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User manual
Dear patient,
The entire package leaflet must be read carefully because of the
content of the important information of the usage of this respira-
tory therapy device. If further questions occur, please contact
your doctor or pharmacist.
Contents:
•
main part with mouthpiece
•
funnel
•
stainless steel ball
•
vented screw-on headpiece
•
instruction manual
Fields of application
resi is a device for respiratory therapy that helps to loosen sticky,
viscous bronchial slime, even with constricted airways. resi is in-
tended for use by patients with obstructive airway diseases, such
as chronic bronchitis, chronic obstructive bronchitis or similar ail-
ments.
Principle of action and scheme
The respiratory therapy device is a small,
pipe-shaped product consisting of a mouth-
piece, a funnel, a stainless steel ball and a
perforated headpiece. At rest (without res-
piratory movement), the stainless steel ball
closes the funnel. When the patient exhales,
a positive expiratory pressure (PEP) is cre-
ated in the device and the airways. The PEP
prevents the airway from collapsing through
resi and increases until it is large enough to
move the stainless steel ball so that it rolls
up the wall of the funnel (Figure 1).
Exhaling through the resi creates vibrations
that increase the pressure in the bronchial
tubes - down to the deepest branches - and
vibrate the exhaled air so that the mucus is
loosened from the bronchial walls and can
be better transported away toward the
mouth.
This movement clears the way through the funnel and allows the
pressure or air to escape. Then the stainless steel ball falls back
and closes the opening in the funnel again. This causes the pres-
sure to build up again in the unit (Figure 2).
The process repeats rapidly during exhalation, causing the bronchi
to vibrate with oscillating positive exhalation pressure (OPEP). Tilt-
ing up or down causes the stainless steel ball to move faster or
slower.
Contraindications
The therapy device is not to be used if the patient suffers from a
pneumothorax. (A pneumothorax is an abnormal collection of air
in the space between the lung and the chest wall. This may lead
to a partial or complete collapse of one of the lung lobes.)
Warnings
The material used for the construction of resi is impact-resistant
but breakable under high use of force. Please be careful: dropping
the device on a hard surface (e.g. tiles) can cause damage. Espe-
cially the stainless steel ball and other parts of the resi are not to
be put in the mouth (Caution, choking hazard!). Do not sterilize
the device with gas with ethylene oxide, hot air, hydrogen perox-
ide or radiation! The device will be melted or destroyed in a mi-
crowave vaporizer! If too much pressure is built up in the ball
body, it blowback may cause damage to the teeth.
Side Effects
No side effects will occur by using resi as described. In case of el-
evated breathing speed, mild dizziness and numbness can occur
around the mouth and in the hands. If these side effects occur, the
use of the device must be stopped immediately. The symptoms
will subside after a few minutes with normalized breathing. Dan-
gerous overpressure in the lungs is not created during the use of
resi because exhaling forcefully will lift the stainless steel ball out
of the funnel, clearing the way for air and the pressure to escape.
The pressure generated during slow and relaxed breathing is only
slight and amounts to pressure fluctuations of about 10 – 25 cm
water column. For patients with a sensitive bronchial system, this
has no irritating effect on the airways.
Note
Please report all serious incidents directly to the manufacturer
and to relevant national authorities.
Application instructions
To enable a successful airway therapy, please always follow the
instructions. Adult supervision is recommended during usage and
cleaning by children.
Before the first use
We recommend cleaning resi thoroughly and allow it to dry before
using it for the first time. Recommended cleaning with hot water
containing soap or dish soap and rinsing completely. Once resi is
dry, it can be assembled as described in the next paragraph:
•
Take the main part ① in your hand.
•
Place the funnel ② in the indentation provided.
Place the stainless steel ball ③ in the funnel.
•
Screw the head part ④ to the main part. The screw connec-
•
tion is tight when both semicircular marks on the head and
Figure 1
main part form a flush circle (Figure 3).
Figure 2
Using resi
1.
For the best possible success we recommend sitting relaxed
on a table with your elbows on the top. Please make sure
not to cover the holes of resi while holding it in your hands
2.
Put the mouthpiece in your mouth.
3.
Inhale slowly and relaxed through the nose and hold this
breath for 1 - 2 seconds.
4.
Then breathe out slowly and for as long as possible via the
mouthpiece. Make sure to keep your cheeks taut by tensing
the muscles.
5.
Keep the device in your mouth and repeat step 2 and 3, do
not to strain or breathe rapidly.
6.
You are using resi correctly, when you
feel distinct, thumping vibrations in
the chest. You may need to raise or
lower the device to determine the
ideal position.
7.
If you should experience a coughing impulse, try to huff the mucus loosened by the application of resi up
as if you were breathing on a pane of glass. With this so-called "huffing" you avoid strained coughing,
which in turn would make it more difficult to remove the mucus, since the bronchi are being constricted
due to the coughing.
Frequency of use
Our recommendation is to apply resi several times a day.
Cleaning of resi
For hygienic reasons, we recommend that resi is used individually.
1.
Cleaning the device at home
Clean the device daily to keep it hygienically clean and avoid contamination with germs. Cleaning instructions:
•
Disassemble the device.
•
In case of severe dirt accumulation in the device, we recommend pre-cleaning with water and soap or
dish soap
•
All 4 components of resi should now be placed in boiling tap water for 3 minutes. Make sure that all
components are completely submerged.
•
Let resi dry under a clean cloth in a warm place (overnight recommended).
The device can also be cleaned in the dishwasher.
2.
Cleaning in a clinical setting, etc.
Disinfection through immersion in a disinfectant is possible, as long as the manufacturer's instructions are fol-
lowed. Experimental testing has demonstrated effectiveness with conventional alcohol-based disinfectant (70
% ethanol content). Cleaning with a vaporizer is recommended. In addition, autoclaving up to 134°C with super-
heated steam is possible. resi is also suitable for cleaning in the dishwasher.
Storage instructions
The medical device should not be stored below 0°C and above 50°C (ideal: room temperature) and should be
kept away from children!
Disposal instructions
Dispose resi in the household waste. Packaging and instructions in the paper waste.
Technical characteristics
The OPEP device weighs approx. 58 g. The stainless steel ball for generating the oscillation weighs approx. 28 g.
The pressure generated in resi by exhalation of the user can be varied between 10 – 25 cm water columns.
When using resi while it is in a horizontal position, the frequency at which the stainless steel ball oscillates during
expiration is approximately 15 Hz.
Material
resi is made of POM and is dyed blue (BLUE RAL 5002).
Figure 3
Anel AG
Weyermannsstrasse 12
3008 Bern, Switzerland
International Associates Auditing
& Certification Limited
The Black Church, St Mary's Place,
Dublin 7, D07 P4AX Ireland
EUAR@ie.ia-net.com
State of information:
03.02.2023
Lot designa-
Medical device
tion
"Usable until"
Protect from sunlight
Follow the in-
For reuse on a single
structions for
patient
use
Temperature limits
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