Medin NC3 Instructions For Use Manual
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Medin NC3 Instructions For Use Manual

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Instructi ons for use
medin-NC3®
REF 3000

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Summary of Contents for Medin NC3

  • Page 1 Instructi ons for use medin-NC3® REF 3000...
  • Page 2 The medin-NC3® contains batteries and electrical components. Consequently it cannot be disposed of in domestic waste but must be collected separately and recycled in accordance with local regulations. (WEEE directive 2012/19/EU) The user is obligated to report all serious incidents which occur in connection with the product to the manufacturer as well as the competent authority of the member state/country in which the user is located.
  • Page 3 Medical Innovations GmbH is not responsible for loss, costs, expenses, inconveniences or damages which may result from the misuse of the product or the use of parts not originating from medin Medical Innovations GmbH when replacing components or in the event of a change, destruction or removal of the serial number.

  • Page 4: Table Of Contents

    Environmental conditions (operation / transport / storage) ..............20 First Use ................................22 CPAP system components ........................22 Connecting the medin-NC3® and setting up the CPAP system ............... 23 Starting up the system ........................... 27 Operation ................................. 28 Operator console ............................ 29 Display screen ............................
  • Page 5 Hardware switch-off ..........................44 Disconnection ............................44 Disposal and recycling ..........................44 Accessories ..............................46 medin accessories ........................... 46 Components of the rest of the CPAP system ..................48 Alarms and Error Messages ..........................49 Error messages during system start-up ....................49 Error messages during operation ......................

  • Page 6: Introduction

    The general terms of trade of medin Medical Innovations GmbH (hereinafter referred to as medin) are binding. medin accepts no responsibility or liability for the safe use of the medin-NC3® if the device is serviced or repaired by individuals who have not received appropriate specialist training or if an operation that does not comply with correct use is performed.

  • Page 7: Description Of The Device And Conditions For Use

    Nuflow® nasal cannula to administer High Flow therapy to premature infants and neonates. The medin-NC3® must be used under the supervision of expert, specially trained staff in a clinical setting or during intrahospital transport, and the patient’s oxygen saturation must be monitored at the same time.

  • Page 8: Operating Staff

    Operating staff The medin-NC3® must be operated by a doctor or by an individual with the necessary technical skills acting on a doctor’s instructions. Consequently, all operating staff must have a detailed knowledge of these instructions for use and have undergone training in the device.

  • Page 9: Technical Data

    Warning: The medin-NC3® may not be modified without permission from the manufacturer and subsequent appropriate examinations and testing to guarantee continued safe use. 2.6.2. Technical data Basis of measurement: DIN 1343 at 0°C, 1013.25 mbar and 0% air humidity (0/1013)
  • Page 10 Mechanical overpressure valve (opening pressure 6 kPa (= 60 mbar)) External data USB/RS232 port, export of live and trend data Operating time The medin-NC3® can be used for continuous, long-term operation up to 4 weeks without a restart in the interim. Environmental conditions Operation Temperature: 15 to 40°C...

  • Page 11: Overview Of The General Technical Description

    Maintenance Manual, observing warnings in the manual and in these instructions for use: chapter 9.3 • Changes and modifications to the medin-NC3® are not permitted without the permission of the manufacturer: see chapter 9.4 IFU_medin-NC3 EN...

  • Page 12: Installation Of The Medin-Nc3® - Conditions

    Figure 3-1: a) Trolley plate; b) Knurled screw The medin-NC3® must always be securely assembled before the device is started up. To do this, it is placed on the baseplate of the trolley (ancillary equipment REF 5008) such that the feet lie in the intended grooves and then it is fixed in place manually using the knurled screw (Figure 3-1–...

  • Page 13: Power Supply

    Strength of current: at least 1.1 A The power supply unit of the medin-NC3® has a C7 appliance inlet for connection to the mains grid. The power line between the power supply unit of the medin-NC3® and the mains grid must therefore meet the following conditions: •...

  • Page 14: Replacing The External Battery

    A full batt ery is shown with a symbol with fi ve bars. As soon as only two bars remain, the batt ery symbol is shown in red and the medin-NC3® should be connected to the mains soon. As soon as there is only one bar left , the batt ery alarm is triggered.

  • Page 15: Gas Feed

    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 medin-NC3® and the CPAP system which come into contact with oxygen (e.g. gas feed tubes, O inlet to the medin-NC3®, patient outlet, patient tubes and Medijet®) remain free from oil and grease.

  • Page 16: Usb Interface

    (see Figure 3-3: RS232 and USB cable with ferrite). Nonetheless, the functi on of the medin-NC3® must be observed to avoid disrupti ons by the enti re system with regard to electromagneti c infl uences.

  • Page 17: Output Data (Live And Trend Data)

    Attention: The data interfaces of the medin-NC3® may be used only with the cables, including ferrite core, specified above, of type 742-711-32 from the manufacturer Würth Elektronik with double winding. The connected computer system must meet the medically relevant requirements with regard to electrical safety and EMC, otherwise the functionality and EMC of the medin-NC3®...
  • Page 18 The second part of the trend data is deleted each time the medin-NC3® is switched off. It saves the data since the last device start, however for a maximum of 28 days.
  • Page 19 Time: HH:MM:SS; (current time, set in the service menu; switching to local time or daylight savings time (summer time) must be performed manually) Device name: medin-NC3 ZZZZ (can be set in the service menu) SW version: VXXXX (installed main software version) Alarm record;...

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

    Environmental conditions (operation / transport / storage) The medin-NC3® must not be used in rooms at risk of explosion, near to flammable substances or close to locations exposed to splash water. Warning: The medin-NC3® is not suitable for use near magnetic resonance imaging equipment (MR-unsafe) or electrosurgical equipment.
  • Page 21 Attention: If the medin-NC3® is exposed to temperatures of ≤ 15°C during transport, it must be acclimatized at room temperature for at least 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 medin-NC3®.

  • Page 22: First Use

    Warning: If errors are detected when the medin-NC3® is checked before first use or if the medin-NC3® is found to be damaged or does not behave as expected or as intended in the user manual, it must not be connected to a patient under any circumstances.

  • Page 23: Connecting The Medin-Nc3® And Setting Up The Cpap System

    The internal and external rechargeable battery in the medin-NC3® allows the device to keep working in the event of a brief interruption in mains power supply. The medin-NC3® can run on a fully loaded battery for up to approximately four hours.
  • Page 24 Figure 4-2: Rear connecti ons: a) RS232 interface b) USB interface c) Power supply (power supply unit) The charge status of the batt eries is displayed in the upper left of the screen of the medin-NC3® as well as on LEDs on the front.
  • Page 25 Do not insert the power supply plug of the medin-NC3® into ceiling outlets since, due to its weight, it can be pulled out of the outlet in this case.
  • Page 26 Only suitable tube systems with appropriate adapters should be used to connect the patient and the Medijet® to the medin-NC3®/the corresponding Nuflow® nasal cannula, since otherwise there will be an increased likelihood of disconnections. The humidifier should be installed lower than the patient.

  • Page 27: Starting Up The System

    "OK" button. If oxygen calibration is necessary, this is carried out automatically. If the system test is completed without errors, the medin-NC3® starts up in CPAP mode and can be used on the patient. Warning: The system start test must always be conducted and completed before connecting the medin-NC3®...

  • Page 28: Operation

    The medin-NC3® can be used to administer pure CPAP therapy, push-supported CPAP therapy or High Flow therapy. All versions are based on pure CPAP therapy and the pushes are added if required. For this purpose, the medin-NC3® offers three CPAP modes and one High Flow mode: CPAP: Pure CPAP mode in which a constant CPAP pressure in the Medijet®...

  • Page 29: Operator Console

    Dial to change and confirm settings; f) Battery and power supply unit LEDs; g) ON/OFF; The medin-NC3® is operated by means of several buttons and a dial. The usual procedure is to press a button to select the parameter indicated next to that button on the display, then use the dial to select the required value. This is confirmed by pressing the dial.

  • Page 30: Display Screen

    Additional push flow; d) Button for triggering manual push; e) Readings; f) Mode; g) Status displays; h) Pressure course graph; i) Alarm messages; k) Alarm reset button; m) to r) Buttons for other settings The medin-NC3® display screen shows the values set, the readings, status messages and the names of the buttons surrounding the screen: Mode: Displays the selected mode –...

  • Page 31: Basic Cpap Settings

    CPAP pressure which is produced. The medin-NC3® automatically produces a flow of 7 L/min on start-up. The user must adjust this flow while keeping the Medijet® prong adapter closed until the flow produces the desired CPAP pressure.

  • Page 32: O Flush

    (button b in Figure 5-2). If the start button has a green background, pressing the dial can start the O flush. Now the medin-NC3® automatically emits an increased oxygen concentration for one minute. Discontinuation of an O flush:...

  • Page 33: Push (Not In High Flow Mode)

    If the dial is not pushed, the change is made nonetheless. During a push, the medin-NC3® emits, as a flow, the sum...

  • Page 34: Cpap Mode

    Triggering a manual push: A push can be triggered manually in all CPAP modes of the medin-NC3®. This is done by pressing button d in Figure 5-2. The medin-NC3® responds to this by immediately triggering a push. The duration of the triggered push corresponds to the set duration of the inspiration.

  • Page 35: Leak-Assist

    Warning: The CPAP mode does not contain any apnea monitoring and no apnea alarm. IFU_medin-NC3 EN +49 8142 448 460 medin Medical Innovations GmbH Rev 05 Status as of 28.04.2021 info@medin-medical.com Adam-Geisler-Str. 1 35 of 68 www.medin-medical.com...

  • Page 36: Apnea Cpap Mode

    Figure 5-2, which offers the possibility of changing six parameters. To change a parameter, press the corresponding button to select it, turn the dial to the desired setting, and press the dial to confirm your selection. IFU_medin-NC3 EN +49 8142 448 460 medin Medical Innovations GmbH Rev 05 Status as of 28.04.2021 info@medin-medical.com Adam-Geisler-Str. 1 36 of 68 www.medin-medical.com...
  • Page 37 This means that for a selected inspiration time of two seconds, the medin-NC3® does not emit any apnea push for four seconds after the push, even if an apnea time of less than four seconds is set.

  • Page 38: Backup Function

    If patient respiration is detected, the backup will automatically end. In addition, the button Push becomes the End backup button. This can be used if the medin-NC3® does not independently detect respiration and the backup function therefore does not automatically end. Then the backup can be manually discontinued by the user with this button.

  • Page 39: High Flow Mode

    Level of the O flush, d) Leak-Assist. The only purpose of the orange lines is to clarify the approximate situation of both pressure levels. They are not displayed by the medin-NC3®. Inspiration: Figure 5-4 a The setting in this field determines both the time spent at the upper pressure level and also the duration of pushes triggered manually.

  • Page 40: Mode Change

    Disconnection alarm. 5.13 Alarm settings The alarm sub-menu is available in each medin-NC3® mode. This can be opened by pressing the n button in Figure 5-2.
  • Page 41 Push alarm: The push alarm setting can be used to determine how the medin-NC3® informs the user in the event of an automatically triggered push. The following settings are available: Information through an acoustic and visual signal, information only through a visual signal, information only through an acoustic signal or information only through text on the display.

  • Page 42: Trend

    5.15 Standby The standby mode can be used if the medin-NC3® 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 medin-NC3® stores all the settings that have been selected, stops producing a flow and deactivates the alarms.
  • Page 43 In the case of a brief period in standby mode (change in the application such as bonnets and/or mask/prong changes, suctioning, etc.) and activated humidifier, the medin-NC3® should be restarted before the patient is connected to the device. This will avoid the emission of hot shots to the patient.

  • Page 44: Switching Off

    Since the medin-NC3® battery even discharges when the device is switched off, it is recommended to charge the medin-NC3® if it is stored for a longer period of time or to charge it completely before using it on rechargeable battery power.
  • Page 45 Power supply unit Various Touch panel Glass Pneumatic lines Silicone & PA Batteries Lithium batteries IFU_medin-NC3 EN +49 8142 448 460 medin Medical Innovations GmbH Rev 05 Status as of 28.04.2021 info@medin-medical.com Adam-Geisler-Str. 1 45 of 68 www.medin-medical.com 82140 Olching, Germany...

  • Page 46: Accessories

    Accessories medin accessories Various pieces of ancillary equipment or spares are available for use with the medin-NC3®: Table 1: Available accessories Description Comment Medijet® (Box of 20) 1000 nCPAP generator, system including Medifoam Medifoam (Pack of 10) 1030 Fixation cushion for Medijet®...
  • Page 47 Respiratory air and temperature probe MR850 900MR868 Electrical adapter for F&P inspiration 900MR806 Gas supply tubes various medin offers gas feed tubes suitable for various standards. IFU_medin-NC3 EN +49 8142 448 460 medin Medical Innovations GmbH Rev 05 Status as of 28.04.2021 info@medin-medical.com...

  • Page 48: Components Of The Rest Of The Cpap System

    Components of the rest of the CPAP system The medin-NC3® must be used in combination with the Medijet® nCPAP generator and the appropriate accessories (bonnets, masks, prongs and tube circuit sets). Warmed and humidified Nuflow® nasal cannulas (High Flow therapy) can also alternatively be connected in the corresponding (High Flow) mode.

  • Page 49: Alarms And Error Messages

    (blocked?) or contact a service valve or rechargeable battery. The technician. medin-NC3® can no longer be used and must be switched off. Error during tube test – An error occurred during the tube test Check impermeability and repeat restart (e.g.

  • Page 50: Error Messages During Operation

    The O feed pressure is too low Please check O (< 2.8 bar) or too high (> 7.0 bar) – feed. the medin-NC3® is only providing (Tube connected?) pure air. This alarm starts the emergency program. Check gas feed pressure air High The blower is reporting an error –...
  • Page 51 85 seconds until the average value has been fully updated, which can result in a total alarm delay of < 87 seconds. In this case, the medin-NC3® continues to work normally. CPAP pressure low Medium < 38 s...
  • Page 52 Leak-Assist flow of necessary, correct ± 5 L/min is not sufficient for larger leaks. compensation. In this case, the medin-NC3® continues to work normally. Fan blocked 15 s The fan is blocked or defective. Please contact a service technician.
  • Page 53 The medin-NC3® was switched off. Press alarm reset No alarm – informational message Please check to restart flow only:...
  • Page 54 3 mbar. The alarm interval for monitoring the oxygen levels set is always set to ± 5% at start-up. If the medin-NC3® is restarted, the alarms are reset to these levels. This cannot be changed by the user. The alarms CPAP pressure low (yellow) and CPAP pressure high (yellow) analyze whether the average value of the CPAP readings is outside of the alarm thresholds (can be set under Alarm Settings –...

  • Page 55: Emergency Program

    The flow emitted by the medin-NC3® is limited to a maximum of 8 L/min. If a flow of ≤8 L/min was set previously, this setting will be maintained. Otherwise, only a flow of 8 L/min will be emitted instead of the flow set.

  • Page 56: Indicator Lights

    10 seconds for the medin-NC3® to once again emit its set flow. If the alarm was triggered by a blocked flow supply tube or a combination of several alarms of the CPAP pressure high or feed pressure high...

  • Page 57: Cleaning And Maintenance

    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 medin-NC3® and the CPAP system which come into contact with oxygen (e.g. gas feed tubes, O inlet to the medin-NC3®, patient outlet, patient tubes and Medijet®) remain free from oil and grease even during...

  • Page 58: Repairs

    Repairs may only be made to the medin-NC3® by specially trained, professional service personnel in accordance with the instructions and warnings in the service manual. After each maintenance or repair of the medin-NC3®, a complete function test must be performed and passed before this medin-NC3® can be used on a patient once again. Device modifications Warning: The medin-NC3®...

  • Page 59: Filter

    Modification of the power supply unit is not permitted (termination of the warranty). Filter The medin-NC3® contains two replaceable filters: a suction filter of the blower as well as a coarse filter to avoid soiling by the device fan. The blower filter must be cleaned every 2 months by tapping or knocking (dry). The filter needs to be replaced with a new one after 12 months.

  • Page 60: Electromagnetic Compatibility

    Electromagnetic Compatibility The information in this section is provided in order to enable the operator of the medin-NC3® to decide whether the medin-NC3® is suitable for its electromagnetic environment. Attention: The medin-NC3® is a medical electrical device. Consequently, in order to guarantee the function of the medin-NC3®, precautions with regard to electromagnetic compatibility must be taken and the...

  • Page 61: Electromagnetic Immunity

    Guidance and manufacturer’s declaration – electromagnetic immunity The medin-NC3® is intended for use in the electromagnetic environment specified below. The customer or user of the medin-NC3® or the organization responsible should assure that it is used in such an environment.
  • Page 62 6 V in ISM frequency equipment should be used no closer to disturbances bands between bands between any part of the medin-NC3®, including according to 0.15 MHz and 0.15 MHz and cables, than the recommended separation IEC 61000-4-6 80 MHz 80 MHz distance of 30 cm.
  • Page 63 LTE band 7 5240 WLAN 802.11 Pulse modulation 5100 to 5800 5500 217 Hz 5785 IFU_medin-NC3 EN +49 8142 448 460 medin Medical Innovations GmbH Rev 05 Status as of 28.04.2021 info@medin-medical.com Adam-Geisler-Str. 1 63 of 68 www.medin-medical.com 82140 Olching, Germany...

  • Page 64: Symbols

    Symbols The symbols shown below are used as labels on the medin-NC3® or in these instructi ons for use: Symbol Meaning Symbol Meaning CE mark Manufacturer Separate collecti on; Medical device Disposal in a municipal collecti on center The instructi ons for use...
  • Page 65 Setti ngs alarm text conti nue to be displayed. Electrical connecti on to connect the Manual push trigger medin-NC3® power supply unit Charge status of the Power supply unit connected rechargeable batt eries No external batt ery connected Informati on signal for charge status...

  • Page 66: Abbreviations

    Transient tachypnea of the newborn Universal serial bus WEEE Waste of Electrical and Electronic Equipment IFU_medin-NC3 EN +49 8142 448 460 medin Medical Innovations GmbH Rev 05 Status as of 28.04.2021 info@medin-medical.com Adam-Geisler-Str. 1 66 of 68 www.medin-medical.com 82140 Olching, Germany...

  • Page 67: List Of References

    Jaile, JC. Benign Gaseous Distension of the Bowel in Premature Infants Treated with Nasal Continuous Airway Pressure: A Study of Contributing Factors. American Roentgen Ray Society. IFU_medin-NC3 EN +49 8142 448 460 medin Medical Innovations GmbH Rev 05 Status as of 28.04.2021 info@medin-medical.com Adam-Geisler-Str. 1 67 of 68 www.medin-medical.com...

  • Page 68: History Of The Software Versions And Hardware Changes

    History of the Software Versions and Hardware Changes The software of the medin-NC3® consists of various software packets: part of them determines the operating properties of the medin-NC3®, the alarms and the functional range. The display macro version establishes the possible display languages.

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