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

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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

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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.