Ambu aBox-2-V2 Displaying and Processing Unit Instruction Manual

: June 12, 2024
: Ambu

Table of Contents

Important Information
How To Clean and Disinfect the Displaying Unit
Preparing for Spare Part Replacement
How to Replace Spare Parts
Final Inspection and Test
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

Ambu aBox-2-V2 Displaying and Processing Unit Instruction Manual

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.

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.

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.

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.

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)

System Description
The displaying unit is intended to display live imaging data from Ambu visualization devices.

No.	Part	Function
1	Touch Screen	Displays the image from the Ambu visualization device and the

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.

Spare Part	Description	Item numbers
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

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.
Spare Part Replacement Process

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

For heavily soiled surfaces, use a wipe to pre-clean the displaying unit prior to disinfecting.
Unfold a clean wipe and thoroughly wet the surface of the displaying unit.
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.
Let the displaying unit air dry.

Procedure 2 – Cleaning and disinfection with quaternary ammonium compounds

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:

For heavily soiled surfaces, use a wipe to pre-clean the displaying unit prior to disinfecting.
Unfold a clean wipe and thoroughly wet the surface of the displaying unit.
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.
Let the displaying unit air dry

Procedure 3 – Enzymatic detergent cleaning and alcohol disinfection

Cleaning:

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).
Soak a sterile gauze in the enzymatic solution and make sure that the gauze is moist and not dripping.
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.
Wait for 10 minutes (or the time recommended by the manufacturer of the detergent) to allow the enzymes to activate.
Wipe the displaying unit clean using sterile gauze that has been moistened with RO/ DI water. Ensure all traces of the detergent are removed.
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

Preparing for Spare Part Replacement

Tools Needed

Plectrum tool
Screwdriver (Phillips #0) – Not supplied
Compatible (and functioning) Visualization Device – Not supplied

The plectrum tool is provided with the spare parts kits (see section 1.5 Spare Parts).

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.

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|
Screws for VDI board (x2)|
**** Plectrum tool| ****

Additional Tools (not supplied)
Screwdriver (Phillips #0)

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
$Additional Tools $not supplied$$

b) Completely remove the front cover by pulling it carefully from the displaying unit
$Additional Tools $not supplied$$

c) Remove the 2 screws holding each VDI board using a Phillips screwdriver
$Additional Tools $not supplied$$

d) Pull out the VDI boards from the displaying unit and dispose them according to \local guidelines for disposal of electronic waste
$Additional Tools $not supplied$$

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.
$Additional Tools $not supplied$$

f) Carefully fasten the VDI boards with the supplied screws using the Phillips screwdriver into their original positions
$Additional Tools $not supplied$$

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.
$Additional Tools $not supplied$$

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.\
Final Inspection and Test

For other relevant testing of the displaying unit, refer to the requirements of IEC 62353 or other relevant safety tests according to local guidelines.

Ambu A/S
Baltorpbakken 13 2750 Ballerup Denmark
T +45 72 25 20 00
ambu.com