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Getting Started

Please watch asy demonstration and set up video

Instructions to User

Dear customers, thank you very much for choosing the Dr Trust Pulse Oximeter - Doctors Choice. However, before using the pulse oximeter, please read the user manual carefully and follow the instructions stated herein. Failure to follow these instructions can cause measuring abnormality, equipment damage and personal injury. 

Safety Information

Warnings alert the user to potential serious outcomes, such as injury or adverse events to the patient or user. Cautions alert the user to exercise care necessary for the safe and effective use of the pulse oximeter. Notes contain important information that may be overlooked or missed.

Warnings!

  • Do not strike or needle the battery.
  • Do not use the pulse oximeter in an MRI or CT environment.
  • Keep away from source of fire and/or heat.
  • Do not disassemble the oximeter or its accessories.
  • Do not use the pulse oximeter in the presence of flammable anesthetics.
  • Do not use the pulse oximeter in an explosive atmosphere.
  • Chemicals from a broken OLED panel are toxic when ingested.
  • Use caution when the oximeter has a broken display screen.
  • Change measurement site and check skin integrity, circulatory status, and correct alignment at least every 4 hours.
  • Check the pulse oximeter application site frequently to determine the positioning of the measurement and circulation and skin sensitivity of the patient.
  • Prolonged use or the patient’s condition may require changing the measurement site periodically.
  • Inaccurate measurements may be caused by autoclaving, ethylene oxide sterilizing, or immersing the sensors in liquid.

Please check that all accessories as listed in the packing list are complete and whether any component is damaged during shipping. If there is any damage and/or if you have any other concerns, please contact to our customer support department.

Table of Content

  • General Introduction
  • Product Overview
  • Intended use and Scope
  • Environment Requirements
  • Principle of Measurement
  • Display Explanation
  • Battery Installation
  • Mounting the Hanging Rope
  • Operating Guide
  • Clinical Restrictions
  • Ensuring Safe Operations
  • Instructions for Users
  • Technical Specifications
  • Repairing and Maintenance
  • Accessories
  • Troubleshooting
  • Key of Symbols
  • Function Specification
  • Appendix
  • Customer Support
  • About Us

General Introduction

The pulse oxygen saturation is the percentage of HbO2 in the total Hb in the blood, so-called the O2 concentration in the blood. It is an important bio-parameter for the respiration. For the purpose of measuring the SpO2 more easily and accurately, Dr Trust has developed this Dr Trust Pulse Oximeter - Doctors Choice. At the same time, the device can measure the pulse rate simultaneously.

Product Overview

The Dr Trust Pulse Oximeter - Doctors Choice is a reliable, durable and portable monitor. It is powered by 2X1.5V (AAA size) alkaline batteries. The monitor contains an easy-to-read display with a backlight for making easy to read the measurements in the low-light conditions. You can use it in situations where alarms are required as it has alarm feature. The Pulse Oximeter features in small volume, low power consumption, convenient operation and being portable. It is only necessary for patient to put one of his fingers into a fingertip photoelectric sensor for diagnosis, and a display screen will directly show measured value of Hemoglobin Saturation.

Main Features

  • Integrated with SpO2 probe and processing display.
  • Displays SpO2 level with pulse rate in a pulse bar graph, and waveform.
  • Operation of the product is simple and convenient.
  • The product is small in volume and convenient in carrying.
  • Total weight is about 50g including batteries and light in weight.
  • It is packaged with two AAA Batteries.
  • Power consumption of the product is low, and the two originally equipped AAA batteries can be operated continuously for hours.
  • Automatic power off feature saves power.
  • The product will enter standby mode when no signal is in the product within 5 seconds.
  • Display direction can be changed automatically, easy to view.
  • A digital OLED display screen with adjustable brightness.
  • A neck/wrist cord included with casing for secure handling.
  • Low-level battery indication.
  • Accurate readings in different views.
  • 30+ hours of continuous monitoring of pulse rate.
  • 2 Major Applications and Scope of Application 

Intended use and Scope

The Dr Trust Pulse Oximeter - Doctors Choice is intended for monitoring Peripheral Oxygen Saturation (SpO2) and Pulse Rate (PR) for adult, pediatric or neonatal patients continuously. It measures human Hemoglobin Saturation and pulse rate through finger and indicate the pulse intensity by the bar-display. It is designed for spot-checking and continuous monitoring of functional oxygen saturation and pulse rate. This device can be used in both hospital and non-hospital environments including departments of internal medicine in hospitals, outpatient departments, emergency rooms and ordinary departments in clinics, nursing hospitals and community medical institutions etc. It is used on finger of adult and pediatric patients.

Note

  • This device is not intended for continuous monitoring.
  • The problem of overrating would emerge when the patient is suffering from toxicosis which caused by carbon monoxide, the device is not recommended to be used under this circumstance.

Environment Requirements

Storage Environment

  1. a) Temperature: -40 ℃~ +60 ℃
  2. b) Relative humidity: ≤95%
  3. c) Atmospheric pressure: 500 hPa ~ 1060 hPa

Operating Environment

  1. a) Temperature: 10 ℃~ 40 ℃
  2. b) Relative Humidity: ≤75%
  3. c) Atmospheric pressure: 700 hPa ~ 1060 hPa

Principle of Measurement

An experience formula of data process is established taking use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive Hemoglobin (Hb) and Oxyhemoglobin (HbO2) in glow & near-infrared zones. Operation principle of the instrument is: Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning & Recording Technology, so that two beams of different wavelength of lights can be focused onto human nail tip through perspective clamp finger-type sensor. Then measured signal can be obtained by a photosensitive element, information acquired through which will be shown on screen through treatment in electronic circuits and microprocessor.

Figure 1 Operating principle

Cautions

  • The finger should be placed properly (see the attached illustration of this manual, Figure 5), or else it may cause inaccurate measurement.
  • The SpO2 sensor and photoelectric receiving tube should be arranged in a way with the subject’s arteriole in a position there between.
  • The SpO2 sensor should not be used at a location or limb tied with arterial canal or blood pressure cuff or receiving intravenous injection.
  • Make sure the optical path is free from any optical obstacles like rubberized fabric.
  • Excessive ambient light may affect the measuring result. It includes fluorescent lamp, dual ruby light, infrared heater, direct sunlight etc.
  • Strenuous action of the subject or extreme electrosurgical interference may also affect the accuracy.
  • Tester cannot use enamel or other makeup.

Display Explanation

View of the Front Panel 

Figure 2 Front view

Color OLED screen displays:

Key information that appears on the display of the Pulse Oximeter includes;

  • SpO2
  • Pulse Rate (PR)
  • Waveform and pulse bar
  • 4 display modes.

Battery Installation

  • Gently pull the cover off your oximeter.
  • Insert the battery into the opening on the back of it making sure the two AAA size batteries are placed properly in the right direction. (Refer Figure 3 to place the battery)
  • Replace the back cover and press along the edges of it until it clicks into place.

 

Figure 3 Batteries installation

 

Caution: Please take care when you insert the batteries the improper insertion may damage the device. 

Mounting the Hanging Rope

Step 1. Put the end of the rope through the hole.

Step 2. Put another end of the rope through the first one and then tighten it.

 

                                       Figure 4 Mounting the hanging rope 

Operating Guide

Insert the two batteries properly to the direction, and then replace the cover.

Open the clip as shown in Figure 5.

                                                        Figure 5 Put finger in position

 

  • Let the patient’s finger put into the rubber cushions of the clip (make sure the finger is in the right position), and then clip the finger.
  • Press the button once on front panel.
  • Do not shake the finger and keep the patient at ease during the process. Meanwhile, human body is not recommended in movement status.
  • Get the information directly from screen display.
  • The button has two functions. When the device is in standby mode, pressing the button can exit it; When the device is in operation status, pressing the button long can change brightness of the screen.
  • The device could change display direction according to the handing direction.

Caution: Fingernails and the luminescent tube should be on the same side. 

The monitor also contains on-screen controls for changing monitor settings, such as alarm limits, volume, and the backlight. A lock function, when activated, protects against unintended changes to settings. The alarm system generates audible and visual signals that vary according to the priority of the alarm. 

Clinical Restrictions

  • As the measure is taken on the basis of arteriole pulse, substantial pulsating blood flow of subject is required. For a subject with weak pulse due to shock, low ambient/body temperature, major bleeding, or use of vascular contracting drug, the SpO2 waveform (PLETH) will decrease. In this case, the measurement will be more sensitive to interference.
  • For those with a substantial amount of staining dilution drug (such as methylene blue, indigo green and acid indigo blue), or carbon monoxide hemoglobin (COHb), or methionine (Me+Hb) or thiosalicylic hemoglobin, and some with icterus problem, the SpO2 determination by this monitor may be inaccurate.
  • The drugs like dopamine, procaine, prilocaine, lidocaine and butacaine may also be a major factor blamed for serious error of SpO2 measure.
  • As the SpO2 value serves as a reference value for judgement of anemic anoxia and toxic anoxia, some patients with serious anemia may also report good SpO2 measurement.

Ensuring Safe Operations

  • Check the main unit and all accessories periodically to make sure that there is no visible damage that may affect patient's safety and monitoring performance about cables and transducers.
  • It is recommended that the device should be inspected once a week at least. When there is obvious damage, stop using the monitor.
  • Necessary maintenance must be performed by qualified service engineers ONLY. Users are not permitted to maintain it by themselves.
  • The oximeter cannot be used together with devices not specified in the user's manual. Only the accessory that appointed or recommendatory by manufacture can be used with this device.
  • This product is calibrated before leaving factory.
  • Keep the oximeter away from dust, vibration, corrosive substances, explosive materials, high temperature and moisture.
  • If the oximeter gets wet, please stop operating it.
  • When it is carried from cold environment to warm or humid environment, please do not use it immediately.
  • DO NOT operate keys on front panel with sharp materials.
  • High temperature or high-pressure steam disinfection of the oximeter is not permitted. Refer to User Manual in the relative chapter for instructions of cleaning and disinfection.
  • Do not have the oximeter immerged in liquid. When it needs cleaning, please wipe its surface with medical alcohol by soft material. Do not spray any liquid on the device directly.
  • When cleaning the device with water, the temperature should be lower than 60 ℃.
  • As to the fingers which are too thin or too cold, it would probably affect the normal measure of the patients' SpO2 and pulse rate, please clip the thick finger such as thumb and middle finger deeply enough into the probe.
  • Do not use the device on infant or neonatal patients.
  • The product is suitable for children above four years old and adults (Weight should be between 15 kg to 110 kg).
  • The device may not work for all patients. If you are unable to achieve stable readings, discontinue use.
  • The update period of data is less than 5 seconds, which is changeable according to different individual pulse rate.
  • The waveform is normalized. Please read the measured value when the waveform on screen is equably and steady going, here this measured value is optimal value. And the waveform at the moment is the standard one.
  • If some abnormal conditions appear on the screen during test process, pull out the finger and reinsert to restore normal use.
  • The device has normal useful life for three years since the first electrified use.
  • The hanging rope attached the product is made from Non- allergy material, if particular group are sensitive to the hanging rope, stop using it. In addition, pay attention to the use of the hanging rope, do not wear it around the neck avoiding cause harm to the patient.
  • The instrument does not have low-voltage alarm function, it only shows the low-voltage. Please change the battery when the battery energy is used out.
  • When the parameter is particularly, the instrument does not have alarm function. Do not use the device in situations where alarms are required.
  • Batteries must be removed if the device is going to be stored for more than one month, or else batteries may leak.
  • A flexible circuit connects the two parts of the device. Do not twist or pull on the connection.

Dos and Don'ts

  • DO NOT use the oximeter in environment with inflammable gas such as some ignitable anesthetic agents.
  • DO NOT use the oximeter while the testee measured by MRI and CT.
  • The person who is allergic to rubber cannot use this device.
  • The disposal of scrap instrument and its accessories and packings (including battery, plastic bags, foams and paper boxes) should follow the local laws and regulations.
  • Please check the packing before use to make sure the device and accessories are totally in accordance with the packing list, or else the device may have the possibility of working abnormally.
  • Please don't measure this device with function test paper for the device's related information.

Instructions for Users

  • The uncomfortable or painful feeling may appear if using the device ceaselessly, especially for the microcirculation barrier patients.
  • It is recommended that the sensor should not be applied to the same finger for over 2 hours.
  • For the individual patients, there should be a more prudent inspecting in the placing process. The device cannot be clipped on the edema and tender tissue.
  • The light (the infrared is invisible) emitted from the device is harmful to the eyes, so the user and the maintenance man, cannot stare at the light.
  • Testee cannot use enamel or other makeup.
  • Testee’s fingernail cannot be too long.
  • Please peruse the relative content about the clinical restrictions and caution.
  • This device is not intended for treatment.

Caution: Federal law restricts this device to sale by or on the order of a physician.

Technical Specifications

Display Format

OLED Display

SpO2 Measuring Range

0% ~ 100%

Pulse Rate Measuring Range

30 bpm ~ 250 bpm

Pulse Wave Display

Columniation display and the waveform display.

Power Requirements

2×1.5 V AAA alkaline battery (or using the rechargeable battery instead), adaptable range: 2.6 V - 3.6 V.

Power Consumption

Smaller than 30 mA

Resolution

1% for SpO2 and 1 bpm for Pulse Rate.

Measurement Accuracy

±2% in stage of 70%-100% SpO2, and meaningless when stage being smaller than 70%. ±2 bpm during the pulse rate range of 30-99 bpm and ±2% during the pulse rate range of 100 ~ 250 bpm.

Measurement Performance in Weak Filling Condition

SpO2 and pulse rate can be shown correctly when pulse-filling ratio is 0.4%. SpO2 error is ±4%, pulse rate error is ± 2 bpm during the pulse rate range of 30 ~ 99 bpm and ±2% during the pulse rate range of 100 ~ 250 bpm.

Resistance to surrounding light

The deviation between the value measured in the condition of man-made light or indoor natural light and that of darkroom is less than ±1%.

 

It is equipped with a function switch

The product will enter standby mode when no signal is in the product within 5 seconds.  

 

Optical Sensor

  Red light (wavelength is 660 nm, 6.65 mW)

    Infrared (wavelength is 880 nm, 6.75 mW)                                  

 

 

Repairing and Maintenance

  • Please change the batteries when the low voltage displayed on the screen.
  • Please clean the surface of the device before using. Wipe the device with medical alcohol first, and then let it dry in air or clean it by dry clean fabric.
  • Using the medical alcohol to disinfect the product after use, prevent from cross infection for next time use.
  • Please take out the batteries if the oximeter is not in use for a long time.
  • The best storage environment of the device is - 40 ºC to 60 ºC ambient temperature and not higher than 95% relative humidity.
  • Users are advised to calibrate the device termly (or according to the calibrating program of hospital). It also can be performed at the state-appointed agent or just contact us for calibration.

Cautions

  • High-pressure sterilization cannot be used on the device.
  • Do not immerse the device in liquid.
  • It is recommended that the device should be kept in a dry environment. Humidity may reduce the   useful life of the device, or even damage it.

Accessories

  • One hanging rope
  • Two batteries (optional)
  • One User Manual

Troubleshooting

Trouble

Possible Reason

Solution

The SpO2 and Pulse Rate cannot be displayed normally

1. The finger is not properly positioned.

2. The patient’s SpO2 is too low to be detected.

1. Place the finger properly and try again.

2. Try again; Go to a hospital for a diagnosis if you are sure the device works all right.

The SpO2 and Pulse Rate are not displayed stably

1. The finger is not placed inside deep enough.

2. The finger is shaking, or the patient is moving.

1. Place the finger properly and try again.

2. Let the patient keep calm

The device cannot be turned on

1. The batteries are drained or almost drained.

2. The batteries are not inserted properly.

3. The malfunction of the device.

1. Change batteries.

2. Reinstall batteries.

3. Please contact the local service center.

The display is off suddenly

1. The product will enter standby mode when no signal is in the product within 5 seconds  

2. The batteries are almost drained.

1. Normal.

2. Change batteries.

 

 

10 Key of Symbols

Symbol

Description

Type BF

 

Refer to instruction manual/booklet

 

The pulse oxygen saturation (%)

PRbpm

Pulse rate (bpm)

The battery voltage indication is deficient (change the battery in time avoiding the inexact measure)

1.No finger inserted

2. An indicator of signal inadequacy

Battery positive electrode

Battery cathode

 

1.Exit standby mode.

2.Change brightness of the screen.

SN

Serial number    

 

Alarm inhibit

WEEE (2002/96/EC)

IP22

International Protection

 

Manufacturer

 

Manufacture Date

 

Storage and Transport Temperature limitation

 

 

Storage and Transport Humidity limitation

 

Storage and Transport Atmospheric pressure limitation

 

This side up

 

Fragile, handle with care

 

Keep dry  

 

Recyclable

 

 11 Function Specification

Display Information

Display Mode

The Pulse Oxygen Saturation (SpO2)

OLED

Pulse Rate (PR)

OLED

Pulse Intensity (bar-graph)

OLED bar-graph display

Pulse wave

OLED

SpO2 Parameter Specification

Measuring range

0%~100%, (the resolution is 1%).

Accuracy

70%~100%: ±2%, Below 70% unspecified.

Optical Sensor

Red light (wavelength is 660 nm)

Infrared (wavelength is 880 nm)

Pulse Parameter Specification

Measuring range

30 bpm ~ 250 bpm (the resolution is 1 bpm)

Accuracy

±2 bpm or±2% select larger

Pulse Intensity

Range

Continuous bar-graph display, the higher display indicates the stronger pulse.

Battery Requirement

1.5V (AAA size) alkaline batteries × 2 or rechargeable battery                                                                                                                   

Battery Useful Life

Two batteries can work continually for 20 hours

Dimensions and Weight

Dimensions

57(L) × 31(W) × 32(H) mm

Weight

About 50 g (with the batteries)

  

Appendix

Guidance and manufacture’s declaration-electromagnetic emission

for all EQUIPMENT and SYSTEMS

Guidance and manufacture’s declaration –electromagnetic emission

The Dr Trust Pulse Oximeter - Doctors Choice is tended for use in the electromagnetic environment specified below. The customer of the user of the Dr The Dr Trust Pulse Oximeter - Doctors Choice should assure that it is used in such an environment.

Emission test

compliance

Electromagnetic environment-guidance

RF emissions

CISPR 11

Group 1

The Dr Trust Pulse Oximeter - Doctors Choice uses RF energy only for their 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 Dr Trust Pulse Oximeter - Doctors Choice 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 emission

IEC 61000-3-3

Not applicable

 

Guidance and manufacture’s declaration-electromagnetic immunity

for all EQUIPMENT and SYSTEMS

Guidance and manufacture’s declaration-electromagnetic immunity

The Dr Trust Pulse Oximeter - Doctors Choice is intended for use in the electromagnetic environment specified below. The user of the Dr Trust Pulse Oximeter - Doctors Choice should assure that it is used in such an environment.

Immunity test

IEC60601 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 is covered with synthetic material, the relative humidity should be at least 30%.

Power frequency (50Hz) magnetic field

IEC 61000-4-8

3A/m

3A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment

 

Guidance and manufacture’s declaration-electromagnetic immunity

for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING

Guidance and manufacture’s declaration-electromagnetic immunity

The Dr Trust Pulse Oximeter - Doctors Choice is intended for use in the electromagnetic environment specified below. The customer or the user of Dr Trust Pulse Oximeter - Doctors Choice should assure that it is used in such an environment.

 Immunity test

IEC60601 test level

 

Compliance level

Electromagnetic environment -guidance

Radiated RF

ICE 61000-4-3

3V/m

80MHz to 2.5GHz

3V/m

Portable and mobile RF communication equipment should be used no closer to any part of the Dr Trust Pulse Oximeter - Doctors Choice, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

recommended separation distance

  80MHz to 800MHz

 800MHz to 2.5GHz

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

Interference may occur in the vicinity of equipment marked with the following symbol:

  

 

Guidance and manufacture’s declaration-electromagnetic immunity

for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING

Guidance and manufacture’s declaration-electromagnetic immunity

The Dr Trust Pulse Oximeter - Doctors Choice is intended for use in the electromagnetic environment specified below. The customer or the user of Dr Trust Pulse Oximeter - Doctors Choice should assure that it is used in such an environment.

Immunity test

IEC60601 test level

 

Compliance level

Electromagnetic environment -guidance

Radiated RF

ICE 61000-4-3

3V/m

80MHz to 2.5GHz

3V/m

Portable and mobile RF communication equipment should be used no closer to any part of the Dr Trust Pulse Oximeter - Doctors Choice, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

recommended separation distance

  80MHz to 800MHz

 800MHz to 2.5GHz

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

Interference may occur in the vicinity of equipment marked with the following symbol:

  

NOTE 1    At 80MHz and 800MHz, 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.

a. Field strengths from fixed transmitters, such as base stations 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 Dr Trust Pulse Oximeter - Doctors Choice is used exceeds the applicable RF compliance level above, the Dr Trust Pulse Oximeter - Doctors Choice should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Dr Trust Pulse Oximeter - Doctors Choice.

b. Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3V/m.

 

Recommended separation distances between portable and mobile

RF communications equipment and the EQUIPMENT or SYSTEM

for EQUIPMENT or SYSTEM that not LIFE-SUPPORTING

Recommended separation distances between

portable and mobile RF communications equipment and the Dr Trust Pulse Oximeter - Doctors Choice

The Dr Trust Pulse Oximeter - Doctors Choice is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Dr Trust Pulse Oximeter - Doctors Choice r can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Dr Trust Pulse Oximeter - Doctors Choice 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)

150KHz to 80MHz   

80MHz to 800MHz   

800MHz to 2.5GHz

 

0.01

0.12

0.12

0.23

0.1

0.37

0.37

0.74

1

1.17

1.17

2.33

10

3.69

3.69

7.38

100

11.67

11.67

23.33

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 80MHz and 800MHz, 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.

 

 

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