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Lowenstein Medical LM150TD Instructions For Use Manual Download Page 37

10 Annex

LM

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37

10.6.2 Scope of delivery for LMT 31390-

1110 LUISA with HFT mode

The parts below are included in the standard scope of 
delivery: 

10.7 Accessories

10.8 Removable parts

Set, documents in accordance with 
Medizinprodukte-
Betreiberverordnung [German law 
governing the owners/operators of 
medical devices]: Medical devices 
manual, handover log

WM 15100

Final inspection log 

LMT 31588

Accessories bag

LMT 31440

PART

ARTICLE NUMBER

Basic device with HFT mode

LMT 31410

Exhalation module (disposable)

LMT 31425

Single circuit with valve, 22 mm Ø

LMT 31382

Power supply unit 

LMT 31569

Power cord

WM 24177

Oxygen connecting bushing 

WM 30669

Set, 12 fine filters

WM 29652

Set, 2 coarse dust filters

WM 29928

Protective bag

LMT 31010

Bag pendant 

LMT 31408

USB flash drive

LMT 31414

Instructions for use

LMT 68651

Final inspection log 

LMT 31588

Accessories bag

LMT 31440

PART

ARTICLE 

NUMBER

Teleflex Iso-Gard breathing system filter 

WM 27591

Oxygen sensor, complete

LMT 31502

Wilasilent Exhalation system

WM 27589

Silentflow 3 Exhalation system

WM 25500

Single circuit with valve, 15 mm Ø 

LMT 31383

Single circuit with valve, 22 mm Ø 

LMT 31382

Double circuit, 15 mm Ø 

LMT 31577

Double circuit, 22 mm Ø 

LMT 31581

Leakage circuit, 15 mm Ø

WM 29988

Leakage circuit, 22 mm Ø

WM 23962

Leakage circuit, autoclavable, 22 mm Ø

WM 24667

Leakage circuit, mouthpiece ventilation 
15 mm Ø

WM 27651

Mobility bag

LMT 31554

PART 

ARTICLE NUMBER

LUISA hospital trolley, consisting of:
- Trolley 2.0 (LMT 31355)
-Set, LUISA plate for trolley 2.0 
(LMT 31371)
-Power supply unit clamp (LMT 31351)
-Water bag holder (LMT 31353)
-Oxygen cylinder clamp (LMT 31352)
-Hinged arm (LMT 31354)

LMT 31370

LUISA Homecare trolley, consisting of:
-Trolley 2.0 (LMT 31355)
-Set, LUISA plate for trolley 2.0 
(LMT 31371)
-Power supply unit clamp (LMT 31351)

LMT 31360

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 bracket for standard rail

LMT 31368

Exhalation module (disposable)

LMT 31404

Exhalation module (autoclavable)

LMT 31413

Spare internal battery for LUISA

LMT 31550

External battery

LMT 31540

Battery charger

LMT 31594

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° tube 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

PART

ARTICLE 

NUMBER

Summary of Contents for LM150TD

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

Page 2: ...f Start and end therapy 14 4 5 Performing circuit test 14 4 6 Calibrating FiO2 cell 14 4 7 Pairing device with LUISA app 15 5 Settings in the menu 16 5 1 Navigating in the menu 16 5 2 Patient menu structure 16 6 Hygiene treatment and servicing 18 6 1 Hygiene treatment 18 6 2 Function check 19 6 3 Checking alarms 20 6 4 Servicing 20 6 5 Disposal 21 7 Alarms 22 7 1 Sequence in which alarms are displ...

Page 3: ...e measured using an integrated FiO2 cell External SpO2 measurement can also be connected The power is supplied by an external power supply unit The device has an integrated battery so it can continue to be operated without interruption in the event of a power outage In addition a maximum of two external batteries can be connected to operate the device Therapy data are stored in the device and can ...

Page 4: ... 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 e...

Page 5: ...uctions 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 2 1 4 Handling oxygen Supplying oxygen without a special safety device can lead to fire and injure people Follow the instructions for use for the oxygen supply system Set up oxygen sources at a distance of over 1 m from ...

Page 6: ...s occurring in conjunction with the product to the manufacturer and to the responsible authority 2 3 Safety information in these instructions for use Indicates an unusually significant hazardous situation If you ignore this instruction severe irreversible or fatal injuries may result Indicates a hazardous situation If you ignore this instruction mild or moderate injuries may result Indicates a har...

Page 7: ...t 15 Intake area for cooling fan 4 Connection for nurse call system 16 Device inlet port 5 Power supply indicator 17 Device outlet port 6 Alarm acknowledgement key 18 Handle 7 Inlet port for pressure measuring tube 19 On off key 8 Inlet port for valve control tube 20 Power supply unit with power supply unit cable 9 Inlet port for SpO2 sensor 21 Power cord 10 CO2 outlet port not in use 22 O2 inlet ...

Page 8: ... to the individual menus 5 Display lock key locks or unlocks the display so that no settings can be changed as a result of incorrect contact 6 Dimmer key switches to night mode and the display goes dark Touch the display to reactivate it Keep key depressed opens the Display menu 7 Program key provides access to the ventilation programs The medical professional or specialist dealer can preconfigure...

Page 9: ...d flashing Calibration process in progress Patient monitor connected Network connection present Green Bluetooth wireless technology activated Gray Bluetooth wireless technology not activated Wireless connection present Flight mode activated Green USB flash drive connected Gray USB flash drive faulty Low priority alarm triggered Medium priority alarm triggered High priority alarm triggered All phys...

Page 10: ...n to hand and connect the device to the power supply If device and battery have been stored outside the quoted operating temperatures the device can only be started up once it has warmed up or cooled down to the permitted operating temperature 3 6 2 External batteries External batteries can be connected to the device as an additional energy supply If the device is connected to the power supply the...

Page 11: ...ate 3 8 3 Setting up a connection to the LUISA app The LUISA app is an app on a mobile terminal The device can be connected to the LUISA app see 4 7 Pairing device with LUISA app page 15 Material damage if incorrectly configured If trolley 2 0 is not used properly it may tip over or be damaged Use the circuit holder only for the circuit Use the water bag holder only for the refill unit of the acti...

Page 12: ... operate device in the vicinity of a radiator Do not expose device to direct sunlight Only operate the device in the associated mobility bag for mobile use Alternatively you can connect a direct voltage electricity supply 12 VDC or 24 VDC as per ISO 80601 2 72 Risk of asphyxia if invasive or non invasive patient ventilator interfaces without an exhalation system are used If invasive or non invasiv...

Page 13: ...ask to Y piece of the circuit see instructions for use for the patient interface 4 2 4 Connecting circuit for HFT mode 1 Push inspiration tube short 1 onto the device outlet port 2 Push the other end of the inspiration tube short 1 onto the inlet port of the humidifier chamber 4 marked In 3 Push the inspiration tube long 3 onto the outlet port of the humidifier chamber 4 marked Out 4 Connect High ...

Page 14: ...r or not the pressure measuring tube is connected to the pressure measuring tube inlet port 4 Connect circuit patient interface e g breathing mask and accessories to the device If present Disconnect the connection to the patient 5 Follow instructions in the display 6 Press the Next key to start the circuit test 7 If the circuit test is successful press the Finish key If the circuit test is not suc...

Page 15: ...ed by the specialist dealer 4 7 Pairing device with LUISA app The LUISA app is an app on a mobile terminal which you can use to read off the patient s therapy data 1 Activate the Bluetooth function in the System Device settings Connectivity menu 2 Select the entry Add new device in the Device list menu 3 Download the app onto a mobile terminal and follow the instructions in the app After pairing t...

Page 16: ...vice status see 3 3 Symbols in display page 9 Scroll in list Navigate up or down Press Value Opens range of values for setting ventilation parameters Move range of values up or down Decrease or increase value Confirm value Discard selection Switches the view back to the start screen ACTION FUNCTION FiO2 cell Export therapy data Alarm list Event list Alarm event list Flight mode Parameter overview ...

Page 17: ...me internal battery life remaining or charging state of internal battery in percent Circuit test Perform a circuit test here on change of patient and as required This checks for resistance compliance and leaks see 4 5 Performing circuit test page 14 FiO2 cell Activate or deactivate the FiO2 cell and calibrate the FiO2 cell here Export therapy data You can export the set device settings here A USB ...

Page 18: ...2 Clean or 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 18 Consult associated instructions for use 3 Perform function check see 6 2 Function check page 19 Cleaning coarse dust filter gray filter 1 Open filter compartment 2 Remove gray coarse dust filter 3 Wash coarse dust filter under runnin...

Page 19: ...y see 4 1 Setting up and connecting device page 12 6 Switch on device see 4 4 Switch device on and off Start and end therapy page 14 The device automatically performs a few function tests on the sensor system If the device is fully functional the start screen is displayed and the device switches to standby 7 Perform a circuit test see menu System Circuit test If the circuit test fails follow the i...

Page 20: ...s set to a value 60 l m On a double circuit 10 mm Alarm limit is set to a value 35 l min Leave inspiration tube open at patient connection Start ventilation Wait at least 30 seconds more alarms may occur during this period Pressure low Low airway pressure low pressure on inspiration 457 Alarm limit is set to a value 6 hPa Leave inspiration tube open at patient connection Start ventilation Exhalati...

Page 21: ...ny 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 The device packaging cardboard and inserts can be disposed of in paper recycling facilities ...

Page 22: ...to be displayed in the status line and the alarm acknowledgement key flashes until the fault has been rectified Mute all acoustic alarms 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 extreme value may make the alarm system unusable and put the patien...

Page 23: ...idal volume low 450 Leakage in circuit Find and eliminate leak If necessary replace circuit Leak in pneumatic unit FiO2 cell or expiration module Check FiO2 cell or expiration module and fit correctly Perform circuit test see 4 5 p 14 Patient breathing as well Check therapy settings Filter dirty Clean change filter Patient ventilator interface leaking Adjust headgear headband so that the patient v...

Page 24: ...xhalation module 463 Exhalation module is not connected to the device correctly or is not connected at all Check exhalation module Disconnection patient 464 Device operated with open patient ventilator interface mask not applied Check circuit and patient ventilator interface Double circuit selected in menu but expiration tube not connected Double circuit selected in menu but single circuit with va...

Page 25: ...1 life at an end Replace battery Life of battery E2 at an end 563 External battery 2 life at an end Replace battery Battery E1 overheated 564 External 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 off due to temperature Operate device at an ambient...

Page 26: ...se alternative ventilation option Energy supply via internal battery 584 Power supply failed Check that the power cord is securely connected Check function of socket External battery and power supply not connected Note remaining battery life see 3 6 3 p 10 If necessary connect power supply No exhalation valve 753 No exhalation system present Check circuit and patient interface Connect exhalation s...

Page 27: ...ange circuit or have the medical professional or the specialist dealer set the connected circuit in the menu Have the medical professional check the settings Leakage circuit selected in menu but single circuit with valve connected Change circuit or have the medical professional or the specialist dealer set the connected circuit in the menu Have the medical professional check the settings Change ci...

Page 28: ... reach flow CheckFiO2 changeflow setting or accessories Set flow cannot be used Upper flow limit Set a lower HFT flow and adjust O2 supply or use accessories with lower resistance Lower flow limit Set a higher HFT flow and adjust O2 supply or use accessories with higher resistance Disconnection patient 465 Device operated with open patient ventilator interface mask not applied Check circuit fit of...

Page 29: ...red connector to ISO 5356 1 Maximum air flow at 20 hPa 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 power input 5 V 1 1 A Power consumption on standby without battery charging Screen brightness 90 Nurse call 230 VAC 0 07 A 48 VDC 0 3 A 24 VDC 0 61 A 12 VDC 1 21 A Maximum 60 VDC 1 A Power consumption during venti...

Page 30: ... electrical devices must only be installed and commissioned in a defined electromagnetic environment with regard to emission and radio interference immunity More information including test parameters and limit values can be obtained from the manufacturer if required EN 55011 B IEC 61000 4 Parts 2 to 6 Part 11 Part 8 IEC 61000 3 Parts 2 and 3 Heating of respiratory air Maximum 3 C Mean sound pressu...

Page 31: ... to 4 s Target volume tidal volume breath volume minute volume averaged over previous 5 breaths Accuracy Most disadvantageous circuit 50 ml Circuit LMT 31383 Most disadvantageous circuit 50 ml Circuit LMT 31382 Increment Range 30 ml to 400 ml pediatric 100 ml to 3000 ml adult 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 to 3000 ml 0 1 l ...

Page 32: ...ent Tolerance 5 l min to 60 l min 5 l min to 25 l min 1 l min 2 l min 20 of set value Fine filter up to 1 µm up to 0 3 µm Filter class E10 99 5 85 Service life of fine filter approx 250 h USB flash drive USB C 3 0 Materials Housing Fine filter Coarse dust filter Circuit Fire retardant technical thermoplastics and silicones stainless steel Polypropylene Polyurethane Polyethylene Wireless module Fre...

Page 33: ...10 Annex LMT 68651c 02 2022 EN 33 10 Annex 10 1 Pneumatic diagram 10 1 1 Leakage circuit 10 1 2 Single circuit with valve ...

Page 34: ...entioned above Maximum error in pressure measurement 0 0125 hPa ARTICLE NUMBER ARTICLE NAME FLOW BTPS IN L MIN PRESSURE DROP IN HPA LMT 31382 LUISA single circuit with valve 180 cm 22 mm Ø 30 0 11 LMT 31383 LUISA single circuit with valve 150 cm 15 mm Ø 30 0 46 LMT 31384 LUISA single circuit with valve heated i autofill chamber 150 cm 60 cm 15 mm Ø 30 2 04 WM 271704 LUISA leakage circuit heated i ...

Page 35: ...ex 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 Complies INTERFERENCE IMMUNITY TESTS COMPLIANCE LEVEL Discharge of static electricity ESD to IEC 61000 4 2 8 kV contact discharge 15 kV air discharge Radiated HF interference to IEC 61000 4 3 3 V m 80 MHz to 2 7 ...

Page 36: ...estic 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 applied part Manufacturer and if necessary date of manufacture Indicates the product is a medical device Permitted temperature range for transport and storage Permitted humidity range for transport and storage...

Page 37: ...m Ø WM 27651 Mobility bag LMT 31554 PART ARTICLE NUMBER LUISA hospital trolley consisting of Trolley 2 0 LMT 31355 Set LUISA plate for trolley 2 0 LMT 31371 Power supply unit clamp LMT 31351 Water bag holder LMT 31353 Oxygen cylinder clamp LMT 31352 Hinged arm LMT 31354 LMT 31370 LUISA Homecare trolley consisting of Trolley 2 0 LMT 31355 Set LUISA plate for trolley 2 0 LMT 31371 Power supply unit ...

Page 38: ...the warranty conditions on request In the event of a claim under warranty contact your specialist dealer 10 10 Declaration of Conformity Löwenstein Medical Technology GmbH Co KG Kronsaalsweg 40 22525 Hamburg Germany the manufacturer hereby declares that the product complies with the relevant regulations of the Medical Device Directive 93 42 EEC The unabridged text of the Declaration of Conformity ...

Page 39: ......

Page 40: ...LMT 68651c 02 2022 EN 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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