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.

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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.