Biegler RESPIFIT S User manual

Instructions for use
Patients
RESPIFIT S
Inspiratory Muscle Training
Device
Edition 2021-05-18 | 40-246-03
Sales Manufacturer
ENG

RESPIFIT S
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IMPORTANT
These instructions for use are essential for operating the
device. They must be kept in a suitable place near the
device, and should be kept with the device. If the device is
transferred to another user, the instructions for use must be
supplied with it.
For proper and safe operation and use of this device, it is
essential that the instructions for use, including safety
instructions and warnings, are read and complied with prior
to commissioning. It is the user’s responsibility to fully
familiarise themselves with how to operate the device
correctly.
Target group:
These instructions for use are aimed at patients who use the
RESPIFIT S.
More information on the settings and functions is available for clinical
users such as physiotherapists, care staff and doctors in the RESPIFIT S
(clinic) instructions for use.

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Table of Contents
1DESCRIPTION.............................................................................................................................. 4
1.1 GENERAL DESCRIPTION.............................................................................................................. 4
1.2 INTENDED USE ........................................................................................................................... 4
1.3 INDICATION................................................................................................................................. 5
1.4 CONTRAINDICATIONS .................................................................................................................. 5
1.5 SCOPE OF DELIVERY................................................................................................................... 5
1.6 ACCESSORIES ............................................................................................................................ 6
2GENERAL SAFETY INSTRUCTIONS.......................................................................................... 6
3INITIAL OPERATION AND USE .................................................................................................. 8
3.1 HANDHELD PATIENT MODULE....................................................................................................... 9
3.2 DATAKEY.................................................................................................................................. 11
3.3 CONNECTING THE DEVICE AND ACCESSORIES............................................................................. 12
3.4 SETTING UP BEFORE TRAINING .................................................................................................. 12
4TRAINING WITH THE RESPIFIT S............................................................................................ 13
4.1 THE STRENGTH EXERCISE ......................................................................................................... 13
4.2 THE ENDURANCE EXERCISE....................................................................................................... 16
4.3 RESULTS DISPLAY..................................................................................................................... 19
4.4 DECOMMISSIONING................................................................................................................... 19
5CLEANING.................................................................................................................................. 20
6MAINTENANCE.......................................................................................................................... 22
6.1 TROUBLESHOOTING.................................................................................................................. 22
6.2 PERIODIC INSPECTIONS ............................................................................................................ 22
7RETURNING DEVICES OR ACCESSORIES ............................................................................ 23
8DISPOSAL .................................................................................................................................. 23
9MANUFACTURER LIABILITY.................................................................................................... 24
10 WARRANTY CONDITIONS........................................................................................................ 24
11 ELECTROMAGNETIC COMPLIANCE....................................................................................... 26
11.1 EMISSIONS............................................................................................................................... 26
11.2 IMMUNITY TEST LEVEL............................................................................................................... 26
12 SYMBOLS................................................................................................................................... 27
13 OPERATING AND STORAGE CONDITIONS............................................................................ 28
14 TECHNICAL DATA..................................................................................................................... 29
15 MANUFACTURER AND SALES................................................................................................ 30
16 MANUFACTURER’S DECLARATION ....................................................................................... 30

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1 DESCRIPTION
1.1 General Description
The RESPIFIT S is a portable device for inspiratory muscle training.
The device is designed for the following indications: Patients with chronic
obstructive pulmonary disease and lung emphysema; for pre- and post-
operative respiratory therapy in association with pulmonary rehabilitation
and for patients with neuromuscular diseases involving the respiratory
muscles at an early stage of the disease.
The RESPIFIT S can be used to set up training programmes to increase
both strength and endurance of the respiratory muscles. Integrated
functions can also determine the capacity of the inspiratory muscles, i.e.
the strength and endurance of this muscle group.
An essential component of the device is the graphical representation of
the exercise sequence, which shows the patient whether he/she is
actually complying with the required training intensity
The patient’s individual exercise and configuration data is stored on the
removable datakey.
The interchangeable handheld patient module offers the ultimate in
hygiene and safety.
1.2 Intended Use
The RESPIFIT S is designed for personal training to increase the
strength and endurance of the inspiratory respiratory muscles in patients
from the age of 10 years.

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1.3 Indication
Chronic obstructive pulmonary diseases (COPD)
•For COPD stage GOLD II –IV as a measure that is ancillary to
established medicinal therapy and rehabilitation procedures.
Neuromuscular diseases
•Slowly progressive course
•Inspiratory vital capacity > 25% of the reference value
•paCO2 (Carbon dioxide partial pressure in the blood) < 45 mmHg
Other disease patterns involving respiratory muscle weakness,
such as
•Cystic fibrosis
•Kyphoscoliosis or diaphragm dysfunction
•Pre- and post-operatively in thoracic procedures
•Chronic heart failure
1.4 Contraindications
•Any acute disease
•Any acute change in condition, also as part of a chronic underlying
condition
•Any chronic underlying condition that is not sufficiently controlled
with treatment, e.g. arterial hypertension or diabetes
1.5 Scope of delivery
Number
Description
Catalogue number
1
RESPIFIT S device
LR1003004
from SN: 402005
1
RESPIFIT S instructions for use
clinic and patient
FK1003008
FK1003009
1
Handheld patient module
IB1002001
1
Datakey
AG6110050
1
Power supply unit Mean Well Type
GEM06I05
CJ1003004

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1.6 Accessories
Description
Catalogue number
Handheld patient module
IB1002001
Datakey
AG6110050
Power supply unit Mean Well Type GEM06I05
CJ1003004
2 GENERAL SAFETY INSTRUCTIONS
•RESPIFIT S may only be used under the direction of the treating
physician / therapist.
•RESPIFIT S (mouthpiece of the handheld patient module) may only
be used if the mucous membrane is intact.
•If the patient feels dizzy or unwell during the training session, the
exercise must be stopped and a doctor / therapist must be consulted.
•Unplugging the mains plug is the only safe way to disconnect from the
mains power supply. Only plug the power supply unit into sockets that
are easily accessible, so they can be disconnected quickly if
necessary.
•The power supply unit must not be brought into contact with any
liquids.
•It is prohibited to use the RESPIFIT S in extension cable connectors.
•The power supply unit must not be covered while in operation and
must not be operated in immediate proximity to any heater or in direct
sunlight.
•The device must not be used in dusty environments. Fluff and dust
may impair the function of the device.
•The device must be kept away from pests and pets.
•Keep Respifit S out of the reach of children.
•Caution: Risk of strangulation when handling the tube!
•RESPIFIT S must not be used in rooms with potential explosion
hazard.

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•RESPIFIT S may only be used in areas in which the electrical
installations comply with the standards and regulations in force.
•This device is subject to specific preventive measures with regard to
electromagnetic compatibility (EMC) and must therefore be set up and
commissioned in accordance with the EMC instructions contained in
Section 12 of these instructions for use. Portable and mobile HF
communications equipment can affect medical electrical devices. As
specified in Table 6 of IEC 60601-1-2 for medical electrical equipment,
a typical mobile phone with a maximum output of 2 W results in a
distance d = 3.3 m for an immunity level of 3 V/m.
•The device may be impaired by other devices set up in the vicinity, or
may impair these devices.
•All extraneous influences such as radiation or high temperatures must
be kept to a minimum
•Only persons and service centres authorised by Biegler may carry out
repairs and modifications to the RESPIFIT S.
•RESPIFIT S and its accessories must not be sterilised with steam or
by thermochemical methods and must not be immersed in liquid. The
handheld patient module may be immersed in liquid when being
cleaned as described in Section 5.
•It is absolutely essential that the periodic technical safety inspections
(see Section 6.2) are carried out and that the relevant inspection date
is documented.
•Only use original Biegler consumables in conjunction with the
RESPIFIT S.
•Only use original Biegler accessories in conjunction with the
RESPIFIT S. Power supply unit MEAN WELL Type GEM06I05,
handheld patient module, datakey.
•The connector and the patient must not be touched simultaneously.
•The handheld patient module must only be used repeatedly by a
single patient.
•If, as a result of repeated cleaning processes, the handheld patient
module shows signs of functional defects or if the finite operating life
for "single patient use" is exceeded, then the module must no longer
be used and must be replaced with a new handheld patient module.
•If the datakey is pulled out during operation, this may result in device
(menu) or datakey defects.

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•If the device is plugged in without the datakey inserted, the display
indicates “DATAKEY “
•Measurements using RESPIFIT S serve only as a basis for training
settings and do not constitute a complete determination of pulmonary
function. For diagnosis and monitoring, measurements must be
carried out by the treating physician / therapist, independently of the
RESPIFIT S.
•If the device is dropped, damaged due to force, or functions in a way
other than described in the instructions for use, stop using the device
immediately and return it to the service centre.
3 INITIAL OPERATION AND USE
Consult the instructions for use! Users must thoroughly
familiarise themselves with the contents of these instructions
before putting the system in operation.
RESPIFIT S may only be used under the direction of the
treating physician / therapist.
Remove the device from the packaging and wait until the device
has reached room temperature.
If the temperature is in the lower or upper range of the storage
temperature, this process takes no more than 15 minutes.

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Figure 1: RESPIFIT S in packaging
3.1 Handheld patient module
The handheld patient module must only be used repeatedly
by a single patient (refer to cleaning instructions in
Section 6).
Important: The maximum service life of the handheld patient module is
three months. The handheld patient module therefore has to be disposed
of after no more than three months and a new patient module used.
To calculate the resistance RES, three different aperture diameters are
available to the treating physician / therapist: A, B or C.

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Figure 2: Resistance RES in the aperture diameters A, B or C
Once the appropriate aperture has been selected, the adjustment
mechanism is pushed down and locked and is therefore inaccessible to
the patient. Thereafter the adjustment mechanism can no longer be
released.
When purchasing a new handheld patient module, please ensure that
the treating physician / therapist makes the patient-specific adjustments
once again and subsequently locks the adjustment mechanism.
Moreover, for each aperture you can select strength exercise or
endurance exercise by rotating.
Figure 3: Strength / endurance exercise setting

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Assembling the handheld patient module
The handheld patient module must be assembled before starting
therapy. The mouthpiece and tube must be attached in accordance with
the figure below.
Figure 4: Connecting the handheld patient module
3.2 Datakey
Before the patient starts therapy with the RESPIFIT S, the patient-
specific settings must be determined under the direction of the treating
physician / therapist and stored on the datakey.
Figure 5: Insert the datakey into the back of the device
Insert the datakey into the device at the
position indicated.
If the device is plugged in without the
datakey inserted, “DATAKEY “
appears on the screen.

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3.3 Connecting the device and accessories
Figure 6: Connecting the power supply unit to the device
Insert the connector plug
of the connection cable
into the labelled socket of
the device and connect
the power supply unit to
the mains power.
Connect the connection tube to the handheld patient module and the
device with Luer connectors.
Figure 7: Connecting the handheld patient module to the device
Figure 8: Patient module in use
3.4 Setting up before training
Before training, the treating physician / therapist adjusts the device one
single time to the needs of the patient.
As training advances, the treating physician / therapist can make
ongoing adjustments.
GEM06I05

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4 TRAINING WITH THE RESPIFIT S
IMPORTANT
RESPIFIT S may only be used under the direction of the
treating physician / therapist.
Prior to training, commission the device and accessories as
described in Section 3.
Figure 9: Welcome screen
After switching on the device (plugging in the
mains plug) with the datakey inserted, a welcome
screen appears. The name of the patient stored
on the datakey is displayed.
Briefly press the button to access the training mode.
4.1 The strength exercise
Important: A nose clip must be used for carrying out the exercises set
out below. Breathe freely without the handheld patient module between
individual exercises to ensure sufficient tidal breathing.
Each individual strength exercise consists of an inspiratory manoeuvre
against near-maximum resistance. The respiratory muscles, in particular
the diaphragm, are under maximum strain. In the strength exercise, the
cross-section of the air duct is reduced to such an extent that only a
minimum volume of air can be aspirated.
Each inspiratory manoeuvre will start from a state of maximum
exhalation (residual volume). During inhalation, the dumbbell, the icon for
the strength exercise, is raised in accordance with the negative pressure
achieved. In order for an exercise to be successfully completed, the
dumbbell must be held above the preset minimum strength value for one
second.
One strength training (exercise block) consists of up to 20 individual
exercises. The doctor / therapist determines how many individual
exercises should be included in an exercise block. Once all individual
exercises have been successfully completed, the exercise block is
closed and stored on the datakey as a successful training session.
For each exercise block, a defined number of failed attempts may be
permitted. It is deemed to be a failed attempt if the preset minimum

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strength value is not achieved at all or not achieved in one breath
(coughing, etc). It is also deemed to be a failed attempt if the dumbbell is
not held above the preset minimum strength value for one full second. If
there are more defective breaths than are permitted, the exercise block
is closed and stored on the datakey as a failed training session.
There must be a pause between the individual exercises, for recovery. A
minimum pause time of between 1 and 30 seconds is stipulated. The
device is subsequently ready for the next individual exercise.
For the strength exercise, the following parameters must be set in
advance by the treating physician / therapist:
•Minimum strength value
•Number of strength exercises (per exercise block)
•Number of failed attempts (per exercise block)
•Pause time (between the individual exercises)
Before starting the exercises, the arrow on the handheld patient module
must point towards the dumbbell icon (as shown on the screen).
Figure 10: Strength training screen display
Figure 11: The arrow on the handheld patient module points
towards the dumbbell
Press the button to access the training screen for the strength
exercise.

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The training screen for the strength exercise is structured as follows:
Figure 12: Strength exercise training screen
The strength bar shows how high the dumbbell must be lifted for each
exercise. The dumbbell must be held above the preset minimum
strength value for one second.
The dumbbell is raised when inhaling, in accordance with the
pressure reached.
The set minimum strength value, which must be attained for each
exercise, is displayed as a numerical value within the weight. During
inhalation, the current actual pressure attained is displayed.
The number of individual exercises is displayed next to the "exercise"
icon. This number goes down with each successfully completed
individual exercise.
The number of failed attempts that are permitted for each exercise
block is displayed next to the "failed attempt" icon. This number goes
down with each failed attempt.
After each individual exercise, a separate screen indicates whether the
exercise has been carried out correctly or not. A smiling face is displayed
if the exercise was successful and a sad face is displayed after a failed
attempt. An hourglass shows how long the patient should pause between
two exercises.
Figure 13: Exercise successful
Figure 14: Exercise failed

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The strength training is concluded either once the required number of
individual exercises has been completed or the number of permitted
failed attempts has been exceeded.
A separate screen indicates whether the training (exercise block) has
been successfully completed or not.
Figure 15: Training successful
Figure 16: Training failed
Unplug the power supply unit to shut down the device.
If both strength training and endurance training have been set up by the
treating physician / therapist, press the button to access the
endurance training.
4.2 The endurance exercise
Important: A nose clip must be used for carrying out the exercises set
out below. Breathe freely without the handheld patient module between
individual exercises to ensure sufficient tidal breathing.
For the endurance exercise, inhalation is carried out against a pre-
established resistance. The cross-section of the air duct is reduced by
the set aperture (A, B or C).
Inhaling and exhaling through the handheld patient module at normal
breathing rate (tidal breathing frequency) moves the balloon up and
down on the screen. The balloon moves up with each inhalation and
drops back during exhalation. The exercise is deemed to have been
successfully completed if the balloon does not touch either the floor or
the sky during the one-minute exercise duration. The exercise starts as
soon as the first breath is taken.
One endurance training session (exercise block) consists of up to 20
individual exercises. A defined number of failed attempts may be
permitted per exercise block.
There must be a pause between the individual exercises, for recovery. A
minimum pause time of between 1 and 20 seconds is stipulated. The
device is subsequently ready for the next individual exercise.

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For the endurance exercise, the following parameters must be set in
advance by the treating physician / therapist:
•Number of endurance exercises (per exercise block)
•Number of failed attempts (per exercise block)
•Pause time (between the individual exercises)
•Minute volume
•Handheld patient module settings
Before starting the exercises, the arrow on the handheld patient module
must point towards the balloon icon (as shown on the screen).
Figure 17: Endurance training screen display
Figure 18: The arrow on the handheld patient module points
towards the balloon
Press the button to access the training screen for the endurance
exercise.
The training screen for the endurance exercise is structured as
follows:
Figure 19: Endurance exercise training screen
The balloon rises and falls while breathing. The patient's task is now
to move the balloon up and down by inhaling and exhaling at tidal
breathing frequency, making use of the full screen height. The sky

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and the ground, depicted symbolically on the screen, represent the
boundaries within which the balloon must be moved.
During the exercise, the seconds indicator continuously counts down
from 60 seconds and the time bar diminishes accordingly.
The number of individual exercises is displayed next to the "exercise"
icon. This number goes down with each successfully completed
individual exercise.
The number of failed attempts that are permitted for each exercise
block is displayed next to the "failed attempt" icon. This number goes
down with each failed attempt.
After each individual exercise, a separate screen indicates whether the
exercise has been carried out correctly or not. A smiling face is displayed
if the exercise was successful and a sad face is displayed after a failed
attempt. An hourglass shows how long the patient should pause between
two exercises.
Figure 20: Exercise successful
Figure 21: Exercise failed
The endurance training is concluded either once the required number of
individual exercises has been completed or the number of permitted
failed attempts has been exceeded.
A separate screen indicates whether the training (exercise block) has
been successfully completed or not.
Figure 22: Training successful
Figure 23: Training failed
Press the button to go back to the welcome screen.

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4.3 Results display
The results of the exercises can be displayed by pressing on the start
screen.
Figure 24: Results selection on the device
The results of the exercises performed are displayed along with any
stops during the training session.
The settings made by the treating physician / therapist are also shown in
the display, under “INFO”.
Figure 25: Display order of results
The next display is opened by pressing the button.
4.4 Decommissioning
Unplug the power supply unit to shut down the device.

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5 CLEANING
IMPORTANT
Before cleaning, the device must always be disconnected
from the mains power supply.
The device may only be cleaned using a soft cloth with
water-soluble, non-abrasive cleaning agents or special
cleaning agents for plastics.
In all instances of cleaning, never allow any liquid to get into
the device or into the transparent measuring lead (tube) of
the handheld module. Prior to beginning the cleaning
process, disconnect the measuring lead from the system.
The handheld patient module must only be used repeatedly
by a single patient.
The handheld patient module must be cleaned after each application and
must be replaced after 3 months of use or in the event of any operational
defects.
The treating physician / therapist decides whether the handheld patient
module is to be cleaned with or without subsequent disinfection.
The handheld patient module must be cleaned without the connecting
tube, since any moisture remaining in the tube can damage the pressure
sensor in the device.
Cleaning
The handheld patient module must be disassembled and completely
immersed in warm water with a little washing up liquid added to it. It
should then be carefully rinsed off with water and left to dry.
Cleaning and disinfection
The handheld patient module must be disassembled and completely
immersed in warm water with a little washing up liquid added to it. It
should then be carefully rinsed off with water. The disinfection agent
Cidex OPA (0.55% ortho-phthalaldehyde) from Johnson & Johnson,
Gigasept FF from Schülke or Korsolex extra from Bode should be used
to disinfect the handheld patient module. When using the disinfection
solution, the instructions for use supplied by the manufacturer of the