Lowenstein Medical LUISA LM150TD Instructions For Use Manual
Ventilator for home environment
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- Instructions for use manual (104 pages) ,
- Instructions for use for patients (40 pages) ,
- Instructions for use manual (40 pages)
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Summary of Contents for Lowenstein Medical LUISA LM150TD
- Page 1 EN-US Instructions for use for patients For devices of type: LM150TD LUISA Ventilator for home environment...
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Page 2: Table Of Contents
Contents Contents 1 Introduction Responding to an alarm ......24 Intended purpose ........Setting alarms..........24 Description of function........ Physiological alarms ........24 User qualification ......... Technical alarms........... 26 Indications ............ Nurse call and remote alarm ...... 28 Contraindications......... 8 Troubleshooting Side effects............ -
Page 3: Introduction
1 Introduction 1 Introduction Intended purpose The blower output is controlled and the therapy pres- sure adjusted on the basis of the signals detected by The LM150TD ventilator is for the life-support and the pressure and flow sensors. non-life-support ventilation of patients who require An external SpO sensor for measuring oxygen satu- mechanical ventilation. -
Page 4: Indications
1 Introduction The device is designed to be operated within arm’s Clinical benefit length. The viewing angle to the display should be at The clinical benefit for the patient is improved ventila- least 30°. tion (improved blood gas values, less effort for the For blind and partially-sighted users strained respiratory muscles). -
Page 5: Safety
2 Safety 2 Safety Safety information erate the device outside the following temperature range: +5 °C to +40 °C. Operating the device out- side of this temperature range or above this alti- 2.1.1 Energy supply tude can adversely affect device performance and Operating the device outside the specified energy result in a deterioration in the patient’s health or in supply may cause personal injury, damage the device... -
Page 6: Safety Information In These Instructions For Use
2 Safety ⇒ Connection by cable to a patient monitor is not a ture exchangers) for increased resistance and substitute for a remote alarm system. Alarm data blockages. To prevent increased resistance and are transmitted only for documentation purposes. blockages, replace breathing system filters and HMEs (heat and moisture exchangers) more fre- 2.1.6 Wireless communication quently. - Page 7 2 Safety CAUTION Indicates a hazardous situation. If you ignore this instruction, mild or moderate injuries may result. NOTE Indicates a harmful situation. If you ignore this instruction, material damage may result. Indicates useful information and hints.
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Page 8: Product Description
3 Product description 3 Product description Overview 2 3 4 7 8 9 10 11 Connection for external batteries Air intake area, patient air Connection for monitor Compartment for internal battery Connection for USB-C Intake area for cooling fan Remote alarm connection Device inlet Power supply indicator Device outlet... -
Page 9: Display
3 Product description Display Status line - symbols indicate current device status (e.g. Dimmer key - the display dims. Touching the display re- accessories connected, battery capacity). activates it. Keep key depressed to open the Display menu. Alarm acknowledgment key - acknowledges and mutes Program key - provides access to the therapy pro- alarms. -
Page 10: Operating States
3 Product description Operating state "On" and therapy not running Symbol Description Change filter (only if function is activated) • It is possible to make device and therapy settings. • The on/off key is illuminated. After 10 minutes without operation, the display goes Service reminder function (only if function is acti- vated) dark. -
Page 11: Data Management/Compatibility
3 Product description If battery capacity alarms are triggered, the device will Trolley 2.0 switch itself off within a few minutes (See Alarms [} 24]). Connect the device to the power supply as soon as any battery capacity alarms go off. Always have an alternative ventilation option ready when the device is on battery supply. -
Page 12: Preparation And Operation
4 Preparation and operation 4 Preparation and operation Setting up and connecting the Connect circuit device WARNING Risk of injury from incorrectly routed circuits 1. Please note the information on electromagnetic and cables! compatibility (EMC) (See Electromagnetic compati- ⇒ Do not run circuits or cables along the pa- bility (EMC) [} 5]). -
Page 13: Before First Use
4 Preparation and operation 4.2.3 Connecting single circuit with valve 2. Connect mouthpiece to the tube (see instructions for use for the patient interface). WARNING 4.2.5 Connecting the circuit for HFT mode Risk of injury from limited disconnection de- tection! WARNING If no proximal pressure measurement is used, a Risk of injury due to suffocation or baro-... -
Page 14: Switch Device On And Off / Start And End Therapy
4 Preparation and operation Switch device on and off / Start and end therapy Action Requirement Operating state achieved Switch on device Device is connected (See Briefly press the on/off key On, therapy not in progress Setting up and connecting on the device. -
Page 15: Supplying Oxygen
4 Preparation and operation WARNING Risk of injury due to burns! There is a risk of fire associated with the enrich- ment of oxygen during oxygen therapy. Oxygen has an oxidizing effect and can accumulate in clothing, bedding and hair. ⇒... -
Page 16: Calibrating The Fio Cell
4 Preparation and operation Calibrating the FiO cell • LMT 31422 Filter holder 4.11 Transferring data with the USB You can use the optional FiO cell to perform continu- ous FiO measurement. You must activate the FiO cell modem before use and calibrate it every 6 weeks. The USB modem establishes a wireless connection be- Calibration can take place during ventilation. -
Page 17: Transmitting Data With The Com Cable For Monitor
4 Preparation and operation 1. Call up menu System > Device settings > Connec- tivity > Modem. 2. Select menu Transmit current data. The number of manual data transmissions per day is limited in the patient menu. 4.12 Transmitting data with the COM cable for monitor The COM cable for monitor is used to transmit data from LUISA ventilators to Philips IntelliVue monitors... -
Page 18: Settings In The Menu
5 Settings in the menu 5 Settings in the menu Navigating in the menu Action Function Press function key Function keys have a gray background and the function is displayed on the key in text or as a symbol, e.g. Start therapy. Symbols on a black background are not function keys, but serve to provide information about device status (See Symbols in display... - Page 19 5 Settings in the menu 5.2.2 Report menu Connectivity Activate and deactivate Blue- tooth. Alarm list Lists the alarms which have Trigger manual data trans- occurred. mission by USB modem. (if modem connected). Event list Lists the events that have oc- curred.
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Page 20: Reprocessing And Maintenance
6 Reprocessing and maintenance 6 Reprocessing and maintenance 6.1.3 Reprocessing the device Reprocessing WARNING WARNING Risk of injury from electric shock! Risk of infection when reusing device and ac- Ingress of liquids may lead to a short-circuit, in- cessories! jure the user, and damage the device. During a change of patient, infections can be ⇒... -
Page 21: Function Check
6 Reprocessing and maintenance 5. Allow filter to air dry. Replacing the fine filter (white filter) 6. Insert filter. 7. Close expiration module compartment. Function check Carry out a function check before using the device for the first time, after every hygiene treatment, and after every repair, but at least every 6 months. - Page 22 6 Reprocessing and maintenance 2. Check whether the symbol in the status line Calibrate FiO cell lights up green. 1. If a FiO cell is in use: Calibrate FiO cell (See Cali- Do not use a functional tester to assess the accuracy brating the FiO2 cell [} 16]).
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Page 23: Maintenance
6 Reprocessing and maintenance Performing a manual alarm test You can perform a manual alarm test to check the acoustic alarm system. 1. Select System > Device settings > Alarm volume > Alarm test. 2. Select volume and press Start key. A signal is played once at the selected volume. -
Page 24: Alarms
7 Alarms 7 Alarms General information 3. Set and confirm the desired value. When doing so, observe the following conditions: The device uses acoustic and visual alarms to alert • Set sensible alarm limits. you to an acute or impending hazard that requires •... - Page 25 7 Alarms Display Code Cause Action Display Code Cause Action Pulse Set pulse rate Check therapy and Minute Minimum Check therapy and high exceeded. alarm settings for volume minute volume alarm settings for plausibility and suit- on exp. on exhalation plausibility and suit- ability for the patient.
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Page 26: Technical Alarms
7 Alarms Technical alarms Display Code Cause Action Tempera- Internal battery Operate the device at Technical alarms relate to configuration of the device. ture of too warm. the following tempera- The technical alarms are active and cannot be config- internal ture: +5 °C to +40 °C. - Page 27 7 Alarms Display Code Cause Action Display Code Cause Action Error in- Ambient temper- Operate the device at Tempera- Ambient temper- Operate the device at ternal ature too high. the following tempera- ture of ature too high. the following tempera- battery ture: +5 °C to +40 °C.
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Page 28: Nurse Call And Remote Alarm
7 Alarms Display Code Cause Action Connec- Connection to Check connection to tion to patient monitor patient monitor. patient disconnected. monitor discon- nected Blower Blower tempera- Operate the device at tempera- ture too high. the following tempera- ture high Cooling air filter ture:+5 °C to +40 °C. -
Page 29: Troubleshooting
8 Troubleshooting 8 Troubleshooting Fault Cause Action No running noise, nothing No power supply. Check connection of device to power supply. Check in the display. socket. Device is unable to reach Coarse dust filter soiled. Clean coarse dust filter. If necessary, replace filter. the set therapy pressure. -
Page 30: Physical Specifications And Classifications.
9 Technical specifications 9 Technical specifications Ambient conditions Temperature range, operation +5 °C to +40 °C Temperature range, transport and storage -25 °C to +70 °C Humidity for operation, transport and stor- Relative humidity 15% to 90%, non-condensing > 35° C to 70° C at a water vapor pressure of up to 50 hPa Air pressure range 700 hPa to 1100 hPa (1100 hPa corresponds to an altitude of 3000... -
Page 31: Power Supply Unit
9 Technical specifications Power supply unit Output voltage/maximum current 48 V DC: 2.7 A Input frequency 50-60 Hz Input voltage/maximum current 100-240 V AC: 2.0 A - 1.0 A (tolerance: -20% + 10%) Therapy All physiological flow and volume values are displayed All other flow and volume values are displayed in in BTPS conditions (target volume, tidal volume, STPD conditions. -
Page 32: Noise
9 Technical specifications Adjustable target volume, adult 100 ml to 3000 ml Increment for the adjustable target volume from 30 ml 5 ml to 100 ml Increment for the adjustable target volume from 100 10 ml ml to 3000 ml Accuracy of the volume measured by the ventilator ≤ ±... -
Page 33: Batteries
9 Technical specifications Batteries Type Li-ion Nominal capacity 3200 mAh Nominal voltage 29.3 V Energy 93.7 Wh Typical discharge cycles Duration of complete battery charge < 6 hours Duration of 80% battery charge < 5 hours Operating time of internal battery ≥ 6 hours with the following settings: Double circuit, mode: PCV, f: 20 min, Ti: 1s, PEEP: Off, Vt: 800 ml, passive lung: Re- sistance R= 5 hPa /(l/s);... - Page 34 9 Technical specifications The SpO sensors listed in these instructions for use have been validated and tested in accordance with ISO 80601-2-61.
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Page 35: Annex
10 Annex 10 Annex 10.1 Pneumatic diagram 10.1.1 Single circuit with valve O₂ supply O₂ Ambient air Patient interface Inspiration Pressure sensor for valve control Pressure sensor for patient pressure Control valves for exhalation system Exhalation Coarse dust O₂ sensor Humidifier Spontaneous Blower... -
Page 36: System Resistances
10 Annex 10.1.2 Double circuit O₂ supply Ambient air O₂ Ambient air Exhalation Exhalation Circuit Patient interface Flow sensor system Inspiration Pressure sensor for valve control Pressure sensor for Control valves for patient pressure exhalation system Coarse dust O₂ sensor Humidifier Spontaneous Breathing system... -
Page 37: Emission Of Electromagnetic Interference
10 Annex • Functionality of alarms The pressure reduction values of the individual com- ponents can be added to form a total resistance value The total pneumatic resistance of the connected cir- that must not exceed the value mentioned above. cuit and of the connected accessories (e.g. -
Page 38: Markings And Symbols
10 Annex Symbol Description High-frequency electromag- 9 to 28 V/m* netic fields in immediate 385 MHz to 5.785 GHz* Type BF application part proximity to wireless com- * tested to IEC munication equipment (IEC 60601-1-2:2020 Table 9 Protect from moisture 61000-4-3) 27 to 84 V/m* 385 MHz to 5.785 GHz*... -
Page 39: Accessories And Spare Parts
10 Annex 10.6.2 Device with HFT mode Part Article no. The parts below are included in the standard scope of Leakage circuit/breathing tube mouth piece WM 27651 supply: ventilation, 15 mm Ø Leakage circuit/ breathing tube, heated (i), WM 271704 Part Article autofill chamber, passive valve, 150 cm + 60... -
Page 40: Warranty
10 Annex Part Article no. SpO₂ sensor size M LMT 31396 SpO₂ sensor size L LMT 31388 Single circuit with valve, heated (i), autofill LMT 31384 chamber, 150 cm + 60 cm, 15 mm Ø Double circuit, heated (i+e), autofill cham- LMT 31583 ber, 150 cm + 60 cm, 22 mm Ø... - Page 44 Manufacturer Löwenstein Medical Technology GmbH + Co.KG Kronsaalsweg 40 22525 Hamburg, Germany T: +49 40 54702-0 F: +49 40 54702-461 www.loewensteinmedical.com 68691b...
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