Lowenstein Medical LUISA Instructions Manual Download Page 12

4 Preparation and operation

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4.2.1 Connecting leakage circuit

1. Push the circuit onto the device outlet port.
2. Connect the invasive or non-invasive patient/ventilator 

interface to the leakage circuit (see instructions for use 
for the patient/ventilator interface).

4.2.2 Connecting single circuit with 

valve 

1. Push the free end of the circuit onto the device outlet 

port.  

2. Connect the pressure measuring tube to connection 

.

3. Connect the valve control tube to connection 

4.2.3 Connecting double circuit

1. Push the free end of the circuit 

1

 onto the device outlet 

port. 

2. Push circuit 

3

 onto the device inlet for exhaled air.

3. Connect the pressure measuring tube 

2

 to connection 

4. Connect the patient/ventilator interface (e.g. mask) to 

the Y-piece of the circuit.

4.2.4 Connecting circuit for mouthpiece 

ventilation 

1. Push the free end of the circuit onto the device outlet 

port.

2. Connect mouthpiece to the circuit (see instructions for 

use for the patient/ventilator interface).

Risk of injury if patient valve is covered!

If the patient valve is covered, exhaled air can no longer be 
routed away and the patient will be put at risk. 

Always keep the patient valve free. 

P

As an alternative to the leakage circuit, it is also 
possible to use a single circuit with valve or double 
circuit for mouthpiece ventilation.

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Summary of Contents for LUISA

Page 1: ...US Instructions for Use for devices of type LM150TD Device Firmware Version 1 3 LUISA Ventilators...

Page 2: ...ert menu structure 17 5 5 Configuring and enabling ventilation programs 18 6 Hygiene treatment and servicing 19 6 1 Hygiene treatment 19 6 2 Function check 21 6 3 Checking alarms 21 6 4 Servicing 23 6...

Page 3: ...piratory gas in terms of temperature and humidity The patient connection is made using accessories suitable for HFT HFT mode if available and MPV mode are not respiration support modes within the mean...

Page 4: ...m filter more frequently Set up external humidifiers below the device and the patient connection Water in the device may damage the device or injure the patient 2 1 2 Electromagnetic compatibility The...

Page 5: ...e aware that any claim under warranty and liability will be void if original spare parts are not used Connection by cable to a patient monitor is not a substitute for a remote alarm system Alarm data...

Page 6: ...rnal battery 3 USB C connection 15 Exhalation circuit connection 4 Nurse call system connection 16 Device outlet port 5 Power supply indicator 17 Handle 6 Alarm acknowledgement key 18 On off key 7 Pre...

Page 7: ...switches the view back to the start screen 4 Menu keys provide access to the individual menus 5 Display lock key locks or unlocks the display so that no settings can be changed as a result of incorrec...

Page 8: ...ivated SpO2 sensor Gray Not connected Green Connected and high signal quality Yellow Connected and moderate signal quality Red Connected and poor signal quality FiO2 cell Green Activated and full Gray...

Page 9: ...wer supply the batteries are charged first the internal battery then the external batteries In operation via a 12 V or 24 V supply the batteries are charged only when the device is in the Standby or O...

Page 10: ...o and displayed in the prismaTS software 3 8 2 Updating the firmware In order to perform a firmware update plug a USB flash drive with an update file one version higher than the current version into t...

Page 11: ...damage the device Do not cover device and power supply unit with textiles e g bedclothes Do not operate device in the vicinity of a radiator Do not expose device to direct sunlight Only operate the de...

Page 12: ...the device outlet port 2 Push circuit 3 onto the device inlet for exhaled air 3 Connect the pressure measuring tube 2 to connection 4 Connect the patient ventilator interface e g mask to the Y piece o...

Page 13: ...tart screen is displayed and the device switches to standby 4 5 Starting therapy Requirement Device is set up and connected see 4 1 Setting up and connecting device page 11 Patient ventilator interfac...

Page 14: ...llow the instructions in the display and eliminate the faults 4 8 Calibrating FiO2 cell You can use the optional FiO2 cell to perform continuous FiO2 measurement You must activate the FiO2 cell before...

Page 15: ...not function keys but serve to provide information about device status see 3 3 Symbols in display page 8 Scroll in list Navigate up or down Press Value Opens range of values for setting ventilation p...

Page 16: ...values for the up to 4 ventilation programs which can be configured Device usage Obtain information here about the patient s therapy duration days used program proportions and about device usage opera...

Page 17: ...event list Report Alarms Device settings Ventilation mode Various alarms vary depending on configuration Circuit Circuit Patient type Alarm volume Display p y Language Service timer Views Ventilation...

Page 18: ...a USB C flash drive for example A USB flash drive must be connected for exporting Device settings You can configure the device here see Device settings submenu page 18 Device status Obtain informatio...

Page 19: ...replace the mask circuit coarse dust filter fine filter filter for the cooling air fan and the breathing system filter see 6 1 2 Cleaning intervals page 19 3 Perform function check see 6 2 Function c...

Page 20: ...n the latch counterclockwise to the symbol 2 Remove cover 3 Remove exhalation module 4 Remove membrane from the exhalation module 5 Wipe over exhalation module and membrane with disinfectant Both part...

Page 21: ...the display with the prescribed pressure 10 Check the functionality of the batteries Disconnect the device from the power supply The first external battery if present takes over energy supply watch wh...

Page 22: ...REQUIREMENT TEST ALARM ID NO REQUIREMENT TEST Constant pressure level 758 Set IPAP and EPAP PEEP to the identical pressure level Start ventilation Wait 17 seconds Tidal volume low Volume delivered 45...

Page 23: ...e patient connection Wait 15 breaths Exhalation blocked 757 Double circuit connected Start ventilation Seal off circuit No exhalation valve 753 Leakage circuit connected Remove the exhalation valve fr...

Page 24: ...shows the currently regulated airway pressure over time 7 3 1 Adjustable parameters in S mode PARAMETER ADJUSTABLE VALUES DESCRIPTION CPAP 4 20 cmH2O You can select the pressure level here CPAP in ci...

Page 25: ...evel 3 1 5 cmH2O every breath Pressure increase 1 2 3 4 Set the speed at which IPAP is reached here Level 1 100 cmH2O s Level 2 80 cmH2O s Level 3 50 cmH2O s Level 4 20 cmH2O s Pressure reduction 1 2...

Page 26: ...e 1 2 3 4 Set the speed at which IPAP is reached here Level 1 100 cmH2O s Level 2 80 cmH2O s Level 3 50 cmH2O s Level 4 20 cmH2O s Pressure reduction 1 2 3 4 Set the speed at which pressure is reduced...

Page 27: ...the minimum duration of inspiration for spontaneous breaths here Ti max 0 5 s 4 s Set the maximum duration of inspiration for spontaneous breaths here Ti timed Auto 0 5 s 4 s Set the duration of insp...

Page 28: ...taneous breaths here Ti max 0 5 s 4 s Set the maximum duration of inspiration for spontaneous breaths here Ti timed Auto 0 5 s 4 s Set the duration of inspiration for mandatory breaths here On Auto se...

Page 29: ...i 0 5 4 s Set the fixed inspiration time here Trigger sensitivity on inspiration 1 10 Auto Set trigger sensitivity here 1 Highly sensitive 10 Not very sensitive Auto Device optimizes trigger sensitivi...

Page 30: ...nd by parameters F Ti min Ti max and Ti The graph shows the currently regulated airway pressure over time PARAMETER ADJUSTABLE VALUES DESCRIPTION Volume 100 ml 3 000 ml Set the volume delivered Vt her...

Page 31: ...et the maximum duration of inspiration for spontaneous breaths here Ti 0 5 s 4 s Set the duration of inspiration for mandatory breaths here Trigger sensitivity on inspiration 1 10 Auto Set trigger sen...

Page 32: ...halation here Triggering is effected when the following values are reached by maximum flow 95 Highly sensitive 5 Insensitive Trigger lockout time on inspiration 0 2 s dynamic Trigger signals on inspir...

Page 33: ...spiration 1 10 Set trigger sensitivity here 1 Highly sensitive 10 Not very sensitive Trigger lockout time on inspiration 0 2 s 5 s Trigger signals on inspiration are ignored during the set period Pres...

Page 34: ...for 2 minutes Press and hold alarm acknowledgement key Suspend alarm muting Press alarm acknowledgement key again briefly Risk of injury due to extreme alarm limit settings Alarm limits set to an extr...

Page 35: ...cuit Leak in pneumatic unit oxygen sensor or exhalation module Check oxygen sensor or exhalation module and fit correctly Perform circuit test see 4 7 p 14 Patient breathing as well Check therapy sett...

Page 36: ...or is not connected at all Check circuit connections and exhalation module Disconnection patient 464 Device operated with open patient ventilator interface mask not applied Check circuit connections...

Page 37: ...battery 1 overheated Battery has switched off due to temperature Operate device at an ambient temperature of 5 C to 40 C Battery E2 overheated 565 External battery 2 overheated Battery has switched o...

Page 38: ...k function of socket External battery and power supply not connected Note remaining battery life see 3 6 3 p 9 If necessary Connect power supply No exhalation valve 753 No exhalation valve Check circu...

Page 39: ...ircuit with valve connected Change circuit Have settings checked by attending physician Pressure measuring tube not connected correctly Check tubing Circuit defective Check circuit and connections If...

Page 40: ...ated with open patient ventilator interface mask not applied Check circuit connections and patient ventilator interface at the patient Circuit is not connected to the device correctly or is not connec...

Page 41: ...mm tapered connector to ISO 5356 1 Maximum air flow at 20 cmH2O 220 l min System interface 3 VDC 0 2 A When the prisma HUB device is connected 24 VDC 0 2 A USB C interface Maximum power output No pow...

Page 42: ...munity Medical electrical devices must only be installed and commissioned in a defined electromagnetic environment with regard to emission and radio interference immunity More information including te...

Page 43: ...T 31383 Most disadvantageous circuit 50 ml Circuit LMT 31382 Increment Area 100 ml to 3000 ml 50 ml 4 ml 20 of current value 50 ml 4 ml 15 of current value 5 ml from 30 ml to 100 ml 10 ml from 100 ml...

Page 44: ...C 3 0 Materials Housing Fine filter Coarse dust filter Circuit Fire retardant technical thermoplastics and silicones stainless steel Polypropylene Polyurethane Polyethylene Wireless module Frequency b...

Page 45: ...ensor for patient pressure Optional bacteria filter Patient circuit Leakage system Patient Interface Flow sensor Pressure sensor for monitoring Optional humidifier Pressure sensor for patient pressure...

Page 46: ...ioned above Maximum error in pressure measurement 0 0125 cmH2O ARTICLE NUMBER ARTICLE NAME FLOW BTPS IN L MIN PRESSURE DROP IN CMH2O LMT 31382 LUISA single circuit with valve 180 cm 22 mm 30 0 11 LMT...

Page 47: ...91 Teleflex Iso Gard bacteria filter 2 5 0 06 MEASUREMENTS OF INTERFERENCE EMISSION COMPLIANCE HF emissions to CISPR 11 Group 1 Class B Harmonic distortion Class A Voltage fluctuations and flicker Com...

Page 48: ...n domestic waste Follow the instructions for use IP22 Degree of protection against contact with a finger Protection against vertically falling water drops when enclosure tilted up to 15 P Type BF appl...

Page 49: ...valve 15 mm LMA 91102 Single circuit with valve 22 mm LMA 91101 Double circuit 15 mm LMA 91103 Double circuit 22 mm LMA 91104 Leakage circuit 15 mm LMA 91112 Leakage circuit 22 mm LMA 91113 Leakage ci...

Page 50: ...aluation fee for any returned device as to which no problem is found after its investigation LOEWENSTEIN MEDICAL MUST AGREE THAT THE PRODUCT IS DEFECTIVE HOW DO YOU OBTAIN WARRANTY SERVICE To obtain L...

Page 51: ......

Page 52: ...LMT 68541a 06 2021 EN_US Manufactured for Loewenstein Medical Americas Corp 3340 Peachtree Rd Suite 1800 Atlanta GA 30326 United States of America...

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