Aircraft Medical McGRATH MAC EMS User manual

Video Laryngoscope
Operator’s Manual
( Instructions for use )
Doc no: 100-160-000
Revision 1.1
8th January 2013
Aircraft Medical Ltd © 2012 www.aircraftmedical.com

Doc no: 100-160-000 Revision 1.1 Aircraft Medical Ltd © 2013 www.aircraftmedical.com
Contents
1 Introduction 2
1.1 Description 2
1.2 Accessories and Part Numbers 3
1.3 Specifications 3
1.4 Regulatory 4
1.5 Environment 4
2 Functional 5
2.1 Unpacking and Inspection 5
2.2 Battery 6
2.3 Blade Fitting 7
2.4 Using the Laryngoscope 8
3 Maintenance and Decontamination 9
3.1 Decontamination 9
3.2 Cleaning 10
3.3 Rapid Disinfection 12
3.4 High Level Disinfection 13
3.5 Sterilization 14
4 Storage and Transportation 15
5 Troubleshooting 16
6 Warranty 17
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Doc no: 100-160-000 Revision 1.1 Aircraft Medical Ltd © 2013 www.aircraftmedical.com
1 Introduction
1.1 Description
The McGRATH® MAC EMS Video
Laryngoscope (McGRATH® MAC EMS
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 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® 3.6V EMS battery (battery)
mounted within the handle powers the
screen, camera, and LED. The McGRATH®
MAC disposable laryngoscope blade
(blade) range covers the camera and LED
assembly (CameraStick™) to prevent
direct patient contact. The McGRATH®
MAC blades are supplied sterile and
are single use.
McGRATH® MAC EMS
video laryngoscope
(the device)
McGRATH®
3.6V EMS Battery
(battery)
McGRATH® MAC
disposable
laryngoscope
blade (blade)
SUPPLIED SEPARATELY
2
Handle
Blade clip
Clip
CameraStick™
45 °
Power button
Tab
Blade
Heel area
Monitor hinge Monitor
LCD screen
Camera &
light source

Doc no: 100-160-000 Revision 1.1 Aircraft Medical Ltd © 2013 www.aircraftmedical.com
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 AND PATIENT SAFETY
AND VOID WARRANTY
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 2 Disposable Laryngoscope Blades (Carton of 50) 350-017-000
McGRATH® MAC 3 Disposable Laryngoscope Blades (Carton of 50) 350-005-000
McGRATH® MAC 4 Disposable Laryngoscope Blades (Carton of 50) 350-013-000
McGRATH® MAC EMS Quick Start Guide 300-248-000
McGRATH® MAC EMS Instructions for Use (CD) 300-249-000
McGRATH® MAC EMS Product Box including Instructions for Use (CD) and Quick Start Guide 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
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
Disposable Laryngoscope Blade
The device can be used only with McGRATH® MAC disposable laryngoscope blades
Material Medical grade optical polymer
Packaging Packaged sterile for single use only
This device and packaging are latex free
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Doc no: 100-160-000 Revision 1.1 Aircraft Medical Ltd © 2013 www.aircraftmedical.com
1.4 Regulatory
This product complies with 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.
The McGRATH® MAC Disposable Laryngoscope Blades are classified as type BF applied parts
in accordance with section 8.3 of EN60601-1:2006
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).
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.
Only personnel trained in and licensed to perform intubation with a laryngoscope may use this device.
CAUTION : FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE
ORDER OF A LICENSED PRACTITIONER
1.5 Environmental
Operating Conditions:
 • 10ºCto40ºCambient 
 • RelativeHumidity10%to50%
 • AtmosphericPressure700hPato1060hPa
 • Category2PollutionDegree2
Storage & Transport Conditions:
 • -10ºCto+70ºCambient
 • RelativeHumidity10%to90%
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Doc no: 100-160-000 Revision 1.1 Aircraft Medical Ltd © 2013 www.aircraftmedical.com
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.
Both the device and battery unit are supplied in a non-sterile state. It will be necessary to
decontaminate the device before use on a patient. Refer to 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® MAC
disposable laryngoscope blades are not supplied with the device. These are packed and purchased
separately).
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Doc no: 100-160-000 Revision 1.1 Aircraft Medical Ltd © 2013 www.aircraftmedical.com
2.2 Battery
The device will only accept the McGRATH®
3.6V EMS 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 5, 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: 100-160-000 Revision 1.1 Aircraft Medical Ltd © 2013 www.aircraftmedical.com
2.3 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® MAC 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® MAC BLADES MUST ONLY BE USED WITH McGRATH® MAC VIDEO
LARYNGOSCOPES. CHECK THAT THE BLADE IS CORRECTLY FITTED TO THE
CAMERASTICK™ BEFORE USING ON A PATIENT
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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If possible, position the patient in the optimal position for direct
laryngoscopy. Look into the mouth; insert the blade into the right side of
the mouth, moving the device to a central position while sweeping the
tongue to the left.
Advance the blade into the vallecula.
Visualize the epiglottis on the screen. Lift the anatomy forwards and
upwards to expose a direct and indirect view of the glottis.
When the device is in the optimal position the glottis should be viewed
in the central upper section of the screen.
Advance the tube gently and atraumatically through the vocal cords.
Tube placement can be performed either by looking directly in the
mouth, indirectly on the screen or a combination of both.
If a direct pathway for the tube was not created by sweeping the
tongue or aligning the airway axes a stylet or a bougie may need to
be used.
Indirectly visualize the tube placement through the vocal cords.
The screen view can be used to confirm the correct insertion depth of
the endotracheal tube.
2.4 Using the Laryngoscope
8
McGRATH MAC®
McGRATH MAC®
McGRATHMAC ®

Doc no: 100-160-000 Revision 1.1 Aircraft Medical Ltd © 2013 www.aircraftmedical.com
3 Maintenance and Decontamination
3.1 Decontamination
The device should be decontaminated immediately after each patient use. Decontamination
should be carried out in accordance with local regulations. Follow hospital policy and protocol when
handling and cleaning soiled items.
The following methods of decontamination were developed using standard equipment and practices
common to global healthcare facilities and according to regulatory requirements using the guidance
given in AAMI TIR 12 (Designing, Testing, Labelling Reusable Medical Devices for Reprocessing in Health
Care Facilities: A Guide for Device Manufacturers) and ISO 17664:2004 (Sterilization of medical devices
Information to be provided by the manufacturer for the processing of resterilizable medical devices).
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 achieve the
desired result. This normally requires validation and routine monitoring of the process.
Thorough cleaning and rinsing are vital for the decontamination of the device. The purpose of
cleaning and rinsing is to remove soiling and to reduce the number of microbiological agents.
Thorough rinsing is important for removing any residual cleaning agents from the medical device.
The following methods have been approved by Aircraft Medical:
PRODUCT CLEANING RAPID
DISINFECTION*
HIGH LEVEL
DISINFECTION
STERILIZATION
McGRATH® MAC
Disposable
Laryngoscope Blade
Supplied Sterile
Do Not
Reprocess
Supplied Sterile
Do Not
Reprocess
Supplied Sterile
Do Not
Reprocess
Supplied Sterile
Do Not
Reprocess
McGRATH® MAC EMS
with McGRATH® 3.6V
EMS Battery fitted
Cleaning (Manual) -
Non-Immersive Disinfectant Wipe
STERRAD®
50/100S/200/
NX/ 100NX
McGRATH® MAC EMS
with McGRATH® 3.6V
EMS Battery removed
Cleaning (Manual) -
Immersive Disinfectant Wipe
High Level
Disinfectant
Immersion /
Chemical Disinfector
STERRAD®
50/100S/200/
NX/ 100NX
McGRATH®
3.6V EMS Battery
Cleaning (Manual) -
Non-Immersive Disinfectant Wipe Ethylene Oxide Sterilization
*Wherever practical a High Level Disinfection or Sterilization is preferred to a wipe-based process.
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