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Lowenstein Medical prisma VENT AQUA 100506, Инструкция по использованию и техническое описание, Страница: 35 / 44

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35

Guidance and manufacturer's declaration - electromagnetic immunity to interference

The prisma VENT AQUA is intended for operation in an environment as specified below.  
The customer or user of the prisma VENT AQUA should ensure that it is operated in such an 

environment.

Checks for 
immunity to 
interference

IEC 60601 –  
test level 

Conformity  
level

Electromagnetic 
environment - Guidelines

Electrostatic 
discharge (ESD) 
according to  
IEC 61000-4-2

± 8kV contact 

discharge 

± 15kV air 

discharge

± 6kV contact 

discharge 

± 8kV air 

discharge

Floors should be made of 
wood, concrete or ceramic 
tile. If the floor is covered with 
synthetic material, the relative 
humidity must be at least 30%.

Fast transient 
electrical 
interferences / 
bursts according 
to IEC 61000-4-4

± 2kV for power 

lines 

100kHz repeat 

frequency

± 2kV for power 

lines 

100kHz repeat 

frequency

The quality of the supply 

voltage should be typical 
for business or hospital 
environment

Voltage 
fluctuations 
(Surges) according 
to IEC 61000-4-5

± 1kV Differential 

mode voltage 

± 2kV Common 

mode voltage

± 1kV Differential 

mode voltage 

± 2kV Common 

mode voltage

The quality of the supply 

voltage should be typical 
for a business or hospital 
environment.

Содержание prisma VENT AQUA 100506

Страница 1: ...EN prisma VENT AQUA respiratory humidifier Instructions for use and technical description ...

Страница 2: ...ry and special accessories 10 4 2 Consumables 11 5 Installation and commissioning 12 5 1 Connecting components 12 5 2 Installation Mounting the base unit 13 5 3 Installing the humidification chamber 13 5 4 Connect the breathing tube system 15 5 5 Turn on the base unit 18 5 6 Turn off the base unit 19 6 Mode of operation 19 6 1 Description of the operating modes 20 6 1 1 NHW 20 6 1 2 HWC 20 6 1 3 H...

Страница 3: ... 7 6 Impact on the performance 23 7 7 Muting the alarm 23 7 8 Treatment interruption 23 7 9 Warm up time 23 7 10 Alarm delay 24 8 Representation of the operating mode 24 9 Representation of the Guidelines 25 10 Alarms 25 10 1 Causes and Solutions 26 10 2 Alarm OFF Status 26 11 Cleaning 27 12 Maintenance 28 13 Legend 28 14 Technical specifications 30 15 Storage and disposal 33 16 Supplement to the ...

Страница 4: ...and to the therapy device being used suit the medical indication and the respective patient group The prisma VENT AQUA may only be connected to approved therapy devices e g ventilators bilevel and CPAP devices etc if the safety of patients users and the surrounding area is not compromised by this combination If the the safety of the combination is not obvious the user must confirm it e g by an inq...

Страница 5: ... removing the humidification chamber from the humidifier the humidification chamber must be allowed sufficient time to cool down WARNING When using the temperature probe the temperature sensor must be inserted so that the temperature of the respiratory gas is measured in the middle of the breathing tube Failure to observe the temperature of the supplied respiratory gas can lead to exceedance of th...

Страница 6: ...acclimatized prior to operation at an ambient temperature of 18 C to 28 C for 30 minutes WARNING Operating temperatures are different from storage and transport temperatures The prisma VENT AQUA may only be operated at an ambient temperature of 18 C to 28 C WARNING The prisma VENT AQUA respiratory humidifier is not to be operated in the vicinity of radiators and other heat sources Solar radiation ...

Страница 7: ...ified range of operating temperatures CAUTION To avoid overheating a breathing gas flow of at least 5 l min is constantly required in the breathing tube system If the breathing gas supply is interrupted the device must be turned off For applications that require the patient s separation from the humidifier the device needs to be switched to the treatment interruption mode CAUTION The water used to...

Страница 8: ...rescription or the service requirements for the appropriate care of the patient These requirements and service regulations take precedence over this user manual 2 3 Guidelines Guidelines are indicated by the term NOTE Guidelines contain important information that should be respected NOTE Before use follow the instructions of the user manual of each accessory NOTE A change in the room climate for e...

Страница 9: ...fication chamber are not inhalers and therefore are neither suitable nor intended for administration of drugs medical substances or human blood derivatives NOTE Only Löwenstein Medical approved accessories and consumables may be used Accessories and consumables from third party providers may affect the safety of the device NOTE The anticipated operating lifetime of the device and of the jointly su...

Страница 10: ...t 230V 100506 115V 100507 Wire distribution cable for heating i 100 942 Temperature probe 160 cm 100910 or 180 cm 100909 Power cord country specific User instructions country specific Quick Start Guide country specific Base unit Heating wire distributor cable Temperature probe Power cord The 180 cm temperature probe 100909 is a special accessory and must be ordered separately ...

Страница 11: ...gle tube valve system heated i with auto fill chamber for prisma VENT AQUA or AIRcon 150cm 60cm 15mm Ø 271708 Single tube valve system heated i with auto fill chamber for prisma VENT AQUA or AIRcon 150cm 60cm 22mm Ø 270822 Oxi Plus high flow nasal cannula Size 2 retail pack 15 items 270823 Oxi Plus high flow nasal cannula Size 3 retail pack 15 items 270824 Oxi Plus high flow nasal cannula Size 4 r...

Страница 12: ... clip on the power cord Clip Power cord The power plug is connected under the machine Power plug Connect the power cord to an AC outlet or power strip with allowable voltage The connections for the wire distribution cable for heating and for the temperature sensor are mounted laterally on the device These connectors are colored and mechanically coded being marked with appropriate symbols ...

Страница 13: ...g the base unit The prisma VENT AQUA device is equipped with silicone feet and can be placed on a flat solid and level surface Alternatively the device can be suspended with the rear retaining tab in a suitable hook 5 3 Installing the humidification chamber Unpack the humidification chamber with automatic refill device e g C200AF universal and check it before use for any visible damage Closing cap...

Страница 14: ...mber should be oriented so that the MIN and MAX inscriptions on the chamber are easy to read from the front and the breathing tube system is not convoluted Out In First slide the bottom edge of the humidification chamber under the front flap on the base unit Front flap and then fix it under the movable mounting bracket until the bracket clicks into place Mounting bracket Only with correct use of t...

Страница 15: ... sensor must be inserted at the end of the cable into the opening nearest the patient at the end of the breathing tube system Both sensors must be firmly and securely inserted in the respective opening The wiring of the temperature probe can be secured in the appropriate hook of the tubing clamps The green coupling of the heating wire supply is always connected to the green heating wire plug of th...

Страница 16: ...ubing clamps and mounting clamps are to be used The use of sterile water is recommended However other water to a medical specification can be used However this water must not contain any mineral additives or drugs The automatic refill device works when the container filled with the water e g WILAqua 500186 is suspended at least 0 5 m above the humidifier After this the seal plate is removed on the...

Страница 17: ...tles the blue vent cap on the perforator must be opened Venting cap The water gradually fills the humidification chamber and maintains a constant level If the humidification chamber is filled manually it must be ensured that the level of the humidification chamber does not exceed or fall short of the water level markings ...

Страница 18: ...that the treatment parameters are set correctly and that the breathing gas flows freely out of the breathing tube system The following illustration shows the schematic set up of the device 5 5 Turn on the base unit Turn on a humidifier with the lateral main switch only when the breathing tube system the humidification chamber and the water reserve are connected plugged or clamped correctly NOTE Th...

Страница 19: ... of additional setting being done by the operator The device is set via a simple two button operation Thereby the operation mode the current state of the humidification intensity and the alarms are displayed via a light emitting diode An Alarm Mute Key is used to temporarily interrupt the audible alarm If the cause of the alarm is not resolved within 10 minutes the unit switches to the OFF mode A ...

Страница 20: ...ause the breathing gas cools to a temperature level below the dew point on its way to the patient To avoid excessive condensation at low ambient temperatures the heating plate temperature is adjusted automatically Should too much condensation build up in the breathing tube system we recommend reducing the level of humidification 6 1 2 HWC HWC Heated Wire Calculated means with heating wire but with...

Страница 21: ...ent are regulated In operating mode with heating wire and with temperature probe the humidity intensity and the breathing gas temperature are kept in a narrowly defined area whereby the humidity intensity can be selected in three steps 7 Operation 7 1 Representation of the operating controls The following chapters explain the functions of the controls and the meaning of the display messages prisma...

Страница 22: ...between humidification levels 1 low 2 medium and 3 high The Selected Humidification is displayed via prisma VENT AQUA 02 08 2017 AWO M 1 1 all measur RAL 9006 white aluminum metallic RAL 9006 white alluminum metallic prisma VENT AQUA M 1 1 all measures in mm allic 7 4 The temperature ranges NHW HWC and HWT Operation mode Level Temperature near patient NHW 1 approx 23 25 C 1 2 approx 25 28 C 1 3 ap...

Страница 23: ...onds Then the alarm sounds again If the cause of the alarm is not resolved within 10 minutes the unit switches to the OFF mode 7 8 Treatment interruption The treatment interruption may be carried out in normal operation that is if there is no alarm activated by pressing the button for 3 seconds The treatment interruption lasts 3 minutes and can be prematurely terminated at any time by pressing any...

Страница 24: ... the temperature cannot be immediately achieved after switching to the normal mode After changing the humidification level the alarm delay is activated for 3 minutes for the same reason 8 Representation of the operating mode After switching on the device checks whether a temperature probe or a heating wire is connected and it starts automatically with the corresponding operating mode If the temper...

Страница 25: ... to the patient Treatment interruption active Reduction of the power of the heating plate and the heating wire if connected to half The treatment inter ruption period ends automatically after 3 minutes or by pressing any button of the prisma VENT AQUA filled circle means LED is lit filled circle with rays means LED is flashing 10 Alarms When the device is switched on there is an audible signal and...

Страница 26: ...he temperature probe Connect or check the heating wire 4 Chamber heating plate temperature Error Check the installation Check the temperature probe Check the flow filled circle with rays means LED is flashing 10 2 Alarm OFF Status If a sounding alarm is not rectified within 10 minutes or the heating plate temperature increases above 93 C the forced shutdown of all heaters occurs The device can be ...

Страница 27: ...e can be cleaned with a mild detergent e g WILAsil Disinfection is performed by wiping it with any of the following disinfectants Hydrogen peroxide 4 Isopropanol 17 CaviWipes METREX RESEARCH Incidin Plus Ecolab Deutschland GmbH mikrozid sensitive liquid Schülke Mayr GmbH perform Schülke Mayr GmbH quartamon med Schülke Mayr GmbH It is important to ensure that only a damp cloth is used for cleaning ...

Страница 28: ...sing the maintenance and servicing manual 13 Legend Application part Type BF B Body F Floating applied part Warning of a potential danger REF 100 506 Symbol for Order No SN201500001 Manufacturer s serial number CE mark with designated location Manufacturer Disposing of the appliance in accordance with the applicable regulations Protective insulation Protection class II IP22 Protection type Follow ...

Страница 29: ...Operating voltage 230V version 110 120V Operating voltage 115V version 50 60Hz Mains frequency 260VA Volt Ampere electric power 2x H 250V 2A F Fuse for 230V version 2x H 125V 4A F Fuse for 115V version Changing of levels humidification levels Current humidification value Display of operating modes and alarms Identification plates depending on the version ...

Страница 30: ...tion class under IEC 60601 Class II Application parts Type BF heated unheated breathing tube system Temperature probe Protection by housing IP22 protected against solid bodies with diameters greater than 12 5 mm protected against finger access protected against falling drip water if the housing is inclined up to 15 Electrical specifications Operating voltage prisma VENT AQUA 100506 220V 240V prism...

Страница 31: ...ge 5 60l min Maximum operating pressure 200mbar 1 Continuous noise 50dB 1m Decibel level of alarms max 65dB Max volume of water 200 ml humidification system Gas leakage at max operating pressure 10 ml min 2 Gas leakage at 60mbar 5 ml min 2 Pressure drop 0 02 mbar min l 2 Internal Compliance Minimum 1 0 ml mbar 2 Maximum 2 0 ml mbar 2 ...

Страница 32: ...erapy device delivers breathing gas at a higher temperature Measurement range Temperature sensor 9 5 C 50 C nearest the patient 5 C 80 C humidification chamber Use area Heated unheated Breathing tube system Temperature probe 1 Unless the instructions for use of the humidification chamber used require lower maximum pressures 2 Depending on the humidification chamber used and the breathing tube syst...

Страница 33: ... to enable recycling of raw materials the European Commission has determined that electrical and electronic equipment shall be taken back by the manufacturer for their proper disposal The devices with the symbol Not for disposal in municipal waste may not be disposed in the unsorted municipal waste 16 Supplement to the technical description The prisma VENT AQUA measures the breathing gas temperatu...

Страница 34: ... HF emissions according to CISPR 11 Group 1 The prisma VENT AQUA uses HF energy only for its internal functioning Therefore HF emissions are very low and it is unlikely that nearby electronic devices will be disturbed HF emissions according to CISPR 11 Class B The prisma VENT AQUA is suitable for use in the residential area directly connected to a public supply grid that also supplies buildings us...

Страница 35: ...contact discharge 8kV air discharge Floors should be made of wood concrete or ceramic tile If the floor is covered with synthetic material the relative humidity must be at least 30 Fast transient electrical interferences bursts according to IEC 61000 4 4 2kV for power lines 100kHz repeat frequency 2kV for power lines 100kHz repeat frequency The quality of the supply voltage should be typical for b...

Страница 36: ...d At 0 45 90 135 225 270 and 315 degrees 0 UT 1 period and 70 UT 25 30 period Single phase at 0 degrees 0 UT 250 300 period The quality of the supply voltage should be typical for business or hospital environment Magnetic field with supply frequency 50 60 Hz according to IEC 61000 4 8 30A m 30A m Magnetic fields at the mains frequency should correspond to the typical values as they are found in a ...

Страница 37: ...between 0 15MHz and 80MHz 10V m 80 MHz to 2 7 GHz contained in Table 1 3V 6V 10V m 80 MHz to 2 7 GHz contained in Table 1 Portable and mobile radio equipment including cables should not be operated within a shorter distance to the prisma VENT AQUA than the recommended separation distance calculated according to that which applies to the transmission frequency Recommended separation distance d 3 5 ...

Страница 38: ...ers cannot be theoretically predicted with accuracy To determine the electromagnetic environment of stationary transmitters a study of the electromagnetic phenomena of the location should be considered If the measured field strength at the site where the prisma VENT AQUA is used exceeds the above compliance level the prisma VENT AQUA should be monitored to demonstrate proper function If abnormal p...

Страница 39: ...ionb 18Hz 1 8 0 3 27 450 430 to 470 GMRS 460 FRS 460 FMc 5kHz swing 1kHz sine 2 0 3 28 710 704 to 787 LTE Band 13 17 Pulse modula tionb 217Hz 0 2 0 3 9 745 780 810 800 to 960 GSM 800 900 TETRA 800 iDen 820 CDMA 850 LTE Band 5 Pulse modula tionb 18Hz 2 0 3 28 870 930 1720 1700 to 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modula tionb 217Hz 2 0 3 28 1845 1970 ...

Страница 40: ... distance between the transmitter antenna and the ME device or ME system can be reduced to 1 m The 1 m test distance is permitted under IEC 61000 4 3 a For some radio services only the frequencies for the radio connection from the communication device to the base unit en uplink were included in the table b The carrier must be modulated with a square wave signal with 50 duty cycle c As an alternati...

Страница 41: ...ans mitter W Separation distance depending on frequency of transmitter in m 150 KHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 2 1 2 2 3 10 3 7 3 7 7 4 100 12 12 23 For the transmitters whose nominal power is not specified in the above table the distance can be determined using the equation for the respective column where P is ...

Страница 42: ...42 Additional notes ...

Страница 43: ...43 ...

Страница 44: ...öwenstein Medical Technology Kronsaalsweg 40 22525 Hamburg Germany T 49 40 54702 0 F 49 40 54702 461 www loewensteinmedical de WILAmed GmbH Medizinische Geräte und Zubehör Gewerbepark Barthelmesaurach Aurachhöhe 5 7 91126 Kammerstein Germany Phone 49 9178 996999 0 Fax 49 9178 996778 info wilamed com www wilamed com ...

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