Lowenstein Medical LUISA Instructions Manual Download Page 49

11 Annex

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11.7 Accessories

11.8 Removable parts

11.9  Limited Warranty

Loewenstein Medical Americas Corp. (Loewenstein Medical) 
warrants that your product will be free from defects of 
workmanship and materials and will perform in accordance 
with the product specifications for the respective warranty 
period (the Warranty Period) specified for each product 
below (the Limited Warranty). 

This Limited Warranty gives you specific legal rights, and you 
may also have other rights which vary from state to state. 
This Limited Warranty is given in lieu of all other express 
warranties. You are cautioned that no person or entity is 
authorized to make any warranties on behalf of Loewenstein 
Medical, and any such alleged warranties are hereby 
disclaimed by Loewenstein Medical. 

WHAT DOES THIS WARRANTY NOT COVER?

This Limited Warranty does not cover any damage due to: (a) 
transportation; (b) storage; (c) improper use; (d) any damage 
caused by exposure to ozone, activated oxygen or other 
gases; (e) failure to follow the product instructions or 
perform preventive maintenance or regular cleaning; (f) 
modifications; (g) unauthorized repair; (h) normal wear and 
tear; (i) any damage or contamination due to cigarette, pipe, 
cigar or other smoke; (j) environmental conditions (including 
but not limited to water, flame, chemicals, fumes in the 
atmosphere, extreme heat or cold, food or liquid, sand, dirt 
or the like); (k) damage during the return merchandise 
authorization process; or (l) external causes such as 
accidents, abuse, or other actions or events beyond 
Loewenstein Medical’s reasonable control. 

PART

ARTICLE 

NUMBER

Teleflex Iso-Gard breathing system filter 

WM 27591

Oxygen sensor, complete

LMT 31502

Leakage exhalation valve

LMA 91115

Silentflow 3 exhalation valve

WM 25500

Single circuit with valve, 15 mm Ø 

LMA 91102

Single circuit with valve, 22 mm Ø 

LMA 91101

Double circuit, 15 mm Ø 

LMA 91103

Double circuit, 22 mm Ø 

LMA 91104

Leakage circuit, 15 mm Ø

LMA 91112

Leakage circuit, 22 mm Ø

LMA 91113

Leakage circuit, 22 mm Ø with breathing
system filter and leakage exhalation valve

LMA 91106

Leakage circuit, 22 mm Ø without
breathing system filter and with leakage
exhalation valve

LMA 91107

Leakage circuit, 15 mm Ø with breathing
system filter and with leakage exhalation
valve

LMA 91108

Leakage circuit, 15 mm Ø without
breathing system filter and with leakage
exhalation valve

LMA 91109

Leakage circuit, mouthpiece ventilation 
15 mm Ø

WM 27651

Heated circuit

LMA 91116

prismaVENT Aqua 115V

LMA 91120

Mobility bag

LMT 31554

Trolley 2.0

LMT 31355

Power supply unit clamp for trolley 2.0

LMT 31351

Water bag holder for trolley 2.0

LMT 31353

Oxygen cylinder clamp for trolley 2.0

LMT 31352

Hinged arm for trolley

LMT 31354

Set, LUISA mounting plate

LMT 31359

Set, LUISA plate for trolley 2.0

LMT 31371

Wall clamp for ISO rail

LMT 31368

Exhalation module (disposable)

LMT 31404

Exhalation module (autoclavable)

LMT 31413

Replacement internal battery for LUISA

LMT 31550

External battery

LMT 31540

Battery charger

LMT 31594US

VENTI

remote 

alarm,

 

10 m 

LMT 31560

VENTI

remote 

alarm,

 

30 m

LMT 31570

Cable, 10 m, nurse call for LUISA

LMT 31510

Cable, 30 m, nurse call for LUISA

LMT 31520

CD-ROM with prismaTS software

WM 93331

USB flash drive

LMT 31414

COM cable for monitor

LMT 31578

Set, 90° circuit adapter

LMT 15984

Cable, 12 V/24 V, vehicle/FCC 

LMT 31597

SpO

2

 sensor, size S

LMT 31580

SpO

2

 sensor, size M

LMT 31396

SpO

2

 sensor, size L

LMT 31388

Cable, SpO

2

/Xpod sensor

LMT 31593

PART

ARTICLE NUMBER

Filter holder

LMT 31422

Exhalation module cover

LMT 31481

Exhalation module (disposable)

LMT 31425

Set, exhalation module (can be 
subjected to hygiene treatment)

LMT 15961

Exhalation module orifice

LMT 31574

PRODUCT

WARRANTY 

PERIODS

Devices including accessories 

2 years

Batteries

6 months

PART

ARTICLE 

NUMBER

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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