Zacurate 500CL Fingertip Pulse Oximeter User Manual

Zacurate 500CL 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 500CL 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

• Please read the manual carefully before use.

• Do not use the fingertip pulse oximeter in an MRI or CT environment.

• Do not use the fingertip pulse oximeter in situations where alarms are required. The device has no alarms.

• This device is not for continuous monitoring.

• Do not use the fingertip pulse oximeter in an explosive environment.

• 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.

• Do not sterilize the device using autoclaving, ethylene oxide sterilizing, or immersing the device in liquid. The device is not intended for sterilization.

• Follow local ordinances and recycling instructions regarding disposal or recycling of the device and device components, including batteries.

• This equipment complies with IEC 60601-1-2:2014 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.

• Portable and mobile RF communications equipment can affect medical electrical equipment.

• Do not disassemble, repair or modify the equipment.
  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

• 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.

• 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.

• 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.

Product Features

1. Easy to operate. Measure your SpO2 non-invasively.
2. Small, light, and portable.
3. LED screen displays SpO2, Pulse Rate, and Pulse Bar.
4. 2pcs AAA-size alkaline batteries; low-battery indicator and low power consumption.
5. When no or low signal is detected, the device will power off automatically in about 8 seconds.

Intended Use

The 500CL 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 (>12 years old) and adult. The device is for sports and/or aviation use.

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.

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 a case, we suggest that you consult a physician.

Front Panel

• The pulse bar graph is a useful feature 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.

Box Content

1. One pulse oximeter
2. One lanyard
3. Two AAA batteries
4. One instruction manual

Battery Installation

1. Open the battery compartment.
2. Install two AAA batteries by matching the plus (+) and minus (-) signs in the compartment. Note: incorrectly installed batteries may damage the device.
3. Slide the battery cover back until it snaps in place.

Notes:

• Please remove the batteries if the pulse oximeter will not be used for a long period of time.
• Please replace the batteries when the battery level indicator is low.

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 battery level indicator is low.
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
   LED display

2. SpO2

   • Display range: 0%~99%
   • Measurement range: 70%~99%
   • Accuracy: 70%~99%: ±2%; 0%~69% no definition
   • Resolution: 1%
     A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or sensor. Clinical testing is used to establish the SpO2 accuracy. The measured arterial hemoglobin saturation value (SpO2) of the sensors is compared to arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a laboratory CO-oximeter. The accuracy of the sensors in comparison to the CO-oximeter samples measured over the SpO2 range of 70%~100%. Accuracy data is calculated using the root-mean-squared (Arms value) for all subjects, per ISO 9919:2005, Medical Electrical Equipment–Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use. A functional tester is used to measure how accurately the Fingertip Pulse Oximeter is reproducing the specified calibration curve and the PR accuracy. The model of the functional tester is the Index2 FLUKE simulator and the version is 2.1.3.

3. Pulse Rate

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

4. Probe LED Specifications****
    | Wavelength| Radiant Power
   ---|---|---
   RED| 660±2nm| 3.2mW
   IR| 905±10nm| 2.4mW

5. Power Requirements Two AAA alkaline batteries

   • Power consumption: Less than 25mA
   • Battery life : Two AAA 1.5V, 1200mAh alkaline batteries could be continuously operated as long as 16 hours.

6. 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

7. Equipment Response Time
   As shown in the following figure. Response of slower average is 8s.

8. 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, (applied part: the rubber part of the device);
   • 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 actual performance observed in the clinical validation study of healthy adult volunteers. The ARMS value analysis statement and Bland-Altman plot of data is shown as following:

ARMS Value Analysis Statement

Bland-Altman Plot Graphic

Declaration

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

Guidance and Manufacturer’s declaration – electromagnetic emission

for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11| Class B| The pulse Oximeter (500CL) is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2| Not Applicable|
Voltage fluctuations/ flicker emissions IEC 61000-3-3| Not Applicable

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

Guidance and Manufacturer’s declaration – electromagnetic immunity

Immunity test| IEC 60601 test level| Compliance Level| Electromagnetic Environment – guidance
---|---|---|---
Electrostatic Discharge (ESD) IEC 61000-4-2| +/- 6kV contact, +/- 8kV air| +/- 6kV contact, +/- 8kV air| Floors should be wood, concrete or ceramic tile. If floor are covered with synthetic material, the relative humidity should be at least 30%.
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8| 3A/m| 3A/m| Power frequency magnetic fields should be at levels characteristics of a typical location in a typical commercial or hospital environment.

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

Guidance and Manufacturer’s declaration – electromagnetic immunity (continued)

Immunity test| IEC 60601 test level| Compliance Level| Electromagnetic Environment – guidance
---|---|---|---
Radiated RF IEC 61000-4-3| 3 V/m| 3 V/m| Portable and mobile RF communications equipment should be used no closer to any part of the Pulse Oximeter (500CL), including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance:

• (80 MHz to 800 MHz)
• (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 meters (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 structures, objects and people.
• Field strengths from fixed transmitters, such as base station 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 Pulse Oximeter (500CL) should be observed to verify normal operation. If abnormal performance is observed, additional measurements may be necessary, such as reorienting of the relocating the Pulse Oximeter (500CL).
• Over the frequency range 150 kHz to 80 MHz, fields strengths should be less than 3 V/m

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

Recommended separation distances between portable and mobile RF communications equipment and Pulse Oximeter (500CL)

The Pulse Oximeter (500CL) is intended for use in electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Pulse Oximeter (500CL) can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Pulse Oximeter (500CL) 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)
---|---
80 MHz to 800 MHz| 800 MHz to 2.5 GHz
d = 1.2√P| d = 2.3√P
0.01| 0.1167
0.1| 0.3689
1| 1.1667
10| 3.6893
100| 11.6667

For transmitters rated at a maximum output power not listed above, the recommended separation distanced in meters (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.

Possible Problems and Solutions

the finger is placed right in between the sensor and LED lights 2. Make sure that nothing is hindering the user’s blood flow
SpO2 or PR changes erratically| 1. Finger might not be inserted deep enough 2. Excessive body movement| 1. Insert the finger deep into the chamber 2. Please do not move during measurement
The oximeter cannot be powered on| 1. Batteries might be inserted incorrectly 2. Batteries are drained| 1. Please refer to ‘Battery Installation’ instruction 2. Please contact local customer service center
The display screen turns off suddenly| 1. The oximeter automatically powers off when no signal is detected for more than 8 seconds 2. The batteries are drained| 1. This is normal. Just turn the oximeter on again 2. Replace the batteries
If Err code is displayed| 1. The oximeter might be damaged| 1. Please contact local customer service center

Symbol Definitions

• Type BF applied part
• Protected against dripping water
• No SpO2 Alarm
• Symbol of oxygen saturation
• Storage temperature and relative humidity
• Attention
• Waste electrical and electronic equipment
• Follow instruction for use
• Symbol of pulse rate

Applicable Models

500CL

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

ALL RIGHTS RESERVED Issued Date: Jan 2020

FREQUENTLY ASKED QUESTIONS

What are the specific dimensions of the Zacurate 500CL Fingertip Pulse Oximeter?

The Zacurate 500CL Fingertip Pulse Oximeter measures 1.97 x 1.97 x 0.79 inches, providing a compact and portable design for easy use.

How much does the Zacurate 500CL Fingertip Pulse Oximeter weigh?

The Zacurate 500CL Fingertip Pulse Oximeter weighs 2.89 ounces, ensuring lightweight and comfortable usage.

What is the battery life of the Zacurate 500CL Fingertip Pulse Oximeter?

The Zacurate 500CL Fingertip Pulse Oximeter has a battery life of 30 hours, allowing for extended monitoring without frequent battery changes.

What type of batteries does the Zacurate 500CL Fingertip Pulse Oximeter require?

The Zacurate 500CL Fingertip Pulse Oximeter requires 2 AAA batteries for operation.

Who is the manufacturer of the Zacurate 500CL Fingertip Pulse Oximeter?

The Zacurate 500CL Fingertip Pulse Oximeter is manufactured by Zacurate, a reputable company known for producing quality medical devices.

What is the specific model number of the Zacurate 500CL Fingertip Pulse Oximeter?

The specific model number of the Zacurate 500CL Fingertip Pulse Oximeter is 500CL.

What is the price of the Zacurate 500CL Fingertip Pulse Oximeter?

The price of the Zacurate 500CL Fingertip Pulse Oximeter is $14.95, offering affordability without compromising on quality.

How long is the warranty period for the Zacurate 500CL Fingertip Pulse Oximeter?

The Zacurate 500CL Fingertip Pulse Oximeter comes with a 12-month warranty, providing assurance of its quality and reliability.

How does the Zacurate 500CL Fingertip Pulse Oximeter facilitate accurate monitoring of oxygen saturation levels?

The Zacurate 500CL Fingertip Pulse Oximeter utilizes advanced sensor technology to accurately measure oxygen saturation levels in the blood through a non-invasive fingertip method. This allows users to conveniently monitor their health status anytime, anywhere.

Why is my Zacurate 500CL Fingertip Pulse Oximeter not displaying any readings?

If your Zacurate 500CL Fingertip Pulse Oximeter is not displaying readings, first ensure that the device is securely placed on your fingertip and that your finger is clean and still. Check the battery compartment to ensure the batteries are properly inserted and fully charged.

How can I address inaccurate readings from my Zacurate 500CL Fingertip Pulse Oximeter?

If you're receiving inaccurate readings from your Zacurate 500CL Fingertip Pulse Oximeter, ensure that it's being used according to the instructions provided. Clean the sensor area and your fingertip to ensure proper contact.

What should I do if my Zacurate 500CL Fingertip Pulse Oximeter is displaying error codes?

If your Zacurate 500CL Fingertip Pulse Oximeter displays error codes, consult the user manual to identify the specific error and its potential causes. Common error codes may indicate issues such as improper placement, low battery, or sensor malfunction.

How do I troubleshoot issues with the display screen of my Zacurate 500CL Fingertip Pulse Oximeter?

If the display screen of your Zacurate 500CL Fingertip Pulse Oximeter is not functioning properly, first check for any visible damage or debris obstructing the screen. Clean the screen gently with a soft, dry cloth.

What should I do if my Zacurate 500CL Fingertip Pulse Oximeter is emitting unusual sounds during operation?

Unusual sounds from your Zacurate 500CL Fingertip Pulse Oximeter may indicate a malfunction. Ensure that the device is properly assembled and that there are no loose parts.

How can I troubleshoot issues with the battery life of my Zacurate 500CL Fingertip Pulse Oximeter?

If you're experiencing short battery life with your Zacurate 500CL Fingertip Pulse Oximeter, try using high-quality, fresh batteries. Avoid leaving the device turned on when not in use to conserve battery power.

What should I do if my Zacurate 500CL Fingertip Pulse Oximeter heats up during use?

If your Zacurate 500CL Fingertip Pulse Oximeter becomes unusually warm during operation, discontinue use and allow it to cool down. Check for any obstructions or damage that may be causing overheating.

How can I troubleshoot issues with the sensor accuracy of my Zacurate 500CL Fingertip Pulse Oximeter?

If you suspect that the sensors of your Zacurate 500CL Fingertip Pulse Oximeter are not functioning accurately, ensure that they are clean and free of debris. Avoid using the device in extreme temperatures or conditions that may affect sensor performance.

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