MHz
d=(1.2√F)
80 MHz – 800
MHz
d=(1.2√F)
800 MHz – 2.5
GHz
d=(1.2√F)
0.01 Not applicable0.12 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 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: Between 80 – 800 MHz the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic transmissions
are affected by absorption and reflection of structures, objects and human bodies.
Manufactured by Medinox London
Solar House, 282 Chase Road,
London N14 6NZ . www.medinox.co.uk
Appplicant:
Australian Sponsor:
Medinox Australia (Pty) Ltd
Unit 15, 265 - 271 Pennant Hills Road,
Thornleigh, 2120 Tel: 1800724903
www.medinox.com.au
South African Sponsor:
Medinox South Africa (Pty) Ltd
2 Sunrock Close, Sunnyrock, Germiston,
Gauteng, 1401 . www.medinox.co.za
Date of issue: June 2020
Should any problems be experienced from
the use of this device, please notify us
immediately at customercare@medinox.co.uk.
Should any serious incident or harm be the
result of the use of this device, please inform
the manufacturer and the health authorities in
the country of sale.
oximeter_Instruction Manual_SA.indd 2oximeter_Instruction Manual_SA.indd 2 2020/08/09 18:492020/08/09 18:49
The oximeter does not
turn on
1. Batteries weak
or batteries not
installed
2. Batteries
incorrectly installed
3. Damaged
oximeter
3. Replace the
batteries
2. Ensure the
batteries are
installed correctly
3. Contact the
manufacturer
The screen suddenly
shuts down
1. The oximeter
is powered off
automatically when
no signal of the
nger is detected for
a long time
2. Inadequate power
of the batteries
1. Normal
2. Replace the
batteries
The oximeter blackout The oximeter probe
failure
The device is
faulty. Contact the
manufacturer.
MX86001(AS-302-L)
displays bar graph with
no SpO2 and pulse rate
The signal of SpO2
source is suspect or
incorrect
Use a different nger
and measure again.
The device is
faulty. Contact the
manufacturer
Symbol Denitions
Symbol Denition Symbol Denition
Type BF Equipment No SpO2 Alarm
Attention! Consult
accompanying
documents
Use by date
Oxygen saturation CE MARK
Pulse rate (BPM)Manufacturers
information
Drip proof Follow operating
instructions
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 gure.
Response time of normal average is 10.4s
Electromagnetic compatibility
Note: Fingertip pulse oximeter MX86001(AS-302-L) comply with the
requirement of the Electromagnetic Compatibility in YY 0505-2012. And IEC
60601-1-2:2007
The user needs to install and use according electromagnetism compatibility
information which is attached to it.
Portable and mobile RF communication devices may influence the
Fingertip Pulse Oximeter MX86001(AS-302-L) performance. So ngertip
pulse oximeter MX86001(AS-302-L) should be kept away from strong
electromagnetic interference such as cell phone in close proximity,
microwave oven and the like during operation. Guidance and manufacturer’s
declaration are stated in the appendix.
Warning: MX86001(AS-302-L) should not be used adjacent to or stacked
with other equipment. If MX86001(AS-302-L) is used with or stacked
with other equipment it should be observed to ensure and verify normal
operation in this conguration.
Appendix:
Guidance and Manufacturer’s declaration – Electromagnetic emission
The MX86001(AS-302-L) Fingertip Oximeter is intended for use in the Electromagnetic
environment specied below. The customer or the user of MX86001(AS-302-L) should
assure they are used to work in such an environment.
Emission Test Compliance Electromagnetic Environment
Guidance
FR emissions GB48424 Group 1 The MX86001(AS-302-L)
Fingertip 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 nearby
electronic equipment.
FR emissions GB48424 Class B The MX86001(AS-302-L)
Fingertip Pulse Oximeters
are suitable for use in all
environments other than
domestic and those directly
connected to the public low
voltage power supply network
that supplies buildings used for
domestic purposes.
Harmonic emissions
GB17625.1
Not applicable.
Voltage fluctuations/flicker
emissions GB17625.2
Not applicable.
Guidance and manufacturers declaration – electromagnetic immunity
The MX86001(AS-302-L) Fingertip Oximeter is intended for use in the Electromagnetic
environment specied below. The customer or the user of MX86001(AS-302-L) should
assure they are used to work in such an environment.
Immunity test IEC60601 test
level
Compliance level Electromagnetic
Environment - Guidance
Electrostatic
discharge
(ESD) GB/T
17626.2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood,
concrete and tile. If the
floor is covered with
synthetic material, the
relative humidity should
be 30%.
Electrical fast
transient/burst
GB/T17626.4
±2 kV power
supply lines
±1 kV input/
output line
Not applicable Main power quality
should be that of a
typical commercial or
hospital environment.
Surge GB/T
17626.5
±1 kV lines to
lines
±2 kV lines 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
GB/T 17626.11
<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 5 s
(>95% dip in UT)
Not applicable Main power quality
should be that of a
typical commercial or
hospital environment.
If the user of
MX86001(AS-302-L)
requires continued
operation during power
mains interruptions, it
is recommended that
the MX86001(AS-302-L)
be powered from an
uninterruptable power
supply or battery.
Power
frequency
magnetic eld
(50/60 Hz )
GB/T 17626.8
3 A/m 3A/m/50Hz Power frequency
magnetic elds
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
The MX86001(AS-302-L) Fingertip Pulse Oximeter is intended for use in the
electromagnetic environment specied below. The customer or the user of
MX86001(AS-302-L) should assure they are used in such an environment.
Immunity test IEC 60601 test level Compliance
Conducted RF
GB/T 17626.6
Radiated RF
GB/T 17626.3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5GHz
Level not applicable.
3 V/m
Electromagnetic environment - Guidance
Portable and mobile RF communication equipment should be used no closer to any
part of the MX86001(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√F)
d=(1.2√F)80MHz to 800 MHz
d=(1.2√F) 80 MHz to 2.5 GHz
Where:
P is the maximum output power of the transmitter in watts (W) according to the
transmitter manufacturer.
D is the recommended separation distance in meters (m).
Field strengths from xed RF transmitters, as determined by an electromagnetic site
survey, should be less than the compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked with the following symbol.
Note 1: Between 80 MHz and 800 MHz 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.
Field strengths from xed 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 xed RF transmitters, and electromagnetic
site survey should be considered. If the measured eld strength in the location in which
the MX86001(AS-302-L) is used exceeds the applicable RF compliance level above,
the MX86001(AS-302-L) should be observed to verify normal operation. If normal
performance is observed, additional measures may be necessary, such as reorienting
the MX86001(AS-302-L). The frequency range between 150 KHz to 80 MHz, eld
strengths be less than 3 V/m.
Recommended distance between portable and mobile RF equipment and Fingertip
Pulse Oximeter MX86001(AS-302-L)
SpO%
2
PR BPM
SN
SpO 2
The MX86001(AS-302-L) are intended for use in electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the MX86001(AS-
302-L) can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters)
and the MX86001(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 MHz
d=(1.2√F)
80 MHz – 800
MHz
d=(1.2√F)
800 MHz – 2.5
GHz
d=(1.2√F)
0.01 Not applicable0.12 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 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: Between 80 – 800 MHz the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic transmissions
are affected by absorption and reflection of structures, objects and human bodies.
Manufactured by Medinox London
Solar House, 282 Chase Road,
London N14 6NZ . www.medinox.co.uk
Appplicant:
Australian Sponsor:
Medinox Australia (Pty) Ltd
Unit 15, 265 - 271 Pennant Hills Road,
Thornleigh, 2120 Tel: 1800724903
www.medinox.com.au
South African Sponsor:
Medinox South Africa (Pty) Ltd
2 Sunrock Close, Sunnyrock, Germiston,
Gauteng, 1401 . www.medinox.co.za
Date of issue: June 2020
Should any problems be experienced from
the use of this device, please notify us
immediately at customercare@medinox.co.uk.
Should any serious incident or harm be the
result of the use of this device, please inform
the manufacturer and the health authorities in
the country of sale.
oximeter_Instruction Manual_SA.indd 2oximeter_Instruction Manual_SA.indd 2 2020/08/09 18:492020/08/09 18:49
The oximeter does not
turn on
1. Batteries weak
or batteries not
installed
2. Batteries
incorrectly installed
3. Damaged
oximeter
3. Replace the
batteries
2. Ensure the
batteries are
installed correctly
3. Contact the
manufacturer
The screen suddenly
shuts down
1. The oximeter
is powered off
automatically when
no signal of the
nger is detected for
a long time
2. Inadequate power
of the batteries
1. Normal
2. Replace the
batteries
The oximeter blackout The oximeter probe
failure
The device is
faulty. Contact the
manufacturer.
MX86001(AS-302-L)
displays bar graph with
no SpO2 and pulse rate
The signal of SpO2
source is suspect or
incorrect
Use a different nger
and measure again.
The device is
faulty. Contact the
manufacturer
Symbol Denitions
Symbol Denition Symbol Denition
Type BF Equipment No SpO2 Alarm
Attention! Consult
accompanying
documents
Use by date
Oxygen saturation CE MARK
Pulse rate (BPM)Manufacturers
information
Drip proof Follow operating
instructions
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 gure.
Response time of normal average is 10.4s
Electromagnetic compatibility
Note: Fingertip pulse oximeter MX86001(AS-302-L) comply with the
requirement of the Electromagnetic Compatibility in YY 0505-2012. And IEC
60601-1-2:2007
The user needs to install and use according electromagnetism compatibility
information which is attached to it.
Portable and mobile RF communication devices may influence the
Fingertip Pulse Oximeter MX86001(AS-302-L) performance. So ngertip
pulse oximeter MX86001(AS-302-L) should be kept away from strong
electromagnetic interference such as cell phone in close proximity,
microwave oven and the like during operation. Guidance and manufacturer’s
declaration are stated in the appendix.
Warning: MX86001(AS-302-L) should not be used adjacent to or stacked
with other equipment. If MX86001(AS-302-L) is used with or stacked
with other equipment it should be observed to ensure and verify normal
operation in this conguration.
Appendix:
Guidance and Manufacturer’s declaration – Electromagnetic emission
The MX86001(AS-302-L) Fingertip Oximeter is intended for use in the Electromagnetic
environment specied below. The customer or the user of MX86001(AS-302-L) should
assure they are used to work in such an environment.
Emission Test Compliance Electromagnetic Environment
Guidance
FR emissions GB48424 Group 1 The MX86001(AS-302-L)
Fingertip 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 nearby
electronic equipment.
FR emissions GB48424 Class B The MX86001(AS-302-L)
Fingertip Pulse Oximeters
are suitable for use in all
environments other than
domestic and those directly
connected to the public low
voltage power supply network
that supplies buildings used for
domestic purposes.
Harmonic emissions
GB17625.1
Not applicable.
Voltage fluctuations/flicker
emissions GB17625.2
Not applicable.
Guidance and manufacturers declaration – electromagnetic immunity
The MX86001(AS-302-L) Fingertip Oximeter is intended for use in the Electromagnetic
environment specied below. The customer or the user of MX86001(AS-302-L) should
assure they are used to work in such an environment.
Immunity test IEC60601 test
level
Compliance level Electromagnetic
Environment - Guidance
Electrostatic
discharge
(ESD) GB/T
17626.2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood,
concrete and tile. If the
floor is covered with
synthetic material, the
relative humidity should
be 30%.
Electrical fast
transient/burst
GB/T17626.4
±2 kV power
supply lines
±1 kV input/
output line
Not applicable Main power quality
should be that of a
typical commercial or
hospital environment.
Surge GB/T
17626.5
±1 kV lines to
lines
±2 kV lines 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
GB/T 17626.11
<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 5 s
(>95% dip in UT)
Not applicable Main power quality
should be that of a
typical commercial or
hospital environment.
If the user of
MX86001(AS-302-L)
requires continued
operation during power
mains interruptions, it
is recommended that
the MX86001(AS-302-L)
be powered from an
uninterruptable power
supply or battery.
Power
frequency
magnetic eld
(50/60 Hz )
GB/T 17626.8
3 A/m 3A/m/50Hz Power frequency
magnetic elds
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
The MX86001(AS-302-L) Fingertip Pulse Oximeter is intended for use in the
electromagnetic environment specied below. The customer or the user of
MX86001(AS-302-L) should assure they are used in such an environment.
Immunity test IEC 60601 test level Compliance
Conducted RF
GB/T 17626.6
Radiated RF
GB/T 17626.3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5GHz
Level not applicable.
3 V/m
Electromagnetic environment - Guidance
Portable and mobile RF communication equipment should be used no closer to any
part of the MX86001(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√F)
d=(1.2√F)80MHz to 800 MHz
d=(1.2√F) 80 MHz to 2.5 GHz
Where:
P is the maximum output power of the transmitter in watts (W) according to the
transmitter manufacturer.
D is the recommended separation distance in meters (m).
Field strengths from xed RF transmitters, as determined by an electromagnetic site
survey, should be less than the compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked with the following symbol.
Note 1: Between 80 MHz and 800 MHz 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.
Field strengths from xed 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 xed RF transmitters, and electromagnetic
site survey should be considered. If the measured eld strength in the location in which
the MX86001(AS-302-L) is used exceeds the applicable RF compliance level above,
the MX86001(AS-302-L) should be observed to verify normal operation. If normal
performance is observed, additional measures may be necessary, such as reorienting
the MX86001(AS-302-L). The frequency range between 150 KHz to 80 MHz, eld
strengths be less than 3 V/m.
Recommended distance between portable and mobile RF equipment and Fingertip
Pulse Oximeter MX86001(AS-302-L)
SpO%
2
PR BPM
SN
SpO 2
The MX86001(AS-302-L) are intended for use in electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the MX86001(AS-
302-L) can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters)
and the MX86001(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 MHz
d=(1.2√F)
80 MHz – 800
MHz
d=(1.2√F)
800 MHz – 2.5
GHz
d=(1.2√F)
0.01 Not applicable0.12 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 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: Between 80 – 800 MHz the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic transmissions
are affected by absorption and reflection of structures, objects and human bodies.
Manufactured by Medinox London
Solar House, 282 Chase Road,
London N14 6NZ . www.medinox.co.uk
Appplicant:
Australian Sponsor:
Medinox Australia (Pty) Ltd
Unit 15, 265 - 271 Pennant Hills Road,
Thornleigh, 2120 Tel: 1800724903
www.medinox.com.au
South African Sponsor:
Medinox South Africa (Pty) Ltd
2 Sunrock Close, Sunnyrock, Germiston,
Gauteng, 1401 . www.medinox.co.za
Date of issue: June 2020
Should any problems be experienced from
the use of this device, please notify us
immediately at customercare@medinox.co.uk.
Should any serious incident or harm be the
result of the use of this device, please inform
the manufacturer and the health authorities in
the country of sale.
oximeter_Instruction Manual_SA.indd 2oximeter_Instruction Manual_SA.indd 2 2020/08/09 18:492020/08/09 18:49
The oximeter does not
turn on
1. Batteries weak
or batteries not
installed
2. Batteries
incorrectly installed
3. Damaged
oximeter
3. Replace the
batteries
2. Ensure the
batteries are
installed correctly
3. Contact the
manufacturer
The screen suddenly
shuts down
1. The oximeter
is powered off
automatically when
no signal of the
nger is detected for
a long time
2. Inadequate power
of the batteries
1. Normal
2. Replace the
batteries
The oximeter blackout The oximeter probe
failure
The device is
faulty. Contact the
manufacturer.
MX86001(AS-302-L)
displays bar graph with
no SpO2 and pulse rate
The signal of SpO2
source is suspect or
incorrect
Use a different nger
and measure again.
The device is
faulty. Contact the
manufacturer
Symbol Denitions
Symbol Denition Symbol Denition
Type BF Equipment No SpO2 Alarm
Attention! Consult
accompanying
documents
Use by date
Oxygen saturation CE MARK
Pulse rate (BPM)Manufacturers
information
Drip proof Follow operating
instructions
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 gure.
Response time of normal average is 10.4s
Electromagnetic compatibility
Note: Fingertip pulse oximeter MX86001(AS-302-L) comply with the
requirement of the Electromagnetic Compatibility in YY 0505-2012. And IEC
60601-1-2:2007
The user needs to install and use according electromagnetism compatibility
information which is attached to it.
Portable and mobile RF communication devices may influence the
Fingertip Pulse Oximeter MX86001(AS-302-L) performance. So ngertip
pulse oximeter MX86001(AS-302-L) should be kept away from strong
electromagnetic interference such as cell phone in close proximity,
microwave oven and the like during operation. Guidance and manufacturer’s
declaration are stated in the appendix.
Warning: MX86001(AS-302-L) should not be used adjacent to or stacked
with other equipment. If MX86001(AS-302-L) is used with or stacked
with other equipment it should be observed to ensure and verify normal
operation in this conguration.
Appendix:
Guidance and Manufacturer’s declaration – Electromagnetic emission
The MX86001(AS-302-L) Fingertip Oximeter is intended for use in the Electromagnetic
environment specied below. The customer or the user of MX86001(AS-302-L) should
assure they are used to work in such an environment.
Emission Test Compliance Electromagnetic Environment
Guidance
FR emissions GB48424 Group 1 The MX86001(AS-302-L)
Fingertip 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 nearby
electronic equipment.
FR emissions GB48424 Class B The MX86001(AS-302-L)
Fingertip Pulse Oximeters
are suitable for use in all
environments other than
domestic and those directly
connected to the public low
voltage power supply network
that supplies buildings used for
domestic purposes.
Harmonic emissions
GB17625.1
Not applicable.
Voltage fluctuations/flicker
emissions GB17625.2
Not applicable.
Guidance and manufacturers declaration – electromagnetic immunity
The MX86001(AS-302-L) Fingertip Oximeter is intended for use in the Electromagnetic
environment specied below. The customer or the user of MX86001(AS-302-L) should
assure they are used to work in such an environment.
Immunity test IEC60601 test
level
Compliance level Electromagnetic
Environment - Guidance
Electrostatic
discharge
(ESD) GB/T
17626.2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood,
concrete and tile. If the
floor is covered with
synthetic material, the
relative humidity should
be 30%.
Electrical fast
transient/burst
GB/T17626.4
±2 kV power
supply lines
±1 kV input/
output line
Not applicable Main power quality
should be that of a
typical commercial or
hospital environment.
Surge GB/T
17626.5
±1 kV lines to
lines
±2 kV lines 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
GB/T 17626.11
<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 5 s
(>95% dip in UT)
Not applicable Main power quality
should be that of a
typical commercial or
hospital environment.
If the user of
MX86001(AS-302-L)
requires continued
operation during power
mains interruptions, it
is recommended that
the MX86001(AS-302-L)
be powered from an
uninterruptable power
supply or battery.
Power
frequency
magnetic eld
(50/60 Hz )
GB/T 17626.8
3 A/m 3A/m/50Hz Power frequency
magnetic elds
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
The MX86001(AS-302-L) Fingertip Pulse Oximeter is intended for use in the
electromagnetic environment specied below. The customer or the user of
MX86001(AS-302-L) should assure they are used in such an environment.
Immunity test IEC 60601 test level Compliance
Conducted RF
GB/T 17626.6
Radiated RF
GB/T 17626.3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5GHz
Level not applicable.
3 V/m
Electromagnetic environment - Guidance
Portable and mobile RF communication equipment should be used no closer to any
part of the MX86001(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√F)
d=(1.2√F)80MHz to 800 MHz
d=(1.2√F) 80 MHz to 2.5 GHz
Where:
P is the maximum output power of the transmitter in watts (W) according to the
transmitter manufacturer.
D is the recommended separation distance in meters (m).
Field strengths from xed RF transmitters, as determined by an electromagnetic site
survey, should be less than the compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked with the following symbol.
Note 1: Between 80 MHz and 800 MHz 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.
Field strengths from xed 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 xed RF transmitters, and electromagnetic
site survey should be considered. If the measured eld strength in the location in which
the MX86001(AS-302-L) is used exceeds the applicable RF compliance level above,
the MX86001(AS-302-L) should be observed to verify normal operation. If normal
performance is observed, additional measures may be necessary, such as reorienting
the MX86001(AS-302-L). The frequency range between 150 KHz to 80 MHz, eld
strengths be less than 3 V/m.
Recommended distance between portable and mobile RF equipment and Fingertip
Pulse Oximeter MX86001(AS-302-L)
SpO%
2
PR BPM
SN
SpO 2
The MX86001(AS-302-L) are intended for use in electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the MX86001(AS-
302-L) can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters)
and the MX86001(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 MHz
d=(1.2√F)
80 MHz – 800
MHz
d=(1.2√F)
800 MHz – 2.5
GHz
d=(1.2√F)
0.01 Not applicable0.12 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 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: Between 80 – 800 MHz the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic transmissions
are affected by absorption and reflection of structures, objects and human bodies.
Manufactured by Medinox London
Solar House, 282 Chase Road,
London N14 6NZ . www.medinox.co.uk
Appplicant:
Australian Sponsor:
Medinox Australia (Pty) Ltd
Unit 15, 265 - 271 Pennant Hills Road,
Thornleigh, 2120 Tel: 1800724903
www.medinox.com.au
South African Sponsor:
Medinox South Africa (Pty) Ltd
2 Sunrock Close, Sunnyrock, Germiston,
Gauteng, 1401 . www.medinox.co.za
Date of issue: June 2020
Should any problems be experienced from
the use of this device, please notify us
Should any serious incident or harm be the
result of the use of this device, please inform
the manufacturer and the health authorities in
the country of sale.
oximeter_Instruction Manual_SA.indd 2oximeter_Instruction Manual_SA.indd 2 2020/08/09 18:492020/08/09 18:49
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