LEONI baby ventilator service manual

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Heinen & Löwenstein GmbH Servicecenter LEONI baby ventilator service manual Changing the sintered filters Page 3 Software version check Page 4 Sensor adjustment Page 5 Flow sensor O2 sensor Flow adjustment AIR Lpm. Page 6 O 2 Lpm. Page 7 Pressure sensor adjustment 0 cm H2O Page 8 60 cm H2O Expiration valve adjustment Page 9

Test report : Intervals 1LED s, Display, Signal Generator Page 2Patient alarms Page 11 3System alarms Page 12 4Flow sensor alarm Page 12 5Pressure measurement Page 13 6Volume measurement Page 14 7Oxygen measurement Page 15 8Safety check Page 15 Service and Safety check Page 16 Spare parts Page 17 2

Changing the sintered filters. Hex key : 4mm Sintered filter : 0207157. The NIST connectors are at the rear of the device. Using the hex key, the fixing screws can be removed in order to take out the filters (or, in newer versions, the filters can be removed directly with the hex key). Software version check: In the onscreen menu settings, press the keys menu and alarm limits in parallel and keep pressed for 5 seconds. The onscreen menu system diagnosis is opened and here you take the readings of the following parameters in the left column: CHK PO DAT PO CHK P1 Ver P1 CHK P2 Ver P2 Check whether the latest version is installed. 3

Sensor adjustment: Flow sensor: Before each adjustment, the device must warm up for 15 min. Assemble LEONI with its sensors, tubing system and test lung. Use the calibration key to choose the onscreen menu sensor check. With the tubing system connected, press soft key flow and keep pressed until sensor check and then ADJUSTMENT shows up. With the message sensor adjusted, adjustment of the flow sensor has been effected successfully. O 2 Sensor: Oxygen calibration must always be done almost pressureless, so first disconnect the expiration tube in order to reach a minimum constant positive pressure. In the same onscreen menu now press the 21% O 2 key and keep pressed until the hourglass starts on the monitor. 21% adjustment has been successful when the hourglass disappears without error message and you see the message sensor adjusted. Finally, press the 0% key and keep pressed until the hourglass starts. 0% adjustment has been successful when the hourglass disappears without error message and you see the message sensor adjusted. 4

Flow adjustment : AIR Screwdriver : slot-head 3,5 x 75 For flow adjustment, disconnect the expiration tube and kink it. As soon as the system alarm starts, acknowledge and mute the system alarms by pressing the keyswitch and the alarm suppression key in parallel. In the lower left corner of the monitor a message shows up. Enter the setup screen via keyswitch and adjust the following parameters: Insp.-Flow 20 Basic flow PEEP P.-Insp. 50 Frequency 30 Insp.-Time 1 Oxygen 21% Re-connect the expiration tube but remove the test lung. Now switch the screen to the graphical mode by means of the menu key and then set to 20 litres compressed air. Check by displaying the flow graph in the 20 l setting. (Switch from pressure to flow by repeatedly pressing the graphs key). Do adjust the flow sensor first! Pressure reducing valves for adjustment are at the rear of the device. Pressure adjustment is achieved by turning the pressure reducer set screw. Compressed air is controlled by the pressurereducer next to the NIST-AIR screwing. Turn until the pressure shown in the screen display corresponds to 20 or litres respectively. 5

Flow adjustment : O 2 Screwdriver : slot-head 3,5 x 75 For flow adjustment, disconnect the expiration tube and kink it. As soon as the system alarm starts, acknowledge and mute the system alarms by pressing the keyswitch and the alarm suppression key in parallel. In the lower left corner of the monitor a message shows up. Enter the setup screen via keyswitch and adjust the following parameters: Insp.-Flow 20 Basic Flow PEEP P.-Insp. 50 Frequency 30 Insp.-Time 1 Oxygen 0% Re-connect the expiration tube but remove the test lung. Now switch the screen to the graphical mode by means of the menu key and then set to 20 litres O 2. Check by displaying the flow graph in the 20 l setting. (Switch from pressure to flow by repeatedly pressing the graphs key). Do adjust the flow sensor first! Pressure reducing valves for adjustment are at the rear of the device. Pressure adjustment is achieved by turning the pressure reducer set screw. Oxygen is controlled by the pressure-reducer next to the NIST-O 2 screwing. Turn until the pressure shown in the screen display corresponds to 20 or litres respectively. 6

Pressure sensor adjustment: Pressure source Pressure monitor 0 cm H 2 O : In the onscreen menu settings press menu and alarm limits keys in parallel and keep pressed for 5 seconds. This leads to the screen System diagnosis. Now leave the proximal pressure input without pressure (disconnect the tube) and keep softkey 0cm H 2 O pressed for approximately 5 seconds until a dot shows up above the key. 60 cm H 2 O : Now connect a pressure source with a constant pressure of 60cm H 2 O and keep softkey 60cm H 2 O pressed until a dot shows up there as well. Then leave the program by pressing the menu key. 7

Expiration valve adjustment Enter the setting screen via keyswitch and set the following parameters: Insp.-Flow 8 Basic Flow 8 PEEP P.-Insp. 50 Frequency 30 Insp.-Time Oxygen 21% Then press the keyswitch repeatedly until all parameters are deframed. Finally press the menu and limits softkeys in parallel for approximately 5 seconds until the screen displays the message AV adjustment. Wait until Pmax = 50 cm H 2 O / Pmedium = 29 cm H 2 O / PEEP = cm H 2 O. Finish adjustment by pressing the mode key. 8

Test report: Serial number: Set complete device running including a double-lobe test lung (LEONI test lung). Set the following values: Mode: IMV Insp.-Flow Basic Flow 5 PEEP P.-Insp. 30 Frequency 60 Insp.-Time 0,5 Oxygen 21% 1 Test LED s, Display and Signaller 1.1 Switch on unit NOK OK LCD screen backlighting Red alarm LED Yellow alarm LED ( Alarm muted) 1.2 Alarm generator (Alarm sound) Switch off unit Alarm generator (power failure) NOK OK Red power failure LED flashes Press mute key, alarm signal stops Red LED goes out 9

2 Patient alarms NOK OK Assemble device completely, including test lung, and switch on. Switch to screen alarm limits, place cursor in topmost line, select all limits auto and set limits via autoset softkey. Wait until auto limits have been set. Stop each alarm after having been activated and acknowledge error message by pressing the second softkey from the left. 2.1 MV, click upper limit and set below the actual real volume. Alarm message: MV too high. Re-set limit. 2.2 MV, click lower limit and set above the actual real volume. Alarm message: MV too low. Re-set limit. 2.3 Set the blue cock of the test lung so that the airway is open to both lung lobes and to one white plug. Alarm message tube leakage too high Re-set blue cock. 2.4 Set breath rate limit below real frequency. Alarm message breath rate too high. Re-set limit. 2.5 Kink the test lung connection tube. Alarm message Apnea Release connection tube.

3 System alarms Stop each alarm after having been activated. Only after all alarms had been activated acknowledge the error message by pressing the right softkey. 3.1 Seal expiration tube by kinking it. Alarm message : System alarm expiration tube Release tube. 3.2 Seal inspiration tube by kinking it. Alarm message : System alarm inspiration tube Release tube. 3.3 Remove the AIR supply plug from the wall supply. Alarm message: inlet pressure air supply Re-insert supply plug. 3.4 Remove the O 2 supply plug from the wall supply. Alarm message: inlet pressure O 2 Re-insert supply plug. 3.5 Remove test lung Alarm message pressure too low, then Disconnection Re-connect test lung. NOK OK 4 Flow sensor alarm NOK OK 4.1 4.2 Disconnect flow sensor, sensor alarm is activated immediately. Alarm message check sensors Re-connect sensor. Connect a defective flow sensor Alarm message Sensor defective Re-connect the intact sensor. 11

5 Pressure measurements: Set he following values Mode: IMV Press calibration key and switch off flow sensor Set the given parameters and enter into table. Insp.-Flow Basic Flow 5 PEEP 5 P.-Insp. Frequency 30 Insp.-Time 1 Oxygen 21% Settings 5 Pressure measurement Readings Pinsp PEEP Pmax Pmed PEEP NOK OK 9...11 4...6 0...1 5.1 0 5.2 20 0 30 0 40 0 50 0 60 0 30 5 30 30 15 30 20 19...21 9...11 0...1 28...32 14...16 0...1 38...42 19...21 0...1 47...53 23...27 0...1 57...63 28...32 0...1 28...32 16...18 4...5 28...32 19...21 9...11 28...32 21...23 14...16 28...32 23...27 19...21 12

6 Volume measurement: Connect calibrated 1 l bottle instead of test lung. Set the following values Mode: IMV Press calibration key and switch on flow sensor. Set the given parameters and enter into table. Display : Graphical + Numerical values Insp.-Flow Basic Flow 5 PEEP 5 P.-Insp. Frequency 30 Insp.-Time 1 Oxygen 21% 6 Volume measurement Settings Readings Pinsp PEEP MV Vte Compliance NOK OK 0,28 0,32 9,5,5 0,7 1,3 6.1 0 6.2 20 0 30 0 40 0 50 0 60 0 30 5 30 30 15 0,57 0,63 19,0 21,0 0,7 1,3 0,86 0,95 28,5 31,5 0,7 1,3 1,14 1,26 38,0 42,0 0,7 1,3 1,43 1,58 47,5 52,5 0,7 1,3 1,71 1,89 57,0 63,0 0,7 1,3 0,71 0,79 23,7 26,3 0,7 1,3 0,57 0,63 19,0 21,0 0,7 1,3 0,42 0,47 14,2 15,8 0,7 1,3 30 20 0,28 0,32 9,5,5 0,7 1,3 13

7 Oxygen measurement: Connect O 2 monitor to inspiration tube. 7 Oxygen measurement 7.1 Settings Tolerance Measuring device 21% 21%-21% % 40% 39%-41% % 60% 58%-62% % 80% 76%-84% % 0% 0%-0% % Nok OK S/N O 2 cell 8 Checking the electrical safety according to VDE 0751 / 1. Documentation on separate original H&L test report. 14

Intervals for service and safety check Every 6 months: -optical check and cleaning of the device housing and accessories -open and clean the casing interior -optically check all tubes, electrical cables, adapters and connectors, all electrical and pneumatic couplings, screws and casing components -optically check all internal components -check completely according to test report -Generate a test report and perform the electrical safety check Every 12 months: -Change AIR and O2 sintered filters -Change O 2 measuring cell (Art.-Nr.0217028) (Art.-Nr.0217028) -Perform calibration Every 3 years: -Replace internal tubing Every 000 hrs. : -Replace air/oxygen blender incl. fine dust filter (Art.-Nr.0217032) -Replace inlet pressure reducer 15

Spare parts: Item Part number Description 1 0217000 LEONI baby ventilator 2 02170 Trolley without drawer 3 02170-1 Trolley XS 4 0217013 Drawer set 5 0217020 LEONI infusion rack 6 0217021 Tube support bracket with rail suspension 7 0217022 Nut for water boom 8 0217500 LEONI M portable baby ventilator 9 0217015 Heated primary tube system, autoclav. 0217015-1 Heated secondary tube system, autoclav. 11 0217015-2 LEONI tube system, autoclaveable, without heating 12 0217015-3 LEONI disposable tube system, pcs 13 0217025 Neonatology Y-connector, autoclaveable 14 0217011 LEONI sensor 15 0217012 LEONI sensor cable 16 0217026 LEONI expiration valve 17 0217027 LEONI test lung 18 8409742 Draeger baby test lung 19 0217028 Sintered filter 20 0217029 Internal fine dust filter 21 0217030 External bacterial filter 22 0217031 LEONI O 2 measuring cell 23 0217032 Air / Oxygen blender 24 0217033 Pressure reducer, O 2 inlet 25 0217034 Pressure reducer, Air inlet 26 27 28 29 30 31 32 33 16