BiLevel ST 22
Contents
1. 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 Adjust the headgear so that there is only a slight pressure trom 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 CO to escape from the mask Without an exhalation system the CO concentration would rise to critical values in the mask and hose thus hindering breathing Furthermore should the unit tail 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 maltunction The sleeve at the end of the hose system has a diameter of 19 5 mm and fits over a 22 mm standard Exhalation system Conus Put the exhalation system into the sleeve of the corrugated tube Sleeve Refer to the Operating Instructions for your exhalation Hose system system 16 Setting up the unit 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 the2. 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 teed air through the hose system The display reverts to the standard display IPAP 6 0 hPa EPAP 4 0 hPa f 22 min 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 Standard display Note 1 01973 hPa corresponds to 1 cm H O Operation 19 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 Soft start display The bar graph shows the pressure levels during IPAP 6 0 hPa Sa peel Sian inspiration ana expiration EPAP 4 0 hPa f 43 min The respiratory phase switch display shows whether the current respiratory phase has been triggered spontaneously by the patient S or by the Bar graph Respiratory machine T The display changes according to the phase switch 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 Q or by breathing You can only turn off Bilevel ST 22 using the On Off s
3. or perforated eardrum e Dehydration Threatening situations were not observed with Bilevel ST 22 Safety instructions 11 2 3 Side effects When using Bilevel ST 22 the following undesirable side effects may occur during shorHerm and long term usage 12 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 2 4 Special markings on the unit Front Unit outlet emission of ambient air at 4 22 hPa Socket electrical connection for the VENTIclick humidifier VVM 24365 Max power consumption at 40V 600 mA Back Service label indicates when the next service is due Unit inlet allows air at room temperature to enter Voltage supply with power supply WVM 24790 12 V 40 V DC Connection for mains independent operation with VENTloower VVM 24100 Side connection sockets Connection for adjusting therapy parameters with VENTlsupport WM 93340 by specialist staff Max power consumption at 12V 15 mA Connection for optional additional units e g analog box Max power consumption at 12V 25 mA Connection for controlling the O valve VENTI O Max power consumption at 12V 125 mA Saf
4. SOMNOcap size L white WM 23687 SOMNOstrap blue WM 23695 SOMNOstrap white WM 23177 SOMNOstrap extra WM 25250 JOYCEstrap WM26290 JOYCEstrap EXTRA 3 packs WM2629 JOYCEstrap EXTRA 4 packs WM26292 JOYCEcap WM26293 JOYCE vented size S WM 26110 JOYCE vented size M WM 26120 JOYCE vented size L WM 26130 JOYCE vented 40 hPa size S WM 26111 JOYCE vented 40 hPa size M WM 26121 44 Scope of supply Parts Order number JOYCE vented 40 hPa size L WM 26131 JOYCEnon vented size S WM 26160 JOYCE non vented size M WM 26170 JOYCE non vented size L WM 26180 JOYCE non vented 40 hPa size S WM26161 JOYCE non vented 40 hPa size M WM26171 JOYCE non vented 40 hPa size L VW M26181 YARA vented size S WM 26410 YARA vented size M WM 26420 YARA vented size L WM 26430 YARA vented 40 hPa size S WM 26411 YARA vented 40 hPa size M WM 26421 YARA vented 40 hPa size L WM 26431 YARA non vented 40 hPa size S WM2646 1 YARA non vented 40 hPa size M WM2647 YARA non vented 40 hPa size L WM2648 When using other mask systems please observe the relevant Operating Instructions Scope of supply 45 9 3 Replacement parts Parts Order number Hose system consisting of WM 24130 Disintectable corrugated tube WM 24108 Pressure measurement hose WM 24038 Hose Adapter WM 24123 Pressure connector WM 24129 Sealing plugs 2x WM 24115 Coa
5. current respiratory phase change is spontaneous or mandatory spontaneous S mandatory T the display changes according to the respiratory phase trom 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 Symbols used in the display Symbol Meaning Status line elif Soft start active remaining time highlighted Filter change necessary Service required Main window N IN Medium priority alarm triggered Abbreviations used in the display Symbol Meaning Status line S S mode active T T 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 H20 f Respiratory rate spontaneously triggered switch in respiratory phase mandatory triggered switch in respiratory phase Symbols and safety tips used in the Operating Instructions War
6. recommend that repairs are only carried out by Weinmann or by authorized dealers Maintenance include Check for completeness Visual inspection for mechanical damage Filter change Cleaning the unit Replacement of any defective parts Complete check of unit tunctions and pressure displays Battery change Final test according to test instruction WWM 24954 38 Maintenance 8 2 Filter change Change coarse dusifilter Only use original Weinmann filters Claims under warranty will be forfeited it filters from outside manufacturers are used these may also restrict function and biocompatibility 1 If the humidifier VENTlIclick is connected first disconnect it from the unit This prevents water running into the unit during a filter change Refer to the Operating Instructions for the VENTIclick 2 Press on the lock of the filter compartment lid and remove the lid 3 Remove the coarse dust filter from the filter compartment lid and dispose of it as normal domestic waste 4 Insert the clean coarse dust filter into the filter compartment lid 5 Then put the filter compartment lid lower edge first into the encasing section Then press the filter compartment lid into the housing until it locks into position Maintenance 39 Change the fine dusifilter The fine dust filter must be changed when it becomes dark and discolored and at least every 1000 operating hours In the latter ca
7. 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 VENTl power The VENTlpower is available tor mains independent operation VENTlpower can be connected to the therapy unit as an alternative to the mains supply Also reter to the Operating Instructions for the VENT power Note We advise against using the humidifier at the same time as the VENTlpower as this considerably reduces the duration of the power supply trom the VENTlpower 18 Setting up the unit 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 CO concentration 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 cb 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
8. 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 It 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 tunction 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 tunction 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 CO On the display the therapy mode and depe
9. 0 hPa approx 30 dB A at 15 hPa approx 28 dB A at 12 hPa approx 26 dB A at 10 hPa approx 24 dB A at 7 hPa Sound pressure level alarm warning at least 62 dB A Technical data 47 BiLevel ST 22 Bilevel ST 22 with VENTIclick IPAP pressure range EPAP pressure range CPAP pressure range Pressure accuracy Increment 6 to 22 hPa A to 20 hPa A to 20 hPa 0 6 hPa 0 2 hPa 1 hPa Imbar 1 cm H2O Minimum stable limit pressure PLS_ min pressure if there is a gt 0 hPa fault Maximum stable limit pressure lt 60 hPa PLS max max pressure if there is a fault Respiratory rate 6 to 45 l min Precision 0 5 1 min Increment 1 min EE Wi7 tk Inspiration time 20 up to 67 of the respiratory cycle Increment 1 Precision 1 moaba adjustable over 6 levels separate for inspiration and expiration in the ST mode the expiration trigger can be disabled Rate of pressure rise adjustable over 6 levels Rate of pressure drop adjustable over 6 levels Precision of volume measurement azo Gra 1 Flow at max speed at O hPa 300 l min 275 min Tolerance 15 min 15 min Flow at max speed with bacteria tilter at OhPa 270 min 250 l min Tolerance 15 min 15 min Warming of air as per the German HMV Medical Technical Aids 20 C depends on heating level Register 48 Technical data Bi
10. 1000 Change the fine filter Filter Change display 4 Sooner if operating hours contaminated Every 6 months Change the coarse dust filter Sooner if contaminated or worn Change the pressure measurement hose sooner it contaminated see 8 3 Change the pressure measurement hose on page 41 Annually Change the hose system Hygienic preparation 25 5 2 Cleaning Cleaning the hose system 1 Remove the hose system trom the unit and exhalation system 2 Pull one end of the pressure measurement hose out shake gently it necessary and seal it with the sealing plug supplied At the other end seal off the small opening of the adapter with the second sealing plug so that no water can enter 3 Using a small amount of detergent in warm water clean the corrugated tube so no residues remain Rinse the inside of the hose thoroughly A Rinse the corrugated tube thoroughly both inside and out using clean warm water 5 Shake the hose system thoroughly Hang up the hose system and allow it to drip to prevent moisture from getting into the Bilevel ST 22 7 Remove the plugs trom the pressure measurement hose Dry the hose system using BiLevel ST 22 I Patient menu Drying process Auto switch on Off Filter change Function check back 26 Hygienic preparation If water should accidentally get into the pressure measurement hose put the suppl
11. 2 and recharge Continue operating Bilevel ST 22 using a mains socket Disconnect power and reconnect Turn the unit on again Ep Water droplets in Dry the pressure Unit failure the pressure measurement hose as FAN MN Medium priority measurement hose described in 5 2 Remove both sealing plugs Disconnect power and reconnect Turn the unit on again without the hose system If there are defects that cannot be rectified at once please contact Weinmann or your dealer immediately to have the unit repaired To avoid greater damage do not use the unit Troubleshooting 37 8 Maintenance 8 1 Intervals Both filters must be regularly checked for contamination e Clean the coarse dust filter once a week and replace it at least every 6 months e The fine filter must be changed at the latest after 1000 operating hours filter change symbol appears on the display For hygiene reasons we recommend that the following parts be changed at the stated intervals e Pressure measurement hose every 6 months sooner if contaminated e Complete mask system depending on contamination every 6 to 12 months e Exhalation system according to the relevant Operating Instructions As a preventative measure maintenance must be carried out at the following intervals e Every 5000 operating hours maintenance symbol A appears in display e At the latest atter 2 years see maintenance label on the back of the device We
12. 50 10 2Satety distances 50 Li WOT 25 6 0s0005 e lt ene eases 51 12 Declaration of Conformity 52 E O E acee ears 53 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 e restrictive and obstructive ventilation problems e g OSAS COPD obesitas hypoventilation syndrome e Problems with the mechanics of breathing e g scoliosis or a chest detormity e neurological muscular and neuromuscular problems e g diaphragmatic paresis e 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 tlows through the hose system and the nasal mask to the patient Description of unit 7 Sensors recognize the pressure in the nasal mask and in
13. Bilevel ST 22 Refer to the Operating Instructions for the VENTIclick Oxygen supply with VENTI O The introduction of oxygen must be administered by the doctor carrying out the treatment For satety 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 O oxygen valve This valve enables up to 4 min of oxygen to be introduced It there is a fault the VENTI O releases the oxygen into the atmosphere This prevents oxygen accumulating in the unit The oxygen can be supplied trom 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 O It is essential that you always follow the safety instructions for handling oxygen as well as the Operating Instructions for the VENTI O oxygen valve and the oxygen unit used Setting up the unit 17 Bacteria filter It Bilevel ST 22 is to be used by several patients e g in a hospital the WM 24148 bacteria filter must be C used to protect against infection It is connected ai between the hose system and the Bilevel ST 22 or _ VENTlclick Also refer to the Operating Instructions supplied with
14. Description of unit and operating instructions for patients Bilevel ST 22 Bilevel ST Home Ventilation Unit WM 27500 WEINMANN Overview BilLevel ST 22 17 Hood 16 Nasal mask 15 Exhalation system EF 10 Sealing plugs 2x 9 Unit outlet 14 Hose system 13 Pressure measurement hose 18 Service label 23 On Off switch 24 Dial 21 Connection for O valve VENTI O gt 28 Soft start 20 Mains connection connection tor battery VENTI power 19 Filter compartment lid air inlet key 33 VENTIO gt 25 Operating keys 26 Menu key 27 Humidifier key with LED 32 Carrying bag 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 VENTlclick supplied as an accessory 9 Unit outlet The air tlows from here via the hose system and nasal mask to the patient 10 Sealing plugs 2x Used to close the p
15. Hose system WM 24130 Drying adapter WM 24203 Carrying bag WM 24995 Power supply cable WM 24177 Power supply WM 24790 Coarse dust filter WM 24880 Fine filter packed WM 15026 Operating instructions Bilevel ST 22 GB WM 66131 Patient record WM 66165 9 2 Accessories The following accessories are not included in the scope of supply and must be ordered separately it needed Parts Order number Humidifier VENTIclick WM 24365 Evaluation software VENTIsupport WM 93340 only for trained medical and engineering stoff Sterilizable hose system consisting of WM 24120 Sterilizable corrugated tube WM 24122 Pressure measurement hose WM 24038 Adapter with pressure connector WM 24149 Plugs 2x WM 24115 Bacteria filter complete WM 24148 Oxygen valve VENTI O WM 24200 Scope of supply 43 Parts Order number Battery VENTl power incl case WM 24100 Inverter 12 V WM 24616 Inverter 24 V WM 24617 SOMNOmask size S WM 25110 SOMNOmask size M WM 25120 SOMNOmask size L WM 25130 SOMNOmask size S blue WM 25210 SOMNOmask size M blue WM 25220 SOMNOmask size L blue WM 25230 SOMNOplus size S WM 25710 SOMNOplus size M WM 25720 SOMNOplus size L WM 25730 Silenttlow WM 23600 lt lt complete alternative exhalation WM 23685 SOMNOcap size M blue WM 23673 SOMNOcap size L blue WM 23674 SOMNOcap size M white WM 23686
16. Level ST 22 BiLevel ST 22 with VENTIclick at 20hPa Ap 1 hPa ShortHterm pressure constant o a is i J measured according to 10 hPa na 1 hP prEN 17510 2005 and German i 7 Pa 7 0 5 HMV criteria in CPAP mode i n T at 5 hPa Ap lt 0 5 hPa at A hPa Ap lt 0 5 hPa Long erm pressure constant measured according to Ap 0 2 hPa prEN 17510 2005 Finetilter separation level to 2 ym 99 7 Fine filter service life 1000 hours with normal room air Permitted humidity for operation and storage lt 95 rF no condensation System resistance with an air flow of 60 l min at the patient connector aperture Bilevel ST 22 with hose system WM 24130 and Silenttlow WM 23600 Bilevel ST 22 with Oo hose system WM 23737 VENTIclick WM 24365 and bacteria filter WM 24148 kPa s 0 20 kPa s 03 1 i All values determined under ATPD conditions ambient temperature and pressure dry 49 Technical data 10 1 Pneumatic diagram Patient mask nasal or full facial mask Ambient Filter element Fan Metering pipe air inlet i Pressure sensor for appliance pressure Pressure sensor for patient pressure 10 2 Safety distances Recommended safety distances between portable and mobile HF telecommunications equipment e g cell phones and the BiLevel ST 22 Nominal output of Safety distance dependent on transmission frequency HF equipment in m in W 150 kH
17. al spare parts e Weinmann is not liable for consequential harm caused by a detect it it is not not based on intention or gross negligence Weinmann is also not liable for minor physical injury to lite or limb resulting trom negligence e Weinmann reserves the right to decide whether to eliminate defects to deliver a defecttree item or to reduce the purchase price by a reasonable amount e If Weinmann rejects a claim against the warranty it assumes no ex pense for transport between customer and manufacturer e Implied warranty claims remain unattected by these changes Warranty 51 12 Declaration of Conformity EEC Letter of Conformity on Medical Devices We the manufacturer Weinmann Ger te f r Medizin GmbH Co KG Kronsaalsweg 40 22525 Hamburg Germany declare in sole responsibility the Product Name Home Mechanical Ventilator Type Model BiLevel ST 22 being in conformity with the respective regulations of the following guideline Medical Device Directive 93 42 EWG Classification lla standards used in particular IEC 6060 1 1 2005 EN 60601 1 2 2001 Al 2006 DIN EN ISO 10651 6 2004 Mark The product has the mark by TUV Rheinland Product Safety GmbH 51105 Cologne Germany Hamburg 10 04 2006 Loa or Dr K A Feldhahn President Chief Technology Officer WEINMANN WM 70201 10 06 52 Declaration of Conformity 13 Index Accessories Alarms Auto switch on Carrying bag Cleani
18. ard display appears again after acknowledging the acoustic alarm It the fault has not been rectified the status line continues to be displayed 5 PAP 6 0 hPa and the yellow status display flashes or is illuminated EPAP 4 0 hPa until the fault is cleared f 4 min a Disconnection If the fault has not been rectified within 120 seconds ot acknowledgement the acoustic alarm buzzer sounds again Assistance with rectitying faults can be found in the following tables Pressure The pressure measurement measurement hose Check that the hose i hose was not correctly ee ee disconnected Medium priority present and has been DMS correctly fitted AA Unit failure A A measurement hose ellie cea Excess pressure measurement hose as P blocked Medium priority Disconnection Medi a N AN edium priori Put the mask on or turn the unit off 36 Troubleshooting Overheating of the E Medium priority junit due to direct sunlight g Let the unit cool down and tind a more suitable place Excess loperating outside lto locate it temperature Medium priority P J the permitted temperature range Check that power supply and power supply cables No mains voltage lare securely connected Acoustic signal for available Check outlet is working by at least 120 connecting another piece of Display seconds no vanished i display visible Medium priority The battery from the Bilevel ST 2
19. ars on the main screen see also 7 Troubleshooting on page 34 1 Check the buzzer and the status displays Each time you turn the Bilevel ST 22 on check that you can hear the buzzer and that the status display lights up 2 Check the power failure alarm Start Bilevel ST 22 Now pull the power supply cable out of the socket the display goes out and the buzzer sounds Note Bilevel ST 22 must have been connected to the mains for at least 5 minutes before carrying out the test Turn the unit off after the functional check has been completed by pressing the on off D switch Functional check 33 7 Troubleshooting 7 1 Malfunctions Malfunctions Malfunction Rectification message Check that power supply and power No supply voltage supply cables are securely connected available Check outlet is working by connecting another piece of equipment e g a lamp Auto switch on not Activate auto switch on 4 2 page 20 Check with your doctor as to whether the Soft start function can be enabled for your treatment Soft start cannot be The Soft start function switched on is disabled Check with your doctor whether the maximum Soft start time for the current therapy session can be extended to 30 minutes Filter soiled Clean change filter 8 2 page 39 ries gt n L dick Adjust the headgear so that the nasal mask oes not reac Mask not airtight f een selected IPAP its snugly or replace it if neces
20. cribed in 8 2 Cleaning the coarse dust filter changing the fine filter k Zs Remove the filter compartment lid again as described in 8 2 Remove the coarse dust filter trom the filer compartment lid and clean it under clear running water until no residue remains Change the fine filter if necessary let the coarse dust filter dry Before start up the coarse dust filter must be completely dry Reinsert the coarse dust tilter and close the filter compartment lid Hygienic preparation 27 Note The tine filter cannot be cleaned It has to be changed every 1000 operating hours as described in 8 2 Accessories To clean the exhalation system the nasal mask the headgear VENTloower VENTI O the bacteria filter and VENTIclick please refer to Hygienic Preparation in the relevant Operating Instructions 5 3 Disinfection and sterilization If necessary tor example after an infectious illness or if the unit has become unusually contaminated you can also disinfect the housing the power supply and cable the hose system the bacteria filter housing VENTIclick VENTI O and VENTlpower Refer to the Operating Instructions for the disinfectant used We recommend that you wear suitable gloves when disinfecting the equipment e g household or disposable gloves Unit The housing power supply and power supply cable of the Bilevel ST 22 are cleaned by being simply wiped over with disinfectant We recommend TERRALIN Hose sy
21. e the following procedure the unit switches periodically between the two pressure levels IPAP and EPAP 2 Count the IPAP phases within one minute and compare them with the display You can recognize the IPAP phase by the louder operating noise or by the bar graph in the standard display Desired values S mode 6 phases a minute T and ST mode prescribed value Permitted deviation maximum phase a minute Triggering Note This check is only necessary if the device is operated in the S or ST modes 1 Turn the unit off by pressing and holding the on off switch for 2 seconds 2 Assemble the nasal mask 3 Turn the unit on by pressing the on off switch CO A Put the nasal mask on and breathe normally In the ST mode your breathing trequency must be above the prescribed frequency so that the unit s time controlled trigger is not active The unit must respond to the change in breathing phases with the change in pressure level Functional check 31 Note It the expiration trigger is not functioning it may have been turned off Ask your doctor if this is the case Soft start Note This check is unnecessary if Soft start has been disabled by the doctor 1 Turn Soft start on by pressing the Soft start key 4 The Soft start display lt 1 appears and the Soft start time is displayed Flow sensor Pressure sensor 1 Plug the supplied red drying adapter into the unit outlet 2 Press the on off switch D t
22. ety instructions 13 Name plate Do not dispose of the unit as domestic waste Protection class B Protection class Il double insulation Year built Refer to Operating Instructions 32 n gt x 14 Safety instructions 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 fo 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 VJ 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 Setting up the unit 15 3 2 Fitting the mask Bilevel ST 22 is designed tor operation with nasal oronasal and tull face masks To
23. he inspection sheet and the service and repair instructions for Bilevel ST 22 Hygienic preparation 29 6 Functional check 6 1 Intervals Implement a tunctional check at least every 6 months If you tind a defect during the functional check do not use Bilevel ST 22 until the defect has been remedied 6 2 Execution Assemble Bilevel ST 22 with the hose system exhalation system and power supply cable ready for operation Close the opening of the hose system e g using your thumb or hand _ Turn the unit on by pressing the on off CD switch A Then depending on the operating mode set check the following functions It Soft start is switched on switch it off by pressing the Soft start key a Function Mode CPAP S T ST Pressure accuracy Respiratory rate minimum _ E R R frequency Triggering Soft start Flow sensor Alarms It the values or functions specified below are not met please send the unit for repair to the dealer or to Weinmann 30 Functional check Pressure accuracy he Wait for approx minute then read the CPAP pressure on the display or the IPAP and EPAP pressure readings on the bar graph and check whether the values displayed correspond to the prescribed values Respiratory rate minimum frequency Note This check is unnecessary if the device is operated in CPAP mode Please observ
24. ial select YESand contirm by pressing the dial To cancel the process select NO and press the dial The process will be canceled If you have selected and confirmed YES the message Filter Change reset appears for 3 seconds When using the bacteria filter WWM 24148 change the particle filter in the bacteria tilter in accordance with the relevant Operating Instructions 8 3 Change the pressure measurement hose Adapter Sleeve Pressure measurement hose Remove the sleeve of the corrugated tube trom the adapter Pull the pressure measurement hose out of the corrugated tube Pull the pressure measurement hose away from the adapter Put the new pressure measurement hose onto the adapter Hold the corrugated tube up and introduce the tree end of the new pressure measurement hose Push the sleeve of the corrugated tube onto the adapter Dispose of the old pressure measurement hose Maintenance 41 8 4 Disposal Do not dispose of the unit as domestic waste To dispose of the unit properly please contact a licensed and certitied electronic waste recycler Names and addresses can be obtained from your Environmental Officer or municipal authorities The unit packaging cardboard box and inserts can be disposed of as waste paper 42 Maintenance 9 Scope of supply 9 1 Standard scope of supply BiLevel ST 22 WM 27500 Parts Order number Bilevel ST 22 Basic unit WM 27510
25. ied red drying adapter into the unit output Push the adapter of the hose system onto the red drying adapter Press the On Off switch 1 to start the drying process Use the menu key J to access the patient menu Press the dial to start the drying process The unit will now dry the hose system 4 The remaining drying time is displayed Atter 30 minutes Bilevel ST 22 automatically switches off You can Mews the process at any time by pressing the Menu key or the On Off switch C for 2 seconds If the hose system is still damp in places atter drying repeat the process Remove the drying adapter trom the unit outlet Cleaning the BiLevel ST 22 housing Warning e Risk of electric shock Before cleaning disconnect the power supply iF 3 cable from the power input of the Bilevel ST 22 and the mains plug from the socket e Make sure no liquid gets into the unit Never immerse the unit in disinfectant or any other liquid This can damage the unit and consequently endanger users and patients Wipe down the unit the power supply and the power supply cable with a damp soft cloth The Bilevel ST 22 must be completely dry before starting up 2 Remove the filter compartment lid 3 Remove the coarse dust filter as described in 8 2 A Clean the filter compartment lid with fresh running water until it is tree trom residue Then dry caretully Reinsert the coarse dust filter and the filter compartment lid as des
26. lease bear in mind that in these cases any warranty entitlement and liability shall lapse it 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 stoff Safety instructions Oxygen supply Warning ted 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 e Smoking and naked flames are prohibited when oxygen is being Caution e Feeding oxygen into the air flow is only permitted using the valve VENTLO WM 24200 e Always refer to the Satety Instructions in the guide to your oxygen system 2 2 Contraindications The Bilevel ST 22 should not be used if the patient is suffering trom 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 e Cardiac decompensation e Severe heart arrhythmia e Severe hypotension particularly in conjunction with intravascular volume depletion e Severe epistaxis e High risk of barotrauma e Pneumothorax or pneumomediastinum e Pneumo encephalus e Head injury e Status after brain operation and surgical procedure performed on hypophysis or on middle or inner ear e Acute inflammation of the sinuses sinusitis middle ear inflammation otitis media
27. ll be retained Operation 23 4 6 Traveling with Bilevel ST 22 Bilevel ST 22 should only be transported over long distances in the carrying bag provided for this purpose Pack the unit the power supply the connection cable the hose system incl drying adapter the nasal mask incl exhalation system and where applicable the VENTIclick humidifier and the VENTFO oxygen valve in the carrying bag Remember as well to take replacement filters and all the Operating Instructions with you If you want to take Bilevel ST 22 with you on a flight please make sure you are familiar with the necessary regulations before departure An air transportation certificate can be obtained trom Weinmann 24 Operation 5 Hygienic preparation 5 1 Intervals Check the filters at regular intervals and wipe the housing and filter compartment lid Head gear hood and straps can also be washed if required Please also observe the following intervals Interval Activity Clean hose system see 5 2 Cleaning on page 26 In accordance with the relevant Operating Instructions Daily Clean nasal mask Clean bacteria filter Clean exhalation system after each use Clean humidifier VENTIclick Every 24 operating hours Change the particle filter in the bacteria filter The nasal mask should be cleaned thoroughly in accordance Weekly with the Operating Instructions Clean the coarse dust filter Every
28. nding on the mode the currently applied values tor 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 Description of unit 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 satety the satety of your patients and to comply with the requirements ot 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 humiditier 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 insufficie
29. ng Disinfection Dry the hose system Exhalation system Filter Functional check Garantie Inspection Inspiration time Malfunctions Nasal mask Replacement parts Respiratory rate Safety instructions Side eftects Soft start Technical data Therapy mode Traveling VENT click VENTI O2 VEN Tlpower 43 35 8 19 20 34 24 25 25 28 26 16 19 23 25 38 44 34 38 46 49 30 5 10 8 34 16 19 23 25 46 8 48 9 11 12 2 20 22 47 8 24 17 22 28 47 17 18 Index 53 For decades Weinmann has been developing producing and marketing medical devices for markets around the world In cooperation with our partners we design economic health systems for diagnosis and therapy in Sleep Medicine Home Mechanical Ventilation Oxygen Medicine and Emergency Medicine WEINMANN wero Ger te f r Medizin GmbH Co KG P O Box 540268 D 22502 Hamburg Phone 49 40 5 47 02 0 Fax 4 49 40 5 47 02 461 EMail int sales weinmann de Internet www weinmann de
30. ning N 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 Contents Description of unit 1 1 Intended use 1 2 User qualification 1 3 Functional description Safety instructions 2 1 Safety regulations 2 2 Contraindications 2 3 Side effects 2 4 Special markings on the unit Setting up the unit 3 1 Positioning and connecting the unit 3 2 Fitting the mask 3 3 Accessories Operation 4 1 Bilevel ST 22 startup 2 4 2 Activate deactivate the auto switch on 2 0 0 00 Setting Soft start Setting the humiditier 4 5 After usage 4 6 Traveling with Bilevel ST 22 Hygienic preparation 5 1 Intervals 000 5 2 Cleaning 05 5 3 Disinfection and sterilization 5 4 Multiple patient use 4 3 4 4 Functional check 6 6 2 Execution Intervals 2 24 Troubleshooting 7 1 Malfunctions 7 2 Alarms 8 Maintenance 006 38 8 1 Intervals 2 00 ee 38 8 2 Filter change 39 8 3 Change the pressure measurement hose 41 8 4 Disposal 2 0 00 00 4 9 Scope of supply 43 9 1 Standard scope of supply 43 9 2 Accessories A3 9 3 Replacement parts 46 10 Technical data 47 10 1 Pneumatic diagram
31. nt therapy delivery and damage to the unit Maintain a sate distance between the Bilevel ST 22 and equipment that emits HF radiation e g cell phones see page 50 The unit may otherwise maltunction Should the unit fail an alternative ventilation system should be available on standby Safety instructions 9 Caution Third party masks may only be used after being approved by Weinmann Using unapproved masks may result in unsuccesstul 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 O valve VENTI O 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 25 to avoid infection or bacterial contamination Transport Accessories Spare Parts Repair 10 Caution Do not transport the Bilevel ST 22 with the VENTIclick humidifier installed Tilting might cause any water remaining in the VENTlclick to run into the Bilevel ST 22 and damage it Malfunctions and a lack of biocompatibility may result if third party products are used P
32. o start the functional check for the flow sensor Use the menu key E to Drying process access the patient menu Auto switch on Off Filter change Function check ST Patient menu J10 i back 3 Using the dial slide the black selection bar to ST Pageant mer l Function check and press the dial Drying process Auto switch on Off Filter change Function check A window opens with the message Function check running The remaining duration of the tunctional check is displayed 32 Functional check When the functional check has finished the message Function check OK appears and Bilevel ST 22 reverts to the standard display It a plausibility error is found during the functional check the message Flow sensor implausible Sensors implausible or Implausible pressure measurement appears Close the window using the menu key turn the Bilevel ST 22 off and disconnect the power for 5 minutes Check whether the drying adapter has been fitted correctly Repeat the functional check It the message Flow sensor implausible Sensors implausible or Implausible pressure measurement appears again please contact Weinmann or your dealer immediately to have your unit repaired Alarms Bilevel ST 22 carries out a CD self test on the sensors when the on off switch is pressed The alarm feature is also tested If an error occurs during the selHest an error message appe
33. r or press the SM key several times 3 To save the heat output time press the Menu key E or the dial The humidifier level window closes automatically If a key is not pressed for 4 seconds the displayed heat output will likewise be saved The settings are retained when the unit is switched off Refer to the Operating Instructions for the VENTlclick 22 Operation Note e Bilevel ST 22 starts automatically with VENTIclick active if this was activated when the unit was last used VENTlclick can be switched on and off at any time by briefly pressing the humidifier key S The green status display next to the humidifier key lights up when the humiditier is activated e If you press the humidifier key 8 but a humidifier is not connected Bilevel ST 22 will not switch this function on 4 5 After usage 1 Remove the headgear with the nasal mask 2 Press and hold the On Off switch for CD 2 seconds to turn the unit off The fan switches off and the duration of the last therapy session appears on the display The unit then switches to standby mode Weinmann Bilevel ST 22 appears in the display Ie 3 Remove the tube connection and if necessary the exhalation system trom the nasal mask 4 Clean the nasal mask and the exhalation system see 5 Hygienic preparation on page 25 Note To save electricity you can remove the power plug from the outlet socket when not in use The stored therapy parameters and settings wi
34. ressure 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 tlows 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 VENTlpower This is where the connecting cable for the power supply is connected For connecting mains independent power supply VENTlpower supplied as an accessory 21 Connection for O2 valve VENTI O2 For connecting the VENTIO gt 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 men
35. rse dust filter WM 24880 Fine filter packed WM 15026 Set of packed replacement filters one year s supply WM 15682 3 x fine filters 2 x coarse filters Carrying bag WM 24995 Power supply cable WM 24177 Power supply WM 24790 Drying adapter WM 24203 46 Scope of supply 10 Technical data Weight Temperature range Operation Storage BiLevel ST 22 Bilevel ST 22 with VENTIclick Product class as per EU Directive i 93 42 EEC Dimensions VVxHxD in cm 23x12x28 23x 12x 39 5 approx 3 7 kg approx 4 0 kg 45 C to 435 C 40 C to 70 C Air pressure range Electrical connection 600 1100 hPa allows for operation in an altitude of up to approximately 4000 meters automatic altitude compensation 115 230 V AC 50 60 Hz Tolerance 20 to 10 Power consumption during Operation Standby Classification as per EN 6060 1 1 Protection against electric shock Type of protection trom electric shock 230V 115V 230V 115V GRA UJA O3A O6A 0 043 A 0 068 A 0 043 A 0 068 A Protection class Type B Electromagnetic compatibility EMC as per EN 6060 1 1 2 Radio shielding Radio interference suppression EN 55011 EN 61000 3 2 EN 61000 3 3 EN 61000 4 2 up to 6 EN 61000 4 8 EN 61000 4 1 1 Average sound pressure level operation according to EN ISO 17510 at 1m distance from the therapy unit in the patient position approx 32 dB A at 2
36. s 1 Close the hose system or put the mask on Operation 21 2 Switch Bilevel ST 22 on and press the Soft start key J until the Soft start window appears Change the Soft start time with the dial rotate to the right increase the time rotate to the left reduce the time or press the Soft start key 4 several times in succession to increase the Soft start time in 5 minute increments It you press the key again atter reaching the maximum time the unit starts again from the minimum time of 5 minutes 3 To save the Sofft start time press the Menu key J or the dial The displayed Soft start time is saved and the Soft start window closes automatically It a key is not pressed for 4 seconds the displayed Soft start time will be saved The settings are retained when the unit is switched off Note Bilevel ST 22 starts automatically in Soft start mode if this was activated when the unit was last used Soft start can be switched on and off at any time by briefly pressing the Soft start key A 4 4 Setting the humidifier The VENTIclick humidifier is used to humidity and warm the air prepared by the Bilevel ST 22 There are 6 heating level options Proceed as follows 1 Close the hose system or put the mask on 2 Switch Bilevel ST 22 on and press the humiditier rap 6 0 Humidifier key until the Humidifier Stage window appears cpap 4 0 Stage Use the dial to change the heat output levels 1 6 221123856 of the humidifie
37. sary Nasal mask is Ren nok de cowe eplace nasal mas Press the alarm acknowledgement key Clean change filter as quickly as possible 8 2 page 39 Filter soiled Clean change filter as quickly as possible 8 2 page 39 34 Troubleshooting Maximum Soft start time has been limited by the doctor Soft start time cannot be set to 30 minutes Malfunctions Malfunction Rectification message Press the alarm acknowledgement key Unit s internal battery Ihave the battery replaced by a dealer so is discharged that the therapy session can be correctly recorded Press the alarm acknowledgement key and have your doctor set the clock so that the therapy session can be correctly recorded Internal clock of the Bilevel ST 22 is not set Unit must be checked or serviced by Weinmann or a dealer as soon as possible If there are defects that cannot be rectified at once please contact Weinmann or your dealer immediately to have the unit repaired To avoid greater damage do not use the unit 7 2 Alarms The Bilevel ST 22 only issues medium priority alarms These are indicated by the symbol Y in the alarm window a flashing yellow status display and an acoustic alarm buzzer Acknowledging alarms If an error triggers an alarm here disconnection alarm press the alarm acknowledgement key 8 The Ny N acoustic alarm is muted for about 120 seconds Disconnection Troubleshooting 35 The stand
38. se the message Please change filter appears on the display when the unit is turned on Aree eres nce Acknowledge the message by pressing the alarm acknowledgement EX key The change filter symbol then remains in the status line To change the fine filter proceed as follows Change filter 1 Press on the lock of the filter compartment lid and remove the lid iS d 2 Replace the fine filter with a new fine filter WM 15026 Dispose of the old filter in the normal domestic waste 3 Then put the filter compartment lid lower edge first into the encasing section Then press the filter compartment lid into the housing until it locks into position Reset the filter change display After you have changed the fine filter you must reset the filter change display This is also necessary if the filter has been changed before the 1000 operating hours have elapsed in which case the filter change symbol does not appear in the display 1 To reset the filter change display press the menu i key when the device is switched on and using Drying process the dial select the Filter change item in the Patient Auto switch on Off Menu Press the dial to call up the Filter Change Filter change menu Function check ST Patient menu a 06 back 40 Maintenance ST Filter change a5 Reset filter change NO Bacteria filter The Reset filter change prompt appears Using the d
39. stem As a disinfectant we recommend GIGASEPT FF Carry out the same steps when using GIGASEPT FF as described under Cleaning Atter disintecting rinse all the parts thoroughly with distilled water Let the parts dry out completely Let the hose system drip dry Dry the hose system and Bilevel ST 22 as described in eZ e The corrugated tube VVM 241 30 transparent can be cleaned in warm water up to 70 C Sterilization is not permitted e The corrugated tube VVM 24120 gray can be steam sterilized in units complying with EN 285 Temperature 134 C minimum hold time 3 minutes Please observe EN 554 or ISO 11134 with respect to validation and monitoring 28 Hygienic preparation Accessories To disinfect or sterilize the exhalation system the nasal mask VENTloower VENTLO he bacteria filter and VENTlclick refer to the Chapter Disinfection and Sterilization in the relevant Operating Instructions 5 4 Multiple patient use If the unit is operated with bacteria filters please observe the following e Change the bacteria filter or e Sterilize the bacteria filter and change the particle filters located inside If the unit is operated without bacteria filters please observe the following e Before passing the unit to a different patient the unit must undergo thorough hygienic preparation This has to be carried out by Weinmann or a dealer The procedure used for the hygiene preparation is described in t
40. u 25 Operating keys Allows the doctor to make quick settings disabled in patient mode 26 Menu key Used to change trom 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 VENTlpower Accessories Available as an accessory provides a mains independent power supply for Bilevel ST 22 Standard display during therapy 1 Status line 7 Active respiratory mode PAP 6 0 hPa EPAP 4 0 hPa f 13 Jmin 6 Ventilation parameters 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 2 Soft start symbol 3 Display respiratory phase Menul 4 Access to the patient menu 5 Bar graph for the pressure display 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
41. witch Activate auto switch on 1 Close the hose system or put the mask on 2 Press the On Off switch D 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 Drying process Auto switch on Off ST Patient menu i0 Filter change Function check back 20 Operation Using the dial select the Auto switch on Off menu ST Patient menu J10 item and press the dial Drying process Auto switch on Off Filter change Function check back The message Auto switch on ON appears for three minutes The Bilevel ST 22 then reverts to the patient menu Auto switch on is now activated Use the dial to quit the patient menu selection bar on back and press the dial or use the menu key Drying process Auto switch on On Filter change It a key is not pressed for 5 minutes the display Function check reverts to the standard display Patient menu J10 Deactivate auto switch on Repeat steps 2 5 as described in Activate auto switch on If auto aa on is switched off you will only be able to turn Bilevel ST 22 on using the key CO 4 3 Setting Soft start 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 also limit the time to less than 30 minutes To set the Soft start time proceed as follow
42. z 80 MHz 80 MHz 800 MHz 800 MHz 2 5 GHz 0 01 0 04 0 04 0 08 0 1 0 11 0 11 0 22 0 35 0 35 0 70 10 1 10 1 10 220 100 JU 3 00 7 OO Further technical data can be obtained on request trom Weinmann and are listed in the hospital manual and the Service and Repair Instructions Subject to design modifications 50 Technical data 11 Warranty e Weinmann offers a warranty that the product when used in accor dance with requirements will remain tree trom defects for a period of two years from date of purchase For products whose durability is clearly indicated as less than two years the warranty expires on the expiration date indicated on the packaging or in the user s manual e Claims against the warranty can be made only when accompanied by the sales receipt which must show salesperson and date of pur chase e We offer no warranty in the case of Disregard of usage instrucitons Operating errors Improper use or handling failure to use original spare parts Third party intervention by unauthorized persons for the purpose of device repair Acts of God e g lightning strikes etc Transport damage as a result of improper packaging of returned items Lack of maintenance Operational and normal wear and tear which includes for example the following components Filters Batteries rechargeable batteries Articles for onetime usage etc Failure to use origin
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