AIRCRAFT MEDICAL

McGrath MAC Video Laryngoscope Instructions For Use Rev B April 2017

Instructions For Use

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File Name: AIRCRAFT MEDICAL - 100-105-000 - McGrath MAC Video Laryngoscope Instructions For Use Rev B April 2017 - 2017-04.pdf

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Page 1

Video Laryngoscope

Operator’s Manual ( Instructions for use )

Manufacturer’s Declaration The McGRATH® MAC Video Laryngoscope (the device) has been tested to product specific standard IEC 60601-1-2:2007 [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 60601-1-2:2007. The following tables contain the corresponding manufacturer’s declaration for the electromagnetic emissions and electromagnetic immunity of the device.

Table 1 - Electromagnetic Emissions

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 and ±6 kV contact ±2 kV, ±4 kV and ± 8 kV air

Compliant

Radiated RF Immunity IEC 61000-4-3:2006 +A1:2007+A2:2010

3 V/m Modulation of 80% AM @ 1 kHz. Frequency 80 MHz - 2.5 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 61000-4-6:2003+A1:2004+A2:2006

Not Applicable

Test not applicable as the device is battery powered

Magnetic Immunity IEC 61000-4-8:2009

3 A/m

Compliant

Voltage Dips IEC 61000-4-11:2004

Not Applicable

Test not applicable as the device is battery powered

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.

Introduction

1.1

Description

1.2

Accessories and Part Numbers

1.3

Specifications

1.4

Regulatory

1.5

Environment

Functional

2.1

Unpacking and Inspection

2.2

Battery

2.3

Disposable Laryngoscope Blade Fitting

2.4

Using the Laryngoscope

Cleaning and Low Level Disinfection

3.1

Device Cleaning

3.2

Device Low Level Disinfection

3.3

Battery Cleaning

3.4

Battery Low Level Disinfection

Storage

Troubleshooting

Warranty

Addendum

• Using The Laryngoscope -McGRATH® MAC blade

• Using The Laryngoscope -McGRATH® X blade™

Contents

1 Introduction 1.1 Description

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)

45 ° Monitor

Monitor hinge

LCD screen

Handle

Camera & light source

Clip

Heel area

CameraStick™

McGRATH® MAC 3.6V Battery (battery)

Power button

Tab

McGRATH® disposable laryngoscope blade (blade) SUPPLIED SEPARATELY

Blade clip

Blade

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.

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

McGRATH® MAC Video Laryngoscope

300-000-000

McGRATH® 3.6V Battery

340-000-000

McGRATH® MAC 1 Disposable Laryngoscope Blades (Carton of 50)

350-072-000

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® X blade

X3-003-000

X3 Disposable Laryngoscope Blades (Carton of 10)

McGRATH® MAC Quick Start Guide

300-048-000

McGRATH® MAC Product Box

300-040-000

1.3 Specifications Laryngoscope Assembly Size Weight Power Protection Light source Display Camera Materials

180mm x 68mm x 110mm 0.200kg Proprietary 3.6V Lithium Battery *Giving 250 minutes of use typically IPx7 High intensity LED 2.5” LCD colour display CMOS 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

The device is supplied with a battery. Blades and additional batteries can be purchased separately from your Aircraft Medical agent or distributor.

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.

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

In addition to the above compliance, sterility aspects of the McGRATH® Disposable Laryngoscope Blade have been certified by Aircraft Medical’s notified body.

1.5 Environmental

McGRATH® MAC Device and Battery Storage & Transport Conditions: • -10ºC to 40ºC ambient • Relative Humidity 10% to 90%

50%

10%

Humidity limitation

90%

10%

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.

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

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 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).

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.

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 off by a single push of the Power button.

Power

Tab

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

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.

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 off. McGRATH® DISPOSABLE LARYNGOSCOPE BLADES ARE SINGLE USE AND MUST BE DISPOSED OF AFTER EACH PATIENT USE

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

Press Clip

ENSURE THAT LOCAL HANDLING PROCEDURES ARE FOLLOWED AT ALL TIMES WHILE HANDLING DISINFECTED DEVICES

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 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™

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.

CLEANING

LOW LEVEL DISINFECTION*

McGRATH® Disposable Laryngoscope Blade

Supplied Sterile Do Not Reprocess

McGRATH® MAC with McGRATH® 3.6V Battery removed

70% IPA Wipe

70% IPA

McGRATH® 3.6V Battery

70% IPA Wipe

70% IPA

PRODUCT

The following methods have been approved by Aircraft Medical:

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.

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.

Monitor: Ensure the 70% IPA wipe gets into the various grooves around the screen. Monitor Hinge: Rotate the monitor to the upright position. Feed the 70% IPA wipe into the space between the monitor and handle to ensure. effective penetration. Rotate the monitor to its opposite position and repeat. 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. Handle: Ensure all surfaces of the handle are thoroughly treated with the 70% IPA wipe. 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. Camera Stick: Ensure all surfaces of the camera stick are thoroughly treated with the 70% IPA wipe. 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.

45 ° 1. Monitor

2. Monitor hinge

LCD screen

3. Battery Bay

4. Handle

7. Camera & light source

5. Clip and Heel area 6. CameraStick™

Subsequent cleaning should be repeated where visible soiling is still present using a new 70% IPA wipe.

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

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.

5. 6.

Battery Slot: Ensure the 70% IPA wipe gets into the two button slots at the back of the battery push button. Contacts: Ensure the 70% IPA wipe gets into the space around and under the two metal battery contacts. Clips: Run the 70% IPA wipe along and into the gaps around the battery retaining clips Lower Slot: Ensure the 70% IPA wipe gets into the lower slot at the base of the battery. Surfaces: Wipe all surfaces of the battery cover with the 70% IPA wipe Tab: Run the 70% IPA wipe along all surfaces of the Tab.

1. Button slots 2. Contacts 5. Surfaces 6. Tabs 3. Clips 2. Contacts 4. Lower Slots 5. Surfaces

Subsequent cleaning should be repeated where visible soiling is still present using a new 70% IPA wipe.

The following process steps should be followed to clean the battery. Using a 70% IPA wipe, clean the

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).

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.

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

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.

• Replace battery unit.

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.

Video Laryngoscope

Using the Laryngoscope McGRATH® blade range • Using the Laryngoscope - McGRATH® MAC blade range • Using the Laryngoscope - McGRATH® X blade™

Addendum

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