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EN

Guidance and manufacturer’s declaration – electromagnetic immunity

The system is intended for use in the electromagnetic environment specified below.  

The customer or the user of the system should assure that it is used in such an environment.

Immunity Test

IEC 60601-1 
test level

Compliance 
Level

Electromagnetic  
Environment Guidance

Electrostatic  
discharge (ESD)
IEC 61000-4-2

+/- 8 kV contact
+/- 2, 4, 8, 15 kV air

+/- 8 kV contact
+/- 2, 4, 8, 15 kV 
air

If floors are covered with 
synthetic material the 
relative humidity shall 
be least 30%.

Electrical fast  
transient / burst 
IEC 61000-4-4 

+/- 2 kV for power 
supply lines
+/- 1 kV for input / 
output lines

+/- 2 kV power 
supply lines N/A

Mains power quality 
shall be that of a typical 
commercial or hospital 
environment.

Surge IEC 61000-4-5

+/- 1 kV line(s)  
to line(s) 
+/- 2 kV line(s)  
to earth

Mains power quality 
shall be that of a typical 
commercial or hospital 
environment.

Voltage Dips, short 
interruptions and 
voltage variations 
on power supply 
input lines 
IEC 61000-4-11

<5% Ut (95% dip 
in Ut) for 0.5 cycle

40% Ut (60% dip 
in Ut) for 5 cycles

70% Ut (30% dip 
in Ut) for 25 cycles

<5% Ut (95% dip 
in Ut) for 5 sec.

100% reduction
0.5 period

40% reduction
for 5 periods

30% reduction
for 25 periods

100% reduction
for 5 sec.

Mains power quality 
shall be that of a  
typical commercial or 
hospital environment.
If the use of the system 
requires continued 
operation during power 
mains interruptions  
the system can be  
powered by the built in 
rechargeable battery.

Power frequency 
(50/60 Hz)  
magnetic field 
IEC 61000-4-8

30 A/m

30 A/m

Power frequency  
magnetic fields  
should be at levels  
characteristic of a  
typical location in a  
typical commercial or 
hospital environment.

Video out is  

not working.

No live image on the 

external screen.

Make sure the external monitor is connect-

ed to aView using the composite cable and 

that the external monitor is displaying the 

correct input. The external monitor shall be 

capable of receiving NTSC or PAL. Toggle 

between NTSC and PAL in the video out 

menu on aView for best result. The external 

monitor is only displaying a live image 

when aView is displaying a live image.  

The image size on the external monitor is 

determined by the settings in the external 

monitor.

The colours, brightness 

and contrast looks  

different from the 

aView screen.

Adjust the colours, brightness and contrast 

on the external monitor to achieve the 

desired result.

Horizontal lines (noise) 

on external monitor.

If horizontal lines (noise) appear on the 

external monitor, try to connect the aView 

power supply.

Appendix 1. Electromagnetic Compatibility 

Like other electrical medical equipment the system requires special precautions to ensure  
electromagnetic compatibility with other electrical medical devices. To ensure electromagnetic 
compatibility (EMC) the system must be installed and operated according to the EMC  
information provided in this manual.
The system has been designed and tested to comply with IEC 60601-1-2 requirements for EMC 
with other devices.

Guidance and manufacturer’s declaration – electromagnetic immunity

The system is intended for use in the electromagnetic environment specified below.  

The customer or the user of the system should assure that it is used in such an environment.

Emissions Test

Compliance

Electromagnetic Environment Guidance

RF emission CISPR 11

Group 1

The system use RF energy only for  
its internal function. Therefore, its RF 
emissions are very low and are not  
likely to cause any interference in  
nearby electronic equipment.

RF emission CISPR 11

Class B

The system is suitable for use in all 
establishments, including domestic 
establishments and those directly 
connected to the public low-voltage  
power supply network that supplies 
buildings used for domestic purposes.

Harmonic emission 
IEC/EN 61000-3-2

Not applicable

Voltage fluctuations 
/ flicker emissions 
IEC/EN 61000-3-3

Complies

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Содержание aView JANUS2-W08-R10

Страница 1: ...For use by trained clinicians physicians only For in hospital use For use with Ambu visualization devices Further instruction details are available online www ambu com Instruction for Use Ambu aView...

Страница 2: ...5b aScope 2 aScope 3 aScope 4 Broncho 6 Ambu is a registered trademark and aScope and aView are trademarks of Ambu A S Pat Pending Contents Page English Instruction for Use 4 17 Deutsch Bedienungsanl...

Страница 3: ...itor 1 1 Intended Use The aViewTM monitor is a non sterile reusable digital monitor intended to display live imaging data from Ambu visualisation devices 1 2 Warnings and Cautions Failure to observe t...

Страница 4: ...Reference Number 2 3 aView Parts No Part Function Material 1 Monitor Casing PC ABS Rubber 2 Touch Screen Displays the image from the Ambu visualization device and a touch screen interface PET Glass 3...

Страница 5: ...INMETRO Certificate Medical Electrical Equipment ABNT NBR IEC 60601 1 ABNT NBR IEC 60601 1 2 ABNT NBR IEC 60601 2 18 4 Use of aView Numbers in gray circles below refer to illustrations on page 2 4 1 P...

Страница 6: ...nsequences by the reprocessor to ensure that the device continues to fulfil its intended purpose Clean and disinfect the aView according to good medical practice using one of the procedures below Clea...

Страница 7: ...w file management tab Return to live image by pressing the blue Live image tab or restart aView by pressing the power button for at least 2 seconds When aView is off restart by pressing power button o...

Страница 8: ...xternal monitor is displaying the correct input The external monitor shall be capable of receiving NTSC or PAL Toggle between NTSC and PAL in the video out menu on aView for best result The external m...

Страница 9: ...n site before shipment to Ambu The cleaning and disinfection procedures explained in section 5 shall be followed Ambu reserve the right to return contaminated medical devices to the sender Guidance an...

Страница 10: ...g der Ausstattung oder eine Abschirmung des genutzten Raums erforderlich Anweisungen zur Platzierung des aView finden Sie in den Tabellen in Anhang 1 12 Achten Sie darauf ob es sich beim angezeigten B...

Страница 11: ...r die Composite Videoaus gangs Schnittstelle siehe Pos 6 PE PVC Abk rzungen PC Polycarbonat PE Polyethylen ABS Acrylnitril Butadien Styrol ZDC3 Zinklegierung PVC Polyvinylchlorid POM Polyoxymethylen...

Страница 12: ...enn der Akkuladezustand sehr niedrig ist sind die Aufnahmefunktionen nicht verf gbar Falls der aView ausgeschaltet und der Akkuladezustand sehr niedrig ist blinkt die Einschalttas te alle zehn Sekunde...

Страница 13: ...ischen Sie den aView anschlie end mit einer sterilen in gefiltertem Trinkwasser RO DI angefeuchteten Gaze ab Stellen Sie sicher dass alle R ckst nde des Reinigungs mittels entfernt wurden 7 Wiederhole...

Страница 14: ...zstecker geerdet 4 Europ ische Konfiguration CEE 7 Netzstecker geerdet 5 D nische Konfiguration 2 5a Netzstecker geerdet 6 Konfiguration f r die Schweiz Typ J Netzstecker geerdet Weitere Informationen...

Страница 15: ...on in der N he befindlichen elektro nischen Ger ten ist unwahrscheinlich HF Emissionen CISPR 11 Klasse B Das System ist f r die Verwendung in allen Einrichtungen geeignet einschlie lich solchen in h u...

Страница 16: ...betragen Empfohlene Trennungsabst nde zwischen tragbaren und mobilen HF Kommunikationsger ten und dem System Das System ist f r den Betrieb in einer elektromagnetischen Umgebung bestimmt in der die H...

Страница 17: ...Ambu A S Baltorpbakken 13 DK 2750 Ballerup Denmark T 45 72 25 20 00 F 45 72 25 20 50 www ambu com 492 4050 00 V01 2017 09 TCC 10368...

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