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English
INTENDED USE / INDICATION
During manual or mechanical ventilation, the Rendell Baker Mask
is used to seal the mouth and nose area.
CLINICAL BENEFIT
Patient ventilation with simultaneous reduction of dead space due
to the mask's design.
PATIENT TARGET GROUP
Newborns to children
CONTRAINDICATION
In non-fasted patients with increased risk of aspiration, mask
ventilation must not be employed except in emergency situations.
SAFETY INSTRUCTIONS
•
Read and follow the instructions for use carefully
before using the product.
•
This product must only be used by medically trained
personnel.
•
The user and/or the patient must report all serious
adverse events that have occurred in connection with
the product to the manufacturer and to the competent
authority of the EU member state in which the user
and/or patient is practising/residing (or the competent
authority of the country concerned if an event occurs
outside of the EU).
•
A check must be performed each time the product is
used or after every reprocessing (see section “Checks”).
Damaged products must not be used.
•
Insufficient ventilation can lead to permanent damage
in patients.
•
If ventilation is not possible with this product, another
adequate type of ventilation must be initiated.
•
Do not use the product in a toxic atmosphere.
•
Do not use oil, grease or any hydrocarbon-based sub-
stance on the product so as to avoid possible flamma
-
bility during use.
•
The product must be cleaned, disinfected and sterilised
prior to reuse (see section “Reprocessing”).
•
The product is suitable for MRI.
USE
Select the suitable mask size (see table “Technical data”).
Connect the mask to a resuscitator bag or ventilation system.
Position the child's head according to age.
CAUTION
If the child's head can be hyperextended according to
age, possible injury to the cervical spine must be taken
into consideration.
Press the mask tightly to the patient's face so that it forms an
airtight seal. If the mask does not fit properly, the ventilation
may be affected.
Fix the mask by hand.
REPROCESSING
(CLEANING, DISINFECTION, STERILISATION)
General information
•
The reusable products are supplied non-sterile and must be
unpacked, cleaned, disinfected and sterilised prior to first use.
•
Products must be reprocessed prior to each use.
•
The manufacturer is not responsible for damage resulting from
improper reprocessing.
•
The user is obliged to validate their procedures or the devices
and accessories and to comply with the validated parameters
during every reprocessing.
•
It is recommended to use an automated procedure because
automated cleaning and disinfection are significantly more
effective.
•
The effectiveness has been verified by an independent and
accredited test laboratory.
•
To achieve effective reprocessing, heavy soiling must not be
allowed to dry on the product and must be removed immedi
-
ately after use.
•
Silicone products must not come into contact with oil and
grease.
Cleaning / disinfection
Automated cleaning / disinfection
Notes regarding the use of washer disinfectors
•
Use de-ionised water.
Notes regarding the use of cleaning agents and disinfect-
ants
•
When alkaline cleaning agents are used, the agent must be
subsequently neutralised.
•
Do not use drying agents.
Procedure validated by the manufacturer:
1.
Position the products in the injector carriage:
Product / Parts
Position in injector carriage
Mask
Injector jet
2.
Start programme with the following parameters:
a.
Pre-rinse with de-ionised water at 20 °C (68 °F) and an
exposure time of 1 min.
b.
Cleaning at 55 °C (131 °F) with an exposure time of 5 min
using de-ionised water and “Sekumatic
®
ProClean” clean
-
ing agent (dose: 0.5% (5 ml/
l
)).
c.
Neutralisation with “Sekumatic
®
FNZ” at 20 °C (68 °F)
with an exposure time of 2 min (dose: 0.1% (1 ml/
l
)).
d.
Rinse with de-ionised water at 20 °C ( 68°F) and an expo
-
sure time of 2 min.
e.
Thermal disinfection at 93 °C (199 °F) for 5 min with
de-ionised water.
f.
Dry at 100 °C (212 °F) for 10 min.
3.
Check for visible contamination. If necessary, repeat the repro
-
cessing.
4.
Check the products according to the section “Checks” and pre
-
pare them for sterilisation (see section “Packaging”).
Summary of Contents for 35-60-000
Page 7: ...7 60 Rendell Baker 1 2 a 20 C 1 min...
Page 9: ...9 60 35 60 000 35 60 001 35 60 002 35 60 003 0 1 2 3 22 mm 10...
Page 14: ...14 60 Rendell Baker MRI 1...
Page 16: ...16 60 35 60 000 35 60 001 35 60 002 35 60 003 0 1 2 3 22 mm 10...
Page 45: ...45 60 Rendell Baker 1...
Page 47: ...47 60 35 60 000 35 60 001 35 60 002 35 60 003 0 1 2 3 22 10...
