Dr Trust 215 Pulse Oximeter User Manual

Dr Trust 215 Pulse Oximeter

ABOUT US

Driven by the passion for innovation, we at Dr Trust endeavour to provide our customers with the latest medical inventions with an objective to promote good health and wellness all around the world. All the medical devices and health monitors provided by Dr Trust are supported by accurate, latest and ground breaking technologies, innovated at our headquarter in NY. USA. All our products adhere to the most stringent CE and FDA guidelines and are strongly recommended by doctors and health practitioners. Our products are designed in the utmost exemplary ways to ensure that their accuracy and convenience are unrivalled. The ease of their use and operation makes them even more suitable for users of all age groups.

Dr Trust strives to enhance the quality of lifestyle by providing with the most trusted and innovative health care and wellness products. Being a renowned global leader in health care products, Dr Trust ensures that our technically efficient team works dynamically and tirelessly to provide the best of the medical devices to our clients. The products that we have to offer a.re suitably designed for use at homes, laboratories and hospitals.

Our ground breaking solutions allow you to monitor your health in the easiest ways possible. In today’s era when all of our lives are too hassled to handle, it becomes a bit difficult to pay attention to our health. But it has now become easier with the coming of the monitoring devices which can be conveniently used at homes and even on the go.We bring to you a variety of best self medical devices, trusted and used by Doctors, medical professionals and home users all over the world.

Quick start Guide

Note: The Medical instrument must be used according to instructions to ensure accurate readings.

SAFETY

Instructions for the Safe Operation and Use of the Dr Trust PulseOximeter-215

• Do not attempt to service the Pulse Oximeter. Only qualified service personnel should attempt any needed internal servicing.
• 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.
• Sp02 measurements may be adversely affected in the presence of high ambient light. Shield the sensor area (with a surgical towel, or direct sun I ight, for example) if necessary. The following reason will cause interference to the testing accuracy of the Dr Trust Pulse Oximeter-215.
• High-frequency electrosurgical equipment.
• Placement of a sensor on an extremity with a blood pressure cuff arterial catheter, or intravascular Ii ne.
• 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 Sp02readings.
• The device should be kept a.t least 10 minutes from non­working temperature to normal temperature.
• The device is non-sterile and not intended to be sterilized.

WARNING: 

• Although the ME equipment conforms to the intent of the standard EN 60601-1-2 in relation to electromagnetic compatibility, electrical equipment may produce interference. If interference is suspected, move equipment away from sensitive device or contact us. The portable and mobile RF communication equipment can affect this instrument’s
• EXPLOSION HAZARD-Do not use the Pulse Oximeter in a flammable atmosphere where concentrations of flammable anesthetics or other materials may occur.
• Do not throw batteries in fire as this may cause them to explode.
• Do not attempt to recharge normal dry-cell batteries, they may leak. And may cause a fire or even explode.
• Do not use the Pulse Oximeter in an MRI or CT environment.
• Do not modify this equipment without authorization of the manufacturer.
• If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of equipment

CAUTION:

• Keep the operating environment free of dust, vibrations, corrosive, or flammable materials, and extremes of temperature and humidity.
• 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.
• Never use sharp or pointed objects to operate the front ­panel switches.
• The batteries must be taken out from the battery compartment if the device will not be used for a longtime.
• The device shall only be used if the battery cover is closed.
• The batteries must be proper disposed according to local regulation after their use.
• The device should keep away from the children, pets and pests to avoid swallowing.

Definitions and Symbols

INTRODUCTION

GeneralThis chapter provides a general description of the Dr Trust Pulse Oximeter-215 including:

• Brief device description
• Product features

Indication for Use/Intended UseThe Dr Trust Pulse Oximeter – 215 is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate (PR). This portable device is indicated for use in adult patients in clinical institution and home environments.

Brief Device DescriptionThe Dr Trust Pulse Oximeter-215, based on all digital technology, is intended for noninvasive spot-check measurement of functional oxygen saturation of arterial hemoglobin (Sp02). Advanced DSP algorithm* can minimize the influence of motion artifact and improve measurement accuracy of low perfusion*. The Dr Trust Pulse0ximeter-215can be used to measure human Sp02 and heart rate through finger. The product is suitable for use in family, hospital (including clinical use in internist/surgery, Anesthesia, pediatrics and etc.) Oxygen Bar, social medical organizations, physical care in sports and etc.

Product Features

• Lightweight for carrying and easy-to-use.
• Manually adjust the direction of interface.
• Color LED display, simultaneous display for testing value and plethysmography.
• Low Perfusion: 0.3%. (Advanced DSP algorithm can improve measurement accuracy, under the condition of low perfusion.)
• Visual & sound reminder function. Real-time spot-checks. Low Battery voltage indicator.
• Automatically switch off.
• Standard two AAA 1.5V Alkaline Battery support more than 20 hours continuous work.

CAUTION:

• The device cannot be used to measure the child below 3 years as the test result is not guarantee to accurate.
• The Pulse Oximeter is intended only as an adjunct in patient assessment. It must be used in conjunction with other methods of assessing clinical signs and symptoms.
• The patient is an intended operator and can perform the maintenance of the equipment
• A function tester cannot be used to assess the accuracy of a Pulse Oximeter monitor or sensor.

Clinical testing is used to establish the Sp02 accuracy. The measured arterial Sp02 value (Sp02) of the sensor is compared to arterial hemoglobin oxygen (Sa02) 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 Sp02 range of 70-100%. Accuracy data is calculated using the root-mean-square (Arms value) for all subjects. Only about two ­thirds of PULSE OXIMETER EQUIPMENT measurements can be expected to fall within ±Arms of the value measured by a CO ­oximeter.

CAUTION: Pulse simulator shall be used to assess pulse rate Accuracy. The measured pulse rate is compared to the preset pulse rate value in simulator. Accuracy data is calculated using the root ­mean-square (Arms value) for all subjects.

DSP algorithm: Digital Signal Processor algorithm.Low Perfusion: In physiology, perfusion is the process of a body delivering blood to a capillary bed in its biological tissue. Under the condition of low perfusion, the measurement of non-invasive saturation of pulse-blood oxygen is low-accurate.Plethysmograph: It is an instrument for measuring changes in volume within an organ or whole body (usually resulting from fluctuations in the amount of blood or air it contains).

INSTALLATION, SETUP, ANDOPERATION

Description of the Front Panel (asfigure3.1.1) 

Item                  Name                                     Description1                      Power button                           Turn on the machine2                      LED Panel                               Display theSP02/PR data &3                      Battery Compartment              Plethysmogram

DisplayAfter switching on, the LED display of the Dr Trust Pulse Oximeter- 215 is as follows:

Operation

Install batteryInstalling two AAA batteries into battery cassette in correct polarities and cover it.

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

Turn the Pulse Oximeter ON

Put one of fingers into rubber hole of the Pulse Oximeter (it is best to put the finger thoroughly) with nail surface upward, then releasing the clamp.Press power button to turn the Pulse Oximeter on. The oximeter will be automatically powered off when no finger in the device for longer than 16seconds.

Read correspondent data from display screen.Press the “power” button for 3 seconds to turn on / off the beep sound

Note: When battery power is at lowest level, the battery capacity indicates symbol C] of in LED, remind users of replacement of battery.

CLEANING AND DISINFECTION

CleaningSwitch off the power and take out the batteries before cleaning.Keep the exterior surface of the device clean and free of dust and dirt Cleaning exterior surface (LED display 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.

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

CAUTION:

• Don’t use strong solvent like acetone.
• Never use an abrasive such as steel wool or metal polish.
• Do not allow any liquid into the product, and do not immerse any parts of the device into any liquids.
• Avoid pouring Iiquids on the device while cleaning.
• Don’t remain any cleaning solution on the surface of the device.

MAINTENANCE AND TROUBLESHOOTING

Maintenance

• Replace the batteries timely when battery indication is low. Clean surface of the 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 longtime.
• It is better to preserve the product in a place where ambient temperature is-25-55 °C (-13°F to 131°F) and humidity is 15%- 93%.
• Regular inspection to make sure that no obvious damage existed to affect the safety and performance of device.
• No flammable substance overtops or lower temperature and humidity existed in operation conditions.

Troubleshooting

DISPOSALObserve the applicable regulations when disposing of the Dr Trust Pulse Oximeter-215 and batteries.This pulse oximeter must not be disposed of together with domestic waste. All users are obliged to hand in all electrical or electronic devices, regardless of whether or not they contain toxic substances, at a municipal or commercial collection point so that they can be disposed of in an environmentally acceptable manner.Please remove the batteries before disposing of the Dr Trust Pulse Oximeter -215. Do not dispose of old batteries with your household waste, but at a battery collection station at a recycling site or in a shop.

CUSTOMER SUPPORT

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