Weinmann VENTIlogic BiLevel ST Operating instructions

1
VENTI logic
BiLevel ST - Home Ventilation Unit WM 27000
Description of unit and operating instructions for patients

2 Overview
EN
19 Battery connection
VENTI power
1. Overview
VENTI logic
2 Connec ting
cord
6 Connection for humidifier
11 Pressure
measuring
hose
12 Hose system
8 Sealing plug (2x)
13 Exhalation
system
5 Control panel and display
4 Serial interfaces
15 Headgear
7 Unit outlet
14 Mask
10 Adapter
26 Humidifier switch with LED
27 Soft start
switch
22 On/off
switch
29 Rating plate
31 Carrying bag
30 VENTI click
28 VENTI power
25 Menu switch
1 Bacteria filter
9 Drying adapter
32 VENTI- O
2
3 Handle
21 Alarm acknowledgement switch with LED
23 Dial
24 Operating switches
20 O
2
connection
VENTI- O
2
16 Filter compartment cover, air inlet
18 Cable se -
curing clip
17 Supply connection

Overview 3
EN
1 Bacteria filter
For protecting patient from bacteria, especially if
the device is being used by several patients.
2 Connec ting cord
For connecting the VENTI logic to the supply.
3 Handle
For transporting the unit.
4 Serial interfaces
These are used to connect devices for displaying
and analysing therapy data.
5 Control panel and display
For controlling and monitoring the VENTI logic
and connected accessories.
6 Connection for humidifier
For connecting the VENTI click humidifier availa -
ble as an accessory.
7 Unit outlet
Respiratory air flows out from here to the patient
via the hose system and mask.
8 Sealing plug (2x)
For sealing the pressure measuring hose during
cleaning.
9 Drying adapter
Required if the hose system is being dried with the
VENTI logic .
10 Adapter
For connecting the hose system to the unit outlet.
11 Pressure measuring hose
For measuring the pressure in the mask and thus
for controlling flow.
12 Hose system
The air flows to the mask through the hose system.
The hose system consists of corrugated hose,
pressure measurement tube and adapter.
13 Exhalation system
Carbon dioxide-enriched expired air escapes
here during therapy.
14 Mask
Respiratory air at the necessary therapy pressure
is administered to the patient via the mask.
15 Headgear
For correct and secure positioning of the mask.
16 Filter compartment cover, air inlet
For covering and securely positioning the coarse
and fine dust filter.
17 Supply connection
This is where the connecting cord is attached to
the unit.
18 Cable securing clip
Prevents the unit being disconnected inadvertently
from the power supply.
19 Battery connection VENTI power
For connecting the VENTIpower mobile power
supply available as an accessory.
20 O2connection VENTI-O2
For connecting the VENTI-O2oxygen connection
valve available as an accessory.
21 Alarm acknowledgement switch with LED
The alarm acknowledgement switch can be used
for temporary muting of alarms. The LED gives a
visual indication of alarms.
22 On/off switch
For switching the VENTIlogic on and off.
23 Dial
Central control for the VENTIlogic, for navigating
in the menu.
24 Operating switches
For rapid setting by a doctor, locked out in
patient mode.

4Overview
EN
25 Menu switch
For switching between the standard display and the
menu.
26 Humidifier switch with LED
For setting humidifier stage. Six stages are availa-
ble. The LED indicates whether the humidifier is
activated.
27 Soft start switch
Used for activating Softstart and for setting the
Softstart time up to the maximum set by the
physician.
This function is not available in TA mode.
28 VENTIpower
Available as an accessory, to provide mains-inde-
pendent power to the VENTIlogic.
29 Rating plate
Provides information about the unit, like serial num-
ber and year of manufacture.
30 VENTIclick
Available as an accessory, for humidifying and
heating respiratory air.
31 Carrying bag
For transporting the VENTIlogic.
32 VENTI-O2
Obtainable as an accessory, for introducing
oxygen into the mask.
Standard display during therapy:
1 Status line
This is where information about the status of the unit
is displayed, like filter change or maintenance due.
2 Soft start symbol
Indicates that soft start is activated, the number
showing time remaining in minutes.
3 Respiratory phase switch indicator
Indicates whether the current respiratory phase
switch is spontaneous or mandatory (spontaneous:
S, mandatory: T); the indicator switches from left
(inspiration) to right (expiration) depending on respi-
ratory phase; mandatory expiration is shown here.
4 Access to patient menu
The switch next to this menu item is used to switch
between the patient menu and the standard
display.
5 Bar chart for pressure indication
For graphical display of therapy pressure.
6 Ventilation parameters
The relevant current ventilation parameters are
displayed depending on the active mode.
7 Active ventilation mode
The active ventilation mode is displayed at this
point in the status line.
1Status line
7Active ventilation
mode
5Bar chart for pressure indication
4Access to patient menu
3Respiratory phase switch
indicator
2Soft start symbol
6Ventilation
parameters T

Overview 5
EN
Symbols used in the display
Abbreviations used in the display
Symbol Significance
Status line:
Soft start active, remaining time faded in
Filter change required
Maintenance required
Acoustic signal for the IPAPmin and VTmin alarms silent
Alarm for IPAPmin and VTmin alarms deactivated
Main window:
Low-priority alarm triggered
Medium-priority alarm triggered
Symbol Significance
Status line:
TA TA mode active
SS mode active
ST ST mode active
TT mode active
SX SX mode active
SXX SXX mode active
+V Volume compensation activated (after mode: e.g. SXX+V)
AADevice analyses patient’s respiratory rhythm (TA mode)
Main window:
IPAP Inspiration pressure
EPAP Expiration pressure
hPa Pressure indication in Hectopascal: 1,01973 hPa equal 1 cm H2O
fRespiratory frequency
SSpontaneously-triggered respiratory phase switch
TMandatorily-triggered respiratory phase switch

6Contents
EN
Contents
1. Overview . . . . . . . . . . . . . . . . . . . .2
2. Description of unit . . . . . . . . . . . . . .7
2.1 Intended use . . . . . . . . . . . . . 7
2.2 User qualification . . . . . . . . . . 7
2.3 Functional description . . . . . . . 7
3. Safety instructions . . . . . . . . . . . . . .9
3.1 Safety instructions . . . . . . . . . . 9
3.2 Contraindications . . . . . . . . . 11
3.3 Side effects . . . . . . . . . . . . . 12
3.4 Special labelling on unit. . . . . 13
4. Set up unit . . . . . . . . . . . . . . . . . .14
4.1 Set up and connect unit . . . . . 14
4.2 Put on the Mask . . . . . . . . . . 15
4.3 Accessories . . . . . . . . . . . . . 15
5. Operation . . . . . . . . . . . . . . . . . . .18
5.1 Start up the VENTIlogic . . . . . 18
5.2 Auto switch-on . . . . . . . . . . . 19
5.3 Set soft start (not in TA mode) . 20
5.4 Set humidifier . . . . . . . . . . . . 21
5.5 Therapy in TA mode . . . . . . . 22
5.6 After usage . . . . . . . . . . . . . 22
5.7 Travelling with VENTI series
devices . . . . . . . . . . . . . . . 23
6. Hygienic preparation . . . . . . . . . .24
6.1 Intervals . . . . . . . . . . . . . . . .24
6.2 Cleaning . . . . . . . . . . . . . . .25
6.3 Disinfection, sterilization . . . . . 27
6.4 Change in patients. . . . . . . . . 28
7. Function check . . . . . . . . . . . . . . . .29
7.1 Intervals . . . . . . . . . . . . . . . .29
7.2 Method . . . . . . . . . . . . . . . .29
8. Troubleshooting . . . . . . . . . . . . . .33
8.1 Malfunctions . . . . . . . . . . . . .33
8.2 Alarms . . . . . . . . . . . . . . . . .34
9. Maintenance . . . . . . . . . . . . . . . . .39
9.1 Intervals . . . . . . . . . . . . . . . .39
9.2 Filter change. . . . . . . . . . . . .40
9.3 Change pressure measuring
hose . . . . . . . . . . . . . . . . . .42
9.4 Disposal. . . . . . . . . . . . . . . .42
10. Scope of supply . . . . . . . . . . . . . . .43
10.1 Standard scope of supply. . . . 43
10.2 Accessories . . . . . . . . . . . . .43
10.3 Spare parts . . . . . . . . . . . . .45
11. Technical specifications . . . . . . . . .46
11.1 Pneumatic diagram . . . . . . . .48
11.2 Safety distances . . . . . . . . . . 49
12. Warranty . . . . . . . . . . . . . . . . . . .50
13. Index . . . . . . . . . . . . . . . . . . . . . .52

Description of unit 7
EN
2. Description of unit
2.1 Intended use
The VENTIlogic is a home ventilation unit for non-invasive, non-life support ventilation
of adult patients with respiratory insufficiency in whom there is evidence of autono-
mous respiratory drive. This corresponds to the following clinical pictures:
• Obstructive respiratory disorders such as COPD
• Restrictive respiratory disorders such as scoliosis and thorax
deformities
• Neurological, muscular and neuromuscular respiratory disorders
such as paresis of the diaphragm
• central respiratory regulation disorders
• Obstructive sleep apnoea syndrome OSAS
The VENTIlogic is not suitable for life-support use.
Use the unit only for the purpose described here.
2.2 User qualification
The VENTIlogic may only be used by a doctor on an individual basis for a specific
patient.
When the VENTIlogic is handed over to the patient, the doctor in charge or hospital
staff must instruct the patient in how the unit works.
2.3 Functional description
Provision of therapy pressure
An electronically-controlled fan draws in ambient air through a filter and delivers it to
the unit outlet. From here, the air flows through the hose system and the mask to the
patient.

8Description of unit
EN
Sensors detect the pressure in the mask and in the hose system and also the respira-
tory phase switch (trigger point). The fan accordingly provides the IPAP and EPAP
pressures set by the doctor.
Therapy modes
The VENTIlogic can be operated in six therapy modes: CPAP, S, ST, T, SX, SXX and
TA mode. Your doctor will set the mode required for your therapy on the unit. In the
adaptive, controlled TA mode the device automatically adapts to your individual res-
piratory rhythm and supplies the therapy pressure in accordance with exactly this
rhythm.
Your doctor can activate volume compensation. Minimum volume and maximum
pressure increase are set for this purpose. If the minimum volume is undershot, the
unit automatically increases pressure continuously until the set maximum pressure
(therapy pressure + max. pressure increase) is reached.
In time-controlled mode T and in assisted-controlled mode ST, your doctor can set
respiratory frequency in the range from 6 to 45 breaths a minute and inspiration time
in the range from 20 % to 67 % of the respiratory period.
In assisted modes S, SX and SXX and in assisted-controlled mode ST, your doctor
can select one of 6 trigger stages for both inspiration and expiration. Your doctor
can switch off the trigger for expiration. Expiration is then time-controlled.
If no breath is taken into the unit in S mode, the pressure is switched at a minimum
frequency of 6 breaths a minute.
Other functions
The Softstart function makes it easier for you to go to sleep or to get used to higher
ventilation pressures. Your doctor sets initial pressures for inspiration and expiration
which rise continuously to the therapy pressures during the soft start phase. This func-
tion can be locked out by the doctor.
The VENTIlogic has an auto switch-on system. If this is activated, the unit can be
switched on by a breath being taken into the mask. The unit is still switched off using
the on / off switch .
The display shows therapy mode and, depending on mode, the values currently be-
ing applied for CPAP/IPAP and EPAP and for respiratory frequency (f). Spontaneous
or mechanical respiratory phase switches are also displayed and the pressure
change shown in the form of a graph.

Safety instructions 9
EN
3. Safety instructions
3.1 Safety instructions
Read these operating instructions carefully. They form part of the unit and must be
available at all times. Use the unit only for the purpose described here (see “2.1 In-
tended use” on page 7).
For your own safety please observe the following points.
Operating the unit
Caution!
• Check that the supply voltage of the unit matches your supply volt-
age. The unit can operate with voltages of 115 V and 230 V. It sets
itself to one of these voltages automatically.
• Always secure the supply plug with the cable securing clip to pre-
vent the plug being pulled out inadvertently.
• The VENTIlogic must be connected to an easily accessible supply
socket so that in the event of a malfunction, the supply plug can be
removed quickly.
• Do not place the unit near a source of heating or expose to direct
sunlight to prevent the unit overheating. Condensation could also
form in the VENTIclick humidifier which would then condense in the
hosesystem.
• Do not cover the unit with blankets etc.. The air inlet would be
blocked and the unit could overheat. This can lead to inadequate
therapy and damage to the unit.
• Maintain a safe distance between the VENTIlogic and devices
which emit high-frequency radiation (e.g. mobile phones), other-
wise there may be malfunctions (see page 49.)
•An alternative ventilation system should be on hand in case of a unit
failure.

10 Safety instructions
EN
Caution!
• Third-party masks may be used only after approval from the manu-
facturer (WEINMANN). Use of non-approved masks puts successful
therapy in jeopardy.
•If a pneumotachograph with a high flow resistance is used in deter-
mining flow rate to start or check therapy, the trigger function may
be restricted. If you have any questions, please contact the manu-
facturer (WEINMANN).
• No antistatic or electrically-conductive hoses may be used.
• Using the VENTIclick humidifier, bacteria filter and O2connection
valve VENTI-O2accessories may modify the characteristics of the
unit. Subsequent additions to these accessories may render it neces-
sary to readjust the unit parameters. Consult your doctor if neces-
sary.
•Please comply with Section “6. Hygienic preparation” on page 24
to prevent infection or bacterial contamination.
Transport/accessories/spare parts/repair
Caution!
• Do not transport the VENTIlogic with the VENTIclick humidifier at-
tached. Tilting might cause water remaining in the VENTIclick to run
into the VENTIlogic and damage it.
•Malfunctions and a lack of biocompatiblity may result if third-party
articles are used. Please bear in mind that in these cases, any war-
ranty entitlement and liability shall lapse where neither the accesso-
ries recommended in the instructions for use nor original spare parts
have been used.
•Have all inspections and repair work carried out only by the manu-
facturer (WEINMANN) or specialist staff.

Safety instructions 11
EN
Oxygen supply
Warning!
•When oxygen is introduced into the respiratory flow, smoking and
naked flames are prohibited. Risk of fire. The oxygen may be depos-
ited in clothing, bedlinen or hair. It can only be removed by thor-
ough ventilation.
Caution!
•Oxygen may only be introduced into the respiratory flow using the
O2supply valve VENTI-O2, WM 24200.
•Always follow the safety information included in the instructions for
your oxygen system.
3.2 Contraindications
The VENTIlogic should be used only with particular caution, if at all, with the follow-
ing diseases. In each case, the decision whether to treat with the VENTIlogic lies with
the doctor in charge.
• Cardiac decompensation
• Severe cardiac arrhythmia
• Severe hypotension, particularly in conjunction with intravascular
volume depletion
• Severe epitaxy
• High risk of barotrauma
• Pneumothorax or pneumomediastinum
• Pneumoencephalus
• Cranial trauma
•Status following brain surgery and surgical procedure performed on
the pituitary gland or middle/inner ear
• Acute sinusitis, inflammation of the middle ear (otitis media) or per-
forated eardrum
• Dehydration
Threatening situations have not been observed with the VENTIlogic.

12 Safety instructions
EN
3.3 Side effects
The following undesired side effects may occur during short and long-term usage of
the VENTIlogic:
•pressure points on the face caused by the mask and forehead padding
• reddening of skin on face
• blocked nose
• dry nose
• dry mouth in the morning
• feeling of pressure in sinuses
• irritation of conjunctiva of eyes
• gastrointestinal insufflation of air ("stomach bloating")
• nosebleeds.
3.4 Special labelling on unit
Front
7Unit outlet: outlet for ambient air at 4 - 35 hPa
6Socket: electrical connection for the VENTIclick humidifier, WM 24365; max.
power consumption at 40 V: 600 mA
19 20 4a 4b 16 6 7
33 34

Safety instructions 13
EN
Rear
16 Unit inlet: inlet for ambient air at room temperature
33 Servicing label: indicates when the next service is due.
34 Safety check label: (in Germany only) marks when the next safety check as per §6
of the German law relating to users of medical devices is required.
Side connection sockets
4a Connection for specialist staff to adjust therapy parameters with VENTIsupport,
WM 93340; max. power consumption at 12 V: 15 mA
4b Connection for optional additional SaO2devices; max. power consumption at 12
V: 25 mA
19 Connection for supply-independent operation using VENTIpower, WM 24100;
power supply: 12 V/40 V DC
20 Connection for controlling the O2connection valve VENTI-O2, WM 24200.
Max. power consumption at 12 V: 125 mA
Rating plate
Do not dispose of the unit in domestic waste!
Protection class B
Protection class II, protective insulation
Year of manufacture

14 Set up unit
EN
4. Set up unit
4.1 Set up and connect unit
Set up the unit on a flat surface, e.g. on a bedside cabinet or on the floor next to the
bed. Keep a space of min. 5 cm between the rear of the unit and the wall, as the
air inlet is on the rear of the unit.
Caution!
Do not cover the unit with blankets etc.. The air inlet would be
blocked and the unit could overheat. This can lead to inadequate
therapy and damage to the unit.
1. Connect the connecting cord to the supply con-
nection of the unit. To do so, lift the cable securing
clip, plug the plug into the supply connection and
clip the cable securing clip over the plug.
Caution!
Always secure the supply plug with the cable se-
curing clip to prevent the plug being pulled out in-
advertently.
2. Connect the connectig cord to a supply socket.
The VENTIlogic is designed for a supply voltage
of 115 V ~ to 230 V ~.
3. Plug the hose system adapter in the unit outlet.
The unit is now operational.
Cable-securing clip

Set up unit 15
EN
4.2 Put on the Mask
The VENTIlogic is designed for use with nasal, nasal/oral and full facial masks. Pro-
ceed as follows to put on the mask.
1. Adjust the forehead support of the l mask (if provided).
2. Connect the headgear/the headband to the mask and position the mask.
3. Adjust the headgear/headband so that the bulge of the mask only results in low
pressure to prevent pressure points on the face.
Please refer to the operating instructions for the relevant mask.
4.3 Accessories
Separate exhalation system
A separate exhalation system is required if you are using a mask without an integrat-
ed exhalation system.
Used carbon dioxide (CO2)-enriched air escapes from the mask through the exhala-
tion system. Without an exhalation system, the CO2concentration would rise to crit-
ical values in the mask and hose, thus hindering your breathing.
The exhalation system also allows you to breathe through the nose or mouth if the
unit malfunctions. In the event of a malfunction with a full facial mask, you breathe
through a safety valve on the mask.
The sleeve on the end of the hose system has a diam-
eter of 19.5 mm and fits over a 22 mm standard
cone. Put the exhalation system on the sleeve of the
creased hose.
Please refer to the operating instructions for your exha-
lation system.
Exhalation
system
Hose system
Sleeve

16 Set up unit
EN
Humidifier VENTIclick
The VENTIclick humidifier is positioned between the
VENTIlogic and the hose system. The inlet connection
stub and the electrical connection of the heating element
must be pointing at the VENTIlogic. Please also see the
operating instructions for the VENTIclick.
Oxygen supply using the VENTI-O2
The supply of oxygen must have been prescribed by
the doctor in charge.
For safety reasons (risk of fire), the direct introduction
of oxygen into the hose system or the mask is not per-
mitted without a special protective device.
On the VENTIlogic, the introduction of oxygen is permitted solely using the VENTI-O2
oxygen valve, WM 24200. This valve allows up to 4 l/min. of oxygen to be intro-
duced. In the event of a fault, the VENTI-O2gives off the oxygen into the ambient air.
This means that it cannot accumulate in the unit.
The oxygen can be supplied using an oxygen concentrator (e.g. Oxymat 3), central
gas supply system, liquid oxygen or an oxygen cylinder with a suitable pressure re-
ducer. The external oxygen source must be equipped with a flow-adjustment device
independent of the VENTI-O2.
You must follow the safety instructions for handling oxygen without fail, as well as the
operating instructions for the VENTI-O2oxygen valve and the oxygen device used.

Set up unit 17
EN
Bacteria filter
If the VENTIlogic is intended for use by several patients
(e.g. in hospital), bacteria filter WM 24148 should
be used to protect against infection. It is installed be-
tween the hose system and the VENTIlogic or the
VENTIclick. Please also observe the enclosed operat-
ing instructions for the bacteria filter.
Caution!
The bacteria filter represents an additional resistance in the air stream. This may
lead to a change in the response characteristics of the trigger. For this reason,
you should have the unit parameters reset if a bacteria filter is fitted retrospectively.
VENTIpower
For mains-power independant operation VENTIpower
is available.
VENTIpower can also be connected to VENTIlogic in
parallel to mains power. VENTIpower then remains in
standby mode. If mains power fails, VENTIpower au-
tomatically supplies power to the therapy device with
a delay of about 4 seconds.
Using VENTIpower you can operate VENTIlogic inde-
pendant from mains power in the carrying bag
WM 24888. To do so place VENTIpower in the ded-
icated section of the carrying bag and connect it to the
therapy device.
Please also observe the operating instructions for
VENTIpower.

18 Operation
EN
5. Operation
5.1 Start up the VENTIlogic
1. If your mask has no integrated exhalation system,
place the exhalation system on the end of the hose
system(see “ Separate exhalation system” on
page 15).
Caution!
Always use an exhalation system. Otherwise the
CO2concentration would rise to critical values in
the mask and hose, thus hindering your breathing.
2. Put on the mask (see “4.2 Put on the Mask” on
page 15) and connect the hose system including
the exhalation system to the mask (plug cone).
Please follow the relevant operating instructions for
the mask and exhalation systems.
3. Press the on / off switch . If auto switch-on is
activated, you can also position the mask and
switch on the VENTIlogic by taking a breath (see
“5.2 Auto switch-on” on page 19).
Operating hours and the WEINMANN software
version will appear in the display for approx. 3
seconds. The unit starts to convey air through the
hose system. The display switches to the standard
display.
Note
If you are to use TA mode for your therapy, please
observe Chapter “5.5 Therapy in TA mode” on
page 22 as well.
The display shows the therapy mode set, therapy
pressures (only CPAP pressure in CPAP mode) and
current respiratory frequency.
On/off switch
Standard display
T
T

Operation 19
EN
When soft start is activated, the soft start indicator
appears with the remaining soft start time,
max. 30 minutes, or the max soft start time speci-
fied by the doctor (see “5.3 Set soft start (not in TA
mode)” on page 20).
The bar chart shows the inspiratory and expiratory
pressure curve.
The respiratory phase switch indicator shows
whether the current respiratory phase was trig-
gered spontaneously by the patient (S) or mechan-
ically (T). Depending on the respiratory phase, the
indicator switches from left (inspiration) to right (ex-
piration). The illustration shows mechanically-trig-
gered expiration.
5.2 Auto switch-on
When auto switch-on is activated, you can switch on the VENTIlogic using the on /
off switch or by "taking a breath". You can only switch off the VENTIlogic using
the on / off switch .
Activate auto switch-on
1. Seal the hose system or put on the mask.
2. Press the on / off switch to switch on the VENTIlogic.
3. Press the menu switch . The patient menu ap-
pears in the display. The selection bar is over
Drying process.
4. Use the dial to select the menu item Auto switch-on
(Off) and press the dial.
Respiratory
phase switch
Soft start indicator
Bar chart
T

20 Operation
EN
The message Auto switch-on ON appears for three
seconds. After the message, the VENTIlogic re-
verts to the patient menu. Auto switch-on is now ac-
tivated.
5. Exit the patient menu using the dial (move selection
bar to Back and press dial) or using the menu
switch .
If no switch is activated for 5 minutes, the display
reverts to the standard display.
Deactivate auto switch-on
Repeat steps 2.–5. as described in „ Activate auto switch-on“. When the automatic
system is switched off, you can only switch on the VENTIlogic using the switch.
5.3 Set soft start (not in TA mode)
If your doctor has enabled the soft start function, the soft start time can be selected
in 5-minute increments up to a maximum time of 30 minutes. Your doctor can limit
the maximum time to less than 30 minutes. Proceed as follows to set soft start time.
1. Seal the hose system or put on the mask.
2. Switch on the VENTIlogic and hold down the soft
start switch until the soft start window ap-
pears. Change the soft start time using the dial
(turn to the right to increase time and turn to the left
to decrease time). Alternatively, keep pressing the
soft start switch to increase the soft start time
in 5-minute increments (once maximum time is
reached, the unit restarts at the minimum time of 5
minutes if pressed again).
3. Press the menu switch or the dial to store the soft start time. The soft start time
displayed will be stored and the soft start window closes automatically. If no
switch is pressed for 4 seconds, the soft start time displayed is likewise stored.
The settings are retained after the unit is switched off.