Lowenstein Medical LUISA Instructions Manual Download Page 4

2 Safety

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1.5 Side effects

When using the device, the following undesired side effects 
may occur in the short-term or long-term use: Pressure 
points from the mask and the forehead cushion on the face, 
reddening of the facial skin, dry throat, mouth, nose, feeling 
of pressure in the sinuses, irritated conjunctiva in the eyes, 
gastrointestinal insufflation of air ("bloating"), nosebleeds; 
muscular atrophy in the case of long-term ventilation. These 
are general side effects not attributable specifically to use of 
devices of type LM150TD.

2  Safety

2.1 Safety information

2.1.1 Handling the device, the 

components, and the accessories

If the device is damaged or its function is restricted, people 
may be injured.

Only operate the device and its components if they are 
externally undamaged.

Perform a function check at regular intervals 

(see “6.2 

Function check”, page 21)

.

Only operate, store, and transport the device within the 
specified ambient conditions 

(see “10 Technical 

specifications”, page 41)

.

Always keep an alternative means of ventilation 
available in order to avoid a life-threatening situation if 
the device fails.  

Circuit(s) and adaptor(s) may pose choking hazards and 
should be kept out of reach of children.

Do not use the device in an MRI environment or in a 
hyperbaric chamber.

Do not reuse disposables. Disposables may be 
contaminated and/or their function may be impaired.

Do not use or supply anesthetic gases.

Set acoustic alarm volume high enough for the acoustic 
alarm to be heard.

Eliminate leaks on the breathing mask or circuit. In the 
event of unintended leaks, the values displayed for 
volume and exhaled CO

2

 will deviate from actual 

patient values.

Only use accessory parts from the manufacturer. 

Do not use antistatic or electrically-conductive circuits.

The accuracy of the device may be impaired by the gas 
supplied by a pneumatic nebulizer.

Regularly check the breathing system filter for increased 
resistance and blockages. Moistening with nebulizers or 
humidifiers may increase the resistance of breathing 
system filters and thus change the therapeutic pressure 
delivered. In order to prevent increased resistance and 

blockages, replace the breathing system 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 device is subject to special precautions with regard to 
EMC (electromagnetic compatibility). If these precautions 
are not followed, the device may malfunction and individuals 
may be injured.

Portable high-frequency communication equipment 
(e.g. radios and cell phones), including their accessories 
such as antenna cables and external antennas, for 
example, must be used at a distance of at least 30 cm 
from the device and its cables.

Do not use the device in the vicinity of active high-
frequency surgical equipment.

Operate the device within the EMC environment 
specified for this device 

(see “11.4 Electromagnetic 

interference immunity”, page 47)

 in order to prevent 

key performance characteristics being affected - for 
example, ventilation parameters being affected by 
electromagnetic interference.   

Do not operate the device if the housing, cables or other 
equipment for electromagnetic shielding are damaged.

The use of third-party accessories, third-party inverters 
and third-party cables may lead to increased 
electromagnetic interference or reduced 
electromagnetic interference immunity of the device 
and to faulty operation. Only use original connecting 
cables from the manufacturer.

Do not operate the device in the immediate vicinity of 
other devices, otherwise there may be malfunctions. If it 
is necessary to operate the device in the immediate 
vicinity of other devices, keep all the devices under 
observation to ensure that they are all operating 
properly. 

2.1.3 Energy supply

Operating the device outside the specified energy supply 
may injure the user, damage the device or impair the 
performance of the device, and injure the patient.

Operate the power supply unit only at voltages from 
100 V to 240 V.

Use DC cable LMT 31597 for operation on voltages of 
12 V or 24 V.

Keep access to the power supply connector and the 
power supply free at all times.

When using a battery-operated wheelchair: Connect 
the device to the wheelchair battery only if a connection 
of that kind is expressly provided in the instructions for 
use for the wheelchair.

When operating using the cigarette lighter socket in a 
car: Disable the car’s auto start/stop feature. Start the 
car first, then connect the device.

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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