FaceLake FL-100 User manual

ModeL:FL-100
Pulse Oximeter
General Description
Oxygen Saturation is a percentage of Oxyhemoglobin (HbO2) capacity,
compounded with oxygen, by all combinative hemoglobin (Hb) capacity in
blood. In other words, it is consistency of Oxyhemoglobin in blood. It is a
very important parameter for the Respiratory Circulation System. Many
respiratory diseases can result in oxygen saturation being lowered in
human blood. Additionally, the following factors can reduce oxygen
saturation: Automatic regulation of organ dysfunction caused by
Anesthesia, Intensive Postoperative Trauma, injuries caused by some
medical examinations. That situation might result in light-headedness,
asthenia, and vomiting. Therefore, it is very important to know the oxygen
saturation of a user so that doctors can find problems in a timely manner.
The fingertip pulse Oximeter features small size, low power consumption,
convenient operation and portability. It is only necessary for a user to put
one of his fingers into the fingertip photoelectric sensor for diagnosis, and a
display screen will show oxygen saturation. It has been proven in clinical
experiments that it also features high precision and repeatability.
Measurement principle
Principle of the Oximeter is as follows: Amathematical formula is
established making use of Lambert Beer Law according to Spectrum
Absorption Characteristics of Reductive hemoglobin(RHb) and
Oxyhemoglobin (HbO2) in glow and near-infrared zones. Operation
principle of the instrument: Photoelectric Oxyhemoglobin Inspection
Technology is adopted in accordance with Capacity Pulse Scanning and
Recording Technology, so that two beams of different wavelength of lights
(660nm glow and 940nm near infrared light) can be focused onto a human
nail tip through a clamping finger-type sensor. Ameasured signal obtained
by a photosensitive element, will be shown on the Oximeter’s display
through process in electronic circuits and microprocessor shown on the
Oximeter’s display through electronic circuits and a microprocessor.
Diagram of Operation Principle
1. Red and Infrared-ray Emission Tube
2. Red and Infrared-ray
3. Receipt Tube
Precautions for use
1 Do not use the pulse oximeter in an MRI or CT environment
2 Do not use the pulse oximeter in situations where alarms are required.
The device has no alarms.
3 Explosion hazard: Do not use the pulse oximeter in an explosive
atmosphere.
4 The pulse oximeter is intended only as an adjunct in user assessment. It
must be used in conjunction with other methods of assessing clinical
signs and symptoms.
5 Check the pulse oximeter sensor application site frequentlyto determine
the positioning of the sensor and circulation and skin sensitivity of the
user.
6 Do not stretch the adhesive tape while applying the pulse oximeter
sensor. This may cause inaccurate readings or skin blisters.
7 Before use, carefully read the manual.
8 The pulse oximeter has no SPO2alarms; it is not for continuous
monitoring.
9 Prolonged use or the user’s condition may require changing the sensor
site periodically. Change sensor site and check skin integrity, circulatory
status, and correct alignment at least every 4 hours.
10Inaccurate measurements may be caused by autoclaving, ethylene
oxide sterilizing, or immersing the sensors in liquid.
11Significant levels of dysfunctional hemoglobins (such as carbonxy-
hemoglobin or methemoglobin) may cause inaccurate readings.
12Intravascular dyes such as indocyanine green or methylene blue.
13SPO2measurements may be adversely affected in the presence of high
ambient light. Shield the sensor area (with a surgical towel, or direct
sunlight, for example) if necessary.
14Excessive user movement may cause inaccurate readings.
15Venous pulsations may cause inaccurate readings.
16High-frequency electrosurgical interference may cause inaccurate
readings.
17Placement of a sensor on an extremity with a blood pressure cuff,
arterial catheter, or intravascular line.
18The user has hypotension, severe vasoconstriction, severe anemia, or
hypothermia.
19The user is in cardiac arrest or is in shock.
20Fingernail polish or false fingernails may cause inaccurate SPO2
readings.
Follow local ordinances and recycling instructions regarding
disposal or recycling of the device and device components, including
batteries.
Product Properties
1 Operation of the product is simple and convenient
2 The product is small in volume, light in weight and convenient in
carrying.
3 Power consumption of the product is low and the two AAA batteries can
be operated continuously for 24 hours.
4 A low voltage warning will be indicated in visual window when battery
voltage is so low that normal operation of the oximeter might be
influenced.
5 The product will automatically be powered off when no signal is in the
product for longer than 16 seconds.
Product Operation Scope
Fingertip PULSE OXIMETER is a portable non-invasive, spot-check,
oxygen saturation of arterial hemoglobin (SPO2) and pulse rate of adult
and pediatric user at home, and hospital (including clinical use in
internist/surgery, Anesthesia, intensive care etc). It is not for continuously
monitoring.
Operation Instructions
1 Install two AAA batteries into battery compartment correctly.
2 Place clamp over finger nail as the following diagram.
3 Insert one finger into rubber hole of the Oximeter fully.
4 Press the switch once on the front panel.
5 Finger and body should not tremble during measuring.
6 Read correct data from display screen.
After turn on the oximeter, each time you press the function button, the
oximeter will switch to another display mode, there are 4 display modes
totally.
Long press the function button to enter the settings screen.
Short press to switch among the settings, long press to change the
current settings of sounds and alarm limits.
Notes:
When your finger insert into the Oximeter, your nail surface must be
upward.
The results may be wrong if you did not plug the finger thoroughly in the
Oximeter.
Please use medical alcohol to clean the rubber touching the finger inside
of Oximeter, and clean the test finger using alcohol before and after each
test. (The rubber inside of the Oximeter belongs medical rubber, which
has no toxin and no harmful to the skin).
Brief Description of Front Panel
The Pulse bar graph displays corrernding with the user’s pulse beat. The
height of the bar graph shows the user’s pulse strength.
Product Accessories
1. Lanyard
2. Two batteries
3. One user manual
Battery Indicator
Functional oxygen
saturation of arterial
hemoglobin
Bargraph
Pulse Rate
Plethysaogram
Power On

ModeL:FL-100
Pulse Oximeter
General Description
Oxygen Saturation is a percentage of Oxyhemoglobin (HbO2) capacity,
compounded with oxygen, by all combinative hemoglobin (Hb) capacity in
blood. In other words, it is consistency of Oxyhemoglobin in blood. It is a
very important parameter for the Respiratory Circulation System. Many
respiratory diseases can result in oxygen saturation being lowered in
human blood. Additionally, the following factors can reduce oxygen
saturation: Automatic regulation of organ dysfunction caused by
Anesthesia, Intensive Postoperative Trauma, injuries caused by some
medical examinations. That situation might result in light-headedness,
asthenia, and vomiting. Therefore, it is very important to know the oxygen
saturation of a user so that doctors can find problems in a timely manner.
The fingertip pulse Oximeter features small size, low power consumption,
convenient operation and portability. It is only necessary for a user to put
one of his fingers into the fingertip photoelectric sensor for diagnosis, and a
display screen will show oxygen saturation. It has been proven in clinical
experiments that it also features high precision and repeatability.
Measurement principle
Principle of the Oximeter is as follows: A mathematical formula is
established making use of Lambert Beer Law according to Spectrum
Absorption Characteristics of Reductive hemoglobin(RHb) and
Oxyhemoglobin (HbO2) in glow and near-infrared zones. Operation
principle of the instrument: Photoelectric Oxyhemoglobin Inspection
Technology is adopted in accordance with Capacity Pulse Scanning and
Recording Technology, so that two beams of different wavelength of lights
(660nm glow and 940nm near infrared light) can be focused onto a human
nail tip through a clamping finger-type sensor. Ameasured signal obtained
by a photosensitive element, will be shown on the Oximeter’s display
through process in electronic circuits and microprocessor shown on the
Oximeter’s display through electronic circuits and a microprocessor.
Diagram of Operation Principle
1. Red and Infrared-ray Emission Tube
2. Red and Infrared-ray
3. Receipt Tube
Precautions for use
1 Do not use the pulse oximeter in an MRI or CT environment
2 Do not use the pulse oximeter in situations where alarms are required.
The device has no alarms.
3 Explosion hazard: Do not use the pulse oximeter in an explosive
atmosphere.
4 The pulse oximeter is intended only as an adjunct in user assessment. It
must be used in conjunction with other methods of assessing clinical
signs and symptoms.
5 Check the pulse oximeter sensor application site frequentlyto determine
the positioning of the sensor and circulation and skin sensitivity of the
user.
6 Do not stretch the adhesive tape while applying the pulse oximeter
sensor. This may cause inaccurate readings or skin blisters.
7 Before use, carefully read the manual.
8 The pulse oximeter has no SPO2alarms; it is not for continuous
monitoring.
9 Prolonged use or the user’s condition may require changing the sensor
site periodically. Change sensor site and check skin integrity, circulatory
status, and correct alignment at least every 4 hours.
10Inaccurate measurements may be caused by autoclaving, ethylene
oxide sterilizing, or immersing the sensors in liquid.
11Significant levels of dysfunctional hemoglobins (such as carbonxy-
hemoglobin or methemoglobin) may cause inaccurate readings.
12Intravascular dyes such as indocyanine green or methylene blue.
13SPO2measurements may be adversely affected in the presence of high
ambient light. Shield the sensor area (with a surgical towel, or direct
sunlight, for example) if necessary.
14Excessive user movement may cause inaccurate readings.
15Venous pulsations may cause inaccurate readings.
16High-frequency electrosurgical interference may cause inaccurate
readings.
17Placement of a sensor on an extremity with a blood pressure cuff,
arterial catheter, or intravascular line.
18The user has hypotension, severe vasoconstriction, severe anemia, or
hypothermia.
19The user is in cardiac arrest or is in shock.
20Fingernail polish or false fingernails may cause inaccurate SPO2
readings.
Follow local ordinances and recycling instructions regarding
disposal or recycling of the device and device components, including
batteries.
Product Properties
1 Operation of the product is simple and convenient
2 The product is small in volume, light in weight and convenient in
carrying.
3 Power consumption of the product is low and the two AAA batteries can
be operated continuously for 24 hours.
4 A low voltage warning will be indicated in visual window when battery
voltage is so low that normal operation of the oximeter might be
influenced.
5 The product will automatically be powered off when no signal is in the
product for longer than 16 seconds.
Product Operation Scope
Fingertip PULSE OXIMETER is a portable non-invasive, spot-check,
oxygen saturation of arterial hemoglobin (SPO2) and pulse rate of adult
and pediatric user at home, and hospital (including clinical use in
internist/surgery, Anesthesia, intensive care etc). It is not for continuously
monitoring.
Operation Instructions
1 Install two AAA batteries into battery compartment correctly.
2 Place clamp over finger nail as the following diagram.
3 Insert one finger into rubber hole of the Oximeter fully.
4 Press the switch once on the front panel.
5 Finger and body should not tremble during measuring.
6 Read correct data from display screen.
After turn on the oximeter, each time you press the function button, the
oximeter will switch to another display mode, there are 4 display modes
totally.
Long press the function button to enter the settings screen.
Short press to switch among the settings, long press to change the
current settings of sounds and alarm limits.
Notes:
When your finger insert into the Oximeter, your nail surface must be
upward.
The results may be wrong if you did not plug the finger thoroughly in the
Oximeter.
Please use medical alcohol to clean the rubber touching the finger inside
of Oximeter, and clean the test finger using alcohol before and after each
test. (The rubber inside of the Oximeter belongs medical rubber, which
has no toxin and no harmful to the skin).
Brief Description of Front Panel
The Pulse bar graph displays corrernding with the user’s pulse beat. The
height of the bar graph shows the user’s pulse strength.
Product Accessories
1. Lanyard
2. Two batteries
3. One user manual
Battery Indicator
Functional oxygen
saturation of arterial
hemoglobin
Bargraph
Pulse Rate
Plethysaogram
Power On

ModeL:FL-100
Pulse Oximeter
General Description
Oxygen Saturation is a percentage of Oxyhemoglobin (HbO2) capacity,
compounded with oxygen, by all combinative hemoglobin (Hb) capacity in
blood. In other words, it is consistency of Oxyhemoglobin in blood. It is a
very important parameter for the Respiratory Circulation System. Many
respiratory diseases can result in oxygen saturation being lowered in
human blood. Additionally, the following factors can reduce oxygen
saturation: Automatic regulation of organ dysfunction caused by
Anesthesia, Intensive Postoperative Trauma, injuries caused by some
medical examinations. That situation might result in light-headedness,
asthenia, and vomiting. Therefore, it is very important to know the oxygen
saturation of a user so that doctors can find problems in a timely manner.
The fingertip pulse Oximeter features small size, low power consumption,
convenient operation and portability. It is only necessary for a user to put
one of his fingers into the fingertip photoelectric sensor for diagnosis, and a
display screen will show oxygen saturation. It has been proven in clinical
experiments that it also features high precision and repeatability.
Measurement principle
Principle of the Oximeter is as follows: A mathematical formula is
established making use of Lambert Beer Law according to Spectrum
Absorption Characteristics of Reductive hemoglobin(RHb) and
Oxyhemoglobin (HbO2) in glow and near-infrared zones. Operation
principle of the instrument: Photoelectric Oxyhemoglobin Inspection
Technology is adopted in accordance with Capacity Pulse Scanning and
Recording Technology, so that two beams of different wavelength of lights
(660nm glow and 940nm near infrared light) can be focused onto a human
nail tip through a clamping finger-type sensor. Ameasured signal obtained
by a photosensitive element, will be shown on the Oximeter’s display
through process in electronic circuits and microprocessor shown on the
Oximeter’s display through electronic circuits and a microprocessor.
Diagram of Operation Principle
1. Red and Infrared-ray Emission Tube
2. Red and Infrared-ray
3. Receipt Tube
Precautions for use
1 Do not use the pulse oximeter in an MRI or CT environment
2 Do not use the pulse oximeter in situations where alarms are required.
The device has no alarms.
3 Explosion hazard: Do not use the pulse oximeter in an explosive
atmosphere.
4 The pulse oximeter is intended only as an adjunct in user assessment. It
must be used in conjunction with other methods of assessing clinical
signs and symptoms.
5 Check the pulse oximeter sensor application site frequentlyto determine
the positioning of the sensor and circulation and skin sensitivity of the
user.
6 Do not stretch the adhesive tape while applying the pulse oximeter
sensor. This may cause inaccurate readings or skin blisters.
7 Before use, carefully read the manual.
8 The pulse oximeter has no SPO2alarms; it is not for continuous
monitoring.
9 Prolonged use or the user’s condition may require changing the sensor
site periodically. Change sensor site and check skin integrity, circulatory
status, and correct alignment at least every 4 hours.
10Inaccurate measurements may be caused by autoclaving, ethylene
oxide sterilizing, or immersing the sensors in liquid.
11Significant levels of dysfunctional hemoglobins (such as carbonxy-
hemoglobin or methemoglobin) may cause inaccurate readings.
12Intravascular dyes such as indocyanine green or methylene blue.
13SPO2measurements may be adversely affected in the presence of high
ambient light. Shield the sensor area (with a surgical towel, or direct
sunlight, for example) if necessary.
14Excessive user movement may cause inaccurate readings.
15Venous pulsations may cause inaccurate readings.
16High-frequency electrosurgical interference may cause inaccurate
readings.
17Placement of a sensor on an extremity with a blood pressure cuff,
arterial catheter, or intravascular line.
18The user has hypotension, severe vasoconstriction, severe anemia, or
hypothermia.
19The user is in cardiac arrest or is in shock.
20Fingernail polish or false fingernails may cause inaccurate SPO2
readings.
Follow local ordinances and recycling instructions regarding
disposal or recycling of the device and device components, including
batteries.
Product Properties
1 Operation of the product is simple and convenient
2 The product is small in volume, light in weight and convenient in
carrying.
3 Power consumption of the product is low and the two AAA batteries can
be operated continuously for 24 hours.
4 A low voltage warning will be indicated in visual window when battery
voltage is so low that normal operation of the oximeter might be
influenced.
5 The product will automatically be powered off when no signal is in the
product for longer than 16 seconds.
Product Operation Scope
Fingertip PULSE OXIMETER is a portable non-invasive, spot-check,
oxygen saturation of arterial hemoglobin (SPO2) and pulse rate of adult
and pediatric user at home, and hospital (including clinical use in
internist/surgery, Anesthesia, intensive care etc). It is not for continuously
monitoring.
Operation Instructions
1 Install two AAA batteries into battery compartment correctly.
2 Place clamp over finger nail as the following diagram.
3 Insert one finger into rubber hole of the Oximeter fully.
4 Press the switch once on the front panel.
5 Finger and body should not tremble during measuring.
6 Read correct data from display screen.
After turn on the oximeter, each time you press the function button, the
oximeter will switch to another display mode, there are 4 display modes
totally.
Long press the function button to enter the settings screen.
Short press to switch among the settings, long press to change the
current settings of sounds and alarm limits.
Notes:
When your finger insert into the Oximeter, your nail surface must be
upward.
The results may be wrong if you did not plug the finger thoroughly in the
Oximeter.
Please use medical alcohol to clean the rubber touching the finger inside
of Oximeter, and clean the test finger using alcohol before and after each
test. (The rubber inside of the Oximeter belongs medical rubber, which
has no toxin and no harmful to the skin).
Brief Description of Front Panel
The Pulse bar graph displays corrernding with the user’s pulse beat. The
height of the bar graph shows the user’s pulse strength.
Product Accessories
1. Lanyard
2. Two batteries
3. One user manual
Battery Indicator
Functional oxygen
saturation of arterial
hemoglobin
Bargraph
Pulse Rate
Plethysaogram
Power On

Battery Installation
1. Put the two AAA batteries into battery compartment in correct polarities.
2. Push the battery cover horizontally along the arrow shown as below:
Notes:
Battery polarities should be correctly installed. Otherwise, damage may
be caused to the device.
Please put in or remove batteries inright order, or may cause damage to
the device bracket.
Please remove the batteries if the Oximeter will not be used for a long
time.
Strap Installation
1.Thread thinner end of the strap through the loop.
2. Thread thicker end of the strap through the threaded end before pulling
it tightly.
Maintenance and Storage
1. Replace the batteries in time when low voltage lamp is lighted.
2. Clean surface of the fingertip oximeter before it is used in diagnosis for
users.
3. Remove the batteries inside the battery cassette if the oximeter will not
be operated for a long time.
4. It is best to preserve the product in a place where ambient temperatures
is -10℃～50℃and relative humidity is 10%-95%.
5. It is recommended that the product should be kept in a dry environment
anytime.A wet ambient might affect its lifetime and even might damage
the product.
6. Avoid exposure or direct sunlight.
7. Avoid excessive radioactive infrared rays or ultraviolet rays.
8. Please follow the law of the local government to deal with used battery.
Technical Specification
1. Display Type:
Color OLED display, 4 display directions
2. SPO2:
Measurement range: 0%-100%
Resolution: 1%
Accuracy: 70%-100%, ±2%; 0%-69% no definition.
3. Pulse Rate:
Measure range：25BPM -250 BPM
Resolution: 1bpm,
Accuracy：2bpm
Pulse Intensity: Bargraph Indicator
4. Power Requirements:
Two AAA alkaline Batteries
Power consumption: 30mA(Normal)
Low power indication:
Battery Life: Two AAA 1.5V, 600mAh alkaline batteries could be
continuously operated as long as 24 hours.
5. Dimension:
Length: 64mm
Width: 35mm
Height: 34mm
Weight: 57g (including two AAA batteries)
6. Environment Requirements:
Operation Temperature: 5℃～40℃
Storage Temperature: -10℃～50℃
Ambient Humidity: 15%-80%, no condensation in operation.
10%-93%, no condensation in storage
7. Measurement Performance in Low Perfusion Condition:0.3%.
Declaration
EMC of this product complies with IEC60601-1-2 standard.
The materials which the user can come into contact have no toxicity and no
action on tissues comply with ISO10993-1, ISO10993-5 and ISO10993-10.
Guidance and manufacturer’s declaration – electromagnetic
emissions-for all EQUIPMENT and SYSTEMS
Guidance and manufacturer’s declaration –electromagnetic
emission
The Pulse Oximeter is intended for use in the electromagnetic
environment specified below. The customer or the user of the Pulse
Oximeter should assure that it is used in such an environment.
Emission
test
Complian
ce
Electromagnetic environment –
guidance
RF
emissions
CISPR 11
Group 1
The Pulse Oximeter uses RF energy only
for its internal function. Therefore, its RF
emissions are very low and are not likely
to cause any interference in nearby
electronic equipment.
RF emission
CISPR 11
Class B
The Pulse Oximeter is suitable for use in
all establishments, including domestic
establishments and those directly
connected to the public low-voltage power
supply. network that supplies buildings
used for domestic purposes.
Possible Problems and resolutions
Problems
Possible reason
Solution
SPO2or PR
can not be
shown
normally
1. Finger is not inserted
correctly
2. User’s Oxyhemoglobin
value is too low to be
measured
1..Retry by inserting the finger
2. Try some more times, If you
can make sure no problem
is existing in the product.
Please go to a hospital
timely for exact diagnosis.
SPO2or PR
is shown
unstably
1. Finger might not be
inserted deep enough.
2. Finger is trembling or
1. Retry by inserting the finger
2. Try not to move
user’s body is in
movement status.
The
Oximeter
can not be
powered on
1. Power of batteries might
be inadequate or not be
there at all
2. Batteries might be installed
incorrectly
3. The Oximeter might be
damaged
1. Please replace batteries
2. Please reinstall the
batteries
3. Please contact with local
customer service centre
The screen
are suddenly
off
1. The product is
automatically powered off
when no signal is
detected longer than 8
seconds
2. Power quantity of the
batteries is started being
inadequate
1. Normal
2. Replace the batteries
There are no user-serviceable parts inside the oximeter. The
cover should only be removed by qualified service personnel.
If you are uncertain about the accuracy of any measurement, check the
user’s vital signs by alternate means; then make sure the oximeter is
functioning correctly.
Do not spray, pour, or spill any liquid on the oximeter, its accessories,
connectors, switches, or openings in the enclosure as this may damage the
oximeter.
Symbol Definitions
Symbol
Definition
CE Mark: The Product system conforms to essential
requirements of the Medical Device Directive
93/42/EEC.
Type BF equipment (Refer to IEC 60601-1:1995)
Attention, consult accompanying documents.
﹪SPO2
Oxygen saturation
/Min
Pulse rate
Symbol for the marking of electrical and electronics
devices according to Directive 200296/EC.
The device, accessories and the packaging have to
be disposed of waste correctly at the end of the
usage. Please follow Local Ordinances or Regulations
for disposal.
Note: The Oximeter is applied to this regulation.
Note：The illustration used in this manual may differ slightly from the
appearance of the actual product.
www.FaceLake.com
37 Sherwood Terrace, Unit 124,
Lake Bluff, IL 60044 USA
0482

Battery Installation
1. Put the two AAA batteries into battery compartment in correct polarities.
2. Push the battery cover horizontally along the arrow shown as below:
Notes:
Battery polarities should be correctly installed. Otherwise, damage may
be caused to the device.
Please put in or remove batteries inright order, or may cause damage to
the device bracket.
Please remove the batteries if the Oximeter will not be used for a long
time.
Strap Installation
1.Thread thinner end of the strap through the loop.
2. Thread thicker end of the strap through the threaded end before pulling
it tightly.
Maintenance and Storage
1. Replace the batteries in time when low voltage lamp is lighted.
2. Clean surface of the fingertip oximeter before it is used in diagnosis for
users.
3. Remove the batteries inside the battery cassette if the oximeter will not
be operated for a long time.
4. It is best to preserve the product in a place where ambient temperatures
is -10℃～50℃and relative humidity is 10%-95%.
5. It is recommended that the product should be kept in a dry environment
anytime.A wet ambient might affect its lifetime and even might damage
the product.
6. Avoid exposure or direct sunlight.
7. Avoid excessive radioactive infrared rays or ultraviolet rays.
8. Please follow the law of the local government to deal with used battery.
Technical Specification
1. Display Type:
Color OLED display, 4 display directions
2. SPO2:
Measurement range: 0%-100%
Resolution: 1%
Accuracy: 70%-100%, ±2%; 0%-69% no definition.
3. Pulse Rate:
Measure range：25BPM -250 BPM
Resolution: 1bpm,
Accuracy：2bpm
Pulse Intensity: Bargraph Indicator
4. Power Requirements:
Two AAA alkaline Batteries
Power consumption: 30mA(Normal)
Low power indication:
Battery Life: Two AAA 1.5V, 600mAh alkaline batteries could be
continuously operated as long as 24 hours.
5. Dimension:
Length: 64mm
Width: 35mm
Height: 34mm
Weight: 57g (including two AAA batteries)
6. Environment Requirements:
Operation Temperature: 5℃～40℃
Storage Temperature: -10℃～50℃
Ambient Humidity: 15%-80%, no condensation in operation.
10%-93%, no condensation in storage
7. Measurement Performance in Low Perfusion Condition:0.3%.
Declaration
EMC of this product complies with IEC60601-1-2 standard.
The materials which the user can come into contact have no toxicity and no
action on tissues comply with ISO10993-1, ISO10993-5 and ISO10993-10.
Guidance and manufacturer’s declaration – electromagnetic
emissions-for all EQUIPMENT and SYSTEMS
Guidance and manufacturer’s declaration –electromagnetic
emission
The Pulse Oximeter is intended for use in the electromagnetic
environment specified below. The customer or the user of the Pulse
Oximeter should assure that it is used in such an environment.
Emission
test
Complian
ce
Electromagnetic environment –
guidance
RF
emissions
CISPR 11
Group 1
The Pulse Oximeter uses RF energy only
for its internal function. Therefore, its RF
emissions are very low and are not likely
to cause any interference in nearby
electronic equipment.
RF emission
CISPR 11
Class B
The Pulse Oximeter is suitable for use in
all establishments, including domestic
establishments and those directly
connected to the public low-voltage power
supply. network that supplies buildings
used for domestic purposes.
Possible Problems and resolutions
Problems
Possible reason
Solution
SPO2or PR
can not be
shown
normally
1. Finger is not inserted
correctly
2. User’s Oxyhemoglobin
value is too low to be
measured
1..Retry by inserting the finger
2. Try some more times, If you
can make sure no problem
is existing in the product.
Please go to a hospital
timely for exact diagnosis.
SPO2or PR
is shown
unstably
1. Finger might not be
inserted deep enough.
2. Finger is trembling or
1. Retry by inserting the finger
2. Try not to move
user’s body is in
movement status.
The
Oximeter
can not be
powered on
1. Power of batteries might
be inadequate or not be
there at all
2. Batteries might be installed
incorrectly
3. The Oximeter might be
damaged
1. Please replace batteries
2. Please reinstall the
batteries
3. Please contact with local
customer service centre
The screen
are suddenly
off
1. The product is
automatically powered off
when no signal is
detected longer than 8
seconds
2. Power quantity of the
batteries is started being
inadequate
1. Normal
2. Replace the batteries
There are no user-serviceable parts inside the oximeter. The
cover should only be removed by qualified service personnel.
If you are uncertain about the accuracy of any measurement, check the
user’s vital signs by alternate means; then make sure the oximeter is
functioning correctly.
Do not spray, pour, or spill any liquid on the oximeter, its accessories,
connectors, switches, or openings in the enclosure as this may damage the
oximeter.
Symbol Definitions
Symbol
Definition
CE Mark: The Product system conforms to essential
requirements of the Medical Device Directive
93/42/EEC.
Type BF equipment (Refer to IEC 60601-1:1995)
Attention, consult accompanying documents.
﹪SPO2
Oxygen saturation
/Min
Pulse rate
Symbol for the marking of electrical and electronics
devices according to Directive 200296/EC.
The device, accessories and the packaging have to
be disposed of waste correctly at the end of the
usage. Please follow Local Ordinances or Regulations
for disposal.
Note: The Oximeter is applied to this regulation.
Note：The illustration used in this manual may differ slightly from the
appearance of the actual product.
www.FaceLake.com
37 Sherwood Terrace, Unit 124,
Lake Bluff, IL 60044 USA
0482

Battery Installation
1. Put the two AAA batteries into battery compartment in correct polarities.
2. Push the battery cover horizontally along the arrow shown as below:
Notes:
Battery polarities should be correctly installed. Otherwise, damage may
be caused to the device.
Please put in or remove batteries inright order, or may cause damage to
the device bracket.
Please remove the batteries if the Oximeter will not be used for a long
time.
Strap Installation
1.Thread thinner end of the strap through the loop.
2. Thread thicker end of the strap through the threaded end before pulling
it tightly.
Maintenance and Storage
1. Replace the batteries in time when low voltage lamp is lighted.
2. Clean surface of the fingertip oximeter before it is used in diagnosis for
users.
3. Remove the batteries inside the battery cassette if the oximeter will not
be operated for a long time.
4. It is best to preserve the product in a place where ambient temperatures
is -10℃～50℃and relative humidity is 10%-95%.
5. It is recommended that the product should be kept in a dry environment
anytime.A wet ambient might affect its lifetime and even might damage
the product.
6. Avoid exposure or direct sunlight.
7. Avoid excessive radioactive infrared rays or ultraviolet rays.
8. Please follow the law of the local government to deal with used battery.
Technical Specification
1. Display Type:
Color OLED display, 4 display directions
2. SPO2:
Measurement range: 0%-100%
Resolution: 1%
Accuracy: 70%-100%, ±2%; 0%-69% no definition.
3. Pulse Rate:
Measure range：25BPM -250 BPM
Resolution: 1bpm,
Accuracy：2bpm
Pulse Intensity: Bargraph Indicator
4. Power Requirements:
Two AAA alkaline Batteries
Power consumption: 30mA(Normal)
Low power indication:
Battery Life: Two AAA 1.5V, 600mAh alkaline batteries could be
continuously operated as long as 24 hours.
5. Dimension:
Length: 64mm
Width: 35mm
Height: 34mm
Weight: 57g (including two AAA batteries)
6. Environment Requirements:
Operation Temperature: 5℃～40℃
Storage Temperature: -10℃～50℃
Ambient Humidity: 15%-80%, no condensation in operation.
10%-93%, no condensation in storage
7. Measurement Performance in Low Perfusion Condition:0.3%.
Declaration
EMC of this product complies with IEC60601-1-2 standard.
The materials which the user can come into contact have no toxicity and no
action on tissues comply with ISO10993-1, ISO10993-5 and ISO10993-10.
Guidance and manufacturer’s declaration – electromagnetic
emissions-for all EQUIPMENT and SYSTEMS
Guidance and manufacturer’s declaration –electromagnetic
emission
The Pulse Oximeter is intended for use in the electromagnetic
environment specified below. The customer or the user of the Pulse
Oximeter should assure that it is used in such an environment.
Emission
test
Complian
ce
Electromagnetic environment –
guidance
RF
emissions
CISPR 11
Group 1
The Pulse Oximeter uses RF energy only
for its internal function. Therefore, its RF
emissions are very low and are not likely
to cause any interference in nearby
electronic equipment.
RF emission
CISPR 11
Class B
The Pulse Oximeter is suitable for use in
all establishments, including domestic
establishments and those directly
connected to the public low-voltage power
supply. network that supplies buildings
used for domestic purposes.
Possible Problems and resolutions
Problems
Possible reason
Solution
SPO2or PR
can not be
shown
normally
1. Finger is not inserted
correctly
2. User’s Oxyhemoglobin
value is too low to be
measured
1..Retry by inserting the finger
2. Try some more times, If you
can make sure no problem
is existing in the product.
Please go to a hospital
timely for exact diagnosis.
SPO2or PR
is shown
unstably
1. Finger might not be
inserted deep enough.
2. Finger is trembling or
1. Retry by inserting the finger
2. Try not to move
user’s body is in
movement status.
The
Oximeter
can not be
powered on
1. Power of batteries might
be inadequate or not be
there at all
2. Batteries might be installed
incorrectly
3. The Oximeter might be
damaged
1. Please replace batteries
2. Please reinstall the
batteries
3. Please contact with local
customer service centre
The screen
are suddenly
off
1. The product is
automatically powered off
when no signal is
detected longer than 8
seconds
2. Power quantity of the
batteries is started being
inadequate
1. Normal
2. Replace the batteries
There are no user-serviceable parts inside the oximeter. The
cover should only be removed by qualified service personnel.
If you are uncertain about the accuracy of any measurement, check the
user’s vital signs by alternate means; then make sure the oximeter is
functioning correctly.
Do not spray, pour, or spill any liquid on the oximeter, its accessories,
connectors, switches, or openings in the enclosure as this may damage the
oximeter.
Symbol Definitions
Symbol
Definition
CE Mark: The Product system conforms to essential
requirements of the Medical Device Directive
93/42/EEC.
Type BF equipment (Refer to IEC 60601-1:1995)
Attention, consult accompanying documents.
﹪SPO2
Oxygen saturation
/Min
Pulse rate
Symbol for the marking of electrical and electronics
devices according to Directive 200296/EC.
The device, accessories and the packaging have to
be disposed of waste correctly at the end of the
usage. Please follow Local Ordinances or Regulations
for disposal.
Note: The Oximeter is applied to this regulation.
Note：The illustration used in this manual may differ slightly from the
appearance of the actual product.
www.FaceLake.com
37 Sherwood Terrace, Unit 124,
Lake Bluff, IL 60044 USA
0482