Weinmann BiLevel ST 22 Description Of Unit And Instructions For Use

Brand: Weinmann

Model: BiLevel ST 22

Type: Description Of Unit And Instructions For Use

BiLevel ST 22

Ventilation and Sleep Therapy Device

BiLevel ST 22

Description of unit and instructions for use

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

O2 valve VENTI-O2

19 Filter compartment lid, air inlet

20 Mains connection/connec-

tion for battery VENTIpower

2Power supply

18 Service label

4Cable securing clip

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 O2 valve VENTI-O2

For connecting the VENTI-O2 oxygen 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.

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

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

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

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

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

• You must not use antistatic or electrically conductive hoses.

• The use of the VENTIclick humidifier, bacteria filter and O2 valve VENTI-O2 accessories

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 O2 valve VENTI-O2,

WM 24200.

• Always refer to the Safety Instructions in the guide to your oxygen system.

Safety instructions 11

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 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 O2 valve 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

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

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

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 CO2 concentration 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 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-O2 oxy-

gen valve. This valve enables up to 4 l/min of oxygen to be introduced. If there is a fault,

the VENTI-O2 releases 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-O2 oxygen 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 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

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

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

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Weinmann BiLevel ST 22 Description Of Unit And Instructions For Use

Brand: Weinmann

Model: BiLevel ST 22

Type: Description Of Unit And Instructions For Use

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Weinmann BiLevel ST 22 Description Of Unit And Instructions For Use

Weinmann BiLevel ST 22 Description Of Unit And Instructions For Use

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