Pulse Oximeter - Protekt® Proactive Finger

SKU 20110
$48.95
In stock
1
Product Details
  • Ideal for use in multiple applications; hospital, nursing home, community medical treatment, home care, sports center, etc.
  • Portable non-invasive spot check oxygen saturation and heart rate.
  • Displays digital SpO2 and pulse rate while using bar graph technology to monitor heart rate.
  • Automatic power off.
  • Two AAA batteries included.
  • 1 Year limited warranty.

OACTIVE MEDICAL FINGER PULSE OXIMETER

Warning

The information you should know to protect patients and medical staff from possible injury


Instructions for the Safe Operation and Use of the Pulse Oximeter

Do not attempt to service the pulse oximeter. Only qualified service personnel should attempt any needed internal servicing.
Do not use the oximeter in situations where alarms are required.
Prolonged use or the patient’s condition may require changing the sensor site periodically. Change sensor site and check skin integrity, circulatory status and correct alignment at least every 2 hours.

SpO2 measurements may be adversely affected in the presence of high ambient light. Shield the sensor area (with a surgical towel, or direct sunlight, for example) if necessary.
The following reasons will cause interference.

 High-frequency electrosurgical
Placement of a sensor on an extremity with a blood pressure cuff arterial

catheter, or intravascular line
The patient has hypotension severe vasoconstriction severe anemia or

hypothermia.
 The patient is in cardiac arrest or is in shock.
 Fingernail polish or false fingernails may cause inaccurate SpO2 readings.

USER’S MANUAL V1.0

2.1 Brief Device Description

The Pulse Oximeter, based on all digital technology, is intended for noninvasive spot-check measurement of functional oxygen saturation of arterial hemoglobin (SpO2). Advanced DSP algorithm can diminish the influence of motion artifact and improve measurement accuracy of low perfusion.

The Oximeter can be used to measure human Hemoglobin Saturation and heart rate through finger. The product is suitable for family, hospital (including clinical use in internist/surgery, pediatrics, etc.), Oxygen Bar, social medical organizations, physical care in sports and etc.

2.2 Intended Use

This product is suitable for the hospital (including surgery, anesthesiology, pediatrics, and clinical use), oxygen bar, sports health (using them before or after sports, do not advise using them during the movement), and community health care, etc.
2.3 Contraindication

It is not for intensive care and person whose finger is injured.

2.4 Product Features

 Lightweight for carrying and Easy-To-Use.
 Manually adjust the direction of interface.
 LEDdisplay,simultaneousdisplayfortestingvalueandplethysmogram.  Real-time spot-check.
 Low-Battery voltage indicator.
 Automatically standby or sleep.

Section 3 Installation, Setup, and Operation

3.1 Description of the Front Panel (as FIG.1)
1 2 Table 1 Part Definition and Description

3

FIG.1 Parts of front & back panel

3.2 Display

After switching on, the LED display is as follows:

FIG.2 LED display

3.3 Operation

3.3.1 Install battery
Installing two AAA batteries into battery cassette in correct polarities and cover it

page1image352175888

1.2 Warning

WARNING: EXPLOSION HAZARD — Do not use the oximeter in a flammable atmosphere where concentrations of flammable anesthetics or other materials may occur.

WARNING: Do not throw batteries in fire as this may cause them to explode.

WARNING: Do not use the pulse oximeter in an MRI or CT environment.

CAUTION: Keep the operating environment free of dust, vibrations, corrosive, or flammable materials, and extremes of temperature and humidity.

CAUTION: Do not operate the unit if it is damp or wet because of condensation or spills. Avoid using the equipment immediately after moving it from a cold environment to a warm, humid location.

WARNING: Do not attempt to recharge normal dry-cell batteries, they may leak. And may cause a fire or even explode.

CAUTION: Never use sharp or pointed objects to operate the front-panel switches.

CAUTION: The battery must be taken out from the battery compartment if the device will not be used for a long time.

CAUTION: The device shall only be used if the battery cover is closed.

CAUTION: The battery must be proper disposed according to local regulation after their use.

page1image391914800 page1image391915072 page1image391915344 page1image391915616 page1image391915904

Item

page1image391919376

Name

page1image391917152

Description

1

LED Panel

Display the SPO2/PR data & Bargraph

2

page1image391940448

Key

page1image391938560

Start the working state

3

page1image391947488 page1image391949648

Battery Compartment

2*AAA 1.5V Alkaline battery

page1image391958272
page1image391958864 page1image391959136 page1image391959408

1.3 Definitions and Symbols

Symbol

Description

page1image391972416

Symbol

page1image391971552
page1image391975312

Description

page1image391978592
page1image391981328

Type BF Equipment

page1image391986288 page1image391986512

Information of manufacture, including name and address

page1image391993568
page1image391996544

Refer to the instruction manual /booklet

page1image392002960

When the end-user wishes to discard this product, it must be sent to separate collection facilities for recovery and recycling

page1image392017152 page1image392016096 page1image392018544

Serial NO*

page1image392022384

No SpO2 Alarm

(as FIG.3)

FIG.3
3.3.2 Turn the Pulse Oximeter on

Put one of fingers into rubber hole of the oximeter (it is best to put the finger thoroughly) with nail surface upward (as FIG.4), then releasing the clamp.

FIG.4

Caution

The information you should know to protect the equipment from possible damage

page1image392057616 page1image392058208 page1image392058736 page1image392058944 page1image392059152

Note

The important information you should know

page1image392064528 page1image392065328 page1image392065600

Section 2 Introduction

page1image392067840 page1image392068128

WARNING: Do not attempt to recharge normal alkaline batteries, they may leak and may cause a fire or even explode.

page1image392078928 page1image392079216 page1image392079488 page1image392080352 page2image419588256 page2image419593008
page2image419469088

Oxyhemoglobin or heart rate cannot be shown normally

page2image419658336

1. Finger is not plugged correctly.
2. Patient’s perfusion is too low to be measured.

page2image419669328

1. Retry by plugging the finger. 2. Try some more times, if you can make sure about no problem existing in the product, please go to a hospital timely for exact diagnosis.

page2image419683712

Oxyhemoglobin or heart rate is shown unstably

page2image419690352
page2image419693168

1. Finger might not be plugged deep enough.
2. Finger is trembling or patient's body is in movement status.

page2image419703376
page2image419705632

11.Retry by plugging the finger. 2.Try not to move, Let the patient keep calm.

page2image419713008

The oximeter can’t go into the working state

1. Power of batteries might be inadequate or not be there at all 2. Batteries might be installed incorrectly.

3.The Oximeter might be damaged.

1. Please replace batteries 2.Please reinstall the batteries 3.Please contact with local customer service center

page2image419744304

The screen is suddenly off

page2image419749408
page2image419752560

1.The product is automatically standby or sleep when no signal is detected longer than 8 seconds.

2.Power quantity of the batteries is exhausted.

page2image419765712
page2image419767904

1.Normal.
2.Replace the batteries.

page2image419771376

Press the key, oximeter will go into the working state.
The oximeter will automatic standby or go asleep after 8 seconds without finger in.

3.3.3 Read correspondent data from display screen. 3.3.4 Display Description of LED

The display interface of “LED” can rotate two directions after pressing the key for less than 0.5s. It is shown as below:

FIG.5
Note: when battery power is at lowest level, the battery capacity indicates symbol of

“ ”in LED, remind users of replacement of battery.

3.4 Install Hanging Rope

Let the thin end of the rope go through the hole, next let the big point of rope go through the thin rope hole, then tighten the rope.

FIG.6 Install hanging rope

Section 4 Maintenance

4.1 Cleaning

Switch off the power and take out the batteries before cleaning, Cleaning exterior surface (screen included) of the unit with a dry and soft cloth. Use 75% density of medical alcohol to clean the surface and use dry fabric with little alcohol to avoid alcohol permeates into the device
4.2 Disinfection

Disinfecting the machine after using by the patient if multiple patient use the machine in the hospital. Use 75% density of medical alcohol to clean the surface that contacting with the patient.

CAUTION: Don’t remain any cleaning solution on the surface of the device.

4.3. Warranty

The host product’ design life is 2 years, and 1 years warranty. Under normal circumstances, the malfunction of the product during the warranty period (from the date of purchase) should be sent back to the company for maintenance, and our company is responsible for all maintenance costs (users should cover the freight themselves). Outside the warranty period, our company shall charge some maintenance fee (users should cover the freight themselves) if the product has broken down and is sent back for maintenance. The battery is beyond the scope of the warranty. If you have the purchase and sale contract, the costs of the maintenance shall be in accordance with the purchase and sale contract execution. Our company can provide the designated qualified technical personnel with files listed GB9706.1 6.8.3 C. Besides, it is recommended that users should use them no more than five years. And over the using life, the using risks may increase due to the equipment’ aging.
4.4 Maintenance

  •  Replace the batteries timely when battery indication is low. Clean surface of theе Pulse Oximeter before it is used in diagnosis for patients.
  •  Remove the batteries inside the battery cassette if the Oximeter will not be operated for a long time.
  •  It is better to preserve the product in a place where ambient temperature is -20 - 55°C and humidity is 10%-95%.
  •  Regular inspection to make sure that no obvious damage existed to affect the safety and performance of device.
  •  No flammable substance, overtop or lower temperature and humidity existed in operation conditions.

4.6 Disposal

To avoid contaminating or infecting personnel, the environment or other equipment, make sure you disinfect or decontaminate the device appropriately before disposing of it in accordance with your country’s law for equipment containing electrical and electronic parts.

Section 5 Specification

Physical Characteristics

Machine Dimensions: 57mm (L) * 31mm (W) * 30.5mm (D) Machine Weight -approx.: 54 g( including 2 * AAA battery)

Classification

Anti-electric Shock Type:Internally powered equipment Anti-electric Shock Degree:Type BF equipment EMC:Type B class I
Mode of operation: Continuous Operation

Enclosure Degree of ingress protection: IP22

※IP22 mean shell of this product can withstand the water dropping to the surface when the shell deviate 15 degree from horizontal surface.
Power

Environmental

Electronics Parameters

page2image393606368 page2image393606720 page2image393607136 page2image393607424

CAUTION: Don’t use strong solvent. For example, acetone.

CAUTION: Never use an abrasive such as steel wool or metal polish.

CAUTION: Do not allow any liquid into the product, and do not immerse any parts of the device into any liquids.

CAUTION: Avoid pouring liquids on the device while cleaning.

page2image393639776

Internal:

page2image393643392
page2image352147280

2*AAA 1.5v alkaline battery

page2image352192416
page2image352124624

Power Consumption:

page2image352128992

Smaller than 30mA(Normal)

page2image352120144 page2image352120880

Operating Temperature:

5°C to 40°C

page2image393651808 page2image393650992

Storage Temperature:

page2image393655376 page2image393655936

–20°C to 55°C

page2image393660432 page2image393660800

Relative Humidity:

15% to 85% non-condensing

Parameter

page2image419893728

Value

Hemoglobin saturation Display

35-100%

Pulse rate Display

25-250 BPM

Perfusion Index Display

0-30%

Resolution

page2image419921888

Hemoglobin Saturation

page2image419927856

1%

Pulse rate

1 BPM

Measure Accuracy

page2image419941792

Hemoglobin Saturation

2% (80% - 100%) 3% (70% - 80%) Unspecified (≤70%)

Pulse rate

2 BPM

4.5 Troubleshooting

Applicable models

20110

PROACTIVE MEDICAL PRODUCTS 270 WASHINGTON STREET MOUNT VERNON, NY 10553 855-237-7622 www.proactivemedical.com

PROACTIVE MEDICAL FINGER PULSE OXIMETER

Warning

The information you should know to protect patients and medical staff from possible injury

page1image391830224 page1image391830496 page1image391830768 page1image391831040 page1image391831648 page1image391831920 page1image391832464 page1image391832864 page1image391833136 page1image391833408 page1image391833680

Section 1 Safety

1.1

 

 

Instructions for the Safe Operation and Use of the Pulse Oximeter

Do not attempt to service the pulse oximeter. Only qualified service personnel should attempt any needed internal servicing.
Do not use the oximeter in situations where alarms are required.
Prolonged use or the patient’s condition may require changing the sensor site periodically. Change sensor site and check skin integrity, circulatory status and correct alignment at least every 2 hours.

SpO2 measurements may be adversely affected in the presence of high ambient light. Shield the sensor area (with a surgical towel, or direct sunlight, for example) if necessary.
The following reasons will cause interference.

 High-frequency electrosurgical
Placement of a sensor on an extremity with a blood pressure cuff arterial

catheter, or intravascular line
The patient has hypotension severe vasoconstriction severe anemia or

hypothermia.
 The patient is in cardiac arrest or is in shock.
 Fingernail polish or false fingernails may cause inaccurate SpO2 readings.

USER’S MANUAL V1.0

2.1 Brief Device Description

The Pulse Oximeter, based on all digital technology, is intended for noninvasive spot-check measurement of functional oxygen saturation of arterial hemoglobin (SpO2). Advanced DSP algorithm can diminish the influence of motion artifact and improve measurement accuracy of low perfusion.

The Oximeter can be used to measure human Hemoglobin Saturation and heart rate through finger. The product is suitable for family, hospital (including clinical use in internist/surgery, pediatrics, etc.), Oxygen Bar, social medical organizations, physical care in sports and etc.

2.2 Intended Use

This product is suitable for the hospital (including surgery, anesthesiology, pediatrics, and clinical use), oxygen bar, sports health (using them before or after sports, do not advise using them during the movement), and community health care, etc.
2.3 Contraindication

It is not for intensive care and person whose finger is injured.

2.4 Product Features

 Lightweight for carrying and Easy-To-Use.
 Manually adjust the direction of interface.
 LEDdisplay,simultaneousdisplayfortestingvalueandplethysmogram.  Real-time spot-check.
 Low-Battery voltage indicator.
 Automatically standby or sleep.

Section 3 Installation, Setup, and Operation

3.1 Description of the Front Panel (as FIG.1)
1 2 Table 1 Part Definition and Description

3

FIG.1 Parts of front & back panel

3.2 Display

After switching on, the LED display is as follows:

FIG.2 LED display

3.3 Operation

3.3.1 Install battery
Installing two AAA batteries into battery cassette in correct polarities and cover it

page1image352175888

1.2 Warning

WARNING: EXPLOSION HAZARD — Do not use the oximeter in a flammable atmosphere where concentrations of flammable anesthetics or other materials may occur.

WARNING: Do not throw batteries in fire as this may cause them to explode.

WARNING: Do not use the pulse oximeter in an MRI or CT environment.

CAUTION: Keep the operating environment free of dust, vibrations, corrosive, or flammable materials, and extremes of temperature and humidity.

CAUTION: Do not operate the unit if it is damp or wet because of condensation or spills. Avoid using the equipment immediately after moving it from a cold environment to a warm, humid location.

WARNING: Do not attempt to recharge normal dry-cell batteries, they may leak. And may cause a fire or even explode.

CAUTION: Never use sharp or pointed objects to operate the front-panel switches.

CAUTION: The battery must be taken out from the battery compartment if the device will not be used for a long time.

CAUTION: The device shall only be used if the battery cover is closed.

CAUTION: The battery must be proper disposed according to local regulation after their use.

page1image391914800 page1image391915072 page1image391915344 page1image391915616 page1image391915904

Item

page1image391919376

Name

page1image391917152

Description

1

LED Panel

Display the SPO2/PR data & Bargraph

2

page1image391940448

Key

page1image391938560

Start the working state

3

page1image391947488 page1image391949648

Battery Compartment

2*AAA 1.5V Alkaline battery

page1image391958272
page1image391958864 page1image391959136 page1image391959408

1.3 Definitions and Symbols

Symbol

Description

page1image391972416

Symbol

page1image391971552
page1image391975312

Description

page1image391978592
page1image391981328

Type BF Equipment

page1image391986288 page1image391986512

Information of manufacture, including name and address

page1image391993568
page1image391996544

Refer to the instruction manual /booklet

page1image392002960

When the end-user wishes to discard this product, it must be sent to separate collection facilities for recovery and recycling

page1image392017152 page1image392016096 page1image392018544

Serial NO*

page1image392022384

No SpO2 Alarm

(as FIG.3)

FIG.3
3.3.2 Turn the Pulse Oximeter on

Put one of fingers into rubber hole of the oximeter (it is best to put the finger thoroughly) with nail surface upward (as FIG.4), then releasing the clamp.

FIG.4

Caution

The information you should know to protect the equipment from possible damage

page1image392057616 page1image392058208 page1image392058736 page1image392058944 page1image392059152

Note

The important information you should know

page1image392064528 page1image392065328 page1image392065600

Section 2 Introduction

page1image392067840 page1image392068128

WARNING: Do not attempt to recharge normal alkaline batteries, they may leak and may cause a fire or even explode.

page1image392078928 page1image392079216 page1image392079488 page1image392080352
page2image419588256 page2image419593008
page2image419469088

Oxyhemoglobin or heart rate cannot be shown normally

page2image419658336

1. Finger is not plugged correctly.
2. Patient’s perfusion is too low to be measured.

page2image419669328

1. Retry by plugging the finger. 2. Try some more times, if you can make sure about no problem existing in the product, please go to a hospital timely for exact diagnosis.

page2image419683712

Oxyhemoglobin or heart rate is shown unstably

page2image419690352
page2image419693168

1. Finger might not be plugged deep enough.
2. Finger is trembling or patient's body is in movement status.

page2image419703376
page2image419705632

11.Retry by plugging the finger. 2.Try not to move, Let the patient keep calm.

page2image419713008

The oximeter can’t go into the working state

1. Power of batteries might be inadequate or not be there at all 2. Batteries might be installed incorrectly.

3.The Oximeter might be damaged.

1. Please replace batteries 2.Please reinstall the batteries 3.Please contact with local customer service center

page2image419744304

The screen is suddenly off

page2image419749408
page2image419752560

1.The product is automatically standby or sleep when no signal is detected longer than 8 seconds.

2.Power quantity of the batteries is exhausted.

page2image419765712
page2image419767904

1.Normal.
2.Replace the batteries.

page2image419771376

Press the key, oximeter will go into the working state.
The oximeter will automatic standby or go asleep after 8 seconds without finger in.

3.3.3 Read correspondent data from display screen. 3.3.4 Display Description of LED

The display interface of “LED” can rotate two directions after pressing the key for less than 0.5s. It is shown as below:

FIG.5
Note: when battery power is at lowest level, the battery capacity indicates symbol of

“ ”in LED, remind users of replacement of battery.

3.4 Install Hanging Rope

Let the thin end of the rope go through the hole, next let the big point of rope go through the thin rope hole, then tighten the rope.

FIG.6 Install hanging rope

Section 4 Maintenance

4.1 Cleaning

Switch off the power and take out the batteries before cleaning, Cleaning exterior surface (screen included) of the unit with a dry and soft cloth. Use 75% density of medical alcohol to clean the surface and use dry fabric with little alcohol to avoid alcohol permeates into the device
4.2 Disinfection

Disinfecting the machine after using by the patient if multiple patient use the machine in the hospital. Use 75% density of medical alcohol to clean the surface that contacting with the patient.

CAUTION: Don’t remain any cleaning solution on the surface of the device.

4.3. Warranty

The host product’ design life is 2 years, and 1 years warranty. Under normal circumstances, the malfunction of the product during the warranty period (from the date of purchase) should be sent back to the company for maintenance, and our company is responsible for all maintenance costs (users should cover the freight themselves). Outside the warranty period, our company shall charge some maintenance fee (users should cover the freight themselves) if the product has broken down and is sent back for maintenance. The battery is beyond the scope of the warranty. If you have the purchase and sale contract, the costs of the maintenance shall be in accordance with the purchase and sale contract execution. Our company can provide the designated qualified technical personnel with files listed GB9706.1 6.8.3 C. Besides, it is recommended that users should use them no more than five years. And over the using life, the using risks may increase due to the equipment’ aging.
4.4 Maintenance

  •  Replace the batteries timely when battery indication is low. Clean surface of theе Pulse Oximeter before it is used in diagnosis for patients.
  •  Remove the batteries inside the battery cassette if the Oximeter will not be operated for a long time.
  •  It is better to preserve the product in a place where ambient temperature is -20 - 55°C and humidity is 10%-95%.
  •  Regular inspection to make sure that no obvious damage existed to affect the safety and performance of device.
  •  No flammable substance, overtop or lower temperature and humidity existed in operation conditions.

4.6 Disposal

To avoid contaminating or infecting personnel, the environment or other equipment, make sure you disinfect or decontaminate the device appropriately before disposing of it in accordance with your country’s law for equipment containing electrical and electronic parts.

Section 5 Specification

Physical Characteristics

Machine Dimensions: 57mm (L) * 31mm (W) * 30.5mm (D) Machine Weight -approx.: 54 g( including 2 * AAA battery)

Classification

Anti-electric Shock Type:Internally powered equipment Anti-electric Shock Degree:Type BF equipment EMC:Type B class I
Mode of operation: Continuous Operation

Enclosure Degree of ingress protection: IP22

※IP22 mean shell of this product can withstand the water dropping to the surface when the shell deviate 15 degree from horizontal surface.
Power

Environmental

Electronics Parameters

page2image393606368 page2image393606720 page2image393607136 page2image393607424

CAUTION: Don’t use strong solvent. For example, acetone.

CAUTION: Never use an abrasive such as steel wool or metal polish.

CAUTION: Do not allow any liquid into the product, and do not immerse any parts of the device into any liquids.

CAUTION: Avoid pouring liquids on the device while cleaning.

page2image393639776

Internal:

page2image393643392
page2image352147280

2*AAA 1.5v alkaline battery

page2image352192416
page2image352124624

Power Consumption:

page2image352128992

Smaller than 30mA(Normal)

page2image352120144 page2image352120880

Operating Temperature:

5°C to 40°C

page2image393651808 page2image393650992

Storage Temperature:

page2image393655376 page2image393655936

–20°C to 55°C

page2image393660432 page2image393660800

Relative Humidity:

15% to 85% non-condensing

Parameter

page2image419893728

Value

Hemoglobin saturation Display

35-100%

Pulse rate Display

25-250 BPM

Perfusion Index Display

0-30%

Resolution

page2image419921888

Hemoglobin Saturation

page2image419927856

1%

Pulse rate

1 BPM

Measure Accuracy

page2image419941792

Hemoglobin Saturation

2% (80% - 100%) 3% (70% - 80%) Unspecified (≤70%)

Pulse rate

2 BPM

4.5 Troubleshooting

Applicable models

20110

PROACTIVE MEDICAL PRODUCTS 270 WASHINGTON STREET MOUNT VERNON, NY 10553 855-237-7622 www.proactivemedical.com page1image391773616 page1image391819600 page1image391811408 page1image391826832 page1image391825632 page1image391787040 page1image391822368 page1image391778144 page1image391683696 page1image391828672 page1image391814176 page1image391793168

PROACTIVE MEDICAL FINGER PULSE OXIMETER

Warning

The information you should know to protect patients and medical staff from possible injury

page1image391830224 page1image391830496 page1image391830768 page1image391831040 page1image391831648 page1image391831920 page1image391832464 page1image391832864 page1image391833136 page1image391833408 page1image391833680

Section 1 Safety

1.1

 

 

Instructions for the Safe Operation and Use of the Pulse Oximeter

Do not attempt to service the pulse oximeter. Only qualified service personnel should attempt any needed internal servicing.
Do not use the oximeter in situations where alarms are required.
Prolonged use or the patient’s condition may require changing the sensor site periodically. Change sensor site and check skin integrity, circulatory status and correct alignment at least every 2 hours.

SpO2 measurements may be adversely affected in the presence of high ambient light. Shield the sensor area (with a surgical towel, or direct sunlight, for example) if necessary.
The following reasons will cause interference.

 High-frequency electrosurgical
Placement of a sensor on an extremity with a blood pressure cuff arterial

catheter, or intravascular line
The patient has hypotension severe vasoconstriction severe anemia or

hypothermia.
 The patient is in cardiac arrest or is in shock.
 Fingernail polish or false fingernails may cause inaccurate SpO2 readings.

USER’S MANUAL V1.0

2.1 Brief Device Description

The Pulse Oximeter, based on all digital technology, is intended for noninvasive spot-check measurement of functional oxygen saturation of arterial hemoglobin (SpO2). Advanced DSP algorithm can diminish the influence of motion artifact and improve measurement accuracy of low perfusion.

The Oximeter can be used to measure human Hemoglobin Saturation and heart rate through finger. The product is suitable for family, hospital (including clinical use in internist/surgery, pediatrics, etc.), Oxygen Bar, social medical organizations, physical care in sports and etc.

2.2 Intended Use

This product is suitable for the hospital (including surgery, anesthesiology, pediatrics, and clinical use), oxygen bar, sports health (using them before or after sports, do not advise using them during the movement), and community health care, etc.
2.3 Contraindication

It is not for intensive care and person whose finger is injured.

2.4 Product Features

 Lightweight for carrying and Easy-To-Use.
 Manually adjust the direction of interface.
 LEDdisplay,simultaneousdisplayfortestingvalueandplethysmogram.  Real-time spot-check.
 Low-Battery voltage indicator.
 Automatically standby or sleep.

Section 3 Installation, Setup, and Operation

3.1 Description of the Front Panel (as FIG.1)
1 2 Table 1 Part Definition and Description

3

FIG.1 Parts of front & back panel

3.2 Display

After switching on, the LED display is as follows:

FIG.2 LED display

3.3 Operation

3.3.1 Install battery
Installing two AAA batteries into battery cassette in correct polarities and cover it

page1image352175888

1.2 Warning

WARNING: EXPLOSION HAZARD — Do not use the oximeter in a flammable atmosphere where concentrations of flammable anesthetics or other materials may occur.

WARNING: Do not throw batteries in fire as this may cause them to explode.

WARNING: Do not use the pulse oximeter in an MRI or CT environment.

CAUTION: Keep the operating environment free of dust, vibrations, corrosive, or flammable materials, and extremes of temperature and humidity.

CAUTION: Do not operate the unit if it is damp or wet because of condensation or spills. Avoid using the equipment immediately after moving it from a cold environment to a warm, humid location.

WARNING: Do not attempt to recharge normal dry-cell batteries, they may leak. And may cause a fire or even explode.

CAUTION: Never use sharp or pointed objects to operate the front-panel switches.

CAUTION: The battery must be taken out from the battery compartment if the device will not be used for a long time.

CAUTION: The device shall only be used if the battery cover is closed.

CAUTION: The battery must be proper disposed according to local regulation after their use.

page1image391914800 page1image391915072 page1image391915344 page1image391915616 page1image391915904

Item

page1image391919376

Name

page1image391917152

Description

1

LED Panel

Display the SPO2/PR data & Bargraph

2

page1image391940448

Key

page1image391938560

Start the working state

3

page1image391947488 page1image391949648

Battery Compartment

2*AAA 1.5V Alkaline battery

page1image391958272
page1image391958864 page1image391959136 page1image391959408

1.3 Definitions and Symbols

Symbol

Description

page1image391972416

Symbol

page1image391971552
page1image391975312

Description

page1image391978592
page1image391981328

Type BF Equipment

page1image391986288 page1image391986512

Information of manufacture, including name and address

page1image391993568
page1image391996544

Refer to the instruction manual /booklet

page1image392002960

When the end-user wishes to discard this product, it must be sent to separate collection facilities for recovery and recycling

page1image392017152 page1image392016096 page1image392018544

Serial NO*

page1image392022384

No SpO2 Alarm

(as FIG.3)

FIG.3
3.3.2 Turn the Pulse Oximeter on

Put one of fingers into rubber hole of the oximeter (it is best to put the finger thoroughly) with nail surface upward (as FIG.4), then releasing the clamp.

FIG.4

Caution

The information you should know to protect the equipment from possible damage

page1image392057616 page1image392058208 page1image392058736 page1image392058944 page1image392059152

Note

The important information you should know

page1image392064528 page1image392065328 page1image392065600

Section 2 Introduction

page1image392067840 page1image392068128

WARNING: Do not attempt to recharge normal alkaline batteries, they may leak and may cause a fire or even explode.

page1image392078928 page1image392079216 page1image392079488 page1image392080352
page2image419588256 page2image419593008
page2image419469088

Oxyhemoglobin or heart rate cannot be shown normally

page2image419658336

1. Finger is not plugged correctly.
2. Patient’s perfusion is too low to be measured.

page2image419669328

1. Retry by plugging the finger. 2. Try some more times, if you can make sure about no problem existing in the product, please go to a hospital timely for exact diagnosis.

page2image419683712

Oxyhemoglobin or heart rate is shown unstably

page2image419690352
page2image419693168

1. Finger might not be plugged deep enough.
2. Finger is trembling or patient's body is in movement status.

page2image419703376
page2image419705632

11.Retry by plugging the finger. 2.Try not to move, Let the patient keep calm.

page2image419713008

The oximeter can’t go into the working state

1. Power of batteries might be inadequate or not be there at all 2. Batteries might be installed incorrectly.

3.The Oximeter might be damaged.

1. Please replace batteries 2.Please reinstall the batteries 3.Please contact with local customer service center

page2image419744304

The screen is suddenly off

page2image419749408
page2image419752560

1.The product is automatically standby or sleep when no signal is detected longer than 8 seconds.

2.Power quantity of the batteries is exhausted.

page2image419765712
page2image419767904

1.Normal.
2.Replace the batteries.

page2image419771376

Press the key, oximeter will go into the working state.
The oximeter will automatic standby or go asleep after 8 seconds without finger in.

3.3.3 Read correspondent data from display screen. 3.3.4 Display Description of LED

The display interface of “LED” can rotate two directions after pressing the key for less than 0.5s. It is shown as below:

FIG.5
Note: when battery power is at lowest level, the battery capacity indicates symbol of

“ ”in LED, remind users of replacement of battery.

3.4 Install Hanging Rope

Let the thin end of the rope go through the hole, next let the big point of rope go through the thin rope hole, then tighten the rope.

FIG.6 Install hanging rope

Section 4 Maintenance

4.1 Cleaning

Switch off the power and take out the batteries before cleaning, Cleaning exterior surface (screen included) of the unit with a dry and soft cloth. Use 75% density of medical alcohol to clean the surface and use dry fabric with little alcohol to avoid alcohol permeates into the device
4.2 Disinfection

Disinfecting the machine after using by the patient if multiple patient use the machine in the hospital. Use 75% density of medical alcohol to clean the surface that contacting with the patient.

CAUTION: Don’t remain any cleaning solution on the surface of the device.

4.3. Warranty

The host product’ design life is 2 years, and 1 years warranty. Under normal circumstances, the malfunction of the product during the warranty period (from the date of purchase) should be sent back to the company for maintenance, and our company is responsible for all maintenance costs (users should cover the freight themselves). Outside the warranty period, our company shall charge some maintenance fee (users should cover the freight themselves) if the product has broken down and is sent back for maintenance. The battery is beyond the scope of the warranty. If you have the purchase and sale contract, the costs of the maintenance shall be in accordance with the purchase and sale contract execution. Our company can provide the designated qualified technical personnel with files listed GB9706.1 6.8.3 C. Besides, it is recommended that users should use them no more than five years. And over the using life, the using risks may increase due to the equipment’ aging.
4.4 Maintenance

  •  Replace the batteries timely when battery indication is low. Clean surface of theе Pulse Oximeter before it is used in diagnosis for patients.
  •  Remove the batteries inside the battery cassette if the Oximeter will not be operated for a long time.
  •  It is better to preserve the product in a place where ambient temperature is -20 - 55°C and humidity is 10%-95%.
  •  Regular inspection to make sure that no obvious damage existed to affect the safety and performance of device.
  •  No flammable substance, overtop or lower temperature and humidity existed in operation conditions.

4.6 Disposal

To avoid contaminating or infecting personnel, the environment or other equipment, make sure you disinfect or decontaminate the device appropriately before disposing of it in accordance with your country’s law for equipment containing electrical and electronic parts.

Section 5 Specification

Physical Characteristics

Machine Dimensions: 57mm (L) * 31mm (W) * 30.5mm (D) Machine Weight -approx.: 54 g( including 2 * AAA battery)

Classification

Anti-electric Shock Type:Internally powered equipment Anti-electric Shock Degree:Type BF equipment EMC:Type B class I
Mode of operation: Continuous Operation

Enclosure Degree of ingress protection: IP22

※IP22 mean shell of this product can withstand the water dropping to the surface when the shell deviate 15 degree from horizontal surface.
Power

Environmental

Electronics Parameters

page2image393606368 page2image393606720 page2image393607136 page2image393607424

CAUTION: Don’t use strong solvent. For example, acetone.

CAUTION: Never use an abrasive such as steel wool or metal polish.

CAUTION: Do not allow any liquid into the product, and do not immerse any parts of the device into any liquids.

CAUTION: Avoid pouring liquids on the device while cleaning.

page2image393639776

Internal:

page2image393643392
page2image352147280

2*AAA 1.5v alkaline battery

page2image352192416
page2image352124624

Power Consumption:

page2image352128992

Smaller than 30mA(Normal)

page2image352120144 page2image352120880

Operating Temperature:

5°C to 40°C

page2image393651808 page2image393650992

Storage Temperature:

page2image393655376 page2image393655936

–20°C to 55°C

page2image393660432 page2image393660800

Relative Humidity:

15% to 85% non-condensing

Parameter

page2image419893728

Value

Hemoglobin saturation Display

35-100%

Pulse rate Display

25-250 BPM

Perfusion Index Display

0-30%

Resolution

page2image419921888

Hemoglobin Saturation

page2image419927856

1%

Pulse rate

1 BPM

Measure Accuracy

page2image419941792

Hemoglobin Saturation

2% (80% - 100%) 3% (70% - 80%) Unspecified (≤70%)

Pulse rate

2 BPM

4.5 Troubleshooting

Applicable models

20110

PROACTIVE MEDICAL PRODUCTS 270 WASHINGTON STREET MOUNT VERNON, NY 10553 855-237-7622 www.proactivemedical.com page1image391799232 page1image391815728 page1image391773616 page1image391819600 page1image391811408 page1image391826832 page1image391825632 page1image391787040 page1image391822368 page1image391778144 page1image391683696 page1image391828672 page1image391814176 page1image391793168

PROACTIVE MEDICAL FINGER PULSE OXIMETER

Warning

The information you should know to protect patients and medical staff from possible injury

page1image391830224 page1image391830496 page1image391830768 page1image391831040 page1image391831648 page1image391831920 page1image391832464 page1image391832864 page1image391833136 page1image391833408 page1image391833680

Section 1 Safety

1.1

 

 

Instructions for the Safe Operation and Use of the Pulse Oximeter

Do not attempt to service the pulse oximeter. Only qualified service personnel should attempt any needed internal servicing.
Do not use the oximeter in situations where alarms are required.
Prolonged use or the patient’s condition may require changing the sensor site periodically. Change sensor site and check skin integrity, circulatory status and correct alignment at least every 2 hours.

SpO2 measurements may be adversely affected in the presence of high ambient light. Shield the sensor area (with a surgical towel, or direct sunlight, for example) if necessary.
The following reasons will cause interference.

 High-frequency electrosurgical
Placement of a sensor on an extremity with a blood pressure cuff arterial

catheter, or intravascular line
The patient has hypotension severe vasoconstriction severe anemia or

hypothermia.
 The patient is in cardiac arrest or is in shock.
 Fingernail polish or false fingernails may cause inaccurate SpO2 readings.

USER’S MANUAL V1.0

2.1 Brief Device Description

The Pulse Oximeter, based on all digital technology, is intended for noninvasive spot-check measurement of functional oxygen saturation of arterial hemoglobin (SpO2). Advanced DSP algorithm can diminish the influence of motion artifact and improve measurement accuracy of low perfusion.

The Oximeter can be used to measure human Hemoglobin Saturation and heart rate through finger. The product is suitable for family, hospital (including clinical use in internist/surgery, pediatrics, etc.), Oxygen Bar, social medical organizations, physical care in sports and etc.

2.2 Intended Use

This product is suitable for the hospital (including surgery, anesthesiology, pediatrics, and clinical use), oxygen bar, sports health (using them before or after sports, do not advise using them during the movement), and community health care, etc.
2.3 Contraindication

It is not for intensive care and person whose finger is injured.

2.4 Product Features

 Lightweight for carrying and Easy-To-Use.
 Manually adjust the direction of interface.
 LEDdisplay,simultaneousdisplayfortestingvalueandplethysmogram.  Real-time spot-check.
 Low-Battery voltage indicator.
 Automatically standby or sleep.

Section 3 Installation, Setup, and Operation

3.1 Description of the Front Panel (as FIG.1)
1 2 Table 1 Part Definition and Description

3

FIG.1 Parts of front & back panel

3.2 Display

After switching on, the LED display is as follows:

FIG.2 LED display

3.3 Operation

3.3.1 Install battery
Installing two AAA batteries into battery cassette in correct polarities and cover it

page1image352175888

1.2 Warning

WARNING: EXPLOSION HAZARD — Do not use the oximeter in a flammable atmosphere where concentrations of flammable anesthetics or other materials may occur.

WARNING: Do not throw batteries in fire as this may cause them to explode.

WARNING: Do not use the pulse oximeter in an MRI or CT environment.

CAUTION: Keep the operating environment free of dust, vibrations, corrosive, or flammable materials, and extremes of temperature and humidity.

CAUTION: Do not operate the unit if it is damp or wet because of condensation or spills. Avoid using the equipment immediately after moving it from a cold environment to a warm, humid location.

WARNING: Do not attempt to recharge normal dry-cell batteries, they may leak. And may cause a fire or even explode.

CAUTION: Never use sharp or pointed objects to operate the front-panel switches.

CAUTION: The battery must be taken out from the battery compartment if the device will not be used for a long time.

CAUTION: The device shall only be used if the battery cover is closed.

CAUTION: The battery must be proper disposed according to local regulation after their use.

page1image391914800 page1image391915072 page1image391915344 page1image391915616 page1image391915904

Item

page1image391919376

Name

page1image391917152

Description

1

LED Panel

Display the SPO2/PR data & Bargraph

2

page1image391940448

Key

page1image391938560

Start the working state

3

page1image391947488 page1image391949648

Battery Compartment

2*AAA 1.5V Alkaline battery

page1image391958272
page1image391958864 page1image391959136 page1image391959408

1.3 Definitions and Symbols

Symbol

Description

page1image391972416

Symbol

page1image391971552
page1image391975312

Description

page1image391978592
page1image391981328

Type BF Equipment

page1image391986288 page1image391986512

Information of manufacture, including name and address

page1image391993568
page1image391996544

Refer to the instruction manual /booklet

page1image392002960

When the end-user wishes to discard this product, it must be sent to separate collection facilities for recovery and recycling

page1image392017152 page1image392016096 page1image392018544

Serial NO*

page1image392022384

No SpO2 Alarm

(as FIG.3)

FIG.3
3.3.2 Turn the Pulse Oximeter on

Put one of fingers into rubber hole of the oximeter (it is best to put the finger thoroughly) with nail surface upward (as FIG.4), then releasing the clamp.

FIG.4

Caution

The information you should know to protect the equipment from possible damage

page1image392057616 page1image392058208 page1image392058736 page1image392058944 page1image392059152

Note

The important information you should know

page1image392064528 page1image392065328 page1image392065600

Section 2 Introduction

page1image392067840 page1image392068128

WARNING: Do not attempt to recharge normal alkaline batteries, they may leak and may cause a fire or even explode.

page1image392078928 page1image392079216 page1image392079488 page1image392080352
page2image419588256 page2image419593008
page2image419469088

Oxyhemoglobin or heart rate cannot be shown normally

page2image419658336

1. Finger is not plugged correctly.
2. Patient’s perfusion is too low to be measured.

page2image419669328

1. Retry by plugging the finger. 2. Try some more times, if you can make sure about no problem existing in the product, please go to a hospital timely for exact diagnosis.

page2image419683712

Oxyhemoglobin or heart rate is shown unstably

page2image419690352
page2image419693168

1. Finger might not be plugged deep enough.
2. Finger is trembling or patient's body is in movement status.

page2image419703376
page2image419705632

11.Retry by plugging the finger. 2.Try not to move, Let the patient keep calm.

page2image419713008

The oximeter can’t go into the working state

1. Power of batteries might be inadequate or not be there at all 2. Batteries might be installed incorrectly.

3.The Oximeter might be damaged.

1. Please replace batteries 2.Please reinstall the batteries 3.Please contact with local customer service center

page2image419744304

The screen is suddenly off

page2image419749408
page2image419752560

1.The product is automatically standby or sleep when no signal is detected longer than 8 seconds.

2.Power quantity of the batteries is exhausted.

page2image419765712
page2image419767904

1.Normal.
2.Replace the batteries.

page2image419771376

Press the key, oximeter will go into the working state.
The oximeter will automatic standby or go asleep after 8 seconds without finger in.

3.3.3 Read correspondent data from display screen. 3.3.4 Display Description of LED

The display interface of “LED” can rotate two directions after pressing the key for less than 0.5s. It is shown as below:

FIG.5
Note: when battery power is at lowest level, the battery capacity indicates symbol of

“ ”in LED, remind users of replacement of battery.

3.4 Install Hanging Rope

Let the thin end of the rope go through the hole, next let the big point of rope go through the thin rope hole, then tighten the rope.

FIG.6 Install hanging rope

Section 4 Maintenance

4.1 Cleaning

Switch off the power and take out the batteries before cleaning, Cleaning exterior surface (screen included) of the unit with a dry and soft cloth. Use 75% density of medical alcohol to clean the surface and use dry fabric with little alcohol to avoid alcohol permeates into the device
4.2 Disinfection

Disinfecting the machine after using by the patient if multiple patient use the machine in the hospital. Use 75% density of medical alcohol to clean the surface that contacting with the patient.

CAUTION: Don’t remain any cleaning solution on the surface of the device.

4.3. Warranty

The host product’ design life is 2 years, and 1 years warranty. Under normal circumstances, the malfunction of the product during the warranty period (from the date of purchase) should be sent back to the company for maintenance, and our company is responsible for all maintenance costs (users should cover the freight themselves). Outside the warranty period, our company shall charge some maintenance fee (users should cover the freight themselves) if the product has broken down and is sent back for maintenance. The battery is beyond the scope of the warranty. If you have the purchase and sale contract, the costs of the maintenance shall be in accordance with the purchase and sale contract execution. Our company can provide the designated qualified technical personnel with files listed GB9706.1 6.8.3 C. Besides, it is recommended that users should use them no more than five years. And over the using life, the using risks may increase due to the equipment’ aging.
4.4 Maintenance

  •  Replace the batteries timely when battery indication is low. Clean surface of theе Pulse Oximeter before it is used in diagnosis for patients.
  •  Remove the batteries inside the battery cassette if the Oximeter will not be operated for a long time.
  •  It is better to preserve the product in a place where ambient temperature is -20 - 55°C and humidity is 10%-95%.
  •  Regular inspection to make sure that no obvious damage existed to affect the safety and performance of device.
  •  No flammable substance, overtop or lower temperature and humidity existed in operation conditions.

4.6 Disposal

To avoid contaminating or infecting personnel, the environment or other equipment, make sure you disinfect or decontaminate the device appropriately before disposing of it in accordance with your country’s law for equipment containing electrical and electronic parts.

Section 5 Specification

Physical Characteristics

Machine Dimensions: 57mm (L) * 31mm (W) * 30.5mm (D) Machine Weight -approx.: 54 g( including 2 * AAA battery)

Classification

Anti-electric Shock Type:Internally powered equipment Anti-electric Shock Degree:Type BF equipment EMC:Type B class I
Mode of operation: Continuous Operation

Enclosure Degree of ingress protection: IP22

※IP22 mean shell of this product can withstand the water dropping to the surface when the shell deviate 15 degree from horizontal surface.
Power

Environmental

Electronics Parameters

page2image393606368 page2image393606720 page2image393607136 page2image393607424

CAUTION: Don’t use strong solvent. For example, acetone.

CAUTION: Never use an abrasive such as steel wool or metal polish.

CAUTION: Do not allow any liquid into the product, and do not immerse any parts of the device into any liquids.

CAUTION: Avoid pouring liquids on the device while cleaning.

page2image393639776

Internal:

page2image393643392
page2image352147280

2*AAA 1.5v alkaline battery

page2image352192416
page2image352124624

Power Consumption:

page2image352128992

Smaller than 30mA(Normal)

page2image352120144 page2image352120880

Operating Temperature:

5°C to 40°C

page2image393651808 page2image393650992

Storage Temperature:

page2image393655376 page2image393655936

–20°C to 55°C

page2image393660432 page2image393660800

Relative Humidity:

15% to 85% non-condensing

Parameter

page2image419893728

Value

Hemoglobin saturation Display

35-100%

Pulse rate Display

25-250 BPM

Perfusion Index Display

0-30%

Resolution

page2image419921888

Hemoglobin Saturation

page2image419927856

1%

Pulse rate

1 BPM

Measure Accuracy

page2image419941792

Hemoglobin Saturation

2% (80% - 100%) 3% (70% - 80%) Unspecified (≤70%)

Pulse rate

2 BPM

4.5 Troubleshooting

Applicable models

20110

PROACTIVE MEDICAL PRODUCTS 270 WASHINGTON STREET MOUNT VERNON, NY 10553 855-237-7622 www.proactivemedical.com

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