Lowenstein Medical prisma VENT30 Instructions For Use Manual
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Lowenstein Medical prisma VENT30 Instructions For Use Manual

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EN Instructions for Use for devices of type WM 110 TD and WM 120 TD
prisma VENT30
prisma VENT30-C
prisma VENT40
prisma VENT50
Ventilators

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Summary of Contents for Lowenstein Medical prisma VENT30

  • Page 1 EN Instructions for Use for devices of type WM 110 TD and WM 120 TD prisma VENT30 prisma VENT30-C prisma VENT40 prisma VENT50 Ventilators...

  • Page 2: Table Of Contents

    Contents Contents Introduction 1.1 Intended use ..................... 4 1.2 Description of function ................4 1.3 User qualifications ..................4 1.4 Indications ....................5 1.5 Contraindications ..................5 1.6 Side effects ....................5 Safety 2.1 Safety information ..................6 2.2 General information .................. 7 2.3 Warnings in this document ...............
  • Page 3 Contents 5.1 Navigating in the device ................23 5.2 Menu structure ..................23 5.3 System menu (device settings) ..............24 5.4 Ventilation menu (ventilation settings) ............ 25 5.5 softSTART/softSTOP menu ..............25 5.6 Report menu (usage data) ............... 26 Hygiene treatment 6.1 General information ................

  • Page 4: Introduction

    1 Introduction 1 Introduction 1.1 Intended use WM 110 TD Device WM 110 TD 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 5: Indications

    1 Introduction When the device is handed over to the patient, the attending physician or hospital staff must instruct the patient in the function of the device. 1.4 Indications Obstructive ventilation disorders (e.g. COPD), restrictive ventilation disorders (e.g. scolioses, deformities of the thorax), neurological, muscular, and neuromuscular disorders (e.g.

  • Page 6: 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 7: General Information

    2 Safety  Only transport the device with the cover fitted.  Transport or store the device in the associated carrying bag. 2.2 General information • The use of third-party articles may lead to incompatibility with the device. In such cases, please be aware that any claim under warranty and liability will be void if genuine replacement parts are not used.

  • Page 8: Product Description

    3 Product description 3 Product description 3.1 Overview 3.1.1 prisma VENT30, prisma VENT30-C, prisma VENT40 1 Humidifier connection with cover 2 Control panel with display 3 System interface for connecting modules 4 Handle 5 Release catch 6 Filter compartment with air filter and pollen filter...
  • Page 9 3 Product description 9 Connection for power supply cable 10 Strain relief for power supply cable 11 Breathing tube with connection for breathing mask 12 Latching bores for connecting modules 13 SD card slot 14 Connection for tube heater 15 Device outlet port 16 Power cord 17 SD card 18 O...

  • Page 10: Operating States

    3 Product description 2 Control panel with display 3 System interface for connecting modules 4 Handle 5 Release catch 6 Filter compartment with air filter and pollen filter 7 Cooling air opening supply 9 Connection for power supply cable 10 Strain relief for power supply cable 11 Breathing tube with active valve 12 Latching bores for connecting modules 13 SD card slot...

  • Page 11: Control Panel

    3 Product description 3.3 Control panel Enter 1 Alarm acknowledgment key - mutes an alarm for 2 minutes 2 LIAM key (only present on prisma VENT50) 3 Dial for navigating in the menu 4 Function keys for switching between the System, softSTART/softSTOP, Ventilation or Report menus and the Back function 5 Monitor key for switching between different screen views 6 Home key - switches the view back to the start screen, provides access to the...
  • Page 12 3 Product description SYMBOL DESCRIPTION Set tube diameter 15 mm (prisma VENT30, prisma VENT30-C, prisma VENT40 only) Set tube diameter 22 mm (prisma VENT30, prisma VENT30-C, prisma VENT40 only) Device on standby. The blower is off. Air filter change required (only if filter function is activated).
  • Page 13 3 Product description SYMBOL DESCRIPTION 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 % 0 segments: Battery capacity below 5 % Battery fault...

  • Page 14: Accessories

    3 Product description 3.5 Accessories 1 Humidifier 2 Inverter 3 Breathing tube with 15 mm/22 mm diameter 4 Communication module prismaCONNECT module - links the device and a PC or the PSG module. 5 SpO and nurse call module prisma CHECK - links the device to a call system and determines SpO and pulse frequency data.

  • Page 15: 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 16: Connect The Breathing Tube

    4 Preparation and operation 4.2 Connect the breathing tube 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 exhalation system are used, CO concentration may rise to critical values and put the patient at risk.
  • Page 17 4 Preparation and operation 4.2.2 Connect breathing tube with patient valve (prisma VENT50 only) Risk of injury if patient valve is covered! If the patient valve is covered, exhaled air can no longer be taken away and the patient will be put at risk. ...

  • Page 18: Before First Use

    4 Preparation and operation 4.2.3 Connect patient circuit for mouthpiece ventilation 1. Push the free end of breathing tube 1 onto the device outlet port. 2. Connect mouthpiece 2 to the breathing tube (see Instructions for Use for the patient/ventilator interface). As an alternative to leakage ventilation, it is also possible to use a breathing tube with patient valve for mouthpiece ventilation.

  • Page 19: End Therapy/Switch Off Device

    4 Preparation and operation 2. Press on/off key briefly. If the Autostart function is activated: Breathe into the patient/ventilator interface. Therapy starts. If the softSTART function is activated in the selected program, therapy automatically starts with softSTART. For more information on Autostart: See "5 Settings in the menus", page 23.

  • Page 20: Liam (Prisma Vent50 Only)

    4 Preparation and operation Risk of injury from the use of incorrect ventilation programs Use of ventilation programs which have not been configured for an individual can lead to incorrect therapy and put the patient at risk.  Only use ventilation programs if they have been configured for the patient in question.

  • Page 21: Use Sd Card (Optional)

    4 Preparation and operation 1. Start therapy (see "4.4 Start therapy", page 18). Therapy automatically starts with softSTART. Remaining time is displayed in the button bar in minutes and seconds 2. Press the softSTART/softSTOP key (center function key 4) to switch off softSTART. 3.

  • Page 22: Use Battery (Optional)

    4 Preparation and operation If you wish to send away the SD card: Mark the SD card with name and date of birth to prevent confusion when it reaches the physician or specialist dealer. 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 outage, the battery automatically starts supplying the device.

  • Page 23: Settings In The Menus

    Select menu item Confirm set value Press Home key Back to start screen Press Monitor key Switches between different screen views. 5.2 Menu structure prisma VENT30 prisma VENT30-C prisma VENT50 prisma VENT40 Alarm volume Alarm volume Alarm list End of therapy...

  • Page 24: System Menu (Device Settings)

    Here you can see whether the alarm is activated/ (prisma VENT50 only) deactivated at the end of therapy/if softSTOP is triggered. Tube - Ø (prisma VENT30, prisma You select the tube diameter used here. VENT30C, prisma VENT40 only) Bacteria filter (prisma VENT30, prisma You set whether a bacteria filter is being used here.

  • Page 25: Ventilation Menu (Ventilation Settings)

    5 Settings in the menus 5.4 Ventilation menu (ventilation settings) The Ventilation menu shows the settings for current ventilation parameters. The parameters displayed vary depending on the ventilation mode set. This menu can only be manipulated in the Expert area. The settings cannot be changed in Patient mode. If more than one preconfigured program is enabled in the device, the program can be selected here.

  • Page 26: Report Menu (Usage Data)

    5 Settings in the menus 5.6 Report menu (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 23. PARAMETER DESCRIPTION Alarm list...

  • Page 27: 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 to the next patient.  Do not reuse disposables.  Use of a bacteria filter is obligatory when the device is used for several patients. Risk of injury due to contaminated or infected patient circuit! A contaminated or infected patient circuit may transmit contamination or infections to the next patient.

  • Page 28: Hygiene Treatment For Device

    6 Hygiene treatment INTERVAL ACTION Have specialist dealer perform a hygiene treatment on the device On change of before using it again (see "6.3 Hygiene treatment for device", patient page 28). Reset device to factory settings. 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.
  • Page 29 6 Hygiene treatment 6.3.1 Clean air filter (gray filter) 1. Clean air filter under running water. 2. Allow air filter to dry. 6.3.2 Replace pollen filter (white filter) 1. Remove air filter 1. 2. Replace white pollen filter 2. 3. Replace air filter 1 in the holder.

  • Page 30: Hygiene Treatment For Breathing Tube

    7 Function check 6.4 Hygiene treatment for breathing tube Risk of material damage as a result of ingress of liquids! The device may be damaged by the ingress of liquids.  Use the breathing tube only when completely dry. If you use a heated breathing tube, see the Instructions for Use for the breathing tube.
  • Page 31 7 Function check 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 15). 5. Interrupt softSTART if necessary (see "4.9 Switching softSTART on and off", page 20).

  • Page 32: Alarms And Faults

    8 Alarms and faults 8 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 33 8 Alarms and faults DISPLAY CAUSE ACTION Minimum therapy pressure Clean/change soiled filters. undershot. Patient/ventilator interface Re-adjust patient/ventilator leaking. interface. Pressure low Patient/ventilator interface Replace patient/ventilator interface. defective. Have settings checked by attending Settings implausible. physician. Frequency high Maximum respiratory Have settings checked by attending frequency exceeded.

  • Page 34: Technical Alarms

    8 Alarms and faults DISPLAY CAUSE ACTION Patient/ventilator interface Check patient/ventilator interface faulty or defective. and replace if necessary. Oxygen supply faulty or inadequate. Ventilation parameter settings not suitable. Have settings checked by attending physician. Alarm settings implausible (minimum alarm setting for patient's oxygen saturation undershot).
  • Page 35 8 Alarms and faults DISPLAY CAUSE ACTION Battery not present. Battery defective. Service necessary. Have device repaired. Unapproved battery in use. Battery capacity highly Battery discharged (less than Connect the device to the power critical 5 % capacity remaining). supply. Battery capacity Battery discharged (less than Connect the device to the power...
  • Page 36 8 Alarms and faults DISPLAY CAUSE ACTION Patient valve does not open in exhalation (medication has caused it to stick, for Rebreathing Check patient circuit and replace if example). necessary Patient's reinhalation volume excessive at high frequency. Valve control tube and pressure measurement tube Check tubes.
  • Page 37 8 Alarms and faults DISPLAY CAUSE ACTION Breathing tube or device outlet port Breathing tube kinked or Check that breathing tube and blocked blocked. device outlet port are not blocked. Check tubes. If necessary: Replace breathing tube. Valve ventilation selected. No Change patient circuit.

  • Page 38: Troubleshooting

    8 Alarms and faults DISPLAY CAUSE ACTION prismaCONNECT module defective. Please get in touch prismaCONNECT module Have module replaced. with your specialist defective. dealer/contact prisma CHECK prisma CHECK module Replace module or connect module not present. defective or not connected. correctly.

  • Page 39: Servicing

    9 Servicing 9 Servicing The device is designed for a service life of 6 years. If used in accordance with the intended use, the device requires no servicing during this period. If the device is used beyond this period, it needs checking by an authorized specialist dealer.

  • Page 40: Appendix

    12 Appendix 12 Appendix 12.1 Technical data 12.1.1 Device DEVICE DEVICE prisma VENT30, prisma VENT50 SPECIFICATION prisma VENT30-C, prisma VENT40 Product class to 93/42/EEC Dimensions W x H x D in cm 21.8 x 17.5 x 21.8 Weight 2.4 kg 2.5 kg...
  • Page 41 12 Appendix DEVICE DEVICE prisma VENT30, prisma VENT50 SPECIFICATION prisma VENT30-C, prisma VENT40 Internal battery (if present) - Type Li-ion - Nominal capacity 3,100 mAh 39.6 V - Nominal voltage 121 Wh - Nominal power 600 charging cycles - Typical discharge cycles...
  • Page 42 12 Appendix DEVICE DEVICE prisma VENT30, prisma VENT50 SPECIFICATION prisma VENT30-C, prisma VENT40 Approx. 26 dB(A) at Approx. 28 dB(A) at Mean sound pressure level/operation to 10 hPa (corresponds 10 hPa (corresponds to ISO 80601-2-70 to a sound power a sound power level of...
  • Page 43 Increment Ti/Ti max 0.5 s to 4 s Precision ± 0.1 s 0.1 s Increment Target volume (not on prisma VENT30) 100 ml to 2,000 ml Precision ± 20 % 10 ml Increment Trigger stage 1 (high sensitivity) to 8 (low sensitivity)
  • Page 44 12 Appendix DEVICE DEVICE prisma VENT30, prisma VENT50 SPECIFICATION prisma VENT30-C, prisma VENT40 Memory size 256 MB to 8 GB can be used, SD card interface compatible with SD physical layer version 2.0 The physiological alarms are triggered 3 breaths after the alarm limit is reached.
  • Page 45 12 Appendix 12.1.2 Pneumatic diagram Breathing tube with leakage ventilation *Alternative O Patient interface supply Inlet for ambient air Flow Optional Optional Optional Breathing Exhalation Air filter Blower humidifier sensor bacteria filter humidifier tube system Pressure sensor for patient supply* pressure Pressure sensor for monitoring...
  • Page 46 12 Appendix 12.1.3 System resistances prisma VENT50 prisma VENT30, prisma VENT30-C, prisma Breathing tube with Breathing tube with VENT40 valve ventilation leakage ventilation Flow Exhalation Inspiration Exhalation Inspiration Exhalation Inspiration Device with 22 mm breathing tube and humidifier 15 l/min 0.3 hPa 0.4 hPa...

  • Page 47: Markings And Symbols

    12 Appendix 12.2 Markings and symbols 12.2.1 Markings on the device prisma VENT30, prisma VENT30-C, prisma VENT40 NO. SYMBOL DESCRIPTION Serial number of the device Year of manufacture Follow Instructions for Use. Device inlet: ambient air inlet Follow Instructions for Use.
  • Page 48 12 Appendix NO. SYMBOL DESCRIPTION Device outlet port for connecting the breathing tube. prisma VENT50 NO. SYMBOL DESCRIPTION Serial number of the device Year of manufacture Follow Instructions for Use. Device inlet: ambient air inlet Follow Instructions for Use. Oxygen connection: maximum supply rate 15 l/min at < 1000 hPa Electrical connection Slot for SD card...
  • Page 49 12 Appendix NO. SYMBOL DESCRIPTION USB port (optional) Connection for control tube for patient valve Connection for pressure measuring tube (marked blue) Device outlet port for connecting the breathing tube. On/off: Identifies the on/off key 12.2.2 Device ID plate underneath the device SYMBOL DESCRIPTION Type designation of the device...

  • Page 50: Scope Of Supply

    The parts below are included in the standard scope of supply: PART ITEM NUMBER Varies depending on Basic device device. Breathing tube with leakage ventilation (prisma VENT30, WM 23962 prisma VENT30-C, prisma VENT40)) Breathing tube with valve ventilation (prisma VENT50) WM 27181 Power cord...

  • Page 51: Declaration Of Conformity

    12 Appendix 12.6 Declaration of conformity Löwenstein Medical Technology GmbH + Co. KG, Kronsaalsweg 40, 22525 Hamburg, Germany, the manufacturer of the devices described in these Instructions for Use, hereby declares that the product complies with the respective regulations of Medical Devices Directive 93/42/EEC.
  • Page 52 Löwenstein Medical Technology GmbH + Co. KG Kronsaalsweg 40 22525 Hamburg, Germany T: +49 40 54702-0 F: +49 40 54702-461 www.loewensteinmedical.de...

This manual is also suitable for:

Prisma vent30-cPrisma vent40Prisma vent50Prisma vent50-c

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