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8. EMC information

WARNING:

The use of the

ASSKEA secretion aspirator proVisio

®

M28

directly

adjacent to or stacked with other devices should be avoided, since this could lead
to impermissible operation. If the use of the

ASSKEA secretion aspirator

proVisio

®

M28

adjacent to or stacked with other devices is required, the

ASSKEA

secretion aspirator proVisio

®

M28

and the other devices should be monitored in

order to verify proper operation in this arrangement!

WARNING:

The use of accessories and spare parts, transformers and cables for

the

ASSKEA secretion aspirator proVisio

®

M28

not indicated or provided by

ASSKEA GmbH may increase the electromagnetic emissions or reduce the
electromagnetic immunity of the

ASSKEA secretion aspirator proVisio

®

M28

,

resulting in impermissible operation.
No warranty is provided for damages caused by using accessories and spare parts,
transformers and cables not recommended or by improper use.
Only use original

ASSKEA

accessories and spare parts!

WARNING:

The use of the indicated or provided accessories and spare parts,

transformers and cables for other devices than the

ASSKEA secretion aspirator

proVisio

®

M28

may increase the electromagnetic emissions or reduce the

electromagnetic immunity. No warranty is provided for damages caused by using
the indicated or provided accessories and spare parts, transformers and cables
with other devices or by improper use. Only use the accessories and spare parts,
transformers and cables with the

ASSKEA secretion aspirator proVisio

®

M28

!

WARNING:

Portable and mobile RF communication equipment (incl. peripheral

devices such as antenna cables and external antennas) may influence medical
electrical devices and therefore should not be used within a range of 30 cm of any
part of the

ASSKEA secretion aspirator proVisio

®

M28

incl. its cables. Otherwise

the performance of the device may be impaired.

WARNING:

The

ASSKEA secretion aspirator proVisio

®

M28

may influence other

devices, examinations and treatments electromagnetically. For this reason, special
attention should always be paid to other devices and examinations or treatments
performed in parallel so that any influence is detected as quickly as possible.

The

ASSKEA secretion aspirator proVisio

®

M28

meets the requirements of IEC 60601-1-2 /

EN 60601-1-2 `Electromagnetic Compatibility - Medical Electrical Equipment´ without deviations
or restrictions. Therefore electromagnetic interference is reduced to a minimum. Follow the
indicated instructions and guidelines to sustain the basic safety and the essential features of the

ASSKEA secretion aspirator proVisio

®

M28

over its entire service life.

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Содержание 100739

Страница 1: ...GA29 revision D 04 2016 Instruction for Use ASSKEA secretion aspirator proVisio M28 0843 ...

Страница 2: ...EU Council Directive 93 42 EEC concerning medical devices and meets the essential requirements of Annex I of this directive The ASSKEA secretion aspirator proVisio M28 has been tested in accordance with IEC 62353 The quality management system applied by ASSKEA GmbH is certified in compliance with the relevant international standards The ASSKEA secretion aspirator proVisio M28 is a medical aspirato...

Страница 3: ... 7 Information on product liability 11 1 8 Material compatibility 11 1 9 2 Product description 12 Whole view of the ME system 12 2 1 Product contents 12 2 2 Product properties 12 2 3 Information on the bacterial filter 13 2 4 Information on the battery 14 2 5 Warranty 14 2 6 3 Operation 15 Set up and startup 15 3 1 3 1 1 Connecting the ASSKEA secretion aspirator proVisio M28 15 Startup 16 3 2 3 2 ...

Страница 4: ... secretion canister 27 4 2 4 Hygienic cleaning and disinfection of the suction tube 27 4 2 5 Hygienic cleaning and disinfection of the rinsing bottle 27 Further use of the device 28 4 3 Maintenance and service 28 4 4 Inspection of the ASSKEA secretion aspirator proVisio M28 29 4 5 5 Troubleshooting 30 6 Transport storage and disposal 31 Decontamination prior to shipment 31 6 1 Storage 31 6 2 Dispo...

Страница 5: ...ion for use forms an integral part of the ASSKEA secretion aspirator proVisio M28 Therefore please keep this instruction for use in an easily accessible place Include this instruction for use when passing the ASSKEA secretion aspirator proVisio M28 on to third parties Icons 1 2 1 2 1 Device packaging and accessories Symbol Meaning Symbol Meaning Attention possible bodily injury health risks or pos...

Страница 6: ...hat bacteria and viruses from the aspirate have come into contact with the device Degree of protection I The degree of protection indicates the protection of applied parts against electric shock Applied parts of type BF have to be installed isolated from earth and are not suitable for direct application to the heart incl IP22 M Abbreviation for including International Protection Protection Class T...

Страница 7: ...imarily spontaneous aspiration of aspirate from the trachea The ASSKEA secretion aspirator proVisio M28 is not operational in motion and therefore it may only be operated at rest Typical areas of application are in outpatient and inpatient care professional healthcare facility environment in the homecare area home healthcare environment especially for the aspiration of aspirate from tracheostomy p...

Страница 8: ...ed in medical rooms where potential equalization is required e g heart surgery The device is not intended to be used in hazardous areas in the MRI environment The device is not intended to be used outdoors during transport Health risks due to the handling of infectious or pathogenic germs Infectious and pathogenic germs in the aspirate cause health risks Never operate the device without bacterial ...

Страница 9: ...ified in the instruction for use may compromise the safety and function of the ME system Any warranty is excluded for damage caused by connecting devices or installations resp pieces of equipment not recommended with the ASSKEA secretion aspirator proVisio M28 or by improper use Only connect recommended original parts with the ASSKEA secretion aspirator proVisio M28 Damage of the device by heat Do...

Страница 10: ...28 has the IP classification IP22 against the ingress of liquids Nevertheless protect the device from moisture Do not use the device near splashing water Do not use the device in damp rooms or while bathing or showering Avoid wet conditions on power supply unit control panel and socket for the power supply unit Never submerge the device in water or other liquids also not while it is switched off K...

Страница 11: ...ths Each participant receives a certificate as proof of training Information on product liability 1 8 The liability for the operation of the device is channeled to the operator in the following cases the device is used outside its intended use the device is not used in accordance with the instruction for use the device is opened by unauthorized personnel the safety seal is removed broken installat...

Страница 12: ...nstructions multilingual safety instruction for handling battery packs Used Medical Device label and decontamination certificate test report in accordance with IEC 62353 optional accessories depending on the order Product properties 2 3 Hazards of persons due to improper handling Only use the device for its intended purpose Never use the device for aspiration in the low vacuum range e g thoracic d...

Страница 13: ...irator fig 8 9 This also establishes the vacuum connection between the aspirator and secretion canister The device is charged or operated via the supplied 12V power supply unit fig 1 E Information on the bacterial filter 2 4 Health risks due to the handling of infectious or pathogenic germs Infectious and pathogenic microbes in the suction material can pose a risk to health Never operate the devic...

Страница 14: ...during charging If the battery temperature is exceeded during charging due to ambient conditions not intended charging will be automatically interrupted temporary to allow cooling This feature ensures the safety of the battery and protects it from wear Warranty 2 6 WARNING Modifications of the ME device are not permitted The ASSKEA secretion aspirator proVisio M28 is covered by warranty for 2 year...

Страница 15: ... C and 70 C during transport storage according to the technical data see section 7 it must firstly acclimatize for ca 2 h at room temperature ca 20 C before the intended use is possible Set up and startup 3 1 The following section describes the operating elements connections and the startup of the ASSKEA secretion aspirator proVisio M28 3 1 1 Connecting the ASSKEA secretion aspirator proVisio M28 ...

Страница 16: ...ace without slope Prior to the initial startup it is essential to follow the safety instructions in section 1 6 Only operate the device with inserted bacterial filter and connected secretion canister Bacterial filter and secretion canister are already fitted on delivery Note the following instructions for all further applications Always have one backup bacterial filter at hand since it is absolute...

Страница 17: ...o that the hooks snap into place and the secretion canister is securely closed Fig 5 3 Insert the bacterial filter into the device by introducing the filter with the lever pointing vertically downwards in the opening provided Subsequently move the lever a quarter turn clockwise so that the lever is in the horizontal position afterwards Fig 6 Fig 7 Please note that the reusable secretion canister c...

Страница 18: ... bottom and pivoting it into the device until it snaps into place Fig 8 Fig 9 5 Connect the suction tube to the port in the middle of the secretion canister lid In doing so ensure that the tube is fixed sufficiently tight Fig 10 6 Connect the other ending of the suction tube to the aspiration catheter with the aid of a fingertip ...

Страница 19: ...inuously red canister full filter blocked motor switches off automatically button illuminates continuously green device is running vacuum setting Low is adjusted vacuum 0 2bar button illuminates continuously red canister full filter blocked motor switches off automatically display illuminates continuously green battery capacity 100 to 60 display illuminates continuously orange battery capacity 60 ...

Страница 20: ...B C As described in section 3 3 1 the vacuum setting buttons correspond to certain vacuum ranges 3 You can perform fine adjustments of the set vacuum via the additional air opening on the fingertip fig 12 Fig 12 4 Switch off the device by holding the on off button fig 11 F pressed for 1 2 seconds 3 3 3 Aspiration 1 Perform the aspiration procedure as you were instructed by specialized personnel 2 ...

Страница 21: ...irate and the parts contaminated with aspirate must be disposed of properly 1 Switch off the device after the aspiration by holding the on off button fig 11 F pressed for 1 2 seconds 2 Disconnect the power supply unit from the mains supply 100V to 240V AC if attached and remove the device plug from the aspiration device afterwards 3 Remove the suction tube fig 1 G from the aspiration catheter and ...

Страница 22: ... that is in the horizontal position a quarter turn counterclockwise so that the lever points vertically downwards subsequently Fig 16 Fig 17 9 When the lever is in this position pull the bacterial filter out of the fitting and dispose of the bacterial filter properly Fig 18 10 Insert a new bacterial filter see section 3 2 1 11 Clean the surface of the device according to section 4 1 2 resp 4 2 2 1...

Страница 23: ...at have come into contact with the aspirate must be cleaned disinfected or disposed of The aspirate and the parts contaminated with aspirate must be disposed of properly Health risks due to the handling of disinfectants The use of appropriate protective clothing during disinfection is recommended Follow the disinfectant manufacturer s instructions Damage of the device due to improper cleaning agen...

Страница 24: ...by a service partner authorized by ASSKEA GmbH 4 1 3 Cleaning and disinfection of the reusable secretion canister A Reusable secretion canister lid B Overflow protection with sphere Fig 19 1 Empty the reusable secretion canister and dispose of the aspirate properly 2 Remove the sphere before performing the following cleaning instructions fig 19 B 3 Rinse all components of the reusable secretion ca...

Страница 25: ...Even when the suction tube is used for one patient only ASSKEA GmbH recommends to replace the suction tube at least every 4 weeks since the material may become discolored and brittle due to frequent applications 4 1 5 Cleaning and disinfection of the rinsing bottle 1 Remove the lid off the rinsing bottle and rinse both parts under running water 2 Immerse the rinsing bottle and the lid in disinfect...

Страница 26: ... device see section 4 3 After each aspiration all components that have come into contact with the aspirate must be cleaned disinfected or disposed of The aspirate and the parts contaminated with aspirate must be disposed of properly Health risks resp damages of the device due to the handling of disinfectants If you have the possibility to use disinfectants please observe the information in section...

Страница 27: ...on tube properly before the device is used by a new patient 2 If the device is used for one patient only rinse the suction tube with clear water using the rinsing bottle after each aspiration and place it daily in a water bath at 65 C temperature for 15 minutes once a day 3 Afterwards rinse the suction tube thoroughly with clear water and let it dry Even when the suction tube is used for one patie...

Страница 28: ...ments Maintenance and service may only be performed considering the service instructions for the ASSKEA secretion aspirator proVisio M28 ASSKEA GmbH will also provide additional documents on request in case these can support the service staff WARNING Modifications of the ME device are not permitted The ASSKEA secretion aspirator proVisio M28 is maintenance free if used in accordance with the instr...

Страница 29: ...ories and spare parts are not used the user instructions in this instruction for use are not followed installation settings modifications enhancements or repairs are not performed by ASSKEA GmbH or by personnel authorized by ASSKEA GmbH Inspection of the ASSKEA secretion aspirator proVisio 4 5 M28 ASSKEA GmbH offers its partners and customers fast and professional processing as well as required te...

Страница 30: ...t the correct power supply unit check the power supply Insufficient flow rate illuminates green orange Bacterial filter is blocked Leak in the suction line or in the canister Service life of vacuum pump expired Replace the bacterial filter Check that secretion canister lid and tube connections are tight and no leakages are apparent Please contact service illuminates green No flow rate green orange...

Страница 31: ...on aspirator proVisio M28 in accordance with the indications in the technical data section 7 Charge the battery of the ASSKEA secretion aspirator proVisio M28 before storing the device This ensures that it is operational at all times If the ASSKEA secretion aspirator proVisio M28 is not used for a longer period of time approximately 10 months the battery must be fully recharged again Disposal 6 3 ...

Страница 32: ...I IP degree of protection IP22 CE marking CE0843 Sound emission without vacuum approximately 60 dB A Ambient conditions Transport Storage ambient temperature 25 C to 70 C relative humidity up to 90 non condensing air pressure 700 hPa to 1060 hPa Operation ambient temperature 5 C to 40 C relative humidity 15 to 90 non condensing air pressure 700 hPa to 1060 hPa Battery 10 8 V 5800 mAh lithium ion b...

Страница 33: ...e electromagnetic immunity No warranty is provided for damages caused by using the indicated or provided accessories and spare parts transformers and cables with other devices or by improper use Only use the accessories and spare parts transformers and cables with the ASSKEA secretion aspirator proVisio M28 WARNING Portable and mobile RF communication equipment incl peripheral devices such as ante...

Страница 34: ...n IEC 61000 3 2 Voltage fluctuations flicker IEC 61000 3 3 Housing Phenomenon Test method Immunity test levels Electrostatic discharge IEC 61000 4 2 8 kV contact 15 kV air Radiated RF disturbances IEC 61000 4 3 28 V m 80 MHz to 6 GHz 80 AM at 1 kHz Magnetic field at rated power frequency 50 Hz IEC 61000 4 8 30 A m Power supply AC Phenomenon Test method Immunity test levels Fast transient electrica...

Страница 35: ... Phenomenon Test method Immunity test levels Electrostatic discharge IEC 61000 4 2 8 kV contact 15 kV air Conducted RF disturbances IEC 61000 4 6 3V 0 15 MHz to 80 MHz 6V in ISM bands and amateur radio bands between 0 15 MHz and 80 MHz 80 AM at 1 kHz Signal input and output channels Phenomenon Test method Immunity test levels Electrostatic discharge IEC 61000 4 2 8 kV contact 15 kV air Fast transi...

Страница 36: ...gation is affected by absorption and reflection from structures objects and people and since the field strength from fixed transmitters cannot be predicted in advance with accuracy a site survey of the electromagnetic phenomena at the location at which the ASSKEA secretion aspirator proVisio M28 shall be operated should be considered to assess the existing electromagnetic environment at this locat...

Страница 37: ...tion 3 100744 Bacterial filter proVisio 5 100745 Universal holder proVisio 1 100732 Stand with 5 rollers 1 100733 Filing tray for roller stand 1 100748 Device holder for roller stand proVisio 1 100746 Bag proVisio 1 100282 Rinsing bottle reusable 250 ml 1 100747 Tube mount proVisio 5 100698 3 Power supply unit GlobTek GTM91099 6015 3 0 T2 incl mains cable 1 100284 Car connecting cable 1 100713 2 S...

Страница 38: ...38 of 38 10 Publishing information Created and published by ASSKEA GmbH Haßlocher Straße 9 99189 Gebesee GERMANY Contact details Phone 49 36201 5797 0 Fax 49 36201 5797 33 E Mail info asskea de www asskea de ...

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