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Medin medinCNO User Manual

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User manual for
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medinCNO
medin Medical Innovations GmbH  Adam-Geisler-Str. 1  D-82140 Olching
+498142-448460  www.medingmbh.com  support@medingmbh.com

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  • Page 1 User manual for ® medinCNO medin Medical Innovations GmbH  Adam-Geisler-Str. 1  D-82140 Olching +498142-448460  www.medingmbh.com  support@medingmbh.com...
  • Page 2 – info@medingmbh.com www.medingmbh.com Made in Germany ® OP_medinCNO Rev 07 Correct as of 09.09.2015 medin Medical Innovations GmbH  Adam-Geisler-Str. 1  D-82140 Olching +498142-448460  www.medingmbh.com  info@medingmbh.com OP_cno Rev 07 - Correct as of: 09.09.2015 2 of 64...

  • Page 3: Table Of Contents

    Basic CPAP settings ....................... 29 Push..........................30 flush ..........................32 Backup function ....................... 32 CPAP mode ........................33 medin Medical Innovations GmbH  Adam-Geisler-Str. 1  D-82140 Olching +498142-448460  www.medingmbh.com  info@medingmbh.com OP_cno Rev 07 - Correct as of: 09.09.2015 3 of 64...
  • Page 4 Electromagnetic immunity ..................58 Symbols ..........................62 Abbreviations......................... 63 History of the Software Versions and Hardware Changes ........... 64 medin Medical Innovations GmbH  Adam-Geisler-Str. 1  D-82140 Olching +498142-448460  www.medingmbh.com  info@medingmbh.com OP_cno Rev 07 - Correct as of: 09.09.2015...

  • Page 5: Introduction

    (e.g. nCPAP generators and humidifiers) is described in the relevant instructions for use. Users must also comply with those instructions for use. General liability conditions The general terms of trade of Medin Medical Innovations GmbH (hereinafter referred to as Medin) are binding. ®...

  • Page 6: Description Of The Device And Conditions For Use

    IEC 60601- 1:2005 chapter 16 and the requirements with regard to EMC according to IEC 60601-1-2 must be ® met, otherwise the device function, electrical safety and EMC of the medinCNO are not guaranteed.

  • Page 7: Technical Description Of Function

    CPAP driver that can be used in combination with the Medijet nCPAP ® generator to administer CPAP therapy. The role of the medinCNO in this CPAP system is to provide the necessary, possibly oxygen-enriched drive flow, which is fed to the nCPAP generator ®...

  • Page 8: Overview Of The General Technical Description

    , it should be ensured that this plug is always freely accessible and ® can be disconnected from the mains without difficulty. The medinCNO does not contain any switch which disconnects it from the mains. medin Medical Innovations GmbH  Adam-Geisler-Str. 1  D-82140 Olching +498142-448460 ...
  • Page 9 Only the patient tubes, the Medijet and the masks and prongs used are used in the direct vicinity of the patient. medin Medical Innovations GmbH  Adam-Geisler-Str. 1  D-82140 Olching +498142-448460  www.medingmbh.com  info@medingmbh.com OP_cno Rev 07 - Correct as of: 09.09.2015...

  • Page 10: Installation Of The Medincno - Conditions

    ® The overpressure valve must be kept clear whenever the medinCNO is in use, and it must always hang free in the air.

  • Page 11: Battery Operation

    Figure 3-2: Battery charge status displayed in the top left-hand area of the screen ® The charge status of the internal battery is displayed in the top left-hand area of the medinCNO screen (Figure 3-2). medin Medical Innovations GmbH  Adam-Geisler-Str. 1  D-82140 Olching +498142-448460 ...

  • Page 12: Power Supply Unit

    (up to 5 hours). In addition, the battery will be damaged by ® this exhaustion and will need to be replaced sooner. Since the battery of the medinCNO also ®...

  • Page 13: External Alarm Interface And Data Interfaces

    Attention: Only devices and systems which are approved for medical use and which meet the relevant ® electrical safety and EMC standards may be connected to the medinCNO data interface and alarm interface. medin Medical Innovations GmbH  Adam-Geisler-Str. 1  D-82140 Olching +498142-448460 ...

  • Page 14: External Alarm

    (that is, correction of the alarm condition and acknowledgement of the alarm by the user). ® The cable supplied by Medin must be used to connect the medinCNO to an external alarm system in order to achieve EMC according to DIN EN 60601-1-2:2007 (REF 39-114) and the connection must be set up initially by an appropriately trained technician.

  • Page 15: Rs232 Interface

    742-711-32 from the manufacturer Würth Elektronik with double winding and a computer system that meets the medically relevant requirements in terms of ® electrical safety and EMC, otherwise the functionality and EMC of the medinCNO cannot be guaranteed.

  • Page 16: Output Data (Live And Trend Data)

    0x0002: CPAP pressure high (adjustable)  0x0004: CPAP pressure low (adjustable)  0x0008: Oxygen concentration high medin Medical Innovations GmbH  Adam-Geisler-Str. 1  D-82140 Olching +498142-448460  www.medingmbh.com  info@medingmbh.com OP_cno Rev 07 - Correct as of: 09.09.2015 16 of 64...
  • Page 17 The structure of the trend data is shown below as an example: ###;2014-04-07;14:20:14;medin-cno1004;V1.3;alarm record; start;2014-04-04;10:59; alarm;04;11:07;0000;0008;0000;for 14:48 alarm;04;13:50;0000;0004;0000;for 00:30 alarm;04;14:14;0002;0002;0000;for 00:36 ###;2014-04-07;14:20:15;medin-cno1004;V1.3;trend record; CPAP;Flow;FiO2;Finsp;Mode;RR;BU;Rinsp;min;max;Pinsp;Fr eq;AmpS;AmpP;Tinsp;Tapn; medin Medical Innovations GmbH  Adam-Geisler-Str. 1  D-82140 Olching +498142-448460  www.medingmbh.com  info@medingmbh.com OP_cno Rev 07 - Correct as of: 09.09.2015 17 of 64...
  • Page 18 Every 20 seconds, a line is saved. If a value is not available in the current mode, it is replaced with blank spaces. The structure is as follows: medin Medical Innovations GmbH  Adam-Geisler-Str. 1  D-82140 Olching +498142-448460  www.medingmbh.com  info@medingmbh.com OP_cno Rev 07 - Correct as of: 09.09.2015...

  • Page 19: Environmental Conditions (Operation / Transport / Storage)

    The device is to be kept dry during operation. Ambient pressure: 700hPa to 1100hPa ≤ 2000 m above sea level Altitude: medin Medical Innovations GmbH  Adam-Geisler-Str. 1  D-82140 Olching +498142-448460  www.medingmbh.com  info@medingmbh.com OP_cno Rev 07 - Correct as of: 09.09.2015 19 of 64...
  • Page 20 ® lithium batteries which may only be transported under special conditions. If the medinCNO contains defective batteries, these may not be transported and must be removed in advance and disposed of in accordance with local regulations.
  • Page 21 - not in locations exposed to significant environmental stress - not outdoors Vibrations: not in locations exposed to constant vibration medin Medical Innovations GmbH  Adam-Geisler-Str. 1  D-82140 Olching +498142-448460  www.medingmbh.com  info@medingmbh.com OP_cno Rev 07 - Correct as of: 09.09.2015...

  • Page 22: First Use

    A bonnet of the correct size A system for monitoring the patient’s oxygen saturation and checking the efficacy of ® CPAP therapy (this is an essential condition for the use of the medinCNO Tip: ® The medinCNO should always be used in combination with an active respiratory gas humidifier in order to avoid the patient’s airways drying out and cooling.

  • Page 23: Connecting The Medincno And Establishing The Cpap System

    Gas feed connection: The oxygen inlet “O -IN” (Figure 4-1 -a) and air inlet “Air-IN” (Figure 4-1 -b) of the medinCNO ® must be connected to an external air and oxygen source using gas feed tubes before the device is switched on.
  • Page 24 ® medinCNO User Manual ® The charge status of the internal battery is displayed in the top left-hand area of the medinCNO screen. Attention: ® When the medinCNO is running on battery power, an alarm is sounded when the internal battery is low.

  • Page 25: Starting Up The System

    ® is started and its system test is automatically triggered by pressing the “On/Off” The medinCNO button (Figure 5-1 – a). This test examines the functions of the medinCNO ® , checks the oxygen calibration and determines the properties of the tube system to which it is connected.

  • Page 26: Operation

    5 to 20 Hz instead of constant CPAP pressure. ® The fifth mode, Standby, can be used for the time between preparation of the medinCNO and its actual use as well as for pauses in the CPAP therapy for a patient.

  • Page 27: Operator Console

    However, if a new alarm becomes active during this time, this will also be emitted acoustically. Other Settings: (Figure 5-1 –f) to select and alter mode-specific and other settings medin Medical Innovations GmbH  Adam-Geisler-Str. 1  D-82140 Olching +498142-448460  www.medingmbh.com  info@medingmbh.com OP_cno Rev 07 - Correct as of: 09.09.2015...

  • Page 28: Display Screen

    (RR) or push frequencies (R - corresponds to the insp ® number of inspiration pushes per minute automatically emitted by the medinCNO ) are ® shown above in the coloured bar of the medinCNO (Figure 5-2 position e).

  • Page 29: Basic Cpap Settings

    CPAP pressure produced as shown in graph h in Figure 5-2. The operator can terminate activation, and thereby the ability to change the flow value, by ® pressing the dial. If the dial is not pressed to conclude the flow change, the medinCNO still accepts the flow volume change.

  • Page 30: Push

    (see chapter 5.5). Push ® In addition to the basic CPAP mode, the medinCNO can increase the CPAP pressure if necessary for a short time. These short periods are called ‘pushes’ and can be used to stimulate the patient.
  • Page 31 CPAP pressure high alarm, it is possible that the text ® Press alarm reset to start flow may also be displayed. In this case, the medinCNO stops the flow until the user restarts it by pressing the Alarm Reset button.

  • Page 32: O 2 Flush

    The push alarm cannot be deactivated during the active backup function. There are only the following setting options available: optical, optical & acoustic and only apnoea. medin Medical Innovations GmbH  Adam-Geisler-Str. 1  D-82140 Olching +498142-448460  www.medingmbh.com  info@medingmbh.com OP_cno Rev 07 - Correct as of: 09.09.2015...

  • Page 33: Cpap Mode

    In the trend, backup pushes administered are indicated with a blue line. CPAP mode ® CPAP mode provides a pure basic CPAP therapy. In this mode the medinCNO produces a ® constant flow all the time which is converted into a constant CPAP pressure in the Medijet The setting, action and information options are: Flow (chapter 5.3)

  • Page 34: Apnoea Cpap Mode

    ® respiration and apnoea. They are not displayed by the medinCNO . Instead, the sensitivity is displayed on the left-hand edge of the CPAP curve as a pair of arrows (blue).
  • Page 35 Figure 5-2 as described in chapter 5.4. medin Medical Innovations GmbH  Adam-Geisler-Str. 1  D-82140 Olching +498142-448460  www.medingmbh.com  info@medingmbh.com OP_cno Rev 07 - Correct as of: 09.09.2015...

  • Page 36: Snippv Mode

    Display: When operating in APNOEA CPAP mode, the current respiration rate (RR - breaths >1 mbar per ® minute) and number of pushes automatically generated by the medinCNO per minute (R ) are insp shown in the orange bar on the top of the screen in addition to the information referred to in chapter 5.2.
  • Page 37 The expiration pause time determines the maximum push frequency (Tr. rate max), as the longer ® the time selected, the fewer pushes can be triggered automatically by the medinCNO . In addition, the minimum adjustable expiration pause is dependent on the duration of the inspiration time.
  • Page 38 If each breath is to be supported, the tr. rate max must be larger than the patient's respiration rate. medin Medical Innovations GmbH  Adam-Geisler-Str. 1  D-82140 Olching +498142-448460  www.medingmbh.com  info@medingmbh.com OP_cno Rev 07 - Correct as of: 09.09.2015...

  • Page 39: Oscillation Mode

    In oscillation mode, an oscillating fluctuation is available in addition to the basic CPAP. This is ® modulated on the basis of the background basic CPAP. In this case the medinCNO produces a flow which is periodically blocked and thus reduced in accordance with the oscillation frequency ®...
  • Page 40 User Manual ® time checking the results on the basis of the pressure course curve displayed in the medinCNO and the effect on the patient. Since oscillation therapy affects the CO concentration in the patient's blood, it is recommended that this be regularly checked during oscillation.

  • Page 41: Switching Between Modes

    The selected mode appears on a blue background. The mode selected must then ® be confirmed by pressing the Confirm button. Only then does the medinCNO switch to this mode. The user can check whether mode switch has taken place correctly by checking the mode display in the top left-hand area of the screen after making the switch.
  • Page 42 ® Push alarm: The push alarm setting can be used to determine how the medinCNO informs the user in the event of a triggered push. The following settings are available: information via an acoustic signal and an optical signal, information via an optical signal alone or no information.

  • Page 43: Trend

    Warning: ® The standby mode can only be used when no patient is attached to the medinCNO medin Medical Innovations GmbH  Adam-Geisler-Str. 1  D-82140 Olching +498142-448460  www.medingmbh.com  info@medingmbh.com OP_cno Rev 07 - Correct as of: 09.09.2015...
  • Page 44 In the case of a brief period in standby mode (manipulation such as bonnets and/or ® mask/prong changes, suctioning, etc.) and activated humidifier, the medinCNO should be restarted before the patient is connected to the device. This will avoid the emission of hot shots to the patient.

  • Page 45: Switching Off

    ® There are two ways of switching off the medinCNO Software switch-off ® Holding the ON/OFF button down for at least three seconds switches off the medinCNO . The ® medinCNO stops supplying air and oxygen and switches off the electronic components. If the ®...

  • Page 46: Accessories

    User Manual Accessories Ancillary equipment ® Various pieces of ancillary equipment or spares are available for use with the medinCNO Gas feed tubes Medin offers gas feed tubes suitable for various standards. ® Water trap A water trap for the medinCNO air feed can be ordered ®...

  • Page 47: Alarms And Error Messages

    11 months ago and must be repeated no later than the date indicated. Contact a service YY.MM.DD technician. medin Medical Innovations GmbH  Adam-Geisler-Str. 1  D-82140 Olching +498142-448460  www.medingmbh.com  info@medingmbh.com OP_cno Rev 07 - Correct as of: 09.09.2015...

  • Page 48: Error Messages During Operation

    (>6.0 bar) - the medinCNO is only high providing air. This alarm starts the emergency programme. medin Medical Innovations GmbH  Adam-Geisler-Str. 1  D-82140 Olching +498142-448460  www.medingmbh.com  info@medingmbh.com OP_cno Rev 07 - Correct as of: 09.09.2015 48 of 64...
  • Page 49 The temperature in the medinCNO is too high. Check the environmental conditions middle and contact a service technician. medin Medical Innovations GmbH  Adam-Geisler-Str. 1  D-82140 Olching +498142-448460  www.medingmbh.com  info@medingmbh.com OP_cno Rev 07 - Correct as of: 09.09.2015 49 of 64...
  • Page 50 > 1 mbar for at least 30 sec has already been measured. (3) Maximum time delay, including maximum required time to completely re-calculate the average value. medin Medical Innovations GmbH  Adam-Geisler-Str. 1  D-82140 Olching +498142-448460  www.medingmbh.com  info@medingmbh.com OP_cno Rev 07 - Correct as of: 09.09.2015...
  • Page 51 The alarm oxygen concentration high/low is triggered when the measured oxygen concentration is ® outside of the set limits. These thresholds are always automatically set by the medinCNO alarm thresholds mode at the level of the set interval (can be set under alarm automatic FiO settings;...

  • Page 52: Emergency Programme

    Instead of oscillation, leak-assist or pushes, the medinCNO limits its operation to ® normal basic CPAP. That is, the oscillation is stopped and the medinCNO does not emit any more manual pushes, apnoea pushes, backup pushes and SNIPPV pushes. Likewise, the leak assist function pauses. After the emergency programme has ended,...

  • Page 53: Indicator Lights

    This LED is activated if the operator can change or confirm settings by turning or pressing the dial. If this LED is deactivated, the dial does not have any function at the present moment. medin Medical Innovations GmbH  Adam-Geisler-Str. 1  D-82140 Olching +498142-448460  www.medingmbh.com  info@medingmbh.com OP_cno Rev 07 - Correct as of: 09.09.2015...

  • Page 54: Cleaning And Maintenance

    Warning: In order to avoid fires, oxygen must not come into contact with oil or grease. It is therefore ® essential to ensure that all parts of the medinCNO and the CPAP system which come into contact ® with oxygen (e.g. gas feed tubes, O...

  • Page 55: Repairs

    The power supply unit may only be repaired by authorized specialists. Warning: ® To avoid an electrical shock, the housing of the power supply unit of the medinCNO should not be opened. Modification of the power supply unit is not permitted (termination of the warranty).

  • Page 56: External Filter

    Figure 6: external filter Please note: Only a type PPI 30 filter should be used. medin Medical Innovations GmbH  Adam-Geisler-Str. 1  D-82140 Olching +498142-448460  www.medingmbh.com  info@medingmbh.com OP_cno Rev 07 - Correct as of: 09.09.2015...

  • Page 57: Electromagnetic Compatibility

    ® medinCNO User Manual Electromagnetic Compatibility ® The information in this section is provided in order to enable the operator of the medinCNO ® decide whether the medinCNO is suitable for its electromagnetic environment. Attention: ® The medinCNO is a medical electrical device. Consequently, in order to guarantee the ®...

  • Page 58: Electromagnetic Immunity

    Note: is the a.c. supply voltage prior to application of the test level medin Medical Innovations GmbH  Adam-Geisler-Str. 1  D-82140 Olching +498142-448460  www.medingmbh.com  info@medingmbh.com OP_cno Rev 07 - Correct as of: 09.09.2015...
  • Page 59 The ISM bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz and 40.66 MHz to 40.70 MHz. medin Medical Innovations GmbH  Adam-Geisler-Str. 1  D-82140 Olching +498142-448460  www.medingmbh.com  info@medingmbh.com OP_cno Rev 07 - Correct as of: 09.09.2015...
  • Page 60 Over the frequency range 150 kHz - 80 MHz, the field strength should be less than 1 V/m. medin Medical Innovations GmbH  Adam-Geisler-Str. 1  D-82140 Olching +498142-448460  www.medingmbh.com  info@medingmbh.com OP_cno Rev 07 - Correct as of: 09.09.2015...
  • Page 61 RF ® disturbances are controlled. The customer or the user of the medinCNO , or the organisation responsible, can help to prevent electromagnetic interference by maintaining a minimum distance ®...

  • Page 62: Symbols

    ® medinCNO User Manual Symbols ® The symbols with the meanings indicated below are used as labels on the medinCNO or in these instructions for use: Symbol Meaning Symbol Meaning APNOEA CPAP mode CPAP mode symbol symbol SNIPPV mode symbol...

  • Page 63: Abbreviations

    Respiratory frequency Tr Rate min/max Maximum/ minimum push frequency which was limited by settings Electromagnetic compatibility medin Medical Innovations GmbH  Adam-Geisler-Str. 1  D-82140 Olching +498142-448460  www.medingmbh.com  info@medingmbh.com OP_cno Rev 07 - Correct as of: 09.09.2015 63 of 64...

  • Page 64: History Of The Software Versions And Hardware Changes

    V102-ZH - Priority added in alarms during operation - List of abbreviations medin Medical Innovations GmbH  Adam-Geisler-Str. 1  D-82140 Olching +498142-448460  www.medingmbh.com  info@medingmbh.com OP_cno Rev 07 - Correct as of: 09.09.2015 64 of 64...

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