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
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_
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
orCPR (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 onuser
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
to2.5 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
AA1.5V 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 (Figure2.1).
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.
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.
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). Theblade will slide off the Camera
Module (Figure 3.9f) without making contact with the contaminated tip of the blade. It
should then be disposed ofin 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
AA1.5V 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
forsome 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