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+49 8142 448 460

[email protected]

www.medin-medical.com

medin Medical Innovations GmbH

Adam-Geisler-Str. 1

D-82140 Olching

OP_medinCNO EN

Rev 12 Stand 06.03.2019

von

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

the medinCNO

, precautions with regard to electromagnetic compatibility must be taken and the

medinCNO

must be set up and used in accordance with the conditions set out below.

The characteristics of the medinCNO

determined by transmissions permit it to be used in

industrial settings and hospitals (CISPR 11, class A). When used in a residential setting (for which

class B is usually necessary, according to CISPR 11), this device may not offer appropriate

protection from radiocommunication services. If necessary, the user must take corrective

measures such as moving or reorienting the device.

Portable or mobile RF communications equipment (e.g. mobile phones) should not be used less

than 30 cm near Medin parts and cables associated with the medinCNO

. Failure to observe these

instructions can lead to a reduction in the performance of the device.

Please note:

Electromagnetic interference may affect the device and this can be manifested through alarms (for a detailed

description, see chapter 8) or limitations in normal function of the medinCNO

(see chapter 8.3).

10.1

Electromagnetic transmission

Guidance and manufacturer’s declaration - electromagnetic emissions

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 (CISPR11, group 1, class A).

Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions, CISPR11

Group 1

The medinCNO

uses RF energy only for its

internal function. Therefore, its RF

emissions are very low and not likely to

cause any interference in nearby electronic

equipment.

RF emissions, CISPR11

Class A

The medinCNO

is intended for use in

professional healthcare institutions

(CISPR11, group 1, class A).

Harmonic emissions,

IEC 61000-3-2

Class A

Voltage fluctuations/flicker

emissions, IEC 61000-3-3

Complies

Содержание medinCNO

Страница 1: ...User manual for medinCNO...

Страница 2: ...al components Consequently it cannot be disposed of in domestic waste but must be collected separately and recycled in accordance with local regulations WEEE 0483 Classification according to COUNCIL D...

Страница 3: ...inCNO Conditions 10 3 1 Mounting 10 3 2 Power supply 11 3 2 1 Mains operation 11 3 2 2 Battery operation 11 3 2 3 Power supply unit 12 3 3 Gas feed 13 3 4 External alarm interface and data interfaces...

Страница 4: ...messages during system start up 50 8 2 Error messages during operation 51 8 3 Emergency programme 55 8 4 Indicator lights 56 9 Cleaning and Maintenance 57 9 1 Cleaning 57 9 2 Maintenance and exchange...

Страница 5: ...ing the products and follow the instructions warnings and tips closely The medinCNO may only be used by individuals with a thorough knowledge of these instructions for use in accordance with these ins...

Страница 6: ...esia gases or other flammable materials while in use The medinCNO may not be operated in an oxygen enriched environment US legislation stipulates that this device may only be sold to or on the instruc...

Страница 7: ...dijet in order to react to the patient s breathing and trigger a higher flow impulse in the event of apnoea or synchronously with the patient s inhalation This triggers a pressure impulse with elevate...

Страница 8: ...king range Basis of measurement DIN 1343 at 0 C 1013 25 mbar and 0 air humidity 0 1013 O2 flush Duration 1 minute Level 10 20 30 vol above set target oxygen concentration or 100 oxygen Electronic shut...

Страница 9: ...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 personnel and only in accordance with the in...

Страница 10: ...the knurled screws Figure 3 1 d It is important to ensure that the rear and lateral ventilation slits Figure 3 1 b including prefilters are not covered and that the overpressure valve Figure 3 1 c on...

Страница 11: ...imum rated voltage the minimum rated voltage of the power line must be at least as high as the voltage of the local mains supply Recommended 240 V Minimum rated current 1 1 A Maximum length 2 metres i...

Страница 12: ...reases the recharging time 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 discharges while switched...

Страница 13: ...as a result of the operating temperature it is possible that condensate may form despite a relatively low concentration of H2O in the air then the concentration of H2O must be reduced accordingly Fig...

Страница 14: ...4 1 External alarm The medinCNO has an interface for connection to an external alarm system The interface can open or close an external current circuit in the event of an alarm The interface thus act...

Страница 15: ...hiving and processing patient data a standard USB cable USB 2 0 type A to USB 2 0 type B with double winding through a ferrite of the type 742 711 32 from the manufacturer W rth Elektronik can be used...

Страница 16: ...ferrite core twice as in the case of RS232 cable 3 4 3 RS232 interface The RS232 interface can be installed optionally The function data and settings are identical to the USB interface A ferrite W rt...

Страница 17: ...rated by via the USB interface The currently measured CPAP pressure in the CPAP Apnoea CPAP and SNIPPV mode or the CPAP average value in oscillation mode in XX X mbar Set target flow in XX X L min for...

Страница 18: ...to be saved even if the medinCNO is switched off The second part of the trend data is deleted each time the medinCNO is switched off It saves the data since the last device start for a maximum of 28 d...

Страница 19: ...y and the duration min sec of the alarms are saved alarm DD HH MM HHHH MMMM LLLL for MM SS The alarm coding takes place analogously to the coding in the live data for detailed information see chapter...

Страница 20: ...ta been fully received 3 5 Environmental conditions operation transport storage The medinCNO must not be used in rooms at risk of explosion near to flammable substances or close to locations exposed t...

Страница 21: ...contamination during transport and storage Attention If the medinCNO is exposed to temperatures of 15 C during transport it must be acclimatised at room temperature for at least 24 hours at the locati...

Страница 22: ...ental conditions of the power supply unit during transport and storage Temperature not in locations exposed to significant temperature fluctuations Moisture only in dry locations not in locations expo...

Страница 23: ...as expected or as intended in the user manual it must not be connected to a patient under any circumstances The power supply unit should not be used if it has visible damage to the housing or cord The...

Страница 24: ...es before the device is switched on The air and oxygen must comply with the quality requirements laid down in chapter 3 3 Attention The medicinal air and oxygen supplied to the medinCNO must meet the...

Страница 25: ...al outlet Otherwise the medinCNO is still connected to the mains even when it is turned off Therefore when setting up the medinCNO it should be ensured that the plug of the power supply unit is still...

Страница 26: ...t 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 comp...

Страница 27: ...to check the CPAP pressure sensors the entire tube system and the Medijet must now be connected to the medinCNO and the Medijet prong adapter must be closed Once this has been done the process of mea...

Страница 28: ...oth during apnoea and when he or she is breathing normally In addition it is possible to use the backup function Nevertheless the SNIPPV mode is only a CPAP mode and is not a substitute for ventilator...

Страница 29: ...en use the dial to select the required value 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 Basic CPAP...

Страница 30: ...f the set target value for FiO2 Manual push the manual push trigger button position d in Figure 5 2 Readings the values measured by the medinCNO for the average CPAP pressure CPAP and the measured oxy...

Страница 31: ...er must be closed by the operator during this process e g by holding it shut This simulates the CPAP pressure which is produced If a patient is connected to the Medijet during flow adjustment the pron...

Страница 32: ...NO 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 A push is determined by the additional flow used for it a...

Страница 33: ...to be able to use the manual push function at all times the level of the additional push flow Finsp should be set in advance e g at the start of the CPAP therapy and adjusted as needed in the event o...

Страница 34: ...20 an oxygen content of 45 would be emitted during the O2 flush However a maximum of 100 oxygen can be emitted The setting 100 of the O2 flush causes pure oxygen 100 to always be emitted during the O...

Страница 35: ...sp additional push flow and manual PUSH chapter 5 4 Alarm settings chapter 5 12 Trend graphs chapter 5 13 In addition the CPAP settings also include the Leak Assist This compensates for the difference...

Страница 36: ...n then change 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 Figure 5 3 Submenu Apno...

Страница 37: ...sitivity the value selected here must be lower than the pressure fluctuation caused by the patient s normal respiration However the value must also be greater than the pressure fluctuations caused by...

Страница 38: ...yed in the top left hand area 5 9 SNIPPV mode The difference between the SNIPPV mode and the Apnoea CPAP mode is that in this case an automatic push is triggered not only in the event of apnoea but al...

Страница 39: ...ssure falls below the trigger threshold again a short time after the push The next push is not produced until after the end of the expiration pause The expiration pause time determines the maximum pus...

Страница 40: ...AP system and smaller than the pressure changes caused by respiration For the pressure signal displayed in Figure 5 4 without respiration on the right with respiration on the left the sensitivity show...

Страница 41: ...on is additionally activated this is likewise displayed in the top left hand area 5 10 Oscillation mode In oscillation mode an oscillating fluctuation is available in addition to the basic CPAP This i...

Страница 42: ...w volume produced affects the maximum pressure during oscillation Increasing the drive flow results in higher maximum pressure Amplitude The button c in Figure 5 5 can be used to select between variou...

Страница 43: ...AP mode this is displayed instead of the mode display When switching between two modes the medinCNO transfers all the settings that are available in both modes The following situations represent excep...

Страница 44: ...o the currently set oxygen concentration the button FiO2 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 de...

Страница 45: ...of pushes per minute can also be shown In the NIPPV special case no respiration rate is shown and if a backup was actively running the line is shown in blue Rinsp Tr rate min max In SNIPPV mode a tren...

Страница 46: ...respiratory gas humidifier chamber during time spent in standby mode Recommendation In the case of a brief period in standby mode manipulation such as bonnets and or mask prong changes suctioning etc...

Страница 47: ...t an alarm sound lasting for two minutes is additionally triggered To suppress this two minute alarm sound early the medinCNO must be started until the step Attention Do not connect a patient to the m...

Страница 48: ...without power supply unit REF 39 116 Power plug USA Japan without power supply unit REF 39 117 Power plug Australia without power supply unit REF 39 118 Power plug China without power supply unit REF...

Страница 49: ...ns GmbH Adam Geisler Str 1 D 82140 Olching OP_medinCNO EN Rev 12 Stand 06 03 2019 49 von 68 device cannot be ensured the correct alarm function cannot be guaranteed sufficient CPAP pressure will not b...

Страница 50: ...ected to the oxygen feed The medinCNO cannot be operated without oxygen Device error device shut down necessary There is a defect in the device s pneumatic system at the overpressure valve or recharge...

Страница 51: ...ergency programme CPAP pressure high red high 1s CPAP pressure 18 mbar the medinCNO briefly interrupts the flow This alarm starts the emergency programme Feed pressure high red high 1s Feed pressure 4...

Страница 52: ...s reason there is a total alarm delay of 17 seconds In this case the medinCNO continues to work normally CPAP pressure low yellow medium 101s 2 3 For 15 seconds the CPAP average pressure was constantl...

Страница 53: ...arged The medinCNO was switched off Press Alarm Reset to restart flow red high No alarm informational message only Triggered by a prolonged high feed pressure e g if a flow tube is blocked by several...

Страница 54: ...resholds can be set under Alarm Settings see chapter 5 12 Thus the alarm CPAP pressure high is triggered if the CPAP average value was above the alarm threshold for more than one second The alarm CPAP...

Страница 55: ...alarms are self sustaining That is these alarms are not deactivated until after confirmation by the user and elimination of the alarm condition Medium and low priority alarms yellow are not self susta...

Страница 56: ...w is stopped for the time being and in addition to the feed pressure high CPAP pressure high alarm a text message appears informing the user that the flow will be restarted by pressing the Alarm Reset...

Страница 57: ...voltage improper use as well as consumables e g oxygen cells filters batteries 9 1 Cleaning The surface of the medinCNO should be disinfected before first use using a slightly damp cloth1 and every ti...

Страница 58: ...ces Warning The two internal batteries 3V and rechargeable may only be replaced by the battery types listed above and only by trained professional service personnel and in accordance with the instruct...

Страница 59: ...ot be opened Modification of the power supply unit is not permitted termination of the warranty 9 6 External filter The filter must be cleaned every 2 months by tapping or knocking dry The filter need...

Страница 60: ...or mobile RF communications equipment e g mobile phones should not be used less than 30 cm near Medin parts and cables associated with the medinCNO Failure to observe these instructions can lead to a...

Страница 61: ...kV for power supply lines 100 kHz repetition frequency 1 kV for input output lines 100 kHz repetition frequency 2 kV for power supply lines 100 kHz repetition frequency 1 kV for input output lines 100...

Страница 62: ...bances according to IEC 61000 4 6 3 V 0 15 MHz to 80 MHz 6 V in ISM frequency bands a between 0 15 MHz and 80 MHz 80 AM at 1 kHz 3 V 0 15 MHz to 80 MHz 6 V in ISM frequency bands a between 0 15 MHz an...

Страница 63: ...nity test level V m 385 380 to 390 TETRA 400 Pulse modulati on 18 Hz 1 8 0 3 27 450 430 to 470 GMRS 460 FRS 460 FM 5 kHz deviation 1 kHz sine 2 0 3 28 710 704 to 787 LTE band 13 17 Pulse modulati on 2...

Страница 64: ...symbol Indicates devices that contain RF transmitters or deliberately emit RF energy Manual push trigger Charge status of the internal rechargeable battery Alarm sound paused for the time indicated A...

Страница 65: ...supply unit Air gas inlet Interface for external alarm system Oxygen gas inlet Temperature limit Air humidity limit Air pressure limit Power supply unit symbols Symbol Meaning Symbol Meaning Declarati...

Страница 66: ...s Abbreviation Meaning nCPAP CPAP nasal continuous positive airway pressure SNIPPV NIPPV synchronized non invasive positive pressure ventilation Rinsp Push frequency of number of pushes per minute emi...

Страница 67: ...push alarm for only apnoea pushes Addition of the manual FiO2 alarm adjustment Reference of the CPAP alarms in oscillation mode to the average value and display of the average value in the graph Expa...

Страница 68: ...6 03 2019 68 von 68 SW version V131 2 49 0 together with display macro version V102 X or V103 x X depends on language pack V102 or V103 depends on display hardware V131 Internal process in LeakAssist...

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