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Video Laryngoscope Operator's Manual
Video Laryngoscope Operator's Manual
Video Laryngoscope
TM
Operator’s Manual
( Instructions for use )
300-000-000
TM
Manufacturer’s Declaration
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The McGRATH™ MAC video laryngoscope (the device) has been tested to product specific standard IEC 60601-1-2:2014
[Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard:
Electromagnetic disturbances - Requirements and tests].
In addition, specific requirements of standard IEC 60601-2-18:2009 [Medical electrical equipment - Part 2-18: Particular
requirements for the basic safety and essential performance of endoscopic equipment] have been applied that relate to IEC
60601-1-2:2014.
The following tables contain the corresponding manufacturer’s declaration for the electromagnetic emissions and
electromagnetic immunity of the device.
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Contents TM
1 Introduction 5
1.1 Description 5
1.2 Accessories 6
1.3 Intended Use/Purpose 6
1.4 Indications 6
1.5 Contrainidications 6
1.6 Warnings 6
1.7 Cautions 7
1.8 Adverse Events 7
1.9 Specifications 7
1.10 Environment 8
2 Functional 9
2.1 Unpacking and Inspection 9
2.2 Operation 10
2.3 Battery 10
2.4 Disposable Laryngoscope Blade Fitting 11
2.5 Using the Laryngoscope 12
3 Cleaning and Low-Level Disinfection 13
3.1 Device Cleaning 14
5 Troubleshooting 18
6 Warranty 19
7 Symbols 20
Addendum 22
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1 Introduction
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45 °
McGRATH™ MAC
video laryngoscope Monitor
1.1 Description Monitor
(device) hinge
The McGRATH™ MAC video laryngoscope LCD screen
(device) is a tool used to aid the intubation of
the trachea. As a rigid laryngoscope it holds
and shapes the anatomy allowing a clear view
of the larynx and entrance to the trachea.
The device incorporates a light source (LED) Handle
and miniature camera (camera) to view the
larynx during the procedure of laryngoscopy. Camera &
The image is displayed on an LCD screen light source
(screen) contained within a monitor mounted to
(LED) Clip Heel area
the handle of the device.
A McGRATH™ 3.6V battery (battery unit)
mounted within the handle powers the screen,
CameraStick™
camera, and LED. The McGRATH™ disposable
laryngoscope blade (blade) covers the camera
and LED assembly (CameraStick™) to prevent
direct patient contact. Blades are supplied
sterile and are single use.
McGRATH™
The device and its accessories are intended for Power button
3.6V battery
use in a professional healthcare environment
(battery)
only.
Tab
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1.2 Accessories TM
1.4 Indications
The visualization of the oropharynx and larynx for general laryngoscopy and/or to aid in the securement of airway.
1.5 Contraindications
None known.
1.6 Warnings
• Blades cannot be adequately cleaned and/or sterilized by the user in order to facilitate safe reuse, and are therefore
intended for single use. Attempts to clean or sterilize the blades may result in bio-incompatibility, infection, or
product failure risks to the patient.
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1.7 Cautions
• Do not use any other type of laryngoscope blade with this medical device.
• Do not use in the presence of flammable mixtures.
• Do not use any other type of battery with this device.
• Federal (USA) law restricts this device to sale by or on the order of a physician.
1.9 Specifications
Laryngoscope Assembly
Size 180mm x 68mm x 110mm
Weight 0.200kg
Power Proprietary 3.6V Lithium Battery
*Giving 250 minutes of use typically
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Disposable Laryngoscope
TM Blade
The device must be used only with McGRATH™ disposable laryngoscope blades
Material The blades are disposable, composed of medical grade optical polymer which
have not been made with natural rubber latex and not made with DEHP.
Blades are packaged individually in pouches that have not been made with
natural rubber latex.
Applied Part Type BF
Note: Dispose of device, battery, and blade according to local regulations.
1.10 Environment
McGRATH™ MAC Device and Battery
Operating Conditions:
• 10°C (50°F) to 40°C (104°F)
• Relative Humidity 10% to 50%
• Atmospheric Pressure 70kPa to 106kPa
• Category 2 Pollution Degree 2
McGRATH™ MAC Device and Battery
Storage & Transport Conditions:
• -10°C (14°F) to 40°C (104°F)
• Relative Humidity 10% to 90%
McGRATH™ Disposable Laryngoscope Blades
Storage & Transport Conditions:
• -10°C (14°F) to 70°C (158°F)
Note: The McGRATH™ MAC video laryngoscope and replacement batteries when purchased are supplied non-sterile prior to use.
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2 Functional
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2.2 Operation
The device turns on and off by a single push of the power
button. Always check that the LED is on, screen shows an
image, and that there is sufficient remaining power in the
battery prior to starting a clinical procedure. Power
2.3 Battery
The device must only be used with the McGRATH™ 3.6V
battery. Push the battery unit into the cavity of the handle
as illustrated. Tab
The device turns on and off by a single push of the Power
button.
The life of the battery unit is displayed on the bottom right
hand corner of the screen. This counts down from 250 as
each unit of power is consumed. When the counter reaches
4, the battery icon unit number will flash intermittently (1)
from 4 down to 0 and the screen will go blank. The LED will
remain on (2). Replace the battery unit when this happens.
When the screen is blank and you turn off the device and
on again, the battery empty flashing icon will appear on the
blank screen (3).
Remove the battery unit by pulling the tab and dispose of
under local regulations for disposal of batteries. 250 mins 4 mins 0 mins
If the device is not to be used for an extended period of time
(more than 1 month) remove the battery unit before storage.
2 3
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Multiple disposable blade types are available for use with the McGRATH™ MAC video laryngoscope. The McGRATH™ MAC range
of disposable blades are for use with routine and difficult airways. The McGRATH™ X blade™ range are for use with difficult and
extreme airways. These blades require different techniques which are explained in the Addendum section of this manual.
The Addendum comprises the following sections:
• Using the Laryngoscope - McGRATH™ MAC blade range
• Using the Laryngoscope - McGRATH™ X blade™
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McGRATH™
Supplied Sterile Supplied Sterile
Disposable
Do Not Do Not
Laryngoscope
Reprocess Reprocess
Blade
McGRATH™ MAC
with McGRATH™ 70% Isopropyl Alcohol
70% IPA Wipe
3.6V Battery (IPA) Wipe
removed
McGRATH™
70% IPA Wipe 70% IPA Wipe
3.6V Battery
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Clean with 70% IPA wipe, with McGRATH™ 3.6V battery removed:
The following process steps should be followed to clean the device: using a 70% IPA wipe, clean the device systematically
working from Steps 1 through 7 (from top to bottom of the device). Ensure that the 70% IPA wipe comes in contact with all
surfaces of the device even if no visible soiling is present. Ensure a minimum contact time of 1 minute on all surfaces when using
70% IPA wipes.
1. Monitor: Ensure the 70% IPA wipe gets into the various grooves around the screen.
2. Monitor hinge: Rotate the monitor to the upright
position. Feed the 70% IPA wipe into the space 45 °
between the monitor and handle to ensure
effective penetration. Rotate the monitor to its 1. Monitor
2. Monitor hinge
opposite position and repeat.
3. Battery bay: Ensure all surfaces of the battery bay LCD screen
(with battery removed) are thoroughly treated with
the 70% IPA wipe. Ensure that the join between
the battery module and the handle is thoroughly
treated with the 70% IPA wipe.
4. Handle: Ensure all surfaces of the handle are 3. Battery bay 4. Handle
thoroughly treated with the 70% IPA wipe.
5. Clip and heel area: Take particular care in ensuring
that the small metal clip feature is clean, in 5. Clip and
particular the internal corner between the clip and 7. Camera lens heel area
the surrounding plastic body.
6. CameraStick™: Ensure all surfaces of the camera
stick are thoroughly treated with the 70% IPA wipe. 6. CameraStick™
7. Camera lens: Clean the camera lens with the 70%
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Low-level disinfect with 70% IPA wipe, with McGRATH™ 3.6V battery removed:
Follow the same process steps as per Section 3.1 of this manual to low-level disinfect the device. Using a new 70% IPA wipe,
disinfect the device systematically working from Steps 1 through 7 as per Section 3.1 of this manual (from top to bottom of
the device). Ensure that the 70% IPA wipe comes in contact with all surfaces of the device. Ensure a minimum contact time of 1
minute on all surfaces when using 70% IPA wipes.
5. Surfaces
6. Tab
2. Contacts
4. Lower slot
5. Surfaces
Subsequent cleaning should be repeated where visible soiling is still present using a new 70% IPA wipe.
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4 Storage TM
After cleaning and low-level disinfection, the device and battery should be air dried or wiped dry with a lint free cloth. The device
has to be completely dry before use.
Cleaned and low-level disinfected devices should be packed immediately upon completion of the two minute drying phase and
should be stored in accordance with local guidelines. The device cannot be stored in its original packaging for reuse.
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5 Troubleshooting
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6 WarrantyTM
The device is supplied with a manufacturer’s warranty.
• Only products supplied by an approved Aircraft Medical agent or distributor are covered by the manufacturer’s warranty.
• To be covered by the warranty the product must be maintained in accordance with the procedures in this document.
• Before returning the device under a warranty claim, clean and low-level disinfect the device per the instructions in this
document.
For full terms of warranty, please contact your Aircraft Medical agent or distributor.
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7 SymbolsTM
Device, Battery and Blade Symbols
Prescription only device
Medical device
This side up
Package quantity
XX
Device and Battery Symbols
MR Unsafe
Battery Symbols
(Positive) terminal
Stand-by
Blade Symbols
Single sterile barrier system
Stacking limitation of 5
5
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_°F
_°C
Temperature limit
_°F
_°C
Keep dry
Fragile
Date of manufacture
Caution
_%
Humidity limitation
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Video Laryngoscope
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Addendum
Using the Laryngoscope -
McGRATH™ blade range
• Using the Laryngoscope - McGRATH™ MAC blade range
• Using the Laryngoscope - McGRATH™ X blade™
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MAC blade
USING THE
LARYNGOSCOPE -
McGRATH™ MAC blade
TM range
1 2 3
If possible, position the patient in the optimal Look into the mouth; insert the blade into the Move the device to a central position while
position for direct laryngoscopy. right side of the mouth. sweeping the tongue to the left.
4 5 6
McGRATH MAC ®
Advance the tip of the McGRATH™ MAC Visualise the epiglottis on the screen. Lift the Advance the endotracheal tube (E.T. tube)
blade into the vallecula. anatomy forwards and upwards to expose a gently and atraumatically through the vocal
direct and indirect view of the glottis. When cords. Tube placement can be performed
the device is in the optimal position the glottis either by looking directly in the mouth,
should be viewed in the central upper section indirectly on the screen or a combination of
of the screen. both(1).
Indirectly visualise the E.T. tube placement The screen view can be used to confirm the
through the vocal cords. In optimal tube correct insertion depth of the E.T. tube.
placement technique, the E.T. tube will enter
from the right side of the display.
(1) If a direct pathway for the E.T. tube was not created by sweeping the tongue or aligning the airway axes, a stylet or a bougie may need to be used.
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™
USING THE
LARYNGOSCOPE -
McGRATH™ X blade™
1 2 3
Load the E.T. tube onto a stylet(1) and form Where possible, elevate the patient’s head Using a mid-line approach roll the blade into
to the curvature of the X blade™. into the “sniffing” position for optimal access. the mouth. Ensuring the anterior side of the
blade maintains contact with the tongue,
advance the blade until the epiglottis is seen
on the top of the screen.
4 5 6
Place the tip of the X blade™ into the Using minimal force, rock the device back When the device is in the optimal position,
vallecula. towards the user to lift the epiglottis and obtain the glottis will be viewed in the central upper
an indirect view of the glottis. section of the screen(2).
7 8 9
The DepthGuide™ numeric markings on the Insert the E.T. tube at the right side corner When using optimal technique, the E.T. tube
posterior side of the blade may be used as an of the mouth. Advance in a rolling movement should enter the screen on the right side;
indication of the depth of blade insertion(3). following the curvature of the blade, ensuring advance the tube until the tip is in front of the
it maintains contact with the section of the vocal cords.
blade labelled E.T. CONTACT ZONE™.
10 11
Holding the stylet secure, slide the tube off The screen view can be used to confirm the
the stylet and through the cords, ensuring correct insertion depth of the E.T. tube.
the stylet does not pass through the cords.
Once the E.T. tube has passed through the
cords, remove the stylet completely.
(1) Clinical experience has shown that intubation with a stylet is required to facilitate optimal tube placement. Use of a bougie is not advised. Where
possible, position the patient's head for optimal access.
(2) It is important not to advance the blade too deeply in order to maintain maximum space to facilitate the E.T. tube placement.
(3) Reference to these numbers can be useful during training to avoid inserting the blade too far.
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Part No. PT00113650 Rev A 2020-02
Aircraft Medical Ltd.,
9-10 Saint Andrew Square,
Edinburgh,
EH2 2AF,
United Kingdom
Medtronic B.V.,
Earl Bakkenstraat 10,
6422 PJ Heerlen,
The Netherlands.
www.medtronic.com/mac-first