Ambu aBox 2 Operating and safety instructions

For use by qualified biomedical technicians only.
Ambu®aBox™2
SPARE PART
REPLACEMENT
MANUAL

Ambu is a registered trademark and aScope and aBox are trademarks of Ambu A/S.
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Content Page
1. Important Information ...........................................................................................................4
1.1. Qualification Requirements for Personnel Performing Spare Part Replacement.............4
1.2. Warnings and Cautions ............................................................................................................................4
1.3. Data Security.................................................................................................................................................5
1.4. System Description.....................................................................................................................................6
1.5. Spare Parts......................................................................................................................................................7
1.6. Spare Part Replacement Process...........................................................................................................8
2. How To Clean and Disinfect the Displaying Unit................................................................9
3. Preparing for Spare Part Replacement..............................................................................10
3.1. Tools Needed ............................................................................................................................................. 10
4. How to Replace Spare Parts ................................................................................................11
4.1. Visualization Device Interface Board Replacement.....................................................................11
5. Final Inspection and Test.....................................................................................................15
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1. Important Information
This is a Spare Part Replacement Manual for Ambu® aBox™ 2. It is applicable to aBox 2 with
item number 505001000 only.
The following terms are used in this Spare Part Replacement Manual:
•“Displaying unit” refers to Ambu® aBox™ 2.
•“Visualization device” refers to compatible Ambu endoscopes and other compatible
visualization devices that can be connected to and used with the displaying unit.
This manual may be updated without further notice. Contact your local Ambu representative
or download the most recent version from ambu.com found om the download section on the
product page.
Please observe that the warranty will be void, if parts of the displaying unit has been changed
within the warranty period without the written consent from Ambu.
1.1. Qualification Requirements for Personnel Performing Spare Part
Replacement
Do not start replacing any spare part of the displaying unit, unless you have read
through this document and are qualified in the following areas:
•Knowledge, experience and acquaintance with electronic repair and safety testing
according to IEC 60601-1
(Medical electrical equipment, Part 1: General requirements for basic safety and essential
performance) and
IEC 62353 (Medical electrical equipment – Recurrent test and test after repair of medical
equipment).
•Knowledge of and experience with local regulations.
•Having read the Instruction for Use for the displaying unit (find the Instruction for Use in
the sales package or download the current version from ambu.com).
•Knowledge of the environment where the displaying unit is installed and used.
•
1.2. Warnings and Cautions
WARNINGS
•To avoid risk of electric shock, always disconnect the power cable from the
displaying unit before performing spare part replacement.
•To avoid contamination, always clean and disinfect the displaying unit before and
after spare part replacement and wear gloves during handling.
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CAUTIONS
• To avoid harming the electrical components, always use ESD protection when
disassembling, replacing a spare part, and reassembling the displaying unit.
• To ensure the displaying unit functions optimally and to avoid compromising
electrical safety, always perform the tests specified in section 5 after it has been
reassembled. If any part of the tests fails after spare part replacement, do not use the
displaying unit.
• To avoid malfunction of the equipment, only use spare parts supplied by Ambu. Do
not modify the spare parts.
• Cleaning and disinfection wipes shall be moist, but not dripping to ensure no
damage to internal electronics of the displaying unit.
• If using wipes containing hypochlorite or citric acid for cleaning, ensure that all
residue is completely removed. Wipes containing hypochlorite or citric acid may
affect the screen's antireflective coatings over time. You should limit the use of wipes
containing hypochlorite or citric acid to required cases only.
1.3. Data Security
To avoid possible loss of data, it is recommended to export important files before performing
any spare part replacement (please refer to the Instruction for Use).
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1.4. System Description
The displaying unit is intended to display live imaging data from Ambu visualization devices.
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4
Wi-Fi
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Figure 1 System illustration
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No. Part Function
1Touch Screen Displays the image from the Ambu visualization
device and the graphical user interface.
2
VDI port (connector port for
specific Ambu visualization
devices)
Connector port geometry and colour ensures
correct connection with compatible visualization
devices.
3USB 3.0 port (front) Enables connection of external USB flash drives.
4USB cover Protects the front USB port.
5Power button Turns the power ON or switches to STAND-BY mode.
6Base Contains the main unit.
7Power cable Connects the displaying unit to a power outlet.
8Wi-Fi antenna Connect Wi-Fi antenna to the displaying unit for
improved Wi-Fi signal.
9Positioning arm
Enables manual positioning of the touch screen.
The screen can be adjusted horizontally and
vertically as well as rotated.
10 Video output ports (2 x DVI-D)
Enable connection to external monitor or external
medical imaging recorder.
11 Video output ports (2 x
3G-SDI)
12 Wi-Fi antenna connector Enables connection of Wi-Fi antenna.
13 USB 3.0 ports Enable connection of external USB flash drives.
14 LAN port Enables connection to ethernet.
15 USB 2.0 ports Enable connection of external USB flash drives.
16 Trigger output ports (2 x 3.5
mm jack) Enable connection to an external medical imaging
recorder to transfer trigger signals.
17 Trigger output ports (2 x
D-SUB9)
18 Power inlet Enables connection to power cable.
19 Connector for potential
equalization cable
Used for bonding of electrical products to eliminate
potential differences between conductive parts.
1.5. Spare Parts
The spare parts may not be available in all countries. Please contact your local Ambu
representative.
CAUTIONS
• To avoid malfunction of the equipment, only use spare parts supplied by Ambu. Do
not modify the spare parts.
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Spare Part Description Item numbers
Thickness: 4 pt
Ambu® aBox™ 2 -Visualization
device interface kit - Grey-Empty-
Green
Contains:
One grey and one green visualization
device interface board (VDI), a front
cover with a colour ring (grey and
green), a plectrum tool, and two
screws for the VDI.
505000530
Power cables - J (CH), K (DK), I (AUS/NZ)
Power cable - B (US, JP)
Power cables - G (UK), E/F (EU, not DK,
CH)
505000520
505000521
505000522
1.6. Spare Part Replacement Process
This section specifies a spare part replacement process which is in compliance with IEC 62353.
Read these Instructions for Use carefully before performing any replacements on the Ambu®
aBox™ 2.
The technician and personnel being responsible for the replacement process should fulfil the
requirements outlined in section 1.1.
Follow the process in Figure 2 to replace spare parts in the displaying unit.
Use the Trouble
Shooting guide in
the IFU
Contact Ambu, if
you need further
assistance
Order and receive
relevant parts to be
replaced.
Chapter 2:
Clean and disinfect
the displaying unit
Chapter 4:
Replace the
relevant part(s) of
the displaying unit
Chapter 5:
Inspect the
displaying unit
Chapter 2:
Clean and disinfect
the displaying unit
Follow the standard operating procedures
required by your organization
Figure 2 Spare part replacement flow
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2. How To Clean and Disinfect the Displaying Unit
CAUTIONS
• Cleaning and disinfection wipes shall be moist, but not dripping to ensure no
damage to internal electronics of the displaying unit.
• If using wipes containing hypochlorite or citric acid, ensure that all residue is
completely removed. Wipes containing hypochlorite or citric acid may affect the
screen's antireflective coatings over time. You should limit the use of wipes
containing hypochlorite or citric acid to required cases only.
The displaying unit is a reusable medical device. According to the Spaulding classification, the
displaying unit is a non-critical device.
The displaying unit should be cleaned and disinfected before and after repair and replacement
procedures following one of the procedures below.
Any deviation from the instructions should be properly evaluated for effectiveness and
potential adverse consequences by the person responsible for cleaning and disinfection, to
ensure that the device continues to fulfil its intended purpose. Cleaning procedures should
begin as soon as possible following use. Excessive soil should be removed on accessible areas
of the device, excluding electrical ports.
Limitations: The displaying unit is not compatible with ultrasonic or automatic cleaners and
should not be immersed.
Procedure 1 - Cleaning and disinfection with hypochlorite
Hypochlorite-based wipes approved for disinfection of medical devices, e.g., Sani-Cloth®
Bleach from PDI, should be used in accordance with the wipe manufacturer’s instructions.
Cleaning: Use a wipe to remove heavy soil. All blood and other body fluids must be
thoroughly cleaned from surfaces and objects. Inspect the displaying unit for cleanliness,
function and integrity before disinfection by germicidal wipe. If visible soil remains,
reclean the displaying unit.
Disinfecting:
1. For heavily soiled surfaces, use a wipe to pre-clean the displaying unit prior to
disinfecting.
2. Unfold a clean wipe and thoroughly wet the surface of the displaying unit.
3. The treated surfaces must remain visibly wet for a full four (4) minutes (or the time
recommended by the manufacturer of the disinfectant, at least 4 minutes). Use
additional wipes if needed to assure continuous 4 minutes wet contact time.
4. Let the displaying unit air dry.
Procedure 2 - Cleaning and disinfection with quaternary ammonium compounds
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Wipes containing a mixture of quaternary ammonium compounds and isopropyl alcohol
approved for disinfection of medical devices, e.g., Super Sani-Cloth® from PDI, should be
used in accordance with the wipe manufacturer’s instructions.
Cleaning: Use a wipe to remove heavy soil. All blood and other body fluids must be
thoroughly cleaned from surfaces and objects. Inspect the displaying unit for cleanliness,
function, and integrity before disinfection by germicidal wipe. If visible soil remains,
reclean the displaying unit.
Disinfecting:
1. For heavily soiled surfaces, use a wipe to pre-clean the displaying unit prior to
disinfecting.
2. Unfold a clean wipe and thoroughly wet the surface of the displaying unit.
3. The treated surfaces must remain visibly wet for a full two (2) minutes (or the time
recommended by the manufacturer of the disinfectant, at least 2 minutes). Use
additional wipes if needed to assure continuous 2 minutes wet contact time.
4. Let the displaying unit air dry.
Procedure 3 – Enzymatic detergent cleaning and alcohol disinfection
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, external side of rubber covers, screen, external casing
of the monitor with the moist gauze. Avoid getting the displaying unit wet to
prevent damaging internal electronic components.
4. Wait for 10 minutes (or the time recommended by the manufacturer of the
detergent) to allow the enzymes to activate.
5. Wipe the displaying unit clean using sterile gauze that has been moistened with RO/
DI water. Ensure all traces of the detergent are removed.
6. Repeat steps 1 to 5.
Disinfecting: Wipe the surfaces of the displaying unit for approximately 15 minutes using
a piece of sterile gauze moistened with the alcohol mixture indicated below
(approximately once every 2 minutes). Follow safety procedures for the handling of
isopropyl. The gauze should be moist and not dripping since liquid can affect the
electronics inside the displaying unit. Pay close attention to the button, external side of
rubber covers, screen, external casing and slots and gaps on the displaying unit. Use a
sterile cotton swab for these areas. Solution: Isopropyl (alcohol) 95%; Concentration:
70-80%; Preparation: 80cc of 95% Isopropyl (alcohol) added to 20cc of purified water
(PURW). Alternatively, use EPA-registered hospital disinfection wipes containing at least
70% isopropyl. Safety precautions and directions of use of the manufacturer must be
followed.
NOTE: After cleaning and disinfection, the displaying unit must be submitted to the pre-check
procedure in chapter 5.
3. Preparing for Spare Part Replacement
3.1. Tools Needed
• Plectrum tool
• Screwdriver (Phillips #0) – Not supplied
• Compatible (and functioning) Visualization Device – Not supplied
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The plectrum tool is provided with the spare parts kits (see section 1.5 Spare Parts).
Thickness: 2 pt
Figure 3 Plectrum tool
4. How to Replace Spare Parts
This section covers the replacement of the Visualization Device Interface board (VDI board).
WARNINGS
• To avoid risk of electric shock, always disconnect the power cable from the
displaying unit before performing spare part replacement.
CAUTIONS
• To avoid harming the electrical components, always use ESD protection when
disassembling, replacing a spare part, and reassembling the displaying unit.
• To avoid malfunction of the equipment, only use spare parts supplied by Ambu. Do
not modify the spare parts.
4.1. Visualization Device Interface Board Replacement
Ambu® aBox™ 2 Visualization Device
Interface Kit - Grey-Empty-Green 505000530
Grey Visualization Device Interface board
(VDI board)
Green Visualization Device Interface board
(VDI board)
Front cover, incl. colour ring (grey) and USB
cover
Thickness: 2 pt
Screws for VDI board (x2)
Thickness: 2 pt
Plectrum tool
Thickness: 2 pt
Additional Tools (not supplied)
Screwdriver (Phillips #0)
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IMPORTANT:
Ensure all cables and equipment are disconnected from the displaying unit before
initiating the replacement procedure!
The pictures are for illustration purposes. The number, color and position of front
connectors may differ. Please make sure to install the exchanged parts at the original
positions.
a) Detach the front cover from the displaying unit
Locate the groove on one of the sides of the front cover where a snap feature is located
on the inside. Press inwards with the plectrum tool and a finger to detach the front cover
from one side.
NOTE: Be careful not to press on the top or bottom of the displaying unit, as it will
complicate removal of the front cover
b) Completely remove the front cover by pulling it carefully from the displaying unit
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c) Remove the 2 screws holding each VDI board using a Phillips screwdriver
d) Pull out the VDI boards from the displaying unit and dispose them according to
local guidelines for disposal of electronic waste
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e) Carefully insert the new VDI boards into their original positions
Ensure that the VDI boards are oriented correctly as shown on the picture below.
NOTE: Insert the VDI boards straight and horizontally into the original main board
connector positions to ensure correct connection of the VDI board to the displaying unit.
f) Carefully fasten the VDI boards with the supplied screws using the Phillips
screwdriver into their original positions
g) Attach the new front cover supplied with the replacement kit
Start by attaching from one end. Ensure that the snap features on each end is placed
inside the housing of the displaying unit. The front cover is pressed in place until all top
and bottom snap features click in place.
NOTE: Ensure that the colour rings are fitted correctly in the front cover and that colours
and arrows on the front cover and the displaying unit match.
NOTE: Ensure the USB cover flap is inserted underneath the USB port.
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5. Final Inspection and Test
CAUTIONS
• To ensure the displaying unit functions optimally and to avoid compromising
electrical safety, always perform the tests specified in section 5 after it has been
reassembled. If any part of the tests fails after spare part replacement, do not use the
displaying unit.
Perform the following inspections and tests after assembly prior to use:
a) Examine displaying unit for visual damage
Closely examine the displaying unit and other parts for any damage I. Do not use the
displaying unit if it is damaged in any way.
b) Visual inspection with a functioning scope
Connect the displaying unit to a suitable power outlet via the power cable II . Connect
a functioning visualization device to the displaying unit by plugging it into the
visualization device connector (VDC) port III . Ensure that the connector colours are
matching, and the arrows are aligned. Turn on the displaying unit on the power button.
Verify that a live video image appears on the screen by pointing the distal end of the
Ambu visualization device towards an object, e.g. the palm of your hand, when the Live
View tab is selected in the toolbar to the left IV .
I II
III IV
For other relevant testing of the displaying unit, refer to the requirements of IEC 62353 or other
relevant safety tests according to local guidelines.
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495407500 - V02 - 2022/04
Ambu A/S
Baltorpbakken 13
2750 Ballerup
Denmark
T [phone]
ambu.com