Ambu aBox Duodeno User manual
Instruction For Use
Ambu® aBox™ Duodeno
For use by trained clinicians/physicians only.
For in-hospital use.
For use with Ambu® aScope™ Duodeno.
OK
OK
min.
20kg
OK
1... 2... 3...
HD-SDI 1
HD-SDI 2
DVI
Trig-1, -2, -3
1
2
5 x
5aScope
Duodeno
7aScope
Duodeno
9
3
12
4
6
8
ab
a b
Ambu is a registered trademark and aBox™ Duodeno is a trademark of Ambu A/S.
2
EN
1. Table of Contents
1. ImportantInformaon–PleaseReadBeforeUse! 4
4
4
4
4
4
2. SystemDescripon 8
2.1 System Parts 8
9
9
3. ExplanaonOfSymbolsUsed 10
3.1 Symbols 10
4. Ancillary Equipment And Accessories 11
11
5. PreparaonAndInspeconForUse 12
12
12
12
13
6. EndingAProcedureAndShungDownTheSystem 14
14
6.2 System Shutdown 14
7. FuseReplacement 15
8. PeristalcPumpReplacement 15
9. CleaningOfTheaBox™DuodenoExternalSurfaces 15
10. TechnicalData 16
16
16
10.3 Accessories 16
16
11. EnvironmentalProtecon 17
12. Troubleshoong 17
12.1 Returning The aBox™ Duodeno To Ambu 20
12.2 Compliance And Licensing 20
20
13. Contact 23
Appendix1. ConneconConguraonsDescripons 24
Appendix2. WPF-Mediakit 25
3
1. ImportantInformaon–PleaseReadBeforeUse!
to teach the beginner the proper technique or any medical aspects regarding the use of the
equipment. It is the responsibility of each medical facility to ensure that only appropriately trained
grade electrical equipment which configures a medical system and is therefore responsible that the
1.1 IntendedUse/IndicaonForUse
for endoscopy and endoscopic surgery within the duodenum.
Note:
1.2 TargetUserGroupsAndUserQualicaons
The physician should be capable of safely performing the planned endoscopy and endoscopic
procedures.
1.3 Contraindicaons
1.4 InstallaonAndMaintenance
maintenance.
1.5 WarningsAndCauons
equipment. The manufacturer
4
EN
Warnings
PreparaonforUse
•
of the system. Connect only medical grade equipment to the aBox™ Duodeno.
•
equipment damage.
•
inspect or use the aBox™ Duodeno with wet hands.
•
room ready for use.
•
• Always set the minimum required brightness. The brightness of the image on a medical
inappropriate use.
•
burns. This product may interfere with other medical grade electronic equipment used
•
all equipment to be used.
•
performance of the product.
•
•
InspeconoftheaBox™Duodeno
• Do not connect the power plug to the 2-pole power circuit with a 3-pole to 2-pole
• Do not use the aBox™ Duodeno if not inspected as instructed. Inspect other equipment
•
may occur.
5
ConnecontotheACMainsPowerSupply
•
•
-
•
•
system center and ancillary equipment is not guaranteed. Troubles caused in this case
OperaonoftheaBox™Duodeno
•
•
equipment damage.
•
-
•
Ancillary Equipment
•
away from the aBox™ Duodeno so that the medical agents do not come into contact
•
the monitor can occur or the loss of the endoscopic image.
•
might occur and it may cause equipment failure.
•
FuseReplacement
•
•
•
result.
•
6
EN
•
Care and Storage
•
•
PotenalofFire
•
Installaon,RepairandMaintenance
•
Cauons
General
•
•
•
•
•
equipment such as cellular
•
•
result.
• -
stand the weight of the equipment installed on it.
•
Care and Storage
•
Duodeno.
7
•
Damage to the aBox™ Duodeno can occur.
•
•
•
•
•
result.
•
•
-
Accessories
•
•
can be damaged.
•
2. SystemDescripon
2.1 SystemParts
Duodeno is shipped with one power cable that supplies the power necessary to run the aBox™
Ambu® aBox™ Duodeno
ReusableDevice
Partnumber
OK
485001000US
BoleHolder
8
EN
PowerCable
POAGCable
2.2 CompableDevice(ApplicaonPart)
Ambu® aScope™ Duodeno
Sterileandsingle-usedevice
Partnumber Distal End
Outer
Diameter ø
Working
Channel
Inner
Diameter ø
482001000 41.2 Fr
12.6 Fr
2.3 aBox™DuodenoDescriponAndFuncon
to be used with the aScope™ Duodeno.
No. Part Function
1 Retainer for sterile water
2 Lens washing
3Connector snap
4
5
and aBox™ Duodeno.
6Light source button
7Control panel
information menu of the aBox™ Duodeno.
9
No. Part Function
8Power button with power indicator Press button for power ON before procedure
and power OFF after procedure. The button will
light up green when turned ON.
9
10 Switch button for power ON and power OFF
11 AC power inlet
12
13 Ventilation
14 Video output
15 DVI connection Video output
16
17 D-SUB 9P
18
3. ExplanaonOfSymbolsUsed
3.1 Symbols
Symbols Indication Symbols Indication
Consult Instruction
for Use NRTL Symbol
Protect the
from moisture
indicating that waste
must be collected
according to local
regulation and
collection schemes
for disposal of
electronic and
electrical waste
Protection against electric
RxOnly
IP 21 Ingress protection
Serial Number
number and year of
Reference Number
Ground connection
10
EN
4. Ancillary Equipment And Accessories
•
•
•
•
•
•
•
•
4.1 AachingTheBoleHolderToTheaBox™ Duodeno
Ambu® aBox™ Duodeno BoleHolder
OK
aBox Bottleholder - Assembly
5 x
11
5. PreparaonAndInspeconForUse
-
•
•
•
• .
•
-
cord is not integral part of the aBox™ Duodeno. Connect the power supply cable to the AC
• -
• Connect the aBox™ Duodeno to at least one medical grade monitor. It is recommended to use
• al grade monitor or a medical grade recorder can be connected to
•
5.1 PoweringUpAndStarngTheaBox™Duodeno
•
up green when the aBox™ Duodeno is powered up.
•
screen.
5.2 PreparingAndConnecngTheAmbu®aScope™Duodeno
Please refer to the IFU of the aScope™ Duodeno.
5.3 TheMainMonitorScreen
1
2
2
3
3
3
3
3
4a
5
12
EN
and connect the CO
the OK button
5.4 ControlPanelNavigaon
of the aBox™ Duodeno.
Explanation of control panel buttons
Button Name Function
Light source button
Left button
informations and settings menu
Right button
Up button
Down button
OK OK button Confirms messages and/or settings
Image settings 1
left button . Press once to exit the setting and twice to close the
menu.
6
1
2
3
4
5
13
Remoteswitches 2. Open the menu by pressing any button on the control panel and select
• To exit the information and settings menu use the left button . Press once to exit the
setting and twice to close the menu.
•
function.
Shutdown 3. After the final procedure of the day select the Shutdown button on the settings
the OK button on the control panel to confirm. The system will now begin the process of
powering down. Shutdown is completed when the power button on the aBox™ Duodeno is no
longer lit.
Infobuon 4.
the OK
button to confirm and the left button to close the menu.
Standard buon 5. Press the standard button from the settings menu to return to standard
settings.
The system will display messages on the main screen monitor if an iregularity occurs. For detailed
ExplanationoftheSymbols
Symbol Name Description
Persitaltic pump Icon will be displayed when the lid of the peristaltic
pump is open
Warning Icon appears if a message is displayed and not confirmed
increased or decreased brightness
increased or decreased brightness
Image capture This icon will be displayed when a image has been
captured
Video recording
Zoom
Rinsing This icon will be displayed when the rinsing function is
6. EndingAProcedureAndShungDownTheSystem
6.1 ConcludingAPaentProcedure
refer to the IFU of the aScope™ Duodeno.
6.2 SystemShutdown
aBox™ Duodeno is no longer lit.
7
8
14
EN
7. FuseReplacement
Always use the fuses recommended by Ambu. To order new fuses please contact your sales
replacement.
Turn the aBox™ Duodeno OFF and disconnect the power cable from the walls mains outlet.
•
• Pull the fuse box straight out.
• Replace both fuses.
•
8. PeristalcPumpReplacement
closed.
•
side of the pump housing.
•
•
•
9. CleaningOfTheaBox™DuodenoExternalSurfaces
1 3 42
1 2 43
9
15
Procedure-SUPER-SANI-CLOTH®fromPDIorequivalent
10. TechnicalData
system.
10.1 aBox™DuodenoSpecicaons
Power Supply Voltage AC 120V / 230V
Frequency
91 VA
5mm x 20mm
Dimensions
Weight
IP21
10.2 StorageAndOperaonEnvironmentSpecicaons
Storage temperature 10°C - 25°C
10°C - 40°C
Atmospheric pressure
10.3 Accessories
-
-
10.4 ListOfAccessories-Examinaon
Accessory Part of the System
Rinsing water
with a punch-through hole
No
water
Yes
16
EN
Accessory Part of the System
Waste Canister
used
No
11. EnvironmentalProtecon
12. Troubleshoong
The following table shows the possible causes of and countermeasures against troubles that may
aBox™ Duodeno. Troubles or failures
other than those listed in the following table need repair. As repair performed by persons who are
to
contact Ambu for repair.
Possible Cause
The power fails to come on
The power switch and/or the
Duodeno is set to OFF.
Set the power switch to ON.
The power cord is not
connected.
Connect the power cord with
an electrical source as descri-
The aBox™ Duodeno or
ancillary equipment is not
switched ON.
Switch aBox™ Duodeno and
ancillary equipment on.
not properly connected or
defect.
Connect the medical grade
monitor properly.
aScope™ Duodeno not/
not properly connected or
defect.
Connect the aScope™
Duodeno correctly or connect
a new aScope™ Duodeno.
aBox™ Duodeno does not
boot up
aBox™ Duodeno not
powered ON
Power the aBox™ Duodeno
ON.
not properly connected or
defect
Shutdown aBox™ Duodeno
and connect the medical
grade monitor properly.
Try to power ON the aBox™
Power fails to come on
Power cable not connected Connect the power cable
Fuse blown Replace fuse. Please refer to
17
Possible Cause
aBox™ Duodeno will not
shut down
connected
Please unplug the aScope™
Duodeno from the aBox™
Duodeno and press the power
down the system.
too short
least 3 sec.
aBox™ Duodeno defect Switch the aBox™ Duodeno
aBox™ Duodeno and contact
support.
Rinsing not possible
-
aBox™ Duodeno not
powered ON
Power the aBox™ Duodeno
ON.
water was connected.
aScope™ Duodeno is not
connected
Connect the aScope™
Duodeno
The endoscopic image is
-
the aBox™ Duodeno are
The medical grade monitor
Set a proper brightness as de-
scribed in the medical grade
power mode
sterile water if necessary or
the aScope™ Duodeno IFU.
The endoscopic image is too
bright
the aBox™ Duodeno are
Set a proper brightness or
contrast as described in the
18
EN
Possible Cause
The color tone of the endo-
scopic image is unusual
The medical grade monitor
The monitor cable is con-
nected incorrectly
Connect the monitor cable
properly as described in
The medical grade monitor
cable is defect
Connect a new power cable to
the medical grade monitor.
The endoscopic image
The image cannot be stored
connected
StandardMessagesDuringSet-upAndProcedure
Possible Cause
of sterile water.
Standard request before
sterile water was connected.
is open.
is open.
pump.
Increased temperature of
the distal end
pump
wait.
an image drop-out was
detected.
an image on the monitor.
If nothing happens contact
ErrorMessages
Possible Cause
aScope™ Duodeno defect Please connect a new aScope™
Duodeno.
set on increased intensity
Reduce the intensity of the
electrosurgical instrument
low.
Framer grabber not
detected
the controller board and the
aBox™ Duodeno
-
roller board.
Remote switches and rinsing
endoscope due to a defect
endoscope.
aScope™ Duodeno for conclu-
ding the procedure.
error.
19
12.1 ReturningTheaBox™DuodenoToAmbu
-
competent authority.
12.2 ComplianceAndLicensing
12.3 ElectromagnecCompability
GeneralInformaon
The manufacturer can only guarantee compliance of the equipment if the accessory parts listed in
the following pages of all tables.
Table 1 Recommended safety distances
Table1RecommendedSafetyDistance
and the aScope™ Duodeno
-
-
[W]
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
11.2 1.2 2.3
10 3.7 3.7 7.4
100 12 12 23
20
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