Zacurate 300A Children Digital Fingertip Pulse Oximeter User Manual

Zacurate 300A Children Digital Fingertip Pulse Oximeter

General Description

SpO2 stands for peripheral capillary oxygen saturation. Oxygen saturation is defined as the ratio of oxyhemoglobin (HbO2) to the total concentration of hemoglobin (i.e. Oxyhemoglobin + reduced hemoglobin) present in the blood. It is an important physiological parameter involved in respiration and circulation. The Pulse Oximeter feature herein is small, portable, non- invasive and easy to use. The user only needs to insert a finger into the chamber to measure his/her SpO2 level and pulse rate. It has also been proven to be highly precise and reliable in clinical tests.

Measurement Principle

Oxygenated blood absorbs light preferentially at 905nm (near-infrared light), whereas deoxygenated blood absorbs light preferentially at 660nm (red light). A pulse oximeter works by passing a beam of red and infrared light through a pulsating capillary bed and then measuring the amount of red and infrared light emerging from the tissues via a sensor. To improve accuracy, the 300A uses a proprietary algorithm to collect data from pulsatile arterial blood and excludes noise from the tissues. The relative absorption of light by oxyhemoglobin (HbO) and deoxyhemoglobin is then calculated according to Beer- Lambert’s law and a quantitative measurement of the users’ oxyhemoglobin status i.e. Oxygen saturation level (SpO2) is derived.

Diagram of Operation Principle

1. Red and Infrared-ray Emission Tube
2. Sensor

Precautions For Use

1. Please read the manual carefully before use.
2. Do not use the fingertip pulse oximeter in an MRI or CT environment.
3. Do not use the fingertip pulse oximeter in situations where alarms are required. The device has no alarms.
4. This device is not for continuous monitoring.
5. Do not use the fingertip pulse oximeter in an explosive environment.
6. In order to ensure proper sensor alignment and skin integrity, the maximum application time at a single site for the device should be less than half an hour.
7. Do not sterilize the device using autoclaving, ethylene oxide sterilizing, or immersing the device in liquid. The device is not intended for sterilization.
8. Follow local ordinances and recycling instructions regarding disposal or recycling of the device and device components, including batteries.
9. This equipment complies with IEC 60601-1-2:2007 for electromagnetic compatibility for medical electrical equipment and/or systems. However, because of the proliferation of radio-frequency transmitting equipment and other sources of electrical noise in healthcare and other environments, it is possible that high levels of such interference due to close proximity or strength of a source might disrupt the performance of this device.
10. Portable and mobile RF communications equipment can affect medical electrical equipment.
11. Do not disassemble, repair or modify the equipment.
12. It may be unsafe to：
    • use accessories, detachable parts and materials not described in the instructions for use
    • interconnect this equipment with other equipment not described in the instructions for use
    • disassemble, repair or modify the equipment
13. The medical silicone and ABS plastic enclosure which contact the user’s skin when the device is used have been assessed by and passed the ISO10993-5 Tests for in vitro cytotoxicity and ISO10993-10 Tests for irritation and delayed-type hypersensitivity.
14. The fingertip pulse oximeter is dependent on blood flow to obtain an accurate SpO2 measurement. Verify that nothing is hindering your blood flow before taking your SpO2 readings.
15. This device is not intended to diagnose or treat any medical condition or disease. It is intended for non-medical use by healthy people to monitor their pulse rate and blood oxygen levels. It is for sports and/or aviation use. People who need SpO2 and pulse rate measurements because of a medical condition should not use this pulse oximeter and should consult with their physician.

Inaccurate measurements may be caused by

1. Significant levels of dysfunctional hemoglobin (such as carbonyl-hemoglobin or methemoglobin).
2. Intravascular dyes such as indocyanine green or methylene blue.
3. High ambient light. Shield the sensor area if necessary.
4. Excessive user movement.
5. High-frequency electrosurgical interference and defibrillators.
6. Venous pulsations.
7. Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line.
8. The user has hypotension, severe vasoconstriction, severe anemia, or hypothermia.
9. The user is in cardiac arrest or is in shock.
10. Fingernail polish or artificial fingernails.
11. Weak pulse quality (low blood perfusion).
12. Low hemoglobin.

Features

1. Easy to operate. Measure your SpO2 non-invasively
2. Small, light and portable
3. OLED screen displays SpO2, Pulse Rate, Pulse Bar and Plethysmograph.
4. Level 1-10 adjustable brightness.
5. 6 display modes.
6. 2pcs AAA-size alkaline batteries; low-battery indicator and low power consumption.
7. When no or low signal is detected, the screen will display ‘Finger Out’ and the device will power off automatically in about 8 seconds.

Intended Use

The 300A Fingertip pulse oximeter is a portable non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of children (>2 years old) and adult. It is for sports and/or aviation use.

• Recommended age range: ≥2years old child or adult with small fingers.
• Recommended weight range: 33-99 lbs (15-45kg)
• Finger size range: 0.2 – 0.6 inches (5-16mm)

Operation Instructions

1. Install two AAA batteries according to the Battery Installation instructions.
2. Place one of your fingers into the finger chamber of the pulse oximeter.
3. Press the on/off button on the front panel to turn the pulse oximeter on.
4. Keep your hand and finger still for the reading. It is recommended that you do not move your body while taking a reading.
5. Read the data from the display screen.
6. Press (<1 sec) the button again to toggle between six display modes (see below).
7. Press and hold (>1 sec) the on/off button to adjust the brightness of the display. There are 10 levels of brightness, with 10 being the brightest. The default level is four.

After turning the Oximeter on, each time you press the on/off button, the Oximeter will switch to another display mode.

There are 6 display modes shown as follows:

Tips to getting a good reading

1. Make sure that your finger is inserted deep into the chamber so that the fingertip is placed directly in between the LED sensor and the LED light source.

2. Avoid making any body movement, especially your finger while taking measurements.

3. Long fingernails may obstruct the light sensor and prevent accurate measurement. Please keep the fingernails short while using the device.

4. Excessive ambient infrared light, especially in an overly bright lit room, can interfere with the sensor, preventing an accurate measurement.

5. Poor blood circulation can affect oximeter readings. Warm your hands and fingers before taking your measurements. Note
   that the pulse oximeter is measuring your SpO2 and PR based on your blood flow. If the blood flow in your finger drops
   below a certain level, the pulse oximeter will not be able to get a reading.

6. Some people with medical conditions such as anemia, hypotension, and hypothermia may experience an inaccurate reading during use. In such case, we suggest that you consult a physician.

Front Panel

The PR (Pulse Rate) Bar Graph and Plethysmograph (SpO2 Waveform) are useful features that can be used to determine the reliability of a reading. If the height of the pulse bar is less than 30%, this indicates signal inadequacy and the displayed SpO2 or pulse rate value is potentially incorrect. Adjust your finger so that it is directly between the LED lights and the sensor. The plethysmograph indicates the amount of blood flow detected by the pulse oximeter. Each wave in the plethysmograph corresponds to a heartbeat and the wave amplitude corresponds to the amount of blood detected by the pulse oximeter. The pulse oximeter is optimized when the height of the wave amplitude is consistent throughout as shown in the figure above. That is when you should take the reading. If the wave amplitude is very small, warm your hands to increase blood flow and retake your measurement. If the waveform is not consistent, try to keep your hand and body as still as possible.

Package Content

1. One pulse oximeter
2. One silicone cover
3. One lanyard
4. Two AAA batteries
5. One instruction manual
6. One carrying bag/pouch

Battery Installation

1. Open the battery door cover as shown in the figure.
2. Install two AAA batteries into the battery compartment in opposite polarity by matching the plus (+) and minus (-) signs in the compartment. Note: Incorrectly installed batteries may damage the device.
3. Close the battery door cover.

Note:

• Please remove the batteries if the pulse oximeter will not be used for a long period of time.
• Please replace the batteries when the power indicator starts flickering.

Using the Lanyard

1. Thread the thin end of the lanyard through the lanyard hole on the device.
2. Thread the thick end of the lanyard through the thin loop (threaded in step 1) and pull to tighten.

Warnings!

• Keep the oximeter away from young children. Small items such as the battery door, battery, and lanyard are choking hazards.
• Do not hang the lanyard from the device’s electrical wire.
• Please note that the lanyard tied to the oximeter may cause strangulation due to its length.

Maintenance and Storage

1. Replace the batteries when the low power indicator appears.
2. Clean the finger chamber and surface of the oximeter before use.
3. Remove the batteries if you are not planning to use the oximeter for a long period of time.
4. Store the product in a cool and dry place, Extreme moisture may damage the oximeter or affect its lifespan.
5. Dispose battery properly; follow any applicable local battery disposal laws.

Cleaning the fingertip pulse oximeter

It is recommended to clean the oximeter before and after use. To clean, use a soft cloth lightly dampened with water to wipe the finger chamber and the surface of the oximeter. Allow the oximeter to dry thoroughly before use.
CAUTION: Do not pour or spray liquids onto the oximeter, and do not allow any liquid to enter any openings in the device.

Disinfecting the fingertip pulse oximeter

The oximeter can be disinfected as needed. To disinfect, use a soft cloth lightly dampened with 70% isopropyl alcohol. Other recommended disinfectants include: 70% ethanol or glutaraldehyde-type 2% liquid disinfectants.
CAUTION: Do not use EtO (Ethylene oxide) or formaldehyde for disinfection.
The lifespan of the pulse oximeter is estimated to be five years if 15 measurements are taken per day and each measurement takes 10 minutes. Stop using and contact local service center if one of the following incidents occurs:

• An error in the Possible Problems and Solutions is displayed on the screen.
• The oximeter cannot be powered on even though new batteries are installed.
• There is a crack on the oximeter or damage to the display resulting in unidentifiable readings.
• The spring is defective.
• The button is unresponsive.
  The pulse oximeter is factory calibrated. You do not need to calibrate it again during its lifespan.

Specifications

1. Display Type

   • OLED display

2. SpO2

   • Display range: 0%~100%
   • Measurement range: 70%~100%
   • Accuracy: 70%~100%: ±2%; 0%~69% no definition
   • Resolution: 1%

3. Pulse Rate

   • Display range: 30bpm~250bpm
   • Measurement range: 30bpm~250bpm
   • Accuracy: 30bpm~99bpm, ±2bpm; 100bpm~250bpm, ±2%
   • Resolution: 1bpm

4. Probe LED Specifications
   

5. Power Requirements

6. Two AAA alkaline Batteries

7. Power consumption: Less than 40mA

8. Battery Life: Two AAA 1.5V, 1200mAh alkaline batteries could be continuously operated as long as 18 hours.

9. Environment Requirements

   • Operation Temperature: 5°C ~40°C
   • Storage Temperature: -25°C ~+70°C
   • Ambient Humidity: 15%～93% no condensation in operation; ≤93% no condensation in storage/transport
   • Atmosphere pressure: 70kPa~106kPa

10. Equipment Data Update Period
    As shown in the following figure. Data update period of slower average is 8s
    

11. Classification
    According to the type of protection against electric shock: INTERNALLY POWERED EQUIPMENT; According to the degree of protection against electric shock: TYPE BF APPLIED PART （The application part is rubber inside of the Pulse Oximeter）; According to the degree of protection against ingress of water: IP22 According to the mode of operation: CONTINUOUS OPERATION

Clinical Study Summary

The following details are provided to disclose the actual performance observed in the clinical validation study of healthy adult volunteers. The ARMS value analysis statement and Bland-Altman plot of data are shown as follows:

ARMS Value Analysis Statement

Declaration

Guidance and Manufacturer’s declaration – electromagnetic emissions-For all EQUIPMENT and SYSTEMS

Guidance and Manufacturer’s declaration – electromagnetic immunity-For all EQUIPMENT and SYSTEMS

Guidance and Manufacturer’s declaration – electromagnetic immunity- For all EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING

Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEMS – For all EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING

Applicable Models

300A
Notes:

1. The illustrations used in this manual may differ slightly from the appearance of the actual product.
2. The specifications are subject to change without prior notice.

Manufactured for: Einstein Associates LLC 10101 Stafford Centre Drive Suite B Stafford TX 77477

FAQs

Is it FDA-approved?****

Yes, it is FDA-approved.

How to use the pulse oximeter?****

Insert your index finger into the chamber and press the power button. The device will automatically measure your SpO2 level and pulse rate.

Can I use it to measure other people’s SpO2 levels?****

Yes, you can use it to measure other people’s SpO2 levels.

What is the accuracy of the pulse oximeter?****

The accuracy of this device is ±2% (at 95%).

What is its lifespan?****

It has a lifespan of 5 years.

How accurate is an oximeter for kids?****

As long as your child’s finger extends all the way to the end of the probe, you can use an adult pulse oximeter on them. Smaller children may receive an incorrect value from an adult oximeter.

Do kids need a different pulse oximeter?****

If your child’s finger extends all the way to the end of the probe on an adult pulse oximeter, you may use it on them. Smaller children may not provide an accurate reading when using an adult oximeter.

Where should a pulse oximeter be placed on a child?****

The palm and the foot are the ideal locations for pulse oximetry in babies. For newborns, a pediatric pulse oximeter probe should always be used, never an adult pulse oximeter clip.

Which pulse oximeter is specially designed for children?****

The kid’s pulse oximeter is convenient, non-intrusive, and portable. In order to measure his or her SpO2 and Pulse Rate, the user merely needs to place a finger within the chamber. Although it is ideal for adults with little fingers and teens, it is made exclusively for kids.

What age is a Pediatric pulse oximeter?****

Children and toddlers between the ages of 2 and 12 can utilize the Zacurate children digital fingertip pulse oximeter, a portable, non-invasive, and simple-to-use pulse oximeter.

Is there a pediatric oximeter?****

Pediatric pulse oximeters are made to be able to read heart rate and oxygen saturation (SpO2%) largely from the toes and/or fingers of newborns (under 8 pounds), infants (between 5 and 45 pounds), and kids (under 75 lbs.).

Which finger is more accurate for an oximeter?****

The majority of health professionals will position the device on the index fingers, but a study of 37 volunteers indicated that the third finger on the dominant hand provided the greatest result. The dominant thumb came in second. Use your right middle finger if you are right-handed.

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