Medin medinCNO User Manual
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Medin medinCNO User Manual

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  • Page 1 User manual for medinCNO ®...
  • Page 2 (WEEE) 0483 Classification (according to COUNCIL DIRECTIVE 93/42/EEC Annex IX): IIb medin Medical Innovations GmbH Adam-Geisler-Str. 1 – 82140 Olching – Germany +49 8142-44846-0 – www.medin-medical.com –...

  • Page 3: Table Of Contents

    2.5.1 Principles of function ......................7 2.5.2 Technical data ........................7 2.5.3 Overview of the general technical description ..............8 Installation of the medinCNO – Conditions ..................10 ® Mounting ............................10 Power supply..........................11 3.2.1 Mains operation ........................ 11 3.2.2...
  • Page 4 Electromagnetic transmission ....................60 10.2 Electromagnetic immunity ...................... 61 Symbols ............................... 64 Abbreviations ............................66 History of the Software Versions and Hardware Changes ..............67 medin Medical Innovations GmbH  +49 8142 448 460 OP_medinCNO EN Adam-Geisler-Str. 1 info@medin-medical.com Rev 12 Stand 06.03.2019 www.medin-medical.com...

  • Page 5: Introduction

    ® repaired by individuals who have not received appropriate specialist training or if an operation that does not comply with correct use is performed. Medin also accepts no responsibility or liability for the safe use of the medinCNO if the function tests and maintenance that are specified are not carried out. The user is responsible ®...

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

    CPAP ® ® therapy to premature infants and newborns. The medinCNO must be used under the supervision of expert, ® specially trained staff in a clinical setting, and the patient’s oxygen saturation must be monitored at the same time.

  • Page 7: Technical Description Of Function

    The flow volume of the gas mix within a range of 4 L/min to 15 L/min can be set depending on the mode selected. According to the flow volume set, the medinCNO provides a constant drive flow. This generates a ®...

  • Page 8: Overview Of The General Technical Description

    Description of the power supply: see chapter 3.2 • The device is disconnected from the mains by pulling the power supply unit cable of the medinCNO out of the electrical outlet. Thus when installing the medinCNO , it should be ® ®...
  • Page 9 ® the mains. • Changes and modifications to the medinCNO are not permitted without the permission of ® the manufacturer: see chapter 9.4 Repairs and an exchange of parts may only be made by trained, professional service •...

  • Page 10: Installation Of The Medincno

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

  • Page 11: Power Supply

    Power supply 3.2.1 Mains operation The power supply unit (REF 39-113) of the medinCNO may only be connected to a power supply with the ® following properties: • Voltage: 100 – 240 V~ (alternating current) • Frequency: 50 – 60 Hz •...

  • Page 12: Power Supply Unit

    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). A full battery is shown with a symbol with five bars. As soon as only two bars remain, the battery symbol is shown in red and the medinCNO should be connected to the mains soon.

  • Page 13: Gas Feed

    (Figure 3-3) (REF 39-800). This allows ® small amounts of condensate to be removed from the air supply provided to the medinCNO if the water trap ®...

  • Page 14: External Alarm Interface And Data Interfaces

    The functionality of the medinCNO can only be guaranteed if both the oxygen and medicinal air supplied to it ® are free from condensate water, oil and contaminants. If this is not guaranteed, the medinCNO could be ® damaged. Even the use of a water trap can only remove small amounts of condensate from the air.

  • Page 15: Usb Data Interface

    3.4.2 USB data interface The USB data interface of the medinCNO can be used to retrieve internal device data and to install software ® updates. In addition, there is the option to prompt an export of the trend data in the trend by pressing the corresponding buttons.

  • Page 16: Rs232 Interface

    (REF 39-125) specified ® above (see Figure 3-4) 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 17: Output Data (Live And Trend Data)

    In addition, date, time, device name and software version are regularly indicated. The live data are automatically and constantly indicated in normal operation. However, they are not saved in the medinCNO . If the live data ®...
  • Page 18 The trend data are divided into two parts: The first part contains logfiles of saved alarms and device starts. This recording contains the data of the last device uses and will continue to be saved even if the medinCNO ®...
  • Page 19 Measured respiration rate in XXX / min Status of backup (B = actively running; -= currently not actively running or generally off ) Push frequency R in XXX / min insp medin Medical Innovations GmbH  +49 8142 448 460 OP_medinCNO EN Adam-Geisler-Str. 1 info@medin-medical.com Rev 12 Stand 06.03.2019...

  • Page 20: Environmental Conditions (Operation / Transport / Storage)

    ® stacked. If use as described above is nonetheless necessary, this device and other devices should be observed to ensure that they are working properly. Environmental conditions for the medinCNO during operation: ® Temperature: 15°C to 35°C...
  • Page 21 24 hours at the location where it is to be used before being switched on and used for the first time. If this is not done, the condensate which has formed could damage the medinCNO ®...
  • Page 22 - not in locations exposed to significant amounts of moisture or condensate - not in locations exposed to significant environmental stress - not outdoors Vibrations: not in locations exposed to constant vibration medin Medical Innovations GmbH  +49 8142 448 460 OP_medinCNO EN Adam-Geisler-Str. 1 info@medin-medical.com Rev 12 Stand 06.03.2019 www.medin-medical.com...

  • Page 23: 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 ® Please note: The medinCNO should always be used in combination with an active respiratory gas humidifier in order to ®...

  • Page 24: Connecting The Medincno ® And Setting Up The Cpap System

    Users are recommended to keep the medinCNO connected to the mains ® at all times while it is in use. The internal rechargeable battery in the medinCNO allows the device to keep ®...
  • Page 25 Figure 4-2: 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. ® Attention: When the medinCNO is running on battery power, an alarm is sounded when the internal battery is low. It ®...

  • Page 26: Starting Up The System

    , the humidifier and the patient tube kits is described in the user manuals for these ® devices, along with important additional information and warnings regarding their use. Users must also know and comply with these other user manuals even though they may be familiar with the medinCNO user manual. ®...
  • Page 27 CPAP mode and can be used on the ® patient. Warning: The system start test must always be conducted and completed before connecting the medinCNO ® to a patient. No patient may be connected to the medinCNO during the system test.

  • Page 28: 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 29: Operator Console

    This is confirmed by pressing the dial. The various buttons are divided into several groups: ON/OFF: (Figure 5-1–a) to switch the medinCNO on and off ®...

  • Page 30: Display Screen

    Display screen Figure 5-2: Display and button assignment of the medinCNO a) Flow; b) FiO value or start and ® discontinuation of the O flush; c) Additional push flow; d) Manual push trigger button; e) Readings; f) Mode; g) Status displays;...

  • Page 31: Basic Cpap Settings

    Alter the oxygen concentration by using button b in Figure 5-1 to highlight the current oxygen concentration and then turning the dial to select the desired value. Press the dial to confirm the new figure. This completes the process of adjusting the oxygen concentration. It is only now that the medinCNO alters the oxygen ®...

  • Page 32: Push

    If the dial is not pushed, the change is made nonetheless. As flow during a push, the medinCNO emits the sum ®...
  • Page 33 The CPAP pressure high alarm sounds and briefly stops the flow emission to the patient starting from a CPAP pressure of 18 mbar. That is, if the push is set such that its pressure is very high, a slight change in the leakage or expiration against push by the patient will cause the medinCNO ®...

  • Page 34: Flush

    (button b in Figure 5-2). If the start button has a blue background, pressing the dial can start the O flush. Now the medinCNO automatically emits an increased oxygen concentration for one minute. ®...

  • Page 35: Cpap Mode

    If patient respiration is detected, the backup will automatically end. In addition, the button Push becomes the Abort backup button. This can be used if the medinCNO does not ®...

  • Page 36: Apnoea Cpap Mode

    The only purpose of the orange lines is to clarify the significance of the sensitivity setting as a demarcation between 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 ®...
  • Page 37 Figure 5-3 (without respiration on the left, with respiration on the right), the sensitivity shown in orange would be correct as it is lower than the pressure fluctuations caused by respiration and greater than the noise of the pressure signal without respiration. The purpose of this setting is to allow the medinCNO ®...

  • Page 38: 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 shown in the orange bar ®...
  • Page 39 The next push is not produced until after the end of the expiration pause. 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 ®...
  • Page 40 The lower threshold of this sensitivity is used as a trigger for a push synchronised ® with respiration. If the CPAP pressure reading is below this threshold, the medinCNO triggers a push. The ® sensitivity setting is also used to identify apnoea. Consequently, it is important to select a value that is greater than the pressure fluctuations (e.g.

  • Page 41: Oscillation Mode

    5.10 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 ®...
  • Page 42 Medijet ), oscillation must always be set carefully and gradually, while at the same 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 43: Switching Between Modes

    A mode change during the safety mode is only possible if the safety mode was activated by the Disconnection alarm. 5.12 Alarm settings The alarm sub-menu is available in each medinCNO mode. This sub-menu can be opened by pressing button ® n in Figure 5-2.
  • Page 44 FiO alarm refresh is dimmed and instead, the button to change the alarm interval will be visible. Push alarm: The push alarm setting can be used to determine how the medinCNO informs the user in the ®...

  • Page 45: Trend

    The standby mode can be used if the medinCNO is not being used to treat an acute case but should be kept ® ready for use. If the device is switched from one of the other modes to this mode, the medinCNO stores all ®...
  • Page 46 Warning: The standby mode can only be used when no patient is attached to the medinCNO ® Please note: In standby mode, no gas flow can be emitted from the device. When combining with an active respiratory gas humidifier, the following points must be borne in mind: If no gas flow is issued and if the respiratory gas humidifier is continuing to heat, there can be so- called "hot shots".

  • Page 47: Switching Off

    To suppress this two-minute alarm sound early, the medinCNO must be started until the step: Attention: Do ® not connect a patient to the medin-cno during system start-up and then the ON/OFF button should be held down briefly once again. Disconnection...

  • Page 48: Accessories

    Accessories Accessories Various accessories and spare parts are available from Medin for operation of the medinCNO ® Gas supply tubes Medin provides gas supply tubes compliant with various standards. Water trap A water trap for the air supply of the medinCNO can be ordered ®...
  • Page 49 CPAP pressure will not be generated and neither apnoea detection nor synchronisation in SNIPPV mode will work. medin Medical Innovations GmbH  +49 8142 448 460 OP_medinCNO EN Adam-Geisler-Str.

  • Page 50: Alarms And Error Messages

    ® a service technician. Maintenance necessary! The last maintenance of the medinCNO took place at ® Next maintenance necessary: least 11 months ago and must be repeated no later than the date indicated. Contact a service technician.

  • Page 51: Error Messages During Operation

    12 seconds. This alarm starts the emergency programme. CPAP pressure high red/ <1s CPAP pressure >18 mbar - the medinCNO ® briefly interrupts the flow. high This alarm starts the emergency programme. Feed pressure high red/ <1s...
  • Page 52 Check gas feed pressure air red/ The air feed pressure is too low (<3 bar) or too high (>6.0 bar) - the medinCNO is only ® high providing oxygen. This alarm starts the emergency programme. CPAP pressure high yellow/ <87s The CPAP average pressure was continuously greater for >1 second than...
  • Page 53 In this case, the medinCNO continues to ® work normally. Pure alarm sound, medinCNO <1s This alarm is triggered if the medinCNO ® ® switched off power supply fails completely, for example because the power supply unit was not connected to the mains although the battery was discharged.
  • Page 54 CPAP average value is again above the alarm threshold and not directly after adjusting the alarm threshold or correcting the problem. 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 in automatic FiO alarm ®...

  • Page 55: Emergency Programme

    If high-priority alarms occur during operation of the medinCNO due to errors or supply breakdowns, the ® medinCNO tries to maintain operation as long as possible. In doing so, the normal function of the medinCNO ® ® is limited as follows:...

  • Page 56: Indicator Lights

    ® medinCNO restarts its flow after approximately 4 seconds. If it takes longer than this amount of ® time for the pressure to decrease, the medinCNO restarts its flow gradually, whereby it takes ® approximately 10 seconds for the medinCNO to once again emit its set flow.

  • Page 57: Cleaning And Maintenance

    Cleaning The surface of the medinCNO® should be disinfected before first use using a slightly damp cloth and every time after it has been used on a patient. 70% isopropyl alcohol solution can be used for this purpose.

  • Page 58: Repairs

    Repairs may only be made to the medinCNO by specially trained, professional service personnel in accordance ® with the instructions and warnings in the service manual. After each maintenance or repair of the medinCNO ® a complete function test must be performed and passed before this medinCNO can be used on a patient once ®...

  • Page 59: External Filter

    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 60: Electromagnetic Compatibility

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

  • Page 61: Electromagnetic Immunity

    Guidance and manufacturer’s declaration - electromagnetic immunity The medinCNO is intended for use in the electromagnetic environment specified below. The customer or ® user of the medinCNO , or the organisation responsible, should assure that it is used in such an environment. ® Electromagnetic...
  • Page 62 IEC 60601 test level Compliance level environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the medinCNO ® including cables, than the 0.15 MHz to 80 MHz 0.15 MHz to 80 MHz Conducted...
  • Page 63 LTE band 7 5240 Pulse 5100 to WLAN 802.11 5500 modulati 5800 on 217 Hz 5785 medin Medical Innovations GmbH  +49 8142 448 460 OP_medinCNO EN Adam-Geisler-Str. 1 info@medin-medical.com Rev 12 Stand 06.03.2019 www.medin-medical.com 63 von 68 D-82140 Olching...

  • Page 64: Symbols

    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 CPAP mode symbol Apnoea CPAP mode symbol SNIPPV mode symbol Oscillation mode symbol Indicates devices that...
  • Page 65 Patient connection USB interface pressure meter line Electrical connection to connect the medinCNO ® Air gas inlet power supply unit Interface for external Oxygen gas inlet alarm system Temperature limit Air humidity, limit Air pressure, limit Power supply unit symbols:...

  • Page 66: Abbreviations

    Abbreviations Abbreviation Meaning nCPAP / CPAP (nasal) continuous positive airway pressure SNIPPV / NIPPV (synchronized) non-invasive positive pressure ventilation Push frequency (of number of pushes per minute emitted by the medinCNO ® insp Push flow insp Oxygen concentration Respiratory rate...

  • Page 67: History Of The Software Versions And Hardware Changes

    History of the Software Versions and Hardware Changes The software of the medinCNO consists of various software packets: Part of them determines the operating ® properties of the medinCNO , the alarms and the functional range. The display macro version establishes the ®...
  • Page 68 - V102-X or V103-X adaption on different language pack, V102 or display hardware V103 depends - No influence on usage of medinCNO ® display hardware) medin Medical Innovations GmbH  +49 8142 448 460 OP_medinCNO EN Adam-Geisler-Str. 1 info@medin-medical.com...

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