Related Manuals for Lowenstein Medical prisma VENT30
Summary of Contents for Lowenstein Medical prisma VENT30
- Page 1 EN Instructions for use for patients for devices of type WM110TD and WM120TD prisma VENT30 prisma VENT30-C prisma VENT40 prisma VENT40-C prisma VENT50 prisma VENT50-C Ventilators...
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Page 2: Table Of Contents
2.1 Safety information ..................8 2.2 General information .................. 9 2.3 Warnings in this document ..............10 Product description 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 .................. - Page 3 Contents 4.11 Use battery (optional) ................25 Settings in the menus 5.1 Navigating in the device ................27 5.2 Patient menu ..................28 Hygiene treatment 6.1 General information ................32 6.2 Intervals ....................32 6.3 Hygiene treatment for device ..............33 6.4 Clean air filter (gray filter) ...............
- Page 4 Contents 11.8 Warranty ....................61 11.9 Declaration of conformity ............... 61...
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Page 5: Introduction
1 Introduction 1.1 Intended use WM110TD (prisma VENT30, prisma VENT30-C, prisma VENT40, prisma VENT40-C) Device WM110TD is for ventilating patients with an independent respiratory drive. It can be used on patients who weigh over 10 kg and have respiratory insufficiency. It can be used in both stationary and mobile applications in both domestic and clinical environments. -
Page 6: User Qualifications
1 Introduction 1.3 User qualifications The person operating the device is referred to in these Instructions for Use as the user. A patient is the person receiving the therapy. As an owner/operator or user, you must be familiar with the operation of this medical device. -
Page 7: Side Effects
1 Introduction 1.6 Side effects When using the device, the following undesired side effects may occur in short-term or long-term use: (Allergic) rhinitis, feeling unwell, aerophagia, central sleep apnea, rhinorrhea, headaches, otitis/earache, aerophagia/aspiration, inability to tolerate pressure, anxiety, fatigue, chest complaints. These are general side effects not attributable specifically to use of devices of type WM110TD/WM120TD. -
Page 8: Safety
2 Safety 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. ... -
Page 9: General Information
2 Safety Keep access to the power supply connector and the power supply free at all times. 2.1.3 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. ... -
Page 10: Warnings In This Document
2 Safety 2.3 Warnings in this document Warnings indicate information relevant to safety in front of a step which contains a hazard to persons or objects. There are three levels of warning depending on the degree of hazard: Warning! Indicates an unusually significant hazardous situation. If you ignore this instruction, severe irreversible or fatal injuries may result. -
Page 11: Product Description
3 Product description 3 Product description 3.1 Overview prisma VENT30, prisma VENT30-C, prisma VENT40, prisma VENT40-C 1 Humidifier connection with cover Strain relief for power supply cable 2 Control panel with display Leakage circuit 3 System interface for connecting modules 12... -
Page 12: Overview Prisma Vent50, Prisma Vent50-C
3 Product description 9 Connection for power supply cable connector (option) 3.2 Overview prisma VENT50, prisma VENT50-C 1 Humidifier connection with cover Single circuit with valve 2 Control panel with display Latching bores for connecting modules 3 System interface for connecting modules 13 SD card slot 4 Handle Connection for tube heater, valve... -
Page 13: Operating States
3 Product description 10 Strain relief for power supply cable 3.3 Operating states On: Therapy is running. • • Standby: Blower is off, but immediately operational if the on/off key is pressed briefly. Settings can be made on the device when it is in standby mode. Off: The device is switched off. -
Page 14: Symbols In The Display
3 Product description 3.5 Symbols in the display SYMBOL DESCRIPTION Device in patient mode. Expert menu locked. Device in expert mode (device enabled) Leakage circuit connected (prisma VENT50 and prisma VENT50-C only). Single circuit with valve connected (prisma VENT50 and prisma VENT50-C only). - Page 15 3 Product description SYMBOL DESCRIPTION AirTrap Control switched on. LIAM activated (prisma VENT50 and prisma VENT50-C only). 5 segments green: Battery capacity above 85 % 4 segments green: Battery capacity above 65 % 3 segments green: Battery capacity above 45 % 2 segments green: Battery capacity above 25 % 1 segment orange: Battery capacity below 25 % 1 segment red: Battery capacity below 10 %...
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Page 16: Preparation And Operation
4 Preparation and operation 4 Preparation and operation 4.1 Set up the device Material damage from overheating! Excessive temperatures may lead to the device overheating and damage the device. Do not cover device and power supply unit with textiles (e.g. bedclothes). ... -
Page 17: Connecting Circuit
4 Preparation and operation 4.2 Connecting circuit Risk of injury from incompatible accessory parts! The use of accessories not intended for the ventilator described may put the patient at risk. Only use accessory parts intended for use with the ventilator described. Risk of asphyxia if non-invasive or invasive patient/ventilator interfaces without an exhalation system are used! If non-invasive or invasive patient/ventilator interfaces without an integrated... - Page 18 4 Preparation and operation 4.2.1 Connecting leakage circuit 1. Push leakage circuit onto the device outlet port. 2. Connect the non-invasive or invasive patient/ventilator 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 from re-inhaling CO If the patient valve is covered, exhaled air can no longer be routed away and the...
- Page 19 4 Preparation and operation 1. Push the free end of single circuit with valve 1 onto the device outlet port. 2. Connect valve 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 ventilation without pressure being measured at the patient.
- Page 20 4 Preparation and operation 4.2.3 Connect patient circuit for mouthpiece ventilation (prisma VENT50 and prisma VENT50-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 interface).
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Page 21: Before First Use
4 Preparation and operation 4.2.4 Connecting HFT circuit (prisma VENT40-C and prisma VENT50-C only, in conjunction with a humidifier suitable for HFT) 1. Push inspiration tube (short) 1 onto the device outlet port. 2. Push the other end of inspiration tube (short) 1 onto the connection for humidifier chamber 2 marked In. -
Page 22: Start Therapy
4 Preparation and operation 4.4 Start therapy Requirement • Device is set up and connected (see "4.1 Set up the device", page 16). • Patient/ventilator interface is connected (see Instructions for Use for patient/ ventilator interface) 1. If the display is dark: Press on/off key briefly. -
Page 23: Set Humidifier
4 Preparation and operation 4.6 Set humidifier 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 upper respiratory tract may put patients at risk. ... -
Page 24: Liam (Prisma Vent50, Prisma Vent50-C Only)
4 Preparation and operation 4.8 LIAM (prisma VENT50, prisma VENT50-C only) LIAM (Lung Insufflation Assist Maneuver) supports the cough process or sigh ventilation. Requirement • Therapy is running, • LIAM has been enabled by the physician. 1. Press the LIAM key The device switches to LIAM mode and the process is started to synchronize with the next inspiration. -
Page 25: Use Sd Card (Optional)
4 Preparation and operation 4.10 Use SD card (optional) If an SD card is present, the device automatically saves the therapy data to the SD card. An SD card is not required to operate the device. Therapy data and settings are also stored inside the device (maximum 14 days). - Page 26 4 Preparation and operation 4.11.1 General information • Battery running time depends on ventilation settings and ambient temperature. • When planning your time, take account of the fact that battery running time is considerably reduced at low or very high outdoor temperatures. •...
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Page 27: Settings In The Menus
5 Settings in the menus 5 Settings in the menus 5.1 Navigating in the device RESULT ACTION IN THE MENU WITHIN A MENU ITEM Press function key Function is displayed directly in the display via the key (e.g. System, softSTART/softSTOP or Ventilation or Report menus or Back menus). -
Page 28: Patient Menu
5 Settings in the menus 5.2 Patient menu 5.2.1 Patient menu structure System Report Alarm volume Alarm list End of therapy* Event list Brightness Alarm/event list Circuits Trends** Humidifier stage Parameter summary Device usage Autostart Device status Filter timer Date/time Ventilation Device status Varies depending on... - Page 29 5 Settings in the menus Here you can see which patient circuit is being used and perform the tube test. The O supply must be switched off during the tube test. Patient circuits For the accuracy of therapy, it is helpful to conduct this test when changing circuit.
- Page 30 5 Settings in the menus 5.2.4 Patient menu - softSTART/softSTOP To call up the softSTART/softSTOP menu, the device must be on standby. If enabled by the physician or specialist dealer, the following parameters can be set here: ADJUSTABLE PARAMETER DESCRIPTION VALUES 5-minute increments Here you can set the time for which...
- Page 31 5 Settings in the menus 5.2.5 Patient menu - Report (usage data) Information about the parameters in this menu can be found in the table below. For more information about navigating through the menu: See "5.1 Navigating in the device", page 27. PARAMETER DESCRIPTION Alarm list...
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Page 32: Hygiene Treatment
6 Hygiene treatment 6 Hygiene treatment Risk of infection when the device is used again! If the device is used by several patients, infections may be transmitted. Do not reuse disposables. Use a bacteria filter when the device is used for several patients. Risk of injury due to contaminated or infected circuit! A contaminated or infected circuit may transmit contamination or infections to the next patient. -
Page 33: Hygiene Treatment For Device
6 Hygiene treatment 6.3 Hygiene treatment for device Risk of injury from electric shock! Ingress of liquids may lead to a short-circuit, injure the user and damage the device. Disconnect the device from the power supply before the hygiene treatment. ... -
Page 34: Clean Air Filter (Gray Filter)
6 Hygiene treatment 6.3.2 Extended hygiene treatment on change of patient 1. Replace air filter, pollen filter, and bacteria filter. 2. Reprocess the device and components in accordance with the table below: PART DISINFECTING STERILIZATION Housing including device outlet Disinfect by wiping port/inlet, power cord (recommended products: Not permitted... -
Page 35: Replace Pollen Filter (White Filter)
6 Hygiene treatment 6.5 Replace pollen filter (white filter) 1. Remove air filter 1. 2. Replace white pollen filter 2. 3. Replace air filter 1 in the holder. 6.6 Function check Carry out a function check after every hygiene treatment and repair, but at least every 6 months. - Page 36 6 Hygiene treatment 10. If there is an internal battery: • Disconnect 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.
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Page 37: Alarms And Faults
7 Alarms and faults 7 Alarms and faults A distinction is made between two types of alarm: Physiological alarms relate to ventilation of the patient. Technical alarms relate to configuration of the device. All physiological alarms are deactivated on delivery or when the device is reset. The technical alarms are active and cannot be configured. -
Page 38: Physiological Alarms
7 Alarms and faults 2. Mute all acoustic alarm signals for 2 minutes: Press and hold alarm acknowledgment key 7.4 Physiological alarms DISPLAY CAUSE ACTION Apnea No spontaneous breathing Have settings checked by attending within set time. physician. Pressure high Have settings checked by attending Maximum pressure exceeded. - Page 39 7 Alarms and faults DISPLAY CAUSE ACTION Maximum alarm setting for high Have settings checked by attending patient's oxygen saturation physician. exceeded. Patient/ventilator interface Check patient/ventilator interface faulty or defective. and replace if necessary. Oxygen supply faulty or inadequate. Ventilation parameter settings not suitable.
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Page 40: Technical Alarms
7 Alarms and faults 7.5 Technical alarms DISPLAY CAUSE ACTION Service necessary. Technical fault which can only Please get in touch be eliminated by an Have device repaired. with your specialist authorized specialist dealer. dealer/contact. Battery defective. Battery defective. Have battery replaced. Service necessary. - Page 41 7 Alarms and faults DISPLAY CAUSE ACTION Circuit is not connected to the Permanent device correctly or is not disconnection; check Check connection from device to connected at all. breathing tube and patient/ventilator interface at the Device operated with open patient connection patient via the circuit.
- Page 42 7 Alarms and faults DISPLAY CAUSE ACTION Circuit is not connected to the device correctly or is not Check connection from device to Disconnection. connected at all. patient/ventilator interface at the Check breathing tube Device operated with open patient via the circuit. and patient patient/ventilator interface connection...
- Page 43 7 Alarms and faults DISPLAY CAUSE ACTION Battery not charging due to Operate device at an ambient excessive temperature Battery too hot. temperature of 5 °C to 40 °C. Internal battery not Operate device at an ambient charging - too cold Battery too cold.
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Page 44: Troubleshooting
7 Alarms and faults DISPLAY CAUSE ACTION HFT MODE ONLY Upper flow limit: set a lower HFT Flow rate cannot be flow rate and adjust O supply or achieved. use accessories with lower Check FiO , change resistance. Set flow rate cannot be used. flow rate setting or Lower flow limit: set a higher HFT accessories. -
Page 45: Servicing
8 Servicing 8 Servicing 8.1 Safety information Risk of injury from modified ME equipment! An unauthorized modification to the ME equipment may put the patient at risk. Do not modify the device without the manufacturer’s consent. If the device is modified, carry out the relevant investigations and tests 8.2 General information •... -
Page 46: Disposal
10 Disposal 10 Disposal Do not dispose of the product or any batteries 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 authority. -
Page 47: Appendix
11 Appendix 11 Appendix 11.1 Technical data 11.1.1 Device DEVICE DEVICE prisma VENT30, prisma VENT50 prisma VENT30-C, SPECIFICATION prisma VENT50-C prisma VENT40, prisma VENT40-C Product class to MDR (EU) 2017/745 Dimensions W x H x D in cm 21.8 x 17.5 x 21.8 Weight 2.4 kg... - Page 48 11 Appendix DEVICE DEVICE prisma VENT30, prisma VENT50 prisma VENT30-C, SPECIFICATION prisma VENT50-C prisma VENT40, prisma VENT40-C Internal battery (if present) Li-ion - Type - Nominal capacity 3,100 mAh - Nominal voltage 39.6 V - Nominal power 121 Wh - Typical discharge cycles...
- Page 49 IEC 60601-1-8 for all alarm conditions (high, medium, low priority) Level 4: 80 dB(A) ±5 dB(A) IPAP pressure range prisma VENT30, prisma VENT30-C 4 hPa to 30 hPa prisma VENT40, prisma VENT40-C 4 hPa to 40 hPa prisma VENT50, prisma VENT50-C...
- Page 50 11 Appendix DEVICE DEVICE prisma VENT30, prisma VENT50 prisma VENT30-C, SPECIFICATION prisma VENT50-C prisma VENT40, prisma VENT40-C Leakage ventilation: 4 hPa; pressure control PWmin (minimum therapy pressure) Valve ventilation: 0 hPa Respiratory frequency 0 to 60 bpm Precision ± 0.5 bpm Increment 0.5 bpm...
- Page 51 11 Appendix DEVICE DEVICE prisma VENT30, prisma VENT50 prisma VENT30-C, SPECIFICATION prisma VENT50-C prisma VENT40, prisma VENT40-C 5 to 60 l/min HFT flow rate range Increment: 1 l/min Pollen filter Filter class E10 up to 1 µm ≥ 99.5 % up to 0.3 µm...
- Page 52 11 Appendix Devices of types WM110TD and WM120TD use the following open source software: FreeRTOS.org The software of this device contains code which is subject to the GPL. You can obtain the source code and the GPL on request. Standards applied •...
- Page 53 11 Appendix Single circuit with valve *Alternative O supply* supply Pressure sensor for patient pressure Patient interface Pressure sensor for valve control Switching valves for exhalation system Inlet for ambient air Optional Optional Optional Breathing Exhalation Air filter Blower Flow sensor humidifier bacteria filter humidifier...
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Page 54: Emission Of Electromagnetic Interference
11 Appendix 11.1.3 System resistances prisma VENT30, prisma prisma VENT50, prisma VENT50-C VENT30-C, prisma VENT40, prisma Single circuit with valve Leakage circuit VENT40-C Flow Exhalation Inspiration Exhalation Inspiration Exhalation Inspiration Device with 22 mm circuit and humidifier 15 l/min 0.3 hPa 0.4 hPa... -
Page 55: Electromagnetic Interference Immunity
11 Appendix 11.3 Electromagnetic interference immunity GUIDELINES AND MANUFACTURER DECLARATION - ELECTROMAGNETIC INTERFERENCE IMMUNITY The device can be used in both static and mobile operation, in both domestic and appropriate hospital environments. In a domestic environment, the device may cause radio interference, possibly making it necessary to take suitable remedial measures, such as realigning the device, for example. -
Page 56: Electromagnetic Interference Immunity For Me Equipment And Me Systems
11 Appendix GUIDELINES AND MANUFACTURER DECLARATION - ELECTROMAGNETIC INTERFERENCE IMMUNITY The device can be used in both static and mobile operation, in both domestic and appropriate hospital environments. In a domestic environment, the device may cause radio interference, possibly making it necessary to take suitable remedial measures, such as realigning the device, for example. -
Page 57: Markings And Symbols
11 Appendix GUIDELINES AND MANUFACTURER DECLARATION - ELECTROMAGNETIC INTERFERENCE IMMUNITY The device can be used in both static and mobile operation, in both domestic and appropriate hospital environments. In a domestic environment, the device may cause radio interference, possibly making it necessary to take suitable remedial measures, such as realigning the device, for example. - Page 58 11 Appendix SYMBOL DESCRIPTION USB port (optional) Connection for valve control tube for patient valve Connection for pressure measuring tube (marked blue) TYP: Type designation of the device Degree of protection against contact with a finger. Protection against IP22 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.
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Page 59: Scope Of Supply
The parts below are included in the standard scope of supply: PART ITEM NUMBER Varies depending on Basic device device. Leakage circuit (prisma VENT30, prisma VENT30-C, WM 23962 prisma VENT40, prisma VENT40-C) Single circuit with valve (prisma VENT50, prisma WM 27181 VENT50-C) - Page 60 11 Appendix ARTICLE PART NUMBER Single circuit with valve, 15 mm Ø WM 29988 HYBERNITE heatable circuit WM 29083 Leakage circuit for mouthpiece ventilation 15 mm Ø WM 27651 WILAsilent exhalation valve WM 27589 Teleflex Iso-Gard breathing system filter WM 27591 Set, 12 pollen filters WM 29652 Set, 2 air filters...
- Page 61 11 Appendix 11.8 Warranty Löwenstein Medical gives the customer a limited manufacturer warranty on a new genuine Löwenstein Medical product and on any replacement part fitted by Löwenstein Medical in accordance with the warranty conditions applicable to the product in question and in accordance with the warranty periods from date of purchase listed below.
- Page 64 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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