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Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
PROFESSIONAL MEDICAL PRODUCTS
www.gimaitaly.com
MASCHERA LARINGEA RIUTILIZZABILE
LARYNGEAL AIRWAY MASK
Manuale d’uso - User manual
ATTENZIONE: Gli operatori devono leggere e capire
completamente questo manuale prima di utilizzare il prodotto.
ATTENTION: The operators must carefully read
and completely understand the present manual before using the product.
34424 - 34425 - 34426
34427 - 34428 - 34429
Gima S.p.A.
Via Marconi, 1
20060 Gessate (MI) Italy
Made in Taiwan
M34424-M-Rev.4-11.18
0476
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CONTENTS
1 Intended Use ........................................................................................12
2 Specification ........................................................................................12
2.1 Name of products parts ...................................................................12
3 Preparation for use ..............................................................................13
3.1 Cleaning and sterilization ................................................................13
3.1.1 Cleaning instruction ..................................................................13
3.1.2 Sterilization instruction .............................................................14
3.2 Functional testing ...........................................................................15
3.2.1 Test 1-Visual inspection ...........................................................16
3.2.2 Test 2-Ination/deation test ....................................................16
4 Insertion ...............................................................................................17
4.1 Pre-insertion preparation ................................................................17
4.2 Insertion ..........................................................................................17
4.3 Ination ...........................................................................................18
4.4 Usage .............................................................................................19
5 Removal procedure ............................................................................19
6 Adverse Effects ..................................................................................19
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1. Intended Use
• The Laryngeal airway is an oropharyngeal airway, it is a device inserted
into a patients pharynx through the mouth to provide a patient airway.
• GIMA Laryngeal Airway is indicated for use as an alternative to the facemask for achieving and marinating control of the airway during routine and
emergency anesthetic procedures. It is not indicated for use as a replacement for the end tracheal tube and is best suited for use in elective surgical
procedures where tracheal intubations are not necessary.
• The airway is also indicated in known or unexpected difcult airway situation. It is also indicated as a method of establishing a clear airway during resuscitation in the profoundly unconscious patient with absent gloss
pharyngeal and laryngeal reexes who may need articial ventilation. In
these cases, the airway should be used only when tracheal intubations is
not possible.
2. Specification
Mask Size
Size #1,5 #2 #2,5 #3 #4 #5
Description Infant Infant Child Boy Adult Adult
Recommended weights 5-10 kg 10-20 kg 20-30 kg 30-50 kg 50-70 kg > 70kg
Cuff Ination 7 ml 10 ml 14 ml 20 ml 30 ml 40 ml
Maximum Cuff pressure 60 cmH2O
Table 1: Selection guildlines for GIMA Laryngeal Airway.
2.1 Name of product parts
Cuff
Air Connector
Airway Tube
Pilot Tube
Pilot Balloon
Ination Valve
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3. Preparation for use
3.1 Cleaning and sterilization
Cleaning and sterilization as described below must be carried out for each
subsequent use.
The GIMA Laryngeal Airway can be used a maximum of 40 times by attending the recommended cleaning, sterilization and handling procedures. Proper cleaning and sterilization of the device is essential to ensure continued
safe usage up to 40 times.
GIMA has validated the instructions provided below as being capable of
preparing an GIMA Laryngeal Airway for re-use. It remains the responsibility of the processor to ensure that processing as actually performed using
equipment, materials and personnel in the processing facility achieve the
desired result. This requires validation and routine monitoring of the process. Likewise any deviation by the processor from the instructions provided should be properly evaluated for effectiveness and potential adverse
consequences.
CAUTION
Handle the GIMA Laryngeal Airway carefully as it is made of silicone, which
can be torn or punctured. Avoid contact with sharp or pointed objects.
WARNING
Do not replace or disassembly any components of the GIMA Laryngeal
Airway as it may cause product failures.
3.1.1 Cleaning instruction
It is recommended to follow the described validated manual cleaning procedure to ensure proper cleaning.
CAUTION
Do not expose the ination valve to any liquid as it may cause premature
ination valve failure.
The GIMA Laryngeal Airway should be kept moist between the time of use
and subsequent cleaning. Remove excess soil with disposable cloth/paper
wipe. Thoroughly rinse the GIMA Laryngeal Airway in cold running water to
avoid protein coagulation.
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Wash the device thoroughly in water using a mild detergent until all adherent visible soil is removed. It is recommended to wash the GIMA Laryngeal
Airway with Endozime manufactured by Ruhof. The working solution should
be prepared by using 35 ml Endozime per 4 liter warm water (one ounce of
Endozime to 1 gallon of warm water).
CAUTION
All detergents should be used in the recommended dilution/concentration,
temperature, water quality (e.g., ph, hardness), and exposure (soak or contact) time, in accordance with the detergent manufacturer’s directions.
WARNING
Do not use germicides, disinfectants, or chemical agents such as glutaraldehyde, ethylene oxide, phenol-based cleaners, iodine-containing cleaners
or quaternary ammonium compounds to clean or sterilize the GIMA Laryngeal Airway. The material absorbs such substances, resulting in exposure of
the patient to potentially severe tissue burns and possible deterioration of
the device. Do not use an GIMA Laryngeal Airway that has been exposed to
any of these substances.
To ensure proper cleaning of the airway tube it is recommended to use a soft
bristle brush. Brushes should have a tight t, but be able to move back and
forth in the area being cleaned. Never use hard brushes or other materials,
which might damage the silicone cuff or surface.
Remove all cleaning residues by thoroughly rinsing the cuff and airway tube
in running tap water for 1 minute. Make sure that the water passes through the tube. Closely examine the GIMA Laryngeal Airway to ensure that all
visible foreign matter has been removed. Repeat the above procedure as
necessary.
CAUTION
Effective cleaning must be carried out to achieve proper sterilization.
3.1.2 Sterilization instruction
The only recommended sterilization method is steam autoclaving. Strictly
adhere to the following validated instructions to ensure sterilization and to
prevent damage.
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Immediately prior to steam autoclaving, deate the cuff completely. Ensure
that the valve and syringe used to deate the cuff are dry.
Caution: Any air or moisture left in the cuff will expand during autoclaving
process and will cause irreparable damage to the cuff and /or pilot balloon.
If a deated mask immediately and spontaneously reinates (even slightly),do not autoclave or reuse this mask. This may indicate the leak or valve
malfunctioning.
The GIMA Laryngeal Airway should be placed in an appropriate steam autoclave-proof bag before steam autoclaving. Ensure that the pack is large
enough to contain the device without stressing the seals. It is recommended
to use the following sterilization cycle according to AAMI TIR 12:2004
Item Exposure time
Drying time
At 135°C (275°F)
Wrapped utensils 10 min 30 min
Table 2. Parameters for gravity-displacement steam sterilization cycles
The record card should be completed each time the GIMA Laryngeal Airway
is sterilized. After sterilization the GIMA Laryngeal Airway should be stored
in accordance with accepted hospital practice. The GIMA Laryngeal Airway
should not be exposed to direct sunlight or or elevated temperatures during
storage. Store in unopened bags at temperature between 10°C/50°F and
25°C/77°F
3.2 Functional testing
Functional testing as described below must be carried out before using the
device. The tests should be conducted in a manner consistent with accepted medical practice that minimizes contamination of the GIMA Laryngeal
Airway prior to insertion.
WARNING
Do not use and destroy the device if any one test fails. Dispose of the GIMA
Laryngeal Airway in a safe manner according to local guidelines of medical
waste.
CAUTION
Always wear gloves during the preparation and insertion of the GIMA Laryngeal Airway to minimize contamination.
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3.2.1 Test 1-Visual inspection
Closely examine the surface of the GIMA Laryngeal Airway for any damage,
perforation, scratches, etc. Do not use the GIMA Laryngeal Airway if it is
damaged in any way. Check that the interior of the tube and cuff are free
from blockage and any loose parts. Parts and blockages should be removed
as these may prevent the device from functioning properly. Do not use the
GIMA Laryngeal Airway if any of loose parts or blockages cannot be removed. Check that the airway connector on the GIMA Laryngeal Airway is tted
tightly to the airway tube. Ensure that it cannot easily be pulled off. Do not
twist the connectors as this may break the seal. Closely examine the pilot
balloon for any damages.
WARMING
Do not use the GIMA Laryngeal Airway if the mask connector does not t
tightly into the outer end of the airway tube.
3.2.2 Test 2-Inflation/deflation test
Deate the cuff of the GIMA Laryngeal Airway completely. Once deated,
check the cuff thoroughly for any wrinkles or folds. Over-inate the cuff to
the appropriate volume as specied in Table 3. Check that the inated cuff
is symmetrical and smooth. There should not be any bulge nor any sign of
leakage in the cuff, pilot tubing or balloon.
WARNING
Do not use the GIMA Laryngeal Airway if there are any bulges on the cuff or
if there are any signs of leakage.
Mask size
#1,5 #2 #2,5 #3 #4 #5
Over-ination
10 ml 15 ml 21 ml 30 ml 45 ml 60 ml
Cuff volumes
Table 3. Over-inflation volumes for the GIMA Laryngeal Airway.
CAUTION
The ination volumes specied in Table 3 are for testing purposes only. These volumes are not to be used during normal use of the device the recommended standard ination volumes can be found in Table 1.
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4. Insertion
4.1 Pre-insertion preparation:
Before insertion of the GIMA Laryngeal Airway, the cuff should be completely deated so that the cuff is at and free of wrinkles. Simply press the cuff
down onto a at sterile surface (e.g. a piece of sterile gauze) while at the
same time deating the device with a syringe. Complete deation results in
a shape like the rim of a saucer, and facilitates insertion and correct positioning of the device. To further facilitate insertion into the patient, a sterile, water-based lubricant (e.g. K-Y Jelly®) should be applied to the distal posterior
surface of the cuff (local anesthesia is not recommended.)
WARNING
Lubricate only the posterior tip of the cuff to prevent blockage of the airway
aperture or aspiration of the lubricant.
4.2 Insertion
Before insertion, it is essential that all clinicians using the GIMA Laryngeal
Airway are familiar with the warnings, precautions and indications, found in
these directions for use.
The following points are extremely important
- Check for correct deation and lubrication as described above.
- The size of the GIMA Laryngeal Airway must t the patient. Use the guide-
lines in Table 1 combined with clinical judgement to select the correct size.
- Always have a spare GIMA Laryngeal Airway ready for use.
- Pre-oxygenate and use standard ready for use.
- Check that the level of anesthesia (or unconsciousness) is adequate befo-
re attempting insertion.
- The head of the patient should be extended with exion of the neck in a
position normally used for tracheal intubation (i.e “the snifng position”)
- Never use excessive force.
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4.3 Inflation
After insertion, the line on the airway tube should be oriented anteriorly
toward the patient’s nose. Without holding the tube, inate the cuff with just
enough air to obtain a seal, equivalent to intracuff pressures of approximately 60 cmH2O. In many cases, only half of the maximum volume is sufcient
to achieve a seal-please refer table 1 for maximum volume. Check the cuff
pressure at start and periodically, either with a cuff pressure gauge or by
feeling the tension in the pilot ballon. This is especially important when N2O
gases are used.
Never over-inflate the cuff. Avoid prolonged intracuff pressures greater
than 60 cmH2O. The initial cuff pressure varies according to patient, mask
size, head position, and depth of anesthesia. Do not hold the tubing during ination as this prevents the mask from seating itself correctly. A small
outward movement of the tube is often seen as the mask settles into the
hypopharynx.
To avoid overination, it is very important to strictly adhere to the cuff-ination volumes stated in table 1. Over-ination can be entirely avoided by
completely deating the cuff prior to insertion by withdrawing all of the air
with a suitable syringe. This is the method recommended by GIMA.
In instances where an alternative technique is adopted, for example if the
cuff is inserted in a neutral or semi-inated state, there is a risk that the cuff
may be over-inated. Extra care therefore has to be taken after insertion to
compensate for the air already in the mask when subsequently inating the
cuff. The maximum extra volume depends on mask size and initial volume
of air in the mask when inserted.
WARMING
Never overinate the cuff after insertion.
Looking for the following signs of correct placement: the slight outward
movement of the tube upon cuff ination, the presence of a smooth oval
swelling in the neck around the thyroid and cricoid area, or no cuff visible
in the oral cavity.
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4.4 Usage
5. Removal procedure
Removal should always be carried out in an area where suction equipment
and the facility for rapid tracheal intubation are available. Do not fully deate
the cuff until after its removal to avoid secretions entering the larynx and
to prevent larygospasm. Alternatively, it may be removed moderately inated to aid complete removal of secretions. If the mask is to be removed in
the Post-Anesthesia Care Unit, recovery room staff should receive thorough
training in all aspects of the GIMA Laryngeal Airway.
6. Adverse Effects
Use of the GIMA Laryngeal Airway may cause minor adverse effects (e.g.,
sore throat) and major adverse effects (e.g. aspiration).
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Codice prodotto
Product code
Numero di lotto
Lot number
Attenzione! Leggere le avvertenze d’uso
Caution! Read instructions carefully
Fabbricante
Manufacturer
Prodotto conforme alla Direttiva Europea n. 93/42/CE
0476
Product complies with European Directive no. 93/42/CEE
Conservare in luogo fresco e asciutto
Keep in a cool, dry place
Conservare al riparo da fonti di calore e luce solare
diretta
Keep away from sunlight
Consultare le istruzioni prima dell’uso
Read instructions carefully
Data di scadenza
Expiration date
Data di fabbricazione
Date of manufacture
Sterilizzato mediante ossido di etilene
Sterilised using ethylene oxide
20
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