McGrath MAC User manual

INSTRUCTIONS
FOR USE
301-000-000
TM

2
en Instructions For Use
fr Mode d’emploi
de Gebrauchsanweisung
nl Gebruiksaanwijzing
it Istruzioni per l’uso
es Instrucciones de uso
da Brugsanvisning
cs Návod k použití
sk Návod na použitie
ro Instrucțiuni de utilizare
et Kasutusjuhised
hr Upute za uporabu
sr Uputstvo za upotrebu
id Petunjuk Penggunaan

3
en:See Quick Start Guide Figure 1 for graphic representation of
device parts. fr:Pour une représentation graphique des pièces du
dispositif, voir la gure1 du Guide de démarrage rapide. de:Siehe
Kurzanleitung Abbildung 1 für die grasche Darstellung von
Geräteteilen. nl:Zie afbeelding 1 van de Beknopte Handleiding voor
een grasche voorstelling van de onderdelen van het hulpmiddel.
it:Vedere la guida di avvio rapido, gura 1, per la rappresentazione
graca dei componenti del dispositivo. es:Vea en la Figura 1 de la
Guía de consulta rápida una representación gráca de las partes
del instrumento. da:Se en grask fremstilling af instrumentets
dele i hurtigvejledningens gur 1. cs:Gracké znázornění součástí
přístroje viz obrázek1 ve stručné příručce rychlého spuštění.
sk:Gracké znázornenie častí pomôcky nájdete na obrázku 1
v príručke rýchleho spustenia. ro:Consultați Ghidul de pornire
rapidă Figura 1 pentru reprezentarea gracă a componentelor
dispozitivului. et:Vaadake seadme osade kujutisi kiirjuhendi
jooniselt 1. hr:Pogledajte grački prikaz dijelova uređaja na slici 1 u
Vodiču za brzi početak. sr:Grački prikaz delova uređaja potražite na
slici 1 u„Kratkom vodiču”. id:Lihat Gambar 1 Panduan Mulai Cepat
untuk representasi gras dari bagian-bagian perangkat.
1en:Handle fr:Poignée de:Handgri nl:Handgreep
it:Impugnatura es:Empuñadura da:Håndtag cs:Rukojeť
sk:Rukoväť ro:Mâner et:Käepide hr:Drška sr:Drška id:Gagang
2en:Battery Bay fr:Logement de la batterie de:Batterieschacht
nl:Batterijvak it:Vano della batteria es:Compartimento de la
batería da:Batterirum cs:Přihrádka na baterii sk:Priehradka
na batériu ro:Compartiment pentru baterie et:Akupesa
hr:Odjeljak za baterije sr:Ležište baterije id:Tempat Baterai
3en:CameraStickTM fr:CameraStickTM de:CameraStickTM
nl:CameraStickTM it:CameraStickTM es:CameraStickTM
da:CameraStickTM cs:CameraStickTM sk:CameraStickTM
ro:CameraStickTM et:CameraStickTM hr:CameraStickTM
sr:CameraStickTM id:CameraStickTM
4en:Blade retaining clip fr:Clip de retenue de la lame de:Spatel-
Halteclip nl:Spatelborgclip it:Gancio di ssaggio della
lama es:Clip de retención de la hoja da:Holdeklips til blad
cs:Západka přidržující krytku sk:Príchytka na uchytenie lopatky
ro:Clemă xare lamă et:Keele kinnitusklamber hr:Učvrsna
kopča lopatice sr:Noseća kopča za špatulu id:Klip penahan bilah

4
5en:Heel fr:Base de:Ende nl:Hiel it:Area terminale es:Área
inferior da:Hæl cs:Patka sk:Päta ro:Bază et:Kand hr:Peta
sr:Peta id:Tumit
6en:Camera and Light Source fr:Caméra et source lumineuse
de:Kamera und Lichtquelle nl:Camera en lichtbron
it:Videocamera e sorgente luminosa es:Cámara y fuente de luz
da:Kamera og lyskilde cs:Kamera a světelný zdroj sk:Kamera
a zdroj svetla ro:Videocameră și sursă de lumină et:Kaamera ja
valgusallikas hr:Kamera i izvor svjetlosti sr:Kamera i izvor svetla
id:Kamera dan Sumber Cahaya
7en:Camera Cover fr:Cache de la caméra de:Kameraabdeckung
nl:Camerakapje it:Copertura della videocamera es:Tapa de la
cámara da:Beskyttelsesdel til kamera cs:Kryt kamery sk:Kryt
kamery ro:Capac videocameră et:Kaamera kate hr:Poklopac
kamere sr:Poklopac kamere id:Penutup Kamera
8en:Monitor fr:Moniteur de:Monitor nl:Monitor it:Monitor
es:Monitor da:Monitor cs:Monitor sk:Monitor ro:Monitor
et:Monitor hr:Monitor sr:Monitor id:Monitor
9en:LCD fr:Écran à cristaux liquides de:LCD nl:LCD it:LCD
es:LCD da:LCD cs:LCD sk:LCD ro:LCD et:LCD hr:LCD sr:LCD
id:LCD
10 en:Monitor Hinge fr:Charnière du moniteur de:Monitorgelenk
nl:Monitorscharnier it:Perno del monitor es:Bisagra del
monitor da:Monitorhængsel cs:Závěs monitoru sk:Pánt
monitora ro:Balama monitor et:Monitori liigend hr:Zglob
monitora sr:Šarka monitora id:Engsel Monitor
11 en:Blade fr:Lame de:Spatel nl:Spatel it:Lama es:Hoja da:Blad
cs:Krytka sk:Lopatka ro:Lamă et:Keel hr:Lopatica sr:Špatula
id:Bilah
12 en:Blade Clip fr:Clip de la lame de:Spatel-Clip nl:Spatelclip
it:Gancio della lama es:Clip de la hoja da:Bladklips cs:Západka
krytky sk:Príchytka lopatky ro:Clemă lamă et:Keele klamber
hr:Kopča lopatice sr:Karika špatule id:Klip Bilah
13 en:Battery fr:Batterie de:Batterie nl:Batterij it:Batteria
es:Batería da:Batteri cs:Baterie sk:Batéria ro:Baterie et:Aku
hr:Baterija sr:Baterija id:Baterai

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14 en:Power Button fr:Bouton marche/arrêt de:Ein/Aus-Taste
nl:Aan/uit-knop it:Pulsante di accensione es:Botón de
encendido/apagado da:Tænd/sluk-knap cs:Vypínač sk:Vypínač
ro:Buton pornire/oprire et:Toitenupp hr:Tipka napajanja
sr:Dugme napajanja id:Tombol Daya
15 en:Carbon Contact fr:Contact en charbon de:Carbon-Kontakt
nl:Koolstofcontact it:Contatto al carbonio es:Contacto de
carbono da:Kulstofkontakt cs:Karbonová pilulka sk:Karbónový
kontakt ro:Contact de carbon et:Süsinikkontakt hr:Kontakt-
tipka sr:Ugljenični kontakt id:Kontak Karbon
16 en:Power Contacts fr:Contacts d’alimentation de:Ein/Aus-
Kontakte nl:Voedingscontacten it:Contatti per alimentazione
es:Contactos de potencia da:Tænd/sluk-kontakter cs:Kontakty
baterie sk:Elektrické kontakty ro:Contacte de alimentare
et:Elektrikontaktid hr:Kontakti napajanja sr:Kontakti napajanja
id:Kontak Daya
17 en:Removal Tab fr:Languette de retrait de:Entfernungslasche
nl:Verwijderlip it:Linguetta per rimozione es:Pestaña
de retirada da:Aftagningstap cs:Úchyt pro vyjímání
sk:Uvoľňovacia západka ro:Clapetă de scoatere
et:Eemaldussakk hr:Jezičac za vađenje sr:Jezičak za skidanje
id:Tab Pelepasan
18 en:Retaining Clips fr:Clips de retenue de:Halte-Clips
nl:Borgclips it:Ganci di ssaggio es:Clips de retención
da:Holdeklips cs:Pojistné západky sk:Pripevňovacie príchytky
ro:Cleme de xare et:Kinnitusklambrid hr:Učvrsne kopče
sr:Noseće kopče id:Klip Penahan

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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 xed-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 0123
For ordering please contact your local representative.
en

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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
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 bio-incompatibility, 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 tted 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 t poorly.
•Ensure the device is completely dry before use.
•Do not autoclave the device.

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•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.
•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
- Fire, explosion, and severe burn hazard.
- Do not recharge, disassemble, heat above 212°F (100°C),
incinerate, or expose device to water.
- Do not crush.
•Do not use in an MR environment. Attempting to use the battery
in an MR environment could cause burns or adversely aect 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 ammable 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.

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Specications
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 eects 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
CISPR CISPR 11 Group 1 Class B
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.

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Operating Conditions
Device temperature 10°C (50°F) to 40°C (104°F)
Atmospheric pressure 620hPa to 1060hPa
Relative humidity 10% to 95% (non-condensing)
Storage and Transportation
Device and Battery
Device temperature -10°C (14°F) to 40°C (104°F)
Atmospheric pressure 620hPa to 1060hPa
Relative humidity 10% to 95% (non-condensing)
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 rst
patient use, as instructed in the cleaning and disinfection section.
Operation
The device turns on and o by a single push of the power button.
Always check that the device is working properly and that there is
sucient 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 ash.
Replace the battery unit when this happens. If the counter is allowed to
run down to zero, the battery icon will continue to ash. Pull on the tab
to remove the battery.

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Power Saving
To save power, the device will automatically switch o when motionless
for a period of time. After 15 seconds of inactivity, the device screen will
dim in preparation for switch o. The device reactivates when it detects
movement. However, if the period of inactivity continues for a total of 3
minutes, the device will switch o. When this occurs, the device can be
switched back on by a single push of the power button.
Disposable Laryngoscope Blade Fitting
To t the blade, open the peel pouch and slide the blade over the
CameraStick™ portion of the device. The blade is correctly tted when
the blade clip is rmly latched to the CameraStick™. Remove the blade
from the peel pouch just prior to intubation. To remove the blade after
intubation, lift the clip, pull the blade o 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 dicult airways.
The McGRATH™ X blade™ range are for use with dicult and extreme
airways. These blades require dierent 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.

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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 conrm 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.
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 o 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.

13
8. The screen view can be used to conrm 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.
Product Cleaning Intermediate Level
Disinfection
McGRATH™
MAC with
McGRATH™
3.6V Battery
removed
Quaternary
ammonia
+ isopropyl
alcohol (IPA)
(e.g. Super
sani-cloth or
equivalent)
1. Quaternary ammonia
+ isopropyl alcohol
(e.g. Super sani-cloth or
equivalent)
Product Cleaning Low-Level Disinfection
McGRATH™
3.6V Battery
70% IPA wipe 70% IPA wipe
Dispose of wipes in accordance with local regulations and hospital
policy.

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Device Cleaning
Use the following process to clean the device:
1. Ensure the battery is removed prior to cleaning.
2. Use a quaternary ammonium and isopropyl alcohol wipe (e.g., Sani-
Cloth 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 eective 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.
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. Camera Stick™: 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 Camera Stick™ 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 sani-
cloth or equivalent).

15
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
• 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.
McGRATH™ 3.6V Battery Low-Level Disinfection
Disinfect with 70% IPA wipe
Follow the same process as per the battery cleaning section above to
low-level disinfect the battery.
Using a new 70% IPA wipe, disinfect the device, systematically working
through the six steps of the battery cleaning section instructions (from
top to bottom of the battery).

16
Decontaminated batteries should be packaged immediately upon
completion of the 2 minute drying phase and should be stored in
accordance with local guidelines.
Storage
After cleaning and decontamination, the device and battery should
be air dried or wiped dry with a lint free cloth. The device has to be
completely dry before use.
Decontaminated devices should be packed immediately after drying
and stored in accordance with local guidelines. The device cannot be
stored in its original packaging for reuse.
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 o. (after 3 minutes of no motion)
e. System error, this screen shows if there is a startup error
including if there are 0 (zero) minutes available on the battery
Figure 4
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.
If neither of the above achieves positive results, contact local
representative for diagnostics and repair. There are no serviceable parts
inside the device.

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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 theVideo 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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Description
Le laryngoscope vidéo McGRATH™ MAC (appelé ici dispositif) est
un outil d’aide à l’intubation trachéale. Comme le laryngoscope est
rigide, il maintient et donne une forme à l’anatomie, orant ainsi une
visualisation nette du larynx et de l’accès à la trachée.
Ce dispositif comprend une source lumineuse (DEL) et une mini-caméra
(caméra) incorporées pour visualiser le larynx pendant la laryngoscopie.
L’image est achée sur un écran à cristaux liquides (écran) contenu
dans un moniteur monté sur la poignée du dispositif.
Une batterie McGRATH™ MAC de 3,6 V (batterie) montée dans la
poignée alimente l’écran, la caméra et la DEL. La lame jetable du
laryngoscope McGRATH™ (lame) recouvre l’ensemble caméra et DEL
(CameraStick™) pour éviter tout contact direct avec le patient. Les lames
sont livrées stériles et sont à usage unique.
L’environnement d’utilisation peut inclure les hôpitaux, les
établissements de type hospitalier, le transport à l’intérieur d’un hôpital,
les applications médicales d’urgence mobiles, y compris le transport
terrestre et aérien. Les environnements de transport comprennent le
transport à l’intérieur d’un hôpital et le transport terrestre et aérien
d'urgence : ambulances routières, aéronefs à voilure xe et hélicoptères.
Accessoires
340-000-000 Batterie McGRATH™ de 3,6 V
350-072-000 Lames de laryngoscope jetables McGRATH™ MAC 1
350-017-000 Lames de laryngoscope jetables McGRATH™ MAC 2
350-005-000 Lames de laryngoscope jetables McGRATH™ MAC 3
350-013-000 Lames de laryngoscope jetables McGRATH™ MAC 4
X3-003-000 Lames de laryngoscope jetables McGRATH™ X blade X3
Toutes les lames décrites ci-dessus sont conformes à la réglementation
0123
Pour commander, veuillez prendre contact avec le représentant local.
fr

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Utilisation prévue
Le laryngoscope vidéo McGRATH™ MAC et les lames de laryngoscope
jetables McGRATH™ sont destinés à être utilisés par des personnes
formées et agréées pour visualiser les cordes vocales lors
d'interventions médicales, en règle générale par laryngoscopie.
Indications
La visualisation de l'oropharynx et du larynx pour une laryngoscopie
générale et/ou pour faciliter l'immobilisation des voies respiratoires.
Contre-indications
Aucune connue.
Avertissements
•Les lames ne peuvent ni être nettoyées ni stérilisées correctement
par l'utilisateur pour faciliter leur réutilisation sans risque ; elles
sont donc à usage unique. Toute tentative de nettoyage ou de
stérilisation de ces lames peut présenter pour le patient des
risques de bio-incompatibilité, d'infection, ou de défaillance du
produit.
•Le dispositif ne doit être utilisé qu’avec des lames de laryngoscope
jetables McGRATH™.
•Vérier que la lame est correctement xée sur le CameraStick™
avant utilisation.
•Si le clip de la lame ne s’enclenche pas correctement sur le
CameraStick™, ne pas tenter d’utiliser la lame.
•S'il apparaît que l'emballage de la lame a été ouvert ou
endommagé, ne pas utiliser cette lame.
•Seul un personnel dûment formé et agréé pour pratiquer
l’intubation à l’aide d’un laryngoscope est autorisé à utiliser
ce dispositif.
•Ne pas utiliser les lames avec un autre type de laryngoscope. Les
lames sont conçues pour être utilisées avec le laryngoscope vidéo
McGRATH™ MAC uniquement.
•N'ouvrir aucune partie scellée du dispositif. Cela risquerait de
nuire aux performances du dispositif, d'annuler la garantie et
d'avoir un impact sur la sécurité du patient.
•Ne pas utiliser si l'un des composants est desserré, physiquement
endommagé ou mal xé.

20
•S'assurer que le dispositif est complètement sec avant utilisation.
•Ne pas passer le dispositif en autoclave.
•Ne pas retraiter ce dispositif dans un nettoyeur à ultrasons.
•Toujours vérier que le dispositif fonctionne correctement avant
chaque utilisation sur un patient.
•Retirer la batterie avant de procéder au nettoyage et/ou à
la désinfection.
•Ne pas modier le dispositif.
•Les appareils portables de communication par radiofréquence
(y compris les périphériques tels que câbles d'antennes et
antennes externes) ne doivent pas être utilisés à moins de 30 cm
(12 pouces) du dispositif.
•Batterie McGRATH™ MAC de 3,6 V
- Danger d’incendie, d’explosion et de brûlures graves.
- Ne pas recharger, démonter, chauer à une température
supérieure à 100 °C (212 °F), incinérer, ou exposer le dispositif
à l’eau.
- Ne pas broyer.
•Ne pas utiliser dans un environnement d’IRM. Toute tentative
d’utilisation de la batterie dans un environnement d'IRM peut
provoquer des brûlures ou nuire à la qualité des images d’IRM.
•Veiller à respecter à tout moment les procédures de manipulation
locales lors de la manipulation de dispositifs jetables.
•La température de la partie électroluminescente du laryngoscope
vidéo peut dépasser 41 °C dans le cadre d'un fonctionnement
normal. Lorsque le dispositif est utilisé comme indiqué, un contact
continu avec cette zone est peu probable.
Mises en garde
•N'utiliser aucun autre type de lame de laryngoscope avec ce
dispositif médical.
•Ne pas utiliser en présence de mélanges inammables.
•N'utiliser aucun autre type de batterie avec ce dispositif.
•La loi fédérale des États-Unis n’autorise la vente de ce dispositif
que par un médecin ou sur ordonnance médicale.
Eets indésirables
Les événements indésirables suivants ont été rapportés avec l'utilisation
de laryngoscopes lors de la laryngoscopie et/ou de l'intubation, classés
par ordre de fréquence et de gravité : lésion des muqueuses, retard