Lowenstein Medical leon plus User Manual
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Lowenstein Medical leon plus User Manual

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leon plus
User manual
Rev. 3.11.13
from software version 3.11.x
As at 03.11.2022
Please read this instruction manual carefully
before using the device and keep it to hand at all
times!

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  • Page 1 User manual Rev. 3.11.13 from software version 3.11.x As at 03.11.2022 Please read this instruction manual carefully before using the device and keep it to hand at all times!
  • Page 2 Copyright ® 2022 Löwenstein Medical SE & Co. KG Subject to change 03.11.2022 Löwenstein Medical SE & Co. KG Arzbacher Straße 80 56130 Bad Ems, Germany +49 2603/9600−0 : +49 2603/9600−50 loewensteinmedical.com User manual leon plus Order no.: Ba-0301v311...

  • Page 3: Table Of Contents

    Operating concept ........................ 37 Function levels ........................37 Icons ............................39 User interface .......................... 47 Concepts ..........................47 Keypad ..........................48 Touchscreen ........................49 Rotary switch ........................51 Tab system .......................... 52 Title bar ..........................52 leon plus- As at 03.11.2022 - 3.11.13...
  • Page 4 Preparations ........................... 68 First installation ........................68 Adaptation to ambient conditions..................68 Customer requirements at the application site (leon plus – Standard configuration) ..69 Emergency power supply ....................70 Charging batteries........................ 70 Out-of-operation for a longer period ..................70 Preparation for start-up ......................
  • Page 5 Execution of the FiO calibration ..................132 Passed FiO calibration ..................... 132 calibration not passed ....................133 Alarm test ..........................133 General information ......................133 Test of alarm functions ...................... 134 Power off ..........................138 leon plus- As at 03.11.2022 - 3.11.13...
  • Page 6 Fresh gas blender in the event of failure of a carrier gas ..........193 Display of damaged fresh gas blender ................194 Gas supply pressures ......................194 Central gas supply pressures .................... 195 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 7 Error search respirator ...................... 243 Error search flow sensors ....................244 Error search circulation system ..................245 Error search FiO calibration ..................... 248 External supply units failure ....................249 No central gas supply ......................249 leon plus- As at 03.11.2022 - 3.11.13...
  • Page 8 Maintenance of the high-pressure regulator ..............279 Technical safety controls ....................279 Accessories ......................... 285 General information ....................... 285 Replacement part ........................286 Accessories ........................... 286 Product combinations ......................287 General information ....................... 287 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 9 Lists and short instructions ....................319 Ordering replacement parts ....................319 Ordering accessories......................319 leon plus Short checklist before start-up ................319 leon plus Short operating instructions ................319 leon plus Technical safety controls checklist ..............319 Technical data ........................320 Index .............................
  • Page 10 This page has been left blank intentionally. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 11: List Of Abbreviations

    Lung elasticity CPAP Continuous Positive Airway Pressure Constant positive airway pressure Compliance (static) stat. Des. Volatile anaesthetic – desflurane Expiration Enf. Volatile anaesthetic – enflurane f, Freq. Frequency, number of breaths per minute leon plus- As at 03.11.2022 - 3.11.13...
  • Page 12 Dinitrogen monoxide (nitrous oxide) No. of charts Number of real-time curves (minimum 1, maximum 4) Oxygen flush Oxygen flush Patient category Fast selection of preconfigured ventilation parameter settings and alarm limits for adult ventilation Adult 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 13 With N O as the carrier gas, the minimum concentration setting for = 25% Cleaning and disinfection device Settings Settings Sev. Volatile anaesthetic – sevoflurane S−IMV Synchronized Intermittent Mandatory Ventilation Triggered form of ventilation leon plus- As at 03.11.2022 - 3.11.13...
  • Page 14 Option of synchronising the ventilator of the anaesthesia workstation with spontaneous patient breathing activity Uninterrupted power supply Volume V ̇ Flow Vapour anaesthetic vaporiser Video graphics array (computer graphics standard) Tidal volume expiration Tidal volume guarantee Tidal volume inspiration 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 15: About This User Manual

    ▪ leon plus Short check list/instructions before start-up ▪ leon plus, leon and leon mri List of accessories and replacement parts ▪ Checklist of technical safety controls for leon plus The checklist, short instructions and copyable forms can be found at the end of the document.

  • Page 16: Structure And Purpose Of The User Manual

    Löwenstein Medical customer services immediately. Further information If you have any questions or remarks regarding this instruction manual or the device, please contact your authorised regional specialist vendor or the manufacturer directly. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 17: Safety For You And The Patient

    CAUTION indicates a latent hazard that does not represent a direct threat but can lead to physical injury if not avoided. CAUTION WARNING indicates a hazard that represents a direct threat and can lead to severe injury or death if not avoided. WARNING leon plus- As at 03.11.2022 - 3.11.13...

  • Page 18: Residual Hazards

    WARNING tube connector. ▪ If, in the event of a recognisable fault in the leon plus anaesthesia device, it can no longer be guaranteed that life can be sustained, the ventilation of the patient must be started promptly with independent ventilation equipment, e.g.

  • Page 19: Messages To The Manufacturer And Authorities

    PORTABLE HF communications equipment (radios) (including their ACCESSORIES such as antenna cables and external antennas) should not be used within 30 cm (or 12 inches) of leon plus parts and wiring designated by the MANUFACTURER. Failure to do so may reduce the performance of the device.

  • Page 20: Liability And Guarantee

    Appropriate use (ventilation gas filter close to the patient) ▪ Design of the water trap ▪ Return of the test gas before the CO absorber ▪ Gas return filter into the patient part 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 21: Classification Of The Device

    Definition of servicing in accordance with DIN 31051: ▪ Inspection: Establishing of actual state ▪ Servicing: Methods for retaining the desired state ▪ Repairs: Methods for restoring the desired state ▪ Maintenance: Inspection, servicing and repairs leon plus- As at 03.11.2022 - 3.11.13...

  • Page 22: Device Overview

    Chapter Device overview Intended use 4. Device overview Intended use ▪ The leon plus is an anaesthesia workstation for adults, children, infants and premature babies. ▪ It enables controlled, manual ventilation as well as spontaneous breathing. Operating requirements It is recommended that the leon plus is ▪...

  • Page 23: Anaesthesia Systems

    This may pose a risk of acetone accumulation in the patient. ▪ If malignant hyperthermia is suspected: Do not use volatile anaesthetics or the leon plus with residual concentrations of these gases. ▪ Among other things, oxygen, nitrous oxide, volatile anaesthetics or medication are applied.

  • Page 24: Guidelines And Manufacturer's Declaration - Electromagnetic Emissions

    The leon plus is intended for operation in the electromagnetic environment given below. The customer or user of the leon plus must ensure that the leon plus is used in such an environment. Table 3: Guidelines and manufacturer's declaration – Electromagnetic emissions...

  • Page 25: Guidelines And Manufacturer's Declaration - Electromagnetic Immunity

    The leon plus is intended for operation in the electromagnetic environment given below. The customer or user of the leon plus must ensure that the leon plus is used in such an environment. Only use the accessories from the list in the appendix: leon plus, leon and leon mri “Accessories...
  • Page 26 HF transmitters, an examination of the site is recommended. If the investigated field strengths at the site of the leon plus exceed the compliance level given above, the leon plus must be observed with regard to its normal operation at each application location.
  • Page 27 The carrier must be modulated with a square wave signal with a 50 % duty cycle. As an alternative to frequency modulation (FM), pulse modulation with a 50% duty cycle at 18 Hz can be used, as this would represent the worst case, if not the actual modulation. leon plus- As at 03.11.2022 - 3.11.13...
  • Page 28 Monitoring the airway pressure Limitation to be expected by the operator due to Exceeding or falling below the set alarm limit the presence of higher EM INTERFERENCES triggers an alarm 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 29: Device Description

    (9) display and control elements (3) patient module (10) writing shelf (4) options board (11) drawers (5) 15" touchscreen display (12) brakes (optional) (6) anaesthetic vaporiser mounting (13) cupboard with drawer (7) manoeuvring handle leon plus- As at 03.11.2022 - 3.11.13...
  • Page 30 (16) Bronchial aspiration mounting (7) cover for additional sockets (17) additional sockets (8) clip for mains cable for additional display (18) fuses for additional sockets (9) data connections (10) FO connection (optional) 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 31: Patient Module

    Anaesthetic vaporiser mounting Please also refer to the anaesthetic vaporiser user manual. (→ "Setting up the anaesthetic vaporiser" p. 90) Ventilator ▪ pneumatic drive (O or medical air) ▪ hanging bellows ▪ compliance-compensated ▪ pressure-limited leon plus- As at 03.11.2022 - 3.11.13...

  • Page 32: Railing System

    Chapter Device overview Device description Railing system The leon plus has a railing system on the right and on the left that can be adapted using accessories, e.g.: Device rails ▪ Max. load: 5 kg ▪ available in different lengths Support arms ▪...

  • Page 33: Writing Shelf, Drawers, Storage Compartment

    The total weight to be placed on the writing shelf may not exceed 15 kg. ATTENTION Improper loading of the drawers! Damage to the device itself and to the drawers ▪ The total load in the drawers may not exceed 5 kg. ATTENTION leon plus- As at 03.11.2022 - 3.11.13...

  • Page 34: Tube And Cable Guides

    CGS and guided backwards away from the device. Opening of the rear wall doors by pulling the tubes is prevented. (→ "Rear wall" p. 63) 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 35: Delivery Contents

    The angle of inclination of the device may not exceed 10°. The delivery contents (basic ▪ anaesthesia workstationleon plus equipment) of the leon plus include the – gas measurement following items: – integrated vacuum connector for bronchial aspiration –...

  • Page 36: Operating Instructions

    The leon plus is only intended for stationary conditions operation. The leon plus can be used near the active equipment of HF SURGICAL DEVICES. The leon plus cannot be used in HF shielded rooms used for magnetic resonance imaging in which high intensity EM INTERFERENCES occur.

  • Page 37: Operating Concept

    The selftest (starts when the device is turned on) must be carried out once a day. The operating concept of the leon plus is built on three main levels, which are further divided into sub- levels within which the actual functions ultimately start.
  • Page 38 Selection of a form of ventilation with the corresponding ventilation parameters Fresh gas settings Selection of monitoring values page 1/2 Display of gas measurement measured values Display of alarm limits and gas supply pressures Stopwatch 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 39: Icons

    Type B applied part (applied part for use on the body, but not on an open heart) Non-ionised electromagnetic radiation Icon for the separated collection of electrical and electronic devices CE with ID number of the notified body – confirmation of fulfilment of EU requirements leon plus- As at 03.11.2022 - 3.11.13...
  • Page 40 0 = Off ▪ adjustable ▪ Change a value by turning Change a value in stages by turning Button for O flush (on the front) Outlet (pneumatic) Inlet (pneumatic) Outlet (for energy and signals) 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 41 Ethernet port 1st and 2nd Serial port FO outlet (additional monitor) USB port Lamp; light; lighting Auxiliary sockets charge with max. 2 A Connection for high-pressure sensors fuel cell LM Watertrap (in preparation) leon plus- As at 03.11.2022 - 3.11.13...
  • Page 42 Volume System time Option Config Volume Option Button to start ventilation Standby button (stop ventilation and change to standby) Mute alarm for two or ten minutes button (10 minutes only in MAN/SPONT) 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 43 Screen icon/display: No batteries available Screen icon/display: Mains voltage available Screen icon/display: Mains voltage not available Screen icon/display: Upper and lower alarm limits Screen icon/display: CGS pressures Screen icon/display: 10 L bottle pressures leon plus- As at 03.11.2022 - 3.11.13...
  • Page 44 Button Zoom loop in X direction Button Shift 0 point in X direction Button Zoom loop in Y direction Button Shift 0 point in Y direction Button Autoscale loops ON Button Autoscale loops OFF Close window button 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 45 Adapt alarm button automatically Freeze loop Start loop Save loop as reference loop Display reference loop and start current loop (activate comparison mode) Delete reference loop and start current loop (deactivate comparison mode) leon plus- As at 03.11.2022 - 3.11.13...
  • Page 46 (dark blue when active) Trend curve window Tabular trend window Event Log Alarm Log Extras System Config Volume Option Config Volume Option time Monitoring values page 1 or 2 Tab with further pages 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 47: User Interface

    Chapter Operating concept User interface User interface The user interface of the leon plus consists of three components: ▪ screen (TFT) with touchscreen (touch) ▪ keypad ▪ rotary switch (encoder) The main control element is the touchscreen, but the device can also be fully operated by the keypad and rotary switch.

  • Page 48: Keypad

    (→ "Control element functions" p. 50) Keypad Operation of keypad Various functions are carried out using the keypad (→ "Table 9: Icons/buttons" p. 42) Operating states are visualised through LEDs. (→ "Table 10: Icons/LEDs" p. 43) 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 49: Touchscreen

    (1) Show window for loops with the loop window button (2) Show window for limit values (alarm limits) with the alarm limits window button (3) Show display pressures CGS and 10 L bottles with the alarm limits window button leon plus- As at 03.11.2022 - 3.11.13...
  • Page 50 An icon with a function (e.g. control element of real-time charts) is outlined in green in a window and highlighted in pale blue. A tab is highlighted in dark blue. Scrolling data in the window slow/fast close open window 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 51: Rotary Switch

    The shifting of the input focus to a button is carried out inside a window by turning the rotary switch. A ventilation parameter is unlocked by pressing the rotary switch, changed by turning and confirmed by pressing once more. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 52: Tab System

    (2) patient category or “weight” lettering if selected (3) alarm mute state or display of alarm setting according to environment volume (quiet, medium, loud) if no alarm suppressed (4) state of electricity supply and rechargeable batteries (5) date, time 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 53: Hlm Form Of Ventilation

    (outside of CPAP) is turned off. Alarms switched off! Risk of oxygen deficiency ▪ Be extra vigilant during the ventilation. WARNING In the MON form of ventilation, fresh gas administration is switched off. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 54: Monitoring Of Muting Of Alarm

    This function should only be used when patients are disconnected from the device. Screensaver A screensaver can be set up in the configuration menu. It should only be set up by trained specialist staff or by Löwenstein Medical-authorised service technicians. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 55: Control Elements And Displays

    – adjustable – (3) Rotary switch for vacuum dosage (turn anticlockwise to increase the vacuum) (4) Manometer for vacuum pressure (5) Manometer for O bottle pressure (6) Manometer for N O bottle pressure leon plus- As at 03.11.2022 - 3.11.13...
  • Page 56 There are two variants for producing the vacuum for the bronchial aspirator: ▪ injector principle ▪ vacuum (wall connection) 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 57: Options Board

    (3) Flowmeter for external O outlet (4) External O outlet; ISO cone 22 mm outside, 15 mm inside The “DRYLINE™ watertrap” variant consists of a container with a removable lid and removable gas measurement tube. leon plus- As at 03.11.2022 - 3.11.13...
  • Page 58 (2) External fresh gas outlet; ISO cone 22 mm outside, 15 mm inside External O outlet options board version (1) Flowmeter for external O outlet (2) External O outlet; ISO cone 22 mm outside, 15 mm inside 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 59: Device Connections

    ▪ Bain ▪ Jackson Rees systems The concentrations of gases from the fresh gas outlet are set as follows: Narcotic gases on the anaesthetic vaporiser; O O, AIR on the fresh gas blender leon plus- As at 03.11.2022 - 3.11.13...

  • Page 60: Operation Of The Device Connections

    Depending on the version of the flowmeter, no gas flows in the intermediate position, or less than 50 % of the adjacent higher setting. 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 61 Chapter Operating concept Device connections Gas measurement The leon plus is equipped with a sidestream measurement as standard. An FiO meter is optional. The corresponding configuration occurs in servicing and may only be carried out by Löwenstein Medical- authorised service technicians.
  • Page 62 (1) DRYLINE™ watertrap (→ "Gas measurement maintenance (sidestream measurement)" p. 263) If the leon plus is on standby, the gas measurement runs independently of the screensaver configuration for another 20 to 90 minutes. After this, it too switches to standby. If a button or the touchscreen is used, the gas measurement goes back into operation.

  • Page 63: Rear Wall

    (9) 1 x USB connection (covered, for service (17) Mains: 100–240 VAC purposes only) (18) Type plate (10) Workstation illumination connection (19) Sensor gas measurement LM (11) Workstation light connection fuse Watertrap (in preparation) (12) Connection for potential equalisation leon plus- As at 03.11.2022 - 3.11.13...

  • Page 64: Patient Module

    Damage to the device itself and to the patient module ▪ Before locking the docking station, it is vital to ensure that the docking ATTENTION station and the patient module are swivelled in fully. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 65: Connection For Ventilation Tubes, Anaesthesia Gas Scavenging System And Ventilation Bag

    Connection of the AGSS on the rear of the device (1) AGSS connection on the front of the casing (Ø 22 mm) (2) AGSS connection on the front of the casing (Ø 22 mm) Please also refer to the AGSS user manual. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 66: Connection For Respiratory Bellows, Dome And Co

    (4) Respiratory bellows connection (1) Lock nut (2) Flow sensor (3) PEEP valve diaphragm cover (4) PEEP valve diaphragm Without the CO absorber, the two pins must be in place as shown in the illustration. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 67: Apl Valve

    There are two variants for producing the vacuum: ▪ injector principal ▪ vacuum wall connection Please also refer to the bronchial aspiration user manual. (1) Vacuum connection for bronchial aspiration (2) filter (3) Bronchial aspiration glass leon plus- As at 03.11.2022 - 3.11.13...

  • Page 68: Preparations

    You should refer to a service technician authorised by Löwenstein Medical for this first installation. Adaptation to ambient conditions If the leon plus is subject to extreme ambient conditions (temperature, moisture) during transport or storage, give the device, while switched off, the opportunity to adapt to the conditions at the installation site.

  • Page 69: Customer Requirements At The Application Site (Leon Plus - Standard Configuration)

    Class I device! Risk of injury through electrocution. ▪ The mains to which the device is connected must be earthed. WARNING Table 16: Requirements at the application site (leon plus default configuration) Voltage Supply 100-240 V , 50/60 Hz The maximum internal resistance may not lead to an...

  • Page 70: Emergency Power Supply

    The batteries charge even if the device is turned off. Out-of-operation for a longer period If the leon plus is not used for a longer period, it should remain plugged into the mains to avoid the batteries discharging.

  • Page 71: Preparation For Start-Up

    ATTENTION Release the screw fixing between the gas cylinder and the high pressure regulator. Put the protective cap on the connections. Store the device in dry and clean conditions. leon plus- As at 03.11.2022 - 3.11.13...
  • Page 72 Use ISO 32-compliant colour-coded pressure tubes: (1) O : white (2) N O: blue (3) AIR: black-and-white Vacuum: yellow (not illustrated) Short CGS check Check the CGS pressures. Check the seals on the connections. 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 73 Make sure that the bottles are filled. Pressure O > 40 kPa × 100 ( bar ) – – Check the seals on the connections. Make sure that the bottle valves are closed. leon plus- As at 03.11.2022 - 3.11.13...
  • Page 74 Preparations Preparation for start-up 10 L bottle connection instead of CGS Instead of the central gas supply, the leon plus can also be supplied with fresh gas from two 10 L bottles. The gases available are O and optionally either AIR or N O.
  • Page 75 Short CGS check Check the CGS pressures. Check the seals on the connections (→ "Short check of 10 L bottles" p. 75). Use the 1.9 kPa x 100 (bar) pressure reducer prescribed by Löwenstein Medical. leon plus- As at 03.11.2022 - 3.11.13...
  • Page 76 For AIR there is the option of parallel connection to a 10 L cylinder and the CGS. This requires a pressure tube with a T-connector. (→ leon plus, leon and leon mri List of accessories and replacement parts) Screw the pressure tube with the NIST fitting to the T-connector on the device’s NIST connector.

  • Page 77: Electrical Connections

    The plug icon appears in green in the title bar on the right if mains voltage is available. The battery icon appears in white with the display of the charging state shown as a percentage. leon plus- As at 03.11.2022 - 3.11.13...
  • Page 78 (2) Workstation light socket These are inert 2AL fuses. The attachments for the fuses are released with a size 1.2 x 6.5 slot screwdriver. The lamp is turned off during battery operation. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 79: Connection Of The Respiratory Bellows And The Dome

    Risk of CO rebreathing ▪ If the CO absorber is changed during ventilation, it should be done rapidly, as CO rebreathing could occur due to the short circuit when the WARNING absorber is removed. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 80: Changing, Emptying, Filling The Co

    Risk of poisoning and irritation of the skin and respiratory tract ▪ Get medical help immediately. WARNING ▪ After swallowing, do not induce vomiting; drink plenty of water. ▪ After inhalation, get into fresh air immediately. 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 81 (1) protective cap (2) gas feed Filling the CO absorber jar Fill the absorber jar up to at least the min filling mark and to the max filling mark at most. (1) max (2) min leon plus- As at 03.11.2022 - 3.11.13...

  • Page 82: Connection Of The Ventilation Tubes

    Use of antistatic or conductive tubes and high-frequency electrosurgical devices! Risk of burning WARNING ▪ Do not use any antistatic or conductive tubes. No unauthorised auxiliary parts! Electrical risk to the patient ▪ Use authorised accessories only. WARNING 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 83: Gas Measurement

    Use an adapter instead of the inspiratory sight glass to place the FiO sensor on the patient module. Connect the sensor via a cable on the rear wall. (→ "Rear wall" p. 63) (1) Cable (2) FiO sensor (3) Adapter leon plus- As at 03.11.2022 - 3.11.13...
  • Page 84 (→ "Gas measurement maintenance (sidestream measurement)" p. 263). The watertrap should be changed once per month. The device may only be operated with one of the two watertrap variants. 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 85 Insert suitable VSF (on the patient’s side on the patient adapter). Use patient adapters and Y-piece as listed in leon plus, leon and leon mri List of accessories and replacement parts, as otherwise measured values may be falsified. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 86: Connection Of The Ventilation Bag

    (3) test adapter Join the ventilation bag via an adapter to the ventilation tube. Hang the ventilation bag to the suspension bracket provided. (1) ventilation bag (2) disposable tube connector (3) tube 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 87: Connection To The Anaesthesia Gas Scavenging System

    If an intake system is not used, it is imperative that this adapter (with four drill-holes as additional air intake) is used. The aspiration performance of the waste removal system must be between ATTENTION 55 and 66 l/min. leon plus- As at 03.11.2022 - 3.11.13...
  • Page 88 (1) AGSS tube (2) disposable tube connector (3) angled adapter (4) ISO 22/22 plug adapter (→ leon plus, leon and leon mri List of accessories and replacement parts) 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 89: Suspension Bracket Of The Intake System On The Rear Of The Device

    Suspension bracket of the intake system on the rear of the device The intake system is suspended on a standard rail on the rear of the leon plus. To connect, use the construction described in (→ "Connection of the AGSS on the rear of the device" p. 65).

  • Page 90: Apl Valve

    (1) APL (2) APL bayonet catch (3) test adapter Setting up the anaesthetic vaporiser The leon plus provides a mounting for two anaesthetic vaporisers. The anaesthetic vaporisers have a transportation safety catch, which must be removed before start-up (the arrow on the adjusting ring must lie over the arrow on the housing).

  • Page 91: Connection Of The Bronchial Aspiration

    (1) aspiration tube holder (2) bronchial aspiration connection (3) filter (4) lid connection For connection and checking, refer to the bronchial aspiration manual. Observe correct connections on the lid of the absorber glass. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 92: Connection Of Auxiliary Devices

    Overloading of auxiliary outlets! Fuses blow The total power consumption of the device including the 4 auxiliary outlets ATTENTION may not exceed 9 A. ▪ Follow the instructions of the accessory when installing. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 93: Connection Of Data Communication

    More detailed information on the connections is contained in the instruction manual “GA_Ba-Interfaces” or from a Löwenstein Medical representative. The leon plus provides the following interfaces: (1) USB (for service purposes only) (2) Ethernet: RJ-45 (3) Serial (COM 1): D-sub, 9-pin...

  • Page 94: Start-Up

    Start-up Preparation for start-up 7. Start-up Ensure that you have correctly checked the leon plus as described in the “Short checklist before start-up” (→ "leon plus Short checklist before start-up" p. 319). The execution of a system test is strongly recommended.

  • Page 95: Short Check (Recommended By Dgai)

    In the event of any abnormalities, the connection between the patient and the anaesthesia device is disconnected again and systematic troubleshooting is initiated. Meanwhile, ventilated patients are ventilated with the obligatory separate manual breathing bag. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 96: Configuration (In Standby)

    Activate the corresponding tab of the tab in the 2nd row. The following settings are available: ▪ settings – brightness (TFT) – illumination (is only shown if configured in the service) ▪ service (1) Config tab (2) Extras tab 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 97 The brightness of the TFT can be set on the Config tab. ▪ brightness: 0 – 100 ▪ increment: 5 Select the Display Brightness button. Unlock the function. Select a value for the brightness of the screen (TFT). Confirm the value. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 98: Volume Tab

    Unlock the function. Select a value for the volume. Confirm the value. If a red alarm is active, the alarm value cannot be changed (numeric keypad “medium-priority alarms” is inactive). 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 99: System Time Tab

    (2) Extras tab Date, time Select the entry to be changed in the Date or Time fields (day, month, year, or hour, minute, second). Unlock (day, month, year, or hour, minute, second), set and confirm. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 100: Option Tab

    (2) Option tab Configuration (during ventilation) Config tab The following settings are available: ▪ settings – brightness (TFT) – Lighting (is only shown if configured in the service) (1) Config tab (2) Extras tab 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 101: Volume Tab

    Alarms, ventilation parameters and fresh gas blenders ▪ Curves, trend curves, tabular trend ▪ All settings (1st and 2nd) Only the settings of the currently selected patient category are reset. (→ "Load default settings" p. 143) leon plus- As at 03.11.2022 - 3.11.13...
  • Page 102 Shifting of 0 point in the window ▪ Scaling of the Y-axis ▪ ON/OFF autoscaling ▪ Number (minimum 1, maximum 4) of the displayed trend curves ▪ Scaling of the X-axis (10 min - 72 hours) 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 103 The following start values of the fresh gas blender can be configured: ▪ Carrier gas (N O or AIR ) ▪ concentration ▪ Fresh gas flow (→ "Fresh gas setting" p. 145) leon plus- As at 03.11.2022 - 3.11.13...
  • Page 104 Chapter Start-up Configuration (during ventilation) Limit values configuration You can configure the upper and lower alarm limits manually. (→ "Setting patient alarm limits manually" p. 207) 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 105 (→ "Monitoring ventilation measured values and calculated values I" p. 184) Configuration of form of ventilation The following ventilation parameters can be configured as starting values per form of ventilation: (→ "Buttons for setting ventilation parameters" p. 158) leon plus- As at 03.11.2022 - 3.11.13...

  • Page 106: Service

    The first digit of the current software version is displayed in the line Version: (for full versions, see (→ "Service information" p. 109)). This information is useful when seeking telephone support from a Löwenstein Medical representative. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 107: Login

    Confirm. Confirm the whole password. Do not leave the device in a logged-in state, as unauthorised persons could change settings and calibration data. Restart the device if you were logged in. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 108: Service Tab

    Selection buttons (4) Change password (5) Save settings as default (6) Logout (7) Standby You will find a more detailed explanation of individual points in the service manual of the leon plus. 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 109 This information is useful when seeking telephone support from a Löwenstein Medical representative. Service settings Language Select the Select Language button. Unlock. Select a language. Confirm. leon plus- As at 03.11.2022 - 3.11.13...
  • Page 110 You should refer to a service technician authorised by Löwenstein Medical for these settings. Change password Select the User field. Select the User. Confirm. Select the New Password field. Select a password. Confirm. Confirm with OK. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 111: Configuration Tab

    Drive gas ▪ ▪ ▪ ▪ bottle (10 L) ▪ not available ▪ ▪ bottle (10 L) ▪ ▪ bottle (10 L) ▪ not available Gas type check (in the system test) ▪ ▪ leon plus- As at 03.11.2022 - 3.11.13...
  • Page 112 Access to this feature of the service is only possible via a login with password. You should refer to a service technician authorised by Löwenstein Medical for these settings. 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 113 O fresh gas flow is lower than double the is equal to or higher than consumption + O leak double the O (minimum is limit to red). consumption + O leak. leon plus- As at 03.11.2022 - 3.11.13...
  • Page 114 A doubling of the perceived volume is therefore assigned 10 dB, a quadrupling then corresponds to 20 dB and an eightfold increase to 30 dB. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 115: Configuration Tab

    Config tab. Access to this Service feature is only possible via a login with password. You should refer to a service technician authorised by Löwenstein Medical for these settings. Lighting leon plus- As at 03.11.2022 - 3.11.13...

  • Page 116: Procedure For Saving The System Configuration

    Switch to standby. Different default alarm settings! Danger of harm to patients Any alarms that occur are only displayed visually. WARNING ▪ Check the default alarm settings. (→ "Load default settings" p. 143) 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 117 Select the patient category that should be active at system start-up. Select the form of ventilation that should be active at system start-up. Save the current settings as default (button). Restart the system. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 118: Device Check

    (→ "Turn on" p. 120) Make sure the environment is quiet. The selftest (starts when the device is turned on) and the associated hardware check must be run once a day. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 119: System Test

    Only a passed system test will mute the alarm and delete the red bar. Short checklist before start-up This list is chained to the right side of the leon plus, but is also available as a copyable text “Short checklist before start-up”. You will find the text at the end of this document.

  • Page 120: Limited Start-Up Option

    Please make a note of the error number and notify a service technician authorised by Löwenstein Medical. After a successfully completed self check, the system test screen appears and the device is ready for operation. 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 121 Start of complete system test (→ "External fresh gas outlet before the system test" p. 125) ▪ Switch directly to standby (Skip system test Quick start (→ "Quick start" p. 149) ▪ Start individual system test block. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 122: System Test

    – traffic light display – alphanumeric value ▪ test start/stop button The system test blocks can be started individually only if the system test has been run completely once before. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 123: Operating States Of The System Test Block

    Traffic light Test can be aborted Running fields are alternately filled in white Test cannot be started Completed, Test can be started Result passed individually Completed, operation possible Completed, not passed leon plus- As at 03.11.2022 - 3.11.13...

  • Page 124: Results Of The Selftest

    Before the complete system test is started, a check of whether the O emergency dosing is switched off is carried out. During the ongoing system test the O emergency dosing is switched off internally and cannot be activated 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 125: External Fresh Gas Outlet Before The System Test

    267) Set the fresh gas outlet to position 0, if available. Confirm with OK. The button label switches from Start to Stop. The system test can now be aborted by repressing the button. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 126: Skip/Cancel System Test (Quick Start)

    If no system test is carried out for 24 hours, a light blue bar under the title bar with the message Last device restart > 24h. Please restart. draws attention to the need to restart the device and conduct a system test. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 127: Back To The System Test From Standby

    Test of the drive gas generator: ▪ Traffic light: only red or green possible Circuit system Determination of compliance ▪ Traffic light: red, yellow or green possible Determination of leakage ▪ Traffic light: red, yellow or green possible leon plus- As at 03.11.2022 - 3.11.13...

  • Page 128: Passed System Test And Display Of Values For Compliance And Leakage Rate

    If system test blocks are repeated individually, as they have not been passed, a system test that has not been passed with the subsequent passed system test blocks can be seen in the event log. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 129: Display Of Values For Compliance And Leakage Rate

    If a switch is made from standby to the system test screen (e.g. to redetermine compliance after changing the patient tube system), an individual test is started and not passed, a yellow bar with the label “Individual Test Not Passed” appears. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 130: Tightness Of Tube System And Full System

    Not suitable for low flow Yellow Table 23: Total system tightness Value in ml/min Status Traffic light <500 Tight Green ≤1000 Not suitable for minimal flow Green >1000 Not suitable for low flow Yellow 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 131: System Test Procedure

    Chapter Start-up System test procedure System test procedure leon plus- As at 03.11.2022 - 3.11.13...

  • Page 132: Fio Calibration

    Red, yellow or green traffic light possible (→ "FiO2 measurement" p. 83) Passed FiO calibration If the test is successfully executed, the “traffic light” remains on green and no error message is given. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 133: Fio 2 Calibration Not Passed

    Set the alarm limits of the monitored data in accordance with the following table. Start the given test. All of the triggered alarms are stored in the alarm log and can (→ "Alarm log" p. 206) be seen here. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 134: Test Of Alarm Functions

    Set the anaesthetic vaporiser to approx. 2%. [%] low value Set the alarm limit (low). Squeeze the bag several times until the alarm is triggered. Set the anaesthetic vaporiser to 0%. 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 135 Set the alarm limit (low). Wait until the alarms are triggered. VTe [ml] low >1000 ml MV [l/min] high <2 l/min Set the alarm limit (high). Wait until the alarms are triggered. PPeak [mbar] <20 mbar leon plus- As at 03.11.2022 - 3.11.13...
  • Page 136 Restore the test set-up for the system test. Irrigate the system thoroughly. Activate the Reset To Default Settings button. (→ "Load default settings" p. 143) DO NOT FORGET: Replace the patient adapter of the gas measurement on the Y-connector. 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 137 In the event of any abnormalities, the connection between the patient and the anaesthesia device is disconnected again and systematic troubleshooting is initiated. Meanwhile, ventilated patients are ventilated with the obligatory separate manual breathing bag. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 138: Power Off

    If the ON/OFF button is pressed while ventilation is running, the (→ "To switch to standby (stop ventilation)" p. 161) standby dialogue appears. To completely separate from the mains power, pull the mains plug. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 139: O 2 Emergency Dosing During Shutdown Of The Device

    Otherwise, close the emergency dosing. The OK button becomes active. Confirm the dialogue with the OK button. In both cases the further shutdown process takes place. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 140: Ventilation

    The lower the tidal volume, the bigger the constant share of the compliance volume becomes. Therefore, use child tube systems for children to lower the total gas volume of the system, if necessary. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 141: Weight (Ibw)

    5-50 50-99 Ventilation parameters with weight entry If the ventilation parameters are preset by entering the weight, the restrictions of the setting options of the ventilation parameters through the patient categories are lifted. leon plus- As at 03.11.2022 - 3.11.13...
  • Page 142 1:4−4:1 1:4−4:1 0.2-10 0.2-10 insp. PEEP [mbar] OFF, 1−20 OFF, 1−20 Plateau [%] OFF, 10-50 10-90 0.1-0.5 0.1-0.5 Trigger [l/min] 0.6-5 0.6-5 6-10 6-10 4-10 4-10 Backup [s] 10-15 10-15 15-45 15-45 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 143: Load Default Settings

    PEEP and P is 5 mbar. insp. When increasing the PEEP settings, the P setting insp. must also be increased correspondingly, as otherwise it would lead to a lowering of the V or MV. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 144: Moisture In The Ventilation System

    AGSS. The fill state of the ventilation system corresponds to the fill Low flow ≤1000 l/min ≤300 ml/min state of the ventilation bag serving as a reservoir. Minimal ≤500 ml/min ≤150 ml/min flow 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 145: Fresh Gas Setting

    There is a graphic display of the amount in the tube as a bar graph. If not confirmed, presets (yellow) are closed again after 10 seconds Select the fresh gas blender button in the window to implement the settings. leon plus- As at 03.11.2022 - 3.11.13...
  • Page 146 Presetting the fresh gas is also possible in standby. If the fresh gas blender fails its control elements become inactive. Then ensure the fresh gas flow through the O emergency supply 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 147: Fresh Gas Ecometer

    = factors that can be changed in the service to individually adjust the threshold from red to green and from green to yellow leon plus- As at 03.11.2022 - 3.11.13...

  • Page 148: Borderline Fresh Gas Settings

    100 (bar) automatic switch-over to O (100 %) with the fresh gas flow remaining the same Setting of the anaesthetic vaporiser Please operate the anaesthetic vaporiser in accordance with its user manual. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 149: Quick Start

    Low or minimal flow are not allowed to run WARNING The O emergency dosing of the leon plus is active in the turned-off state. If it is opened before the start and if the system test is skipped, it remains active until a ventilation is started.

  • Page 150: Execute Quick Start

    (→ "Fresh gas setting" p. 145). Select the Form Of Ventilation button. Confirm the selection. Select the Ventilation Parameters button. Set the parameter. Confirm the entry. Set the anaesthetic vaporiser to the desired concentration. Start ventilation. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 151: Forms Of Ventilation

    Set the anaesthetic vaporiser to the desired concentration. Start the monitoring and ventilate the patient with the ventilation bag. Activate the O flush on the front of the device to fill the system quickly. leon plus- As at 03.11.2022 - 3.11.13...
  • Page 152 Trigger [l/min] Backup [s] fresh gas parameters [% of fresh gas flow], minimal O concentration fresh gas blender: ▪ with carrier gas AIR 21 % ▪ with carrier gas N O 25 % 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 153 Ventilation Forms of ventilation HLM (ventilation using a heart-lung machine) If the leon plus is operated together with a heart-lung machine, the HLM form of ventilation is available. The HLM form of ventilation is the equivalent of the MAN/SPONT form of ventilation, except that here the monitoring of all of the limit values (except for CPAP) is switched off.
  • Page 154 Plateau [%] Trigger [l/min] Backup [s] fresh gas parameters [% of fresh gas flows], minimal O concentration fresh gas blender: ▪ with carrier gas AIR 21% ▪ with carrier gas N O 25% 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 155 Forms of ventilation MON mode For regional anaesthesias (with adequate spontaneous breathing) or when monitoring an awake patient, the leon plus provides the MON (monitoring) form of ventilation. The patient can be supplied with O via a mask and the internal O...
  • Page 156 Fresh gas cannot be given via the fresh gas blender. Follow the prompts on the screen: – Connect the multi gas analyser to the respiratory mask. – Connect the respiratory mask to an O outlet. – Open the O outlet. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 157: Mechanical Ventilation

    Chapter Ventilation Forms of ventilation Mechanical ventilation Selection of a mechanical form of ventilation The leon plus provides the following mechanical forms of ventilation: ▪ volume-controlled ventilation: IMV ▪ pressure-controlled ventilation: PCV ▪ synchronised intermittent mandatory ventilation: S−IMV ▪ pressure-controlled synchronised ventilation: S-PCV ▪...
  • Page 158 Percentage share of inspiration time in which the ventilation pressure in the patient’s lungs is kept constant inspiratory ventilation volume that should be reached per breath Pressure limit from which the plateau is developed 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 159 Backup Length of apnoea period until the leon plus triggers a mechanical breath independently Manual the user can trigger a mechanical breath breath him/herself leon plus- As at 03.11.2022 - 3.11.13...
  • Page 160 Select the Form Of Ventilation button. Confirm the selection. Select the Ventilation Parameters button in the form of ventilation/parameters window. Set the parameter. Confirm the entry. Set the anaesthetic vaporiser to the desired concentration. Start ventilation. 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 161 45 seconds and the previous active parameters are retained. To switch to standby (stop ventilation) Activate the Standby button on the keyboard. Confirm the screen dialogue on the touchscreen with Yes. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 162: Description Of The Forms Of Ventilation

    If this maximum desired P pressure limit is exceeded, the plateau phase is started too early and the set tidal volume is not completely administered. It then becomes a volume-controlled, pressure-limited form of ventilation. 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 163 Trigger [l/min] Backup [s] fresh gas parameters [% of fresh gas flow], minimal O concentration fresh gas blender: ▪ with carrier gas AIR 21 % ▪ with carrier gas N O 25 % leon plus- As at 03.11.2022 - 3.11.13...
  • Page 164 I:E ratio timing and ventilation frequency. The setting of a PEEP and a plateau phase as a percentage share of the inspiration time is available. The leon plus first ventilates the patient with a high, constant flow until the set P inspiration pressure is insp.
  • Page 165 P is not reached if possible. If V switched off, the ventilation parameter P changes back to P and P is allocated as start insp. insp. value with the monitoring value P peak leon plus- As at 03.11.2022 - 3.11.13...
  • Page 166 Backup [s] O2 fresh gas parameters [% of fresh gas flow], minimal O concentration fresh gas blender: ▪ with carrier gas AIR 21 % ▪ with carrier gas N O 25 % 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 167 With the S-IMV the mechanical breath is administered via volume-controlled V .
  • Page 168 6-10 Backup [s] fresh gas parameters [% of fresh gas flow], minimal O concentration fresh gas blender: ▪ with carrier gas AIR 21 % ▪ with carrier gas N O 25 % 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 169 When the time has come for the mechanical breath according to the set frequency, a "Trigger" is activated by the leon plus (the patient can release the trigger). The next inspiration effort by the patient leads to administration of the mechanical breath. The...
  • Page 170 6-10 Backup [s] fresh gas parameters [% of fresh gas flow], minimal O concentration fresh gas blender: ▪ with carrier gas AIR 21 % ▪ with carrier gas N O 25 % 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 171 25% of the previously reached maximum value. The setting of a PEEP is possible. If the leon plus is not triggered by an adjustable apnoea time (backup) of the patient, the leon plus starts an inspiration independently.
  • Page 172 10-15 15-45 15-45 fresh gas parameters [% of fresh gas flow], minimal O concentration fresh gas blender: ▪ with carrier gas AIR 21 % ▪ with carrier gas N O 25 % 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 173 P inspiration pressure of 16, the P must insp. insp. first of all be increased. Maximum ventilation frequency with a given I:E ratio (adult) Maximum ventilation frequency with a given I:E ratio (child) leon plus- As at 03.11.2022 - 3.11.13...
  • Page 174 No parameters are taken over or transferred in and out of the PSV and HLM forms of ventilation. Other parameters are taken over only if they are available and valid as settings in the new form of ventilation. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 175: Monitoring

    Chapter Monitoring General information 9. Monitoring General information All measured values are administered for BTPS. Flow, pressure and concentrations are measured by sensors. All other sizes are derived from these measured values. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 176: Data

    (real- (9) Bar graphs time, trend) – Fresh gas amount (O O, AIR) – values as a numerical display (monitoring, tabular) Is only displayed with an existing plateau. 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 177 General information (1) alarm messages (5) Loops (2) real-time graphs – Volume over pressure (3) limit values – Flow over pressure (4) supply pressures – Flow over volume – – 10 L bottles leon plus- As at 03.11.2022 - 3.11.13...

  • Page 178: Alarm Muting (Mute)

    Limit values (→ "Limit values (patient alarm limits)" p. 207) Alarm messages (→ "List of alarm messages" p. 214) Batteries (→ "Batteries" p. 199) Device functions (→ "Monitoring of device functions" p. 192) 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 179: Monitored Data

    – isoflurane [%] – sevoflurane [%] – desflurane [%] Select the Curves tab. Select the button in the window. (→ "Table 12: Icons/screen (control elements)" p. 44) Set the parameters. Confirm the entry. leon plus- As at 03.11.2022 - 3.11.13...
  • Page 180 [%] Calculated values I ▪ ▪ Compliance – static [ml/mbar] – dynamic [ml/mbar] ▪ Resistance [mbar/l/s] (1) P Peak (2) P Mean (3) PEEP Is only displayed with an existing plateau. 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 181 [%] anaesthetics high (except for desflurane) DES [%] 0 − +22 insp. DES alarm high O [%] 0 − +100 Concentration in the curve value setting: autoscaling=OFF, X-axis range=0−40 mmHg leon plus- As at 03.11.2022 - 3.11.13...

  • Page 182: Tabular Trend

    /PEEP [mbar] Peak – [mbar] Mean – MV [l/min] – Freq [1/min] Calculated values I � � – – static /dynamic compliance [ml/mbar] ▪ Resistance [mbar/l/s] Is only displayed with an existing plateau. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 183: Event Log

    Chapter Monitoring Monitored data Event log All of the settings made, occurring alarms and events on the leon plus are displayed in the event log. Events can be displayed in a detailed view: ▪ display – coding – date –...

  • Page 184: Measured Values In A Numerical Display

    Spont. [s] ▪ calculated values I – leak [%] – – Compliance (static [mbar/ml] , dynamic [mbar/ml]) – C20/C ▪ Resistance [mbar/l/s] Is only displayed with an existing plateau. 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 185 Select the measured value in the window. Change the value. Confirm the entry. Call up the measured values on page 1 or 2. The monitoring window can only be selected via the touchscreen. leon plus- As at 03.11.2022 - 3.11.13...
  • Page 186 Freq. [1/min] 0-300 Freq. [1/min] 0-300 Spont. Freq. [1/min] 0-100 Spont [s] 0-10 0-10 Compl. stat. [ml/mbar] 0-1000 Compl. dyn. [ml/mbar] 0-1000 C20/C 0-200 Resist. [mbar/l/s] 0-1000 %Spont. [%] 0-100 Leak [%] 10-100 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 187 ▪ numerical gas measurement values are issued as “–” ▪ the real-time charts of the gas concentrations continue to run constantly at the last displayed value until the end of the calibration phase leon plus- As at 03.11.2022 - 3.11.13...
  • Page 188 The deployment of alcohol-containing cleaning products can also falsify the measurement. Gas measurement window only with FiO measurement Only inspiratory FiO is displayed for monitoring. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 189: Entry Of Age For Mac Calculation

    The display of the MAC value and the age entry to be calculated take place in the gas measurement window. Focus the gas measurement window. Select the MAC field in the window. Change the value. Confirm the entry. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 190: Manual Selection Of The Narcotic Gas

    In the S-IMV, S-PCV and PSV forms of ventilation, in which the patient can trigger a mechanical breath, the moment of triggering can be marked by a vertical line in the real-time charts in the relevant chart colour. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 191: Loops (Monitoring Of Lung Function)

    With this button, you can close the full screen window or the window with three loops. Other operating elements: (→ "Table 12: Icons/screen (control elements)" p. 44) (→ "Table 13: Icons/screen (buttons)" p. 44) leon plus- As at 03.11.2022 - 3.11.13...

  • Page 192: 10. Monitoring Of Device Functions

    (only as alarm message) ▪ absorber (only as alarm message) ▪ fans (only as alarm message) (1) alarm messages (2) batteries (3) fresh gas blender (4) gas supply pressures (→ "Errors and measures" p. 233) 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 193: Fresh Gas Blender

    If AIR fails, O is used as carrier gas. Requirement for reserve gas bottle operation: – Reserve gas bottles available – Reserve gas bottles sufficiently filled – Reserve gas bottles opened leon plus- As at 03.11.2022 - 3.11.13...

  • Page 194: Display Of Damaged Fresh Gas Blender

    (→ "Fresh gas blender" p. 193) You can open the Threshold window with this button. You can close the Threshold window with both of these buttons. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 195: Central Gas Supply Pressures

    With no CGS the pressures of the central gas supply are displayed in red. If the leon plus is supplied with fresh gas from 2 L or 3 L gas bottles only, this is only marked by a message in the alarm window.

  • Page 196: Pressure Display When Supply From 10 L Bottles

    Gas supply pressures Pressure display when supply from 10 L bottles If the leon plus is supplied with fresh gas via 10 L gas bottles and the pressure of the bottles is monitored, (40 kPa × 100 ( bar ) ) next to the bottle icon is the this is marked by a gas bottle icon.

  • Page 197: Drive Gas Generator

    If AIR fails as the drive gas (fault in the CGS), or if the leon plus is supplied with fresh gas via 10 L O and N O gas bottles, O is used as the drive gas.

  • Page 198: Fresh Gas Shortage

    The maximum O concentration in the housing of the leon plus should not exceed 25%. To guarantee this, the housing is ventilated with a fan. A useful side- effect is the cooling of the inside of the housing. If the fan fails, the alarm message “Fan failed”...

  • Page 199: Batteries

    Stop: Briefly touch the stopwatch on the ▪ touchscreen again Reset: Keep the stopwatch on the touchscreen ▪ pressed down for longer than two seconds Confirmation is also possible via the rotary button. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 200: 11. Alarms

    The alarm limits of the measured values displayed as real-time curves are marked in a broken line in the curve colour concerned. 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 201 Please make a note of the error number before you notify a Löwenstein Medical-authorised Patient Patient service technician. User System Technical fault Techno- Löwenstein logy Medical leon plus- As at 03.11.2022 - 3.11.13...

  • Page 202: Factory Settings Of The Alarms

    ENF [%] low insp. ISO [%] high insp. ISO [%] low insp. SEV [%] high Insp. SEV [%] low insp. DES [%] high 10.0 10.0 insp. DES [%] low [%] high 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 203 Form of ventilation Child Adult Alarm [%] low Leak [%] Apnoea [s] MV [l/min] high 12.0 MV [l/min] low [ml] low [mbar] + 10 + 10 Peak insp. insp. CPAP [mbar] Freq high Freq leon plus- As at 03.11.2022 - 3.11.13...

  • Page 204: Alarm Muting

    If during the mute time there is no alarm the mute function is cancelled early. The next alarm to appear sounds according to its priority. ▪ Informative priority alarms are deleted from the alarm window if the Mute button is pressed. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 205: 10 Minute Alarm Muting

    A minute counter appears in the title bar (→ "Mute 10 min." p. 54) in mm:ss format, highlighted in red, which displays the remaining mute time. System alarms and technical alarms are audibly sounded and mute is reset. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 206: Alarm Log

    If the capacity limit of the alarm log store is reached, the oldest data are deleted (fifo) The alarm log can only be seen during the ventilation. In standby it is part of the event log. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 207: Limit Values (Patient Alarm Limits)

    Set the parameters. Confirm the entry. Close the window. Further control elements in the Thresholds window: Adapting active alarms to the current measured value. (→ "Adjusting alarm limits to current measured value (autoset)" p. 211) leon plus- As at 03.11.2022 - 3.11.13...

  • Page 208: Adjustable Alarm Limits

    “Apnoea”. The adjustable alarm limit for “Apnoea” is on the bottom right. In the MAN/SPONT form of ventilation, the MV minute volume is not displayed as a limit value. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 209: Application Area And Increment Of Alarm

    SEV [%] low 0-9.9 0-9.9 insp. DES [%] high 0.1 0.1-22 0.1-22 insp. DES [%] low 0-21.9 0-21.9 [%] high 19-99 19-99 [%] low 18-98 18-98 Leak [%] 10-100 10-100 Apnoea [s] leon plus- As at 03.11.2022 - 3.11.13...
  • Page 210 Table 42: Application area and increment of alarm Form of ventilation Child Adult Alarm MV [l/min] high 0.2-30 0.1-30 MV [l/min] low 0.1-19.9 0-19.9 [ml] low 10-600 50-1600 [mbar] Peak CPAP [mbar] Freq high Freq 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 211: Adjusting Alarm Limits To Current Measured Value (Autoset)

    MV × 0,6 at least [ml] low × 0,6 × 0,6 [mbar] + 10 + 10 peak plateau plateau The alarm limit is automatically adjusted only if the set alarm limit is exceeded. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 212: Alarm Limits That Are Automatically Followed

    [%] detection of a breath detection of a high/low breath [%] high immediately after immediately after is not displayed the start of a the start of the ventilation ventilation 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 213 30 seconds after is not is not displayed the start of the displayed ventilation Freq high/low is not displayed is not displayed is not immediately after displayed the start of the ventilation leon plus- As at 03.11.2022 - 3.11.13...

  • Page 214: List Of Alarm Messages

    Only resettable via reboot Rechargeable 134 Battery voltage < 21V Restore mains 22.1 V > 20 s battery empty supply. Not possible during operation. Only resettable via reboot 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 215 209) Apnoea backup 301 Backup breath in the Patient does not breath was PSV mode was trigger, forced triggered emitted (apnoea) breath is triggered by machine leon plus- As at 03.11.2022 - 3.11.13...
  • Page 216 120 s min) FG blender check O in system test failed FG flow measurement < 20 ADC 30 s disconnected. Cable for FG blender valves probably also pulled out -> fail FG dosing 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 217 (drive gas blender gas blender check ml/min < 500 max, MAN/SPONT failed, in system test mbar < 1 possible. disconnected/dropped Peep off drive gas tube, ≥ V × 0,5 blockage drive gas channel) leon plus- As at 03.11.2022 - 3.11.13...
  • Page 218 313 Expiratory CO Inspiratory CO high 311 Inspiratory CO high Insp. DES too high 322 Inspiratory desflurane Change vaporiser too high setting Insp. DES too low 323 Inspiratory desflurane too low 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 219 Not possible during without function without function operation. Only resettable via reboot Set pressure P 307 Pressure not reached Change ventilation 2 breaths insp not reachable. parameters Set volume V 305 Volume not reached reachable. leon plus- As at 03.11.2022 - 3.11.13...
  • Page 220 331 Insp. oxygen Change ventilation (→ "Application area and 3 breaths concentration too high parameters increment of alarm" p. 209) too low 330 Insp. oxygen concentration too low 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 221 Can only be reset via reboot (possible replacement/repair) Gas measurement: 137 O2 cell depleted Insert new O2 cell O2 cell depleted Calibrating gas 138 Multi-gas analyser in measurement calibration mode; no measured values leon plus- As at 03.11.2022 - 3.11.13...
  • Page 222 Broken loudspeaker Replace / repair possible. No decompression 190 Pressure cannot be Check PEEP valve PEEP Setting + 5 mbar > = 16 s during expiration reduced in the system (valve clips) 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 223 > V Look for leak (→ "Application area and 3 breaths increment of alarm" p. 209) Fan fail Fan fault Replace / repair Gas measurement 126 Sample line occluded Remove sample occlusion line obstruction leon plus- As at 03.11.2022 - 3.11.13...
  • Page 224 Reserve ok supply CGS PS4 < PS5 u, PS4 < 2.5 O supply fail 180 N O (CGS and Restore N < 1.1 bar reserve) supply fail supply (CGS or reserve) 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 225 “Yes” dosing. boot process fail. Fresh gas 170 O (CGS and reserve) Restore O supply < 1,1 with air. supply fail, air ok (CGS or reserve) Reserve > = 1,1 leon plus- As at 03.11.2022 - 3.11.13...
  • Page 226 175 O CGS supply has Check O supply 1.1 < PS2 < 2.5 at 10 s low input pressure but consumption > still supplies gas PS2 < 2.5 with O consumption = 0 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 227 3 breaths + 10 PCV, SPCV: Pinsp + 10 Manspont: Adult 40 Child 35 PEEP not reached 335 The PEEP set is not Change ventilation PEEP setting - 2 mbar 5 breaths reached parameters leon plus- As at 03.11.2022 - 3.11.13...
  • Page 228 119 Anaesthetic gas blend anaesthetic gas recognised with recognised MAC>3 (MAC>3) Sensor fail, only Faulty pressure Not possible during +/- 5 mbar MAN/SPONT sensor or not operation. Only possible calibrated resettable via reboot 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 229 Insp. SEVO too high 320 Inspiratory Change vaporiser 3 breaths (→ "Application area and sevoflurane too high setting increment of alarm" p. 209) Insp. SEVO too low 321 Inspiratory sevoflurane too low leon plus- As at 03.11.2022 - 3.11.13...
  • Page 230 Only repeated, make a resettable via note of the error reboot. Use the O number and notify a emergency dosing service technician authorised by Löwenstein Medical 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 231 Only repeated, make a resettable via note of the error reboot. Use the O number and notify a emergency dosing service technician Replace/repair use authorised by the O emergency Löwenstein Medical dosing leon plus- As at 03.11.2022 - 3.11.13...
  • Page 232 209) VueLink not 192 VueLink is not Received valid 60 s connected connected/incorrectly requests/ VueLink connected deactivated Change watertrap 129 Watertrap blocked or Change watertrap gas measurement full 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 233: 12. Errors And Measures

    General information Patient monitoring System and technical errors have error numbers. System errors can generally be fixed by the user. To fix a technical error, you should refer to a Löwenstein Medical-authorised service technician. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 234: Pressure Relief Valve

    APL. During mechanical ventilation, the APL is decoupled. Excess fresh gas leaks through the excess diaphragm. If the valves malfunction, pressures that could endanger the patient can leak through the plateau and PEEP valve. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 235: Defined Safe State

    Chapter Errors and measures Defined safe state Defined safe state In the leon plus, the ventilation unit, user interface and monitoring system are separate, independent modules. Two safe states are defined: ▪ Patientsafe: If the user interface with monitoring fails, the ventilation unit continues to run.

  • Page 236: Failsafe Defined Safe State

    ▪ fresh gas is supplies in accordance with the emergency dose settings ▪ flush is available ▪ anaesthetic vaporisers available 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 237: Inoperability Or Failure Of The Device

    Closes the Patientsafe error dialogue (emergency operation). Ventilation continues with the last fresh gas settings and ventilation parameters set. The O emergency dosing is released. (→ "Execute quick start" p. 150) leon plus- As at 03.11.2022 - 3.11.13...
  • Page 238 Use an external gas monitor ▪ Check for a possible alternative continuation of the anaesthetic gas If you are unable to fix the error yourself, notify a Löwenstein Medical-authorised technician. (→ "Execute quick start" p. 150) 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 239: Self Check Error Search

    ▪ cabling damaged Battery Traffic light is ▪ damaged ▪ cabling damaged Traffic light is ▪ battery voltage low yellow Gas measurement Traffic light is ▪ damaged ▪ cabling damaged ▪ tubing damaged leon plus- As at 03.11.2022 - 3.11.13...

  • Page 240: Error Search System Test

    Oxygen concentration > 35% or < 10% if AIR ▪ AIR incorrectly connected flows AIR check: AIR input pressure outside of CGS pressure too high or too low ▪ check AIR CGS wall connection permissible range 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 241: Error Search Fresh Gas Blender

    O detected calibration: Signal too high at calibration 21% or 100% value ▪ cell fail considerably too high ▪ fresh gas blender untight calibration: Data not stable Signal not stable ▪ cell fail leon plus- As at 03.11.2022 - 3.11.13...
  • Page 242 Flow of a valve out of permissible range or ▪ valve fresh gas blender fail range obstruction ▪ emergency dosing untight ▪ CGS not connected or pressure too low ▪ occlusion in the fresh gas branch 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 243: Error Search Respirator

    ▪ PEEP valve hangs Drive gas blender: AIR, O not available Drive gas blender: AIR, O not available ▪ and/or AIR erroneously or not (only with leon plus) connected leon plus- As at 03.11.2022 - 3.11.13...

  • Page 244: Error Search Flow Sensors

    Contaminated (insp. wire) ▪ Flow sensor contaminated (insp.) Sensor contaminated (exp. wire) ▪ Flow sensor contaminated (exp.) Failed (insp. wire) ▪ Flow sensor fail (insp.) Failed (exp. wire) ▪ Flow sensor fail (exp.) 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 245: Error Search Circulation System

    ▪ blue insp. valve diaphragm, not available, damaged, fits incorrectly ▪ blue insp. valve diaphragm, not available, Compl.:insp. Valve: Pressure not reached blue inspiratory valve diaphragm untight damaged, fits incorrectly leon plus- As at 03.11.2022 - 3.11.13...
  • Page 246 O-ring on the slide valve auto/manual damaged Compl.:pressure rise on zero flow Pressure rise although flow turned off ▪ fresh gas blender untight ▪ pressure port on the excess diaphragm untight ▪ slide valve APL 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 247 ▪ insp. flow sensor fail ▪ dome untight or not properly screwed on ▪ O-ring dome carrier damaged or failed Leak, bellows:not available Bellows not recognised ▪ Bellows not available or dropped off leon plus- As at 03.11.2022 - 3.11.13...

  • Page 248: Error Search Fio Calibration

    21% and 100% value ▪ cell fail considerably too high calibration.:data not stable Signal not stable ▪ cell fail (only for option "external O fuel cells”) 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 249: External Supply Units Failure

    100% 1.1, 1.2 setting failed failed closed closed 100% Blender Blender failed closed closed setting setting Blender Blender failed open closed setting setting failed empty closed 21% (AIR) 2.2, 2.3 leon plus- As at 03.11.2022 - 3.11.13...
  • Page 250 100% ventilation 2, 3.2 not possible operation not operation failed failed failed empty open 4, 3.2 possible not possible operation not operation failed failed failed empty empty possible not possible 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 251 Check for a possible alternative continuation of the anaesthetic gas Failure of the device Death or permanent injury of the patient Only if the following errors occur at the same time should the leon plus no WARNING longer be operated: O...

  • Page 252: Mains Supply Failure

    Shortly before the battery voltage falls below 22.1 V, meaning the batteries can no longer guarantee power supply, and the leon plus shuts down automatically, the dialogue occurs: ▪ The battery is now empty. The device shuts down.
  • Page 253 ▪ workstation light Measures for mains supply failure With full batteries, all functions of the leon plus are available without restriction for a further 100 minutes. If you are unable to fix the error yourself, make a note of the error number and notify a technician authorised by Löwenstein Medical.

  • Page 254: Failure Of The Anaesthesia Gas Scavenging System

    If you are unable to fix it yourself, notify your technical department or the AGSS manufacturer. Remember that N O and volatile narcotics get into the ambient air and could impair your consciousness. Please also refer to the AGSS user manual. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 255: Failure Of Internal Units

    Operate the device via the buttons on the keyboard and the rotary button. These operating processes are described in the relevant chapters. You are now in the right column of the particular table. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 256: Fresh Gas Dosing Failure

    Notify your technical department or the CGS manufacturer. If you are unable to fix the error yourself, make a note of the error number and notify a technician authorised by Löwenstein Medical. 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 257 Notify your technical department or the CGS manufacturer. If you are unable to fix the error yourself, make a note of the error number and notify a technician authorised by Löwenstein Medical. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 258: Ventilator Failure

    The patient can continue to be ventilated with the ventilation bag. If you are unable to fix the error yourself, make a note of the error number and notify a Löwenstein Medical-authorised technician. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 259: Gas Measurement Failed

    (sidestream measurement)" p. 263). ▪ If necessary, change the watertrap. If you are unable to fix the error yourself, make a note of the error number and notify a technician authorised by Löwenstein Medical. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 260: Flow Measurement Failure

    Reaction of the system to failure of the expiratory flow measurement ▪ Possible messages: – Exp. volume measurement no longer possible ▪ The device continues to ventilate in the current ventilation mode ▪ Audible and visual alarm 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 261: Pressure Measurement Failure

    Löwenstein Medical-authorised technician. Pressure measurement failure! Too-high ventilation pressures lead to lung damage ▪ The patient can continue to be ventilated with the ventilation bag. WARNING ▪ Set an alternative ventilation pressure measurement. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 262: 13. Maintenance And Servicing

    Do not carry out any servicing or maintenance work while the device is WARNING being used on a patient. The leon plus must be serviced (→ "Servicing interval" p. 275) regularly by a Löwenstein Medical- authorised service technician. All maintenance...

  • Page 263: Gas Measurement Maintenance (Sidestream Measurement)

    (1) strap (2) strap (3) lid When ventilating neonates, please use the watertrap and the sample line for neonates (blue coding (→ "Connecting the sample line (only for variant DRYLINE™ watertrap)" p. 85)). leon plus- As at 03.11.2022 - 3.11.13...
  • Page 264 – adults: 28 h – neonates: 34 h ▪ with a maximum specified test gas flow (only for DRYLINE™ watertrap) (200 or 120 ml/min) – adults: 17 h – neonates: 20 h 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 265: Flow Sensor Servicing

    Slide the flow sensor with the side on which the O-ring is positioned into the patient module. Take care when installing that the plug on the flow sensor is guided into the nut of the patient module carrier. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 266: Peep Valve Diaphragm Servicing

    (→ "Connection for respiratory bellows, dome and CO2 absorber, PEEP valve diaphragm cover, flow sensors" p. 66) Installation of the PEEP valve diaphragm (1) PEEP valve diaphragm (2) metal disc (3) PEEP valve diaphragm cover 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 267: Servicing Of The Insp./Exp. Valve Diaphragms

    Cut off the two flag rods sticking out from the inside of the valve diaphragm holder. ATTENTION ▪ If the valve diaphragms are removed from the diaphragm holder, these valve diaphragms may not be used again and must be replaced by new valve diaphragms. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 268: Servicing Of Fans

    Change the fan filter pad on the rear of the housing if soiling is detected. Pull the protective grid vertically from the mounting. Change the filter pad. Press the protective grid back into the mounting. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 269: Servicing Of Reserve Gas Bottles And 10 L Bottles

    ATTENTION The high-pressure regulator is not fitted with a back pressure manometer. If monitoring of the back pressure in operation is desired, it is monitored by the connected device. leon plus- As at 03.11.2022 - 3.11.13...
  • Page 270 The connection must be removed without pressure. The removal of the connection under pressure and using a tool may only be carried out in an emergency. The seal ring is destroyed by this procedure. 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 271 Repair by a Löwenstein Medical- the spring bonnet authorised service technician Case 4 Maximum flow is not Filter in the inlet Repair by a Löwenstein Medical- reached pressure authorised service technician connection blocked leon plus- As at 03.11.2022 - 3.11.13...

  • Page 272: Disposal

    Disposal of water trap and sample line Water trap and sample line can be contaminated by patient gas. For disposal please refer to the hygiene guidelines of your hospital. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 273: Disposal Of O Sensor

    Otherwise, dispose of this material according to the label if marked. If in doubt, please proceed in accordance with the disposal guidelines of your hospital or contact a Löwenstein Medical representative. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 274: Disposal Of Battery

    Before beginning maintenance an inspection is required (establishment of actual state). The inspection establishes whether along with the actual maintenance other measures are needed to maintain or restore the proper operational state of the device. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 275: Servicing Interval

    Every 6 years or every 20,000 operating hours (general overhaul) : ▪ STC (to establish faults) ▪ annual service ▪ 3-year service ▪ 6-year service ▪ system adjustment/system calibration ▪ STC (check of work carried out) leon plus- As at 03.11.2022 - 3.11.13...

  • Page 276: Replacing And Calibrating The O 2 Cell

    Insert the new O cell. Remove the sample line from the patient adapter. Insert the watertrap with the sample line connected to the watertrap. Wait approx.20 seconds. (1) O cell 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 277: Side Power Measurement Servicing

    (3) Y-piece: (for inner tube diameter 2 mm) (4) Watertrap The flow meter is needed to ensure that the multi gas analyser does not draw in any air from the room at the same time. leon plus- As at 03.11.2022 - 3.11.13...
  • Page 278 25 °C) is required before the given concentrations are reliable. ▪ Twist or turn the container If the values are outside of the tolerance, notify a service technician authorised by Löwenstein Medical. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 279: Maintenance Of The High-Pressure Regulator

    Scope of the tests and documentation All test and measuring results must be logged in the medical product book. leon plus- As at 03.11.2022 - 3.11.13...
  • Page 280 Check for perfect mechanical state Cable support arm (if available) Check for perfect mechanical state Workstation illumination (if available) Check for perfect mechanical state and functionality Trolley Check wheels and brakes for perfect mechanical state 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 281 Reserve device earth The reserve device earth leakage on the 1.0 mA leakage on the leon plus must be checked with an appropriate leon plus IEC 60601-1 earth leakage measurement device. It is measured on the protective earth conductor or on the components joined to the protective...
  • Page 282 Fresh gas blender Flow Connect an external flow meter to the connection pin for fresh gas. Set the various flow values on the leon plus and compare the displayed values with the external flow meter. Gas concentrations Connect an external gas measurement to the connection pin for fresh gas.
  • Page 283 <0.6 kPa × 100 ( bar ) . wait until the O pressure has dropped to It is no longer possible to administer N Flush Proceed according to the leon plus short checklist before start-up. (→ "leon plus Short checklist before start-up" p. 319) Switch-over Start controlled ventilation.
  • Page 284 Checklist leon plus Technical safety controls A suggestion for a copyable text “Checklist of technical safety controls” for the leon plus is located in the final pages of this document. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 285: 14. Accessories

    Only the following listed accessories and replacement parts may be used with the leon plus: ▪ leon plus, leon and leon mri List of accessories and replacement parts The use of accessories and replacement parts other than those specified can limit the performance and safety of the system.

  • Page 286: Replacement Part

    Chapter Accessories Replacement part Replacement part (→ leon plus, leon and leon mri List of accessories and replacement parts) Accessories (→ leon plus, leon and leon mri List of accessories and replacement parts) 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 287: 15. Product Combinations

    15. Product combinations General information Only the following listed auxiliary devices may be used with the leon plus. The use of auxiliary devices other than those specified can limit the performance and safety of the system. The accessories and replacement parts that are used with the leon plus must nonetheless comply with the requirements of DIN EN ISO 80601-2-13.

  • Page 288: Mounting Additional Monitors

    ISO 5356-1 ▪ 93/42/EEC or MDR (EU) 2017/745 If in doubt, contact a Löwenstein Medical representative. Bronchial aspiration Only vacuum-driven bronchial aspirations may be connected. If in doubt, contact a Löwenstein Medical representative. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 289: Support Arms

    If in doubt, contact a Löwenstein Medical representative. PDMS On request. On request. AGSS The AGSS used must comply with the requirements of DIN EN ISO 80601-2-13. If in doubt, contact a Löwenstein Medical representative. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 290: 16. Appendix

    Chapter Appendix Notes 16. Appendix Notes Table 63: Notes Number Entry 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 291 Chapter Appendix Notes Table 63: Notes Number Entry leon plus- As at 03.11.2022 - 3.11.13...

  • Page 292: Gas Flow Plans

    Table 64: Legend for gas flow plans 1 Non-return valve open Non-return valve closed Electrically controlled valve open Electrically controlled valve closed Gas flow with direction Tube system under pressure Excess gas 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 293 Slide valve of open system Absorber decoupling valve Fresh gas outlet change-over valve Plateau valve Inspiratory flow sensor PEEP valve Expiratory flow sensor AGSS Connection to the anaesthesia gas Manual overdrive valve scavenging system Excess diaphragm leon plus- As at 03.11.2022 - 3.11.13...

  • Page 294: Manual Ventilation (Patient Module 0209100)

    Chapter Appendix Gas flow plans Manual ventilation (patient module 0209100) Inspiration (manual) Fig. 1: Manual ventilation, inspiration patient module 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 295 Chapter Appendix Gas flow plans Expiration (manual) Fig. 2: Manual ventilation, expiration patient module leon plus- As at 03.11.2022 - 3.11.13...

  • Page 296: Mechanical Ventilation (Patient Module 0209100)

    Chapter Appendix Gas flow plans Mechanical ventilation (patient module 0209100) Inspiration (semi-closed) Fig. 3: Inspiration patient module (semi-closed) 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 297 Chapter Appendix Gas flow plans Expiration (semi-closed) Fig. 4: Expiration patient module (semi-closed) leon plus- As at 03.11.2022 - 3.11.13...
  • Page 298 Chapter Appendix Gas flow plans PEEP Fig. 5: PEEP patient module 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 299 Chapter Appendix Gas flow plans Plateau Fig. 6: Plateau patient module leon plus- As at 03.11.2022 - 3.11.13...

  • Page 300: Manual Ventilation (Patient Module 0209100Hul200)

    Chapter Appendix Gas flow plans Manual ventilation (patient module 0209100hul200) Inspiration (manual) Fig. 7: Manual ventilation, inspiration patient module hul200 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 301 Chapter Appendix Gas flow plans Expiration (manual) Fig. 8: Manual ventilation, expiration patient module hul200 leon plus- As at 03.11.2022 - 3.11.13...

  • Page 302: Mechanical Ventilation (Patient Module 0209100Hul200)

    Chapter Appendix Gas flow plans Mechanical ventilation (patient module 0209100hul200) Inspiration (semi-closed) Fig. 9: Inspiration patient module hul200 (semi-closed) 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 303 Chapter Appendix Gas flow plans Expiration (semi-closed) Fig. 10: Expiration patient module hul200 (semi-closed) leon plus- As at 03.11.2022 - 3.11.13...
  • Page 304 Chapter Appendix Gas flow plans PEEP Fig. 11: PEEP patient module hul200 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 305 Chapter Appendix Gas flow plans Plateau Fig. 12: Plateau patient module hul200 leon plus- As at 03.11.2022 - 3.11.13...

  • Page 306: Manual Ventilation (Patient Module 0209100Lm300)

    Chapter Appendix Gas flow plans Manual ventilation (patient module 0209100lm300) Inspiration (manual) Fig. 13: Manual ventilation, inspiration patient module lm300 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 307 Chapter Appendix Gas flow plans Expiration (manual) Fig. 14: Manual ventilation, expiration patient module lm300 leon plus- As at 03.11.2022 - 3.11.13...

  • Page 308: Mechanical Ventilation (Patient Module 0209100Lm300)

    Chapter Appendix Gas flow plans Mechanical ventilation (patient module 0209100lm300) Inspiration (semi-closed) Fig. 15: Inspiration patient module lm300 (semi-closed) 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 309 Chapter Appendix Gas flow plans Expiration (semi-closed) Fig. 16: Expiration patient module lm300 (semi-closed) leon plus- As at 03.11.2022 - 3.11.13...
  • Page 310 Chapter Appendix Gas flow plans PEEP Fig. 17: PEEP patient module lm300 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 311 Chapter Appendix Gas flow plans Plateau Fig. 18: Plateau patient module lm300 leon plus- As at 03.11.2022 - 3.11.13...

  • Page 312: Calculation Methods

    = number of mechanical mech breaths (untriggered) Leck [ % ] = - MV Leak: × 100 Difference between inspiratory and expiratory minute volume. = exp. minute volume = insp. minute volume 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 313 Static inspiratory resistance of the lungs and of the max. tube system/device stat. = static V ̇ = Plateau pressure Plat. = maximum expiratory flow max. Is only displayed with an existing plateau. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 314: Pressure Flow Characteristics

    Chapter Appendix Pressure flow characteristics Pressure flow characteristics Inspiratory and expiratory pressure flow characteristics of the system to the patient connection opening 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 315 Chapter Appendix Pressure flow characteristics Inspiratory and expiratory pressure flow characteristics of the absorber module of the breath circulation system leon plus- As at 03.11.2022 - 3.11.13...

  • Page 316: Service Life Of Replacement Parts

    Service life of O cell (sidestream measurement, unleaded cell) ▪ 10,000 hrs. @ 100% O ▪ damaged Service life of FiO cell (unleaded cell) ▪ 20,000 hrs. @ 100% O ▪ damaged 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 317: Life Of The Flow Sensors

    ▪ damaged The reusable CO absorber is subject to a guarantee of 1 year or a maximum of 52 executed cleaning cycles. Damage caused by neglect is excluded from this guarantee. leon plus- As at 03.11.2022 - 3.11.13...

  • Page 318: Service Life Of Inspection Glasses

    Service life of inspection glasses untight � � defective � � The inspection glasses are guaranteed for 1 year or a maximum of 52 cleaning cycles. Damage caused by neglect is excluded from this guarantee. 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 319: Lists And Short Instructions

    List of Accessories and Replacement Parts). leon plus Short checklist before start-up A copyable text “Short checklist before start-up” for the leon plus is located in the final pages of this document. leon plus Short operating instructions A copyable text “Short operating instructions” for the leon plus is located in the final pages of this document.

  • Page 320: 17. Technical Data

    Chapter Technical data 17. Technical data The maximum equipment of the leon plus is described in the technical data. For information on basic equipment and options, please contact a representative of Löwenstein Medical. Table 67: Basic data, weight, dimensions Chassis...
  • Page 321 Rechargeable battery supply 2 x 12 V each with 7.2 Ah Rechargeable battery life At least 100 minutes (with fully charged batteries) Auxiliary outlets 4 units, each with 2 x T 2 A fuses leon plus- As at 03.11.2022 - 3.11.13...
  • Page 322 OFF, 4, 5, 6, 7, 8, 9, 10, 12 ,15 l/min Other connections Fresh gas outlet 22 mm external/15 mm internal ISO cones Ext. O outlet 22 mm external/15 mm internal ISO cones 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 323 APL without quick exhaust max. setting 90 Pa × 100 (mbar) ▪ APL with quick exhaust max. setting 80 Pa × 100 (mbar) Accuracy ± 10 Pa × 100 (mbar) or max. ±15% leon plus- As at 03.11.2022 - 3.11.13...
  • Page 324 ≥minute volume MV Accuracy of drive gas generator Volume up to 150 ml ±10 % min. ±10 ml from 150 ml ±5 % min. ±15 ml frequency ±10 % of set value or ±1 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 325 1:4 − 4:1 (incremental 0.1) OFF, 1 − 20 Pa × 100 ( mbar ) PEEP Plateau OFF, 10 − 50% (incremental 10%) 10 − 80 Pa × 100 ( mbar ) Pressure limitation (P leon plus- As at 03.11.2022 - 3.11.13...
  • Page 326 OFF, 300 − 1600 ml (adults) Numerical values in brackets: optional OFF, 20 (3) − 1600 ml (IBW) 5 − 60 Pa × 100 ( mbar ) Pressure limitation (P 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 327 Table 87: Ventilation using a heart-lung machine HLM Ventilation bag Manual ventilation is produced with the ventilation bag, which serves as a reservoir CPAP via APL Fresh gas settings at 0 l/min possible leon plus- As at 03.11.2022 - 3.11.13...
  • Page 328 Range 0 − 50 l Minute volume Accuracy of displays ±10 % or 50 ml Resolution 10 ml Range 0 − 150 1/min Frequency (spontaneous) Accuracy ± 1/min Resolution of displays 1/min 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 329 0 − 250 kPa × 100 ( bar ) Type Metallic thin-film sensor Bottle pressure ±4 % or 2 kPa × 100 ( bar ) Range 1 kPa × 100 ( bar ) Accuracy Resolution of displays leon plus- As at 03.11.2022 - 3.11.13...
  • Page 330 0 – 40 ± (1% + 1% 40 – 60 ± (1% + +2 % OXIMA™ 60 – 80 ± (1% + +3 % (optional) 80 – 100 ± (1% + +4 % 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 331 Not specified <18 p. spec. normal range 18 – 24 ±2.2 0.44 24 – 30 -2.2/+6.0 0.86 O + O 30 – 32 -2.2/+8.0 1.10 2. Agent Not specified >32 Not specified Not specified leon plus- As at 03.11.2022 - 3.11.13...
  • Page 332 (8) Ambient pressure effects are specified for 1.5 times the normal range of the maximum concentrations (except for DES). The effects are added to the specification of inaccuracy. Ambient pressure effects increase with increasing gas concentration and are specified for 1.5 times the normal range. 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 333 Inspiratory fuel cell Sidestream measurement standard Measurement paramagnetic or fuel cell inspiratory/expiratory Measurement infrared spectrometry inspiratory/end-tidal Measurement infrared spectrometry inspiratory/end-tidal Anaesthetic gases Measurement infrared spectrometry inspiratory/end-tidal Halothane, enflurane, isoflurane, sevoflurane and desflurane Auto ID leon plus- As at 03.11.2022 - 3.11.13...
  • Page 334 5 s, maximum 9 s every 4 hours Duration of zero phase Accuracy ISO (11196) after 45 s, full after 10 min Rated value of breathing rate 2 – 100 1/min Establishment of the minimum alveolar concentration 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 335 D--SUB, socket (standard, 9--pin) galvanically separated, 3 kV Ethernet IEE 802.3, 100BaseT, CAT5 LC socket (optional) Table 98: protocols Phillips VueLink COM1 Philips Intellibridge COM1 HuLBus COM2 Ethernet Update, Logfiles Mirror UI on external screen leon plus- As at 03.11.2022 - 3.11.13...
  • Page 336 (ISO 80601-2-13:2011); German edition EN ISO 80601-2-13:2012 DIN EN ISO 80601-2-55:2018 Medical electrical devices – Section 2-55: General specifications for safety including essential performance features of monitoring devices for patient gases (ISO 80601-2-55:2018) 3.11.13 - As at 03.11.2022 - leon plus...

  • Page 337: 18. Index

    80 Colour concept ..........48 Battery ......... 70, 178, 199, 252 charge ............ 199 Compliance ......11, 180, 245, 313 failure ............. 199 Compliance compensation ....... 140 Concepts ............. 47 low ............199 leon plus- As at 03.11.2022 - 3.11.13...
  • Page 338 Monitoring calculated values I ....185 sensor ..........273 Monitoring ventilation ......185 sample line ..........272 Control elements ......... 55 soda lime ..........272 data ............. 50 valve diaphragm ........273 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 339 Gas measurement . 61, 62, 83, 144, 187, 188, reaction of the system ......238 197, 259, 316 external supply units ......249 only with FiO2 ........188 flow measurement ......... 260 Gas supply ..........111 leon plus- As at 03.11.2022 - 3.11.13...
  • Page 340 Loops ............191 Mute ............54 Low flow ............ 144 10 min............54 MAC ..........12, 189, 312 2 min............54 Mains connection fuses ......78 Notes ............290 maintenance 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 341 ...... 277 Central gas supply ......... 195 Servicing pressure display insp./exp. valve diaphragms ....267 supply from 10 L bottles......196 reserve gas bottles ........ 269 Pressure display Servicing interval ........275 leon plus- As at 03.11.2022 - 3.11.13...
  • Page 342 ..........191 Window start ............125 System test .. 38, 94, 119, 120, 122, 124, 125, Gas measurement ......... 188 126, 127, 129, 132, 265 Writing shelf ..........33 Execution ..........121 3.11.13 - As at 03.11.2022 - leon plus...
  • Page 343 Short checklist before start-up for leon plus Passed Test Description Yes No Visual monitoring Technical monitoring of damage, completely correct set-up, hygienic cleanliness, suitable accessories, test seal Turn off device Plug in CGS, plug in mains cable Mains supply available (green LED mains connection control lit)
  • Page 344 Short operating instructions Keypad Touch screen leon plus ON + OFF Display mains operation / battery operation Standby (stop ventilation) Select patient category Start of a form of ventilation Preset form of ventilation and parameters Selection fresh gas blender...
  • Page 345 Checklist of technical safety controls Technical safety controls carried out in accordance with DIN EN 62353 by: Company / Department Name of checker Name of device (serial name / inventory number) Passed Mechanical safety Gas connection tubes Keypad Touchscreen Patient module Bag-in-bottle unit absorber Anaesthetic vaporiser...
  • Page 346 Passed Functional safety Check for tightness Alarms LEDs keyboard, audible PEEP valve Ventilation pressure Fresh gas blender Flow Gas concentrations Anaesthetic vaporiser Gas measurement Ratio system N2O cut-off Flush Reserve Switch-over Return flow Batteries Passed Miscellaneous Visual check of external changes Visual check of external faults or damage Check device combinations Labels complete and legible...
  • Page 347 Result of check Remarks on check No technical safety faults Faults were immediately fixed Faults that require servicing Fixable faults; this device may only be used after faults have been fixed. Danger for patients, users or third parties. Name of checker Signature Check date...
  • Page 348 Löwenstein Medical SE & Co. KG Arzbacher Straße 80 56130 Bad Ems/Germany : +49 2603/9600−0 : +49 2603/9600−50 : loewensteinmedical.com Checklist of technical safety controls for leon plus...
  • Page 350 Subject to change As at 03.11.2022 Löwenstein Medical SE & Co. KG Arzbacher Straße 80 56130 Bad Ems/Germany : +49 2603/9600−0 : +49 2603/9600−50 : loewensteinmedical.com User manual leon plus Order no.: Ba-0301v311...

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