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11 Annex

T 6

a 0

6/2

11.3 Emission of electromagnetic interference

11.4 Electromagnetic interference immunity

Key performance characteristics of the device

as per ISO 80601-2-72

•

Accuracy of airway pressure

•

Accuracy of the volume delivered in a single breath

•

No faulty setting of ventilation parameters

•

Functionality of alarms

LMT 31582

LUISA, double circuit, heated (i+e), A-shaped adapter,
autofill chamber, 150 cm + 60 cm, 15 mm Ø

Inspiration circuit: 2.03
Inspiration circuit from
patient to device: 2.05
Exhalation circuit: 2.06

LMT 31383

LUISA, double circuit, heated (i+e), A-shaped adapter,
autofill chamber, 150 cm + 60 cm, 22 mm Ø

Inspiration circuit: 0.22
Inspiration circuit from
patient to device: 0.32
Exhalation circuit: 0.37

LMT 31386

LUISA, double circuit, heated (i+e), A-shaped adapter,
autofill chamber, 120 cm + 60 cm, 10 mm Ø

Inspiration circuit: 0.17
Inspiration circuit from
patient to device: 0.16
Exhalation circuit: 0.09

WM 27591

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

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 GHz

Test specifications for the interference immunity of sheathing to
high-frequency wireless communication equipment
IEC 61000-4-3

Table 9 of EN 60601-1-2:2014

Electrical fast transients/bursts to IEC 61000

± 2 kV for power supply cables
± 1 kV for input and output lines

Surge immunity to IEC 61000-4-5

± 1 kV line to line
± 2 kV line to ground

Conducted HF interference to IEC 61000-4-6

3 Vrms
150 KHz to 80 MHz
6 Vrms
in ISM frequency bands between 150 kHz and 80 MHz

Magnetic field at the power supply frequency
(50/60 Hz) to IEC 61000-4-8

30 A/m

Voltage dips/short interruptions and variations in power supply to
IEC 61000-4-11

0 % UT; 250/300 periods

ARTICLE

NUMBER

ARTICLE NAME

FLOW (BTPS)

IN L/MIN

PRESSURE DROP IN

CMH2O

Содержание LUISA

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 51: ......

Страница 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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