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Nox Medical A1 Manual

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MANUAL
Copyright 2013 Nox Medical

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Summary of Contents for Nox Medical A1

  • Page 1 MANUAL Copyright 2013 Nox Medical...
  • Page 2 Users must accept all responsibility for any results obtained by or concluded from data obtained by the products including software from Nox Medical. All clinical conclusions and decisions that are based on the use of this product are the responsibility of the user.

  • Page 3: Table Of Contents

    Signal and Status Checks ........................13 Patient Hookup ............................16 Inserting a Battery to the A1 Device ....................16 Attaching the A1 Device and the RIP Belts ..................18 Attaching the Nasal Cannula ......................20 Measuring EEG Signals ........................21 Measuring EMG/ECG Signals ......................
  • Page 4 Nox A1 Manual Specifications ............................36 A1 Device ............................36 Material Information ......................... 37 Battery Information ........................... 38 Regulatory Information .......................... 39 Performance Testing and Validation Summary ................. 39 Classifications ............................ 39 Description of Symbols and Abbreviations ..................39 Bluetooth® Wireless Technology ....................... 41 EMC Information ..........................

  • Page 5: Introduction

    EMC Information section of this manual.  The A1 device is designed to be safe for use for pacemaker patients as long as the pacemakers comply with the EN 50061 standard of electrical safety of medical devices. However it should be noted that a continuous low current impedance test at 500 Hz is ongoing throughout the sleep study.
  • Page 6 Nox A1 Manual  To avoid risk of battery leakage, the A1 device should not be stored with a battery inserted in the battery compartment.  External equipment intended for connection to signal input, signal output or other connectors shall comply with the relevant product standard e.g. IEC 60950-1 for IT equipment and the IEC 60601-series for medical electrical equipment.

  • Page 7: Device Description

    The device is powered with one AA battery. Intended Use The NOX A1 device is intended for recording of physiological signals during sleep. The A1 device is intended for patients greater than 2 years of age. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient’s home.

  • Page 8: A1 Interface

    Nox A1 Manual A1 Interface The A1 device interface consists of a display, buttons, sensor inputs/connections and a USB connector. The USB connector is placed under the battery lid and connects to a mini USB cable for device configuration and data download. The display allows for various status checks, like battery charge and Bluetooth connection.
  • Page 9 Nox A1 Manual Battery lid – Covers the battery and the USB connector Battery lid pin Metal snaps – Connects to thorax RIP belt Metal snaps – Connects to abdomen cable ~ 9 ~...

  • Page 10: Operating The Device

    Connecting the A1 Device to a Computer To connect an A1 device to a computer you need to access the USB connector on the device. The USB connector is placed under the battery lid making it inaccessible and tamper proof for children. To open the battery lid, press with a pen or a similar tool on the battery lid pin and slide the battery lid down, towards the bottom of the device.

  • Page 11: Manually Starting/Stopping A Recording

    Nox A1 Manual Manually Starting/Stopping a Recording If the device has been configured to start the recording manually, you can use the Middle button to manually start a recording. Pressing the middle button turns on the display. The device will instruct you to “Hold middle button down to start recording”.

  • Page 12: Starting A Recording At A Scheduled Time

    Nox A1 Manual Starting a Recording at a Scheduled Time If the device has been configured to automatically, start a recording at a scheduled time there are no actions required for the recording to start. Pressing the Middle button before the recording has started will display a countdown to the specified start time of the recording.

  • Page 13: Signal And Status Checks

    Nox A1 Manual Signal and Status Checks The indicator light on the device blinks green when a recording is in progress and the device is functioning normally. When there are any device warnings the indicator light blinks orange. Warnings might include: ...
  • Page 14 Bluetooth symbol is displayed on the screen of the oximeter. If the Bluetooth symbol is not displayed, the Bluetooth is inactive and the A1 device cannot connect to the oximeter. If the Bluetooth symbol is not visible, press the small button at the top of the oximeter and hold it down for 3 seconds or until the Bluetooth symbol appears on the screen.
  • Page 15 (mmHg) and respiratory rate/respiration per minute (rpm). NOTE: If the A1 device has not succeeded in connecting with the capnography monitor, the display will indicate that it is still trying to connect and will display the serial number of the NOX EtCO interface.

  • Page 16: Patient Hookup

    The A1 system is only to be operated by skilled health care professionals. A trained clinician should perform the hookup of A1 system to the patient using the instructions provided in this manual. If the patient is supposed to start the recording at home, the clinician trains the user how to do so.
  • Page 17 Nox A1 Manual  Always use fully charged or fresh battery for each sleep recording.  All lithium batteries used with the A1 device shall be according to the standard IEC 60086-4 Primary batteries - Part 4: Safety of lithium batteries.

  • Page 18: Attaching The A1 Device And The Rip Belts

    Nox A1 Manual Attaching the A1 Device and the RIP Belts Step 1 Snap the clips that are attached to the device to the patient’s shirt. Step 2 to Step 4  Snap the abdomen cable to the back of the device.
  • Page 19 (BMI). Belt size selection tables accompany the product for more detailed instruction.  The A1 device and RIP belts should be worn over clothing.  The RIP belts should fit the patient snugly without being uncomfortably tight.

  • Page 20: Attaching The Nasal Cannula

    A1 device. If it is preferred to use a non-filtered Luer-lock cannula, it is necessary to use a filter tube connector from Nox Medical to interface with the A1 device.

  • Page 21: Measuring Eeg Signals

    Measuring EEG Signals Connect the Nox EEG Head Cable to the E2-E1, F4-F3, C4-C3, O2-O1, M2-M1 unipolar and ground inputs of the A1 device. Place a snap-on electrode on the middle of the patient´s forehead. Route the head cable behind the patients head and snap the cable to the electrode.

  • Page 22: Measuring Emg/Ecg Signals

    Measuring EMG/ECG Signals The A1 device is equipped with 4 bipolar channels suitable for thermistor and recording of ECG and EMG signals such as leg EMG or masseter EMG for bruxism detection. The A1 bipolar channels are labeled with THER, ECG, LM1, LM2 and connect to bipolar electrode leads with keyhole connectors.

  • Page 23: Measuring Mask Pressure

    Measuring Mask Pressure A mask pressure tube is used for connection to CPAP masks for measuring mask pressure. The pressure tube connects to the pressure lock on the A1 device via a filter tube connector from Nox Medical. Refer to the section Compatible Sensors and Devices regarding the types of mask pressure tubes that have been validated with the A1 device.

  • Page 24: Measuring Capnography

    Nox A1 Manual Measuring Capnography The A1 device is able to communicate with a capnography monitor over a Bluetooth® link using NOX EtCO Interface. Refer to the section Compatible Sensors and Devices regarding the types of capnography monitors that have been validated with the A1 device.

  • Page 25: Inserting Batteries Into The Oximeter

    Steps 3 and 4 Put the probe of the oximeter on your finger and within 5 minutes use the buttons on the A1 device to check the connection of the oximeter and the oximeter signals (this action puts the oximeter in the correct mode).
  • Page 26 Nox A1 Manual NOTE: Now the oximeter is correctly configured. Do not open the battery compartment of the oximeter after checking the oximeter signals because that causes the oximeter to return to factory settings which can lead to an unsuccessful recording. If the battery compartment is opened, the steps above need to be redone.

  • Page 27: Selecting Oximeter Sensor Size

    Nox A1 Manual Selecting Oximeter Sensor Size Soft Sensor Soft sensor size recommendations are based on digit height (thickness). The digit height (H) is measured as shown in the figure below. For digit height from 7.5 mm (0.3 in) to 12.5 mm (0.5 in), size small should be selected.

  • Page 28: Attaching The Pulse Oximeter Module And Sensor

    Nox A1 Manual Attaching the Pulse Oximeter Module and Sensor Nonin 3150 Pulse Oximeter Step 1 to Step 4 1. Separate the short end of the wristband from the long end. 2. Insert the short end in the loops on the oximeter. Place the probe wire between the short and long end of the wristband.
  • Page 29 Nox A1 Manual Step 5 to Step 6 5. Place the wristband around the patient’s wrist. 6. Put the probe on a finger. Step 7 Verify the connection status: The Bluetooth indicator is displayed with animated bars when the connection is established.

  • Page 30: Maintenance

    Maintenance The A1 device and accessories should be stored in a clean, dry place. Handle the A1 device with care and protect it against mechanical shocks, dirt and liquids. The device is not waterproof or splash proof. To update the A1 device you will need the Noxturnal software running on the computer which the device is connected to.
  • Page 31 Allow the unit to dry thoroughly before use. All Nox cables used with the A1 device are reusable. Clean the cables with a moist cloth using hospital grade cleaner. Do not immerse the cables in liquid and avoid contact of the cleaning solution with the connectors.

  • Page 32: Compatible Sensors And Devices

     To ensure patient safety and effective use of the A1 device, only use accessories that have been validated for use by Nox Medical. The items listed below are Nox products and have been validated for use with the A1 device: NOX RIP BELTS...
  • Page 33 Nox A1 Manual Nox Service Kit 569010 Nox Battery Lid 569011 Nox Clip Strap 569013 UNIPOLAR SNAP-ON LEADS Type Catalogue Number Nox Snap-on Lead 50 cm, white, 1.5mm connector, 2 units 554020 Nox Snap On Lead 30 cm, beige-white, 1.5 mm connector, 2 units 554021 Nox Snap On Lead 100 cm, green, 1.5 mm connector, 1 unit...
  • Page 34 Nox A1 Manual Type Catalogue Number Nox Standard Gold Cup Electrode, 10 units 554410 Nox A1 EEG 5 Lead Electrode Cable 554411 SYSTEM EXTENSIONS Type Catalogue Number Nox EtCO Interface with RespSense ™ 545010 The items listed below are 3...
  • Page 35 Nox A1 Manual MASK PRESSURE TUBING Type Catalogue Number Mask tubing 183cm (72in) Male x Male, 50 units 552310 Mask tubing 183cm (72in) Female x Male, 50 units 552320 ELECTRODES Type Catalogue Number Lead with Attached Electrode 100 cm, 1.5 mm connector, 10 units 554109 Lead with Attached Electrode 152 cm, 1.5 mm connector, 10 units...

  • Page 36: Specifications

    Nox A1 Manual Specifications A1 Device DESCRIPTION PROPERTIES FUNCTION  Storage Capacity 1GByte  Recording Time 8 hours  Internal Channels Thorax Respiratory Effort  Abdomen Respiratory Effort  Pressure  Respiratory sound/snoring  Four bipolar  Thirteen unipolar ...

  • Page 37: Material Information

    Nox A1 Manual  Continuous impedance measurements: <1uA @500 Hz  Independent floating reference (automatic reference adjustment)  Abdomen Cable Length 570 mm (2.24”)  Type of USB connector at device end: Mini-B Nox USB Cable  Type of USB connector at PC end: Standard A ...

  • Page 38: Battery Information

     The Nox A1 components and Nox sensors addressed in this manual are not made with natural rubber latex. Battery Information The list below is provided to assist the user in selecting the appropriate battery type for the A1 study:  Alkaline batteries can be used to record up to 8 hours.

  • Page 39: Regulatory Information

    Regulatory Information Performance Testing and Validation Summary The Nox A1 system has been tested and verified in various phases to include internal testing, verification and validation as well as external testing to assure product safety, effectiveness and reliability. The design was verified and validated, including clinical evaluation, throughout the design process, according to requirement specifications and intended use.
  • Page 40 Nox A1 Manual  Batch code  Catalogue number  Type BF applied part (patient isolation from electrical shock)  This product is not made with natural rubber latex  In compliance with the European Directive on Waste of Electrical and...

  • Page 41: Bluetooth® Wireless Technology

     Keep away from rain  Fragile, handle with care Bluetooth® Wireless Technology The A1 device uses Bluetooth® wireless technology to receive signals from external Bluetooth modules. The Bluetooth wireless technology is based on a radio link that offers fast and reliable transmission of data.
  • Page 42 Declaration of Conformity with USA Federal Communications Commission (FCC) and Canadian Ministry of Health Rules for Electromagnetic Compatibility The A1 device complies with Part 15 of the FCC Rules and RSS 210 of Industry Canada. Operation is subject to the following two conditions: 1.
  • Page 43 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions Guidance and manufacturer’s declaration – electromagnetic emissions The A1 device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.
  • Page 44 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 A1 device is used exceeds the applicable RF compliance level above, the A1 device should be observed to verify normal operation.
  • Page 45 Nox A1 Manual 0.38 0.38 0.73 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 of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

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