McGrath MAC EMS User manual

Operator’s Manual
( Instructions for use )
Doc no: PT00098114
Revision A
July 2019
Aircraft Medical Ltd © 2019 www.medtronic.com/mac-first
Video Laryngoscope

Doc no: PT00098114 Revision A Aircraft Medical Ltd © 2019 www.medtronic.com/mac-first
Manufacturer’s Declaration
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.
Table 1 - Electromagnetic Emissions
The device is intended for use in the electromagnetic environment specified below. The operator of the device should
assure that it is used in such an environment.
Emissions Test Compliance Level Notes
Conducted RF emissions CISPR 11:2009
+A1:2010
Not Applicable Test not applicable as the device is
battery powered
Radiated RF emissions CISPR 11:2009
+A1:2010
Group 1 Class B Compliant
Harmonic emissions IEC 61000-3-2:2005
+A1:2008+A2:2009
Not Applicable Test not applicable as the device is
battery powered
Voltage fluctuations/flicker
IEC 61000-3-3:2008
Not Applicable Test not applicable as the device is
battery powered
Table 2 - Electromagnetic Immunity
The device is intended for use in the electromagnetic environment specified below. The operator of the device should
assure that it is used in such an environment.
Immunity test Compliance level Notes
Electrostatic Discharge (ESD)
IEC 61000-4-2:2008
±2 kV, ±4 kV, ±6 kV and ±8 kV contact
±2 kV, ±4 kV, ±8 kV and ±15 kV air
Compliant
Radiated RF Immunity
IEC 61000-4-3:2006 +A1:2007+A2:2010
10 V/m Modulation of 80% AM @
1 kHz. Frequency 80 MHz - 2.7 GHz
Compliant
Electrical Fast Transient Bursts
IEC 61000-4-4:2012
Not Applicable Test not applicable as the device is
battery powered
Surge Immunity
IEC 61000-4-5:2014
Not Applicable Test not applicable as the device is
battery powered
Conducted RF Immunity
IEC 61000-4-6:2013
Not Applicable Test not applicable as the device is
battery powered
Magnetic Immunity
IEC 61000-4-8:2009
30 A/m Compliant
Voltage Dips
IEC 61000-4-11:2004
Not Applicable Test not applicable as the device is
battery powered
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Doc no: PT00098114 Revision A Aircraft Medical Ltd © 2019 www.medtronic.com/mac-first
Contents
1 Introduction 3
1.1 Description 3
1.2 Accessories and Part Numbers 4
1.3 Specifications 4
1.4 Regulatory 5
1.5 Environment 6
2 Functional 7
2.1 Unpacking and Inspection 7
2.2 Battery 8
2.3 Disposable Laryngoscope Blade Fitting 9
2.4 Using the Laryngoscope 10
3 Cleaning and Low Level Disinfection 11
3.1 Device Cleaning 13
3.2 Device Low Level Disinfection 14
3.3 Battery Cleaning 14
3.4 Battery Low Level Disinfection 15
4 Storage 16
5 Troubleshooting 17
6 Warranty 18
Addendum 19
• Using The Laryngoscope -McGRATH® MAC blade 20
• Using The Laryngoscope -McGRATH® X blade™ 21
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Doc no: PT00098114 Revision A Aircraft Medical Ltd © 2019 www.medtronic.com/mac-first
1 Introduction
1.1 Description
The McGRATH® MAC Video Laryngoscope
(McGRATH® MAC or the 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 need to provide a secure airway is
fundamental to an anesthesiologist’s role
prior to a surgical procedure. Paramedics,
emergency physicians and general
practitioners may also be required to
insert a tracheal tube in an emergency
to keep the airway open where an
unconscious patient is undergoing
cardio-pulmonary resuscitation. The
device and its accessories are intended
for use in a professional healthcare
environment only.
The device incorporates a light source
(LED) and miniature camera (camera) to
view the larynx during the procedure of
laryngoscopy. The image is displayed on
an LCD screen (screen) contained within
a monitor mounted to the handle of
the device.
A McGRATH® MAC 3.6V battery (battery
unit) mounted within the handle powers
the screen, camera, and LED. The
McGRATH® disposable laryngoscope
blade (blade) covers the camera and LED
assembly (CameraStick™) to prevent
direct patient contact. McGRATH® blades
are supplied sterile and are single use.
McGRATH® MAC
Video Laryngoscope
(the device)
McGRATH® MAC
3.6V Battery
(battery)
McGRATH®
disposable
laryngoscope
blade (blade)
SUPPLIED SEPARATELY
3
Handle
Blade clip
Clip
CameraStick™
45 °
Power button
Tab
Blade
Heel area
Monitor hinge Monitor
LCD screen
Camera &
light source

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1.2 Accessories and Part Numbers
UNDER NO CIRCUMSTANCES SHOULD ANY OTHER TYPE OF LARYNGOSCOPE BLADE
BE USED WITH THIS MEDICAL DEVICE
DO NOT OPEN ANY SEALED PART OF THE DEVICE UNDER ANY CIRCUMSTANCES.
TO DO SO WILL IMPAIR THE PERFORMANCE OF THE DEVICE, PATIENT SAFETY AND
VOID THE WARRANTY
NOT SUITABLE FOR USE IN THE PRESENCE OF FLAMMABLE MIXTURES
The device is supplied with a battery. Blades and additional batteries can be purchased separately from
your Aircraft Medical agent or distributor.
McGRATH® MAC EMS Video Laryngoscope 300-200-000
McGRATH® 3.6V EMS Battery 340-200-000
McGRATH® MAC 1 Disposable Laryngoscope Blades (Carton of 10) 350-082-000
McGRATH® MAC 1 Disposable Laryngoscope Blades (Carton of 50) 350-072-000
McGRATH® MAC 2 Disposable Laryngoscope Blades (Carton of 10) 350-084-000
McGRATH® MAC 2 Disposable Laryngoscope Blades (Carton of 50) 350-017-000
McGRATH® MAC 3 Disposable Laryngoscope Blades (Carton of 10) 350-086-000
McGRATH® MAC 3 Disposable Laryngoscope Blades (Carton of 50) 350-005-000
McGRATH® MAC 4 Disposable Laryngoscope Blades (Carton of 10) 350-088-000
McGRATH® MAC 4 Disposable Laryngoscope Blades (Carton of 50) 350-013-000
McGRATH® X bladeTM X3 Disposable Laryngoscope Blades (Carton of 10) X3-003-000
McGRATH® MAC EMS Quick Start Guide 300-248-000
McGRATH® MAC EMS Product Box 300-240-000
1.3 Specifications
Laryngoscope Assembly
Size 180mm x 68mm x 110mm
Weight 0.200kg
Power Proprietary 3.6V Lithium Battery
*Giving 250 minutes of use typically
Protection IPx7
Light source High intensity LED
Display 2.5” LCD colour display
Camera CMOS
Materials Durable medical grade thermoplastics with reinforced structural alloy core.
The device and packaging are latex free
* WHERE THE AMBIENT TEMPERATURE IS 20°C. BATTERY LIFE MAY VARY WHERE THE AMBIENT TEMPERATURE IS HIGHER OR LOWER 4

Doc no: PT00098114 Revision A Aircraft Medical Ltd © 2019 www.medtronic.com/mac-first
Disposable Laryngoscope Blade
The device must be used only with McGRATH® disposable laryngoscope blades
Material Medical grade optical polymer
Packaging Packaged sterile for single use only
This device and packaging are latex free
1.4 Regulatory
This product complies with ISO 7376, EN 60601-1 and EN 60601-1-2 safety standards. The
CE mark indicates that it meets the requirements of European Council Directives 93/42/EEC
and 2007/47/EC concerning medical devices.
In addition to the above compliance, sterility aspects of the McGRATH® Disposable
Laryngoscope Blade have been certified by Aircraft Medical’s notified body.
The McGRATH® Disposable Laryngoscope Blade is classified as a type BF applied part in
accordance with section 8.3 of EN60601-1.
The device is regulated in the USA under FDA Regulation Number 868.5540 and device listed under
the name McGRATH® MAC.
“McGRATH” is a registered trademark of Aircraft Medical Limited.
“Aircraft” is a registered trademark of Aircraft Medical Limited.
“CameraStick” is a trademark of Aircraft Medical Limited.
“X blade” and “X3” are trademarks of Aircraft Medical Limited.
“E.T. CONTACT ZONE” is a trademark of Aircraft Medical Limited.
“DepthGuide” is a trademark of Aircraft Medical Limited.
Only personnel trained in and licensed to perform intubation with a laryngoscope may use this device.
The user must contact their Aircraft Medical agent or distributor to arrange responsible
disposal and compliance with Waste Electrical and Electronic Equipment regulations
applicable, and any similar future environmental regulation applicable (including but not
limited to Directives 2002/95/EC and 2002/96/EC as implemented in the country of use).
CAUTION : FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE
ORDER OF A LICENSED PRACTITIONER
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1.5 Environmental
McGRATH® MAC Device and Battery
Operating Conditions:
• 10ºC to 40ºC ambient
• Relative Humidity 10% to 50%
• Atmospheric Pressure 700hPa to 1060hPa
• Category 2 Pollution Degree 2
McGRATH® MAC Device and Battery
Storage & Transport Conditions:
• -10ºC to 40ºC ambient
• Relative Humidity 10% to 90%
McGRATH® MAC Blade
Storage & Transport Conditions:
• -10ºC to 70ºC
The McGRATH® MAC Video Laryngoscope and replacement batteries when purchased are supplied non
sterile prior to use. They should be cleaned and disinfected before use.
Humidity
limitation
10%
50%
Humidity
limitation
10%
90%
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Doc no: PT00098114 Revision A Aircraft Medical Ltd © 2019 www.medtronic.com/mac-first
2 Functional
2.1 Unpacking and Inspection
Unpack the device and check for any visible signs of damage that may have occurred during shipment.
In the event of signs of damage, do not use the device and inform your Aircraft Medical agent or
distributor.
Remove the protective sheet from the monitor screen. The device and battery unit are supplied
separately in a non-sterile state. It will be necessary to clean and disinfect the device and battery
before first patient use, as instructed in Section 3 of this manual.
The laryngoscope blade is supplied in a sterile state. Ensure that handling precautions are taken in
accordance with local, national and harmonised standards. (Please note that the McGRATH® disposable
laryngoscope blades are not supplied with the device. These are packed and purchased separately).
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Doc no: PT00098114 Revision A Aircraft Medical Ltd © 2019 www.medtronic.com/mac-first
2.2 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.
The device turns on and o 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 will flash. Replace the battery unit
when this happens.
Remove the battery unit by pulling the tab and
dispose of under local regulations for disposal
of batteries.
If the device is not to be used for an extended
period of time (more than 1 month) remove the
battery unit before storage.
Flashing
Power
Tab
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Doc no: PT00098114 Revision A Aircraft Medical Ltd © 2019 www.medtronic.com/mac-first
2.3 Disposable Laryngoscope Blade Fitting
To fit the blade, open the peel pouch and slide the blade over the
CameraStick™ portion of the device. The blade is fully located when the
blade clip is firmly latched to the CameraStick™. To remove the blade
lift the clip and pull the blade o.
McGRATH® DISPOSABLE LARYNGOSCOPE BLADES ARE
SINGLE USE AND MUST BE DISPOSED OF AFTER EACH
PATIENT USE
ENSURE THAT LOCAL HANDLING PROCEDURES
ARE FOLLOWED AT ALL TIMES WHILE HANDLING
DISINFECTED DEVICES
McGRATH® DISPOSABLE LARYNGOSCOPE BLADES
MUST ONLY BE USED WITH A McGRATH® MAC
VIDEO LARYNGOSCOPE. CHECK THAT THE BLADE IS
CORRECTLY FITTED TO THE CAMERASTICK™
BEFORE USE
PRESS THE BLADE CLIP TO ENSURE THAT THE BLADE
IS SECURELY ENGAGED. IF THE BLADE CLIP DOES NOT
SECURELY ENGAGE ONTO THE CAMERASTICKTM
DO NOT ATTEMPT TO USE THE BLADE
DO NOT ATTEMPT TO USE ANY OTHER LARYNGOSCOPE
BLADES WITH THE DEVICE
IF THERE IS ANY EVIDENCE THAT THE BLADE
PACKAGING HAS BEEN BREACHED, DO NOT USE
THE BLADE
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Press
Clip

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2.4 Using the Laryngoscope
Multiple disposable blade types are available for use with the McGRATH® MAC Video Laryngoscopes.
The McGRATH® MAC range of disposable blades are for use with routine and dicult airways. The
McGRATH® X blade™ range are for use with dicult and extreme airways. These blades require
dierent 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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3 Cleaning and Low Level Disinfection
The device and battery should be cleaned and low level disinfected separately after each patient use.
Cleaning and low level disinfection should be carried out as per section 3.1, 3.2, 3.3, and 3.4 of the
manual in accordance with local regulations. Follow hospital policy and protocol when handling and
cleaning soiled items.
The instructions provided have been validated by Aircraft Medical as being capable of preparing the
device for re-use. It remains the responsibility of the processor to ensure that the reprocessing as
actually performed using equipment, materials and personnel in the reprocessing facility achieves the
desired result. This normally requires validation and routine monitoring of the process.
The following methods have been approved by Aircraft Medical:
PRODUCT CLEANING LOW LEVEL
DISINFECTION
McGRATH®
Disposable
Laryngoscope Blade
Supplied Sterile
Do Not
Reprocess
Supplied Sterile
Do Not
Reprocess
McGRATH® MAC
with McGRATH®
3.6V Battery removed
70% IPA* Wipe 70% IPA Wipe
McGRATH®
3.6V Battery 70% IPA Wipe 70% IPA Wipe
*IPA = Isopropyl Alcohol

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ENSURE THE DEVICE IS COMPLETELY DRY BEFORE USING
DO NOT AUTOCLAVE THE DEVICE
DO NOT REPROCESS THIS DEVICE IN AN ULTRASONIC CLEANER
When cleaning and low level disinfecting the McGRATH® MAC with the battery unit removed, low level
disinfection claims will only apply to exposed surfaces of the McGRATH® MAC and McGRATH® 3.6V
Battery.
Dispose of 70% IPA wipes in accordance with local regulations and hospital policy.
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Doc no: PT00098114 Revision A Aircraft Medical Ltd © 2019 www.medtronic.com/mac-first
3.1 Device Cleaning
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 between the
monitor and handle to ensure eective
penetration. Rotate the monitor to its
opposite position and repeat.
3. Battery Bay: Ensure all surfaces of
the Battery Bay (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 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 particular the
internal corner between the clip and the
surrounding plastic body.
6. Camera Stick: Ensure all surfaces of
the camera stick are thoroughly treated
with the 70% IPA wipe.
7. Camera Lens: Clean the camera lens
with the 70% IPA wipe, ensure that the
interface between the metal Camera
Stick and camera lens is clean.
Subsequent cleaning should be repeated where visible soiling is still present using a new 70% IPA wipe.
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4. Handle3. Battery Bay
6. CameraStick™
45 °
5. Clip and
Heel area
2. Monitor hinge 1. Monitor
LCD screen
7. Camera &
light source

Doc no: PT00098114 Revision A Aircraft Medical Ltd © 2019 www.medtronic.com/mac-first
3.2 Device Low Level Disinfection
Disinfect with 70% IPA Wipe, With McGRATH® 3.6V Battery Removed
Follow the same process steps as per cleaning, to low level disinfect the device. Using a new 70% IPA
wipe, disinfect the device systematically working from Steps 1 through 7 as per cleaning instruction
(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.
3.3 Battery Cleaning
Clean with 70% IPA Wipe - McGRATH® 3.6V Battery
The following process steps should be followed to clean the battery. Using a 70% IPA wipe, clean the
device systematically working from Steps 1 through 6 (from top to bottom of the battery cover). 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. Button Slots: Ensure the 70% IPA wipe
gets into the two button slots at the
back of the battery push button.
2. Contacts: Ensure the 70% IPA wipe
gets into the space around and under
the two metal battery contacts.
3. Clips: Run the 70% IPA wipe along
and into the gaps around the battery
retaining clips
4. Lower Slot: Ensure the 70% IPA wipe
gets into the lower slot at the base of
the battery.
5. Surfaces: Wipe all surfaces of the
battery cover with the 70% IPA wipe
6. Tab: Run the 70% IPA wipe along all
surfaces of the Tab.
Subsequent cleaning should be repeated where visible soiling is still present using a new 70% IPA wipe.
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1. Button slots
2. Contacts
5. Surfaces
6. Tab
5. Surfaces
3. Clips
2. Contacts
4. Lower Slots

Doc no: PT00098114 Revision A Aircraft Medical Ltd © 2019 www.medtronic.com/mac-first
3.4 Battery Low Level Disinfection
Disinfect with 70% IPA Wipe - McGRATH® 3.6V Battery
Follow the same process steps as per cleaning, to low level disinfect the battery.
Using a new 70% IPA wipe, disinfect the device systematically working from Steps 1 through 6 as per
cleaning instruction (from top to bottom of the device).
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4 Storage
Post cleaning and decontamination, the device and battery should be air dried or wiped dry with a lint
free cloth.
Decontaminated devices should be packaged immediately upon completion of the 2 minute drying
phase and should be stored in accordance with local guidelines.
The McGRATH® MAC Video Laryngoscope and replacement batteries when purchased are supplied non
sterile prior to use. They should be cleaned and disinfected before use.
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5 Troubleshooting
IF ANY COMPONENTS BECOME LOOSE, PHYSICALLY DAMAGED OR FIT POORLY,
UNDER NO CIRCUMSTANCES USE THE EQUIPMENT. INSTEAD RETURN IT TO YOUR
AIRCRAFT MEDICAL AGENT OR DISTRIBUTOR FOR REPAIR OR REPLACEMENT.
No image shown on screen
If, when switched on, there is no display on the screen
• Replace battery unit.
Poor picture quality
If the image displayed on the screen is blurred or fuzzy
• Replace the blade
• Remove the blade and check that the image is clear. If necessary wipe the camera at the end
of the CameraStick™ with a lint free wipe.
If none of the above achieves positive results, return the unit to your Aircraft Medical agent or
distributor for diagnostics and repair.
No parts of the device are to be serviced or maintained while in use with the patient.
Ensure that before each use, the outer surface of the blade should be checked to ensure there are no
unintended rough surfaces, sharp edges or protrusions which may cause harm.
During use with MAC blade, if the camera system loses function and the LED remains functioning, the
device can still be used as a direct view Laryngoscope. During use with the MAC blade, a failure of the
LED requires the removal of the Video Laryngoscope and an alternative device to be used. During use
with the X-Blade, any failure of the camera system or LED requires the removal of the Video
Laryngoscope and an alternative device to be used.
Device switches o unexpectantly
If, when switched on, the device switches o without warning
• Press on/o button to switch the device back on
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6 Warranty
The McGRATH® MAC 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 documented in the Operator’s Manual.
• Devices returned under the warranty claim should be decontaminated per the Cleaning and
Low Level Disinfection method defined in section 3 before transportation.
For full terms of warranty, please contact your Aircraft Medical agent or distributor.
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