Weinmann BiLevel ST 22 User manual

BiLevel ST 22
BiLevel ST - Home Ventilation Unit
WM 27500
Description of unit and
operating instructions for patients

Overview
BiLevel ST 22
BiLevel ST 22
3 Power supply
cable
8 Humidifier connection
13 Pressure
measurement
hose
14 Hose system
10 Sealing plugs (2x)
15 Exhalation system
7 Control panel and display
6 Serial interfaces
17 Hood
9 Unit outlet
16 Nasal mask
12 Adapter
27 Humidifier key with LED
28 Soft start
key
23 On/Off
switch
30 Nameplate
32 Carrying bag
31 VENTI click
29 VENTI power
26 Menu key
1 Bacteria filter
11 Drying adapter
33 VENTI- O
2
5 Handle
22 Alarm acknowledgement key with LED
24 Dial
25 Operating keys
21 Connection for
O
2
valve VENTI- O
2
19 Filter compartment lid, air inlet
20 Mains connection/connection
for battery VENTI power
2 Power supply
18 Service label
4 Cable securing clip

1 Bacteria filter (Accessories)
Used to protect the patient from bacteria,
particularly if the unit is being used by a number of
patients.
2 Power supply
Used to supply power to the therapy unit.
3 Power supply cable
Connects the power supply to the power supply.
4 Cable securing clip
Prevents accidental disconnection of the unit from
the mains supply.
5 Handle
Used for carrying the unit.
6 Serial interfaces
Used to connect to units for visualization and
evaluation purposes.
7 Control panel and display
For controlling and monitoring the BiLevel ST 22
and the connected accessories.
8 Humidifier connection
For connecting the humidifier VENTI click supplied
as an accessory.
9 Unit outlet
The air flows from here via the hose system and
nasal mask to the patient.
10 Sealing plugs (2x)
Used to close the pressure measurement hose
during cleaning.
11 Drying adapter
Required to dry the hose system with the
BiLevel ST 22 and for function check .
12 Adapter
Connects the hose system to the unit outlet.
13 Pressure measurement hose
To measure the pressure in the nasal mask.
14 Hose system
The air flows through the hose system to the mask.
The hose system consists of the corrugated tube,
pressure measurement hose and adapter.
15 Exhalation system (Accessories)
Exhalation air containing carbon dioxide is
diverted here during the therapy.
16 Nasal mask (Accessories)
The nasal mask is used to administer air to the
patient at the required therapy pressure.
17 Hood (Accessories)
Helps fit the nasal mask correctly and securely.
19 Filter compartment lid, air inlet
Covers and securely holds the coarse and fine dust
filters.
20 Mains connection/connection for battery
VENTIpower
This is where the connecting cable for the power
supply is connected. For connecting mains-
independent power supply VENTI power supplied
as an accessory.
21 Connection for O 2 valve VENTI-O2
For connecting the VENTI- O
2
oxygen valve
(supplied as an accessory).
22 Alarm acknowledgement key with LED
The alarm acknowledgement key temporarily mutes
the alarms. The LED provides the visual display of
the alarms.
23 On/Off switch
For switching BiLevel ST 22 on and off.
24 Dial
Central operating element of the BiLevel ST 22,
used to navigate in the menu.
25 Operating keys
Allows the doctor to make quick settings; disabled
in patient mode.

26 Menu key
Used to change from the standard display to the
menu and back again.
27 Humidifier key with LED
For setting the humidifier level. Six levels are
available. The LED shows whether the humidifier is
activated.
28 Soft start key
To activate Soft start and to adjust the Soft start time
up to the maximum Soft start time set by the doctor.
29 VENTIpower (Accessories)
Available as an accessory, provides a mains-
independent power supply for BiLevel ST 22.
30 Nameplate
Provides information about the unit, e.g. serial
number and year built.
31 VENTIclick (Accessories)
Available as an accessory, used to humidify and
warm the air
32 Carrying bag
For carrying the BiLevel ST 22.
33 VENTI-O2 (Accessories)
Available as an accessory, used to supply oxygen
to the nasal mask.
Standard display during therapy:
1 Status line
This is where information about the status of the unit
is displayed, such as filter change or service due.
2 Soft start symbol
Indicates that Soft start is activated, the number
indicates the remaining minutes.
3 Display respiratory phase
Displays whether the current respiratory phase
change is spontaneous or mandatory
(spontaneous: S, mandatory: T), the display
changes according to the respiratory phase from
left (inspiration) to right (expiration); in this case
mandatory expiration.
4 Access to the patient menu
The key next to this menu item allows you to change
to the patient menu and back to the standard
display.
5 Bar graph for the pressure display
Displays therapy pressure in graphical form.
6 Ventilation parameters
Depending on the active mode the corresponding
current ventilation parameters are displayed.
7 Active respiratory mode
The active ventilation mode is displayed at this
point of the status line.
1Status line
7Active
respiratory mode
5Bar graph for the pressure display
4Access to the patient menu
3Display respiratory phase
2Soft start symbol
6Ventilation parameters

Symbols used in the display
Abbreviations used in the display
Symbols and safety tips used in the Operating Instructions:
Warning!
Warns about danger of injury and possible damage to property.
Caution!
Warns about damage to property and possible incorrect therapy results.
Note
Contains useful tips.
Symbol Meaning
Status line:
Soft start active, remaining time highlighted
Filter change necessary
Service required
Main window:
Medium priority alarm triggered
Symbol Meaning
Status line:
SS mode active
TT mode active
ST ST mode active
CPAP CPAP mode active
Main window:
IPAP Inspiration pressure
EPAP Expiration pressure
hPa Pressure given in Hectopascal; 1.01973 hPa correspond to 1 cm H2O.
fRespiratory rate
Sspontaneously triggered switch in respiratory phase
Tmandatory triggered switch in respiratory phase

Contents
1. Description of unit . . . . . . . . . . . . . .7
1.1 Intended use . . . . . . . . . . . . . 7
1.2 User qualification . . . . . . . . . . 7
1.3 Functional description . . . . . . . 7
2. Safety instructions . . . . . . . . . . . . . .9
2.1 Safety regulations . . . . . . . . . . 9
2.2 Contraindications . . . . . . . . . 11
2.3 Side effects . . . . . . . . . . . . . 12
2.4 Special markings on the unit . 13
3. Setting up the unit . . . . . . . . . . . . .15
3.1 Positioning and connecting
the unit . . . . . . . . . . . . . . . . 15
3.2 Fitting the mask. . . . . . . . . . . 16
3.3 Accessories . . . . . . . . . . . . . 16
4. Operation . . . . . . . . . . . . . . . . . . .19
4.1 BiLevel ST 22 startup . . . . . . . 19
4.2 Activate/deactivate the auto
switch-on. . . . . . . . . . . . . . . 20
4.3 Setting Soft start . . . . . . . . . . 21
4.4 Setting the humidifier . . . . . . . 22
4.5 After usage . . . . . . . . . . . . . 23
4.6 Traveling with BiLevel ST 22 . . 24
5. Hygienic preparation . . . . . . . . . .25
5.1 Intervals. . . . . . . . . . . . . . . . 25
5.2 Cleaning. . . . . . . . . . . . . . . 26
5.3 Disinfection and sterilization . . 28
5.4 Multiple patient use . . . . . . . . 29
6. Functional check . . . . . . . . . . . . . .30
6.1 Intervals. . . . . . . . . . . . . . . . 30
6.2 Execution. . . . . . . . . . . . . . . 30
7. Troubleshooting . . . . . . . . . . . . . .34
7.1 Malfunctions . . . . . . . . . . . . 34
7.2 Alarms . . . . . . . . . . . . . . . . 35
8. Maintenance . . . . . . . . . . . . . . . . .38
8.1 Intervals . . . . . . . . . . . . . . . . 38
8.2 Filter change. . . . . . . . . . . . . 39
8.3 Change the
pressure measurement hose . . . 41
8.4 Disposal. . . . . . . . . . . . . . . . 42
9. Scope of supply . . . . . . . . . . . . . .43
9.1 Standard scope of supply . . . .43
9.2 Accessories . . . . . . . . . . . . . 43
9.3 Replacement parts . . . . . . . . .46
10. Technical data . . . . . . . . . . . . . . . .47
10.1Pneumatic diagram . . . . . . . .50
10.2Safety distances. . . . . . . . . . . 50
11. Warranty . . . . . . . . . . . . . . . . . . .51
12. Declaration of Conformity . . . . . . .52
13. Index . . . . . . . . . . . . . . . . . . . . . .53

Description of unit 7
1. Description of unit
1.1 Intended use
The BiLevel ST 22 is a home breathing apparatus for non-invasive, non-life-saving
ventilation of adult patients with respiratory insufficiency, but who are evidently able
to breathe independently. This is in keeping with the following clinical scenarios:
•restrictive and obstructive ventilation problems, e.g. OSAS, COPD,
obesitas hypoventilation syndrome
•Problems with the mechanics of breathing, e.g. scoliosis or a chest
deformity
• neurological, muscular and neuromuscular problems, e.g.
diaphragmatic paresis
• Central respiratory regulation disturbances
BiLevel ST 22 is not designed for life-support.
Only use the unit for the purposes described here.
1.2 User qualification
The settings on BiLevel ST 22 may only be set by a doctor and to suit the individual
patient.
When handing over BiLevel ST 22 to the patient, the doctor treating the patient or
the clinic staff must instruct the patient on how the unit works.
1.3 Functional description
Preparing the therapy pressure
An electronically controlled fan draws in ambient air via a filter and conveys it to the
unit outlet. From here the air flows through the hose system and the nasal mask to the
patient.

8Description of unit
Sensors recognize the pressure in the nasal mask and in the hose system as well as
any respiratory phase change (trigger moment). Accordingly the fan initializes the
IPAP and EPAP pressures set by the doctor.
Therapy modes
BiLevel ST 22 can be operated in four therapy modes: S, T, ST, CPAP. Your doctor
will set the mode required for your therapy on the unit.
In the time-controlled mode T and the assisted-controlled mode ST your doctor can
adjust the respiratory rate to within a range of 6 to 45 breaths per minute and the
inspiration time to within a range of 20 % to 67 % of the respiratory cycle.
In the assisted mode S and in the assisted-controlled mode ST your doctor can select
one of 6 trigger levels for inspiration and expiration. In the ST mode your doctor can
turn the expiration trigger off. Expiration is then time-controlled.
If the patient does not breathe into the unit in the S mode then the pressure is changed
to a minimum frequency of 6 breaths per minute.
Other functions
The Soft start function makes going to sleep easier. Your doctor sets the initial
pressure for inspiration and expiration, which is then continuously increased during
the Soft start phase until the therapy pressure is reached. The doctor can disable this
function. Or the doctor can limit the Soft start time.
BiLevel ST 22 has an auto switch-on function. If this is activated, the nasal mask can
be turned on by breathing. The unit is turned off using the on/off switch .
On the display the therapy mode and, depending on the mode, the currently applied
values for IPAP and EPAP or CPAP and respiratory rate (f) are shown. Further, the
spontaneous or mandatory (triggered by the machine) respiratory phase changes are
displayed and the pressure change shown graphically.

Safety instructions 9
2. Safety instructions
2.1 Safety regulations
Please read these Operating Instructions through carefully. They form part of the unit
and should be available at all times. Only use the unit for the purposes described
(see "1.1 Intended use" on page 7).
For your own safety, the safety of your patients, and to comply with the requirements
of EU Directive 93/42 EEC, please observe the following:
Operating the unit
Caution!
• The power supply supplied allows the unit to be operated at
voltages between 115 V and 230 V. Check that your supply
voltage falls within this range.
•Always secure the mains socket on the power supply using the cable
securing clip to prevent unintentional removal of the plug.
• BiLevel ST 22 must be connected to an easily accessible socket, so
that in the event of a failure, the mains plug can be quickly removed.
•To avoid overheating, do not position the unit near a source of heat
or in direct sunlight. Condensation could also form in the VENTIclick
humidifier, which then condenses out in the hose system.
•Do not cover the unit with bedding etc. The air inlet would then be
blocked and the unit could overheat, resulting in insufficient therapy
delivery and damage to the unit.
•Maintain a safe distance between the BiLevel ST 22 and equipment
that emits HF radiation (e.g. cell phones) (see page 50). The unit
may otherwise malfunction.
• Should the unit fail, an alternative ventilation system should be
available on standby.

10 Safety instructions
Caution!
• Third-party masks may only be used after being approved by
Weinmann. Using unapproved masks may result in unsuccessful
therapy.
• If a pneumotachograph with a high flow resistance is used when
starting therapy or for flow checking purposes, this can lead to a
limitation of the trigger function of the BiLevel ST 22. If you have any
questions please contact Weinmann.
• You must not use antistatic or electrically conductive hoses.
• The use of the VENTIclick humidifier, bacteria filter and O2valve
VENTI-O2accessories can change the response of the unit. A
subsequent addition of one of these accessories may make it
necessary to adjust the unit parameters. If necessary ask your
doctor.
•Refer to the section "5. Hygienic preparation" on page 25 to avoid
infection or bacterial contamination.
Transport/Accessories/Spare Parts/Repair
Caution!
• Do not transport the BiLevel ST 22 with the VENTIclick humidifier
installed. Tilting might cause any water remaining in the VENTIclick
to run into the BiLevel ST 22 and damage it.
•Malfunctions and a lack of biocompatibility may result if third-party
products are used. Please bear in mind that in these cases any
warranty entitlement and liability shall lapse if the accessories
recommended in the Operating Instructions or original spare parts
are not used.
• Only have inspections and repairs carried out by Weinmann or
specialist staff.

Safety instructions 11
Oxygen supply
Warning!
• Smoking and naked flames are prohibited when oxygen is being
fed into the air flow. There is a risk of fire! The oxygen can become
deposited in clothing, bedding or in your hair. It can only be
removed by ventilating the room thoroughly.
Caution!
•Feeding oxygen into the air flow is only permitted using the O2valve
VENTI-O2, WM 24200.
• Always refer to the Safety Instructions in the guide to your oxygen
system.
2.2 Contraindications
The BiLevel ST 22 should not be used if the patient is suffering from one of the
following illnesses (or only with particular caution). In each case the decision whether
to use BiLevel ST 22 for therapy lies with the doctor in charge.
• Cardiac decompensation
• Severe heart arrhythmia
• Severe hypotension, particularly in conjunction with intravascular
volume depletion
• Severe epistaxis
• High risk of barotrauma
• Pneumothorax or pneumomediastinum
• Pneumo-encephalus
• Head injury
• Status after brain operation and surgical procedure performed on
hypophysis or on middle or inner ear
•Acute inflammation of the sinuses (sinusitis), middle ear inflammation
(otitis media) or perforated eardrum.
• Dehydration
Threatening situations were not observed with BiLevel ST 22.

12 Safety instructions
2.3 Side effects
When using BiLevel ST 22 the following undesirable side effects may occur during
short-term and long-term usage:
• Pressure points on the face caused by the nasal mask and the
forehead padding
• Reddening of the skin on face
• Nasal congestion
• Dry nose
• Dry mouth in morning
• Feeling of pressure in sinuses
• Irritation of conjunctiva of eyes
• Gastrointestinal insufflation of air ("bloated stomach")
• Nosebleeds.

Safety instructions 13
2.4 Special markings on the unit
Front
9Unit outlet: emission of ambient air at 4 - 22 hPa
8Socket: electrical connection for the VENTIclick humidifier, WM 24365;
Max. power consumption at 40V: 600 mA
Back
18 Service label: indicates when the next service is due.
19 Unit inlet: allows air at room temperature to enter
20 Voltage supply with power supply WM 24790: 12 V/40 V DC
Connection for mains-independent operation with VENTIpower, WM 24100
Side connection sockets
6a Connection for adjusting therapy parameters with VENTIsupport, WM 93340 by
specialist staff; Max. power consumption at 12V: 15 mA
6b Connection for optional additional units, e.g. analog box;
Max. power consumption at 12V: 25 mA
21 Connection for controlling the O2valve VENTI-O2.
Max. power consumption at 12V: 125 mA
20 216a 6b 1989 18

14 Safety instructions
Name plate
Do not dispose of the unit as domestic waste!
Protection class B
Protection class II, double insulation
Year built
Refer to Operating Instructions

Setting up the unit 15
3. Setting up the unit
3.1 Positioning and connecting the unit
Set up the unit on a flat surface, e.g. a bedside cabinet or on the floor next to the
bed. Keep a distance between the wall and the back of the unit of at least 5 cm,
because at the back of the unit there is an air inlet.
Caution!
Do not cover the unit with bedding etc. The air inlet would then be
blocked and the unit could overheat, resulting in insufficient therapy
delivery and damage to the unit.
1. Plug the power supply cable into the supply
connection of the BiLevel ST 22. Then plug the
power supply into a socket outlet (using the power
supply cable).
Note
Always secure the mains socket to the power
supply using the cable securing clip to prevent
unintentional removal of the plug.
2. Connect the power supply cable to a mains
socket. The power supply automatically
determines the appropriate mains voltage (150 -
230 V). “Weinmann BiLevel ST 22” appears on
the display.
3. Insert the hose system adapter into the unit outlet.
The unit is now ready to use.
Cable securing clip

16 Setting up the unit
3.2 Fitting the mask
BiLevel ST 22 is designed for operation with nasal, oronasal and full face masks. To
fit the nasal mask, proceed as follows:
1. Adjust the forehead support (if fitted) of the mask.
2. Connect the headgear to the mask and put the mask on.
3. Adjust the headgear so that there is only a slight pressure from the mask cushion
in order to prevent pressure points on the face.
Refer to the Operating Instructions for the respective nasal mask.
3.3 Accessories
Separate exhalation system
A separate exhalation system is necessary if you use a mask without an integrated
exhalation system.
The exhalation system allows the used air containing carbon dioxide (CO2) to
escape from the mask. Without an exhalation system the CO2concentration would
rise to critical values in the mask and hose, thus hindering breathing.
Furthermore, should the unit fail, the exhalation system allows you to breath through
the nose or mouth. With full face masks, the patient can breathe through a safety
valve on the mask in the event of a malfunction.
The sleeve at the end of the hose system has a
diameter of 19.5 mm and fits over a 22 mm standard
conus. Put the exhalation system into the sleeve of the
corrugated tube.
Refer to the Operating Instructions for your exhalation
system.
Exhalation system
Hose system
Sleeve

Setting up the unit 17
Humidifier VENTIclick
The VENTIclick humidifier is connected between the
BiLevel ST 22 and the hose system. The input
connections and the electrical adapter of the heating
element must point toward the BiLevel ST 22. Refer to
the Operating Instructions for the VENTIclick.
Oxygen supply with VENTI-O2
The introduction of oxygen must be administered by
the doctor carrying out the treatment.
For safety reasons (fire risk), the direct introduction of
oxygen into the breathing hose or the mask without
any special protective device is not permitted.
The introduction of oxygen for the BiLevel ST 22 is only permitted using the VENTI-
O2oxygen valve. This valve enables up to 4 l/min of oxygen to be introduced. If
there is a fault, the VENTI-O2releases the oxygen into the atmosphere. This prevents
oxygen accumulating in the unit.
The oxygen can be supplied from an oxygen concentrator (e.g. Oxymat 3), the
central gas unit, liquid oxygen as a continuous flow or an oxygen bottle with the
appropriate pressure reducer. For flow adjustment purposes, the external oxygen
source must be fitted with a device that is independent of the VENTI-O2.
It is essential that you always follow the safety instructions for handling oxygen as
well as the Operating Instructions for the VENTI-O2oxygen valve and the oxygen unit
used.

18 Setting up the unit
Bacteria filter
If BiLevel ST 22 is to be used by several patients (e.g.
in a hospital), the WM 24148 bacteria filter must be
used to protect against infection. It is connected
between the hose system and the BiLevel ST 22 or
VENTIclick. Also refer to the Operating Instructions
supplied with the bacteria filter.
Caution!
The bacteria filter provides additional resistance to the air flow: This can bring
about a change in how the trigger responds. The unit parameters must therefore
be adjusted if a bacteria filter is added later.
VENTIpower
The VENTIpower is available for mains-independent
operation.
VENTIpower can be connected to the therapy unit as
an alternative to the mains supply.
Also refer to the Operating Instructions for the
VENTIpower.
Note
We advise against using the humidifier at the same time as the VENTIpower, as
this considerably reduces the duration of the power supply from the VENTIpower.

Operation 19
4. Operation
4.1 BiLevel ST 22 startup
1. If your nasal mask does not have an integrated
exhalation system, put the exhalation system onto
the end of the hose system (see " Separate
exhalation system" on page 16).
Caution!
Always use an exhalation system. Otherwise the
CO2concentration in the mask and hose would
rise to critical values and hinder your breathing.
2. Put the mask on (see "3.2 Fitting the mask" on
page 16) and connect the hose system including
exhalation system to the nasal mask (plug cone).
Please follow the relevant Operating Instructions
for the mask and exhalation system.
3. Press the On/Off switch . If auto switch-on is
activated, you can also put on the mask and turn
BiLevel ST 22 on by breathing (see "4.2 Activate/
deactivate the auto switch-on" on page 20).
The operating hours and the Weinmann software
version appear for approx. 3 seconds on the
display. The buzzer sounds and the unit begins to
feed air through the hose system. The display
reverts to the standard display.
The therapy mode that has been set and therapy
pressures in hPa (in CPAP mode, CPAP pressure
only) are displayed together with the current
respiratory rate in l/min.
Note: 1.01973 hPa corresponds to 1 cm H2O.
BiLevel ST 22
On/Off switch
Standard display

20 Operation
If Soft start is activated, the Soft start display
appears indicating the remaining Soft start time, a
maximum of 30 minutes, or the Soft start time set
by the doctor (see "4.3 Setting Soft start" on
page 21).
The bar graph shows the pressure levels during
inspiration and expiration.
The respiratory phase switch display shows
whether the current respiratory phase has been
triggered spontaneously by the patient (S) or by the
machine (T). The display changes according to the
respiratory phase from left (inspiration) to right
(expiration). The diagram shows expiration
triggered by the machine.
4.2 Activate/deactivate the auto switch-on
If auto switch-on is activated, you can turn on BiLevel ST 22 using the On/Off switch
or by “breathing”. You can only turn off BiLevel ST 22 using the On/Off switch
.
Activate auto switch-on
1. Close the hose system or put the mask on.
2. Press the On/Off switch to turn BiLevel ST 22on.
3. Press the Menu key . The patient menu appears
on the display. The selection bar is positioned on
Drying process.
Respiratory
phase switch
Soft start display
Bar graph