AAM APA Video Laryngoscope User manual

APA
™
Video Laryngoscope
en INSTRUCTIONS FOR USE
ar
da BRUGSANVISNING
de BEDIENUNGSANLEITUNG
es INSTRUCCIONES DE USO
fi KÄYTTÖOHJE
fr MODE D’EMPLOI
it ISTRUZIONI PER L’USO
ja 使用説明書
ko 사용설명서
nl GEBRUIKSAANWIJZING
no BRUKSANVISNING
pl INSTRUKCJA UŻYCIA
pt INSTRUÇÕES DE UTILIZAÇÃO
sv BRUKSANVISNING
tr KULLANMA TALİMATI
zh 使用说明
Venner Medical (Singapore) Pte Ltd
35 Joo Koon Circle, Singapore 629110
www.vennermedical.com
Advena Ltd
Tower Business Centre, 2nd Flr.,
Tower Street, Swatar, BKR 4013 Malta
www.advenamedical.com

Contents
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1. Device description 5
1.1 APA™Video Viewer 6
1.2 APA™Handle and MAC or MIL Camera Module 7
1.3 Technical specifications 8
2. Operating instructions 9
2.1 Inspection 9
2.2 Cleaning 9
2.3 Batteries 9
2.4 Assembling the device 10
2.5 Fitting a new blade 11
2.6 Using the device 12
2.6.1 MAC (Macintosh) Blade 12
2.6.2 DAB (Difficult Airway Blade) or
U-DAB (Unchannelled Difficult Airway Blade) 13
2.6.3 MIL (Miller) Blade 14
2.6.4 OXY (Oxygenation) Blade 15
2.6.5 APA™Stylet 16
2.7 Removing the blade after use 16
3. Battery and charging information 17
3.1 Charging instructions for the Video Viewer 17
3.2 Video Viewer LED light indicators 18
3.3 Battery replacement in the Handle 19
4. Decontamination 20
4.1 Preparation 20
4.2 Cleaning 20
4.3 Disinfection 21
4.4 Sterilisation 21
4.4.1 Low temperature 21
4.4.2 Steam sterilisation 21
4.5 APA IP Shield™VL and DL 22
5. Service and maintenance 22
5.1 General maintenance 22
5.2 Preventive maintenance 22
6. Troubleshooting 22
6.1 As a video laryngoscope 23
6.2 As a laryngoscope 23
7. Warnings and precautions 24
8. Warranty 24
9. Symbols used on the labelling 25

1
+
_
MACCameraModule
MACCameraModule
MAC Camera Module
MIL Camera Module (S)
MIL Camera Module (L)
MAC 3 Blade
MAC 4 Blade
DAB
U-DAB
MIL 2 Blade
Handle Video Viewer MIL 1 Blade
AA battery
O2 MAC 3 Blade
O2 MAC 4 Blade
O2 DAB
O2 U-DAB
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These instructions for use are for the following APA™products:
Product code Description Quantity / box
701000 APA™Video Viewer 1
701006 APA™Handle 1
700930 APA™MAC Camera Module 1
702910 APA™MIL Camera Module (S) 1
702930 APA™MIL Camera Module (L) 1
702110 APA™MIL 1 Blade (clean, non-sterile) 10
702120 APA™MIL 2 Blade (clean, non-sterile) 10
700130 APA™MAC 3 Blade (clean, non-sterile) 10
700140 APA™MAC 4 Blade (clean, non-sterile) 10
700170 APA™DAB (clean, non-sterile) 10
700180 APA™U-DAB (clean, non-sterile) 10
700330 APA™O2MAC 3 Blade (clean, non-sterile) 5
700340 APA™O2MAC 4 Blade (clean, non-sterile) 5
700370 APA™O2DAB (clean, non-sterile) 5
700380 APA™O2U-DAB (clean, non-sterile) 5
Only APA™Blades are to be used with the APA™Video Laryngoscope.
1. Device description
The APA™Video Laryngoscope (Figure 1) is a multi-functional device designed to
assist direct and indirect laryngoscopy in routine and difficult airway intubations.
It may be used to facilitate endotracheal intubation as part of general anaesthesia
orCPR (cardiopulmonary resuscitation) during cardiac arrest. It is suitable for use
in pre-hospital, hospital and extended care facilities.
The video laryngoscope is reusable, DEHP-free and latex-free. It is fully detachable into
three components: APA™Video Viewer, APA™Handle and APA™MAC or MIL Camera
Module. When used as a standard laryngoscope, the appropriate Camera Module is
attached to the Handle to obtain a view of the laryngeal inlet during endotracheal
intubation. When used as a video laryngoscope, the Video Viewer is attached to the
Handle and Camera Module to provide improved visualisation during laryngoscopy
and endotracheal intubation. An appropriate blade is attached to the Camera Module
in both scenarios to restrain and position the tongue to allow a clear view of the
larynx and entrance to the trachea, including the delivery of continuous oxygenation
when required. Ten types of single use blades are available to be used with the video
laryngoscope. They are anti-fog coated, DEHP-free and latex-free.
CAUTION: Intubation with the device should be performed by trained medical personnel.
Figure 1: APA™Video Laryngoscope and its disposable blade types

(+) button
(-) button
LED light indicator
1.1
TEST button
Video output
Connector
1.2
Single replaceable
AA 1.5V battery
APA
TM
Handle
APA
TM
MAC Camera Module
High intensity light source
Miniature camera
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The APA™Video Viewer (Figure 1.1) is a lightweight, high-resolution 86mm (3.5”) LCD
colour display. Its connector allows attachment to the Handle and Camera Module and
when connected, switches on automatically to provide a real-time image of the procedure
being undertaken. The display can be rotated up to 90 degrees depending onuser
requirements. It has an ambient light sensor which adjusts the display’s backlight
automatically for optimal viewing and power saving.
The Video Viewer has a built-in rechargeable battery which should be charged using
the APA™Video Viewer Charger. The LED light indicator on the Video Viewer displays
the battery and/or charge status. When used as a video laryngoscope, the Video
Viewer supplies power to the whole device. A fully charged Video Viewer provides up
to2.5 hours of intermittent use.
The Video Viewer function buttons:
A TEST button allows the user to test that the battery is operating correctly without
being connected to any device.
A (+) and a (-) button which supports maintenance at the authorised service centre,
if required.
The Video Viewer also has a NTSC video output MMCX jack which displays real-time
images when connected to a suitable monitor or screen via the APA™Video Cable.
To record video the video cable may be connected to a suitable recording device.
The Video Viewer cannot be autoclaved and must be cleaned and disinfected between
first use and each patient use, refer to Section 4.
The Handle incorporates and is powered by a single replaceable alkaline or lithium
AA1.5V battery and the Camera Module incorporates a high intensity light source and
a miniature camera. When used as a standard laryngoscope, the light source provides
high intensity white LED illumination for a clear and direct view of the larynx during
endotracheal intubation. An alkaline AA 1.5V battery will power the laryngoscope for a
continuous use of minimum 48 hours. (Note: Exact time is dependent on the quality of
battery used).
When used as a video laryngoscope, the miniature camera in the Camera Module
projects a high quality image via the Video Viewer’s high resolution display for an
indirect view of the larynx during endotracheal intubation. When used as a video
laryngoscope, the power is supplied from the rechargeable battery within the
Video Viewer.
The Camera Module clips into the Handle, rotates and locks into 3 positions: ‘OFF,
‘BLADE REMOVAL’ and ‘ON’. To switch on the light source/Video Viewer, rotate the
Camera Module into the ‘ON’ position. To switch off the device rotate the Camera
Module into the ‘OFF’ position.
Both the Handle and Camera Module cannot be autoclaved and must be cleaned and
disinfected between first use and each patient use, refer to Section 4.
1.1 APA™Video Viewer 1.2 APA™Handle and APA™MAC or MIL Camera Module
Figure 1.1: APA™Video Viewer
Figure 1.2: APA™Handle and APA™MAC Camera Module

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Video Viewer
Display 3.5” LCD (320 x 240 pixels)
Weight 135g
Power consumption 8W
Battery type 3.7V lithium polymer
Battery output 5V DC
Mains power supply to
Charger 100V to 240V
Ingress protection IP33
Handle
Size 35 mm x 130 mm
Weight 200g (incl. battery)
Power 1 x alkaline or lithium AA 1.5V battery
Material Medical grade thermoplastic
Ingress protection IP52
Camera Modules MAC MIL (S) MIL (L)
Size 35 mm x 110 mm 35 mm x 83 mm 35 mm x 136 mm
Weight 98g 70g 90g
Power Supplied from Handle
Camera 1/18” CMOS sensor with integrated lens
Light source High intensity LED
Material Stainless steel
Ingress protection IP52
Blades
Material Polycarbonate
Coating Anti-fog coated
Type Clean, non-sterile for single use
Check all areas of the video laryngoscope before first use and between each patient
use. In the event of signs of damage or defects, refer to Section 5.1, do not use and
inform the local distributor.
The video laryngoscope is supplied in a non-sterile, reusable state. It will be
necessary to clean it before use, refer to Section 4.
Check the battery of the laryngoscope: Before using the device as a standard
laryngoscope, ensure that the Camera Module illuminates when the device locks
in the ‘ON’ position.
CAUTION: The AA 1.5V battery MUST be changed regularly. Inadequate battery
level may cause the laryngoscope to fail suddenly without warning.
Check the battery of the Video Viewer: If using the device as a video laryngoscope,
ensure that the Video Viewer has adequate charge prior to use. Without connecting
to the laryngoscope, press the TEST button for at least 5 seconds to illuminate the
display and check that the LED light indicator glows a steady GREEN. This indicates
that the Video Viewer has sufficient charge and is operating correctly. If the LED
light indicator is flashing, proceed to charge the device with the Video Viewer
Charger, refer to Section 3.1.
CAUTION: If the LED light indicator on the Video Viewer is flashing then there is
NOT sufficient battery to use the device safely.
1.3 Technical specifications 2. Operating instructions
2.1 Inspection
2.2 Cleaning
2.3 Batteries

Click!
OFF ONBLADE REMOVAL
2
2.1
3
3.13.23.3
Concave point
Convex point
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To use the device as a laryngoscope, align the notch on the Camera Module with the
steel pin on the Handle and attach them together (Figure 2). An audible “click” may
be heard when the Camera Module is fitted correctly. Ensure that the Camera Module
rotates smoothly and locks in the ‘OFF’, ‘BLADE REMOVAL’ and ‘ON’ positions (Figure2.1).
Check that the laryngoscope powers up in the ‘ON’ position. A bright light should
appear at the tip of the Camera Module. To preserve battery, store in the ‘OFF’ position.
CAUTION: Do not look directly into the light source of the Camera Module.
Figure 2: Assembling the laryngoscope Figure 2.1: Lock positions
To use the device as a video laryngoscope, first rotate the connector of the Video
Viewer outwards (Figure 3). With the Handle in one hand, fold back the connector cap
on its flexible spine from the top of the Handle (Figure 3.1). With the other hand,hold the
Video Viewer firmly and ensure that the convex point on the Video Viewer matches
the concave point on the Handle (Figure 3.2). The fold back connector cap should
be aligned with the backside of the Video Viewer. Proceed to slot the Video Viewer
connector into the Handle connector recess, firmly pressing downwards into place,
until the limit of travel is reached (Figure 3.3). To confirm correct attachment rotate
the Camera Module into the ‘ON’ position, the Video Viewer screen should then turn
on. If using as a video laryngoscope, the Video Viewer should be attached to the
laryngoscope before using on a patient.
CAUTION: If an image cannot be seen on the Video Viewer, check that it is correctly
attached to the Handle.
Avoid applying any pressure on the Video Viewer screen while attaching the devices.
Take care not to dislodge the connection between the devices at any time.
Figure 3: Rotate the connector outwards
Figure 3.1: Fold back the connector cap
Figure 3.2: Ensure correct direction by matching the convex and concave points
Figure 3.3: Attach devices together
To fit a new blade the Camera Module needs to lock in the ‘ON’ position. Open the
blade packaging pouch and without fully removing the blade from the packaging,
slide it onto the Camera Module (Figure 3.4). An audible “click” may be heard when
the blade is fitted correctly (In the case of the Miller, matching an identical colour
code between the blade and Camera Module suggests a correct pairing). Proceed
to remove the blade packaging completely without touching the blade.
CAUTION: Do not use the blade if the packaging has been opened or damaged.
Take note to pair the same style of blade and Camera Module, and check that the
blade is correctly fitted to the Camera Module prior to using on a patient.
2.4 Assembling the device
2.5 Fitting a new blade

3.4
MAC Camera Module
with MAC 3 Blade
MIL Camera Module (L)
with MIL 2 Blade
3.5a 3.5b 3.5c
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Figure 3.4: Attach the correct blade style to the appropriate Camera Module
The device has been tested for transport, storage and usage at temperatures between
+4°C to +40°C.
As the normal mode of operation, it is recommended that the video laryngoscope
should not be left on for an extended time after use. Where possible the device should
be turned off to maximise battery life and avoid the possibility of heat build-up.
CAUTION: When used as a video laryngoscope, DO NOT hold the Handle close to the
connection of the Video Viewer to avoid applying a force unintentionally which may
cause the device to disconnect without warning.
The laryngoscope with the MAC Blade attached is used to assist routine endotracheal
intubation in a similar manner to a standard Macintosh laryngoscope. Attach the Video
Viewer if desired, for indirect visualisation of the glottis.
Introduce the device into the right side of the mouth (Figure 3.5a). As the blade
advances, it is directed towards the midline displacing the tongue to the left
(Figure 3.5b). The blade tip is positioned in the vallecula (Figure 3.5c) and the epiglottis
is elevated by lifting the Handle of the laryngoscope, exposing the laryngeal inlet.
Withdirect visualisation of the laryngeal inlet a correctly sized ETT (EndoTracheal
Tube) can be introduced into the trachea. Ensure that the ETT is adequately lubricated
prior to use. An introducer/stylet may be used to assist the introduction. Correct
placement of the ETT should be both visual and by the use of capnography.
CAUTION: Avoid putting pressure on the patient’s teeth during laryngoscopy.
2.6 Using the device
2.6.1 MAC (Macintosh) Blade
Figure 3.5: Introducing the device with MAC Blade
Both the DAB and U-DAB Blades are used with the video laryngoscope to assist
endotracheal intubations for difficult airways.
Introduce the device using a midline approach into the mouth (Figure 3.6a and b).
The blade tip can be positioned posterior to the epiglottis in a similar manner to a
Miller (straight) blade OR above the epiglottis in the vallecula, in a similar manner to
a Macintosh (curved) blade (Figure 3.6c).
Once a view of the laryngeal inlet is obtained through the screen, advance a correctly
sized ETT into the trachea. Ensure that the ETT is adequately lubricated prior to use.
If using the DAB, advance the ETT through the channel on the blade. The channel can
accommodate up to a size 9.0mm (I.D) or 12.8mm (O.D) ETT.
2.6.2 DAB (Difficult Airway Blade) or
U-DAB (Unchannelled Difficult Airway Blade)

3.6a 3.6b 3.6c
3.7a 3.7b 3.7c
3.8
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Figure 3.6: Introducing the device with DAB or U-DAB
Do not use an introducer or stylet with the DAB however, you may use an introducer
or stylet with the U-DAB. An indirect view of the ETT passage into the glottis can be
observed on the screen. Correct placement of the ETT should be both visual and by the
use of capnography. When using the DAB, the video laryngoscope can be removed by
sliding the DAB laterally during removal from the mouth to release the ETT.
The laryngoscope with a MIL Blade attached is used to assist routine endotracheal
intubation in a similar manner to a standard Miller laryngoscope. Attach the Video
Viewer if desired, for indirect visualisation of the glottis.
Introduce the device into the right side of the mouth (Figure 3.7a). As the blade
advances, it is directed towards the midline displacing the tongue to the left
(Figure 3.7b). The blade tip is positioned posterior to the epiglottis (Figure 3.7c) and
elevated by lifting the Handle of the laryngoscope, exposing the laryngeal inlet.
With direct visualisation of the laryngeal inlet a correctly sized ETT (EndoTracheal
Tube) can be introduced into the trachea. Ensure that the ETT is adequately lubricated
prior to use. An introducer/stylet may be used to assist the introduction. Correct
placement of the ETT should be both visual and by the use of capnography.
Figure 3.7: Introducing the device with MIL Blade
Figure 3.8: Connecting the Oxy Blade
APA Oxy Blade™range consist of a 4 metre long oxygen tubing and is used to assist
routine (MAC) and difficult airway (DAB and U-DAB) endotracheal intubations whenever
small amounts of supplemental oxygen are required, in a similar manner to a standard
MAC or difficult airway laryngoscope.
To use, attach the oxygen tubing on the blade to an oxygen supply at the required flow rate
(Figure 3.8). A flow rate of 15L/min is recommended for optimal oxygenation. Please refer
to the respective blade sections for insertion instructions based on the style of blade used.
In some cases, blade reflections may be visible under bright lighting. This does not
affect the blades’ usability and should be reduced during placement (in dark spaces).
2.6.3 MIL (Miller) Blade
2.6.4 OXY (Oxygenation) Blade
CAUTION: Ensure that all connections are secure and air flow is patent.

BLADE REMOVAL position
3.9a 3.9b 3.9c
3.9d 3.9e 3.9f
Charger
Australia/China
International plug adapters
UK Europe/
South America
North America/
Japan/China
4a 4b
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Figure 3.9: Blade removal sequence
The blade is removed by turning the device upside down (Figure 3.9a), press the thumb
firmly against the exposed heel of the Camera Module to avoid accidental detachment
during blade removal (Figure 3.9b). Rotate and lock the Camera Module into the ‘BLADE
REMOVAL’ position (Figure 3.9c). Using the thumb and index finger of the free hand pinch
the ridged grip zones on the open end of the blade and squeeze firmly together (Figure
3.9d). Whilst the grip is squeezed a force away from the Handle should be applied to clear
the locking catch on the Camera Module (Figure 3.9e). Theblade will slide off the Camera
Module (Figure 3.9f) without making contact with the contaminated tip of the blade. It
should then be disposed ofin accordance with standard departmental practices.
The Video Viewer should be charged when the LED light indicator is flashing, indicating
that there is insufficient charge to use the device correctly and safely. The Video Viewer is
supplied with a charger and 4 international plug adapters (Figure 4a). The charging time
for a completely uncharged battery is approximately 2 hours. It is safe to leave the Video
Viewer fitted with the charger indefinitely if desired.
To begin charging, attach the appropriate plug adapter to the charger (Figure 4b) and
connect to the mains power supply. Once connected, align the convex point of the Video
Viewer connector with the concave point of the Video Viewer Charger connector to confirm
correct charging direction (Figure 4c). Attachment is made easy by the magnetic pins in
the connector of the Video Viewer and Video Viewer Charger (Figure 4d).
CAUTION: Care should be taken during charging operations and limit personnel contact
with any electrical sources.
Figure 4a: Video Viewer Charger and international plug adapters
Figure 4b: Attach the appropriate plug to the charger
2.7 Removing the blade after use
3. Battery and charging information
3.1 Charging instructions for the Video Viewer
CAUTION: The blade is designed with a fail-safe feature and can only be removed when
the Camera Module is in the BLADE REMOVAL position.
The APA™Stylet is designed to work with the APA™U-DAB by providing an angled shape to
facilitate ETT placements during laryngoscopy. It can be used with ETT up to size 9.0mm
(I.D) or 12.8mm (O.D).
Railroad the stylet through the appropriate ETT, and after obtaining a view of the laryngeal
inlet, advance the ETT into the trachea. The APA™stylet is reusable, and should be
cleaned and disinfected before first use and between each patient use similar to the video
laryngoscope, refer to Section 4.
CAUTION: Do not allow the stylet to protrude beyond the end of the ETT during intubation.
2.6.5 APA™Stylet

4c
4d
Convex pointConcave point
4.1a
4.1d 4.1e 4.1f
4.1b 4.1c
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Figure 4c: Ensure correct charging direction by matching the convex and concave points
Figure 4d: Attaching the Video Viewer to its charger
When charging, the LED light indicator on the Video Viewer illuminates to display
the charge status as follows:
RED Battery is charging.
RED up to 2 hours
later
RED LED should switch off, indicating that the battery is now
fully charged and the Video Viewer may be removed for use.
During normal use, the LED light indicator on the Video Viewer illuminates to
display the battery status as follows:
GREEN ON and the Video Viewer is operating correctly.
GREEN steady
flashing
ON but battery has low charge. Proceed to charge the Video
Viewer prior to use.
No light OFF or the battery is exhausted. Proceed to charge the Video
Viewer prior to use.
The GREEN light indicator only ever operates if the video laryngoscope is switched
ON or if the TEST button on the Video Viewer is pressed. It cannot be controlled by
the Video Viewer Charger.
The TEST button should not be used while the Video Viewer is connected to the
charger as the GREEN light indicator may give an incorrect charge indication in
this situation.
CAUTION: Before any procedure, the Video Viewer must be checked to ensure that it
is operating correctly and the battery level is sufficient. If the LED light indicator starts
to flash during a procedure it means that there is limited battery. The procedure
may continue at the clinician’s discretion.
The Camera Module is supplied with an alkaline AA 1.5V battery. When used as a
standard laryngoscope, the Camera Module illuminates when the device locks in the
‘ON’position. The battery should be replaced regularly with an alkaline or lithium
AA1.5V battery to prevent the laryngoscope from failing suddenly without warning.
To replace the single AA 1.5V battery in the Handle, first remove its front cover which is
the side furthest away from the notch (Figure 4.1a). Slide the cover in the direction away
from the connector cap (Figure 4.1b). An audible “click” may be heard as the cover
disengages from its locked position (Figure 4.1c). Lift the cover away from the Handle
to reveal the inner battery cover (Figure 4.1d). Remove the inner battery cover and the
attached battery ribbon will allow the fitted battery (if one is present) to be removed
and replaced (Figure 4.1e). Ensure that the ribbon is placed beneath the new battery
and check that the polarity of the battery cell is aligned correctly to the markings on
the Handle (Figure 4.1f). Once this is done, replace the battery cover and slide the
cover back onto the Handle. If the laryngoscope is to be stored, e.g. not to be used
forsome time, the battery should be removed.
Figure 4.1: Battery replacement in the Handle
3.2 Video Viewer LED light indicators
3.3 Battery replacement in the Handle

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The video laryngoscope must be cleaned and disinfected before first use and between
each patient use, in accordance with local cleaning regime for non-autoclavable,
non-metallic devices. The ingress protection marking for the Video Viewer is IP33
andthe laryngoscope IP52.
All blades are single use, they should be disposed of in accordance with standard
departmental practices after use.
Dissemble all components (Video Viewer, Handle and Camera Module) of the video
laryngoscope. Ensure that the AA battery is removed from the Handle prior to cleaning.
Do not immerse. The video laryngoscope is not waterproof.
Do not autoclave. Electronic components will be damaged by autoclaving conditions.
Do not wipe with a rough cloth, particularly on the Video Viewer screen.
Do not allow excess moisture to enter the connection pins or pool around
the Video Viewer screen and function buttons.
Thorough cleaning and rinsing are important for removing all visible residuals,
micro-organisms and pyrogens from the device.
Each component should be wiped for no less than 2 minutes or as per hospital’s
standard cleaning regime for non-autoclavable, non-metallic devices. Dab a sterile pad
with a suitable solution and wipe all exposed surfaces of the components. Allow the
components to air dry.
If the components are to be sent for reprocessing, place them into a closed bag for
transportation to the sterile processing unit for sterilisation.
CAUTION: Only the Handle and Camera Modules may be sent for reprocessing.
Prepare or dilute a suitable disinfectant in accordance with the manufacturer’s
instructions. Visit the U.S. Environmental Protection Agency (EPA) website for a list of
registered disinfectants.
Spray or wipe the components with a suitable disinfectant (i.e. 70% Isopropyl Alcohol)
and wipe over with a soft, non-abrasive cloth to dry.
Visit www.AAMHealthcare.com/IFU for a list of recommended cleaners and disinfectants
for the video laryngoscope.
CAUTION: Failure to properly clean and dry the device may result in retention of
potentially hazardous residues which can pose serious infection risks.
Clean devices prior to sterilisation, refer to Section 4.2.
4. Decontamination
4.1 Preparation
4.4 Sterilisation
4.2 Cleaning
4.3 Disinfection
The Handle and Camera Modules, excluding the Video Viewer, are approved for the
following STERIS®low temperature sterilisers up to 100 cycles:
V-PRO®1
V-PRO®1 Plus
V-PRO®maX
V-PRO®60
The APA™Stylet is approved for the STERIS®SYSTEM 1E Liquid Chemical Sterilant
Processing System.
The APA™Stylet is approved for steam (autoclave) sterilisation at 121°C (250°F) for 30
minutes.
Visit www.AAMHealthcare.com/IFU for guidelines on sterilising the components.
CAUTION: Do not sterilise the Video Viewer.
Failure to use approved guidelines may void the product’s warranty.
Should damage or corrosion occur during sterilisation, discard the product.
4.4.1 Low temperature
4.4.2 Steam sterilisation

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The following, is a list of possible problems and recommended solutions.
If the problem persists, contact the local distributor.
Problem description Possible cause Action needed
Poor image quality
(Image is not clear or dark)
Dust or fluid trapped in
connector
Check cleanliness of the
connectors
Video Viewer is not
connected correctly with the
laryngoscope
Check for firm connection
between the devices
Illumination failure Refer to Section 3
Contamination, fluid or
lubricant on lens
Clean lens, refer to Section 4
No image
(i) Screen turns off shortly
after connection
(ii) when devices are
connected
(i) Video Viewer’s battery has
no charge
Charge the Video Viewer, refer
to Section 3.1
(ii) Video Viewer is not
connected correctly with the
laryngoscope
Check that the Video Viewer is
inserted in the right direction
and firmly connected with the
Handle, refer to Section 2.4
Electronic circuitry fault Return Video Viewer for
servicing, refer to Section 5
Unable to turn on device
even after long charging
time
Video Viewer’s battery has
exceeded usable life
Return Video Viewer for
servicing, refer to Section 5
Electronic circuitry fault Return Video Viewer for
servicing, refer to Section 5
Video Viewer’s battery is not
recharged after 2 hours
Video Viewer is not connected
to its charger or the power
supply
Check the connection to the
charger and/or the power
supply
Video Viewer is not inserted
properly
Check for firm connection
between the devices
If the Camera Module does not illuminate, check that the battery is inserted in the
correct orientation or replace the battery with a new alkaline or lithium AA 1.5V battery.
If the illumination still does not work, contact the local distributor for servicing,
refer to Section 5.
5. Service and maintenance
6. Troubleshooting
6.1 As a video laryngoscope
6.2 As a laryngoscope
The video laryngoscope should be inspected at regular intervals for:
Visible signs of external damage
Scratches or defects on the Camera Module lens
Build-up of material on connection pin area of the Handle and Camera Module
Any other faults will require diagnosis by an authorised service centre, contact
your local distributor or www.AAMHealthcare.com for technical support.
5.1 General maintenance
The Video Viewer is recommended to be serviced every 2 years for a battery replacement.
When returning the Video Viewer for servicing, pack the Video Viewer in its original
product box or wrap the device carefully for protection. The device should be sent to the
authorised service centre as advised by the local distributor.
5.1 Preventive maintenance
In clinical situations where the risk of contamination and infection increases, use the
APA IP Shield™, a disposable cover designed for the video laryngoscope, to further protect
the device from these exposures.
Use the APA IP Shield™VL if using the device as a video laryngoscope and
APA IP Shield™DL if using the device as a standard laryngoscope. Be sure to apply
standard medical institution practices for using personal protective equipment during
use. After use, the APA IP Shield™should be disposed in accordance with standard
departmental practices for handling contaminated items. Proceed to clean the
APA™Video Laryngoscope as per cleaning instructions, refer to Section 4.
CAUTION: Always ensure that a used APA IP Shield™is safely disposed prior to removing
any personal protective equipment for the prevention of possible self-contamination.
4.5 APA IP Shield™VL and DL

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7.1 To avoid the theoretical risk of pressure trauma to the posterior pharyngeal
wall, the combined weight of the video laryngoscope should be supported
through the Handle. Take care not to allow the weight of the Video Viewer
to displace the other components.
7.2 The video laryngoscope is unsuitable for use in intense magnetic fields,
e.g. magnetic resonance imaging (MRI). Do not keep or use close to sensitive
electronic equipment.
7.3 Do not reuse single use devices, this may cause cross-infection, reduce
product reliability and functionality.
AAM Healthcare warrants the hardware products to be free from defects in material
and workmanship under normal use and service. AAM Healthcare’s obligation
under this warranty is limited to correcting the defect in the product or any part
thereof which is defective in material or workmanship during the warranty period.
Replacement shall be determined by AAM Healthcare wherein such supplies fail to
meet applicable specifications and were purchased directly from AAM Healthcare
or an AAM Healthcare authorised party, for use with APA™products, and provided
the Buyer or Customer has complied with the handling, storage and shelf life
requirements as specified by AAM Healthcare. Any attempts to modify or open
up the device will void its warranty automatically. AAM Healthcare shall have no
responsibility whatsoever for consumable supplies purchased from any other source.
THE ABOVE WARRANTIES ARE EXCLUSIVE OF, AND IN LIEU OF, ALL OTHER
WARRANTIES, WRITTEN OR ORAL, EXPRESS OR IMPLIED, STATUTORY OR
OTHERWISE. NO IMPLIED STATUTORY WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE SHALL APPLY. AAM HEALTHCARE SHALL
NOT BE LIABLE FOR ANY DAMAGES SUSTAINED BY BUYER ARISING FROM DELAY
IN THE REPLACEMENT OR REPAIR OF PRODUCTS UNDER THE ABOVE WARRANTY.
Terms and conditions may change without prior notice. Different charges may apply
for APA™product after the 1 year warranty period unless otherwise specified.
The following symbols appear on the device and packaging materials.
Consult Instructions for Use (IFU): www.AAMHealthcare.com/IFU
Do not re-use (APA™blades and IP Shield)
Non-sterile
Caution: Federal (USA) law restricts this device to sale by or on the
order of a physician. (APA Oxy Blade™and Stylet)
Not made with natural rubber latex
Does not contain phthalates
Type B: Provides a basic degree of protection against electric shock
as specified in the standard IEC60601-1. The applied part typically
has direct earth connection.
Direct current
Protection of equipment against ingress of solid foreign objects
≥2.5mm diameter. Protection against access to hazardous parts
with a tool, thick wire, etc. Protection against water falling as a spray
at any angle up to 60° from the vertical shall have no harmful effect.
Protection of equipment against ingress of dust is not entirely
prevented, but it must not enter in sufficient quantity to interfere
with the satisfactory operation of the equipment; complete protection
against contact. Protection against vertically falling water drops
when equipment is tilted up to 15°.
7. WARNINGS AND PRECAUTIONS 9. Symbols used on labelling
8. Warranty

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WEEE wheeled bin. This product contains electrical and electronic
components that may contain materials which, if disposed with
general waste, could be damaging to the environment. Residents
of the European Union must follow specific disposal or recycling
instructions for this product. Residents outside the European Union
must dispose or recycle this product in accordance with local laws
orregulations that apply.
Device should be stored and used between +4ºC and +40ºC
Keep dry
Keep away from sunlight
Date of manufacture
Legal manufacturer (EU) and Manufactured for (US)
Authorised representative in the European Community
European Conformity mark: Class 1 medical devices
in 93/42/EEC Directive
Serial number
Batch code

AAM Healthcare Inc
www.AAMHealthcare.com
Copyright© 2019 AAM Healthcare. All rights reserved. AAM Healthcare, APA and
Venner are trademarks of the Venner Group of Companies. This product is
covered by patents and patent applications of the Venner Group of Companies in
the US and other territories. Visit www.AAMHealthcare.com/intellectual-property 2266 - H January 2019
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