Weinmann homecare SOMNOvent auto-S Application guide

SOMNOvent a u t o - S / S T
automatic BiLevel S/ST therapy device with autoTriLevel
principle
SOMNOvent a u t o - S
SOMNOvent auto-S with SOMNOclick 300
SOMNOvent a u t o - S 2 3 0 V
SOMNOvent a u t o - S T
SOMNOvent auto-ST with SOMNOclick 300
SOMNOvent auto-ST 230 V
Description of device and instructions for use

Contents 3
Contents
1. Overview . . . . . . . . . . . . . . . . . . . 4
1.1 Markings on the therapy device . 7
1.2 Markings on the packaging . . . . . 8
1.3 Safety information in these
instructions . . . . . . . . . . . . . . . . . . 8
2. Description of device . . . . . . . . . 9
2.1 Intended use. . . . . . . . . . . . . . . . . 9
2.2 Description of function . . . . . . . . 10
3. Safety instructions . . . . . . . . . . 13
3.1 Safety instructions . . . . . . . . . . . 13
3.2 Contraindications . . . . . . . . . . . . 15
3.3 Side effects. . . . . . . . . . . . . . . . . 16
4. Device setup . . . . . . . . . . . . . . . . 17
4.1 Set up and connect therapy
device . . . . . . . . . . . . . . . . . . . . . 17
4.2 For operation without respiratory
air humidifier . . . . . . . . . . . . . . . . 18
4.3 For operation with respiratory air
humidifier . . . . . . . . . . . . . . . . . . 18
4.4 Breathing mask. . . . . . . . . . . . . . 18
4.5 Connect other accessories . . . . . 19
5. Operation . . . . . . . . . . . . . . . . . . 21
5.1 Patient menu . . . . . . . . . . . . . . . 22
5.2 Read out therapy time . . . . . . . . 23
5.3 Auto On/Off . . . . . . . . . . . . . . . . 23
5.4 Mask test . . . . . . . . . . . . . . . . . . 24
5.5 Softstart setting . . . . . . . . . . . . . 25
5.6 Respiratory air humidifier . . . . . . 25
5.7 Operate therapy device. . . . . . . . 27
5.8 After use . . . . . . . . . . . . . . . . . . 29
5.9 Travel with the therapy device . . 30
6. Hygiene treatment . . . . . . . . . . 31
6.1 Intervals . . . . . . . . . . . . . . . . . . . 31
6.2 Breathing tube . . . . . . . . . . . . . . 32
6.3 Clean housing . . . . . . . . . . . . . . 33
6.4 Clean coarse dust filter/change
fine filter . . . . . . . . . . . . . . . . . . . 34
6.5 Accessories . . . . . . . . . . . . . . . . . 34
6.6 Disinfect therapy device . . . . . . . 35
6.7 Change of patient . . . . . . . . . . . . 36
7. Function check . . . . . . . . . . . . . . 37
7.1 Intervals . . . . . . . . . . . . . . . . . . . . 37
7.2 Function check of therapy device . 37
7.3 Function check of respiratory air
humidifier . . . . . . . . . . . . . . . . . . 37
8. Troubleshooting . . . . . . . . . . . . 38
9. Servicing . . . . . . . . . . . . . . . . . . . 39
9.1 Intervals . . . . . . . . . . . . . . . . . . . . 39
9.2 Scope of servicing . . . . . . . . . . . . 39
9.3 Change pressure
measurement tube . . . . . . . . . . . 39
10. Disposal . . . . . . . . . . . . . . . . . . . . 40
11. Scope of supply . . . . . . . . . . . . . 41
11.1 Standard scope of supply . . . . . . . 41
11.2 Accessories . . . . . . . . . . . . . . . . . 45
11.3 Replacement parts . . . . . . . . . . . 47
12. Technical data . . . . . . . . . . . . . . 49
12.1 Specifications . . . . . . . . . . . . . . . . 49
12.2 Pressure/volume curve . . . . . . . . . 52
12.3 Pneumatic diagram . . . . . . . . . . . 53
12.4 Safety distances . . . . . . . . . . . . . . 53
13. Warranty . . . . . . . . . . . . . . . . . . . 54
14. Declaration of Conformity . . . . 55
15. Glossary . . . . . . . . . . . . . . . . . . . 56

4Overview
1. Overview
Therapy device
2Power cord
11 Breathing tube
12 Exhalation system
6Device outlet port with
pressure measurement
connection
3Serial port
14 Head strap
13 Breathing mask
9Click adapter
1Bacteria filter
4Control panel and displays
5Connection for respiratory air humidifier
8Drying adapter
7Sealing plug
10 Pressure measure-
ment tube
19 Respiratory air hu-
midifier
20 Servicing
16 Filter change
18 Unit of measurement for
therapy pressure
17 Inspiration/exhalation/ad-
justable value
15 Softstart
Symbols in the display

Overview 5
Key
1 Bacteria filter (accessory)
For protecting the patient from bacteria, especially
when several patients are using the therapy de-
vice.
2 Power cord
For connecting the therapy device to the power
supply.
3 Serial port
For connecting to devices/computers for setting,
displaying and evaluating therapy data and for
connecting the O2supply valve.
4 Control panel and displays
For controlling and monitoring the therapy device
and connected accessories.
5 Connection for respiratory air
humidifier
For connecting SOMNOclick 300 to the therapy
device.
6 Device outlet port with pressure
measurement connection
The respiratory air flows to the patient from here
through the breathing tube and breathing mask.
7 Sealing plug
For sealing the pressure measurement tube during
cleaning.
8 Drying adapter
Required to dry the breathing tube using the ther-
apy device.
24 Humidifier key
with LED 23 Softstart key
21 On/Off key
22 Menu key
Control panel
26 Filter compartment
lid, air inlet
25 Device ID plate
27 Power supply
connection
29 Carrying bag28 Inverter
30 O2supply valve
31 SOMNOclick 300 respiratory
air humidifier
Accessories

6Overview
9 Click adapter
For connecting the breathing tube to the device
outlet port.
10 Pressure measurement tube
For measuring the pressure prevailing in the
breathing mask.
11 Breathing tube
The air flows to the mask through the breathing
tube. The breathing tube consists of creased tube,
pressure measurement tube and click adapter.
12 Exhalation system (accessory)
This is where the exhaled air containing carbon di-
oxide escapes during therapy.
13 Breathing mask (accessory)
Respiratory air at the required therapy pressure is
supplied to the patient via the breathing mask.
14 Head strap (accessory)
For correct, secure positioning of the breathing
mask.
15 Softstart
This symbol appears when Softstart time is set or
when Softstart is activated.
16 Filter change
This symbol appears after every 250 operating
hours or when the filter is blocked. The fine filter
then needs to be changed.
17 Inspiration/exhalation/adjustable
value
The up arrow is on during inspiration and the
down arrow is on during exhalation.
Both arrows come on if a value can be changed
using + (Softstart key) or - (Humidifier key).
18 Unit of measurement for therapy
pressure
Therapy pressure is displayed in hPa (hectoPascals)
1 hPa = 1 mbar 1 cm H2O.
19 Respiratory air humidifier
This symbol appears when the humidifier is in op-
eration. The set humidifier stage is displayed.
20 Servicing
This symbol appears after every 5,000 operating
hours. The therapy device then needs servicing.
21 On/Off key
For switching the therapy device on and off and
for exiting a menu.
22 Menu key
For opening the Patient menu and for scrolling to
the next value in the Patient menu.
23 Softstart key
For activating/deactivating Softstart, for calling up
Softstart settings and for reducing an adjustable
value.
24 Humidifier key with LED
For activating/deactivating the respiratory air hu-
midifier, for setting humidifier stage during thera-
py and for increasing an adjustable value. The LED
comes on when the humidifier is connected and
switched on.
25 Device ID plate
Provides information about the therapy device,
such as serial number and year of manufacture.
26 Filter compartment lid, air inlet
For covering and securely positioning the coarse
dust and fine filters.
27 Power supply connection
This is where the power cord and optional inverter
are connected to the device.
28 Inverter (accessory)
For operating the therapy device via a DC socket
(12/24 V).
29 Carrying bag
For transporting the therapy device.
30 O2supply valve (accessory)
For supplying oxygen to the breathing mask.
31 SOMNOclick 300 respiratory air
humidifier
For heating and humidifying the air flow generat-
ed by the therapy device.

Overview 7
1.1 Markings on the therapy device
31 33 34 35
32
Symbol Meaning
31 Service label: indicates when the next service is required.
32 Device inlet: inlet for ambient air at room temperature
33 See instructions for use!
Connection for SOMNOclick 300 respiratory air humidifier.
34 Device outlet port: outlet for ambient air at 4 - 20 hPa
35 Connection for adjusting therapy parameters using
WEINMANNadjust PC software or SOMNOadjust remote setting for
professional staff to read out the course of therapy using
WEINMANNsupport or for controlling the O2supply valve. Max. cur-
rent consumption 163 mA.
Analog output for therapy pressure, respiratory flow rate, relative re-
spiratory minute volume, leakage and respiratory status (0 V to
1.0 V DC).

8Overview
Device ID plate
1.2 Markings on the packaging
1.3 Safety information in these instructions
Safety information is marked as follows in these instructions for use.
Warning!
Warns of a risk of injury and potential material damage.
Caution!
Warns of material damage and potentially false therapy results.
Note
Contains useful tips.
Symbol Meaning
Year of manufacture
Degree of protection against electric shock: device type B
Do not dispose of the device in domestic waste!
Follow the relevant instructions for use!
SN Serial number of the device
Type of protection against electric shock: device of protection class II
CE marking: confirms that the device conforms to the applicable Eu-
ropean directives.
Symbol Meaning
Permitted temperature for storage: -20 °C to +70 °C
Permitted humidity for storage: max. 95 % relative humidity.
-20

Description of device 9
2. Description of device
2.1 Intended use
SOMNOvent a u t o - S
SOMNOvent auto-S is an automatically-regulating BiLevel S therapy device with
autoTriLevel principle and up to three pressure levels suitable for treating patients from the
age of 12 with obstructive, mixed or complex sleep apnea and
– a high pressure requirement,
– poor compliance due to high pressure on exhalation,
– fluctuating pressure requirement or
– nocturnal hypoventilation (OHS).
SOMNOvent auto-S is not suitable for life-support purposes on patients requiring
ventilation.
Note
To ensure successful therapy with SOMNOvent auto-S, it is important to determine and
set accordingly therapy mode, pressure limits and minimum respiratory frequency.
SOMNOvent a u t o - S T
SOMNOvent auto-ST is an automatically-regulating BiLevel ST therapy device with
autoTriLevel principle and up to three pressure levels suitable for treating patients from the
age of 12 with obstructive, mixed or complex sleep apnea and
– a high pressure requirement,
– poor compliance due to high pressure on exhalation,
– fluctuating pressure requirement,
– central apneas,
– nocturnal hypoventilation (OHS),
– respiratory insufficiency or
– coprevalent COPD (overlap).
SOMNOvent auto-ST is not suitable for life-support purposes on patients requiring
ventilation.

10 Description of device
Note
To ensure successful therapy with SOMNOvent auto-ST, therapy mode, therapy objective
and possibly other therapy parameters have to be determined and set accordingly by spe-
cialist medical staff.
2.2 Description of function
The therapy device has an electronically-controlled fan which draws in ambient air through
a filter and pumps it to the fan outlet. The air flows to the patient from here through the
breathing tube and the breathing mask.
The therapy device analyzes the pressure in the mask and the air flow to the patient and
from this, detects sleep-related respiratory disorders such as obstructions of the airways or
a central respiratory deficit.
The three pressure levels IPAP (pressure during inspiration), EPAP (pressure at the start of
exhalation) and EEPAP (pressure at the end of exhalation) are adapted to suit the patient’s
current requirements depending on the events detected.
The therapy device has different modes:
•CPAP
•S: one of three pressure variants can be selected for S mode.
•BiLevel: IPAP and EPAP can be set to a fixed value
•TriLevel: IPAP, EPAP and EEPAP can be set to a fixed value.
•auto TriLevel: IPAP, EPAP and EEPAP are continuously adapted to the
patient’s current requirements.
In the event of obstructions, EEPAP is automatically increased within lim-
its which can be set; if there are no obstructions, it is gradually reduced
again.
The difference between IPAP and EPAP (PDIFF) can likewise be adapted
automatically up to an upper limit which can be set.
•ST (can only be selected on SOMNOvent auto-ST): one of three pressure variants can be
selected for S mode:
•BiLevel: IPAP and EPAP can be set to a fixed value.
•TriLevel: IPAP, EPAP and EEPAP can be set to a fixed value.
•auto TriLevel: IPAP, EPAP and EEPAP are continuously adapted to the
patient’s current requirements.
In the event of obstructions, EEPAP is automatically increased within lim-
its which can be set; if there are no obstructions, it is gradually reduced
again.

Description of device 11
The difference between IPAP and EPAP (PDIFF) can likewise be adapted
automatically up to an upper limit which can be set.
•T(can only be selected on SOMNOvent auto-ST).
A minimum frequency for preventing central apneas can be set in S mode. The minimum
respiratory frequency takes effect as a background frequency as soon as the patient
breathes more slowly than set.
One of three therapy objectives can be set in ST mode. Depending on the setting, mean-
ingful default settings are loaded for the remaining parameters and the setting limits for
individual parameters are modified.
ST mode includes two automatic background frequencies, one with the objective of largely
spontaneous ventilation and one with the objective of largely controlled ventilation. The
appropriate background frequency and the I:E ratio are activated automatically when the
therapy objective is selected.
If no therapy objective is set, background frequency up to 30/min, I:E ratio and a latency
time until the first mandatory breath occurs can be specified manually.
In T mode, frequency and I:E ratio can be set in addition to pressure level on inspiration and
exhalation.
The trigger automatically adapts to the patient. If required, the supervising doctor can in-
crease or reduce trigger sensitivity.
A different speed can be set for pressure rise on inspiration if required.
Auto On/Off can be activated on the therapy device. The therapy device can be switched
on by a breath being taken into the mask and switches off automatically if not being used.
The therapy device can be used to check whether the mask is correctly fitted. Leaks due to
a poorly-fitted mask often only occur at relatively high pressures. To check that the mask
is leaktight, it is possible to output a higher pressure during the first 30 seconds after the
therapy device is switched on. This pressure is adjustable.
A qualitative leakage display is available during therapy.
Automatic Softstart is integrated to facilitate falling asleep. When you switch on, the pres-
sure is reduced to the Softstart pressure set by the doctor. Therapy pressure then slowly
rises to the specified value.
In CPAP mode, it is also possible to set an initial pressure which is higher than set CPAP
pressure. The therapy pressure then remains at the set value during the set initial pressure
phase.
The therapy device saves data for checking and adjusting therapy and thus allows extensive
analysis by the doctor.

12 Description of device
If the power supply is interrupted and then restored, the therapy device will be in the state
it was in before the interruption. Saved data are retained.

Safety instructions 13
3. Safety instructions
Please read these instructions for use through carefully. They are a constituent part of the
therapy device and must be available at all times.
Use the therapy device only for the intended use described (see “2.1 Intended use” on
Page 9).
For your own safety and that of your patients, and in accordance with the requirements of
directive 93/42/EEC, observe the following safety instructions.
3.1 Safety instructions
Operating the therapy device
Caution!
• Check whether the power supply voltage on the therapy device matches
that of your local electricity supply. The therapy device can operate with
the voltages 115 V and 230 V. It automatically adjusts to one of these
voltages. Exception: the SOMNOvent auto-S/ST 230 V (WM 29210 /
WM 29410) can only operate with a voltage of 230 V. Use the inverter
available as an accessory for operation with 12 V DC or 24 V DC.
• The therapy device must be connected to an easily accessible socket so
that the plug can be disconnected quickly in the event of a fault.
• Do not set up the therapy device close to a radiator and do not expose it
to direct sunlight, as this could heat up the respiratory air and internal
parts further. This could cause water vapour to form in the respiratory air
humidifier which would then condense in the breathing tube.
• Do not cover the therapy device with blankets etc. This would block the
air inlet and the therapy device might overheat. This may lead to inade-
quate therapy and damage to the device.
• Maintain a safe distance between the therapy device and devices which
emit HF radiation (e.g. cellphones, DECT base stations or wireless con-
nections) (see Page 53), otherwise there may be malfunctions.
• Do not operate the therapy device and the respiratory air humidifier if the
therapy device is not working properly, if parts are damaged or if the re-
spiratory air humidifier is wet at the base of the heated rod.
• The performance of the respiratory air humidifier may change if the ther-
apy device is operated outside the permitted ambient temperatures.

14 Safety instructions
• Follow the instructions for use for your breathing mask.
• Follow the section entitled “6. Hygiene treatment” on Page 31 to pre-
vent an infection or bacterial contamination.
• If the therapy device is intended for use by several patients, a bacteria fil-
ter should be used to protect against infections. This is put in between
the breathing tube with click adapter and the device outlet port. If the
therapy device is to be used for a different patient without using a bac-
teria filter, you must subject the device to a hygiene treatment before-
hand. This must be performed by the manufacturer, Weinmann, or by an
authorized specialist dealer.
Transport
Caution!
Do not transport the therapy device with the respiratory air humidifier attached,
otherwise residual water from the respiratory air humidifier may run into the therapy
device and damage it if it is tilted.
Accessories/replacement parts
Caution!
• If third-party items are used, functional failures and restricted fitness for
use may result. Biocompatibility requirements may also not be met.
Please note that in these cases, any claim under warranty and liability will
be void if neither the accessories nor genuine replacement parts recom-
mended in the instructions for use are used.
• Third-party makes of mask may only be used with the consent of the
manufacturer, Weinmann. The success of therapy is jeopardized by the
use of non-approved masks.
• Ensure that the accessories used for therapy are suitable and complete.
This applies to the exhalation system in particular, otherwise the CO2
content in the exhaled air may obstruct your breathing and there is a risk
of asphyxiation.
Repair
Caution!
• Have servicing and repair work performed only by the manufacturer,
Weinmann, or professional staff.
• It is not permitted to modify the therapy device and SOMNOclick 300.

Safety instructions 15
Oxygen supply
Warning!
If oxygen is used during therapy, smoking and naked flames are prohibited. Risk
of fire. Oxygen may accumulate in clothing, bed-linen or in hair. It can be removed
only by thorough ventilation.
Caution!
Oxygen may only be supplied if O2supply valve WM 24042 is used. With regard to
oxygen, it is essential to follow the safety instructions in the instructions for use for
your oxygen supply system.
3.2 Contraindications
The therapy device should be used with particular caution or not at all with some diseases.
It is up to the doctor supervising treatment to decide whether use is indicated. In such cas-
es, use needs to be tightly controlled and the risk weighed up against the benefits.
This implies:
• Acute cardiac decompensation
• Severe cardiac arrhythmias, atrial fibrillation with reduced filling of the
right ventricle.
• Insufficiency of the right heart or other pulmonary hypertension
• Severe hypotension, especially in combination with intravascular volume
depletion
• High risk of barotraumas
• Bullous lung emphysema
• Severe deyhdration
• Severe epistaxis (nosebleeds)
• Acute sinusitis, otitis media or perforated eardrum
• Pneumothorax or pneumomediastinum
• Pneumoencephalus
• Severe skull trauma
• Status following brain surgery and following surgical intervention on the
pituitary gland or the middle/ inner ear.

16 Safety instructions
3.3 Side effects
When using the therapy device, the following undesired side effects may occur in short-
term or long-term use:
• pressure points on the face from the nasal cannula and forehead cushion
• reddening of facial skin
• blocked nose
•drynose
• dry mouth in the morning
• sensation of pressure in the sinuses
• irritation of the conjunctiva of the eyes
• gastrointestinal insufflation of air (“bloating”)
• nosebleeds
Note
These side effects are general side effects of therapy with a BiLevel device and are
not attributable specifically to use of this therapy device.

Device setup 17
4. Device setup
4.1 Set up and connect therapy device
Location
– Place the therapy device on a flat surface, for example a bedside table or on the floor
next to the bed.
– Keep the rear of the therapy device a distance of at least 5 cm from the wall, as the air
inlet is on the rear of the therapy device.
Caution!
Do not cover the therapy device with blankets etc. Do not operate it close to a radi-
ator or in direct sunlight. The therapy device might overheat. This may lead to inad-
equate therapy and damage to the device.
Power supply
1. Use the power cord to connect the power supply con-
nection of the therapy device to a socket.
The therapy device automatically detects whether
115 V or 230 V are connected and automatically
switches. Exception: the SOMNOvent auto-S/ST 230 V
(WM 29210 /WM 29410) can only operate with a
voltage of 230 V.
“0” for standby appears in the display.
2. If the therapy device is to be operated at a voltage of 12
or 24 V DC, connect the inverter to a cigarette lighter
socket.
For this you may use either:
• inverter, 12 V WM 24131 or
• inverter, 24 V WM 24132
Use the power cord to connect the power supply
connection of the therapy device to the power supply
socket of the inverter.
3. Plug the click adapter of the breathing tube into the
device outlet port.

18 Device setup
4.2 For operation without respiratory air
humidifier
1. To remove the humidifier if required, pull this off the
device outlet port from the front.
2. Push the breathing tube onto the click adapter for the
device outlet port.
3. Plug the click adapter of the breathing tube into the de-
vice outlet port of the therapy device. Ensure that the
locking tab is on top as you do so, and that it engages
in the groove of the device outlet port.
4.3 For operation with respiratory air
humidifier
Note
Follow the instructions for filling and adapting the SOMNOclick 300 respiratory air
humidifier in the associated instructions for use.
4.4 Breathing mask
Put on breathing mask
1. Adjust the forehead support of the breathing mask (if there is one).
2. Attach the headgear/head strap to the mask.
3. Put on the mask.
4. Adjust the headgear/head strap so that the mask cushion creates only slight pressure, so
as to avoid pressure points on the face.
Note
The rest of the process can be found in the instructions for use for the breathing
mask in question. To check that the mask is correctly positioned without leaks, you
can use the mask test (see “5.4 Mask test” on Page 24).

Device setup 19
Warning!
Oronasal masks must be fitted with an emergency exhalation valve so that you can
breathe through your nose or mouth even if the device fails. Oronasal masks with-
out an emergency exhalation valve may not be used!
External exhalation system
On some masks, there is no integrated exhalation system. To enable used air containing
carbon dioxide (CO2) to escape, an external exhalation system is required on these masks.
Follow the instructions for use for the mask.
Warning!
Without an exhalation system, the CO2concentration in the mask and tube may
rise to critical values and thus obstruct your breathing. Risk of asphyxiation!
– Fit the external exhalation system between the breath-
ing mask and the breathing tube.
4.5 Connect other accessories
Bacteria filter
If the therapy device is intended for use by several patients (e.g. in hospital), a bacteria filter
should be used to protect against infections.
– Fit the bacteria filter between the breathing tube with
click adapter and the device.
Caution!
When using a bacteria filter, pressure consistency
and flow rate may be reduced. If a bacteria filter is
connected, check the pressure. Note the manufac-
turer’s information, especially the expiry date for
the filter.

20 Device setup
Oxygen supply
Warning!
For safety reasons (risk of fire), it is not permitted to supply oxygen directly to the
breathing tube or to the breathing mask without a special safety device. If oxygen
supply valve WM 24042 is used, up to 4 l/min oxygen can be supplied to the breath-
ing mask.
It is essential to follow the safety instructions for handling oxygen as well as the in-
structions for use for the oxygen valve and the oxygen device used.
An oxygen concentrator (e.g. Oxymat), liquid oxygen or an
oxygen cylinder with the appropriate pressure reducer can
also be used. This use must be prescribed by the doctor su-
pervising treatment.