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Conox®
Instructions for Use
Manufacturer Quantium Medical S.L.U.
Av. Ernest Lluch 32, Tower 2,
Tecnocampus, 3rd Floor, Office
3.17, 08302 Mataró, Spain
+34 93 702 19 50
www.quantiummedical.com
Distributor
Fresenius Kabi AG
61346 Bad Homburg, Germany
+49 (0) 61 72 / 686-0
www.fresenius-kabi.com
1370

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Summary of Contents for Fresenius Kabi Conox

  • Page 1 Conox® Av. Ernest Lluch 32, Tower 2, Tecnocampus, 3rd Floor, Office 3.17, 08302 Mataró, Spain Instructions for Use +34 93 702 19 50 www.quantiummedical.com Distributor Fresenius Kabi AG 61346 Bad Homburg, Germany +49 (0) 61 72 / 686-0 www.fresenius-kabi.com 1370...
  • Page 3 Abbreviations Alternating Current Analogue-Digital Converter Computed Tomography Direct Current Electroencephalogram Electromagnetic Electromagnetic Compatibility Intermediate Frequency Printed Circuit Board Radio Frequency...
  • Page 4: Table Of Contents

    Table of Contents 3.8 Signal Quality Index General information (SQI) 1.1 About this manual 3.9 EEG waveform 1.2 Intended use 3.10 Parameter trend 1.3 Indications for use graphs 3.11 Electrode 1.4 Contraindications impedance 1.5 Contact address 3.12 Battery status 1.6 Warranty indicator 3.13 Bluetooth ®...
  • Page 5 5.2.6 EEG settings 8.6 Impedance check 8.7 Event sequence/ 5.2.7 Alarm operation 5.2.8 Data repository 8.8 Patient Cable 5.2.9 Brightness disconnect External power supply & 5.3 Data repository battery mode settings 9.1 External power 5.3.1 File format supply 5.3.2 Delete all 9.2 Battery temporary files 5.3.3 Delete all...
  • Page 6: General Information

    1. General Information 1.1. About this manual 1.3. Indications for use This manual contains important Conox is intended to be used on adult information about the operation of patients undergoing general anesthesia Conox Depth Anesthesia or sedation. monitor (the “Device”). Here you will...
  • Page 7: Contact Address

    08302 Mataró, Spain +34 93 702 19 50 product if instructions are not www.quantiummedical.com followed. Distributor 1.8. Disclaimer Fresenius Kabi AG 61346 Bad Homburg Manufacturer reserves all rights. No Germany part this document +49 6172 686 0...
  • Page 8: Safety

    2. Safety 2.1. General safety instructions Follow all instructions, recommendations • Do NOT place the Patient Sensor and warnings throughout this manual electrodes close to the surgical area, without exception. avoid contact of the Patient Cable with conducting wires and ensure •...
  • Page 9: Safety Symbols

    Manufacturer 2.2. Electromagnetic Manufacturing date (where XXXX is year manufactured) compatibility Bluetooth ® communication The Device is intended to be used in a controlled electromagnetic environment ON/OFF switch as defined in this manual. Expiry date The user of the Device is responsible to ensure that the environment meets Single use the requirements defined.
  • Page 10: Description

    3.1. System description bolus or a continuous infusion) might provoke transient Conox is a device designed to be used increase of qCON and/or qNOX by clinicians during anesthesia and indices that is not linked to the sedation procedures. anesthetic state of the patient.
  • Page 11: Controls And Indicators

    3.3. Controls and indicators The Device is controlled and interpreted via a touch sensitive screen: Indicators Controls qCON index EEG graph amplitude qNOX index EEG graph timescale Burst Suppression Ratio (BSR) Trends graph timescale Electromyogram index (EMG) Alarm status Signal Quality Index (SQI) Selected parameter trends EEG waveform Manual impedance check button...
  • Page 12: Qcon Index

    3.4. qCON index qCON Index Expected Clinical State Range The qCON index is a continuously 80-99 Awake processed parameter that correlates with the patient's level of 61-79 Sedation or light anesthesia consciousness on a dimensionless 40-60 Adequate anesthesia scale of 0-99. Decreasing qCON index 0-39 Deep anesthesia values correspond to the gradual loss...
  • Page 13: Burst Suppression Ratio (Bsr)

    3.8. Signal Quality Index (SQI) 3.6. Burst Suppression Ratio (BSR) 0-100 dimensionless scale, represents the quality of the EEG With a range 0-100%, the Burst- signal and is calculated based on Suppression Ratio (BSR) provides a artefacts. measure of the percentage of flat EEG observed in a 30 second time frame.
  • Page 14: Bluetooth Indicator

    3.13. Bluetooth® indicator Press the symbol to display the name of the file is currently being recorded. When the Bluetooth ® is on, a runic B is shown in the lower right side of the display. This B is colored depending on the Bluetooth ®...
  • Page 15: Status

    Paused 3.17. Status The download is paused. The status can display the following Status: Paused messages: Reading OK Artefact The Device is operating correctly. The Device has identified an artefact and rejected it. Status: Reading OK Status: Artefact Reconnecting… Failure of internal data transmission. An artefact is a received signal that is System reconnecting.
  • Page 16: Installation

    • If any parts delivered show signs of damage, do not use and contact the Distributor immediately. Turn the Device on. 4.2. Inside the box Item Code Conox Main Unit See Annex I Patient Cable Z185058 Power supply Z185032 Patient sensor x5...
  • Page 17: Set-Up Menu

    5. Set-up menu the corresponding setting. Selections are confirmed by pressing 5.1. Operating modes the “Confirm” button. Conox has two operating modes: Recording mode is default at turn on. In this mode the Device “Back” button may be used to return automatically starts recording a to the previously displayed screen.
  • Page 18: Language

    Set date and time and press “Confirm”. To change the language, press the “Language” button. • If time is changed while monitoring, data will be saved in a new file. Conox is available in 20 languages: Czech Dutch Danish Norwegian...
  • Page 19: Trends Settings

    Select the desired parameter/s (all To pair Conox to another device: displayed parameters selected) and press “Confirm”. 1. Enable the Conox Bluetooth ® 2. Enable your device’s Bluetooth ® and find the Conox. 3. Select Conox insert password. Bluetooth ®...
  • Page 20: Eeg Settings

    EEG graph timescale EEG graph timescale may be set from Select graph grid “on” the Set-up menu by pressing the “EEG graph timescale” button. Or select graph grid “off”. Select timescale press “Confirm”. 5.2.6. EEG settings Or click directly on the main screen the text label that indicates the EEG graph amplitude current timescale.
  • Page 21: Data Repository

    • Do NOT use the alarm (acoustic or visual) for unattended parameter • Alarm status is indicated in the monitoring. qCON display box. Use “+” and “-” buttons or move the horizontal bars to set the limits. Alarm on Alarm off •...
  • Page 22: Brightness

    5.2.9. Brightness 5.3.1. File format To select the brightness of the display, Press the “File format” button to press the “Brightness” button. change the format of the file. Select brightness level by using “+” Choose a format and press “Confirm”: and “-”...
  • Page 23: Delete All Temporary Files

    5.3.2. Delete all temporary files 5.3.3. Delete all bookmarks To delete all the cases stored at the To delete all the cases stored at the Temporary files folder, press the Bookmarks folder, press the “Delete “Delete all temporary files” button. all bookmarks”...
  • Page 24: Recording A New Case 24

    To start recording a new case, press on the “Elapsed time” area in the status bar, and press the “Confirm” button. Conox will automatically start recording a new case in the following situations: Each time the Device is turned on. Each time the user leaves the Data repository mode to return to the Recording mode.
  • Page 25: Data Repository Mode

    The Bookmarks folder stores the case permanently or until the user deletes it. By default, Conox records and shows To exit the Data Repository mode, the Temporary files folder: press "Back" and confirm the following message. User can access the Bookmarks folder...
  • Page 26: Recorded Cases

    Access a recorded case by clicking on “Download”. it. The selected case will be highlighted in grey and the right hand buttons shall be activated. • The following message will appear if the user presses the “Confirm” button but the Conox is not paired:...
  • Page 27: Add A Case To Bookmarks

    Once the download has finished a Press “Play” to resume the download. notification will be displayed: Press “Stop” to terminate the download. 7.3.2. Add a case to bookmarks • The “Add to bookmarks” button is And the full case will be shown in the only enabled in the Temporary files screen of your PC.
  • Page 28: Review A Saved Case

    • When a case is bookmarked, it will If the file name already exists the be moved to the Bookmarks folder case will not be saved and the (not copied), i.e. it will not be following message will appear: displayed in the Temporary files folder and will be only accessible from the Bookmarks folder.
  • Page 29: Delete A Case

    EMG, BSR, qNOX and button. qCON indices of the saved file. Press the “Back” button to leave the review. • If there is an error Conox will display the following message. The following message will appear to confirm deletion:...
  • Page 30: Using The Device

    8. Using the Device 8.1. Positioning the Device 8.2. Patient Sensor The equipment should not be used Remove Patient Sensor from packaging. adjacent to or stacked with other equipment. If this is necessary, the user should verify normal operation of the Device in the configuration that will be used.
  • Page 31: Skin Preparation

    • The Device is designed to work with electrodes from the patient. Conox Patient Sensors only. If the adhesion or the contact of any of the electrodes is not enough after Patient Sensor may be placed either pressing around the Patient Sensor, left or right side.
  • Page 32: Connect Patient Cable & Turn On

    8.5. Connect Patient Cable & 8.6. Impedance check turn on The Device automatically checks the Connect the Patient Cable to the Main impedance of the Patient Sensor Unit. connections when it is turned on and every 15 minutes when in operation. Impedances below kΩ...
  • Page 33: Event Sequence/ Operation

    electrodes (approx. 5s). The EEG trace will then be displayed. Impedance checked demand by pushing the “Impedance” Simultaneously qCON, qNOX, EMG, button. BSR and SQI values will be displayed and the selected qCON, qNOX, BSR trends will then displayed. The Device is now then ready to use. •...
  • Page 34: External Power Supply & Battery

    The front panel of the Device contains 9.1. External power supply a charge indication LED. When the LED is blue, this indicates that the The Conox is supplied with an external Device is being powered by main power supply. electricity and the battery is charging. Model...
  • Page 35: Cleaning

    10. Cleaning Before and during cleaning, disconnect • Do not immerse the Device or the the Device from the power supply. Patient Cable in liquid. • Do not use abrasive substances nor Clean the monitor and the Patient alcohol based sprays (20%-40%) Cable after each patient usage with a which cause...
  • Page 36: Diagnostic & Troubleshooting

    12. Diagnostic & Troubleshooting service, please contact your Before returning a Device for service Distributor. please carry out the following: • No periodic maintenance is required. • Carefully describe the nature of the If the Device is dropped, damaged, problem. please contact your...
  • Page 37 during electrocautery. It should resume normal operation after electrocautery is complete. The Device may be affected by EMC from EMG index indicates electrical other devices such as activity may be interfering warming blankets. See with EEG section 13 for more information.
  • Page 38 Date and time have not Contact your Defective Device changed Distributor Display Micro SD not The internal micro SD of the Contact your mounted display has become corrupted Distributor If the Device displays this Micro SD error/Damaged Contact your message the internal micro memory Distributor SD card has been corrupted...
  • Page 39: Electromagnetic Immunity

    13. Electromagnetic immunity The Conox system is intended for use This section provides the appropriate in the electromagnetic environment specification tables for the Device as specified below. per IEC 60601-1-2. The user of the Conox must assure that it is used in an environment that meets these requirements.
  • Page 40 150 kHz to 80 MHz communications equipment should be used no closer to any 3 V/m Radiated RF 3 V/m part of the Conox system, 80 MHz to 1 GHz IEC 61000-4-3 80 MHz to 2,5 GHz including cables, than...
  • Page 41: Recommended Separation Distances Between Portable And Mobile Rf

    Note: At 80 MHz and 800 MHz, the higher frequency range applies. Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 1. 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.
  • Page 42: System And Environment Specifications

    14. System and Environment Specifications 14.1. System specifications Monitor main characteristics Dimensions 215x150x65mm Weight 785gr. Display size 7” (154.08x85.92mm) Battery 3.7 V Li-ion, 3500mAh, rechargeable Bluetooth® 2.1, selectable, send only, range up to 8m Patient Cable length Indices performance qCON index range 0-99 qNOX index range 0-99...
  • Page 43 Technical specifications – EEG acquisition EEG resolution 44.58 nV Input Noise ≤ 2.9 μV peak to valley CMRR ≥ 89 dB Sampling Frequency 1024 Hz Input range ± 374 mV Resolution 24 bit ADC Technical specifications – EEG processing Frequency range (-3dB) 0 –...
  • Page 44 Bluetooth Specifications Operating frequency range 2400 – 2483.5 MHz, ISM Band Lower quad band 2 MHz Upper quad band 3.5 MHz Carrier frequency 2402 – 2480 MHz, f=2402+k, k=0..78 Modulation method GFSK (1 Mbps), P/4 DQPSK (2 Mbps) Hopping 1600 hops/s, 1 MHz channel space GFSK: Asynchronous: 732.2 kbps / 57.2 kbps Synchronous: 433.9 kbps...
  • Page 45: Operation And

    14.2. Operation & shipment environment conditions Environment - Operation Temperature 5 – 40°C / 41 – 104°F Relative Humidity (non-condensing) 30 – 80 % Air Pressure 500 – 1060 hPa Environment – Transport & storage Temperature (-10) – 60°C / 14 – 140°F Relative Humidity (non-condensing) 10 –...
  • Page 46: Declaration Of Conformity

    15. Declaration of conformity The Device has passed the Immunity UNE-EN 60601-1:2008 + ERR: 2008 + to emission of active RF surgical CORR: 2010 + A11:2012 (EN 60601- equipment test according 1:2006 + CORR: 2010 + A11:2011 + 60601-1-1, 60601-1-2, A1:2013 + AC: 2014 + A12:2014 / 60601-1-6, IEC 60601-1-8 and IEC IEC 60601-1:2005 + CORR: 2006 +...
  • Page 47: Annex I

    Annex I Conox Main Units are delivered with plugs dependent upon the standard local specifications: Country Code Country Code Argentina Z029142 Malaysia Z029130 Australia Z029192 Mexico Z029182 Austria Z029120 Nepal Z029130 Bangladesh Z029130 Netherlands Z029170 Belarus Z029156 Norway Z029155 Belgium...
  • Page 49 Quantium Medical S.L.U. Fresenius Kabi AG Av. Ernest Lluch 32, Tecnocampus, 61346 Bad Homburg, Germany TCM 2, 3 Floor, Office 3.17, Tel: +49 (0) 61 72 / 686-0 08302 Mataró, Spain www.fresenius-kabi.com Tel: +34 93 702 19 50 www.quantiummedical.com...

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