Asskea proVisio M28 User manual

GA29 / revision D / 04.2016
Instruction for Use
ASSKEA secretion aspirator proVisio®M28
0843

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Copyright © 2016 ASSKEA GmbH, Gebesee.
The safety of the ASSKEA secretion aspirator proVisio®M28 complies with the acknowledged
rules of technology and meets the requirements of the German Medical Devices Act.
The ASSKEA secretion aspirator proVisio®M28 bears the CE marking CE0843 in accordance
with the 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 aspirator classified as class lla in
accordance with EU Council Directive 93/42/EEC, Annex IX.
Errors and omissions excepted.

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Contents
1. User information ...................................................................................................................................5
Using this instruction for use .....................................................................................................51.1
Icons...............................................................................................................................................51.2
1.2.1 Device, packaging and accessories ...................................................................................5
1.2.2 Operating elements.............................................................................................................6
Symbol convention ......................................................................................................................61.3
Glossary.........................................................................................................................................61.4
Purpose .........................................................................................................................................71.5
1.5.1 Intended use ........................................................................................................................7
1.5.2 Essential features ................................................................................................................7
1.5.3 Applied parts ........................................................................................................................7
1.5.4 Indications ............................................................................................................................7
1.5.5 Contraindications ................................................................................................................8
1.5.6 Restrictions on use ..............................................................................................................8
Basic safety instructions - ATTENTION!.....................................................................................81.6
User requirements.....................................................................................................................111.7
Information on product liability ...............................................................................................111.8
Material compatibility................................................................................................................111.9
2. Product description ............................................................................................................................12
Whole view of the ME system...................................................................................................12
2.1
Product contents........................................................................................................................122.2
Product properties.....................................................................................................................122.3
Information on the bacterial filter ...........................................................................................132.4
Information on the battery.......................................................................................................142.5
Warranty......................................................................................................................................142.6
3. Operation .............................................................................................................................................15
Set-up and startup .....................................................................................................................153.1
3.1.1 Connecting the ASSKEA secretion aspirator proVisio®M28 ........................................15
Startup.........................................................................................................................................163.2
3.2.1 Connecting the reusable secretion canister ..................................................................17
Operation ....................................................................................................................................193.3
3.3.1 Control elements and indicators of the ASSKEA secretion aspirator proVisio®M28...
..............................................................................................................................................19
3.3.2 Setting the vacuum............................................................................................................20
3.3.3 Aspiration............................................................................................................................20
Decommissioning ......................................................................................................................213.4

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4. Maintenance ........................................................................................................................................23
Cleaning and care in outpatient and inpatient care..............................................................234.1
4.1.1 General information..........................................................................................................23
4.1.2 Cleaning and disinfection of the surface of the device ................................................24
4.1.3 Cleaning and disinfection of the reusable secretion canister .....................................24
4.1.4 Cleaning/disposal of the suction tube ............................................................................25
4.1.5 Cleaning and disinfection of the rinsing bottle..............................................................25
Cleaning and care in the homecare area................................................................................264.2
4.2.1 General information..........................................................................................................26
4.2.2 Cleaning of the surface of the device..............................................................................26
4.2.3 Hygienic cleaning and disinfection of the reusable 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 ..........................................................................................................284.3
Maintenance and service ..........................................................................................................284.4
Inspection of the ASSKEA secretion aspirator proVisio®M28 .............................................294.5
5. Troubleshooting ..................................................................................................................................30
6. Transport, storage and disposal .......................................................................................................31
Decontamination prior to shipment .......................................................................................316.1
Storage ........................................................................................................................................316.2
Disposal .......................................................................................................................................316.3
7. Technical data......................................................................................................................................32
8. EMC information .................................................................................................................................33
Electromagnetic environment in which the ASSKEA secretion aspirator proVisio®M288.1
may be operated........................................................................................................................34
Handling of electromagnetic interactions ..............................................................................368.2
List of all cables and transformers replaceable by the user ................................................368.3
9. Order information accessories .........................................................................................................37
10. Publishing information ......................................................................................................................38

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1. User information
Using this instruction for use1.1
Please read this entire instruction for use before operating the ASSKEA secretion aspirator
proVisio®M28 for the first time. Alongside instructed medical professionals and trained relatives
of patients, it is also intended that patients operate the device themselves, providing that they
have also been instructed accordingly. In this case all functions can be used safely. If support is
required for startup, operation or maintenance, please contact ASSKEA GmbH
(see section 10). Please also report unexpected operating performance or incidents to ASSKEA
GmbH.
Please read the safety instructions (see section 1.6) to avoid hazards.
This instruction 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.
Icons1.2
1.2.1 Device, packaging and accessories
Symbol
Meaning
Symbol
Meaning
Attention: possible bodily
injury, health risks or possible
property damage
Note with useful information
and tips
Follow the instruction for use
This device must not be
disposed of in domestic waste.
Power supply unit
Order number
Protection class II
Serial number
Protection class: Type BF
(Body Floating)
Lot number
Temperature limitation
Date of manufacture
Air pressure limitation
Manufacturer
Humidity limitation
Operating time
(power-on time and
power-off time)
Do not use if packaging is
damaged!
Do not reuse.
International Protection: IP22
(see section 1.4)