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
1

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
2

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

Doc no: PT00098114 Revision A Aircraft Medical Ltd © 2019 www.medtronic.com/mac-first
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
5

Doc no: PT00098114 Revision A Aircraft Medical Ltd © 2019 www.medtronic.com/mac-first
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%
6

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).
7

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
8