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11 Appendix

USB port (optional)

Connection for valve control tube for patient valve

Connection for pressure measuring tube (marked blue)

TYP:

Type designation of the device

IP22

Degree of protection against contact with a finger. Protection against
vertically falling water drops when enclosure tilted up to 15°.

Degree of protection against electric shock: Protection class II product

Do not dispose of the product in domestic waste.

Suitable for use in aircraft. Meets RTCA/DO-160G Section 21, Category M.

Application part type BF

Manufacturer

CE symbol (confirms that the product conforms to the applicable European
directives/regulations)

Permitted temperature range for transport and storage

Permitted humidity range for transport and storage

Reuse on a single patient

Indicates the product is a medical device

Unique device identifier

SYMBOL DESCRIPTION

Содержание prisma VENT30

Страница 1: ...prisma VENT30 prisma VENT30 C prisma VENT40 prisma VENT40 C prisma VENT50 prisma VENT50 C Ventilators EN Instructions for use for patients for devices of type WM110TD and WM120TD...

Страница 2: ...1 3 1 Overview prisma VENT30 prisma VENT30 C prisma VENT40 prisma VENT40 C 11 3 2 Overview prisma VENT50 prisma VENT50 C 12 3 3 Operating states 13 3 4 Control panel 13 3 5 Symbols in the display 14 4...

Страница 3: ...for display of alarms 37 7 2 Deactivating physiological alarms 37 7 3 Muting alarms 37 7 4 Physiological alarms 38 7 5 Technical alarms 40 7 6 Troubleshooting 44 8 Servicing 45 8 1 Safety information...

Страница 4: ...4 EN LMT 68431 09 2021 Contents 11 8 Warranty 61 11 9 Declaration of conformity 61...

Страница 5: ...he signals detected by the pressure and flow sensors The user interface is for displaying and setting the available parameters and alarms The device can be used with both a leakage circuit and also wi...

Страница 6: ...thorax neurological muscular and neuromuscular disorders if inducing respiratory insufficiency e g pareses of the diaphragm central respiratory regulation disorders obstructive sleep apnea OSA obesity...

Страница 7: ...first minutes of therapy or softSTOP inverse pressure ramp when ventilation is switched off Feeling of asphyxiation more difficult exhalation insomnia dyspnea in the mornings Use of HFT mode prisma VE...

Страница 8: ...s HF radiation e g cell phones This also applies to accessories such as antenna cables and external antennas for example Ignoring this requirement may lead to the device exhibiting reduced performance...

Страница 9: ...h cases please be aware that any claim under warranty and liability will be void if genuine replacement parts are not used Have measures such as repairs servicing and maintenance work as well as modif...

Страница 10: ...g on the degree of hazard Warning Indicates an unusually significant hazardous situation If you ignore this instruction severe irreversible or fatal injuries may result Caution Indicates a hazard If y...

Страница 11: ...power supply cable 2 Control panel with display 11 Leakage circuit 3 System interface for connecting modules 12 Latching bores for connecting modules 4 Handle 5 Release catch 13 SD card slot 6 Filter...

Страница 12: ...lay 12 Latching bores for connecting modules 3 System interface for connecting modules 13 SD card slot 4 Handle 14 Connection for tube heater valve control tube and pressure measuring tube 5 Release c...

Страница 13: ...mutes an alarm for 2 minutes 2 LIAM key only present on prisma VENT50 and prisma VENT50 C 3 Dial for navigating in the menu 4 Function keys for switching between the System softSTART softSTOP Ventila...

Страница 14: ...ed Servicing required only if servicing function is activated Humidifier connected but not active gray symbol Humidifier switched on green symbol Humidifier empty orange symbol Pulse rate if pulsoxime...

Страница 15: ...1 segment red Battery capacity below 10 0 segments Battery capacity below 5 Battery fault Low priority alarm triggered Medium priority alarm triggered High priority alarm triggered All physiological a...

Страница 16: ...to the device overheating and 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 direc...

Страница 17: ...an exhalation system are used If non invasive or invasive patient ventilator interfaces without an integrated exhalation system are used CO2 concentration may rise to critical values and put the patie...

Страница 18: ...ilator interface to the leakage circuit see instructions for use for the patient ventilator interface 4 2 2 Connecting single circuit with valve prisma VENT50 and prisma VENT50 C only Risk of injury f...

Страница 19: ...control tube 2 to connection 3 Connect pressure measuring tube 3 to connection 4 Connect patient ventilator interface e g mask to patient valve 4 The device can also be operated with valve ventilatio...

Страница 20: ...T50 C only 1 Push circuit for mouthpiece ventilation 1 onto the device outlet port 2 Connect mouthpiece 2 to the circuit for mouthpiece ventilation see instructions for use for the patient ventilator...

Страница 21: ...ong 3 onto the connection for humidifier chamber 2 marked Out 4 Connect HFT nasal cannula 4 to inspiration tube long 3 5 If necessary connect the tube heater and temperature probe to inspiration tube...

Страница 22: ...display disappears The device switches to standby If the softSTOP function is activated ventilation pressures and background frequency are continuously reduced Remaining time is displayed in the butt...

Страница 23: ...program using the dial Risk of injury when using prismaAQUA integrated humidifier Use of the prismaAQUA integrated humidifier in conjunction with High Flow therapy or on patients with a bypass of the...

Страница 24: ...ecified time This function is suitable for patients who find elevated pressures unpleasant when awake and are unable to fall asleep Requirement The softSTART function is activated by the physician or...

Страница 25: ...efly and remove the SD card 4 11 Use battery optional Your device can optionally be equipped with an internal battery If the device is no longer connected to the power supply or there is a power outag...

Страница 26: ...the device will switch off in a few minutes time less than 5 capacity remaining Keep an alternative ventilation option to hand If device and battery pack have been stored outside the quoted operating...

Страница 27: ...is displayed directly in the display via the key e g System softSTART softSTOP or Ventilation or Report menus or Back menus Turn dial to the left Navigate upward Reduce value Turn dial to the right Na...

Страница 28: ...htness You can change the brightness of the display here End of therapy prisma VENT50 and prisma VENT50 C only Here you can see whether the alarm is activated deactivated at the end of therapy at the...

Страница 29: ...hen changing circuit This process checks for resistance compliance and leaks Humidifier stage You can change the humidifier stage of the humidifier here The setting suitable for you depends on room te...

Страница 30: ...cannot be selected it needs to be enabled by your physician or specialist dealer softSTART EPAP pressure 0 2 hPa increments within the framework specified by the physician or specialist dealer e g at...

Страница 31: ...list Lists the events which have occurred Alarm event list Lists the alarms and events which have occurred in chronological order Trends Access to the trends if these have been enabled via the expert...

Страница 32: ...njury due to contaminated or infected circuit A contaminated or infected circuit may transmit contamination or infections to the next patient Do not reprocess disposable patient circuits Subject reusa...

Страница 33: ...y be damaged by the ingress of liquids Use the circuit only when completely dry If you are using a heatable circuit or a circuit with an active exhalation valve follow the associated instructions for...

Страница 34: ...t by wiping recommended products terralin protect or perform advanced Alcohol EP Not permitted High gloss surfaces on the housing Leakage circuit Disinfect by immersion Recommended product gigasept FF...

Страница 35: ...external damage 3 Check that components are correctly connected to the device 4 Connect the device to the power supply see 4 1 Set up the device page 16 5 Interrupt softSTART if necessary see 4 9 Swi...

Страница 36: ...nnect the device from the power supply An alarm sounds The battery takes over supplying power Connect the device to the power supply The power supply indicator is green 11 If one of the items is not O...

Страница 37: ...logical alarms As the attending physician you can decide which physiological alarms to activate deactivate or mute in the Ventilation menu Various alarms can be configured depending on the ventilation...

Страница 38: ...ding physician Frequency high Maximum respiratory frequency exceeded Have settings checked by attending physician Frequency low Minimum respiratory frequency undershot Have settings checked by attendi...

Страница 39: ...eliminate leak If necessary Replace circuit Patient breathing as well Have settings checked by attending physician Tidal volume low Filter dirty Clean change filter Patient ventilator interface leaki...

Страница 40: ...discharged less than 5 capacity remaining Connect the device to the power supply Battery capacity critical Battery discharged less than 10 capacity remaining Connect the device to the power supply Bat...

Страница 41: ...ched Check tubes Valve control tube kinked Check that valve control tube is not blocked Fault in patient circuit The valve control tube is incorrectly connected between the device and the patient valv...

Страница 42: ...t blocked Fault in patient circuit Single circuit with valve selected No single circuit with valve connected Check tubes If necessary Replace breathing tube Change patient circuit Have settings checke...

Страница 43: ...dule defective or not connected Replace module or connect correctly Clock not set Internal clock not set Have clock set by a specialist dealer so that course of therapy is recorded correctly Device in...

Страница 44: ...n HFT mode Disconnect prismaAQUA from the therapy device and connect external humidifier suitable for HFT FAULT FAULT MESSAGE CAUSE REMEDY No running noise nothing in the display No power supply Check...

Страница 45: ...k Sicherheitstechnische Kontrolle STK every 2 years Country specific requirements apply to all other countries If the device has a battery this must be replaced every 4 years 9 Transport and storage S...

Страница 46: ...s present with domestic waste To dispose of properly contact a licensed certified electronic scrap disposal merchant This address is available from your Environment Officer or from your local authorit...

Страница 47: ...emperature for 4 h before starting up Allow to heat to room temperature for 4 h before starting up Permitted humidity for operation transport and storage Rel humidity 10 to 95 no condensation Air pres...

Страница 48: ...t connection Protection against harmful ingress of solids and water Protection class II Type BF IP22 Classification to IEC 60601 1 Operating mode Continuous duty Application part Device outlet port br...

Страница 49: ...ENT30 C prisma VENT40 prisma VENT40 C prisma VENT50 prisma VENT50 C Tolerance 4 hPa to 30 hPa 4 hPa to 40 hPa 4 hPa to 50 hPa 1 2 hPa 8 of set value PEEP pressure range Tolerance 4 hPa to 25 hPa 1 2 h...

Страница 50: ...ggered when the patient flow exceeds the trigger limit The trigger on exhalation is triggered when the patient flow on inspiration drops to the percentage value of maximum patient flow on inspiration...

Страница 51: ...ques The physiological alarms are triggered 3 breaths after the alarm limit is reached Exception The alarms Pulse high Pulse low SpO2 high and SpO2 low are triggered 3 seconds after the alarm limit is...

Страница 52: ...cular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment Part 2 80 for design with battery and inverter Particular requirements for bas...

Страница 53: ...essure sensor for valve control Outlet for cooling air O2 supply Alternative O2 supply 1 Inlet for ambient air Patient interface Optional bacteria filter Breathing tube Exhalation system Optional humi...

Страница 54: ...0 hPa 3 3 hPa Device with 15 mm circuit humidifier and bacteria filter 15 l min 0 44 hPa 0 51 hPa 30 l min 1 26 hPa 1 35 hPa 60 l min 3 77 hPa 4 05 hPa Device with 15 mm circuit no humidifier and bact...

Страница 55: ...made of wood or concrete or have ceramic tiles laid on them If the floor has a synthetic material laid on it relative humidity must be at least 30 Electrical fast transients bursts to IEC 61000 4 4 2...

Страница 56: ...axis Magnetic fields at power supply frequency should correspond to the values typical of those found in business and hospital environments GUIDELINES AND MANUFACTURER DECLARATION ELECTROMAGNETIC INTE...

Страница 57: ...structions for Use Inlet do not block openings Alternating current Slot for SD card On off key Follow Instructions for Use Outlet GUIDELINES AND MANUFACTURER DECLARATION ELECTROMAGNETIC INTERFERENCE I...

Страница 58: ...of protection against electric shock Protection class II product Do not dispose of the product in domestic waste Suitable for use in aircraft Meets RTCA DO 160G Section 21 Category M Application part...

Страница 59: ...ters WM 29928 Carrying bag WM 29710 SD card WM 29794 Instructions for use for patients WM 68431 Risk of injury from incompatible accessory parts The use of accessories not intended for the ventilator...

Страница 60: ...WM 27790 Inverter 12 V DC AC inverter WM 24616 Inverter 24 V DC AC inverter WM 24617 Set accessories replacement battery pack WM 15876 Micro USB 2 0 connecting cable 2 m black WM 35130 PSG connecting...

Страница 61: ...arranty conditions on request In the event of a claim under warranty contact your specialist dealer 11 9 Declaration of conformity The manufacturer L wenstein Medical GmbH Co KG Kronsaalsweg 40 22525...

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Страница 64: ...LMT 68431 09 2021 EN L wenstein 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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