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. ImportantInformaon–PleaseReadBeforeUse! 4
  4
  4
  4
  4
  4
2. SystemDescripon 8
2.1 System Parts 8
  9
  9
3. ExplanaonOfSymbolsUsed 10
3.1 Symbols 10
4. Ancillary Equipment And Accessories 11
  11
5. PreparaonAndInspeconForUse 12
  12
  12
  12
  13
6. EndingAProcedureAndShungDownTheSystem 14
  14
6.2 System Shutdown 14
7. FuseReplacement 15
8. PeristalcPumpReplacement 15
9. CleaningOfTheaBox™DuodenoExternalSurfaces 15
10. TechnicalData 16
  16
  16
10.3 Accessories 16
  16
11. EnvironmentalProtecon 17
12. Troubleshoong 17
12.1 Returning The aBox™ Duodeno To Ambu 20
12.2 Compliance And Licensing 20
  20
13. Contact 23
Appendix1. ConneconConguraonsDescripons 24
Appendix2. WPF-Mediakit 25
3

1. ImportantInformaon–PleaseReadBeforeUse!

   
         



    
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 IntendedUse/IndicaonForUse
                                                                             

for endoscopy and endoscopic surgery within the duodenum.
Note: 


1.2 TargetUserGroupsAndUserQualicaons
             
                                                                                       
         



The physician should be capable of safely performing the planned endoscopy and endoscopic


procedures.
1.3 Contraindicaons
                                                                                     

1.4 InstallaonAndMaintenance
             

maintenance.
1.5 WarningsAndCauons
                                                                                          
equipment. The manufacturer          

4

EN
Warnings


PreparaonforUse
• 

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.
• 

            



•            


InspeconoftheaBox™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

ConnecontotheACMainsPowerSupply
• 
• 
-


• 

•                                                                            



system center and ancillary equipment is not guaranteed. Troubles caused in this case
            

OperaonoftheaBox™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.
• 

FuseReplacement
• 

• 

• 

result.
•                
    
6

EN
• 
              

Care and Storage
• 

•            
 

PotenalofFire
• 



Installaon,RepairandMaintenance
• 
                
           

Cauons


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. SystemDescripon
2.1 SystemParts

Duodeno is shipped with one power cable that supplies the power necessary to run the aBox™

Ambu® aBox™ Duodeno
ReusableDevice
Partnumber
OK
485001000US
BoleHolder
8

EN
PowerCable
POAGCable

2.2 CompableDevice(ApplicaonPart)
Ambu® aScope™ Duodeno
Sterileandsingle-usedevice
Partnumber Distal End
Outer
Diameter ø
Working
Channel
Inner
Diameter ø
482001000 41.2 Fr

12.6 Fr

 

2.3 aBox™DuodenoDescriponAndFuncon


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. ExplanaonOfSymbolsUsed
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


RxOnly 
IP 21 Ingress protection 
Serial Number

number and year of

Reference Number
Ground connection 
10