Lowenstein Medical LUISA LM150TD Instructions For Use Manual
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Lowenstein Medical LUISA LM150TD Instructions For Use Manual

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EN Instructions for use for patients for devices of type LMT150TD
LUISA
Ventilators

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Summary of Contents for Lowenstein Medical LUISA LM150TD

  • Page 1 EN Instructions for use for patients for devices of type LMT150TD LUISA Ventilators...

  • Page 2: Table Of Contents

    Contents Contents Introduction Settings in the menu 1.1 Intended use ............ 3 5.1 Navigating in the menu ......... 16 1.2 Description of function ........3 5.2 Patient menu structure ........16 1.3 User qualification ..........3 Hygiene treatment and servicing 1.4 Indications ............

  • Page 3: Introduction

    1 Introduction 1 Introduction 1.1 Intended use In High Flow mode (HFT mode), the device pumps the set flow to an external humidifier suitable for HFT. This conditions the respiratory gas in terms of temperature and The LM150TD LUISA ventilator is for the life-support and humidity.

  • Page 4: Indications

    2 Safety 2 Safety As an owner/operator or user, you must be familiar with the operation of this medical device. The device is a medical device which may only be used as specified by the medical professional or the owner/operator. 2.1 Safety information Notice for blind or partially-sighted users 2.1.1 Handling the device, the...

  • Page 5: General Information

    2 Safety 2.1.2 Electromagnetic compatibility  Set up oxygen sources at a distance of over 1 m from the device. The device is subject to special precautions with regard to  The oxygen rate supplied in l/min must not exceed the EMC (electromagnetic compatibility).

  • Page 6: Safety Information In These Instructions For Use

    2 Safety • Follow the section on hygiene treatment (see “6 Hygiene treatment and servicing”, page 18) to avoid infection or bacterial contamination. • In the event of a power outage, all settings including alarm settings are retained. • In the EU: As a user and/or patient, you must report any serious incidents occurring in conjunction with the product to the manufacturer and to the responsible authority.

  • Page 7: Product Description

    3 Product description 3 Product description 3.1 Overview 2 3 4 10 11 Filter compartment with coarse dust filter and Connection for external batteries fine filter Connection for monitor / prisma HUB Compartment for internal battery USB-C port Intake area for cooling fan Connection for nurse call system Device inlet port Power supply indicator...

  • Page 8: Control Panel In Display

    3 Product description 3.2 Control panel in display Status line - symbols indicate current device status (e.g. accessories connected, battery capacity). Alarm acknowledgement key - Press briefly: Acknowledges alarm. If the alarm persists, the alarm is muted for 120 seconds. Press and hold: Mutes all acoustic alarms for 2 minutes.

  • Page 9: Symbols In Display

    3 Product description 3.3 Symbols in display SYMBOL DESCRIPTION SYMBOL DESCRIPTION ® Green: Bluetooth (wireless technology) Device in Patient menu. Expert menu locked. activated. ® Gray: Bluetooth (wireless technology) not Expert menu unlocked. activated. Indicates respiratory status: Wireless connection present. •...

  • Page 10: Operating States

    3 Product description 3.5 Operating states • If the device is not connected to the power supply, a battery powers the device. The external batteries connected are discharged first, followed by the internal • On: Therapy is in progress. It is possible to make device battery.

  • Page 11: Data Management/Compatibility

    3 Product description 3.8.3 Setting up a connection to the LUISA app Material damage if incorrectly configured! The LUISA app is an app on a mobile terminal. The device can If trolley 2.0 is not used properly, it may tip over or be be connected to the LUISA app (see “4.7 Pairing device with damaged.

  • Page 12: Preparation And Operation

    4 Preparation and operation 4 Preparation and operation 4.1 Setting up and connecting device Risk of injury from inadequate therapy if air inlet and air outlet are blocked! A blocked air inlet and/or air outlet can cause the device to overheat, impair therapy, and damage the device.
  • Page 13 4 Preparation and operation 4. Connect the patient interface (e.g., breathing mask) to the circuit (see instructions for use for the patient interface). Risk of injury from incorrectly routed circuits and cables! 4.2.3 Connecting double circuit Incorrectly routed circuits or cables may injure the patient. ...

  • Page 14: Before First Use

    4 Preparation and operation 4.3 Before first use The device is supplied with a charged internal battery. To charge the internal battery fully, leave the device connected to the power supply for at least 1 hour. The device must be configured before being used for the first time.

  • Page 15: Pairing Device With Luisa App

    4 Preparation and operation 3. Press the Ok key to start calibration. 4. If calibration is successful, press the Finish key. If calibration is not successful, follow the instructions in the display and eliminate the faults. 5. Continue O supply. The FiO cell is continuously emptied as a result of contact with oxygen.

  • Page 16: Settings In The Menu

    5 Settings in the menu 5 Settings in the menu 5.1 Navigating in the menu ACTION FUNCTION ACTION FUNCTION Opens range of values for setting Function keys have a gray Press “Value” ventilation parameters background and the function is displayed on the key in text or as a Move range of values Decrease or increase value symbol (e.g.
  • Page 17 5 Settings in the menu 5.2.2 Report menu in the Patient menu 5.2.4 Device settings submenu (usage data) PARAMETER DESCRIPTION Information about the parameters in this menu can be found The patient can set the alarm level here. in the table below. 1= very quiet, 2= quiet, 3= loud, Alarm volume 4= very loud...

  • Page 18: Hygiene Treatment And Servicing

    6 Hygiene treatment and servicing 6 Hygiene treatment and servicing 6.1 Hygiene treatment 6.1.2 Cleaning intervals INTERVAL ACTION Clean device (see “6.1.3 Cleaning device”, Weekly page 18). Clean coarse dust filter (see “Cleaning Risk of infection when the device and accessories are coarse dust filter (gray filter)”, page 18).

  • Page 19: Function Check

    6 Hygiene treatment and servicing 5. Replace coarse dust filter in the holder. 4. Wash filter under running water. 6. Close filter compartment. 5. Allow filter to dry. 6. Replace filter in the holder. Replacing fine filter (white filter) 7. Close exhalation module compartment. 6.2 Function check Carry out a function check before using the device for the first time, after every hygiene treatment, and after every...

  • Page 20: Checking Alarms

    6 Hygiene treatment and servicing 13. If one of the items is not OK or pressure deviates by > 1 14. If required: Check alarms (see “6.3 Checking alarms”, hPa: Do not use device and contact your specialist dealer. page 20).

  • Page 21: Disposal

    6 Hygiene treatment and servicing 6.5 Disposal Do not dispose of the product or any batteries present with domestic waste. To dispose of it properly, contact a licensed, certified electronic waste disposal merchant. This address is available from your Environment Officer or from your local authority.

  • Page 22: Alarms

    7 Alarms 7 Alarms 7.3 Configuring physiological A distinction is made between two types of alarm: Physiological alarms relate to ventilation of the patient. alarms Technical alarms relate to configuration of the device. The technical alarms are active and cannot be configured. All physiological alarms are deactivated on delivery or when 7.1 Sequence in which alarms the device is reset to factory settings.
  • Page 23 7 Alarms DISPLAY CODE CAUSE ACTION Check connection from device to patient interface Leakage high at the patient via the circuit. Leak Check that the patient/ventilator interface is in position correctly. Minute volume high Maximum minute volume exceeded. Check therapy and alarm settings. Minute volume low Minimum minute volume undershot.

  • Page 24: Technical Alarms

    7 Alarms 7.4 Technical alarms DISPLAY CODE CAUSE ACTION Service necessary. Please Technical fault which can only be Contact your specialist dealer. Have device get in touch with your Various eliminated by a specialist dealer. repaired. specialist dealer. Fault on touch display Touch controller has failed.
  • Page 25 7 Alarms DISPLAY CODE CAUSE ACTION Temperature of internal Battery will switch off due to temperature. battery critically high Internal battery too warm. Operate device at an ambient temperature of 5 °C to 40 °C. Internal battery Battery has switched off due to temperature. overheated Internal battery overheated.
  • Page 26 7 Alarms DISPLAY CODE CAUSE ACTION Error internal battery Internal battery defective. communication Contact your specialist dealer. Device defective. Error battery E1 External battery 1 defective. communication Contact your specialist dealer. Device defective. Error battery E2 External battery 2 defective. communication Contact your specialist dealer.
  • Page 27 7 Alarms DISPLAY CODE CAUSE ACTION Error FiO cell Contact your specialist dealer. Have FiO cell cell defective. replaced. No FiO cell Contact your specialist dealer. Have FiO cell No FiO cell fitted. fitted. cell empty Contact your specialist dealer. Have FiO cell cell empty.

  • Page 28: Nurse Call And Remote Alarm

    8 Faults DISPLAY CODE CAUSE ACTION Maximum device Reduce resistance and restart device. If alarm pressure exceeded Resistance on inspiration too high. recurs: Contact your specialist dealer. Maximum device Reduce resistance and restart device. If alarm pressure reached Resistance on inspiration too high. recurs: Contact your specialist dealer.

  • Page 29: Technical Specifications

    9 Technical specifications 9 Technical specifications SPECIFICATION DEVICE Product class to 93/42/EEC Dimensions W x H x D in cm 30 x 13 x 21 Weight 3.8 kg Temperature range - Operation +5 °C to +40 °C - Transport and storage -25 °C to +70 °C - Transport and storage at +70 °C Allow to cool to room temperature for 4 hours before starting...
  • Page 30 9 Technical specifications SPECIFICATION DEVICE Internal/external battery Type Li-ion Nominal capacity 3200 mAh Nominal voltage 29.3 V Energy 93.7 Wh Typical discharge cycles 500 charging cycles Battery capacity is reduced when the device is operated at low temperatures. Operating hours of internal battery assuming following settings: Double circuit, PCV mode, f=20/min, Ti=1 s, PEEP=off, Vt=800 ml ≥...
  • Page 31 9 Technical specifications SPECIFICATION DEVICE EPAP pressure range 4 hPa - 25 hPa Most disadvantageous circuit for leakage ventilation: Circuit WM 29988, Breathing system filter WM 27591 0 hPa - 25 hPa PEEP pressure range Most disadvantageous circuit for valve ventilation: Circuit LMT 31383, Breathing system filter WM 27591 Accuracy of airway pressure ±(2 hPa + 4 % of the set value)
  • Page 32 9 Technical specifications SPECIFICATION DEVICE Speed of pressure drop (in leakage ventilation only) Level 1: 100 hPa/s Adult Level 2: 80 hPa/s Level 3: 50 hPa/s Level 4: 20 hPa/s Level 1: 135 hPa/s Pediatric Level 2: 100 hPa/s Level 3: 80 hPa/s Level 4: 50 hPa/s Maximum permitted flow for oxygen supply 30 l/min...

  • Page 33: Annex

    10 Annex 10 Annex 10.1 Pneumatic diagram 10.1.1 Leakage circuit       $           !  "           % &    #...

  • Page 34: System Resistances

    10 Annex 10.1.3 Double circuit    !         !  $                        ...

  • Page 35: Emission Of Electromagnetic Interference

    10 Annex ARTICLE FLOW (BTPS) ARTICLE NAME PRESSURE DROP IN HPA NUMBER IN L/MIN Inspiration tube: 2.03 LUISA, double circuit, heated (i+e), A-shaped adapter, Inspiration tube from patient LMT 31582 autofill chamber, 150 cm + 60 cm, 15 mm Ø to device: 2.05 Exhalation tube: 2.06 Inspiration tube: 0.22...

  • Page 36: Markings And Symbols

    10 Annex 10.5 Markings and symbols SYMBOL DESCRIPTION Type BF applied part The following symbols may be applied to the device, the device ID plate, accessories or packaging. Manufacturer and, if necessary, date of SYMBOL DESCRIPTION manufacture Pressure measuring tube connection Indicates the product is a medical device Valve control tube connection Permitted temperature range for transport...

  • Page 37: Accessories

    10 Annex PART ARTICLE NUMBER ARTICLE PART NUMBER Set, documents in accordance with LUISA hospital trolley, consisting of: Medizinprodukte- - Trolley 2.0 (LMT 31355) Betreiberverordnung [German law WM 15100 -Set, LUISA plate for trolley 2.0 governing the owners/operators of (LMT 31371) medical devices]: Medical devices LMT 31370 -Power supply unit clamp (LMT 31351)

  • Page 38: Warranty

    10 Annex 10.9 Warranty Löwenstein Medical Technology gives the purchaser of a new original product and of a spare part fitted by Löwenstein Medical Technology a limited manufacturer warranty in accordance with the warranty conditions applicable to the product in question and in accordance with the warranty periods from date of purchase listed below.
  • Page 40 Löwenstein Medical Technology GmbH + Co. KG Kronsaalsweg 40 22525 Hamburg, Germany T: +49 40 54702-0 F: +49 40 54702-461 www.loewensteinmedical.com...

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