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This Manual is written and compiled in accordance with the council directive MDD93/42/EEC for
medical devices and harmonized standards. In case of modifications and software upgrades, the
information contained in this document is subject to change without notice.
The Manual describes, in accordance with the Pulse Oximeter's features and requirements, the main
structure, functions, specifications, correct methods for transportation, installation, usage, operation,
repair, maintenance and storage, etc. as well as the safety procedures to protect both the user and
equipment. Refer to the respective chapters for details.
Please read the User Manual carefully before using this product. The User Manual which describes the
operating procedures should be followed strictly. Failure to follow the User Manual may cause
measuring abnormality, equipment damage and human injury. The manufacturer is NOT responsible for
the safety, reliability and performance issues and any monitoring abnormalities, human injury or
equipment damage due to users' negligence of the operation instructions. The manufacturer's warranty
service does not cover such faults.
Regrettably, owing to the forthcoming renovation, the specific products you received may not be totally
in accordance with the description of this User Manual.
This product is a medical device and can be used repeatedly.
WARNING:
Discomfort or pain can occur if the device is used ceaselessly, especially for
microcirculation barrier patients. It is recommended that the sensor should not be applied
to the same finger for longer than 2 hours.
For special patients, there should be a more prudent inspection of the placing process. The
device should not be clipped on an edema or tender tissue.
The infrared light emitted from the device, though invisible, is harmful to the eyes. Avoid
staring at it.
The patient cannot use nail enamel or other makeup.
The patient's fingernails must be clipped short.
Please refer to the related content about clinical restrictions and caution.
This device is not intended for treatment.
TORONTEK-E400 Pulse Oximeter
User Instructions

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Summary of Contents for ToronTek E400

  • Page 1 TORONTEK-E400 Pulse Oximeter User Instructions This Manual is written and compiled in accordance with the council directive MDD93/42/EEC for medical devices and harmonized standards. In case of modifications and software upgrades, the information contained in this document is subject to change without notice.
  • Page 2: Table Of Contents

    TORONTEK-E400 Pulse Oximeter Table of Contents 1. Safety ..............................1 1.1 .Instructions for Safe Operations ...................... 1 1.2. Warning ............................1 1.3. Hazards ............................1 2. Overview .............................. 2 2.1. Features ............................2 2.2. Major Applications and Scope of Application ................. 3 2.3.
  • Page 3: Safety

    TORONTEK-E400 Pulse Oximeter 1. Safety 1.1. Instructions for Safe Operations  Inspect the main unit and all accessories periodically to ensure that there is no visible damage that may affect the patient’s safety, and monitor the performance of cables and transducers. It is recommended that the device should be inspected at least once a week.
  • Page 4: Overview

    TORONTEK-E400 Pulse Oximeter  DO NOT immerse the Oximeter in liquid. If it needs cleaning, wipe the surface with medical alcohol using a soft material. Do not spray any liquid directly onto the device.  When cleaning the device with water, ensure that the temperature of the water is lower than 60℃...
  • Page 5: Major Applications And Scope Of Application

    TORONTEK-E400 Pulse Oximeter 2.2. Major Applications and Scope of Application The Pulse Oximeter can be used to measure the pulse oxygen saturation and pulse rate through a finger. The device is suitable for use in the home, hospitals, oxygen bar, community health care, and physical care in sports (it can be used before or after doing sports and is not recommended to be used during sporting activities).
  • Page 6: Technical Specifications

    TORONTEK-E400 Pulse Oximeter 4. Technical specifications 4.1. Main performance A. SpO value display. B. Pulse rate value display, bar graph display. C. Pulse waveform display. D. Low battery indication: low battery indicator appears when the battery is drained. Device may work abnormally when the battery is low.
  • Page 7: Installation

    TORONTEK-E400 Pulse Oximeter 5. Installation 5.1. View of Front Panel Figure 2 Front View 5.2. Installing the Wrist Strap A. Put the thinner side of the strap through the hole. B. Put the wider side of the strap through the thinner side and tighten it.
  • Page 8: Operating Guide

    TORONTEK-E400 Pulse Oximeter 1 Power adapter 1 Data line 1Disk (PC software) 6. Operating guide 6.1. Application Method A. Squeeze the clamp, put a finger into the rubber hole, then release it. a) Press the Power Button on the front panel until the device turns on.
  • Page 9 TORONTEK-E400 Pulse Oximeter Press the power button with a prolonged push (1 second) to enter the Settings Menu Interface (see Figure Note: When the display direction on the screen is in Portrait View, you cannot enter the Menu Interface. Press the power button to switch to Landscape View.
  • Page 10 TORONTEK-E400 Pulse Oximeter c. Pulse sound indication setting Select "Pulse Sound", choose to have the Pulse Sound (heart beat) alarm either "On" or "Off." d. Exiting the Alarm settings Select "EXIT" to exit the Alarm Settings Menu. C. Data transmission setting First, please install the affiliated software onto the computer.
  • Page 11: Attention For Operation

    TORONTEK-E400 Pulse Oximeter interface), the sign "Recording" will appear on the screen in 30 seconds, then the screen will be automatically shut down. If you push the button, the sign "Recording" will appear on the screen, and then the screen will be automatically shut down again; if you press and hold the button, the device will return to the former interface.
  • Page 12: Clinical Restrictions

    TORONTEK-E400 Pulse Oximeter pressure cuff, or receiving intravenous injection. D. Do not fix the SpO sensor with adhesive or else it may result in venous pulsation and inaccurate measure of the SpO and pulse rate. E. Excessive ambient light may affect the measuring result. This includes fluorescent lamps, dual ruby lights, infrared heaters, direct sunlight etc.
  • Page 13: Troubleshooting

    TORONTEK-E400 Pulse Oximeter 8. Troubleshooting Problem Possible Reason Solution 1. The finger is not 1. Place the finger properly and try The SpO and Pulse Rate properly positioned. again. are not displayed 2. Try again; Go to a hospital for a normally 2.
  • Page 14: Key Of Symbols

    TORONTEK-E400 Pulse Oximeter 9. Key of symbols Signal Description Warning – See User Manual %SpO The pulse oxygen saturation(%) Pulse rate (bpm) Fully charged Low battery Turn alarm off Pause alarm Turn alarm on Turn pulse sound indication off Turn pulse sound indication on...
  • Page 15: Function Specification

    TORONTEK-E400 Pulse Oximeter 10. Function specification Information Display Mode The Pulse Oxygen Saturation(%SpO 2-digit digital OLED display Pulse Rate(bpm) 3-digit digital OLED display Pulse Intensity (bar-graph) bar-graph OLED display Parameter Specification Measuring range 0%~100%, (the resolution is 1%). Accuracy 70%~100%:±2% ,Below 70% unspecified.
  • Page 16: Appendix 1

    TORONTEK-E400 Pulse Oximeter Battery working life Charge and discharge no less than 500 times. Power Adapter Input Voltage 100 to 240 VAC, 50/60 Hz Output voltage 5 VDC Output current 250mA Output power 1.25 W Oximeter Probe Wavelength: 660nm 880nm...

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