Ambu aView JANUS2-W08-R10 User manual

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™

1
4
2a 2b
5a 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
Български (Указания за ползване)...................................................................................................... 18-33
Česky (Návod k použití)..............................................................................................................................34-47
Dansk (Brugsanvisning) ..............................................................................................................................48-61
Deutsch (Bedienungsanleitung)..............................................................................................................62-75
Eλληvıĸά (δηγίες Xρήσεως) .......................................................................................................................76-91
Español (Manual de instrucciones) ......................................................................................................92-105
Eesti (Kasutusjuhised)..............................................................................................................................106 -118
Suomi (Käyttöohje)...................................................................................................................................119-132
Français (Mode d´emploi) ......................................................................................................................133-146
Hrvatski (Upute za uporabu) ................................................................................................................ 147-159
Magyar (Használati útmutató) .............................................................................................................160 -173
Italiano (Manuale d’uso) .........................................................................................................................174-188
日本語 (使用法) ................................................................................................................189-201
Lietuviškai (Naudojimo instrukcijos) .................................................................................................202-214
Latviski (Lietošanas instrukcija)...........................................................................................................215-228
Nederlands (Gebruiksaanwijzing)..................................................................................................... 229-243
Norsk (Brukerveiledning) ......................................................................................................................244-257
Polski (Instrukcja obsługi).....................................................................................................................258-272
Português (Manual de instruções) .................................................................................................... 273-287
Português–Brazil (Manual de instruções).......................................................................................288-301
Română (Instrucţiuni de utilizare)......................................................................................................302-316
Pусский (Directions for use).................................................................................................................317-331
Slovenčina (Návod na použitie).......................................................................................................... 332-345
Slovenšcina (Navodila za uporabo)...................................................................................................346-360
Svenska (Instruktionshandbok)...........................................................................................................361-374
Türkçe (Kullanım talimatları)................................................................................................................375-388
( )..........................................................................................................................................389-401

1. Important Information – Read Before Use
Read these safety instructions carefully before using the aView monitor. The Instruction for Use
may be updated without further notice. Copies of the current version are available upon request.
Please be aware that these instructions do not explain or discuss clinical procedures. They
describe only the basic operation and precautions related to the operation of the aView monitor.
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 these warnings and cautions may result in patient injury or damage to the
equipment. Ambu is not responsible for any damage to the system or patient injury result-
ing from incorrect use.
WARNINGS
1. aView images must not be used as an independent diagnostic of any pathology.Physi-
cians must interpret and substantiate any finding by other means and in the light of
the patient's clinical characteristics.
2. Do not use the aView monitor if it is damaged in any way or if any part of the functional
check fails.
3. The aView is not to be used when delivering highly flammable anaesthetic gases to the
patient. This could potentially cause patient injury.
4. The aView is not to be used in a MRI environment.
5. Do not use aView during defibrillation.
6. When handling the patient do not simultaneously touch the aView power socket or
docking connector.
7. Always watch the live endoscopic image on the aView when advancing or withdrawing
a visualization device.
8. To avoid risk of electric shock, this equipment must only be connected to a supply
mains with protective earth. To disconnect aView from mains remove the mains plug
from the wall outlet.
9. Clean and disinfect the aView monitor after each use according to the instructions in
section 5. Disconnect aView from any mains power supply, remove any accessories and
make sure the aView is completely turned off before cleaning and disinfection.
10. Use of accessories, transducers and cables other than those specified or provided
by the manufacturer of this equipment could result in increased electromagnetic emis-
sions or decreased electromagnetic immunity of this equipment and result in improper
operation.
11. Electronic equipment and the aView may affect the normal function of each other. If
the aView is used adjacent to or stacked with other equipment, observe and verify nor-
mal operation of both the aView and the other electronic equipment prior to using it. It
may be necessary to adopt procedures for mitigation, such as reorientation or reloca-
tion of the equipment or shielding of the room in which it is used. Consult the tables in
appendix 1 for guidance in placing aView.
12. Be careful to check whether the image on the screen is a live image or a recorded
image and verify that the orientation of the image is as expected.
13. Portable RF communications equipment (including peripherals such as antenna cables
and external antennas) should be used no closer than 30 cm (12 inches) to any part of
the system, including cables specified by the manufacturer. Otherwise, degradation of
the performance of this equipment could result.
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EN
CAUTIONS
1. Have a suitable backup system readily available for immediate use so the procedure
can be continued if a malfunction should occur.
2. US federal law restricts this device for sale only by, or on the order of, a physician.
3. Keep aView dry during preparation, use and storage.
4. Pay attention to the battery symbol indicator on the aView monitor. Recharge aView
when the battery level is low (see section 4.1). It is recommended that aView is
recharged before every procedure and that a charger be readily available during use.
5. Place or hang the aView monitor on a stable support while in use. Dropping aView
could damage it.
6. Position the power cord where it is unlikely to be stepped on. Do not place any objects
on the power cord.
7. aView is not intended to be repaired. If defect aView shall be discarded.
8. The batteries in aView are not changeable and must only be removed upon disposal.
2. System Description
The aView monitor can be connected with a range of Ambu visualisation devices (cf. section 2.2
for compatible devices) to display the video image from an Ambu visualisation device. The aView
monitor is reusable. No modification of this equipment is allowed.
Ambu® aView™ Part numbers: Bracket Part numbers:
405002000
Model no.
JANUS2-W08-R10
(SW versions v2.XX)
405017700
For aView model no., please check backside label on aView.
aView is not available in all countries. Please contact your local sales office.
Power supplies Part numbers:
x5
aView power supply
manufacturer:
FSP Group Inc.
aView power supply part
number: FSP030-REAM
EU/CH 405014700X
(not DK & UK)
UK 405013700X
DK 405012700X
AUS & NZ
405015700X
US 405016700X
Accessories Part numbers:
aView adaptor
cable for composite
connection
405000712
2.2. Compatible Devices
The compatible Ambu visualisation devices for aView are:
Green connection port (see “5a” on page 2) : Blue connection port (see “5b”on page 2):
- Ambu® aScope™ 2 - Ambu® aScope™ 3 Family
- Ambu® aScope™ 4 Broncho Family
Only one visualization device can be connected to aView at a time. aScope 2, aScope 3 Family and aScope 4
Broncho Family are not available in all countries. Please contact your local sales office.
(e.g. for attaching
the aView to an I.V. pole)
5

2.3. aView Parts
No. Part Function Material
1Monitor Casing -PC / ABS
Rubber
2Touch Screen Displays the image
from the Ambu
visualization device
and a touch screen
interface.
PET / Glass
3Stand To place the display
on a solid surface.
ZDC3
4Connection
for Ambu®
visualization
devices
Power supply and
data connection
Protected by a
rubber cover.
PC / ABS
Rubber
5Power Power inlet for
charging aView.
Protected by a
rubber cover.
Rubber
6Input/output
connections
JACK connector
(video-out) and
USB port.
-
7Power button Push button for
power ON before
procedure and
power OFF after
procedure.
Rubber
8Docking
connector
For future use. -
9Power supply Powers the system
Power cord with
country-specific plug.
PC
PVC
10 Hexagonal key To tighten the bolt
on the bracket.
CrV
11 Bracket Secures the monitor
to e.g. an IV pole.
POM
12 Pouch hook Slide the hook
through the 3 holes
on the bracket. It can
now be used to hold
visualization device
pouches with a hole
in top corner for easy
storage before and
during use.
PAA
13 Adapter cable For the composite
video-out interface
(see no. 6).
PE/PVC
Abbreviations: PC (Polycarbonate), PE (Polyethylene), ABS (Acrylonitrile Butadiene Styrene),
ZDC3 (Zinc alloy), PVC (Polyvinylchloride), POM (Polyoxymethylene), PAA (Polyarylamide),
CrV (Chrome Vanadium)
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10
9
12
11
8
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5
4
1
3 2
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EN
3. Explanation of Symbols Used
Symbols for
the aView
Indication Symbols for
the aView
Indication
Consult Instruction
for Use.
Date of Manufacture,
followed by YYYY-MM-DD.
Caution. Manufacturer.
%
Humidity limitation:
relative humidity
between 30 and
85% in operating
environment.
CE mark. The product
complies with the EU Coun-
cil directive concerning
Medical Devices 93/42/EEC
Atmospheric
pressure limitation:
between 80 and 109
kPa in operating
environment
Waste Bin symbol,
indicating that waste
must be collected according
to local regulation and
collection schemes for
disposal of batteries.
Connection to
external monitor.
Waste Bin symbol,
indicating that waste must
be collected according to
local regulation and
collection schemes for
disposal of electronic and
electrical waste (WEEE).
Direct current. Li-ion
Battery type Lithium ion.
Only applicable for the
battery inside the aView.
Alternating current.
Re-chargeable battery.
Only applicable for the
battery inside the aView.
IP30 Protection against
solid objects. Only for indoor use.
Lot Number,
Batch Code. Tested to comply with
FCC Standards - Medical
Equipment.
Reference Number.
7

Medical — general medical equipment as to
electrical shock, fire and mechanical hazards
only in accordance with
ANSI/AAMI ES60601-1:2005/(R):2012
CAN/CSA-C22.2 No. 60601-1:08 (R2013)
IEC 60601-2-18:2009. UL60601-1, 1st ed.: 2006
CAN/CSA-C22.2 No. 601.1-M90, 2005
IEC 60601-2-18:1996. Control no 4UD1.
4. Use of aView
Numbers in gray circles below refer to illustrations on page 2.
4.1. Preparation and Inspection of aView
1. Closely examine aView and all parts for any damage (free from wear and tear) 1.
2. Place aView on a solid flat surface by using the stand on the back of aView 2a .
If needed, aView can be placed on a pole by using the supplied bracket 2b .
3. Switch aView on by pressing the power button 3. A white hourglass indicating that
aView is loading the User Interface will appear on the screen.
4. Check the battery indicator on aView. A full charge lasts approximately 3 hours. Charge
the aView monitor if necessary by connecting the aView power supply to the wall socket
and insert the power plug into the power inlet of aView 4. Make sure the power supply
is present and working at any time. It is recommended to locate the nearest wall socket
before start of the procedure.
The battery icon remains white until one block is left, after which it turns red.
When remaining battery capacity is 10% the red battery icon starts flashing.
Max. battery
status of
the aView
Min. battery
status of
the aView
Fully charged
battery still connected
to charger
Charging is shown with blocks flashing. Current capacity is shown with non-flashing blocks.
Battery is
charging
Battery current
capacity
Battery damaged
The power button will light up green when aView is turned ON and not connected to mains
and orange when aView is connected to mains. When aView is turned off, fully charged and
connected to mains the button will turn green.
If the battery is critically low, the recording functions will become unavailable.
If the aView is turned off and the battery is critically low, the power button will flash orange
five times every ten seconds to remind that charging is needed.
5. Connect the selected Ambu visualization device to aView by plugging the cable connector
into the corresponding female connector on aView (push aside the rubber cover)
5a or 5b . Align the arrows on the visualisation device and aView before insertion.
6. Verify that a live video image appears on the screen. Point the distal end of the Ambu
visualization device towards an object, e.g. the palm of your hand 6.
7. Adjust the image preferences on aView if necessary – refer to the online aView User
Guide on www.ambu.com.
4.2. Installing, Preparing and Operating the Ambu Visualization Device
Please refer to the Instruction for Use for the specific visualization device.
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4.3. Operating the aView Monitor
Startup Image Mode User Interface
Starts immediately after the power
button is pressed and continues
until the User Interface is loaded
(after approximately 1 min).
A live image is available and the User
Interface displays advanced user functions
(refer to the online aView User Guide on
www.ambu.com).
A live image from the plugged in Ambu
visualization device is available while aView
is loading. If no device is connected the
screen will be blue.
aView starts up in the Blue tab for Live Image
Viewing and recording live image.
The screen layout may vary depending on
the software version.
The screen layout may vary depending on
the software version.
Interface nomenclature
Power button Video recording
Brightness adjustment Viewing and recording
live image.
Contrast adjustment Managing saved files.
Snap shot System settings and User
Accounts.
Live image vs. recorded image
Round BLUE buttons are shown in the blue Live Image tab and indicates a live image.
Square YELLOW or GREEN buttons are shown in the yellow File Management tab and the
green Settings tab and indicates a recorded image.
Battery status: During start up, aView powers up and configures the visualization device.
If the aView battery icon on the screen changes from fully charged to low battery (red battery)
within 30 minutes, aView must be replaced.
Connection to external monitor
The image from an Ambu visualization device can be viewed on an external monitor using the
video out interface on aView. Connect the external monitor to the composite interface on the
right side of aView using the adaptor cable supplied (refer to the online aView User Guide on
www.ambu.com). Please consult the manual of the external monitor for further information on
how to connect an external video source by composite.
9

4.4. After Use
Final steps
1. Disconnect the Ambu visualization device from aView. For disposal of the visualisation
device, refer to the Instruction for Use of the specific device.
2. Switch off aView by pressing the power button for at least 2 seconds. A blue
hourglass indicating that aView is powering down will appear on the screen and
aView will power down.
3. Clean and disinfect aView (cf. section 5).
4. If the battery level of aView is low, charge the aView (cf. section 4.1).
5. Cleaning and Disinfection of aView
The aView should be cleaned and disinfected before and after each use. It is recommended that
aView is cleaned and disinfected before and after use following the instructions below. Ambu
has validated these instructions in accordance with AAMI TIR 12 & 30. Any deviation from the
instructions should be properly evaluated for effectiveness and potential adverse consequences
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:
Procedure 1 - SANI-CLOTH® BLEACH from PDI
Cleaning
Use a wipe to remove heavy soil. All blood and other body fluids must be thoroughly
cleaned from surfaces and objects before disinfection by germicidal wipe.
Disinfecting
1. For heavily soiled surfaces, use a wipe to pre-clean aView prior to disinfecting.
2. Unfold a clean wipe and thoroughly wet the surface of aView.
3. The treated surfaces must remain visibly wet for a full four (4) minutes. Use additional
wipes if needed to assure continuous 4 minutes wet contact time.
4. Let aView air dry.
Procedure 2 - SUPER SANI-CLOTH® from PDI
Cleaning
Use a wipe to remove heavy soil. All blood and other body fluids must be thoroughly
cleaned from surfaces and objects before disinfection by germicidal wipe.
Disinfecting
1. For heavily soiled surfaces, use a wipe to pre-clean aView prior to disinfecting.
2. Unfold a clean wipe and thoroughly wet the surface of aView.
3. The treated surfaces must remain visibly wet for a full two (2) minutes. Use additional
wipes if needed to assure continuous 2 minutes wet contact time.
4. Let aView air dry.
Procedure 3
Cleaning
1. Prepare a cleaning solution using a standard enzymatic detergent prepared per
manufacturers recommendations. Recommended detergent: enzymatic, mild pH:
7-9, low foaming (Enzol or equivalent).
2. Soak a sterile gauze in the enzymatic solution and make sure that the gauze is moist
and not dripping.
3. Thoroughly clean the button, rubber covers, screen, external casing of the monitor
and stand with the moist gauze. Avoid getting the device wet to prevent damaging
internal electronic components.
4. Using a sterile soft bristled brush that has been dipped in the enzymatic solution,
brush the button until all evidence of soil is removed.
5. Wait for 10 minutes (or the time recommended by the manufacturer of the deter-
gent) to allow the enzymes to activate.
6. Wipe the aView clean using sterile gauze that has been moistened with RO/DI water.
Ensure all traces of the detergent are removed.
7. Repeat steps 1 to 6.
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Disinfecting
Wipe the surfaces of aView for approximately 15 minutes using a piece of sterile gauze
moistened with the alcohol mixture indicated below (approximately once every 2 min-
utes). Follow safety procedures for the handling of isopropyl. The gauze should be moist
and not dripping since liquid can affect the electronics inside the aView. Pay close atten-
tion to the button, rubber covers, screen, external casing and stand, slots and gaps on the
aView. Use a sterile cotton swab for these areas.
Solution: Isopropyl (alcohol) 95%; Concentration: 70-80%; Preparation: 80cc of 95% Isopro-
pyl (alcohol) added to 20cc of purified water (PURW) (Alternatively, use EPA-registered hos-
pital disinfection wipes containing at least 70% isopropyl. Safety precautions and direc-
tions of use of the manufacturer must be followed).
After cleaning and disinfection, the aView must be submitted to the pre-check procedure in section 4.1.
Between procedures, aView must be stored in accordance with local guidelines.
6. Maintenance and Disposal
6.1. Maintenance of Battery
To prolong battery life it is recommended to fully charge the monitor at least every third
month and store it in a cool place. If the battery is flat the procedure can take up to 5 hours.
The battery should be charged at temperatures between 10 - 40°C.
6.2. Disposal
At the end of product life open up the aView and dispose of the batteries and aView separately
in accordance with local guidelines.
7. Technical Product Specifications
7.1. Standards Applied
The aView function conforms with:
– Council Directive 93/42/EEC concerning Medical Devices.
– IEC 60601-1 ed 2 Medical electrical equipment – Part 1: General requirements for safety.
– IEC 60601-1 ed 3.1 Medical electrical equipment - Part 1: General requirements for basic safe-
ty and essential performance.
– IEC 60601-1-2: Medical electrical equipment – Part 1-2 General requirements for safety –
Collateral standard: Electromagnetic compatibility - Requirements for test.
The Ambu aView power supply conforms with:
– Council Directive 93/42/EEC concerning Medical Devices.
– IEC 60601-1 ed 2 Medical electrical equipment – Part 1: General requirements for safety.
– IEC 60601-1 ed 3.1 Medical electrical equipment - Part 1: General requirements for basic safe-
ty and essential performance.
7.2. aView Specifications
Display
Max. resolution 800 * 480
Orientation Landscape
Display type 8.5” colour TFT LCD
Brightness control Yes, (“+” / ”-“)
Contrast control Yes, (“+” / ”-“)
Start up time Immediately after pressing the power button.
11

Connections
USB connection Type A
Analog composite video out RCA connection (use adapter cable included)
Storage and transportation
Temperature 10 ~ 40°C (50 ~ 104°F)
Relative humidity 30 ~ 85%
Atmospheric pressure 80-109 kPa
Memory
Storage capacity 8GB
Mounting interface
Mounting interface standard VESA MIS-D, 75 C, VESA FDMI compliant display, Part
D, with centre located mounting interface
Electrical power
Power requirement 18V 1.67A DC input
Battery type 10.8V 4300mAh
Battery Operation Typical battery runtime of a new, fully charged battery
(aView turned on and scope connected) is min. 3 hours
Protection against electrical shock Internally Powered
Fixture
Mounting interface 75 mm (2.96”)
Fits poles with thicknesses 10 mm ~ 45 mm (0.4 ~ 1.8”)
Operating environment
Temperature 10 ~ 40°C (50 ~ 104°F)
Relative humidity 30 ~ 85%
IP Protection Classification Sys-
tem
The aView is classified IP30.
Atmospheric pressure 80-109 kPa
Altitude ≤ 2000 m
Dimensions
Width 241 mm (9.49")
Height 175 mm (6.89")
Thickness 33.5 mm (1.32")
Weight 1500 g (331lbs)
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EN
7.3. aView Power Supply
Dimensions
Weight 360g (0.79 lbs)
Electrical power
Power requirement 100 - 240V AC; 50-60Hz; 0.6A
Power out 18V DC; 1.67A
Protection against
electrical shock
Class I
Operating environment
Temperature 10 ~ 40° C (50 ~ 104° F)
Storage
Temperature 10 ~ 40°C (50 ~ 104°F)
Relative humidity 10 ~ 90%
Plugs
Between the power supply
and aView
Ø5.5mm DC jack connector
6 interchangeable types 1. Model NEMA 5 AC grounded power plug
2. Australian configuration: AS3112, AC grounded
power plug
3. UK configuration: BS1363, AC grounded power plug
4. European configuration: CEE 7, AC grounded
power plug
5. Danish configuration: 2-5a, AC grounded power plug
6. Swiss configuration: Type J, AC grounded power plug
Contact Ambu for further information.
13

8. Trouble Shooting
If problems occur with the aView monitor, please use this trouble-shooting guide to identify
the cause and correct the error.
Problem Possible cause Recommended action
No live image
on the screen
but User
Interface is
present on the
display or the
image shown
is frozen.
An Ambu visualization
device is not connected
to aView.
Connect an Ambu visualization device to
the blue or green port on aView.
aView and the Ambu
visualization device
have communication
problems.
Restart aView by pressing the power but-
ton for at least 2 seconds. When aView is
off restart by pressing the power button
once more.
The Ambu visualization
device is damaged.
Replace the Ambu visualization device with
a new one.
A recorded image is
shown in the yellow
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 once more.
Low picture
quality.
Light reflecting on the
aView screen.
Move aView to a position where no direct
light influences the screen.
Dirty / damp screen. Wipe the screen with a clean cloth.
Brightness and contrast
settings not optimal.
Adjust the contrast and brightness using
the designated menu on aView.
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 dif-
ferent 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.
14

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.
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
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 Envi-
ronment 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.
15

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.
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
test level
Compliance
level
Electromagnetic
Environment Guidance
Conducted
Radio
Frequency
IEC 61000-4-6
3 V RMS
0,15 MHz –
80 MHz
6 V RMS
in ISM bands
80 % AM at
1 kHz
3 V RMS
0,15 MHz –
80 MHz
6 V RMS
in ISM bands
80 % AM at
1 kHz
Portable and mobile RF
communications equipment should
be used no closer to any part of the
system, including its cables, than
the recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.
Recommended separation distance
d = 1.17√P
d = 1.17√P 80 MHz to 800 MHz
d = 2.33√P 800 MHz to 2.7 GHz
Where P is the maximum output
power rating of the transmitter
in watts (W) according to the
transmitter manufacturer and d
is the recommended separation
distance in metres (m).
Field strengths from fixed RF
transmitters, as determined by
an electromagnetic site survey,
a) should be less than the compliance
level in each frequency range
b). Interference may occur in the
vicinity of equipment marked with
the following symbol.
Radiated
Radio
Frequency
IEC 61000-4-3
3 V/m 80 MHz
to 2.7 GHz
80 % AM at
1 kHz
3 V/m
80-2700 MHz
80% AM at
1 kHz
NOTE 1: At 80 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
16

EN
a) Field strengths from fixed transmitters, such as base stations for radio (celluar/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV
broadcast, cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey shall be considered.
If the measured field strength in the location in which the system is used exceeds the
applicable RF compliance level above, the system shall be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the system.
b) Over the frequency range 150kHz to 80MHz, field strengths shall be less than 3 V/m.
Recommended Separation Distances Between Portable and Mobile RF Communication
Equipment and system.
The system is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The user of the system can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters and the system as recommended below,
according to the maximum output power of the communication equipment.
Rated maximum
output power (W)
of transmitter
Separation distance (m) according to frequency of transmitter
150kHZ to 80MHz
D = 1.17√P
80MHz to 800MHZ
D = 1.17√P
800MHz to 2.7GHz
D = 2.33√P
0.01 0.12 m 0.12 m 0.23 m
0.1 0.37 m 0.37 m 0.74 m
11.17 m 1.17 m 2.33 m
10 3.70 m 3.70 m 7.37 m
100 11.7 m 11.7 m 23.3 m
For transmitters rated at a maximum output power not listed above, the recommended
separation distance (D) in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
Appendix 2. Warranty and Replacement Program
The warranty period for the aView is one year from delivery to the customer. Ambu agrees
to replace an aView free of charge if proof can be provided of faulty materials or faulty
workmanship. In doing so Ambu cannot accept the cost of transportation or risk of shipment.
Repair of an aView due to faulty materials or faulty workmanship may be offered in situations
where this option is available. Ambu holds the right to make the choice between repair or
replacement in every situation.
Ambu holds the right to ask the technical department at the customer site, or a similar
department, to carry out repair of an aView under proper guidance by Ambu.
A defective aView must be handled exclusively by persons authorised by Ambu A/S. To
prevent infection, it is strictly forbidden to ship contaminated medical devices. The medical
device (aView or Ambu visualization device) must be decontaminated on 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.
17

1. Важна информация – прочетете преди употреба
Прочетете внимателно тези инструкции за безопасност, преди да използвате монитора
aView. Инструкциите за употреба подлежат на актуализиране без допълнително преду-
преждение. Копия на текущата версия са достъпни при поискване. Имайте предвид, че тези
инструкции не дават обяснения и не разглеждат клиничните процедури. Те описват само
основното действие и предпазните мерки, свързани с работата с монитора aView.
1.1. Предназначение
Мониторът aViewTM е нестерилен цифров монитор за многократна употреба, предназначен
за показване на образни данни в реално време от устройства за визуализиране Ambu.
1.2. Предупреждeния и предпазни мерки
Неспазването на тези предупреждения и предпазни мерки може да доведе до
нараняване на пациента или повреда на оборудването. Ambu не носи отговорност
за каквато и да е повреда на системата или нараняване на пациента в резултат
на неправилно ползване.
ПРЕДУПРЕЖДЕНИЯ
1. Изображенията от aView не трябва да се използват самостоятелно за диагности-
ка на патология. Лекарите трябва да тълкуват и обосновават всяка находка с
други средства и съгласно клиничните характеристики на пациента.
2. Не използвайте монитора aView, ако е повреден по някакъв начин или ако някоя
част от функционалната проверка е неуспешна.
3. aView не трябва да се използва при инхалационна анестезия на пациента с лесно-
запалими газове. Това може евентуално да доведе до нараняване на пациента.
4. aView не трябва да се използва в среда на МРТ.
5. Не използвайте aView по време на дефибрилация.
6. При работа с пациента не докосвайте едновременно захранващото гнездо на
aView или докинг конектора.
7. Винаги следете ендоскопското изображение в реално време на aView при прид-
вижване или изтегляне на устройство за визуализиране.
8. За да се избегне рискът от токов удар, това оборудване трябва да се свързва
само към захранваща електрическа мрежа със защитно заземяване. За да
изключите aView от електрическата мрежа, изключете захранващия щепсел от
електрическия контакт.
9. Почиствайте и дезинфекцирайте монитора aView след всяка употреба в съответ-
ствие с инструкциите в раздел 5. Изключете aView от мрежовото захранване,
извадете всички аксесоари и се уверете, че aView е напълно изключен преди
почистване и дезинфекция.
10. Използването на аксесоари, датчици или кабели, различни от посочените или пре-
доставените от производителя на това оборудване, може да доведе до увеличава-
не на електромагнитните емисии или намаляване на електромагнитната устойчи-
вост на това оборудване и съответно до неправилна работа.
11. Електронно оборудване и aView може да повлияят взаимно на нормалната си
работа. Ако aView се използва в непосредствена близост до или поставен върху
друго оборудване, наблюдавайте и потвърдете нормалната работа на aView и на
другото електронно оборудване, преди да го използвате. Може да е необходимо
да се приложат процедури за смекчаване на смущенията, като например прео-
риентиране или преместване на оборудването, или екраниране на помещение-
то, в което се използва. Консултирайте се с таблиците в Приложение 1 за насоки
при поставяне на aView.
12. Непременно проверете дали изображението на екрана е изображение в реално
време или записано изображение и проверете дали ориентацията на изображе-
нието отговаря на очакванията.
13. Преносимо радиочестотно комуникационно оборудване (включително пери-
ферни устройства, като кабели на антени и външни антени) не трябва да се
използва на разстояние, по-малко от 30 cm (12 инча), от коя да е част на система-
та, включително от кабелите, посочени от производителя. В противен случай
може да възникне влошаване на ефективността на това оборудване.
18

ВНИМАНИЕ
1. Осигурете на разположение подходяща резервна система за незабавна употре-
ба, така че процедурата да може да продължи, ако възникне неизправност .
2. Федералното законодателство на САЩ налага ограничението това устройство да
се продава само от лекар или по поръчка на лекар.
3. Поддържайте aView сух по време на подготовка, употреба и съхранение.
4. Обърнете внимание на символния индикатор за батерията на монитора на aView.
Заредете aView, когато нивото на батерията е ниско (вижте раздел 4.1). Препоръ-
чително е aView да се презарежда преди всяка процедура и зарядното устрой-
ство да бъде на разположение по време на употреба.
5. По време на употреба поставете или закачете aView на стабилна опора. Ако
изпуснете aView, той може да се повреди.
6. Поставете захранващия кабел на място, на което е малко вероятно да бъде
настъпван. Не поставяйте предмети върху захранващия кабел.
7. aView не е предназначен да бъде ремонтиран. При поява на повреда aView тряб-
ва да се изхвърли.
8. Батериите в aView не могат да се сменят и трябва да се извадят само при изхвър-
ляне на уреда.
2. Описание на системата
Мониторът aView може да бъде свързан към гама от устройства за визуализиране Ambu
(вижте раздел 2.2 за съвместимите устройства), за да показва видеоизображението от
устройство за визуализиране Ambu. Мониторът aView е предназначен за многократна
употреба. Не е разрешено модифициране на това оборудване.
Ambu® aView™ Номера на части: Скоба Номера на части:
405002000
№ на модел
JANUS2-W08-R10
(версии на соф-
туера v2.XX)
405017700
За № на модела на aView проверете задния етикет на aView.
aView не се предлага във всички държави. Свържете се с местния търговски офис.
Захранвания Номера на части:
x5
Производител
на захранването
на aView: FSP
Group Inc.
Продуктов
номер на
захранването
на aView:
FSP030-REAM
EU/CH 405014700X
(без Дания и
Обединеното кралство)
Обединеното
кралство 405013700X
Дания 405012700X
Австралия и Нова
Зеландия 405015700X
US 405016700X
Аксесоари Номера на части:
адаптер за aView
кабел за композитна връзка
405000712
(например за закрепване
на aView към инфузионна стойка)
BG
19

2.2. Съвместими устройства
Устройствата за визуализиране Ambu, съвместими с aView, са:
Зелен порт за връзка
(вижте„5a“ на стр. 2):
Син порт за връзка
(вижте„5b“ на стр. 2):
- Ambu® aScope™ 2 - Фамилия Ambu® aScope™ 3
- Фамилия Ambu® aScope™ 4 Broncho
Към aView не може да се свързва повече от едно устройство за визуализиране едновременно. aScope 2,
фамилията aScope 3 и фамилията aScope 4 Broncho не се предлагат във всички държави. Свържете се с
местния търговски офис.
2.3. Части на aView
№ Част Функция Материал
1Корпус на
монитора
-PC / ABS
Гума
2Сензорен екран Показва изобра-
жението от
устройството за
визуализиране
Ambu и интер-
фейса на сензор-
ния екран.
PET (Полиети-
лен фталат)/
Стъкло
3Стойка За поставяне
на монитора
н а твърда
повърхност.
ZDC3
4Връзка за
устройства за
визуализиране
Ambu®
Захранване и
връзка за данни
Защита с гумена
капачка.
PC / ABS
Гума
5Захранване Захранващо
гнездо за зареж-
дане на aView.
Защита с гумена
капачка.
Гума
6Връзки вход/
изход
Жак конектор
(видеоизход)
и USB порт.
-
7Бутон за
захранването
Натиснете буто-
на, за да включи-
те захранването
(ON) преди про-
цедурата и за да
го изключите
(OFF) след проце-
дурата.
Гума
8 Докинг
конектор
За бъдещо
ползване.
-
8
7
6
5
4 1
32
20