Page 3
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].
Disposable Laryngoscope Blade Fitting Using the Laryngoscope Cleaning and Low Level Disinfection Device Cleaning Device Low Level Disinfection Battery Cleaning Battery Low Level Disinfection Storage Troubleshooting Warranty Addendum • Using The Laryngoscope -McGRATH® MAC blade • Using The Laryngoscope -McGRATH® X blade™...
1 Introduction 1.1 Description The McGRATH® MAC Video Laryngoscope McGRATH® MAC 45 ° (McGRATH® MAC or the device) is a tool Video Laryngoscope used to aid the intubation of the trachea. (the device) Monitor Monitor hinge As a rigid laryngoscope it holds and...
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.
• Relative Humidity 10% to 90% Humidity limitation 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.
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).
2.2 Battery The device must only be used with the McGRATH® 3.6V battery. Push the battery Power unit into the cavity of the handle as illustrated. The device turns on and off by a single push of the Power button.
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.
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 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.
McGRATH® Supplied Sterile Supplied Sterile Disposable Do Not Do Not Laryngoscope Blade Reprocess Reprocess McGRATH® MAC with McGRATH® 70% IPA* Wipe 70% IPA Wipe 3.6V Battery removed McGRATH® 70% IPA Wipe 70% IPA Wipe 3.6V Battery *IPA = Isopropyl Alcohol...
Page 14
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.
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.
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).
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...
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.
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 •...
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.
Video Laryngoscope Addendum Using the Laryngoscope - McGRATH® blade range • Using the Laryngoscope - McGRATH® MAC blade range • Using the Laryngoscope - McGRATH® X blade™...
Advance the tip of the McGRATH® MAC Visualise the epiglottis on the screen. Lift the Advance the tube gently and atraumatically blade into the vallecula.
USING THE LARYNGOSCOPE - McGRATH® X blade™ 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.