Gima OXY-200 User Manual
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Gima OXY-200 User Manual

Gima OXY-200 User Manual

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PROFESSIONAL MEDICAL PRODUCTS
OXY-200 PULSE OXIMETER
User manual
ATTENTION: The operators must carefully read and completely
understand the present manual before using the product.
35101 / CMS70A
CONTEC MEDICAL SYSTEMS CO., LTD
No.112 Qinhuang West Street,
Economic & Technical Development Zone,
066004 Qinhuangdao, Hebei Province,
PEOPLE'S REPUBLIC OF CHINA
Made in China
Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537 Hamburg, Germany
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
0123
IP21

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  • Page 1 Gima S.p.A. Via Marconi, 1 - 20060 Gessate (MI) Italy gima@gimaitaly.com - export@gimaitaly.com www.gimaitaly.com PROFESSIONAL MEDICAL PRODUCTS OXY-200 PULSE OXIMETER User manual ATTENTION: The operators must carefully read and completely understand the present manual before using the product. 0123 35101 / CMS70A CONTEC MEDICAL SYSTEMS CO., LTD...
  • Page 2 Instructions to user Dear users, thank you very much for purchasing the device. 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 docu- ment is subject to change without notice.

  • Page 3: Table Of Contents

    Contents Safety ....................4 Instructions for safe operation ............4 Warning ....................4 Attention ....................5 EMC statement ................... 5 Overview .................... 6 Features ....................6 Major applications and scope of application ........6 Contraindications ................7 Principle ..................... 7 Technical specifications ..............

  • Page 4: Safety

    1. SAFETY 1.1 Instructions for safe operation • 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 perfor- mance. It is recommended that the device should be inspected weekly at least.

  • Page 5: Attention

    1.3 Attention  Keep the device away from dust, vibration, corrosive substances, tinder, high temperature and moisture.  If the device gets wet, please stop operating it.  When it is carried from cold environment to warm or humid environment, please do not use it immediately.

  • Page 6: Overview

    2. OVERVIEW The pulse oxygen saturation is the percentage of HbO in the total Hb in the blood, so-called the O concentration in the blood. It is an important bio-pa- rameter for the respiration. A number of diseases relating to respiratory system may cause the decrease of SpO in the blood, furthermore, some other causes such as the malfunction of human body’s self-adjustment, damages during...

  • Page 7: Principle

    3. PRINCIPLE Principle of the Oximeter is as follows: An experience formula of data process is established taking use of Lambert Beer Law according to Spectrum Absorp- tion Characteristics of Reductive Hemoglobin (Hb) and Oxyhemoglobin (HbO in glow & near-infrared zones. Operation principle of the device is: Photoelec- tric Oxyhemoglobin Inspection Technology is adopted in accordance with Ca- pacity Pulse Scanning &...

  • Page 8: Main Parameters

    4.2 Main parameters A Measure of SpO Measure range: 0~100% Accuracy: When the SpO measure range is 70%~100%, the permission of absolute error is ±2%; Below 70% unspecified. B Measure of pulse rate Measure range: 30bpm~250bpm Accuracy: ±2 bpm or ±2% (select larger) C Measure of PI Range: 0~20% When the PI measure range is 1%~20%,...

  • Page 9: Installation

    Operating Environment a) Temperature: 0°C~40°C b) Relative Humidity: ≤75% c) Atmospheric pressure: 700hPa~1060hPa 5. INSTALLATION 5.1 View of the front panel Alarm pause button Mode switch button Display area Up button Menu button Probe jack Return button Alternating current indicator light Power button Left button Down button...

  • Page 10: View Of The Back Panel

    5.2 View of the back panel R pinhole restoration key Fuse pedestal Alternating current Power supply USB port Figure 3. Back view USB port: It is used to connect computer to transmit data by data line. R Pinhole Restoration key: restore the device The computer intended to be connected with this device, shall be approved and certificated according to IEC 60950.

  • Page 11: Operating Guide

    6. OPERATING GUIDE 6.1 Application method 6.1.1 Inserting the lemo probe into the lemo jack of the device (The probe is limited to the one that is provided by our company; and can’t be replaced with the similar one by other manufacturers), then put the finger into the probe as Figure 4. Figure 4.
  • Page 12 6.1.3 Menu operations In the measuring interface, press menu button to enter the main menu interface as figure 5. Figure 5. Main menu interface System setting In the main menu interface, choose “System” item, then press menu button to enter the System setting menu as figure 6: Figure 6.
  • Page 13 ton to affirm setting, then press return button to return the system setting menu interface. Display setting In the main menu interface, choose “Display” item, then press menu button to enter the display setting menu as Figure 7: Figure 7. Display setting menu A Brightness: move the choice bar to the “Brightness”...
  • Page 14 Clock setting In the main menu interface, move the choice bar to “Clock” item, then press the menu button to enter the clock setting menu of Figure 10: Figure 10. Clock setting menu Move the choice bar to the menu item that you want to set, and press left/right button to begin to set.
  • Page 15 B Set alarm state In alarm setting menu, move the choice bar to the “Alarm” item, press left/ right to set the alarm state. Choose “on” to turn on the alarm, and choose “off” to turn off the alarm. C Set alarm pause time In alarm setting menu, move the choice bar to the “Alarm Pause”...
  • Page 16 return to measure interface. c If the inputed ID has existed, the prompt dialog box as figure 14 will appear. Choose “Yes” and click menu button to replace the existed ID, at the same time begin to record and return to the measure interface; choose “No” to return the “Input ID”...
  • Page 17 Figure 16. Delete ID dialog box C Review function setting In record menu interface, move the choice bar to the “Review” item, then choice frame will appear. Press the “left/right button” to choose “VAL- UE”/“TREND”, then press menu button to enter “select ID” interface as fig- ure 17.

  • Page 18: Attention For Operation

    is pulse rate value, the green front on the right bottom is PI value. Press “up button” or “down button” to page up or page down;press “left button” or “right button” to move the recording time which is denoted by pink triangle. Close the device a In the main menu interface, move the choice bar to the “Power”...

  • Page 19: Clinical Restrictions

    E Ensure nothing, such as a plaster, can impede the light passage, or else it may result in inaccurate measure of SpO , pulse rate and PI. F Excessive ambient light may affect the measure result. It includes fluores- cent lamp, dual ruby light, infrared heater, direct sunlight and etc. G Exquisite action of the subject or extreme electrosurgical interference may also affect the accuracy.

  • Page 20: Transportation And Storage

    D Users are advised to calibrate the device termly (or according to the cali- brating program of hospital). It also can be performed at the state-appointed agent or just contact us for calibration. 7.3 Transportation and storage A The packed device can be transported by ordinary conveyance or accord- ing to transport contract.

  • Page 21: Key Of Symbols

    9. KEY OF SYMBOLS Signal Description Signal Description Probe error Alternating current indicator light Signal indication is not enough The pulse oxygen saturation (%) The sensor is off (probe-off) SENSOR OFF Pulse rate (bpm) Sensor fault (probe fault) SENSOR FAULT The battery power is full Perfusion Index (%) Fall short of power little...

  • Page 22: Function Specification

    10. FUNCTION SPECIFICATION Information Display Mode The Pulse Oxygen Saturation 2-digit digital LED display (SpO Pulse Rate (PR) 3-digit digital LED display Pulse Intensity (bar-graph) 8-segment light bar LED display PI (perfusion index) 3-digit digital LED display Parameter Specification Measuring range 0~100%, (the resolution is 1%).

  • Page 23: Factory Default

    11. FACTORY DEFAULT Default Unit Brightness Measure interface display mode LCD Brightness time 0 (mean display at all times ) Demo mode Themes Alarm sound indication Alarm pause time second SpO2 alarm high limit SpO2 alarm low limit Pulse rate alarm high limit Pulse rate alarm low limit Volume...

  • Page 24: Appendix

    APPENDIX Guidance and manufacturer’s declaration – electromagnetic emissions- for all EQUIPMENT and SYSTEMS Guidance and manufacturer’s declaration – electromagnetic emission The CMS70A is intended for use in the electromagnetic environment specified below. The customer of the user of the CMS70A should assure that it is used in such and environment. Emission test Compliance Electromagnetic environment –...
  • Page 25 Guidance and manufacturer’s declaration – electromagnetic immunity – for all EQUIPMENT and SYSTEMS Guidance and manufacturer’s declaration – electromagnetic immunity The CMS70A is intended for use in the electromagnetic environment specified below. The customer or the user of CMS70A should assure that it is used in such an environment. Immunity test IEC 60601 test Compliance...
  • Page 26 Guidance and manufacture’s declaration – electromagnetic immunity – for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacture’s declaration – electromagnetic immunity The CMS70A is intended for use in the electromagnetic environment specified below. The customer or the user of CMS70A should assure that it is used in such an environment. Immunity test IEC 60601 Compliance level...
  • Page 27 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 equip- ment and the CMS70A The CMS70A is intended for use in an electromagnetic environment in which radiated RF distur- bances are controlled.
  • Page 28 Congratulations for purchasing a GIMA product. This product meets high qual- itative standards both as regards the material and the production. The warran- ty is valid for 12 months from the date of supply of GIMA. During the period of validity of the warranty, GIMA will repair and/or replace free of charge all the defected parts due to production reasons.

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