Konsung SONOSAT-F01T User manual

Fingertip Pulse Oximeter
User Manual
Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd
Jiangsu Konsung Bio-Medical Science And Technology
Co., Ltd
NO.8, Shengchang West Road, Danyang
Development Zone, Jiangsu Province, 212300,
P.R. China
Tel: [phone]
WhatsApp:[phone]
E-mail: info@ konsung.com
Website: www.konsungmedical.com
Shanghai International Holding Corp. GmbH
(Europe)
Eiffestrasse 80, 20537 Hamburg Germany
Tel: [phone] Fax: [phone]
E-mail: [e-mail]
Statement
Thanks for your purchasing Fingertip oximeter of Jiangsu Konsung Bio-
Medical Science And Technology Co., Ltd. (hereinafter called Konsung).
Before using this oximeter, please read this manual carefully for
understanding the operation and maintenance of the oximeter.
Konsung holds the rights to modify, update, and ultimately explain this
manual.
Konsung owns the copyrights of this manual. Without prior written
consent of Konsung, any materials contained in this manual shall not be
photocopied, reproduced or translated into other languages.
Materials protected by the copyright law, including but not limited to
confidential information such as technical information and patent
information are contained in this manual, the user shall not disclose such
information to any irrelevant third party.
This manual will help you understand the operation and maintenance of
the product better. It is reminded that the product shall be used strictly
complying with this manual. User‘s operation failing to comply with this
manual may result in malfunction or accident for which Konsung cannot
be held liable.
Fingertip Pulse Oximeter is Class 1 LEDs product. It must be serviced by
specified trained personnel.
Responsibility of the Manufacturer
Konsung only considers itself responsible for any effect on safety,
reliability and performance of the equipment if:
Assembly operations, extensions, re-adjustments, modifications or
repairs are carried out by persons authorized by Konsung, and
The electrical installation of the relevant room complies with national
standards, and
The instrument is used in accordance with the instructions for use.
Upon request, Konsung may provide, with compensation, necessary
circuit diagrams, and other information to help qualified technician to
maintain and repair some parts, which Konsung may define as user
serviceable.
Chapter 1 Safety
1.1 Safety Information
The user should pay attention to and abide by the basic safety
information which was referred to in this chapter.
WARNING
AWARNING label advises against certain actions or situations
that could result in personal injury or death.
CAUTION
ACAUTION label advises against actions or situations that
could damage equipment, produce inaccurate data, or
invalidate a procedure.
NOTE
ANOTE provides useful information regarding a function or a
procedure.
WARNING
1 This device is not intended for treatment.
2 Carefully read this manual about all safety information, operation
and specifications before using this oximeter.
3 Do not open the shell of the instrument. Otherwise you may
damage the instrument. All servicing and future upgrades must be
carried out by the personnel trained and authorized by our company
only.
4 Do not use this device with the defibrillator or other high-frequency
equipment.
5 Explosion hazard: Do not use this device in an explosive atmosphere.
6 Check and change the applied site according to the different
circumstances of the user while using this device for long-time
continuous monitoring. It is recommended to check the finger after
2 hours. Change other finger to be measured if the finger seems to
be unusual. If the oximeter is too tight because the application site
is too large or becomes too large due to edema, excessive pressure
for prolonged periods may result in venous congestion distal from
the application site, leading to interstitial edema and tissue
ischemia.
7 The measuring data displayed on the device are for reference only
and cannot be directly used for diagnostic interpretation.
8 This device is not intended to use of infant and neonate.
9 In some circumstances, the device may interpret motion as good
pulse quality. Minimize patient motion as much as possible.
10 The presence of high ambient light may cause inaccurate SpO2
measurements.
11 Charge this device only by connecting it to a designated device
compliant with IEC60601-1 requirements of electrical safety and
ensure the designated device’s voltage and current meet the
requirements of this Manual.
12 Do not connect it to any external device or operate it for
measurement when this device is being charged.
13 Do not use this device in situations where alarms required. The
oximeter does not support alarms.
14 Users who are allergic to rubber cannot use this product.
15 Disposal of this device and its accessories and packaging (plastic
bags, foam and cartons, etc.) are subject to local laws and
regulations.
CAUTION
1 To ensure patient safety, use only parts and accessories specified in
this manual.
2 Keep the operating environment clean, no vibration, no corrosion
or combustible material and avoid too high or too low temperature
and humidity.
3 Do not use this device near by the source of electromagnetic
interference, such as mobile phones or radio transmitter.
4 Do not spill liquid on the device. Do not immerse the device in
liquid.
5 Always install or carry the device properly to avoid damage caused
by drop, impact, strong vibration or other mechanical force.
6 Do not use this device if the device cannot achieve satisfactory
results.
NOTE
1 Too cold or too thin finger may affect the measurements; thicker
finger (recommended thumb or middle finger) should insert into the
cover fully.
2 Avoid placing the sensor on extremities with an arterial catheter, or
intravascular venous infusion line.
3 Check the device before using. Do not use it if there is significant
damage.
4 Do not use the functional tester to access the SpO2accuracy.
5 This device is calibrated to display functional oxygen saturation.
6 The pictures and interfaces in this manual are for reference only.
7 This Manual is prepared based on the most complete configuration.
Some configurations and functions may be not available in your
device.
8 Fingernail polish or false fingernails may cause inaccurate SpO2
readings.
1.2 Symbols
Symbols
Definition of symbols
Follow instructions for use
Caution
No alarm
Type BF Applied Part
Battery indication
SpO2
Oxygen saturation of arterial hemoglobin
PR
Pulse Rate
The symbol indicates that the device should be
sent to the special agencies according to local
regulations for separate collection after its useful
life.
The symbol indicates that the device complies with
the European Council Directive 93/42/EEC
concerning medical devices.
Authorized representative in the European
community
Serial Number
P/N
Part Number
Batch number
Manufacturer
Date of manufacture
IP22
2 degree Protection Against Ingress of Liquids and
dust.
Chapter 2 General
2.1 Introduction
Sonosat F fingertip pulse oximeter using spectrophotometry, by
detecting the blood red and infrared absorption of light to obtain
the oxygen saturation (SpO2) and pulse rate (PR).
Oxygen saturation is a term referring to the fraction of oxygen-
saturated hemoglobin (HbO2) relative to total hemoglobin(Hb) in the
blood, that is, the oxygen saturation in the blood, which is an
important physiological parameter of the respiratory and circulatory
system. Many respiratory diseases can cause oxygen saturation
decrease. The body's automatic regulatory dysfunction caused by
anesthesia, major surgery trauma, and injury caused by some
medical examination etc., are likely to lead to the oxygen saturation
decrease, resulting in patients with dizziness, weakness, vomiting
and other symptoms; severe cases will be life-threatening. SpO2 has
important significance in the field of clinical medical. And timely
understanding of the patient's blood oxygen saturation situation will
help physician find problems.
This device is not suitable for continuous monitoring of patients.
2.2 Intended Use and Contraindication
Intended use: The fingertip pulse oximeter is intended to measure the
pulse oxygen saturation of arterial hemoglobin and pulse rate of adults
and pediatrics in home care and medical outpatient environment.
Contraindication: none
2.3 Applications
This device is suitable for the following people: People with
vascular disease, such as: coronary heart disease, hypertension,
hyperlipidemia, cerebral thrombosis;
People with respiratory diseases, such as: asthma, trachitis,
chronic bronchitis, chronic cor pulmonale, chronic obstructive
pulmonary disease;
Old people above 60 years old
People who works more than 12 hours a day;
People works on extreme exercise or under the alpine hypoxic
environment;
Long-term alcohol people.
2.4 Appearance
2.4.1 Front view
1. Battery capacity Indicator
Full capacity, the middle part indicates the
capacity.
Capacity is seriously empty, charge it
immediately.
2. Power On/Off switch
Turn on the oximeter: Press the ON/OFF button to
turn on the device.
Turn off the oximeter: Press this button for 2 seconds
to turn the device off.
Press this button to highlight the display when the
display is in low brightness.
3. Display screen
4. SpO2value
5. PR value: Pulse rate per minute.
6. Bluetooth icon
on: means connected to Bluetooth device
off: means disconnected to Bluetooth device
7. Heart symbol
8. Pulse rate bar graph
2.4.2 Side view
1. Micro USB connector: charging battery with specified
charging cable connected to adaptor.
2. Rubber finger cover
Chapter 3 Unpacking and Storage
3.1 Open-case inspection
Before unpacking, examine the packing case carefully for
signs of damage. If any damage is detected, contact the
carrier or us. Take out all bulk packaging from the carton. If
the packing case is intact, open the package and remove the
equipment and accessories carefully.
Check whether there is any damage to the surface of the
oximeter such as notches, dents, abrasions and so on. Check
whether the components are missing according to packing
list.
3.2 Storage
The oximeter is manufactured with precision parts. Do not
place the oximeter in the following places:
Easy to splash;
With Direct sunlight, high temperature, humidity, dust,
and corrosive gas;
Tilt, generate vibration and impact;
Store chemicals or corrosive gases.
Chapter 4 Measurement operation
1. Insert finger to oximeter's cover fully to obtain good
measurements.
2. Press the ON/OFF button to turn the oximeter on.
3. SpO2and pulse rate value displays on screen.
NOTE:
1 The oximeter cannot be measured while charging.
2 Finger can not apply nail polish and other cosmetics.
3 Do not shake the finger, hand or body during the measuring.
4 Tape or other light obstructions around the applied site may
affect the accuracy of SpO2and pulse rate.
5 The oximeter will shut down if no any actions within 10
seconds after it turning on.
The following factors may influence the accuracy of measurement:
Ambient light
Physical movement (passive and imposed motion)
Diagnostic testing
Low perfusion
Electromagnetic interference, such as MRI environment
Electrosurgical units
Dysfunctional haemoglobin, such as carboxyhemoglobin
(COHb)and methemoglobin (MetHb)
Presence of certain dyes, such as methylene and indigo
carmine
Inappropriate positioning of the SpO2sensor, or use of
incorrect SpO2sensor.
Drop of arterial blood flow to immeasurable level caused by
shock, anemia, low temperature or vasoconstrictor.
Chapter 5 Charging Battery
The oximeter uses a built-in non-removable rechargeable
lithium battery. Symbol will flash when battery capacity is
low. Charge the battery according to the following steps.
1. Take out the cable and connect it to oximeter's Micro USB
connector.
2. Plug the other end of cable to USB adaptor. Battery
symbol appear and flashes on the screen while charging.
The performance of the rechargeable lithium battery may
deteriorate over time. If the operating time of the battery is
noticeably shorter than that stated in the specifications,
contact your service personnel.
Follow the appropriate local regulations and do not dispose of
oximeter (includes battery).
1
2
4
5
8
6
7
3
1
2
4
5
8
6
7
3
1
2

Fingertip Pulse Oximeter
User Manual
Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd
Jiangsu Konsung Bio-Medical Science And Technology
Co., Ltd
NO.8, Shengchang West Road, Danyang
Development Zone, Jiangsu Province, 212300,
P.R. China
Tel: [phone]
WhatsApp:[phone]
E-mail: info@ konsung.com
Website: www.konsungmedical.com
Shanghai International Holding Corp. GmbH
(Europe)
Eiffestrasse 80, 20537 Hamburg Germany
Tel: [phone] Fax: [phone]
E-mail: [e-mail]
Statement
Thanks for your purchasing Fingertip oximeter of Jiangsu Konsung Bio-
Medical Science And Technology Co., Ltd. (hereinafter called Konsung).
Before using this oximeter, please read this manual carefully for
understanding the operation and maintenance of the oximeter.
Konsung holds the rights to modify, update, and ultimately explain this
manual.
Konsung owns the copyrights of this manual. Without prior written
consent of Konsung, any materials contained in this manual shall not be
photocopied, reproduced or translated into other languages.
Materials protected by the copyright law, including but not limited to
confidential information such as technical information and patent
information are contained in this manual, the user shall not disclose such
information to any irrelevant third party.
This manual will help you understand the operation and maintenance of
the product better. It is reminded that the product shall be used strictly
complying with this manual. User‘s operation failing to comply with this
manual may result in malfunction or accident for which Konsung cannot
be held liable.
Fingertip Pulse Oximeter is Class 1 LEDs product. It must be serviced by
specified trained personnel.
Responsibility of the Manufacturer
Konsung only considers itself responsible for any effect on safety,
reliability and performance of the equipment if:
Assembly operations, extensions, re-adjustments, modifications or
repairs are carried out by persons authorized by Konsung, and
The electrical installation of the relevant room complies with national
standards, and
The instrument is used in accordance with the instructions for use.
Upon request, Konsung may provide, with compensation, necessary
circuit diagrams, and other information to help qualified technician to
maintain and repair some parts, which Konsung may define as user
serviceable.
Chapter 1 Safety
1.1 Safety Information
The user should pay attention to and abide by the basic safety
information which was referred to in this chapter.
WARNING
AWARNING label advises against certain actions or situations
that could result in personal injury or death.
CAUTION
ACAUTION label advises against actions or situations that
could damage equipment, produce inaccurate data, or
invalidate a procedure.
NOTE
ANOTE provides useful information regarding a function or a
procedure.
WARNING
1 This device is not intended for treatment.
2 Carefully read this manual about all safety information, operation
and specifications before using this oximeter.
3 Do not open the shell of the instrument. Otherwise you may
damage the instrument. All servicing and future upgrades must be
carried out by the personnel trained and authorized by our company
only.
4 Do not use this device with the defibrillator or other high-frequency
equipment.
5 Explosion hazard: Do not use this device in an explosive atmosphere.
6 Check and change the applied site according to the different
circumstances of the user while using this device for long-time
continuous monitoring. It is recommended to check the finger after
2 hours. Change other finger to be measured if the finger seems to
be unusual. If the oximeter is too tight because the application site
is too large or becomes too large due to edema, excessive pressure
for prolonged periods may result in venous congestion distal from
the application site, leading to interstitial edema and tissue
ischemia.
7 The measuring data displayed on the device are for reference only
and cannot be directly used for diagnostic interpretation.
8 This device is not intended to use of infant and neonate.
9 In some circumstances, the device may interpret motion as good
pulse quality. Minimize patient motion as much as possible.
10 The presence of high ambient light may cause inaccurate SpO2
measurements.
11 Charge this device only by connecting it to a designated device
compliant with IEC60601-1 requirements of electrical safety and
ensure the designated device’s voltage and current meet the
requirements of this Manual.
12 Do not connect it to any external device or operate it for
measurement when this device is being charged.
13 Do not use this device in situations where alarms required. The
oximeter does not support alarms.
14 Users who are allergic to rubber cannot use this product.
15 Disposal of this device and its accessories and packaging (plastic
bags, foam and cartons, etc.) are subject to local laws and
regulations.
CAUTION
1 To ensure patient safety, use only parts and accessories specified in
this manual.
2 Keep the operating environment clean, no vibration, no corrosion
or combustible material and avoid too high or too low temperature
and humidity.
3 Do not use this device near by the source of electromagnetic
interference, such as mobile phones or radio transmitter.
4 Do not spill liquid on the device. Do not immerse the device in
liquid.
5 Always install or carry the device properly to avoid damage caused
by drop, impact, strong vibration or other mechanical force.
6 Do not use this device if the device cannot achieve satisfactory
results.
NOTE
1 Too cold or too thin finger may affect the measurements; thicker
finger (recommended thumb or middle finger) should insert into the
cover fully.
2 Avoid placing the sensor on extremities with an arterial catheter, or
intravascular venous infusion line.
3 Check the device before using. Do not use it if there is significant
damage.
4 Do not use the functional tester to access the SpO2accuracy.
5 This device is calibrated to display functional oxygen saturation.
6 The pictures and interfaces in this manual are for reference only.
7 This Manual is prepared based on the most complete configuration.
Some configurations and functions may be not available in your
device.
8 Fingernail polish or false fingernails may cause inaccurate SpO2
readings.
1.2 Symbols
Symbols
Definition of symbols
Follow instructions for use
Caution
No alarm
Type BF Applied Part
Battery indication
SpO2
Oxygen saturation of arterial hemoglobin
PR
Pulse Rate
The symbol indicates that the device should be
sent to the special agencies according to local
regulations for separate collection after its useful
life.
The symbol indicates that the device complies with
the European Council Directive 93/42/EEC
concerning medical devices.
Authorized representative in the European
community
Serial Number
P/N
Part Number
Batch number
Manufacturer
Date of manufacture
IP22
2 degree Protection Against Ingress of Liquids and
dust.
Chapter 2 General
2.1 Introduction
Sonosat F fingertip pulse oximeter using spectrophotometry, by
detecting the blood red and infrared absorption of light to obtain
the oxygen saturation (SpO2) and pulse rate (PR).
Oxygen saturation is a term referring to the fraction of oxygen-
saturated hemoglobin (HbO2) relative to total hemoglobin(Hb) in the
blood, that is, the oxygen saturation in the blood, which is an
important physiological parameter of the respiratory and circulatory
system. Many respiratory diseases can cause oxygen saturation
decrease. The body's automatic regulatory dysfunction caused by
anesthesia, major surgery trauma, and injury caused by some
medical examination etc., are likely to lead to the oxygen saturation
decrease, resulting in patients with dizziness, weakness, vomiting
and other symptoms; severe cases will be life-threatening. SpO2 has
important significance in the field of clinical medical. And timely
understanding of the patient's blood oxygen saturation situation will
help physician find problems.
This device is not suitable for continuous monitoring of patients.
2.2 Intended Use and Contraindication
Intended use: The fingertip pulse oximeter is intended to measure the
pulse oxygen saturation of arterial hemoglobin and pulse rate of adults
and pediatrics in home care and medical outpatient environment.
Contraindication: none
2.3 Applications
This device is suitable for the following people: People with
vascular disease, such as: coronary heart disease, hypertension,
hyperlipidemia, cerebral thrombosis;
People with respiratory diseases, such as: asthma, trachitis,
chronic bronchitis, chronic cor pulmonale, chronic obstructive
pulmonary disease;
Old people above 60 years old
People who works more than 12 hours a day;
People works on extreme exercise or under the alpine hypoxic
environment;
Long-term alcohol people.
2.4 Appearance
2.4.1 Front view
1. Battery capacity Indicator
Full capacity, the middle part indicates the
capacity.
Capacity is seriously empty, charge it
immediately.
2. Power On/Off switch
Turn on the oximeter: Press the ON/OFF button to
turn on the device.
Turn off the oximeter: Press this button for 2 seconds
to turn the device off.
Press this button to highlight the display when the
display is in low brightness.
3. Display screen
4. SpO2value
5. PR value: Pulse rate per minute.
6. Bluetooth icon
on: means connected to Bluetooth device
off: means disconnected to Bluetooth device
7. Heart symbol
8. Pulse rate bar graph
2.4.2 Side view
1. Micro USB connector: charging battery with specified
charging cable connected to adaptor.
2. Rubber finger cover
Chapter 3 Unpacking and Storage
3.1 Open-case inspection
Before unpacking, examine the packing case carefully for
signs of damage. If any damage is detected, contact the
carrier or us. Take out all bulk packaging from the carton. If
the packing case is intact, open the package and remove the
equipment and accessories carefully.
Check whether there is any damage to the surface of the
oximeter such as notches, dents, abrasions and so on. Check
whether the components are missing according to packing
list.
3.2 Storage
The oximeter is manufactured with precision parts. Do not
place the oximeter in the following places:
Easy to splash;
With Direct sunlight, high temperature, humidity, dust,
and corrosive gas;
Tilt, generate vibration and impact;
Store chemicals or corrosive gases.
Chapter 4 Measurement operation
1. Insert finger to oximeter's cover fully to obtain good
measurements.
2. Press the ON/OFF button to turn the oximeter on.
3. SpO2and pulse rate value displays on screen.
NOTE:
1 The oximeter cannot be measured while charging.
2 Finger can not apply nail polish and other cosmetics.
3 Do not shake the finger, hand or body during the measuring.
4 Tape or other light obstructions around the applied site may
affect the accuracy of SpO2and pulse rate.
5 The oximeter will shut down if no any actions within 10
seconds after it turning on.
The following factors may influence the accuracy of measurement:
Ambient light
Physical movement (passive and imposed motion)
Diagnostic testing
Low perfusion
Electromagnetic interference, such as MRI environment
Electrosurgical units
Dysfunctional haemoglobin, such as carboxyhemoglobin
(COHb)and methemoglobin (MetHb)
Presence of certain dyes, such as methylene and indigo
carmine
Inappropriate positioning of the SpO2sensor, or use of
incorrect SpO2sensor.
Drop of arterial blood flow to immeasurable level caused by
shock, anemia, low temperature or vasoconstrictor.
Chapter 5 Charging Battery
The oximeter uses a built-in non-removable rechargeable
lithium battery. Symbol will flash when battery capacity is
low. Charge the battery according to the following steps.
1. Take out the cable and connect it to oximeter's Micro USB
connector.
2. Plug the other end of cable to USB adaptor. Battery
symbol appear and flashes on the screen while charging.
The performance of the rechargeable lithium battery may
deteriorate over time. If the operating time of the battery is
noticeably shorter than that stated in the specifications,
contact your service personnel.
Follow the appropriate local regulations and do not dispose of
oximeter (includes battery).
1
2
4
5
8
6
7
3
1
2
4
5
8
6
7
3
1
2

Fingertip Pulse Oximeter
User Manual
Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd
Jiangsu Konsung Bio-Medical Science And Technology
Co., Ltd
NO.8, Shengchang West Road, Danyang
Development Zone, Jiangsu Province, 212300,
P.R. China
Tel: [phone]
WhatsApp:[phone]
E-mail: info@ konsung.com
Website: www.konsungmedical.com
Shanghai International Holding Corp. GmbH
(Europe)
Eiffestrasse 80, 20537 Hamburg Germany
Tel: [phone] Fax: [phone]
E-mail: [e-mail]
Statement
Thanks for your purchasing Fingertip oximeter of Jiangsu Konsung Bio-
Medical Science And Technology Co., Ltd. (hereinafter called Konsung).
Before using this oximeter, please read this manual carefully for
understanding the operation and maintenance of the oximeter.
Konsung holds the rights to modify, update, and ultimately explain this
manual.
Konsung owns the copyrights of this manual. Without prior written
consent of Konsung, any materials contained in this manual shall not be
photocopied, reproduced or translated into other languages.
Materials protected by the copyright law, including but not limited to
confidential information such as technical information and patent
information are contained in this manual, the user shall not disclose such
information to any irrelevant third party.
This manual will help you understand the operation and maintenance of
the product better. It is reminded that the product shall be used strictly
complying with this manual. User‘s operation failing to comply with this
manual may result in malfunction or accident for which Konsung cannot
be held liable.
Fingertip Pulse Oximeter is Class 1 LEDs product. It must be serviced by
specified trained personnel.
Responsibility of the Manufacturer
Konsung only considers itself responsible for any effect on safety,
reliability and performance of the equipment if:
Assembly operations, extensions, re-adjustments, modifications or
repairs are carried out by persons authorized by Konsung, and
The electrical installation of the relevant room complies with national
standards, and
The instrument is used in accordance with the instructions for use.
Upon request, Konsung may provide, with compensation, necessary
circuit diagrams, and other information to help qualified technician to
maintain and repair some parts, which Konsung may define as user
serviceable.
Chapter 1 Safety
1.1 Safety Information
The user should pay attention to and abide by the basic safety
information which was referred to in this chapter.
WARNING
AWARNING label advises against certain actions or situations
that could result in personal injury or death.
CAUTION
ACAUTION label advises against actions or situations that
could damage equipment, produce inaccurate data, or
invalidate a procedure.
NOTE
ANOTE provides useful information regarding a function or a
procedure.
WARNING
1 This device is not intended for treatment.
2 Carefully read this manual about all safety information, operation
and specifications before using this oximeter.
3 Do not open the shell of the instrument. Otherwise you may
damage the instrument. All servicing and future upgrades must be
carried out by the personnel trained and authorized by our company
only.
4 Do not use this device with the defibrillator or other high-frequency
equipment.
5 Explosion hazard: Do not use this device in an explosive atmosphere.
6 Check and change the applied site according to the different
circumstances of the user while using this device for long-time
continuous monitoring. It is recommended to check the finger after
2 hours. Change other finger to be measured if the finger seems to
be unusual. If the oximeter is too tight because the application site
is too large or becomes too large due to edema, excessive pressure
for prolonged periods may result in venous congestion distal from
the application site, leading to interstitial edema and tissue
ischemia.
7 The measuring data displayed on the device are for reference only
and cannot be directly used for diagnostic interpretation.
8 This device is not intended to use of infant and neonate.
9 In some circumstances, the device may interpret motion as good
pulse quality. Minimize patient motion as much as possible.
10 The presence of high ambient light may cause inaccurate SpO2
measurements.
11 Charge this device only by connecting it to a designated device
compliant with IEC60601-1 requirements of electrical safety and
ensure the designated device’s voltage and current meet the
requirements of this Manual.
12 Do not connect it to any external device or operate it for
measurement when this device is being charged.
13 Do not use this device in situations where alarms required. The
oximeter does not support alarms.
14 Users who are allergic to rubber cannot use this product.
15 Disposal of this device and its accessories and packaging (plastic
bags, foam and cartons, etc.) are subject to local laws and
regulations.
CAUTION
1 To ensure patient safety, use only parts and accessories specified in
this manual.
2 Keep the operating environment clean, no vibration, no corrosion
or combustible material and avoid too high or too low temperature
and humidity.
3 Do not use this device near by the source of electromagnetic
interference, such as mobile phones or radio transmitter.
4 Do not spill liquid on the device. Do not immerse the device in
liquid.
5 Always install or carry the device properly to avoid damage caused
by drop, impact, strong vibration or other mechanical force.
6 Do not use this device if the device cannot achieve satisfactory
results.
NOTE
1 Too cold or too thin finger may affect the measurements; thicker
finger (recommended thumb or middle finger) should insert into the
cover fully.
2 Avoid placing the sensor on extremities with an arterial catheter, or
intravascular venous infusion line.
3 Check the device before using. Do not use it if there is significant
damage.
4 Do not use the functional tester to access the SpO2accuracy.
5 This device is calibrated to display functional oxygen saturation.
6 The pictures and interfaces in this manual are for reference only.
7 This Manual is prepared based on the most complete configuration.
Some configurations and functions may be not available in your
device.
8 Fingernail polish or false fingernails may cause inaccurate SpO2
readings.
1.2 Symbols
Symbols
Definition of symbols
Follow instructions for use
Caution
No alarm
Type BF Applied Part
Battery indication
SpO2
Oxygen saturation of arterial hemoglobin
PR
Pulse Rate
The symbol indicates that the device should be
sent to the special agencies according to local
regulations for separate collection after its useful
life.
The symbol indicates that the device complies with
the European Council Directive 93/42/EEC
concerning medical devices.
Authorized representative in the European
community
Serial Number
P/N
Part Number
Batch number
Manufacturer
Date of manufacture
IP22
2 degree Protection Against Ingress of Liquids and
dust.
Chapter 2 General
2.1 Introduction
Sonosat F fingertip pulse oximeter using spectrophotometry, by
detecting the blood red and infrared absorption of light to obtain
the oxygen saturation (SpO2) and pulse rate (PR).
Oxygen saturation is a term referring to the fraction of oxygen-
saturated hemoglobin (HbO2) relative to total hemoglobin(Hb) in the
blood, that is, the oxygen saturation in the blood, which is an
important physiological parameter of the respiratory and circulatory
system. Many respiratory diseases can cause oxygen saturation
decrease. The body's automatic regulatory dysfunction caused by
anesthesia, major surgery trauma, and injury caused by some
medical examination etc., are likely to lead to the oxygen saturation
decrease, resulting in patients with dizziness, weakness, vomiting
and other symptoms; severe cases will be life-threatening. SpO2 has
important significance in the field of clinical medical. And timely
understanding of the patient's blood oxygen saturation situation will
help physician find problems.
This device is not suitable for continuous monitoring of patients.
2.2 Intended Use and Contraindication
Intended use: The fingertip pulse oximeter is intended to measure the
pulse oxygen saturation of arterial hemoglobin and pulse rate of adults
and pediatrics in home care and medical outpatient environment.
Contraindication: none
2.3 Applications
This device is suitable for the following people: People with
vascular disease, such as: coronary heart disease, hypertension,
hyperlipidemia, cerebral thrombosis;
People with respiratory diseases, such as: asthma, trachitis,
chronic bronchitis, chronic cor pulmonale, chronic obstructive
pulmonary disease;
Old people above 60 years old
People who works more than 12 hours a day;
People works on extreme exercise or under the alpine hypoxic
environment;
Long-term alcohol people.
2.4 Appearance
2.4.1 Front view
1. Battery capacity Indicator
Full capacity, the middle part indicates the
capacity.
Capacity is seriously empty, charge it
immediately.
2. Power On/Off switch
Turn on the oximeter: Press the ON/OFF button to
turn on the device.
Turn off the oximeter: Press this button for 2 seconds
to turn the device off.
Press this button to highlight the display when the
display is in low brightness.
3. Display screen
4. SpO2value
5. PR value: Pulse rate per minute.
6. Bluetooth icon
on: means connected to Bluetooth device
off: means disconnected to Bluetooth device
7. Heart symbol
8. Pulse rate bar graph
2.4.2 Side view
1. Micro USB connector: charging battery with specified
charging cable connected to adaptor.
2. Rubber finger cover
Chapter 3 Unpacking and Storage
3.1 Open-case inspection
Before unpacking, examine the packing case carefully for
signs of damage. If any damage is detected, contact the
carrier or us. Take out all bulk packaging from the carton. If
the packing case is intact, open the package and remove the
equipment and accessories carefully.
Check whether there is any damage to the surface of the
oximeter such as notches, dents, abrasions and so on. Check
whether the components are missing according to packing
list.
3.2 Storage
The oximeter is manufactured with precision parts. Do not
place the oximeter in the following places:
Easy to splash;
With Direct sunlight, high temperature, humidity, dust,
and corrosive gas;
Tilt, generate vibration and impact;
Store chemicals or corrosive gases.
Chapter 4 Measurement operation
1. Insert finger to oximeter's cover fully to obtain good
measurements.
2. Press the ON/OFF button to turn the oximeter on.
3. SpO2and pulse rate value displays on screen.
NOTE:
1 The oximeter cannot be measured while charging.
2 Finger can not apply nail polish and other cosmetics.
3 Do not shake the finger, hand or body during the measuring.
4 Tape or other light obstructions around the applied site may
affect the accuracy of SpO2and pulse rate.
5 The oximeter will shut down if no any actions within 10
seconds after it turning on.
The following factors may influence the accuracy of measurement:
Ambient light
Physical movement (passive and imposed motion)
Diagnostic testing
Low perfusion
Electromagnetic interference, such as MRI environment
Electrosurgical units
Dysfunctional haemoglobin, such as carboxyhemoglobin
(COHb)and methemoglobin (MetHb)
Presence of certain dyes, such as methylene and indigo
carmine
Inappropriate positioning of the SpO2sensor, or use of
incorrect SpO2sensor.
Drop of arterial blood flow to immeasurable level caused by
shock, anemia, low temperature or vasoconstrictor.
Chapter 5 Charging Battery
The oximeter uses a built-in non-removable rechargeable
lithium battery. Symbol will flash when battery capacity is
low. Charge the battery according to the following steps.
1. Take out the cable and connect it to oximeter's Micro USB
connector.
2. Plug the other end of cable to USB adaptor. Battery
symbol appear and flashes on the screen while charging.
The performance of the rechargeable lithium battery may
deteriorate over time. If the operating time of the battery is
noticeably shorter than that stated in the specifications,
contact your service personnel.
Follow the appropriate local regulations and do not dispose of
oximeter (includes battery).
1
2
4
5
8
6
7
3
1
2
4
5
8
6
7
3
1
2

Fingertip Pulse Oximeter
User Manual
Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd
Jiangsu Konsung Bio-Medical Science And Technology
Co., Ltd
NO.8, Shengchang West Road, Danyang
Development Zone, Jiangsu Province, 212300,
P.R. China
Tel: [phone]
WhatsApp:[phone]
E-mail: info@ konsung.com
Website: www.konsungmedical.com
Shanghai International Holding Corp. GmbH
(Europe)
Eiffestrasse 80, 20537 Hamburg Germany
Tel: [phone] Fax: [phone]
E-mail: [e-mail]
Statement
Thanks for your purchasing Fingertip oximeter of Jiangsu Konsung Bio-
Medical Science And Technology Co., Ltd. (hereinafter called Konsung).
Before using this oximeter, please read this manual carefully for
understanding the operation and maintenance of the oximeter.
Konsung holds the rights to modify, update, and ultimately explain this
manual.
Konsung owns the copyrights of this manual. Without prior written
consent of Konsung, any materials contained in this manual shall not be
photocopied, reproduced or translated into other languages.
Materials protected by the copyright law, including but not limited to
confidential information such as technical information and patent
information are contained in this manual, the user shall not disclose such
information to any irrelevant third party.
This manual will help you understand the operation and maintenance of
the product better. It is reminded that the product shall be used strictly
complying with this manual. User‘s operation failing to comply with this
manual may result in malfunction or accident for which Konsung cannot
be held liable.
Fingertip Pulse Oximeter is Class 1 LEDs product. It must be serviced by
specified trained personnel.
Responsibility of the Manufacturer
Konsung only considers itself responsible for any effect on safety,
reliability and performance of the equipment if:
Assembly operations, extensions, re-adjustments, modifications or
repairs are carried out by persons authorized by Konsung, and
The electrical installation of the relevant room complies with national
standards, and
The instrument is used in accordance with the instructions for use.
Upon request, Konsung may provide, with compensation, necessary
circuit diagrams, and other information to help qualified technician to
maintain and repair some parts, which Konsung may define as user
serviceable.
Chapter 1 Safety
1.1 Safety Information
The user should pay attention to and abide by the basic safety
information which was referred to in this chapter.
WARNING
AWARNING label advises against certain actions or situations
that could result in personal injury or death.
CAUTION
ACAUTION label advises against actions or situations that
could damage equipment, produce inaccurate data, or
invalidate a procedure.
NOTE
ANOTE provides useful information regarding a function or a
procedure.
WARNING
1 This device is not intended for treatment.
2 Carefully read this manual about all safety information, operation
and specifications before using this oximeter.
3 Do not open the shell of the instrument. Otherwise you may
damage the instrument. All servicing and future upgrades must be
carried out by the personnel trained and authorized by our company
only.
4 Do not use this device with the defibrillator or other high-frequency
equipment.
5 Explosion hazard: Do not use this device in an explosive atmosphere.
6 Check and change the applied site according to the different
circumstances of the user while using this device for long-time
continuous monitoring. It is recommended to check the finger after
2 hours. Change other finger to be measured if the finger seems to
be unusual. If the oximeter is too tight because the application site
is too large or becomes too large due to edema, excessive pressure
for prolonged periods may result in venous congestion distal from
the application site, leading to interstitial edema and tissue
ischemia.
7 The measuring data displayed on the device are for reference only
and cannot be directly used for diagnostic interpretation.
8 This device is not intended to use of infant and neonate.
9 In some circumstances, the device may interpret motion as good
pulse quality. Minimize patient motion as much as possible.
10 The presence of high ambient light may cause inaccurate SpO2
measurements.
11 Charge this device only by connecting it to a designated device
compliant with IEC60601-1 requirements of electrical safety and
ensure the designated device’s voltage and current meet the
requirements of this Manual.
12 Do not connect it to any external device or operate it for
measurement when this device is being charged.
13 Do not use this device in situations where alarms required. The
oximeter does not support alarms.
14 Users who are allergic to rubber cannot use this product.
15 Disposal of this device and its accessories and packaging (plastic
bags, foam and cartons, etc.) are subject to local laws and
regulations.
CAUTION
1 To ensure patient safety, use only parts and accessories specified in
this manual.
2 Keep the operating environment clean, no vibration, no corrosion
or combustible material and avoid too high or too low temperature
and humidity.
3 Do not use this device near by the source of electromagnetic
interference, such as mobile phones or radio transmitter.
4 Do not spill liquid on the device. Do not immerse the device in
liquid.
5 Always install or carry the device properly to avoid damage caused
by drop, impact, strong vibration or other mechanical force.
6 Do not use this device if the device cannot achieve satisfactory
results.
NOTE
1 Too cold or too thin finger may affect the measurements; thicker
finger (recommended thumb or middle finger) should insert into the
cover fully.
2 Avoid placing the sensor on extremities with an arterial catheter, or
intravascular venous infusion line.
3 Check the device before using. Do not use it if there is significant
damage.
4 Do not use the functional tester to access the SpO2accuracy.
5 This device is calibrated to display functional oxygen saturation.
6 The pictures and interfaces in this manual are for reference only.
7 This Manual is prepared based on the most complete configuration.
Some configurations and functions may be not available in your
device.
8 Fingernail polish or false fingernails may cause inaccurate SpO2
readings.
1.2 Symbols
Symbols
Definition of symbols
Follow instructions for use
Caution
No alarm
Type BF Applied Part
Battery indication
SpO2
Oxygen saturation of arterial hemoglobin
PR
Pulse Rate
The symbol indicates that the device should be
sent to the special agencies according to local
regulations for separate collection after its useful
life.
The symbol indicates that the device complies with
the European Council Directive 93/42/EEC
concerning medical devices.
Authorized representative in the European
community
Serial Number
P/N
Part Number
Batch number
Manufacturer
Date of manufacture
IP22
2 degree Protection Against Ingress of Liquids and
dust.
Chapter 2 General
2.1 Introduction
Sonosat F fingertip pulse oximeter using spectrophotometry, by
detecting the blood red and infrared absorption of light to obtain
the oxygen saturation (SpO2) and pulse rate (PR).
Oxygen saturation is a term referring to the fraction of oxygen-
saturated hemoglobin (HbO2) relative to total hemoglobin(Hb) in the
blood, that is, the oxygen saturation in the blood, which is an
important physiological parameter of the respiratory and circulatory
system. Many respiratory diseases can cause oxygen saturation
decrease. The body's automatic regulatory dysfunction caused by
anesthesia, major surgery trauma, and injury caused by some
medical examination etc., are likely to lead to the oxygen saturation
decrease, resulting in patients with dizziness, weakness, vomiting
and other symptoms; severe cases will be life-threatening. SpO2 has
important significance in the field of clinical medical. And timely
understanding of the patient's blood oxygen saturation situation will
help physician find problems.
This device is not suitable for continuous monitoring of patients.
2.2 Intended Use and Contraindication
Intended use: The fingertip pulse oximeter is intended to measure the
pulse oxygen saturation of arterial hemoglobin and pulse rate of adults
and pediatrics in home care and medical outpatient environment.
Contraindication: none
2.3 Applications
This device is suitable for the following people: People with
vascular disease, such as: coronary heart disease, hypertension,
hyperlipidemia, cerebral thrombosis;
People with respiratory diseases, such as: asthma, trachitis,
chronic bronchitis, chronic cor pulmonale, chronic obstructive
pulmonary disease;
Old people above 60 years old
People who works more than 12 hours a day;
People works on extreme exercise or under the alpine hypoxic
environment;
Long-term alcohol people.
2.4 Appearance
2.4.1 Front view
1. Battery capacity Indicator
Full capacity, the middle part indicates the
capacity.
Capacity is seriously empty, charge it
immediately.
2. Power On/Off switch
Turn on the oximeter: Press the ON/OFF button to
turn on the device.
Turn off the oximeter: Press this button for 2 seconds
to turn the device off.
Press this button to highlight the display when the
display is in low brightness.
3. Display screen
4. SpO2value
5. PR value: Pulse rate per minute.
6. Bluetooth icon
on: means connected to Bluetooth device
off: means disconnected to Bluetooth device
7. Heart symbol
8. Pulse rate bar graph
2.4.2 Side view
1. Micro USB connector: charging battery with specified
charging cable connected to adaptor.
2. Rubber finger cover
Chapter 3 Unpacking and Storage
3.1 Open-case inspection
Before unpacking, examine the packing case carefully for
signs of damage. If any damage is detected, contact the
carrier or us. Take out all bulk packaging from the carton. If
the packing case is intact, open the package and remove the
equipment and accessories carefully.
Check whether there is any damage to the surface of the
oximeter such as notches, dents, abrasions and so on. Check
whether the components are missing according to packing
list.
3.2 Storage
The oximeter is manufactured with precision parts. Do not
place the oximeter in the following places:
Easy to splash;
With Direct sunlight, high temperature, humidity, dust,
and corrosive gas;
Tilt, generate vibration and impact;
Store chemicals or corrosive gases.
Chapter 4 Measurement operation
1. Insert finger to oximeter's cover fully to obtain good
measurements.
2. Press the ON/OFF button to turn the oximeter on.
3. SpO2and pulse rate value displays on screen.
NOTE:
1 The oximeter cannot be measured while charging.
2 Finger can not apply nail polish and other cosmetics.
3 Do not shake the finger, hand or body during the measuring.
4 Tape or other light obstructions around the applied site may
affect the accuracy of SpO2and pulse rate.
5 The oximeter will shut down if no any actions within 10
seconds after it turning on.
The following factors may influence the accuracy of measurement:
Ambient light
Physical movement (passive and imposed motion)
Diagnostic testing
Low perfusion
Electromagnetic interference, such as MRI environment
Electrosurgical units
Dysfunctional haemoglobin, such as carboxyhemoglobin
(COHb)and methemoglobin (MetHb)
Presence of certain dyes, such as methylene and indigo
carmine
Inappropriate positioning of the SpO2sensor, or use of
incorrect SpO2sensor.
Drop of arterial blood flow to immeasurable level caused by
shock, anemia, low temperature or vasoconstrictor.
Chapter 5 Charging Battery
The oximeter uses a built-in non-removable rechargeable
lithium battery. Symbol will flash when battery capacity is
low. Charge the battery according to the following steps.
1. Take out the cable and connect it to oximeter's Micro USB
connector.
2. Plug the other end of cable to USB adaptor. Battery
symbol appear and flashes on the screen while charging.
The performance of the rechargeable lithium battery may
deteriorate over time. If the operating time of the battery is
noticeably shorter than that stated in the specifications,
contact your service personnel.
Follow the appropriate local regulations and do not dispose of
oximeter (includes battery).
1
2
4
5
8
6
7
3
1
2
4
5
8
6
7
3
1
2

Fingertip Pulse Oximeter
User Manual
Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd
Jiangsu Konsung Bio-Medical Science And Technology
Co., Ltd
NO.8, Shengchang West Road, Danyang
Development Zone, Jiangsu Province, 212300,
P.R. China
Tel: [phone]
WhatsApp:[phone]
E-mail: info@ konsung.com
Website: www.konsungmedical.com
Shanghai International Holding Corp. GmbH
(Europe)
Eiffestrasse 80, 20537 Hamburg Germany
Tel: [phone] Fax: [phone]
E-mail: [e-mail]
Statement
Thanks for your purchasing Fingertip oximeter of Jiangsu Konsung Bio-
Medical Science And Technology Co., Ltd. (hereinafter called Konsung).
Before using this oximeter, please read this manual carefully for
understanding the operation and maintenance of the oximeter.
Konsung holds the rights to modify, update, and ultimately explain this
manual.
Konsung owns the copyrights of this manual. Without prior written
consent of Konsung, any materials contained in this manual shall not be
photocopied, reproduced or translated into other languages.
Materials protected by the copyright law, including but not limited to
confidential information such as technical information and patent
information are contained in this manual, the user shall not disclose such
information to any irrelevant third party.
This manual will help you understand the operation and maintenance of
the product better. It is reminded that the product shall be used strictly
complying with this manual. User‘s operation failing to comply with this
manual may result in malfunction or accident for which Konsung cannot
be held liable.
Fingertip Pulse Oximeter is Class 1 LEDs product. It must be serviced by
specified trained personnel.
Responsibility of the Manufacturer
Konsung only considers itself responsible for any effect on safety,
reliability and performance of the equipment if:
Assembly operations, extensions, re-adjustments, modifications or
repairs are carried out by persons authorized by Konsung, and
The electrical installation of the relevant room complies with national
standards, and
The instrument is used in accordance with the instructions for use.
Upon request, Konsung may provide, with compensation, necessary
circuit diagrams, and other information to help qualified technician to
maintain and repair some parts, which Konsung may define as user
serviceable.
Chapter 1 Safety
1.1 Safety Information
The user should pay attention to and abide by the basic safety
information which was referred to in this chapter.
WARNING
AWARNING label advises against certain actions or situations
that could result in personal injury or death.
CAUTION
ACAUTION label advises against actions or situations that
could damage equipment, produce inaccurate data, or
invalidate a procedure.
NOTE
ANOTE provides useful information regarding a function or a
procedure.
WARNING
1 This device is not intended for treatment.
2 Carefully read this manual about all safety information, operation
and specifications before using this oximeter.
3 Do not open the shell of the instrument. Otherwise you may
damage the instrument. All servicing and future upgrades must be
carried out by the personnel trained and authorized by our company
only.
4 Do not use this device with the defibrillator or other high-frequency
equipment.
5 Explosion hazard: Do not use this device in an explosive atmosphere.
6 Check and change the applied site according to the different
circumstances of the user while using this device for long-time
continuous monitoring. It is recommended to check the finger after
2 hours. Change other finger to be measured if the finger seems to
be unusual. If the oximeter is too tight because the application site
is too large or becomes too large due to edema, excessive pressure
for prolonged periods may result in venous congestion distal from
the application site, leading to interstitial edema and tissue
ischemia.
7 The measuring data displayed on the device are for reference only
and cannot be directly used for diagnostic interpretation.
8 This device is not intended to use of infant and neonate.
9 In some circumstances, the device may interpret motion as good
pulse quality. Minimize patient motion as much as possible.
10 The presence of high ambient light may cause inaccurate SpO2
measurements.
11 Charge this device only by connecting it to a designated device
compliant with IEC60601-1 requirements of electrical safety and
ensure the designated device’s voltage and current meet the
requirements of this Manual.
12 Do not connect it to any external device or operate it for
measurement when this device is being charged.
13 Do not use this device in situations where alarms required. The
oximeter does not support alarms.
14 Users who are allergic to rubber cannot use this product.
15 Disposal of this device and its accessories and packaging (plastic
bags, foam and cartons, etc.) are subject to local laws and
regulations.
CAUTION
1 To ensure patient safety, use only parts and accessories specified in
this manual.
2 Keep the operating environment clean, no vibration, no corrosion
or combustible material and avoid too high or too low temperature
and humidity.
3 Do not use this device near by the source of electromagnetic
interference, such as mobile phones or radio transmitter.
4 Do not spill liquid on the device. Do not immerse the device in
liquid.
5 Always install or carry the device properly to avoid damage caused
by drop, impact, strong vibration or other mechanical force.
6 Do not use this device if the device cannot achieve satisfactory
results.
NOTE
1 Too cold or too thin finger may affect the measurements; thicker
finger (recommended thumb or middle finger) should insert into the
cover fully.
2 Avoid placing the sensor on extremities with an arterial catheter, or
intravascular venous infusion line.
3 Check the device before using. Do not use it if there is significant
damage.
4 Do not use the functional tester to access the SpO2accuracy.
5 This device is calibrated to display functional oxygen saturation.
6 The pictures and interfaces in this manual are for reference only.
7 This Manual is prepared based on the most complete configuration.
Some configurations and functions may be not available in your
device.
8 Fingernail polish or false fingernails may cause inaccurate SpO2
readings.
1.2 Symbols
Symbols
Definition of symbols
Follow instructions for use
Caution
No alarm
Type BF Applied Part
Battery indication
SpO2
Oxygen saturation of arterial hemoglobin
PR
Pulse Rate
The symbol indicates that the device should be
sent to the special agencies according to local
regulations for separate collection after its useful
life.
The symbol indicates that the device complies with
the European Council Directive 93/42/EEC
concerning medical devices.
Authorized representative in the European
community
Serial Number
P/N
Part Number
Batch number
Manufacturer
Date of manufacture
IP22
2 degree Protection Against Ingress of Liquids and
dust.
Chapter 2 General
2.1 Introduction
Sonosat F fingertip pulse oximeter using spectrophotometry, by
detecting the blood red and infrared absorption of light to obtain
the oxygen saturation (SpO2) and pulse rate (PR).
Oxygen saturation is a term referring to the fraction of oxygen-
saturated hemoglobin (HbO2) relative to total hemoglobin(Hb) in the
blood, that is, the oxygen saturation in the blood, which is an
important physiological parameter of the respiratory and circulatory
system. Many respiratory diseases can cause oxygen saturation
decrease. The body's automatic regulatory dysfunction caused by
anesthesia, major surgery trauma, and injury caused by some
medical examination etc., are likely to lead to the oxygen saturation
decrease, resulting in patients with dizziness, weakness, vomiting
and other symptoms; severe cases will be life-threatening. SpO2 has
important significance in the field of clinical medical. And timely
understanding of the patient's blood oxygen saturation situation will
help physician find problems.
This device is not suitable for continuous monitoring of patients.
2.2 Intended Use and Contraindication
Intended use: The fingertip pulse oximeter is intended to measure the
pulse oxygen saturation of arterial hemoglobin and pulse rate of adults
and pediatrics in home care and medical outpatient environment.
Contraindication: none
2.3 Applications
This device is suitable for the following people: People with
vascular disease, such as: coronary heart disease, hypertension,
hyperlipidemia, cerebral thrombosis;
People with respiratory diseases, such as: asthma, trachitis,
chronic bronchitis, chronic cor pulmonale, chronic obstructive
pulmonary disease;
Old people above 60 years old
People who works more than 12 hours a day;
People works on extreme exercise or under the alpine hypoxic
environment;
Long-term alcohol people.
2.4 Appearance
2.4.1 Front view
1. Battery capacity Indicator
Full capacity, the middle part indicates the
capacity.
Capacity is seriously empty, charge it
immediately.
2. Power On/Off switch
Turn on the oximeter: Press the ON/OFF button to
turn on the device.
Turn off the oximeter: Press this button for 2 seconds
to turn the device off.
Press this button to highlight the display when the
display is in low brightness.
3. Display screen
4. SpO2value
5. PR value: Pulse rate per minute.
6. Bluetooth icon
on: means connected to Bluetooth device
off: means disconnected to Bluetooth device
7. Heart symbol
8. Pulse rate bar graph
2.4.2 Side view
1. Micro USB connector: charging battery with specified
charging cable connected to adaptor.
2. Rubber finger cover
Chapter 3 Unpacking and Storage
3.1 Open-case inspection
Before unpacking, examine the packing case carefully for
signs of damage. If any damage is detected, contact the
carrier or us. Take out all bulk packaging from the carton. If
the packing case is intact, open the package and remove the
equipment and accessories carefully.
Check whether there is any damage to the surface of the
oximeter such as notches, dents, abrasions and so on. Check
whether the components are missing according to packing
list.
3.2 Storage
The oximeter is manufactured with precision parts. Do not
place the oximeter in the following places:
Easy to splash;
With Direct sunlight, high temperature, humidity, dust,
and corrosive gas;
Tilt, generate vibration and impact;
Store chemicals or corrosive gases.
Chapter 4 Measurement operation
1. Insert finger to oximeter's cover fully to obtain good
measurements.
2. Press the ON/OFF button to turn the oximeter on.
3. SpO2and pulse rate value displays on screen.
NOTE:
1 The oximeter cannot be measured while charging.
2 Finger can not apply nail polish and other cosmetics.
3 Do not shake the finger, hand or body during the measuring.
4 Tape or other light obstructions around the applied site may
affect the accuracy of SpO2and pulse rate.
5 The oximeter will shut down if no any actions within 10
seconds after it turning on.
The following factors may influence the accuracy of measurement:
Ambient light
Physical movement (passive and imposed motion)
Diagnostic testing
Low perfusion
Electromagnetic interference, such as MRI environment
Electrosurgical units
Dysfunctional haemoglobin, such as carboxyhemoglobin
(COHb)and methemoglobin (MetHb)
Presence of certain dyes, such as methylene and indigo
carmine
Inappropriate positioning of the SpO2sensor, or use of
incorrect SpO2sensor.
Drop of arterial blood flow to immeasurable level caused by
shock, anemia, low temperature or vasoconstrictor.
Chapter 5 Charging Battery
The oximeter uses a built-in non-removable rechargeable
lithium battery. Symbol will flash when battery capacity is
low. Charge the battery according to the following steps.
1. Take out the cable and connect it to oximeter's Micro USB
connector.
2. Plug the other end of cable to USB adaptor. Battery
symbol appear and flashes on the screen while charging.
The performance of the rechargeable lithium battery may
deteriorate over time. If the operating time of the battery is
noticeably shorter than that stated in the specifications,
contact your service personnel.
Follow the appropriate local regulations and do not dispose of
oximeter (includes battery).
1
2
4
5
8
6
7
3
1
2
4
5
8
6
7
3
1
2

Chapter 6 Accessories
Use only accessories specified in this manual. Using other
accessories may cause damage to the pulse oximeter. Or the
performance of oximeter cannot meet the specifications
claimed in this specification.
The accessory material that contacts the user or other
personnel has undertaken the bio-compatibility test and is
verified to be in compliance with ISO 10993-1.
1 USB Charging cable
1 User Manual
1 Quality Certificate
Chapter 7 Cleaning and Maintenance
7.1 Cleaning
To clean or disinfect the device should use materials and
methods listed in this section. Otherwise, we shall assume no
responsibility for the effectiveness.
The cleaning agents below can only be used for general
cleaning. If you use them to control infections, we shall assume
no responsibility for the effectiveness. Please consult the
hospital infection prevention departments or epidemic experts
for controlling infection.
To avoid damage to the oximeter, follow these rules：
Dilute the agents according to your local distributor’s
suggestions. The recommended times of disinfection is
three hundred.
Never submerge the device in water or any cleaning
agent, or pour or spray water or any cleaning agent on
the device.
Never permit fluids to run into the casing, switches,
connectors, or any ventilation openings in the device.
Do not allow liquid to enter the sensor connector
Never use abrasive, erosive cleaners (such as steel wool,
silver polishes), or cleaners containing acetone.
WARNING
1Disconnect power-supply before cleaning the pulse oximeter.
2Be sure to shut down the oximeter and disconnect all power
cables from the outlets before cleaning the oximeter.
3Do not disinfect the oximeter with methods such as high
temperature, high pressure, gas fumigation or liquid immerse.
Follow the manufacturer's instructions of cleaning and
disinfection for pulse oximeter.
4Oximeter’s regular calibration and maintenance should be
taken by qualified professionals.
Cleaning agents
70 vol% isopropyl
75 vol% ethyl alcohol
Do as follow steps when cleaning the device
1. Power off the oximeter.
2. Wipe the oximeter case with a soft cloth dampened with a
cleaning agent. Recommended disinfection material,
Alcohol based (Ethanol 75%, Isopropanol 70%) and
aldehyde based.
3. Wipe off excessive cleaning agent with a dry cloth after
cleaning.
4. Dry the oximeter in a cool ventilated environment.
Note:
1 Don’t attempt to disassemble the device or repair it unless
you are trained personnel.
2 If you spill liquid on the equipment or accessories, Wipe the
oximeter immediately and dry the oximeter. If the oximeter
cannot work normal please contact us or your service
personnel.
7.2 Disinfection
Disinfection may cause damage to the oximeter. We
recommend that you disinfect the oximeter only when
necessary. Clean the oximeter before disinfection.
Recommended cleaning agent is Ethanol (75%).
The recommended times of disinfection is not more than 300.
Note: Never use EtO or formaldehyde for disinfection.
7.3 Maintenance
The overall check of the device should be performed only by
qualified personnel every 24 months, and each time after fix up.
The following items should be checked:
If the environment condition and power supply meet
requirement.
If the device and accessories have damage.
Specified accessories.
Battery performance
If all monitoring functions are in good conditions.
If any damage or abnormality is found, please don’t use the device
and contact local Customer Service Center.
Chapter 8 Specification
Safety specifications (classified according to IEC60601-1)
Electric shock protection
Class II with internal power
supply device
Degree of protection against
electrical shock
Type BF applied part
Degree of protection against
ingress of liquid
IPX1, non AP/APG type
Operating mode
Continuous
Physical Specifications
LxWxH
mm x mm x mm
SONOSAT-F01 series: 72 x 32 x 27
SONOSAT-F02 series: 68 x 32 x 27
Weight
SONOSAT-F01 series: less than 50g
SONOSAT-F02 series: less than 50g
Hardware specifications
Display screen
LCD
Buzzle
1, pulse tone
Charging connector
1, Micro USB connector
Environmental Specifications
Working
Transport and
Storage
Temperature(℃)
5～40
-20～60
Relative humidity (non
condensing)
30%～80%
10%～95%
Atmospheric Pressure(kPa)
70～106
70～106
Recommended maximum
charge and discharge ambient
temperature
Charge: 35℃；
Discharge: 45℃
Lithium battery (working power)
Quantity
1
Voltage rating
3.7V
Battery capacity
300mAh
Run time
20 hours(Fully-charged new
battery, Ambient temperature:
25℃)
Charging Voltage & Current
5V～160mA
Charge time
2.5 hours (charge to 90% of
capacity)
Shutdown delay
Max. 5 minutes after the low
battery prompt first occurs.
Note: The information about wavelength range and maximum photic
output consumption can be especially useful to clinicians, for example,
clinicians performing photodynamic therapy.
Chapter 9 Troubleshooting
Problems
Possible Reason
Solutions
Device can’t
be powered
on.
Critical low battery.
Please charge.
Device might be damaged.
Please contact local
customer service
centre.
SpO2or PR
value can’t be
shown
normally.
The sensor is applied
incorrectly.
Re-apply the sensor.
There is very bright light.
Don’t use the bright
light device in the
environment with high
ambient light.
Patient is in low perfusion
or patient’s
oxyhemoglobin is too low
to be measured.
Go to a hospital for
diagnosis.
SpO2or PR
value is
unstable.
Finger might not be
inserted deep enough.
Re-apply the senor.
Finger is trembling or
patient is moving.
Please keep quiet.
Chapter 10 Warranty and Service Policy
10.1 Warranty
Konsung warrants that Konsung’s products meet the labeled
specifications of the products and will be free from defects in
materials and workmanship that occur within warranty period.
The warranty is void in cases of:
damage caused by mishandling during shipping.
subsequent damage caused by improper use or maintenance.
damage caused by alteration or repair by anyone not authorized
by Konsung.
damage caused by accidents.
replacement or removal of serial number label and manufacture
label.
If a product covered by this warranty is determined to be defective
because of defective materials, components, or workmanship, and
the warranty claim is made within the warranty period, Konsung will,
at its discretion, repair or replace the defective part(s) free of charge.
Konsung will not provide a substitute product for use when the
defective product is being repaired.
10.2 Contact Information
If any questions in equipment operation, please contact the
manufacturer or local agency.
Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
Address: NO.8, Shengchang West Road, Danyang Development
Zone, Jiangsu Province, 212300, P.R. China
Tel: [phone]
Fax: [phone]
E-mail: [e-mail]
Chapter 11 EMC
11.1 Electromagnetic Emissions-for all
EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic
emission
The oximeter is intended for use in the electromagnetic
environment specified below. The customer or the user of the
oximeter should assure that it is used in such an environment.
Emission test
Compliance
Electromagnetic environment –
guidance
RF(Radio
frequency)
emissions
CISPR 11
Group 1
The 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(Radio
frequency)
CISPR 11
Class B
The oximeter is suitable for use
in all establishments, other than
domestic establishments and
those directly connected to the
public low-voltage power supply
network that supplies buildings
used for domestic purposes.
Harmonic
emissions
IEC/EN 61000-3-2
Class A
Voltage
fluctuations/
flicker emissions
IEC/EN 61000-3-3
Complies
11.2 Electromagnetic Immunity-for all
EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic
immunity
The oximeter is intended for use in the electromagnetic
environment specified below. The customer or the user of the
oximeter should assure that it is used in such an environment.
Immunity test
IEC/EN
60601 test
level
Compliance
level
Electromagnetic
environment - guidance
Electrostatic
discharge (ESD)
IEC/EN 61000-
4-2
6 kV
contact
8 kV air
6 kV
contact
8 kV air
Floors should be wood,
concrete or ceramic tile.
If floor are covered with
synthetic material, the
relative humidity should
be at least 30%.
Electrical fast
transient/burst
IEC/EN 61000-
4-4
2 kV for
power
supply
lines
1 kV for
input
/output
signal(>3m)
2kV for
power
supply lines
1 kV for
input
/output
signal(>3m)
Mains power quality
should be that of a
typical commercial or
hospital environment.
Surge
IEC/EN 61000-
4-5
1 kV for
line to line
2 kV for
line to
ground
1 kV for
line to line
2 kV for
line to
ground
Mains power quality
should be that of a
typical commercial or
hospital environment.
Power
frequency
(50/60Hz)
magnetic field
IEC/EN 61000-
4-8
3A/m
3A/m
Power frequency
magnetic fields should
be at levels characteristic
of a typical location in a
typical commercial or
hospital environment.
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC/EN 61000-
4-11
<5% UT
(>95% dip
in UT)
for 0.5
cycle
40% UT
(60% dip in
UT)
for 5 cycles
70% UT
(30% dip in
UT)
for 25
cycles
<5% UT
(>95% dip
in UT)
for 5 sec
<5% UT
(>95% dip
in UT)
for 0.5
cycle
40% UT
(60% dip in
UT)
for 5 cycles
70% UT
(30% dip in
UT)
for 25
cycles
<5% UT
(>95% dip
in UT)
for 5 sec
Mains power quality
should be that of a
typical commercial or
hospital environment. If
the user of the Oximeter
requires continued
operation during power
mains interruptions, it is
recommended that the
Oximeter be powered
from an uninterruptible
power supply or a
battery.
NOTE: UTis the AC mains voltage prior to application of the test
level.
11.3 Electromagnetic Immunity-for EQUIPMENT
and SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacture’s declaration – electromagnetic
immunity
The oximeter is intended for use in the electromagnetic
environment specified below. The customer or the user of oximeter
should assure that it is used in such an environment.
Immunity
test
IEC/EN
60601
test
level
Compliance
level
Electromagnetic environment -
guidance
Conducted
RF
IEC/EN
61000-4-6
Radiated
RF
IEC/EN
61000-4-3
3 Vrms
150 kHz
to 80
MHz
3 V/m
80 MHz
to 2.5
GHz
3 Vrms
3 V/m
Portable and mobile RF
communications equipment
should be used no closer to any
part of the Oximeter, including
cables, than the recommended
separation distance calculated
from the equation applicable to
the frequency of the transmitter.
Recommended separation
distance
P
V
d
1
5.3
P
E
d
1
5.3
80 MHz to 800 MHz
P
E
d
1
7
800 MHz to 2.5 GHz
Where P is the maximum
output power rating of the
transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation
distance in metres (m).
Field strengths from fixed RF
transmitters, as determined by
an electromagnetic site survey,a
should be less than the
compliance level in each
frequency range.b
Interference may occur in the
vicinity of equipment marked
with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range
applies.
NOTE 2 These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for
radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the
measured field strength in the location in which the Oximeter is
used exceeds the applicable RF compliance level above, the
Oximeter should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the Oximeter.
b Over the frequency range 150kHz to 80MHz, field strengths
should be less than 3V/m.
11.4 Recommended Separation Distances
Recommended separation distances between portable and
mobile RF communications equipment and the oximeter
The oximeter is intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The
customer or the user of the oximeter can help prevent
electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment
(transmitters) and the oximeter as recommended below, according
to the maximum output power of the communications equipment.
Rated maximum output
power of transmitter
(W)
Separation distance according to
frequency of transmitter(m)
150 kHz to
80 MHz
P
V
d
1
5.3
80 MHz to
800 MHz
P
E
d
1
5.3
800 MHz to
2.5 GHz
P
E
d
1
7
0.01
0.12
0.12
0.23
0.1
0.36
0.37
0.74
1
1.16
1.17
2.33
10
3.69
3.69
7.38
100
11.67
11.67
23.33
For transmitters rated at a maximum output power not listed
above, the recommended separation distance d in metres (m) can
be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the
higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.

Chapter 6 Accessories
Use only accessories specified in this manual. Using other
accessories may cause damage to the pulse oximeter. Or the
performance of oximeter cannot meet the specifications
claimed in this specification.
The accessory material that contacts the user or other
personnel has undertaken the bio-compatibility test and is
verified to be in compliance with ISO 10993-1.
1 USB Charging cable
1 User Manual
1 Quality Certificate
Chapter 7 Cleaning and Maintenance
7.1 Cleaning
To clean or disinfect the device should use materials and
methods listed in this section. Otherwise, we shall assume no
responsibility for the effectiveness.
The cleaning agents below can only be used for general
cleaning. If you use them to control infections, we shall assume
no responsibility for the effectiveness. Please consult the
hospital infection prevention departments or epidemic experts
for controlling infection.
To avoid damage to the oximeter, follow these rules：
Dilute the agents according to your local distributor’s
suggestions. The recommended times of disinfection is
three hundred.
Never submerge the device in water or any cleaning
agent, or pour or spray water or any cleaning agent on
the device.
Never permit fluids to run into the casing, switches,
connectors, or any ventilation openings in the device.
Do not allow liquid to enter the sensor connector
Never use abrasive, erosive cleaners (such as steel wool,
silver polishes), or cleaners containing acetone.
WARNING
1Disconnect power-supply before cleaning the pulse oximeter.
2Be sure to shut down the oximeter and disconnect all power
cables from the outlets before cleaning the oximeter.
3Do not disinfect the oximeter with methods such as high
temperature, high pressure, gas fumigation or liquid immerse.
Follow the manufacturer's instructions of cleaning and
disinfection for pulse oximeter.
4Oximeter’s regular calibration and maintenance should be
taken by qualified professionals.
Cleaning agents
70 vol% isopropyl
75 vol% ethyl alcohol
Do as follow steps when cleaning the device
1. Power off the oximeter.
2. Wipe the oximeter case with a soft cloth dampened with a
cleaning agent. Recommended disinfection material,
Alcohol based (Ethanol 75%, Isopropanol 70%) and
aldehyde based.
3. Wipe off excessive cleaning agent with a dry cloth after
cleaning.
4. Dry the oximeter in a cool ventilated environment.
Note:
1 Don’t attempt to disassemble the device or repair it unless
you are trained personnel.
2 If you spill liquid on the equipment or accessories, Wipe the
oximeter immediately and dry the oximeter. If the oximeter
cannot work normal please contact us or your service
personnel.
7.2 Disinfection
Disinfection may cause damage to the oximeter. We
recommend that you disinfect the oximeter only when
necessary. Clean the oximeter before disinfection.
Recommended cleaning agent is Ethanol (75%).
The recommended times of disinfection is not more than 300.
Note: Never use EtO or formaldehyde for disinfection.
7.3 Maintenance
The overall check of the device should be performed only by
qualified personnel every 24 months, and each time after fix up.
The following items should be checked:
If the environment condition and power supply meet
requirement.
If the device and accessories have damage.
Specified accessories.
Battery performance
If all monitoring functions are in good conditions.
If any damage or abnormality is found, please don’t use the device
and contact local Customer Service Center.
Chapter 8 Specification
Safety specifications (classified according to IEC60601-1)
Electric shock protection
Class II with internal power
supply device
Degree of protection against
electrical shock
Type BF applied part
Degree of protection against
ingress of liquid
IPX1, non AP/APG type
Operating mode
Continuous
Physical Specifications
LxWxH
mm x mm x mm
SONOSAT-F01 series: 72 x 32 x 27
SONOSAT-F02 series: 68 x 32 x 27
Weight
SONOSAT-F01 series: less than 50g
SONOSAT-F02 series: less than 50g
Hardware specifications
Display screen
LCD
Buzzle
1, pulse tone
Charging connector
1, Micro USB connector
Environmental Specifications
Working
Transport and
Storage
Temperature(℃)
5～40
-20～60
Relative humidity (non
condensing)
30%～80%
10%～95%
Atmospheric Pressure(kPa)
70～106
70～106
Recommended maximum
charge and discharge ambient
temperature
Charge: 35℃；
Discharge: 45℃
Lithium battery (working power)
Quantity
1
Voltage rating
3.7V
Battery capacity
300mAh
Run time
20 hours(Fully-charged new
battery, Ambient temperature:
25℃)
Charging Voltage & Current
5V～160mA
Charge time
2.5 hours (charge to 90% of
capacity)
Shutdown delay
Max. 5 minutes after the low
battery prompt first occurs.
Note: The information about wavelength range and maximum photic
output consumption can be especially useful to clinicians, for example,
clinicians performing photodynamic therapy.
Chapter 9 Troubleshooting
Problems
Possible Reason
Solutions
Device can’t
be powered
on.
Critical low battery.
Please charge.
Device might be damaged.
Please contact local
customer service
centre.
SpO2or PR
value can’t be
shown
normally.
The sensor is applied
incorrectly.
Re-apply the sensor.
There is very bright light.
Don’t use the bright
light device in the
environment with high
ambient light.
Patient is in low perfusion
or patient’s
oxyhemoglobin is too low
to be measured.
Go to a hospital for
diagnosis.
SpO2or PR
value is
unstable.
Finger might not be
inserted deep enough.
Re-apply the senor.
Finger is trembling or
patient is moving.
Please keep quiet.
Chapter 10 Warranty and Service Policy
10.1 Warranty
Konsung warrants that Konsung’s products meet the labeled
specifications of the products and will be free from defects in
materials and workmanship that occur within warranty period.
The warranty is void in cases of:
damage caused by mishandling during shipping.
subsequent damage caused by improper use or maintenance.
damage caused by alteration or repair by anyone not authorized
by Konsung.
damage caused by accidents.
replacement or removal of serial number label and manufacture
label.
If a product covered by this warranty is determined to be defective
because of defective materials, components, or workmanship, and
the warranty claim is made within the warranty period, Konsung will,
at its discretion, repair or replace the defective part(s) free of charge.
Konsung will not provide a substitute product for use when the
defective product is being repaired.
10.2 Contact Information
If any questions in equipment operation, please contact the
manufacturer or local agency.
Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
Address: NO.8, Shengchang West Road, Danyang Development
Zone, Jiangsu Province, 212300, P.R. China
Tel: [phone]
Fax: [phone]
E-mail: [e-mail]
Chapter 11 EMC
11.1 Electromagnetic Emissions-for all
EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic
emission
The oximeter is intended for use in the electromagnetic
environment specified below. The customer or the user of the
oximeter should assure that it is used in such an environment.
Emission test
Compliance
Electromagnetic environment –
guidance
RF(Radio
frequency)
emissions
CISPR 11
Group 1
The 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(Radio
frequency)
CISPR 11
Class B
The oximeter is suitable for use
in all establishments, other than
domestic establishments and
those directly connected to the
public low-voltage power supply
network that supplies buildings
used for domestic purposes.
Harmonic
emissions
IEC/EN 61000-3-2
Class A
Voltage
fluctuations/
flicker emissions
IEC/EN 61000-3-3
Complies
11.2 Electromagnetic Immunity-for all
EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic
immunity
The oximeter is intended for use in the electromagnetic
environment specified below. The customer or the user of the
oximeter should assure that it is used in such an environment.
Immunity test
IEC/EN
60601 test
level
Compliance
level
Electromagnetic
environment - guidance
Electrostatic
discharge (ESD)
IEC/EN 61000-
4-2
6 kV
contact
8 kV air
6 kV
contact
8 kV air
Floors should be wood,
concrete or ceramic tile.
If floor are covered with
synthetic material, the
relative humidity should
be at least 30%.
Electrical fast
transient/burst
IEC/EN 61000-
4-4
2 kV for
power
supply
lines
1 kV for
input
/output
signal(>3m)
2kV for
power
supply lines
1 kV for
input
/output
signal(>3m)
Mains power quality
should be that of a
typical commercial or
hospital environment.
Surge
IEC/EN 61000-
4-5
1 kV for
line to line
2 kV for
line to
ground
1 kV for
line to line
2 kV for
line to
ground
Mains power quality
should be that of a
typical commercial or
hospital environment.
Power
frequency
(50/60Hz)
magnetic field
IEC/EN 61000-
4-8
3A/m
3A/m
Power frequency
magnetic fields should
be at levels characteristic
of a typical location in a
typical commercial or
hospital environment.
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC/EN 61000-
4-11
<5% UT
(>95% dip
in UT)
for 0.5
cycle
40% UT
(60% dip in
UT)
for 5 cycles
70% UT
(30% dip in
UT)
for 25
cycles
<5% UT
(>95% dip
in UT)
for 5 sec
<5% UT
(>95% dip
in UT)
for 0.5
cycle
40% UT
(60% dip in
UT)
for 5 cycles
70% UT
(30% dip in
UT)
for 25
cycles
<5% UT
(>95% dip
in UT)
for 5 sec
Mains power quality
should be that of a
typical commercial or
hospital environment. If
the user of the Oximeter
requires continued
operation during power
mains interruptions, it is
recommended that the
Oximeter be powered
from an uninterruptible
power supply or a
battery.
NOTE: UTis the AC mains voltage prior to application of the test
level.
11.3 Electromagnetic Immunity-for EQUIPMENT
and SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacture’s declaration – electromagnetic
immunity
The oximeter is intended for use in the electromagnetic
environment specified below. The customer or the user of oximeter
should assure that it is used in such an environment.
Immunity
test
IEC/EN
60601
test
level
Compliance
level
Electromagnetic environment -
guidance
Conducted
RF
IEC/EN
61000-4-6
Radiated
RF
IEC/EN
61000-4-3
3 Vrms
150 kHz
to 80
MHz
3 V/m
80 MHz
to 2.5
GHz
3 Vrms
3 V/m
Portable and mobile RF
communications equipment
should be used no closer to any
part of the Oximeter, including
cables, than the recommended
separation distance calculated
from the equation applicable to
the frequency of the transmitter.
Recommended separation
distance
P
V
d
1
5.3
P
E
d
1
5.3
80 MHz to 800 MHz
P
E
d
1
7
800 MHz to 2.5 GHz
Where P is the maximum
output power rating of the
transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation
distance in metres (m).
Field strengths from fixed RF
transmitters, as determined by
an electromagnetic site survey,a
should be less than the
compliance level in each
frequency range.b
Interference may occur in the
vicinity of equipment marked
with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range
applies.
NOTE 2 These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for
radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the
measured field strength in the location in which the Oximeter is
used exceeds the applicable RF compliance level above, the
Oximeter should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the Oximeter.
b Over the frequency range 150kHz to 80MHz, field strengths
should be less than 3V/m.
11.4 Recommended Separation Distances
Recommended separation distances between portable and
mobile RF communications equipment and the oximeter
The oximeter is intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The
customer or the user of the oximeter can help prevent
electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment
(transmitters) and the oximeter as recommended below, according
to the maximum output power of the communications equipment.
Rated maximum output
power of transmitter
(W)
Separation distance according to
frequency of transmitter(m)
150 kHz to
80 MHz
P
V
d
1
5.3
80 MHz to
800 MHz
P
E
d
1
5.3
800 MHz to
2.5 GHz
P
E
d
1
7
0.01
0.12
0.12
0.23
0.1
0.36
0.37
0.74
1
1.16
1.17
2.33
10
3.69
3.69
7.38
100
11.67
11.67
23.33
For transmitters rated at a maximum output power not listed
above, the recommended separation distance d in metres (m) can
be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the
higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.

Chapter 6 Accessories
Use only accessories specified in this manual. Using other
accessories may cause damage to the pulse oximeter. Or the
performance of oximeter cannot meet the specifications
claimed in this specification.
The accessory material that contacts the user or other
personnel has undertaken the bio-compatibility test and is
verified to be in compliance with ISO 10993-1.
1 USB Charging cable
1 User Manual
1 Quality Certificate
Chapter 7 Cleaning and Maintenance
7.1 Cleaning
To clean or disinfect the device should use materials and
methods listed in this section. Otherwise, we shall assume no
responsibility for the effectiveness.
The cleaning agents below can only be used for general
cleaning. If you use them to control infections, we shall assume
no responsibility for the effectiveness. Please consult the
hospital infection prevention departments or epidemic experts
for controlling infection.
To avoid damage to the oximeter, follow these rules：
Dilute the agents according to your local distributor’s
suggestions. The recommended times of disinfection is
three hundred.
Never submerge the device in water or any cleaning
agent, or pour or spray water or any cleaning agent on
the device.
Never permit fluids to run into the casing, switches,
connectors, or any ventilation openings in the device.
Do not allow liquid to enter the sensor connector
Never use abrasive, erosive cleaners (such as steel wool,
silver polishes), or cleaners containing acetone.
WARNING
1Disconnect power-supply before cleaning the pulse oximeter.
2Be sure to shut down the oximeter and disconnect all power
cables from the outlets before cleaning the oximeter.
3Do not disinfect the oximeter with methods such as high
temperature, high pressure, gas fumigation or liquid immerse.
Follow the manufacturer's instructions of cleaning and
disinfection for pulse oximeter.
4Oximeter’s regular calibration and maintenance should be
taken by qualified professionals.
Cleaning agents
70 vol% isopropyl
75 vol% ethyl alcohol
Do as follow steps when cleaning the device
1. Power off the oximeter.
2. Wipe the oximeter case with a soft cloth dampened with a
cleaning agent. Recommended disinfection material,
Alcohol based (Ethanol 75%, Isopropanol 70%) and
aldehyde based.
3. Wipe off excessive cleaning agent with a dry cloth after
cleaning.
4. Dry the oximeter in a cool ventilated environment.
Note:
1 Don’t attempt to disassemble the device or repair it unless
you are trained personnel.
2 If you spill liquid on the equipment or accessories, Wipe the
oximeter immediately and dry the oximeter. If the oximeter
cannot work normal please contact us or your service
personnel.
7.2 Disinfection
Disinfection may cause damage to the oximeter. We
recommend that you disinfect the oximeter only when
necessary. Clean the oximeter before disinfection.
Recommended cleaning agent is Ethanol (75%).
The recommended times of disinfection is not more than 300.
Note: Never use EtO or formaldehyde for disinfection.
7.3 Maintenance
The overall check of the device should be performed only by
qualified personnel every 24 months, and each time after fix up.
The following items should be checked:
If the environment condition and power supply meet
requirement.
If the device and accessories have damage.
Specified accessories.
Battery performance
If all monitoring functions are in good conditions.
If any damage or abnormality is found, please don’t use the device
and contact local Customer Service Center.
Chapter 8 Specification
Safety specifications (classified according to IEC60601-1)
Electric shock protection
Class II with internal power
supply device
Degree of protection against
electrical shock
Type BF applied part
Degree of protection against
ingress of liquid
IPX1, non AP/APG type
Operating mode
Continuous
Physical Specifications
LxWxH
mm x mm x mm
SONOSAT-F01 series: 72 x 32 x 27
SONOSAT-F02 series: 68 x 32 x 27
Weight
SONOSAT-F01 series: less than 50g
SONOSAT-F02 series: less than 50g
Hardware specifications
Display screen
LCD
Buzzle
1, pulse tone
Charging connector
1, Micro USB connector
Environmental Specifications
Working
Transport and
Storage
Temperature(℃)
5～40
-20～60
Relative humidity (non
condensing)
30%～80%
10%～95%
Atmospheric Pressure(kPa)
70～106
70～106
Recommended maximum
charge and discharge ambient
temperature
Charge: 35℃；
Discharge: 45℃
Lithium battery (working power)
Quantity
1
Voltage rating
3.7V
Battery capacity
300mAh
Run time
20 hours(Fully-charged new
battery, Ambient temperature:
25℃)
Charging Voltage & Current
5V～160mA
Charge time
2.5 hours (charge to 90% of
capacity)
Shutdown delay
Max. 5 minutes after the low
battery prompt first occurs.
Note: The information about wavelength range and maximum photic
output consumption can be especially useful to clinicians, for example,
clinicians performing photodynamic therapy.
Chapter 9 Troubleshooting
Problems
Possible Reason
Solutions
Device can’t
be powered
on.
Critical low battery.
Please charge.
Device might be damaged.
Please contact local
customer service
centre.
SpO2or PR
value can’t be
shown
normally.
The sensor is applied
incorrectly.
Re-apply the sensor.
There is very bright light.
Don’t use the bright
light device in the
environment with high
ambient light.
Patient is in low perfusion
or patient’s
oxyhemoglobin is too low
to be measured.
Go to a hospital for
diagnosis.
SpO2or PR
value is
unstable.
Finger might not be
inserted deep enough.
Re-apply the senor.
Finger is trembling or
patient is moving.
Please keep quiet.
Chapter 10 Warranty and Service Policy
10.1 Warranty
Konsung warrants that Konsung’s products meet the labeled
specifications of the products and will be free from defects in
materials and workmanship that occur within warranty period.
The warranty is void in cases of:
damage caused by mishandling during shipping.
subsequent damage caused by improper use or maintenance.
damage caused by alteration or repair by anyone not authorized
by Konsung.
damage caused by accidents.
replacement or removal of serial number label and manufacture
label.
If a product covered by this warranty is determined to be defective
because of defective materials, components, or workmanship, and
the warranty claim is made within the warranty period, Konsung will,
at its discretion, repair or replace the defective part(s) free of charge.
Konsung will not provide a substitute product for use when the
defective product is being repaired.
10.2 Contact Information
If any questions in equipment operation, please contact the
manufacturer or local agency.
Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
Address: NO.8, Shengchang West Road, Danyang Development
Zone, Jiangsu Province, 212300, P.R. China
Tel: [phone]
Fax: [phone]
E-mail: [e-mail]
Chapter 11 EMC
11.1 Electromagnetic Emissions-for all
EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic
emission
The oximeter is intended for use in the electromagnetic
environment specified below. The customer or the user of the
oximeter should assure that it is used in such an environment.
Emission test
Compliance
Electromagnetic environment –
guidance
RF(Radio
frequency)
emissions
CISPR 11
Group 1
The 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(Radio
frequency)
CISPR 11
Class B
The oximeter is suitable for use
in all establishments, other than
domestic establishments and
those directly connected to the
public low-voltage power supply
network that supplies buildings
used for domestic purposes.
Harmonic
emissions
IEC/EN 61000-3-2
Class A
Voltage
fluctuations/
flicker emissions
IEC/EN 61000-3-3
Complies
11.2 Electromagnetic Immunity-for all
EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic
immunity
The oximeter is intended for use in the electromagnetic
environment specified below. The customer or the user of the
oximeter should assure that it is used in such an environment.
Immunity test
IEC/EN
60601 test
level
Compliance
level
Electromagnetic
environment - guidance
Electrostatic
discharge (ESD)
IEC/EN 61000-
4-2
6 kV
contact
8 kV air
6 kV
contact
8 kV air
Floors should be wood,
concrete or ceramic tile.
If floor are covered with
synthetic material, the
relative humidity should
be at least 30%.
Electrical fast
transient/burst
IEC/EN 61000-
4-4
2 kV for
power
supply
lines
1 kV for
input
/output
signal(>3m)
2kV for
power
supply lines
1 kV for
input
/output
signal(>3m)
Mains power quality
should be that of a
typical commercial or
hospital environment.
Surge
IEC/EN 61000-
4-5
1 kV for
line to line
2 kV for
line to
ground
1 kV for
line to line
2 kV for
line to
ground
Mains power quality
should be that of a
typical commercial or
hospital environment.
Power
frequency
(50/60Hz)
magnetic field
IEC/EN 61000-
4-8
3A/m
3A/m
Power frequency
magnetic fields should
be at levels characteristic
of a typical location in a
typical commercial or
hospital environment.
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC/EN 61000-
4-11
<5% UT
(>95% dip
in UT)
for 0.5
cycle
40% UT
(60% dip in
UT)
for 5 cycles
70% UT
(30% dip in
UT)
for 25
cycles
<5% UT
(>95% dip
in UT)
for 5 sec
<5% UT
(>95% dip
in UT)
for 0.5
cycle
40% UT
(60% dip in
UT)
for 5 cycles
70% UT
(30% dip in
UT)
for 25
cycles
<5% UT
(>95% dip
in UT)
for 5 sec
Mains power quality
should be that of a
typical commercial or
hospital environment. If
the user of the Oximeter
requires continued
operation during power
mains interruptions, it is
recommended that the
Oximeter be powered
from an uninterruptible
power supply or a
battery.
NOTE: UTis the AC mains voltage prior to application of the test
level.
11.3 Electromagnetic Immunity-for EQUIPMENT
and SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacture’s declaration – electromagnetic
immunity
The oximeter is intended for use in the electromagnetic
environment specified below. The customer or the user of oximeter
should assure that it is used in such an environment.
Immunity
test
IEC/EN
60601
test
level
Compliance
level
Electromagnetic environment -
guidance
Conducted
RF
IEC/EN
61000-4-6
Radiated
RF
IEC/EN
61000-4-3
3 Vrms
150 kHz
to 80
MHz
3 V/m
80 MHz
to 2.5
GHz
3 Vrms
3 V/m
Portable and mobile RF
communications equipment
should be used no closer to any
part of the Oximeter, including
cables, than the recommended
separation distance calculated
from the equation applicable to
the frequency of the transmitter.
Recommended separation
distance
P
V
d
1
5.3
P
E
d
1
5.3
80 MHz to 800 MHz
P
E
d
1
7
800 MHz to 2.5 GHz
Where P is the maximum
output power rating of the
transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation
distance in metres (m).
Field strengths from fixed RF
transmitters, as determined by
an electromagnetic site survey,a
should be less than the
compliance level in each
frequency range.b
Interference may occur in the
vicinity of equipment marked
with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range
applies.
NOTE 2 These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for
radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the
measured field strength in the location in which the Oximeter is
used exceeds the applicable RF compliance level above, the
Oximeter should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the Oximeter.
b Over the frequency range 150kHz to 80MHz, field strengths
should be less than 3V/m.
11.4 Recommended Separation Distances
Recommended separation distances between portable and
mobile RF communications equipment and the oximeter
The oximeter is intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The
customer or the user of the oximeter can help prevent
electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment
(transmitters) and the oximeter as recommended below, according
to the maximum output power of the communications equipment.
Rated maximum output
power of transmitter
(W)
Separation distance according to
frequency of transmitter(m)
150 kHz to
80 MHz
P
V
d
1
5.3
80 MHz to
800 MHz
P
E
d
1
5.3
800 MHz to
2.5 GHz
P
E
d
1
7
0.01
0.12
0.12
0.23
0.1
0.36
0.37
0.74
1
1.16
1.17
2.33
10
3.69
3.69
7.38
100
11.67
11.67
23.33
For transmitters rated at a maximum output power not listed
above, the recommended separation distance d in metres (m) can
be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the
higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.

Chapter 6 Accessories
Use only accessories specified in this manual. Using other
accessories may cause damage to the pulse oximeter. Or the
performance of oximeter cannot meet the specifications
claimed in this specification.
The accessory material that contacts the user or other
personnel has undertaken the bio-compatibility test and is
verified to be in compliance with ISO 10993-1.
1 USB Charging cable
1 User Manual
1 Quality Certificate
Chapter 7 Cleaning and Maintenance
7.1 Cleaning
To clean or disinfect the device should use materials and
methods listed in this section. Otherwise, we shall assume no
responsibility for the effectiveness.
The cleaning agents below can only be used for general
cleaning. If you use them to control infections, we shall assume
no responsibility for the effectiveness. Please consult the
hospital infection prevention departments or epidemic experts
for controlling infection.
To avoid damage to the oximeter, follow these rules：
Dilute the agents according to your local distributor’s
suggestions. The recommended times of disinfection is
three hundred.
Never submerge the device in water or any cleaning
agent, or pour or spray water or any cleaning agent on
the device.
Never permit fluids to run into the casing, switches,
connectors, or any ventilation openings in the device.
Do not allow liquid to enter the sensor connector
Never use abrasive, erosive cleaners (such as steel wool,
silver polishes), or cleaners containing acetone.
WARNING
1Disconnect power-supply before cleaning the pulse oximeter.
2Be sure to shut down the oximeter and disconnect all power
cables from the outlets before cleaning the oximeter.
3Do not disinfect the oximeter with methods such as high
temperature, high pressure, gas fumigation or liquid immerse.
Follow the manufacturer's instructions of cleaning and
disinfection for pulse oximeter.
4Oximeter’s regular calibration and maintenance should be
taken by qualified professionals.
Cleaning agents
70 vol% isopropyl
75 vol% ethyl alcohol
Do as follow steps when cleaning the device
1. Power off the oximeter.
2. Wipe the oximeter case with a soft cloth dampened with a
cleaning agent. Recommended disinfection material,
Alcohol based (Ethanol 75%, Isopropanol 70%) and
aldehyde based.
3. Wipe off excessive cleaning agent with a dry cloth after
cleaning.
4. Dry the oximeter in a cool ventilated environment.
Note:
1 Don’t attempt to disassemble the device or repair it unless
you are trained personnel.
2 If you spill liquid on the equipment or accessories, Wipe the
oximeter immediately and dry the oximeter. If the oximeter
cannot work normal please contact us or your service
personnel.
7.2 Disinfection
Disinfection may cause damage to the oximeter. We
recommend that you disinfect the oximeter only when
necessary. Clean the oximeter before disinfection.
Recommended cleaning agent is Ethanol (75%).
The recommended times of disinfection is not more than 300.
Note: Never use EtO or formaldehyde for disinfection.
7.3 Maintenance
The overall check of the device should be performed only by
qualified personnel every 24 months, and each time after fix up.
The following items should be checked:
If the environment condition and power supply meet
requirement.
If the device and accessories have damage.
Specified accessories.
Battery performance
If all monitoring functions are in good conditions.
If any damage or abnormality is found, please don’t use the device
and contact local Customer Service Center.
Chapter 8 Specification
Safety specifications (classified according to IEC60601-1)
Electric shock protection
Class II with internal power
supply device
Degree of protection against
electrical shock
Type BF applied part
Degree of protection against
ingress of liquid
IPX1, non AP/APG type
Operating mode
Continuous
Physical Specifications
LxWxH
mm x mm x mm
SONOSAT-F01 series: 72 x 32 x 27
SONOSAT-F02 series: 68 x 32 x 27
Weight
SONOSAT-F01 series: less than 50g
SONOSAT-F02 series: less than 50g
Hardware specifications
Display screen
LCD
Buzzle
1, pulse tone
Charging connector
1, Micro USB connector
Environmental Specifications
Working
Transport and
Storage
Temperature(℃)
5～40
-20～60
Relative humidity (non
condensing)
30%～80%
10%～95%
Atmospheric Pressure(kPa)
70～106
70～106
Recommended maximum
charge and discharge ambient
temperature
Charge: 35℃；
Discharge: 45℃
Lithium battery (working power)
Quantity
1
Voltage rating
3.7V
Battery capacity
300mAh
Run time
20 hours(Fully-charged new
battery, Ambient temperature:
25℃)
Charging Voltage & Current
5V～160mA
Charge time
2.5 hours (charge to 90% of
capacity)
Shutdown delay
Max. 5 minutes after the low
battery prompt first occurs.
Note: The information about wavelength range and maximum photic
output consumption can be especially useful to clinicians, for example,
clinicians performing photodynamic therapy.
Chapter 9 Troubleshooting
Problems
Possible Reason
Solutions
Device can’t
be powered
on.
Critical low battery.
Please charge.
Device might be damaged.
Please contact local
customer service
centre.
SpO2or PR
value can’t be
shown
normally.
The sensor is applied
incorrectly.
Re-apply the sensor.
There is very bright light.
Don’t use the bright
light device in the
environment with high
ambient light.
Patient is in low perfusion
or patient’s
oxyhemoglobin is too low
to be measured.
Go to a hospital for
diagnosis.
SpO2or PR
value is
unstable.
Finger might not be
inserted deep enough.
Re-apply the senor.
Finger is trembling or
patient is moving.
Please keep quiet.
Chapter 10 Warranty and Service Policy
10.1 Warranty
Konsung warrants that Konsung’s products meet the labeled
specifications of the products and will be free from defects in
materials and workmanship that occur within warranty period.
The warranty is void in cases of:
damage caused by mishandling during shipping.
subsequent damage caused by improper use or maintenance.
damage caused by alteration or repair by anyone not authorized
by Konsung.
damage caused by accidents.
replacement or removal of serial number label and manufacture
label.
If a product covered by this warranty is determined to be defective
because of defective materials, components, or workmanship, and
the warranty claim is made within the warranty period, Konsung will,
at its discretion, repair or replace the defective part(s) free of charge.
Konsung will not provide a substitute product for use when the
defective product is being repaired.
10.2 Contact Information
If any questions in equipment operation, please contact the
manufacturer or local agency.
Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
Address: NO.8, Shengchang West Road, Danyang Development
Zone, Jiangsu Province, 212300, P.R. China
Tel: [phone]
Fax: [phone]
E-mail: [e-mail]
Chapter 11 EMC
11.1 Electromagnetic Emissions-for all
EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic
emission
The oximeter is intended for use in the electromagnetic
environment specified below. The customer or the user of the
oximeter should assure that it is used in such an environment.
Emission test
Compliance
Electromagnetic environment –
guidance
RF(Radio
frequency)
emissions
CISPR 11
Group 1
The 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(Radio
frequency)
CISPR 11
Class B
The oximeter is suitable for use
in all establishments, other than
domestic establishments and
those directly connected to the
public low-voltage power supply
network that supplies buildings
used for domestic purposes.
Harmonic
emissions
IEC/EN 61000-3-2
Class A
Voltage
fluctuations/
flicker emissions
IEC/EN 61000-3-3
Complies
11.2 Electromagnetic Immunity-for all
EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic
immunity
The oximeter is intended for use in the electromagnetic
environment specified below. The customer or the user of the
oximeter should assure that it is used in such an environment.
Immunity test
IEC/EN
60601 test
level
Compliance
level
Electromagnetic
environment - guidance
Electrostatic
discharge (ESD)
IEC/EN 61000-
4-2
6 kV
contact
8 kV air
6 kV
contact
8 kV air
Floors should be wood,
concrete or ceramic tile.
If floor are covered with
synthetic material, the
relative humidity should
be at least 30%.
Electrical fast
transient/burst
IEC/EN 61000-
4-4
2 kV for
power
supply
lines
1 kV for
input
/output
signal(>3m)
2kV for
power
supply lines
1 kV for
input
/output
signal(>3m)
Mains power quality
should be that of a
typical commercial or
hospital environment.
Surge
IEC/EN 61000-
4-5
1 kV for
line to line
2 kV for
line to
ground
1 kV for
line to line
2 kV for
line to
ground
Mains power quality
should be that of a
typical commercial or
hospital environment.
Power
frequency
(50/60Hz)
magnetic field
IEC/EN 61000-
4-8
3A/m
3A/m
Power frequency
magnetic fields should
be at levels characteristic
of a typical location in a
typical commercial or
hospital environment.
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC/EN 61000-
4-11
<5% UT
(>95% dip
in UT)
for 0.5
cycle
40% UT
(60% dip in
UT)
for 5 cycles
70% UT
(30% dip in
UT)
for 25
cycles
<5% UT
(>95% dip
in UT)
for 5 sec
<5% UT
(>95% dip
in UT)
for 0.5
cycle
40% UT
(60% dip in
UT)
for 5 cycles
70% UT
(30% dip in
UT)
for 25
cycles
<5% UT
(>95% dip
in UT)
for 5 sec
Mains power quality
should be that of a
typical commercial or
hospital environment. If
the user of the Oximeter
requires continued
operation during power
mains interruptions, it is
recommended that the
Oximeter be powered
from an uninterruptible
power supply or a
battery.
NOTE: UTis the AC mains voltage prior to application of the test
level.
11.3 Electromagnetic Immunity-for EQUIPMENT
and SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacture’s declaration – electromagnetic
immunity
The oximeter is intended for use in the electromagnetic
environment specified below. The customer or the user of oximeter
should assure that it is used in such an environment.
Immunity
test
IEC/EN
60601
test
level
Compliance
level
Electromagnetic environment -
guidance
Conducted
RF
IEC/EN
61000-4-6
Radiated
RF
IEC/EN
61000-4-3
3 Vrms
150 kHz
to 80
MHz
3 V/m
80 MHz
to 2.5
GHz
3 Vrms
3 V/m
Portable and mobile RF
communications equipment
should be used no closer to any
part of the Oximeter, including
cables, than the recommended
separation distance calculated
from the equation applicable to
the frequency of the transmitter.
Recommended separation
distance
P
V
d
1
5.3
P
E
d
1
5.3
80 MHz to 800 MHz
P
E
d
1
7
800 MHz to 2.5 GHz
Where P is the maximum
output power rating of the
transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation
distance in metres (m).
Field strengths from fixed RF
transmitters, as determined by
an electromagnetic site survey,a
should be less than the
compliance level in each
frequency range.b
Interference may occur in the
vicinity of equipment marked
with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range
applies.
NOTE 2 These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for
radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the
measured field strength in the location in which the Oximeter is
used exceeds the applicable RF compliance level above, the
Oximeter should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the Oximeter.
b Over the frequency range 150kHz to 80MHz, field strengths
should be less than 3V/m.
11.4 Recommended Separation Distances
Recommended separation distances between portable and
mobile RF communications equipment and the oximeter
The oximeter is intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The
customer or the user of the oximeter can help prevent
electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment
(transmitters) and the oximeter as recommended below, according
to the maximum output power of the communications equipment.
Rated maximum output
power of transmitter
(W)
Separation distance according to
frequency of transmitter(m)
150 kHz to
80 MHz
P
V
d
1
5.3
80 MHz to
800 MHz
P
E
d
1
5.3
800 MHz to
2.5 GHz
P
E
d
1
7
0.01
0.12
0.12
0.23
0.1
0.36
0.37
0.74
1
1.16
1.17
2.33
10
3.69
3.69
7.38
100
11.67
11.67
23.33
For transmitters rated at a maximum output power not listed
above, the recommended separation distance d in metres (m) can
be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the
higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.

Chapter 6 Accessories
Use only accessories specified in this manual. Using other
accessories may cause damage to the pulse oximeter. Or the
performance of oximeter cannot meet the specifications
claimed in this specification.
The accessory material that contacts the user or other
personnel has undertaken the bio-compatibility test and is
verified to be in compliance with ISO 10993-1.
1 USB Charging cable
1 User Manual
1 Quality Certificate
Chapter 7 Cleaning and Maintenance
7.1 Cleaning
To clean or disinfect the device should use materials and
methods listed in this section. Otherwise, we shall assume no
responsibility for the effectiveness.
The cleaning agents below can only be used for general
cleaning. If you use them to control infections, we shall assume
no responsibility for the effectiveness. Please consult the
hospital infection prevention departments or epidemic experts
for controlling infection.
To avoid damage to the oximeter, follow these rules：
Dilute the agents according to your local distributor’s
suggestions. The recommended times of disinfection is
three hundred.
Never submerge the device in water or any cleaning
agent, or pour or spray water or any cleaning agent on
the device.
Never permit fluids to run into the casing, switches,
connectors, or any ventilation openings in the device.
Do not allow liquid to enter the sensor connector
Never use abrasive, erosive cleaners (such as steel wool,
silver polishes), or cleaners containing acetone.
WARNING
1Disconnect power-supply before cleaning the pulse oximeter.
2Be sure to shut down the oximeter and disconnect all power
cables from the outlets before cleaning the oximeter.
3Do not disinfect the oximeter with methods such as high
temperature, high pressure, gas fumigation or liquid immerse.
Follow the manufacturer's instructions of cleaning and
disinfection for pulse oximeter.
4Oximeter’s regular calibration and maintenance should be
taken by qualified professionals.
Cleaning agents
70 vol% isopropyl
75 vol% ethyl alcohol
Do as follow steps when cleaning the device
1. Power off the oximeter.
2. Wipe the oximeter case with a soft cloth dampened with a
cleaning agent. Recommended disinfection material,
Alcohol based (Ethanol 75%, Isopropanol 70%) and
aldehyde based.
3. Wipe off excessive cleaning agent with a dry cloth after
cleaning.
4. Dry the oximeter in a cool ventilated environment.
Note:
1 Don’t attempt to disassemble the device or repair it unless
you are trained personnel.
2 If you spill liquid on the equipment or accessories, Wipe the
oximeter immediately and dry the oximeter. If the oximeter
cannot work normal please contact us or your service
personnel.
7.2 Disinfection
Disinfection may cause damage to the oximeter. We
recommend that you disinfect the oximeter only when
necessary. Clean the oximeter before disinfection.
Recommended cleaning agent is Ethanol (75%).
The recommended times of disinfection is not more than 300.
Note: Never use EtO or formaldehyde for disinfection.
7.3 Maintenance
The overall check of the device should be performed only by
qualified personnel every 24 months, and each time after fix up.
The following items should be checked:
If the environment condition and power supply meet
requirement.
If the device and accessories have damage.
Specified accessories.
Battery performance
If all monitoring functions are in good conditions.
If any damage or abnormality is found, please don’t use the device
and contact local Customer Service Center.
Chapter 8 Specification
Safety specifications (classified according to IEC60601-1)
Electric shock protection
Class II with internal power
supply device
Degree of protection against
electrical shock
Type BF applied part
Degree of protection against
ingress of liquid
IPX1, non AP/APG type
Operating mode
Continuous
Physical Specifications
LxWxH
mm x mm x mm
SONOSAT-F01 series: 72 x 32 x 27
SONOSAT-F02 series: 68 x 32 x 27
Weight
SONOSAT-F01 series: less than 50g
SONOSAT-F02 series: less than 50g
Hardware specifications
Display screen
LCD
Buzzle
1, pulse tone
Charging connector
1, Micro USB connector
Environmental Specifications
Working
Transport and
Storage
Temperature(℃)
5～40
-20～60
Relative humidity (non
condensing)
30%～80%
10%～95%
Atmospheric Pressure(kPa)
70～106
70～106
Recommended maximum
charge and discharge ambient
temperature
Charge: 35℃；
Discharge: 45℃
Lithium battery (working power)
Quantity
1
Voltage rating
3.7V
Battery capacity
300mAh
Run time
20 hours(Fully-charged new
battery, Ambient temperature:
25℃)
Charging Voltage & Current
5V～160mA
Charge time
2.5 hours (charge to 90% of
capacity)
Shutdown delay
Max. 5 minutes after the low
battery prompt first occurs.
Note: The information about wavelength range and maximum photic
output consumption can be especially useful to clinicians, for example,
clinicians performing photodynamic therapy.
Chapter 9 Troubleshooting
Problems
Possible Reason
Solutions
Device can’t
be powered
on.
Critical low battery.
Please charge.
Device might be damaged.
Please contact local
customer service
centre.
SpO2or PR
value can’t be
shown
normally.
The sensor is applied
incorrectly.
Re-apply the sensor.
There is very bright light.
Don’t use the bright
light device in the
environment with high
ambient light.
Patient is in low perfusion
or patient’s
oxyhemoglobin is too low
to be measured.
Go to a hospital for
diagnosis.
SpO2or PR
value is
unstable.
Finger might not be
inserted deep enough.
Re-apply the senor.
Finger is trembling or
patient is moving.
Please keep quiet.
Chapter 10 Warranty and Service Policy
10.1 Warranty
Konsung warrants that Konsung’s products meet the labeled
specifications of the products and will be free from defects in
materials and workmanship that occur within warranty period.
The warranty is void in cases of:
damage caused by mishandling during shipping.
subsequent damage caused by improper use or maintenance.
damage caused by alteration or repair by anyone not authorized
by Konsung.
damage caused by accidents.
replacement or removal of serial number label and manufacture
label.
If a product covered by this warranty is determined to be defective
because of defective materials, components, or workmanship, and
the warranty claim is made within the warranty period, Konsung will,
at its discretion, repair or replace the defective part(s) free of charge.
Konsung will not provide a substitute product for use when the
defective product is being repaired.
10.2 Contact Information
If any questions in equipment operation, please contact the
manufacturer or local agency.
Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
Address: NO.8, Shengchang West Road, Danyang Development
Zone, Jiangsu Province, 212300, P.R. China
Tel: [phone]
Fax: [phone]
E-mail: [e-mail]
Chapter 11 EMC
11.1 Electromagnetic Emissions-for all
EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic
emission
The oximeter is intended for use in the electromagnetic
environment specified below. The customer or the user of the
oximeter should assure that it is used in such an environment.
Emission test
Compliance
Electromagnetic environment –
guidance
RF(Radio
frequency)
emissions
CISPR 11
Group 1
The 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(Radio
frequency)
CISPR 11
Class B
The oximeter is suitable for use
in all establishments, other than
domestic establishments and
those directly connected to the
public low-voltage power supply
network that supplies buildings
used for domestic purposes.
Harmonic
emissions
IEC/EN 61000-3-2
Class A
Voltage
fluctuations/
flicker emissions
IEC/EN 61000-3-3
Complies
11.2 Electromagnetic Immunity-for all
EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic
immunity
The oximeter is intended for use in the electromagnetic
environment specified below. The customer or the user of the
oximeter should assure that it is used in such an environment.
Immunity test
IEC/EN
60601 test
level
Compliance
level
Electromagnetic
environment - guidance
Electrostatic
discharge (ESD)
IEC/EN 61000-
4-2
6 kV
contact
8 kV air
6 kV
contact
8 kV air
Floors should be wood,
concrete or ceramic tile.
If floor are covered with
synthetic material, the
relative humidity should
be at least 30%.
Electrical fast
transient/burst
IEC/EN 61000-
4-4
2 kV for
power
supply
lines
1 kV for
input
/output
signal(>3m)
2kV for
power
supply lines
1 kV for
input
/output
signal(>3m)
Mains power quality
should be that of a
typical commercial or
hospital environment.
Surge
IEC/EN 61000-
4-5
1 kV for
line to line
2 kV for
line to
ground
1 kV for
line to line
2 kV for
line to
ground
Mains power quality
should be that of a
typical commercial or
hospital environment.
Power
frequency
(50/60Hz)
magnetic field
IEC/EN 61000-
4-8
3A/m
3A/m
Power frequency
magnetic fields should
be at levels characteristic
of a typical location in a
typical commercial or
hospital environment.
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC/EN 61000-
4-11
<5% UT
(>95% dip
in UT)
for 0.5
cycle
40% UT
(60% dip in
UT)
for 5 cycles
70% UT
(30% dip in
UT)
for 25
cycles
<5% UT
(>95% dip
in UT)
for 5 sec
<5% UT
(>95% dip
in UT)
for 0.5
cycle
40% UT
(60% dip in
UT)
for 5 cycles
70% UT
(30% dip in
UT)
for 25
cycles
<5% UT
(>95% dip
in UT)
for 5 sec
Mains power quality
should be that of a
typical commercial or
hospital environment. If
the user of the Oximeter
requires continued
operation during power
mains interruptions, it is
recommended that the
Oximeter be powered
from an uninterruptible
power supply or a
battery.
NOTE: UTis the AC mains voltage prior to application of the test
level.
11.3 Electromagnetic Immunity-for EQUIPMENT
and SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacture’s declaration – electromagnetic
immunity
The oximeter is intended for use in the electromagnetic
environment specified below. The customer or the user of oximeter
should assure that it is used in such an environment.
Immunity
test
IEC/EN
60601
test
level
Compliance
level
Electromagnetic environment -
guidance
Conducted
RF
IEC/EN
61000-4-6
Radiated
RF
IEC/EN
61000-4-3
3 Vrms
150 kHz
to 80
MHz
3 V/m
80 MHz
to 2.5
GHz
3 Vrms
3 V/m
Portable and mobile RF
communications equipment
should be used no closer to any
part of the Oximeter, including
cables, than the recommended
separation distance calculated
from the equation applicable to
the frequency of the transmitter.
Recommended separation
distance
P
V
d
1
5.3
P
E
d
1
5.3
80 MHz to 800 MHz
P
E
d
1
7
800 MHz to 2.5 GHz
Where P is the maximum
output power rating of the
transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation
distance in metres (m).
Field strengths from fixed RF
transmitters, as determined by
an electromagnetic site survey,a
should be less than the
compliance level in each
frequency range.b
Interference may occur in the
vicinity of equipment marked
with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range
applies.
NOTE 2 These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for
radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the
measured field strength in the location in which the Oximeter is
used exceeds the applicable RF compliance level above, the
Oximeter should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the Oximeter.
b Over the frequency range 150kHz to 80MHz, field strengths
should be less than 3V/m.
11.4 Recommended Separation Distances
Recommended separation distances between portable and
mobile RF communications equipment and the oximeter
The oximeter is intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The
customer or the user of the oximeter can help prevent
electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment
(transmitters) and the oximeter as recommended below, according
to the maximum output power of the communications equipment.
Rated maximum output
power of transmitter
(W)
Separation distance according to
frequency of transmitter(m)
150 kHz to
80 MHz
P
V
d
1
5.3
80 MHz to
800 MHz
P
E
d
1
5.3
800 MHz to
2.5 GHz
P
E
d
1
7
0.01
0.12
0.12
0.23
0.1
0.36
0.37
0.74
1
1.16
1.17
2.33
10
3.69
3.69
7.38
100
11.67
11.67
23.33
For transmitters rated at a maximum output power not listed
above, the recommended separation distance d in metres (m) can
be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the
higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.

Fingertip Pulse Oximeter
User Manual
Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd
Jiangsu Konsung Bio-Medical Science And Technology
Co., Ltd
NO.8, Shengchang West Road, Danyang
Development Zone, Jiangsu Province, 212300,
P.R. China
Tel: [phone]
WhatsApp:[phone]
E-mail: info@ konsung.com
Website: www.konsungmedical.com
Shanghai International Holding Corp. GmbH
(Europe)
Eiffestrasse 80, 20537 Hamburg Germany
Tel: [phone] Fax: [phone]
E-mail: [e-mail]
Statement
Thanks for your purchasing Fingertip oximeter of Jiangsu Konsung Bio-
Medical Science And Technology Co., Ltd. (hereinafter called Konsung).
Before using this oximeter, please read this manual carefully for
understanding the operation and maintenance of the oximeter.
Konsung holds the rights to modify, update, and ultimately explain this
manual.
Konsung owns the copyrights of this manual. Without prior written
consent of Konsung, any materials contained in this manual shall not be
photocopied, reproduced or translated into other languages.
Materials protected by the copyright law, including but not limited to
confidential information such as technical information and patent
information are contained in this manual, the user shall not disclose such
information to any irrelevant third party.
This manual will help you understand the operation and maintenance of
the product better. It is reminded that the product shall be used strictly
complying with this manual. User‘s operation failing to comply with this
manual may result in malfunction or accident for which Konsung cannot
be held liable.
Fingertip Pulse Oximeter is Class 1 LEDs product. It must be serviced by
specified trained personnel.
Responsibility of the Manufacturer
Konsung only considers itself responsible for any effect on safety,
reliability and performance of the equipment if:
Assembly operations, extensions, re-adjustments, modifications or
repairs are carried out by persons authorized by Konsung, and
The electrical installation of the relevant room complies with national
standards, and
The instrument is used in accordance with the instructions for use.
Upon request, Konsung may provide, with compensation, necessary
circuit diagrams, and other information to help qualified technician to
maintain and repair some parts, which Konsung may define as user
serviceable.
Chapter 1 Safety
1.1 Safety Information
The user should pay attention to and abide by the basic safety
information which was referred to in this chapter.
WARNING
AWARNING label advises against certain actions or situations
that could result in personal injury or death.
CAUTION
ACAUTION label advises against actions or situations that
could damage equipment, produce inaccurate data, or
invalidate a procedure.
NOTE
ANOTE provides useful information regarding a function or a
procedure.
WARNING
1 This device is not intended for treatment.
2 Carefully read this manual about all safety information, operation
and specifications before using this oximeter.
3 Do not open the shell of the instrument. Otherwise you may
damage the instrument. All servicing and future upgrades must be
carried out by the personnel trained and authorized by our company
only.
4 Do not use this device with the defibrillator or other high-frequency
equipment.
5 Explosion hazard: Do not use this device in an explosive atmosphere.
6 Check and change the applied site according to the different
circumstances of the user while using this device for long-time
continuous monitoring. It is recommended to check the finger after
2 hours. Change other finger to be measured if the finger seems to
be unusual. If the oximeter is too tight because the application site
is too large or becomes too large due to edema, excessive pressure
for prolonged periods may result in venous congestion distal from
the application site, leading to interstitial edema and tissue
ischemia.
7 The measuring data displayed on the device are for reference only
and cannot be directly used for diagnostic interpretation.
8 This device is not intended to use of infant and neonate.
9 In some circumstances, the device may interpret motion as good
pulse quality. Minimize patient motion as much as possible.
10 The presence of high ambient light may cause inaccurate SpO2
measurements.
11 Charge this device only by connecting it to a designated device
compliant with IEC60601-1 requirements of electrical safety and
ensure the designated device’s voltage and current meet the
requirements of this Manual.
12 Do not connect it to any external device or operate it for
measurement when this device is being charged.
13 Do not use this device in situations where alarms required. The
oximeter does not support alarms.
14 Users who are allergic to rubber cannot use this product.
15 Disposal of this device and its accessories and packaging (plastic
bags, foam and cartons, etc.) are subject to local laws and
regulations.
CAUTION
1 To ensure patient safety, use only parts and accessories specified in
this manual.
2 Keep the operating environment clean, no vibration, no corrosion
or combustible material and avoid too high or too low temperature
and humidity.
3 Do not use this device near by the source of electromagnetic
interference, such as mobile phones or radio transmitter.
4 Do not spill liquid on the device. Do not immerse the device in
liquid.
5 Always install or carry the device properly to avoid damage caused
by drop, impact, strong vibration or other mechanical force.
6 Do not use this device if the device cannot achieve satisfactory
results.
NOTE
1 Too cold or too thin finger may affect the measurements; thicker
finger (recommended thumb or middle finger) should insert into the
cover fully.
2 Avoid placing the sensor on extremities with an arterial catheter, or
intravascular venous infusion line.
3 Check the device before using. Do not use it if there is significant
damage.
4 Do not use the functional tester to access the SpO2accuracy.
5 This device is calibrated to display functional oxygen saturation.
6 The pictures and interfaces in this manual are for reference only.
7 This Manual is prepared based on the most complete configuration.
Some configurations and functions may be not available in your
device.
8 Fingernail polish or false fingernails may cause inaccurate SpO2
readings.
1.2 Symbols
Symbols
Definition of symbols
Follow instructions for use
Caution
No alarm
Type BF Applied Part
Battery indication
SpO2
Oxygen saturation of arterial hemoglobin
PR
Pulse Rate
The symbol indicates that the device should be
sent to the special agencies according to local
regulations for separate collection after its useful
life.
The symbol indicates that the device complies with
the European Council Directive 93/42/EEC
concerning medical devices.
Authorized representative in the European
community
Serial Number
P/N
Part Number
Batch number
Manufacturer
Date of manufacture
IP22
2 degree Protection Against Ingress of Liquids and
dust.
Chapter 2 General
2.1 Introduction
Sonosat F fingertip pulse oximeter using spectrophotometry, by
detecting the blood red and infrared absorption of light to obtain
the oxygen saturation (SpO2) and pulse rate (PR).
Oxygen saturation is a term referring to the fraction of oxygen-
saturated hemoglobin (HbO2) relative to total hemoglobin(Hb) in the
blood, that is, the oxygen saturation in the blood, which is an
important physiological parameter of the respiratory and circulatory
system. Many respiratory diseases can cause oxygen saturation
decrease. The body's automatic regulatory dysfunction caused by
anesthesia, major surgery trauma, and injury caused by some
medical examination etc., are likely to lead to the oxygen saturation
decrease, resulting in patients with dizziness, weakness, vomiting
and other symptoms; severe cases will be life-threatening. SpO2 has
important significance in the field of clinical medical. And timely
understanding of the patient's blood oxygen saturation situation will
help physician find problems.
This device is not suitable for continuous monitoring of patients.
2.2 Intended Use and Contraindication
Intended use: The fingertip pulse oximeter is intended to measure the
pulse oxygen saturation of arterial hemoglobin and pulse rate of adults
and pediatrics in home care and medical outpatient environment.
Contraindication: none
2.3 Applications
This device is suitable for the following people: People with
vascular disease, such as: coronary heart disease, hypertension,
hyperlipidemia, cerebral thrombosis;
People with respiratory diseases, such as: asthma, trachitis,
chronic bronchitis, chronic cor pulmonale, chronic obstructive
pulmonary disease;
Old people above 60 years old
People who works more than 12 hours a day;
People works on extreme exercise or under the alpine hypoxic
environment;
Long-term alcohol people.
2.4 Appearance
2.4.1 Front view
1. Battery capacity Indicator
Full capacity, the middle part indicates the
capacity.
Capacity is seriously empty, charge it
immediately.
2. Power On/Off switch
Turn on the oximeter: Press the ON/OFF button to
turn on the device.
Turn off the oximeter: Press this button for 2 seconds
to turn the device off.
Press this button to highlight the display when the
display is in low brightness.
3. Display screen
4. SpO2value
5. PR value: Pulse rate per minute.
6. Bluetooth icon
on: means connected to Bluetooth device
off: means disconnected to Bluetooth device
7. Heart symbol
8. Pulse rate bar graph
2.4.2 Side view
1. Micro USB connector: charging battery with specified
charging cable connected to adaptor.
2. Rubber finger cover
Chapter 3 Unpacking and Storage
3.1 Open-case inspection
Before unpacking, examine the packing case carefully for
signs of damage. If any damage is detected, contact the
carrier or us. Take out all bulk packaging from the carton. If
the packing case is intact, open the package and remove the
equipment and accessories carefully.
Check whether there is any damage to the surface of the
oximeter such as notches, dents, abrasions and so on. Check
whether the components are missing according to packing
list.
3.2 Storage
The oximeter is manufactured with precision parts. Do not
place the oximeter in the following places:
Easy to splash;
With Direct sunlight, high temperature, humidity, dust,
and corrosive gas;
Tilt, generate vibration and impact;
Store chemicals or corrosive gases.
Chapter 4 Measurement operation
1. Insert finger to oximeter's cover fully to obtain good
measurements.
2. Press the ON/OFF button to turn the oximeter on.
3. SpO2and pulse rate value displays on screen.
NOTE:
1 The oximeter cannot be measured while charging.
2 Finger can not apply nail polish and other cosmetics.
3 Do not shake the finger, hand or body during the measuring.
4 Tape or other light obstructions around the applied site may
affect the accuracy of SpO2and pulse rate.
5 The oximeter will shut down if no any actions within 10
seconds after it turning on.
The following factors may influence the accuracy of measurement:
Ambient light
Physical movement (passive and imposed motion)
Diagnostic testing
Low perfusion
Electromagnetic interference, such as MRI environment
Electrosurgical units
Dysfunctional haemoglobin, such as carboxyhemoglobin
(COHb)and methemoglobin (MetHb)
Presence of certain dyes, such as methylene and indigo
carmine
Inappropriate positioning of the SpO2sensor, or use of
incorrect SpO2sensor.
Drop of arterial blood flow to immeasurable level caused by
shock, anemia, low temperature or vasoconstrictor.
Chapter 5 Charging Battery
The oximeter uses a built-in non-removable rechargeable
lithium battery. Symbol will flash when battery capacity is
low. Charge the battery according to the following steps.
1. Take out the cable and connect it to oximeter's Micro USB
connector.
2. Plug the other end of cable to USB adaptor. Battery
symbol appear and flashes on the screen while charging.
The performance of the rechargeable lithium battery may
deteriorate over time. If the operating time of the battery is
noticeably shorter than that stated in the specifications,
contact your service personnel.
Follow the appropriate local regulations and do not dispose of
oximeter (includes battery).
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