Zacurate 500DL Pro Series Fingertip Pulse Manual

Zacurate 500DL Pro Series Fingertip Pulse Manual

Copyright © Einstein Associates LLC All rights reserved.
Einstein Associates LLC owns and reserves all of the rights comprised in the copyright of this document. No part of this document may be changed, excerpted, copied, reproduced, or imitated in any form or by any means without prior written consent of Einstein Associates LLC. All statements, information, and recommendations in this document are provided “AS IS” without warranties, guarantees, or representations of any kind, either expressed or implied. The information in this document is subject to change without notice. Einstein Associates LLC reserves the right to the final interpretation of this document.

Letter to Users

Thank you for choosing our Zacurate® 500DL Finger Pulse Oximeter. By listening intently and applying some of the changes suggested by our customers, we hope you will find that the 500DL is a much more user-friendly, reliable, and comfortable pulse oximeter than its predecessor. Before using this product, please read the user manual carefully and follow the instructions stated herein. Please also check that all accessories are complete as listed in the packing list and whether any component is damaged during shipping. If there is any damage and/or if you have any concerns, please contact us at cs@beyondmedshop.com or phone: 1-832-939-8290 with the following information:

1. Product model
2. Serial number of the product
3. Your contact information and address

Precaution

•  Do not attempt to repair the pulse oximeter by yourself. Only certified engineers should maintain and repair it.
• Change the contact position between the oximeter probe and the finger periodically if your finger feels sore or uncomfortable.
• Stop immediately if you have broken skin or the blood circulation of your finger is affected during prolonged use.
• This product is not designed to be used by newborn babies.
• Seek medical care if the measured value goes beyond the
• Do not attempt to repair the pulse oximeter by yourself. Only certified engineers should maintain and repair it.
• Change the contact position between the oximeter probe and the finger periodically if your finger feels sore or uncomfortable.
• Stop immediately if you have broken skin or the blood circulation of your finger is affected during prolonged use.
• This product is not designed to be used by newborn babies.
• Seek medical care if the measured value goes beyond the normal range and you are sure that the device is not malfunctioning.
• The pulse oximeter uses infrared light (invisible to your eyes) to measure your SpO2 level. Hence, please do not stare at the light-emitting components of the oximeter to avoid potential eye damage and/or blindness.

The following factors may affect the performance and accuracy of the oximeter:

• The oximeter is used in an environment with high-frequency devices, such as high-frequency electric knives and/or CT apparatuses.
• Ambient light intensity that is too bright. Hence, please avoid direct exposure to strong light (such as beams from operating lamps or sunlight) during measurement.
• The probe of the oximeter is placed on the same arm that a blood pressure cuff, arterial duct, or intravenous injection is placed.
• The user suffers from hypotension, severe vascular atrophy, severe anemia, or low oxygen.
• The user is in sudden cardiac arrest or shock state.
• The user is wearing nail polish or artificial nails.

Warnings

Do not use the oximeter in an environment with any flammable gases, flammable anesthetic, or other flammable substances. : Keep the unit and lanyard away from children as the included lanyard may pose as an entanglement or choking hazard to small children. Adult supervision is required; never leave children unattended with a unit or lanyard. Do not attempt to charge the included batteries, as that could cause leakage, a fire disaster, or even an explosion. Dispose of the used batteries in accordance with local laws and regulations.

Do not use the oximeter in an MRI or CT environment. Do not operate the oximeter if it is wet. Avoid moving the oximeter from a cold to a hot and humid environment. Install the batteries properly before powering on the oximeter for normal use. Please remove the batteries if you are not planning to use the oximeter for an extended period of time. Close the battery cover when the device is in use.

Overview

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.

Working Principles

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 500DL uses a proprietary algorithm to collect data from pulsatile arterial blood and excludes local 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. Due to the sensitivity of the pulse oximeter, the finger should be kept stationary during measurement. It is recommended that you use this device for measurement before or after sports. Do not use it for continuous monitoring.

Intended Use
The Zacurate® 500DL Finger Pulse Oximeter is a portable non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adults and children (>2 years old).

Product Features

• Lightweight, portable, and easy to use
• Large LED screen for easy reading
• Low Battery indicator
• Automatic shutdown if no signal is detected after 8 seconds.
• The device is equipped with two 1.5V AAA batteries, which will allow the pulse oximeter to operate for approximately 30 hours.

Limitations
The pulse oximeter works by measuring the amount of oxygenated hemoglobin in your blood over a period of time. Spot check pulse oximeter takes 1-2 readings every second and takes an average of 4-6 readings before displaying the result. Hence, you will have to wait at least 4-6 seconds before a result will be displayed on the monitor. If the pulse oximeter fails to detect blood flow for the first few seconds, the results will be delayed accordingly. The pulse oximeter does not work for people with naturally small fingers or low peripheral blood flow. This is because the pulse oximeter could not detect enough blood for a measurement.

Please note that prolonged use of a pulse oximeter, hypotension, vasoconstriction, hypothermia, and certain medications can lead to low or restricted blood flow. Nail polish can also impede the pulse oximeter from taking a reading. To know how much blood flow is being detected by the pulse oximeter, you will need a model that can display the plethysmograph (Model 500D). Finally, it is generally accepted that the saturation percentage is unreliable on the steep part (around 60 mm Hg) of the oxyhemoglobin dissociation curve.

Innovative features of the 500DL

The 500DL is designed to address and alleviate some of the above problems by

1. Increasing the sensitivity of the sensor to allow the user to measure his/her SpO2 levels and Pulse Rate (PR) even at low blood perfusion.
2. Using a self-adjusting smart spring system to fit the user’s finger snugly but not too tight so as to impede blood flow.
3. Using soft, hypoallergenic medical grade silicone in the finger chamber to minimize discomfort to the user’s finger.
4. Using solid ABS plastic to block ambient light from reaching the sensor so that the signal-to-background ratio and accuracy of measurement are dramatically increased.

Schematic Structural Diagram

1. LED screen
2. Power-on key
3. Shaft housing
4. Battery cove

Schematic Diagram of Display

The following figure shows the information displayed on the LED screen of the Oximeter in a normal detection state:

Note:
The display shows all segments during an internal self-check when powered on.

When the battery icon

flickers continuously on the LED screen, the battery is low and needs to be replaced.

Battery Installation

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

Using the Lanyard
Remove the silicone cover. Thread the thin end of the lanyard through the lanyard hole, thread the coarse end of the lanyard through the thin end of the lanyard, and tighten the lanyard. Put the silicone cover back on.

Taking SpO2 and Pulse Rate Readings

1. Insert one of your fingers into the finger chamber of the pulse oximeter. Note: The fingernail should be facing the top chamber (which contains the sensor). The finger should also be inserted completely into the chamber. Otherwise, measurement will be inaccurate.
2. Press the power-on key to turn the pulse oximeter on.
3. Keep your hand and finger still for the reading. It is recommended that you do not move your body while taking a reading.
4. Once the reading stabilizes, read the measured values of the oxygen saturation level and pulse rate on the LED screen.
5. The pulse oximeter will automatically shut down in 8 seconds after the finger is removed from the chamber or if no signal is detected by the device.
   

Note: Before each use, it is recommended to clean the finger and the silicone-padded finger.

Cleaning and Disinfection

It is recommended to clean the pulse oximeter regularly. The pulse oximeter can be disinfected as needed. To clean, use a soft cloth lightly dampened with water. To disinfect, use a soft cloth lightly dampened with isopropyl alcohol.

1. Make sure that the device is off and remove the batteries.
2. Wipe the outer surface of the device and the finger chamber using a lightly dampened soft cloth.
3. Allow the device to air dry thoroughly before use.

Maintenance

• Remove the batteries from the battery compartment if the pulse oximeter will not be used for an extended period of time.
• Replace the batteries if they are low on power.
• Clean the pulse oximeter and the fingertip before every use to ensure an accurate reading.
• Store the pulse oximeter between -13F and 158F (–25C and +70C) and at humidity levels no greater than 93%.
• Periodically check the pulse oximeter for damage.
• Do not use the pulse oximeter in an environment with flammable gases and/or where the temperature or humidity is excessively high or low.

Technical Specifications

1. Dimensions: 58.0 mm (Width) × 32.0 mm (Depth) × 33.2 mm (Height) (Approximately 2.28 inch X 1.25 inch X 1.30 inch) Weight: 49.5 g/1.7 oz (including the weight of two AAA batteries)
2. The peak wavelength range of the light emitted by the probe: red light 660 nm ± 3nm; infrared light 905 nm ± 10nm.
3. The maximum optical output power of the probe: 2.4 mW for infrared light (905 nm) and .3.2mW for infrared light (660nm)
4. Working power supply and current.

Technical Description

1. Oxygen Saturation Accuracy The accuracy is ±2% (in the absence of movement) between 70% to 100%. Note: The oxygen saturation accuracy is a root mean square of the difference. The measured values of the device are distributed according to statistical probability. Only about two-thirds of the measured values of the Pulse Oximeter fall within ±Arms of the measured values of a carbon-monoxide-blood-gas analyzer.
2. Determination of Oxygen Saturation Accuracy The claimed oxygen saturation is supported by coverage of the entire range of clinical research measurements.
3. Data Collection In the clinical test process, data points are recorded with comparable density in the entire claimed range.

REFERENCE LINK

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Zacurate 500DL Pro Series Fingertip Pulse Manual

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