McGRATH MAC Instructions for Use Rev A June 2021

en Description: The McGRATH™ MAC video laryngoscope (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 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. Blades are supplied sterile and are single use. The use environment may include: hospitals, hospital-type facilities, intrahospital transport, mobile emergency medical applications including both ground and air transport. Transport environments include intra-hospital transport and both ground and air emergency transport: road ambulances and fixed-wing aircraft and helicopters. Accessories 340-000-000 McGRATH™ 3.6V Battery 350-072-000 McGRATH™ MAC 1 disposable laryngoscope blades 350-017-000 McGRATH™ MAC 2 disposable laryngoscope blades 350-005-000 McGRATH™ MAC 3 disposable laryngoscope blades 350-013-000 McGRATH™ MAC 4 disposable laryngoscope blades X3-003-000 McGRATH™ X blade X3 disposable laryngoscope blades All blades described above are regulated under:

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For ordering please contact your local representative. Intended Use: The McGRATH™ MAC video laryngoscope and McGRATH™ disposable laryngoscope blades are intended to be used by trained and licensed individuals to gain a view of the vocal cords during medical procedures, typically laryngoscopy. Indications: The visualization of the oropharynx and larynx for general laryngoscopy and/or to aid in the securement of airway. Contraindications: None known.

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Warnings • Blades cannot be adequately cleaned and/or sterilized by the user in order to facilitate safe reuse, and are therefore intended for single use. Attempts to clean or sterilize the blades may result in bioincompatibility, infection, or product failure risks to the patient. • The device must be used only with McGRATH™ disposable laryngoscope blades. • Check that the blade is correctly fitted to the CameraStick™ before use. • If the blade clip does not securely engage onto the CameraStick™ do not attempt to use the blade. • If there is any evidence that the blade packaging has been opened, or damaged, do not use the blade. • Only personnel trained and licensed to perform intubation with a laryngoscope may use this device. • Do not use the blades with any other type of laryngoscope. Blades are designed to be used with the McGRATH™ MAC video laryngoscope only. • Do not open any sealed part of the device. Doing so will impair the performance of the device and void the warranty, and may impact patient safety. • Do not use if any components become loose, physically damaged, or fit poorly. • Ensure the device is completely dry before use. • Do not autoclave the device. • Do not reprocess this device in an ultrasonic cleaner. • Always check that the device is working correctly before each patient use. • Remove the battery prior to cleaning and/or performing disinfection. • Do not modify the device. • Do not use accessories other than those specified or provided by the manufacturer of the device, as such use could result in increased electromagnetic emissions or decreased electromagnetic immunity. • Do not use the device adjacent to or stacked with other equipment. • Portable radio frequency communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to the device. • McGRATH™ MAC 3.6V battery 6

--Do not dispose in fire, recharge, crush, short circuit, force discharge, or heat above 100°C (212°F). • Do not use in an MR environment. Attempting to use the battery in an MR environment could cause burns or adversely affect an MR image. • Ensure that local handling procedures are followed at all times while handling disposable devices. • The light emitting portion of the video laryngoscope may exceed 41°C as part of normal operation. When used as indicated, continuous contact with this area is unlikely. Cautions • Do not use any other type of laryngoscope blade with this medical device. • Do not use in the presence of flammable mixtures. • Do not use any other type of battery with this device. • Federal (USA) law restricts this device to sale by or on the order of a physician. Adverse Events: The following adverse events have been reported to be associated with the use of laryngoscopes during laryngoscopy and/ or intubation listed in order of frequency and severity: mucosal injury, delay of treatment, hypoxia, esophageal or mal-positioning of tracheal tube, change in vital signs, dental injury, intubation related aspiration, bleeding, infection, discomfort, and foreign body. If a serious incident related to the device occurs, immediately report the incident to Aircraft Medical and the applicable competent authority. Specifications Video Laryngoscope Device Size: 180mm x 68mm x 110mm Weight: 0.180kg Internally Powered: Proprietary McGRATH™ 3.6 V Lithium Battery *Giving 250 minutes of use typically Protection: IP38 Please pay attention to the effects of lint, dust, light (including sunlight), etc. Light source: LED Display: 2.5” LCD colour display Camera: CMOS RFID: Transmitting frequency: 13.56MHz Output power: 70mW 7

Electromagnetic Emissions

Radiated RF emissions CISPR 11:2009 +A1:2010 Group 1 Class B Radiated RF emissions ISO 7137:1995 100MHz - 6GHz Electromagnetic Immunity limits established by the home Immunity healthcare environment IEC 60601-1-2:2014 Electrostatic Discharges IEC 61000-4-2:2008 Radiated RF EM Fields IEC 61000-4-3:2006 +A1:2007 +A2:2010 Radiated RF EM Fields and Proximity Wireless Fields IEC 61000-4-3:2006 +A1:2007 +A2:2010 Rated Power-frequency Magnetic Field IEC 61000-4-8:2009 For details about the radiation levels, refer to https://manuals.medtronic.com/manuals/main/region Useful life: 4 years or 2000 decontamination cycles. *Where the ambient temperature is 20°C, battery life may vary where the ambient temperature is higher or lower. Do not store batteries or devices with batteries at more than 40°C (104°F). Doing so will shorten the life of the battery. Disposable Laryngoscope Blade Material: The blades are disposable, composed of medical grade optical polymer which have not been made with natural rubber latex and not made with DEHP. Blades are packaged individually in pouches that have not been made with natural rubber latex. Applied Part Type: BF Note: Dispose of device, battery, and blade according to local regulations. Operating and Transient Conditions Device temperature Atmospheric pressure Relative humidity

10°C (50°F) to 40°C (104°F) 620 hPa to 1060 hPa 10% to 95% (non-condensing)

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Storage and Transportation Device and Battery -10°C (14°F) to 40°C (104°F) 620 hPa to 1060 hPa 10% to 95% (non-condensing) -10°C (14°F) to 10°C (50°F) 7 minutes Blade Device temperature -10°C (14°F) to 70°C (158°F) Unpacking, Inspection: Unpack device and check for any visible signs of damage. In the event of signs of damage, do not use the device and inform your local representative. Remove the protective sheet from the monitor screen and camera cover from the distal end of the CameraStick™. The device and battery unit are supplied separately within the same container in a non-sterile state. Decontaminate the device and battery before first patient use, as instructed in the cleaning and disinfection section. Operation: The device turns on and off by a single push of the power button. Always check that the device is working properly and that there is sufficient remaining power in the battery prior to starting a clinical procedure. Battery: The life of the battery unit is displayed on the bottom right corner of the screen. Refer to quick start guide included with the device for graphic example. When the battery counter reaches 5 minutes, the battery icon will flash. Replace the battery unit when this happens. If the counter is allowed to run down to zero, the battery icon will continue to flash. Pull on the tab to remove the battery. Power Saving: To save power, the device will automatically switch off when motionless for a period of time. After 15 seconds of inactivity, the device screen will dim in preparation for switch off. The device reactivates when it detects movement. However, if the period of inactivity continues for a total of 3 minutes, the device will switch off. When this occurs, the device can be switched back on by a single push of the power button. 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 correctly fitted when the blade clip is firmly latched to the CameraStick™. Remove the blade from the peel pouch just prior Device temperature Atmospheric pressure Relative humidity Stabilization time

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to intubation. To remove the blade after intubation, lift the clip, pull the blade off and dispose of according to local regulations. 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 below. McGRATH™ MAC blade (for graphical representation, refer to quick start guide included within the packaging) 1. If possible, position the patient in the optimal position for direct laryngoscopy. 2. Look into the mouth; insert the blade into the right side of the mouth. 3. Move the device to a central position while sweeping the tongue to the left. 4. Advance the tip of the McGRATH™ MAC blade into the vallecula. 5. 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. 6. Advance the E.T. 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*. 7. Indirectly visualize the E.T. tube placement through the vocal cords. In optimal tube placement technique, the E.T. tube will enter from the right side of the display. 8. The screen view can be used to confirm the correct insertion depth of the E.T. tube. *If a direct pathway for the E.T. tube was not created by sweeping the tongue or aligning the airway axes, a stylet or a bougie may be used. McGRATH™ X blade™ (for graphical representation, refer to quick start guide included within the packaging) 1. Load the E.T. tube onto a stylet and form to the curvature of the X blade™. Clinical experience has shown that intubation with a stylet is required to facilitate optimal tube placement. Use of a bougie is not advised. Where possible, position the patient’s head for optimal access. 10

2. Using a mid-line approach, roll the blade into the mouth. Ensuring the anterior side of the blade maintains contact with the tongue, advance the blade until the epiglottis is seen on the top of the screen. 3. Place the tip of the X blade™ into the vallecula. Using minimal force, rock the device back towards the user to lift the epiglottis and obtain an indirect view of the glottis. When the device is in the optimal position, the glottis will be viewed in the central upper section of the screen*. 4. The DepthGuide™ numeric markings on the posterior side of the blade may be used as an indication of the depth of blade insertion**. 5. Insert the E.T. tube at the right side corner of the mouth. Advance in a rolling movement following the curvature of the blade, ensuring it maintains contact with the section of the blade labelled E.T. CONTACT ZONE™. 6. When using optimal technique, the E.T. tube should enter the screen on the right side; advance the tube until the tip is in front of the vocal cords. 7. Holding the stylet secure, slide the tube off the stylet and through the cords, ensuring the stylet does not pass through the cords. Once the E.T. tube has passed the cords, remove the stylet completely. 8. The screen view can be used to confirm the correct insertion depth of the E.T. tube. *It is important not to advance the blade too deeply in order to maintain maximum space to facilitate the E.T. tube placement. **Reference to these numbers can be useful during training to avoid inserting the blade too far. Cleaning and Disinfection: After unpacking, decontaminate the device and battery before use. The device and battery should be cleaned and disinfected separately after each patient use. Cleaning and disinfection should be carried out as per this instructions for use document and 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. The following methods have been approved: Note: Blades are not intended to be cleaned or disinfected.

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Product Cleaning Disinfection McGRATH™ MAC with McGRATH™ 3.6 V Battery removed Quaternary ammonia + Intermediate level: isopropyl alcohol (IPA) Quaternary ammonia + (e.g. Super Sani-Cloth or isopropyl alcohol (IPA) equivalent) (e.g. Super Sani-Cloth or equivalent) McGRATH™ 3.6 V Battery For low level disinfection: 70% IPA wipe For intermediate level disinfection: Quaternary ammonia + isopropyl alcohol (IPA) (e.g. Super Sani-Cloth or equivalent)

Low level: 70% IPA wipe Intermediate level: Quaternary ammonia + isopropyl alcohol (IPA) (e.g. Super Sani-Cloth or equivalent)

Dispose of wipes in accordance with local regulations and hospital policy. Device Cleaning Use the following process to clean the device: 1. Ensure the battery is removed prior to cleaning. 2. Use a quaternary ammonium + isopropyl alcohol wipe (e.g. SaniCloth or equivalent). 3. Clean the device, systematically working from Step 3a through Step 3g (from top to bottom of the device). Ensure the surfaces remain thoroughly wet by continuously wiping for 1 minute. a. Monitor: Ensure the disinfectant wipe gets into the various grooves around the screen. b. Monitor Hinge: Rotate the monitor to the upright position. Feed the disinfectant wipe into the space between the monitor and handle to ensure effective penetration. Rotate the monitor to its opposite position and repeat. c. Battery Bay: Ensure all surfaces of the Battery Bay (with battery removed) are thoroughly treated with the disinfectant wipe. Ensure that the joint between the battery module and the handle is thoroughly treated with the disinfectant wipe. d. Handle: Ensure all surfaces of the handle are thoroughly treated with the disinfectant wipe. 12

e. Clip and Heel Area: Take particular care in ensuring that the small clip is clean, in particular the internal corner between the clip and the surrounding plastic body. f. CameraStick™: Ensure all surfaces of the camera stick are thoroughly treated with the disinfectant wipe. g. Camera Lens: Clean the camera lens with the disinfectant wipe. Ensure that the interface between the CameraStick™ and camera lens is clean. 4. Visually inspect the device for visible soil. If not visually clean, repeat cleaning from step 3 using a new disinfectant wipe. Device Intermediate-Level Disinfection Use the following process to disinfect the device: 1. Ensure the battery is removed prior to disinfection. 2. Use quaternary ammonia + isopropyl alcohol wipe (e.g. Super SaniCloth or equivalent). 3. Follow the same process as per the device cleaning section above to intermediate-level disinfect the device. Using a new wipe, disinfect the device, systematically working from Step 3a through Step 3g of the device cleaning section above (from top to bottom of the device). Ensure that the wipe comes in contact with all surfaces of the device for the contact time recommended per the wipe manufacturer’s instructions. After reprocessing, wipe the battery contacts. McGRATH™ 3.6V Battery Cleaning Clean with 70% IPA wipe Use the following process to clean the battery: Using a 70% IPA wipe, clean the battery, systematically working through the following six steps (from top to bottom of the battery cover). Ensure that the 70% IPA wipe comes in contact with all surfaces of the battery. Ensure a minimum contact time of 1 minute on all surfaces. • Carbon Pill: Ensure the 70% IPA wipe gets into the two button slots at the back of the battery push button. • Power Contact: 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 Battery Slot: Ensure the 70% IPA wipe gets into the lower slot at the base of the battery • Battery: Wipe all surfaces of the battery cover with the 70% IPA wipe 13

• Tab: Run the 70% IPA wipe along all surfaces of the tab. Repeat cleaning where visible soiling is still present using a new 70% IPA wipe. Ensure that the 70% IPA wipe comes in contact with all surfaces of the device even if no visible soiling is present. Clean with Super Sani-Cloth wipe: Follow the same process as per the battery cleaning section above to clean the battery using a quaternary ammonium + isopropyl alcohol wipe (e.g. Super Sani-Cloth or equivalent). McGRATH™ 3.6V Battery Disinfection Low-Level Disinfection: After cleaning the battery using a 70% IPA wipe per the instructions above, use a new 70% IPA wipe to disinfect the device, systematically working through the six steps of the battery cleaning section instructions (from top to bottom of the battery). Intermediate-Level Disinfection: After cleaning the battery using a quaternary ammonia + isopropyl alcohol wipe (e.g. Super Sani-Cloth or equivalent) per the instructions above, use a new quaternary ammonia + isopropyl alcohol wipe (e.g. Super Sani-Cloth or equivalent) to disinfect the device, systematically working through the six steps of the battery cleaning section instructions (from top to bottom of the battery). Storage: After cleaning and decontamination, the device and battery should be air dried or wiped dry with a lint free cloth. The device and batteries have to be completely dry before use. Decontaminated devices and batteries should be packed immediately upon completion of the 2 minute drying phase and should be stored in accordance with local guidelines. The device and batteries cannot be stored for reuse in the original packaging. Troubleshooting System Messages: For system messages examples see quick start guide included within the packaging. a. Normal screen (250 minutes of battery run time available on battery) Figure 2 b. 5 minutes of battery run time remaining remaining on the battery (it is recommended to replace the battery) Figure 3 c. Unknown minutes of battery runtime available (this is used after the ‘0’ minutes or if there is an internal error after startup) Figure 5 d. Dimmed, device is not sensing any motion. If it remains in this state, the device will turn off. (after 3 minutes of no motion) e. System error, this screen shows if there is a startup error including if there are zero (0) minutes available on the battery Figure 4 14

No Image Shown On Screen or visible damage to the power button • Replace battery unit. Poor Picture Quality: If the image displayed on the screen is blurred or fuzzy: • 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. • Replace the blade. • The performance of the McGRATH™ MAC video laryngoscope may be affected by the operation of nearby equipment that generates electromagnetic energy such as MRI or high-frequency (HF) surgical devices. If unusual operation is observed, it may be necessary to take measures such as relocating, disabling or shielding the nearby equipment. If none of the above achieves positive results, contact local representative for diagnostics and resolution. There are no serviceable parts inside the device. 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. Unexpected Video Interruption • Try to turn the device back on. • Replace the battery unit. Warranty The device 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 in this document. • Before returning the device under a warranty claim, disinfect the device per the instructions in this document. For full terms of warranty, please contact your Aircraft Medical agent or distributor.

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en: MR Unsafe fr: Non compatible avec l’IRM de: MR-unsicher nl: Niet veilig voor MRI it: Pericoloso in tutti gli ambienti di RM es: No apto para RM sv: Inte MR-säker da: Ikke egnet til brug ved MR-scanning no: Ikke MR-sikker fi: Ei turvallinen magneettikuvauksessa pt-PT: Não seguro para RM ru: Небезопасно для применения в МР-среде pl: Urządzenie nie jest bezpieczne w środowisku rezonansu magnetycznego el: Μη ασφαλές για χρήση σε περιβάλλον MR

en: Device and Battery Symbols fr: Symboles sur le dispositif et la batterie de: Geräte- und Batteriesymbole nl: Symbolen op het hulpmiddel en de batterij it: Simboli del dispositivo e della batteria es: Símbolos en el instrumento y la batería sv: Symboler på enheten och batteriet da: Instrument- og batterisymboler no: Symboler på apparat og batteri fi: Laite- ja akkusymbolit pt-PT: Símbolos do dispositivo e bateria ru: Символы на изделии и батарее pl: Symbole urządzenia i akumulatora el: Σύμβολα συσκευής και μπαταρίας

en: Medical device fr: Dispositif médical de: Medizinprodukt nl: Medisch hulpmiddel it: Dispositivo medico es: Instrumento médico sv: Medicinteknisk produkt da: Medicinsk udstyr no: Medisinsk utstyr fi: Lääkinnällinen laite pt-PT: Dispositivo médico ru: Медицинское изделие pl: Wyrób medyczny el: Ιατροτεχνολογικό προϊόν

186

_°F _°C

_°F _°C

Authorized representative in the European Community

Temperature limit

Consult instructions for use

Date of manufacture

Manufacturer

Catalogue number

en: Device, Battery and Blade Symbols fr: Symboles sur le dispositif, la batterie et la lame de: Geräte-, Batterieund Spatelsymbole nl: Symbolen op het hulpmiddel, de batterij en de spatel it: Simboli del dispositivo, della batteria e della lama es: Símbolos en el instrumento, la batería y la hoja sv: Symboler på enheten, batteriet och bladet da: Instrument-, batteri- og bladsymboler no: Symboler på apparat, batteri og blad fi: Laite-, akku- ja lastainsymbolit pt-PT: Símbolos do dispositivo, bateria e lâmina ru: Символы на изделии, батарее и клинке pl: Symbole urządzenia, akumulatora i łyżki el: Σύμβολα συσκευής, μπαταρίας και γλωσσοπίεστρου

en: Harmonized Symbols fr: Symboles harmonisés de: Harmonisierte Symbole nl: Geharmoniseerde symbolen it: Simboli armonizzati es: Símbolos armonizados sv: Harmoniserade symboler da: Harmoniserede symboler no: Harmoniserte symboler fi: Harmonisoidut symbolit pt-PT: Símbolos harmonizados ru: Гармонизированные символы pl: Symbole ujednolicone el: Εναρμονισμένα σύμβολα

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_%

_% Humidity limitation

Caution

en: Battery Symbols fr: Symboles sur la batterie de: Batteriesymbole nl: Symbolen op de batterij it: Simboli della batteria es: Símbolos en la batería sv: Symboler på batteriet da: Batterisymboler no: Symboler på batteriet fi: Akkusymbolit pt-PT: Símbolos da bateria ru: Символы на батарее pl: Symbole akumulatora el: Σύμβολα μπαταρίας

Non-Sterile

en: Device and Battery Symbols fr: Symboles sur le dispositif et la batterie de: Geräte- und Batteriesymbole nl: Symbolen op het hulpmiddel en de batterij it: Simboli del dispositivo e della batteria es: Símbolos en el instrumento y la batería sv: Symboler på enheten och batteriet da: Instrument- og batterisymboler no: Symboler på apparat og batteri fi: Laite- ja akkusymbolit pt-PT: Símbolos do dispositivo e bateria ru: Символы на изделии и батарее pl: Symbole urządzenia i akumulatora el: Σύμβολα συσκευής και μπαταρίας

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Use-by date

Batch code

Keep away from sunlight

Fragile

Single use

Do not use if package is damaged

Keep dry

Sterilized using ethylene oxide

en: Blade Symbols fr: Symboles sur la lame de: Spatelsymbole nl: Symbolen op de spatel it: Simboli della lama es: Símbolos en la hoja sv: Symboler på bladet da: Bladsymboler no: Symboler på bladet fi: Lastainsymbolit pt-PT: Símbolos da lâmina ru: Символы на клинке pl: Symbole łyżki el: Σύμβολα γλωσσοπίεστρου

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Part No. PT00146775 Rev A 2021-06 COVIDIEN, COVIDIEN with logo, and Covidien logo and Positive Results for Life are U.S. and internationally registered trademarks of Covidien AG. ™* brands are trademarks of their respective owners. Other brands are trademarks of a Covidien company. © 2021 Covidien. Covidien llc, 15 Hampshire Street, Mansfield, MA 02048 USA. Medtronic B.V., Earl Bakkenstraat 10, 6422 PJ Heerlen, The Netherlands. www.covidien.com