Weinmann BiLevel ST 22 User manual

BiLevel ST 22
Ventilation and Sleep Therapy Device
BiLevel ST 22
Description of unit and instructions for use

2
EN
Overview
BiLevel ST 22
3Power supply
cable
8Humidifier connection
13 Pressure
measuremen
t hose
14 Hose system
10 Sealing plugs (2x)
15 Exhalation system
7Control panel and display
6Serial interfaces
17 Hood
9Unit 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 VENTIclick
29 VENTIpower
26 Menu key
1Bacteria filter
11 Drying adapter
33 VENTI-O2
5Handle
22 Alarm acknowledgement key with LED
24 Dial
25 Operating keys
21 Connection for
O2valve VENTI-O2
19 Filter compartment lid, air inlet
20 Mains connection/connec-
tion for battery VENTIpower
2Power supply
18 Service label
4Cable securing clip

3
EN
1 Bacteria filter (Accessories)
Used to protect the patient from bacteria, particu-
larly if the unit is being used by a number of pati-
ents.
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 eva-
luation 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 VENTIclick 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 du-
ring 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 di-
verted here during the therapy.
16 Nasal mask (Accessories)
The nasal mask is used to administer air to the pa-
tient at the required therapy pressure.
17 Hood (Accessories)
Helps fit the nasal mask correctly and securely.
18 Service label
The service label shows when the next service is
required.
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-inde-
pendent power supply VENTIpower supplied as
an accessory.
21 Connection for O2valve VENTI-O2
For connecting the VENTI-O2oxygen valve (sup-
plied as an accessory).
22 Alarm acknowledgement key with LED
The alarm acknowledgement key temporarily mu-
tes 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.

4
EN
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-inde-
pendent 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 (spontane-
ous: S, mandatory: T), the display changes accor-
ding to the respiratory phase from left
(inspiration) to right (expiration); in this case man-
datory 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 stan-
dard 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

5
EN
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. . . . . . . . . . . 8
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 . . . . . 23
5. Hygienic preparation . . . . . . . . 24
5.1 Intervals . . . . . . . . . . . . . . . . . . . . 24
5.2 Cleaning . . . . . . . . . . . . . . . . . . . 25
5.3 Disinfection and sterilization . . . . . 27
5.4 Multiple patient use . . . . . . . . . . . 28
6. Functional check . . . . . . . . . . . . . 29
6.1 Intervals . . . . . . . . . . . . . . . . . . . . 29
6.2 Execution . . . . . . . . . . . . . . . . . . . 29
7. Troubleshooting . . . . . . . . . . . . . 33
7.1 Malfunctions . . . . . . . . . . . . . . . . 33
7.2 Alarms . . . . . . . . . . . . . . . . . . . . . 34
8. Maintenance . . . . . . . . . . . . . . . . 37
8.1 Intervals . . . . . . . . . . . . . . . . . . . . 37
8.2 Filter change . . . . . . . . . . . . . . . . 38
8.3 Change the pressure
measurement hose . . . . . . . . . . . 40
8.4 Disposal. . . . . . . . . . . . . . . . . . . . 40
9. Scope of supply . . . . . . . . . . . . . . 41
9.1 Standard scope of supply . . . . . . . 41
9.2 Accessories and spare parts . . . . . 41
10. Technical data . . . . . . . . . . . . . . . 42
10.1 Pneumatic diagram . . . . . . . . . . . 45
10.2 Safety distances . . . . . . . . . . . . . . 46
11. Warranty . . . . . . . . . . . . . . . . . . . 47
12. Declaration of Conformity . . . . . 48
13. Index . . . . . . . . . . . . . . . . . . . . . . 49

Description of unit 7
EN
1. Description of unit
1.1 Intended use
Use as a sleep therapy unit
BiLevel ST 22 is a BiLevel unit for treating sleep-related respiratory disorders, i.e. it uses two
pressure levels (inspiration = IPAP, exhalation = EPAP) to keep the airways open during
sleep. The unit is designed for adult patients with an autonomous respiratory drive. This is
in keeping with the following clinical scenarios:
• obstructive, mixed and central sleep-related respiratory disorders, e.g. OSAS, CS and
obstructive OHS.
BiLevel ST 22 is not designed for life-support.
When used as a sleep therapy unit, BiLevel ST 22 complies with EN ISO 17510-1 (sleep
apnea breathing therapy equipment).
Use as a ventilation device
BiLevel ST 22 is a ventilation device for non-invasive ventilation (not for life-support purpos-
es) of adult patients with respiratory insufficiency but capable of breathing autonomously.
This is in keeping with the following clinical scenarios:
• restrictive and obstructive ventilation problems, e.g. OSAS, COPD, obesitas hypoventila-
tion 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.
When used as a breathing apparatus, BiLevel ST 22 complies with EN ISO 10651-6
(ventilatory support units).
1.2 User qualification
The settings on BiLevel ST 22 may only be set by a doctor and to suit the individual patient.

8Description of unit
EN
When handing over BiLevel ST 22 to the patient, the doctor treating the patient or the clin-
ic 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.
Sensors recognize the pressure in the nasal mask and in the hose system as well as any re-
spiratory 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
EN
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 In-
tended 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 sun-
light. 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 ra-
diation (e.g. cell phones) (see page 46). The unit may otherwise malfunction.
• Should the unit fail, an alternative ventilation system should be available on standby.
Caution!
• Third-party masks may only be used after being approved by Weinmann. Using unap-
proved 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.

10 Safety instructions
EN
• 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 24 to avoid infection or bacte-
rial 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.
• If third-party items are used, functional failures may occur and fitness for use may be
restricted. Biocompatibility requirements may also not be met. Please note that in such
cases, any claim under warranty and liability will be voided if neither the accessories nor
genuine replacement parts recommended in the instructions for use are used.
• Only have inspections and repairs carried out by Weinmann or specialist staff.
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.

Safety instructions 11
EN
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
EN
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
EN
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 WEINMANNsupport, WM 93305
or with SOMNOadjust, WM 23930 by specialist staff;
Max. power consumption at 12V: 15 mA
6b Connection for optional supplementary devices such as Analogbox D/A;
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
EN
Name plate
Do not dispose of the unit as domestic waste!
Protection class B
Type of protection against electric shock: unit of protection class
Year built
Refer to Operating Instructions
CE 0197 symbol: Confirms that the product conforms to the applicable European
directives
IPX1 Degree of protection against penetration by water (drips)
SN Serial number of device

Setting up the unit 15
EN
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 connec-
tion 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 ap-
propriate 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.
Note:
The appliance automatically compensates for dif-
ferences in air pressure (e.g. due to high altitude).
Cable securing clip

16 Setting up the unit
EN
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 exhala-
tion 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
EN
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 In-
structions 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-O2oxy-
gen 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
EN
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 re-
fer to the Operating Instructions supplied with the bacte-
ria 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 adju-
sted 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
EN
4. Operation
4.1 BiLevel ST 22 startup
1. If your nasal mask does not have an integrated exha-
lation system, put the exhalation system onto the end
of the hose system (see " Separate exhalation sy-
stem" on page 16).
Caution!
Always use an exhalation system. Otherwise the CO2
concentration in the mask and hose would rise to cri-
tical 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 ex-
halation 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 acti-
vated, 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 ver-
sion 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 pres-
sures 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.
On/Off switch
Standard display

20 Operation
EN
If Soft start is activated, the Soft start display ap-
pears indicating the remaining Soft start time, a maxi-
mum 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 inspi-
ration 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 pha-
se from left (inspiration) to right (expiration). The dia-
gram 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
Soft start display
Bar