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Innovo CMS 50F PLUS User Manual

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Innovo® CMS 50F PLUS User Manual
Instructions to User
Dear users, thank you for purchasing our Pulse Oximeter.
This Manual is written and compiled in accordance with the
council directive MDD93/42/EEC for medical devices and
harmonized standards. 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, its features, functions, specifications,
transportation methods, 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 lead to measurement abnormality, equipment malfunction
and body injury. The manufacturer is NOT responsible for any
safety, reliability, monitoring abnormality, malfunction and
performance issues with regards to the equipment and/or any
personal injuries that arise due to user's negligence to follow the
manual's instructions.
As the device is undergoing constant revision and improvisation,
the product(s) you received may not be in total accordance with
the description of this User Manual. We sincerely regret for the
inconvenience.
Caution: This device is not intended to diagnose or treat any
medical condition or disease. It is intended for non-medical
use in healthy people to monitor their pulse and blood oxygen
levels during sports and/or aviation only. People who need
SpO
and pulse rate measurements because of a medical
2
condition should not use the device and should consult with
I

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  • Page 1 Innovo® CMS 50F PLUS User Manual Instructions to User Dear users, thank you for purchasing our Pulse Oximeter. This Manual is written and compiled in accordance with the council directive MDD93/42/EEC for medical devices and harmonized standards. The information contained in this document is subject to change without notice.
  • Page 2 Innovo® CMS 50F PLUS User Manual their physician. WARNING:  Users might experience discomfort if the device is used continuously for a long period of time, especially for users suffering from poor microcirculation. It is recommended that the sensor should not be applied to the same finger for over 2 hours.
  • Page 3 Innovo® CMS 50F PLUS User Manual Copyright © Innovo Groups 2014-2015. All rights reserved. Innovo Groups 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...

  • Page 4: Table Of Contents

    Innovo® CMS 50F PLUS User Manual CONTENTS 1 Safety ..................1 1.1 Saftey Information ............. 1 1.2 Warning ................1 1.3 Attention ................2 2 Overview ................... 3 2.1 Features ................4 2.2 Major Applications and Scope of Application....4 2.3 Environment Requirements ..........
  • Page 5 Innovo® CMS 50F PLUS User Manual 9 Symbols ........Error! Bookmark not defined.3 10 Function Specification ....Error! Bookmark not defined. Appendix 1 ........Error! Bookmark not defined. Appendix 2 ................27...

  • Page 6: Safety

    Innovo® CMS 50F PLUS User Manual 1 Safety 1.1 Safety Information a) Check the main unit and all accessories periodically to make sure that there is no visible damage that may affect patient’s safety and/or monitoring performance of the device. The device should be inspected at least once a week.

  • Page 7: Attention

    Innovo® CMS 50F PLUS User Manual with the requirements of IEC 60601-1, or the device might be damaged.  Please do not use the device while charging.  The device should only be used with the Acc U Rate® SnugFit probe. Using the Contec CMS 50F probe might damage the oximeter.

  • Page 8: Overview

    Innovo® CMS 50F PLUS User Manual will be most accurate.  If some abnormal conditions appear on the screen during test process, pull out the finger and reinsert to restore normal use.  You should not use the device after three years.

  • Page 9: Features

    Innovo® CMS 50F PLUS User Manual 2.1 Features 1. The device is simple and easy to operate. 2. The product is small and portable. 3. Low power consumption. 2.2 Major Applications and Scope of Application The Pulse Oximeter can be used to measure SpO and pulse rate through a finger.

  • Page 10: Principle

    Innovo® CMS 50F PLUS User Manual 3 Principle Oxygenated blood absorbs light at 660nm (red light), whereas deoxygenated blood absorbs light preferentially at 940nm (infra-red). Pulse oximeters consist of two light emitting diodes, at 600nm and 940nm, and two light collecting sensors, which measure the amount of red and infra-red light emerging from tissues traversed by the light rays.
  • Page 11 Innovo® CMS 50F PLUS User Manual pulse-oximeter as arterial blood, with a low resultant reading. Finally, it is generally accepted that the saturation percentage is unreliable on the steep part (around 60 mm Hg) of the oxyhemoglobin dissociation curve. The Acc U Rate® SnugFit probe attempts to ameliorate some of the problems by 1) Fitting snugly without causing discomfort to the user’s finger...

  • Page 12: Technical Specifications

    Innovo® CMS 50F PLUS User Manual 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-voltage indication: low-voltage indicator appears before working abnormally which is due to low-voltage E.
  • Page 13 Innovo® CMS 50F PLUS User Manual The device can measure SpO and pulse rate at blood perfusion level as low as 0.4%. However, SpO error is increased to ±4%, and pulse rate error to ±2 bpm or ±2% (select larger).

  • Page 14: Product Description

    Innovo® CMS 50F PLUS User Manual 5 Product Description 5.1 Front Panel View Figure 2. Front view Figure 3. Left view 1. This USB port has multiple uses. It can be used to connect the SpO probe/sensor, upload the data to a personal computer or to charge the lithium battery.

  • Page 15: Probe Connection

    Innovo® CMS 50F PLUS User Manual light turns to green. 5.2 Probe Connection When connecting the Acc U Rate® SnugFit probe, make sure it is inserted properly and all the way into the pulse oximeter as shown in Figure 4.

  • Page 16: Operating Guide

    Innovo® CMS 50F PLUS User Manual 6 Operating Guide 6.1 Using the Device A. Install the probe as outlined in Chapter 5.2. (Please do not use probes made by other manufacturers as the algorithm used by the watch will not work with them. Unapproved probes might also damage the oximeter) B.
  • Page 17 Innovo® CMS 50F PLUS User Manual constant, stable reading. In other words, the wavelength and amplitude of each wave will be identical to the next (Figure 6). F. You may now read the SpO and PR displayed on the OLED screen.
  • Page 18 Innovo® CMS 50F PLUS User Manual (>1 sec) of the button activates different functions of the pulse oximeter. A. Enter the clock interface You can press the button to enter the clock interface from the measuring interface. B. Exit the clock interface 1) The clock interface will automatically return to the measuring interface if no operations are registered within 30 seconds.
  • Page 19 Innovo® CMS 50F PLUS User Manual 1) Backlight adjustment In the main menu interface, PUSH button to select "Brightness". HOLD the button to adjust backlight brightness. 2) Alarm setting In the main menu interface, PUSH button to select "Alarm". HOLD the power button to enter the alarm setting interface as shown in Figure 8: Figure 8.
  • Page 20 Innovo® CMS 50F PLUS User Manual If the alarm function is on, the device will provide medium-priority alarm signal when the data of SpO or pulse rate falls beyond set limit. Intermittent alarm will occur and the measurement will be displayed in yellow font.
  • Page 21 Innovo® CMS 50F PLUS User Manual B) PUSH the button to select the parameter that you want to change. HOLD the button to adjust the data. C) PUSH the button to select "Exit". HOLD the button to exit the clock setting menu. If you have reset the time or date, when exiting the clock setting menu, the renewed time and date would be displayed on the screen before returning to the main menu;...
  • Page 22 Innovo® CMS 50F PLUS User Manual automatically. C. If the data storage function is being turned on, a red "REC" sign and a flashing red dot would appear on the screen when returning to the measuring interface. D. When the device is storing data, “Recording" would appear in the screen for 30 seconds irregardless of the interfaces the device might be in.
  • Page 23 Innovo® CMS 50F PLUS User Manual 8) Exit the main menu In the main menu interface, PUSH the button to select "Exit”. PUSH the button again to exit the main menu. E. Uploading Data You may connect the device to the computer via USB or Bluetooth (in selected model only).

  • Page 24: Clinical Restrictions

    Innovo® CMS 50F PLUS User Manual High priority alarm indicates that immediate operator response is required. 6.2 Cautions Please check device before use to confirm that it is working normally. The SpO and PR should be displayed correctly on the screen.
  • Page 25 Innovo® CMS 50F PLUS User Manual pulse due to shock, low body temperature, major bleeding, or use of vascular contracting drug. Under such circumstances, the measurement will be more sensitive to interference. B. For users with a substantial amount of staining dilution drug...

  • Page 26: Maintain, Transportation And Storage

    Innovo® CMS 50F PLUS User Manual 7 Maintenance, Transportation and Storage 7.1 Cleaning and Disinfecting Use medical alcohol to disinfect the device. Let it air dry or clean it with clean soft cloth. 7.2 Maintenance A. Please clean and disinfect the device as outline above.

  • Page 27: Troubleshooting

    Innovo® CMS 50F PLUS User Manual 8 Troubleshooting Trouble Possible Reason Solution 1. Make sure that the finger is 1. The finger is not inserted properly properly positioned. No SpO into the device. 2. The patient’s Pulse Rate is 2. Make sure...
  • Page 28 Innovo® CMS 50F PLUS User Manual The battery is not 1. Please contact 1. The battery has fully charged the local service malfunctioned after 10 hrs. center. 9 Symbols Symbol Description Refer to instruction manual/booklet %SpO Oxygen saturation (%) PRbpm...
  • Page 29 Innovo® CMS 50F PLUS User Manual Pulse sound activated menu button/power button Type BF Serial number 1. the finger clip falls off ( no finger inserted) 2. Probe error 3. Signal inadequacy indicator IP22 International Protection WEEE (2002/96/EC) 10 Function specification...
  • Page 30 Innovo® CMS 50F PLUS User Manual Average value is derived from 4 previous values. Average value The deviation between average and true value does not exceed Pulse Parameter Specification 30bpm~250bpm, (resolution = Measuring range 1bpm) Accuracy ±2bpm or±2% (select larger) Average value is derived from 4 previous values.
  • Page 31 Innovo® CMS 50F PLUS User Manual Transmit frequency 2.4GHz Dimensions and Weight Dimensions 61(L) × 56(W) × 24 (H) mm About 50g (with the lithium Weight battery*1) Appendix 1 State Alarm condition Alarm signal delay generation delay Low voltage alarm 0.6s...
  • Page 32 Innovo® CMS 50F PLUS User Manual Appendix 2 Guidance and manufacture's declaration – electromagnetic emissions for all EQUIPMENT and SYSTEMS Guidance and manufacture’s declaration – electromagnetic emission The CMS50F PLUS Pulse Oximeter is intended for use in the electromagnetic environment specified below. The user should assure that it is used in such environment.
  • Page 33 Innovo® CMS 50F PLUS User Manual emissions domestic purposes. 61000-3-3...
  • Page 34 Innovo® CMS 50F PLUS User Manual Guidance and manufacture’s declaration – electromagnetic immunity – for all EQUIPMENT and SYSTEMS Guidance and manufacture’s declaration – electromagnetic immunity The CMS50F PLUS Pulse Oximeter is intended for use in the electromagnetic environment specified below. The user should assure that it is used in such an environment.
  • Page 35 Innovo® CMS 50F PLUS User Manual Power 3A/m 3A/m Power frequency frequency (50/60Hz) magnetic fields magnetic field should levels 61000-4-8 characteristic of typical location typical commercial or hospital environment.
  • Page 36 Innovo® CMS 50F PLUS User Manual Guidance and manufacture’s declaration – electromagnetic immunity – for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacture’s declaration – electromagnetic immunity The CMS50F PLUS Pulse Oximeter is intended for use in the electromagnetic environment specified below.
  • Page 37 Innovo® CMS 50F PLUS User Manual               80 MHz to 800 MHz        800 MHz to 2.5 GHz Where maximum output power...
  • Page 38 Innovo® CMS 50F PLUS User Manual vicinity 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 from structures, objects and people.
  • Page 39 Innovo® CMS 50F PLUS User Manual Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM – for EQUIPMENT or SYSTEM that are not LIFE-SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the CMS50F PLUS Pulse Oximeter.
  • Page 40 Innovo® CMS 50F PLUS User Manual 3.689 3.689 7.379 11.67 11.67 23.33 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency...

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