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ENTSORGUNG
VORSICHT
Das Produkt kann mit potenziell infektiösen Stof-
fen menschlichen Ursprungs kontaminiert werden.
Das gebrauchte oder mangelhafte Produkt muss gemäß den
anwendbaren nationalen und internationalen gesetzlichen
Regelungen entsorgt werden.
PRODUKTSPEZIFIKATIONEN
30-40-111
Größe
Endosko-
klein
piemaske
Konnektor
/ Verlän-
15 mm A.D. 15 mm A.D. 15 mm A.D. 15 mm A.D.
gerungs-
schlauch
Länge
Verlän-
gerungs-
schlauch
Öffnung
der Memb-
Ø 2.0 mm
rane
Gewicht
(inkl. Ver-
620 g
packung)
Verpa-
ckungsein-
10
heit
ZUBEHÖR
30-40-420-1
Bezeichnung
Bronchoskop Einführtubus
2
Länge
65 mm
CE-Kennzeich-
nung
Gewicht
(inkl. Verpa-
172 g
ckung)
Verpackungs-
10
einheit
MATERIALDATEN
Bezeichnung
30-40-111,
Endoskopiemaske
30-40-333,
Membrane
30-40-555,
30-40-777
Verlängerungsschlauch
30-40-420-1,
Bronchoskop Einführtubus
30-40-440-1
35-30-255
Fixationsband
30-40-333
30-40-555
mittel
groß
155 mm
Ø 3.0 mm
Ø 5.0 mm
Ø 10.0 mm
840 g
960 g
10
10
30-40-440-1
35-30-255
Fixationsband
4
85 mm
0123
250 g
10
Material
PVC
Silikon
PP, EVA (Schlauch),
PC (Konnektor)
EVA
EPDM
English
INTENDED USE
Endoscopy Mask: To seal mouth and nose during ventilation/
oxygenation of a patient and to allow simultaneous insertion
of an endoscope.
Bronchoscope Airway: To guide and protect the endoscope/
tracheal tube.
Fixation Tape: To hold a face mask in position.
Clinical Benefit: Prevention and control of hypoventilation
30-40-777
and desaturation. Reduces interruptions during endoscopic
procedures.
Patient target group: Children and adults
groß
Place of use: Hospital
INDICATIONS
• Temporary mechanical ventilation/oxygenation during
fibreoptic intubation, bronchoscopy and upper gastroin-
testinal endoscopies.
No other indications are known.
CONTRAINDICATIONS
• In non-fasted patients with increased risk of aspiration,
mask ventilation must not be employed.
No other contraindications are known.
SAFETY INSTRUCTIONS
960 g
• Read and follow the instructions for use care-
10
• This product must only be used by medically
• Only use the product for the patient target group.
• The user and/or patient must report all serious
-
-
• Before use, the product must be inspected visu-
• Application time: ≤ 2 hours
480 g
• It is not permitted to make any changes to the
10
• The product is suitable for conducting oxygen, air,
• The Endoscopy Mask and the Fixation Tape are
• The product is intended for single use and must
• The Endoscopy Mask is not suitable for MRI.
• The Bronchoscope Airway and the Fixation Tape
• The Bronchoscope Airway is sterile (ethylene
STERILE EO
• The product must not be used if the packaging
PRODUCT DESCRIPTION (FIG. 1)
a - Membrane
b - Plug
c - One-way valve with female Luer connector
d - Mask cushion
e - Extension tubing
f - Bronchoscope Airway (accessory)
g - Fixation Tape (accessory)
- 6 / 48 -
fully before using the product and keep them for
future reference.
trained personnel.
adverse events that occurred in connection with
the product to the manufacturer and competent
authorities of the EU member state (or report to
the competent authorities of the country if an
event occurs outside of the EU) in which the user
and/or patient is located.
ally (see section "Visual inspection"). A faulty
product must not be used.
product.
anaesthetic gases and their gas mixtures.
not sterile.
not be reused and/or reprocessed. The function of
the product is impaired by processing. Any reuse
entails a potential infection hazard.
are suitable for MRI.
oxide).
is damaged or the expiration date has expired.
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