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)

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1.2.2 Operating elements
Symbol
Meaning
Symbol
Meaning
Vacuum setting `Low´
( vacuum ≤-0.2bar)
LED status indicator for
battery operation
Vacuum setting `Medium´
(-0.2bar < vacuum ≤-0.5bar)
LED status indicator for
mains operation
Vacuum setting `High´
(-0.5bar < vacuum ≤-0.9bar)
On/off button
Symbol convention1.3
Symbol
Meaning

Enumeration
1.
2.
Perform the actions in the specified order.
Glossary1.4
A
Aspirate
C
Aspirate is the generic term for secretions, bodily fluids and flushing liquids
that are typically accumulated during aspiration of the upper airways. These
can be aspirated easily using the device described here.
Contamination
D
Contamination means that 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
The Protection Class specifies the degree of protection of the device against
contact and ingress of liquids.
The ASSKEA secretion aspirator proVisio®M28 is protected against finger
access and falling water drops at an inclination of up to 15°.
ME
MRI
Medical electrical
Abbreviation for `magnetic resonance imaging´
This technique generates sectional images of the human body with the aid of
a very strong magnetic field for the purpose of analyzing the organs.

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O
Overflow
P
Overflow means that aspirate is sucked into the interior of the device.
Processing
R
The processing procedure is required for each new patient. The term
processing means that all parts that have (potentially) come into contact with
the aspirate must be cleaned, disinfected and replaced if necessary.
Reconditioning may only be performed by ASSKEA GmbH or by a service
partner authorized by ASSKEA GmbH.
resp.
Abbreviation for `respectively´
Purpose1.5
1.5.1 Intended use
The ASSKEA secretion aspirator proVisio®M28 is a network-independent mobile medical
aspirator and serves for temporary and primarily 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 patients.
1.5.2 Essential features
Generation of vacuum (high vacuum)
Generation of flow (high flow)
1.5.3 Applied parts
There are no applied parts, however housing and suction tube are considered as applied parts of
type BF.
1.5.4 Indications
Tracheostomy patients
Aspiration on impaired respiratory function
Aspiration on blood, secretion and food residues from the oral cavity, the pharyngeal zone
and the bronchial system

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1.5.5 Contraindications
The ASSKEA secretion aspirator proVisio®M28 is contraindicated for the following applications:
Liposuction
Gynecology applications
Dental applications
Thoracic drainage
Continuous drainage
Applications in wound areas
1.5.6 Restrictions on use
In medical rooms where potential equalization is required (e.g. heart surgery)
In hazardous areas/in the MRI environment
Outdoors/during transport
Basic safety instructions - ATTENTION!1.6
Warning of damage due to improper power supply
Improper operation causes overvoltage in the device, which may be transmitted to the operator.
Ensure prior to startup that the mains supply for connecting the ASSKEA secretion aspirator
proVisio®M28 is suitable at 100V to 240V AC and a mains frequency of 50-60Hz.
Ensure prior to startup in UL listed markets such as the USA and Canada that the mains
supply is designed for a supply voltage of 120V AC.
Only use the supplied power supply unit with the ASSKEA secretion aspirator
proVisio®M28 (type: GTM91099-6015-3.0-T2 from GlobTek Inc.).
Risk of application under conditions that are not approved
The device is not intended to be used 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 filter.
Prior to each application, make sure that the bacterial filter is dry and clean to ensure
faultless operation.
Always perform the aspiration using a suitable sterile disposable catheter. The suction tube
must never come into direct contact with the aspiration site.
Follow the hygiene, cleaning and decontamination instructions.
Hazard of persons due to strangulation
People may strangle themselves on the tubing or the mains cable, especially if tubes resp.
cables are unduly long.
Ensure that no unauthorized/uninvolved persons are near the device during aspiration.
Store the device incl. accessories in the shipping carton until the next time of use.
Risk of damage due to electromagnetic phenomena
Medical electrical devices are subject to special precautionary measures regarding
electromagnetic compatibility and must be installed and operated in accordance with the EMC
information provided in the accompanying documents (see section 8).

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Hazard 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 drainage).
If aspiration procedures are carried out too often, slight bleeding may occur.
When using the device for the treatment of children, the vacuum setting `Low´ must be
used.
When using the power supply unit, ensure that it is connected to the aspirator firstly and
afterwards to the mains supply (100V to 240V AC).
The disconnection of the power supply unit from the mains supply must be performed in
exactly the opposite sequence (first remove the power supply unit from the mains supply
(100V to 240V AC) and then remove it from the aspirator).
Never touch parts of other devices than ME devices in the patient environment and the
patient simultaneously.
Safety defects due to improper accessories and spare parts
The use of accessories and spare parts, detachable parts or materials that are not
recommended by ASSKEA GmbH and specified in the instruction for use may compromise the
safety and function of the device. Any warranty is excluded for damage caused by using
accessories and spare parts not recommended or by improper use.
Only use original accessories and spare parts.
Warning of safety defects due to improper connections of the ME system
The connection of the ME system with other devices or installations resp. pieces of equipment
not recommended by ASSKEA GmbH and not specified 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 not cover the power supply unit.
Keep the aspirator as well as the mains cable and the power supply unit away from other
heat sources.
Do not place the aspirator directly adjacent to other devices, since this can result in heavy
warming of the aspirator.
Damage of the device due to improper handling
Never aspirate flammable, corrosive or explosive liquids or gases.
Do not drop the device.
Prior to each use check the housing for any damage and do not operate the device in case of
apparent housing damage.
Prior to each use check the suction tube, secretion canister and bacterial filter and if
applicable any other accessories, that are subject to wear and damage, to ensure that the
components are in a perfect condition and proper operation of the device is guaranteed. If
this is not the case, replace the parts immediately.
Inspection of the internal power supply
Since the internal battery is not maintained automatically in a fully operational state, it is
necessary to check the charging status regularly and if necessary, the battery must be replaced
by service staff. The battery may only be replaced by trained service staff, since the replacement
by inadequately trained personnel could result in a hazard (such as excessive temperatures, fire
or explosion)!

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Possible physiological effects and unobvious risks
Select the vacuum range depending on the respective patient and on the medical indication
to avoid personal injuries.
Always place the device upright on a sturdy and flat base without slope. Make sure that the
device cannot be knocked over or fall in such a way that persons could be hit by the falling
device.
Only operate the device with inserted vacuum pump and closed lid. The lid above the vacuum
pump may only be opened by adequately trained service staff! Likewise, the vacuum pump
may only be replaced by adequately trained service staff.
Other devices, examinations or treatments may possibly be influenced by the device. For this
reason, special attention should always be paid to other devices as well as to examinations
and treatments performed in parallel so that any influence is detected as quickly as possible.
When using the device, adequate lighting must always be ensured so that all labels can be
identified clearly.
Small, detached parts could be inhaled or ingested. Therefore ensure that no unauthorized
persons, children or pets are near the device.
Although the materials used have been tested for compatibility, in exceptional cases allergic
reactions to the exposed materials on the device and its accessories may occur. This applies
especially for contact injuries after prolonged contact. In such cases, turn to a doctor
immediately.
Damage of the device by ingress of liquids
The ASSKEA secretion aspirator proVisio®M28 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).
Known, identifiable or foreseeable conditions for medical care within a domestic
environment
Children and pets should be kept away from the device. Make sure that the device cannot be
knocked over or fall in such a way that persons could be hit by the falling device.
Prior to connecting the power supply unit, ensure that the voltage of the device corresponds
to the domestic power supply.
The device may not be used in damp rooms, bathrooms or showers. Avoid wet conditions on
power supply unit, control panel and socket for the power supply unit.
Ensure that fluff and dust are immediately removed from the device incl. accessories, in
order to ensure unimpaired functionality. Furthermore no pests may be allowed in the
proximity of the device, as there is a risk they may get inside the device causing damage.
Never expose the device incl. accessories to direct sunlight as this could result in a strong
heating effect, causing functional impairments.
Some devices and sources that are commonly used in the domestic environment may cause
potential faults in the device incl. accessories, e.g. fireplaces or radiant heaters (strong
heating of the device) resp. inhalers or steam kettles (excessive air humidity). Do not operate
such devices and sources in the vicinity of the ASSKEA secretion aspirator proVisio®M28.

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User requirements
1.7
The ASSKEA secretion aspirator proVisio®M28 may only be operated and used
by instructed and appropriately trained persons. Familiarize yourself with the
mode of operation of the ASSKEA secretion aspirator proVisio®M28 prior to
startup.
Training on how to handle the ASSKEA secretion aspirator proVisio®M28 is provided by
ASSKEA GmbH or an authorized distribution partner of ASSKEA GmbH. Product training takes
approximately one to two hours and, among other things, includes an explanation of the design
and function of the device, the handling of the device, the cleaning and disinfection as well as the
procedure to be followed for each new patient and for disposal.
The training should be repeated regularly every 24 months.
Each participant receives a certificate as proof of training.
Information on product liability1.8
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,
installation, settings, enhancements, routine maintenance or repairs are performed by
unauthorized personnel,
original accessories and spare parts have not been used,
the device is used beyond its lifetime of 3 years.
Advice for the responsible organization:
The assembly of ME systems and modifications during their actual service life shall be evaluated
based on the requirements of the applying standards.
Material compatibility1.9
Aggressive substances can damage the device and the accessories.
Follow the instructions for cleaning and care (see section 4.1 resp. 4.2).

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2. Product description
Whole view of the ME system2.1
A
Secretion canister (reusable) with
integrated overflow protection in the
lid (fig. 19)
B
Control panel
C
On/off button
D
Socket for power supply unit (12V DC)
E
Power supply unit
(GlobTek GTM91099-6015-3.0-T2)
F
Mains cable
G
Suction tube
H
Lid vacuum pump
I
Carrying handle
Fig. 1
Product contents2.2
the ASSKEA secretion aspirator proVisio®M28
the instruction for use of the ASSKEA secretion aspirator proVisio®M28
the power supply unit GlobTek GTM91099-6015-3.0-T2
reusable secretion canister system (incl. suction tube and fingertip)
rinsing bottle, reusable (250 ml)
charging instructions, 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 properties2.3
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
drainage).
Damage to the device due to improper handling
Never aspirate flammable, corrosive or explosive liquids or gases.
Do not drop the device.
Do not operate the device in case of apparent housing damage.
The ASSKEA secretion aspirator proVisio®M28 is an especially handy, battery powered medical
aspiration device for mobile use.
The ASSKEA secretion aspirator proVisio®M28 has a flow rate of max. 30 l/min ± 2 l/min
(see section 7 `Technical data´).

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The ASSKEA secretion aspirator proVisio®M28 is operated via the internal battery or via the
supplied power supply unit that can also be used to recharge the battery. A rotary vane pump
generates the desired vacuum.
After 5 minutes of operation, the device switches off automatically to prevent overheating. The
device should be left switched off for at least 5 minutes to ensure sufficient cooling of the device.
However, the device can be switched on again immediately in emergency situations.
Moreover an overheating protection prevents the battery from overheating by interrupting the
charging process if the temperature of the battery is too high (e.g. due to unfavorable
environmental conditions).
After it is switched on, the vacuum pump generates a vacuum in the secretion canister, which is
used to aspirate secretion (via a suitable sterile aspiration set). The aspirate is directed away from
the patient and collected in the secretion canister. If the secretion canister is full, the aspiration is
stopped by means of a mechanical overflow protection integrated into the lid of the secretion
canister.
The desired vacuum is set by buttons in the control panel (fig. 1(B), see section 1.2.2)). The
secretion canister is attached by sliding it directly into the housing structure of the aspirator
(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 filter2.4
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 device without bacterial filter.
Prior to each application, make sure that the bacterial filter is dry and clean to
ensure faultless operation.
The bacterial filter integrated between the vacuum pump and the secretion canister consists of a
hydrophilic (self-sealing) material and has an efficiency of 99% against bacteria and viruses. Thus
it effectively protects the vacuum pump against overflow and contamination and enables fast,
simple and cost-effective processing.
The integrated bacterial filter is only intended for use on one patient. It must therefore be
replaced by the operator each time a new patient uses the device (see section 3.2.1). If the device
is used on one patient exclusively, the bacterial filter must be replaced at least every 2 weeks.
To ensure consistent performance, the integrated bacterial filter must also be replaced by
authorized service staff if it has come into contact with the aspirate (blocked) or during
maintenance/repair.
Since the drive unit is mechanically isolated from the vacuum pump, it cannot
become contaminated during use independent from the bacterial filter.

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Information on the battery
2.5
The charge state of the battery is indicated by the corresponding LED status indicator (for
explanation see section 3.3.1).
Prior to the initial startup of the ASSKEA secretion aspirator proVisio®M28, it is urgently
recommended to charge the battery completely and to repeat this after the first uses.
The ASSKEA secretion aspirator proVisio®M28 is equipped with a lithium ion battery which
only has a limited self-discharge on its disposal in contrast to conventional battery types.
Lithium ion batteries do not have a memory effect. Therefore they can and should be recharged
at any time after initial charging. Only frequent short charging should be avoided. The typical
service life of the battery amounts to approximately 500 load cycles, subsequently approximately
70% of the primary capacity are still available.
The battery of the ASSKEA secretion aspirator proVisio®M28 is protected against depth
discharge by means of protective measures; however the instructions on charging mentioned
above should be observed. The battery is also protected against overheating 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.
Warranty2.6
WARNING: Modifications of the ME device are not permitted.
The ASSKEA secretion aspirator proVisio®M28 is covered by warranty for 2 years. No
extension or renewal of the warranty is granted in the event that warranty work is performed.
The battery is covered by warranty for 6 months. Wearing parts are excluded from the warranty.
ASSKEA GmbH is responsible for impacts on safety, reliability and specific performance only if:
original ASSKEA accessories and replacement parts are used,
maintenance and repair are performed by professionals authorized by ASSKEA GmbH or by
ASSKEA GmbH itself,
the ASSKEA secretion aspirator proVisio®M28 is used and operated in accordance with the
instruction for use and within its intended use.
All warranty claims shall be void if:
the device is opened by unauthorized personnel,
the safety seal is removed/broken,
repairs are performed by unauthorized personnel,
modifications are made to the device,
since the basic safety of the device can no longer be guaranteed in these cases and
functional limitations may occur.

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3. Operation
Hazard of persons due to improper handling
Please read through sections 3.1 and 3.2 carefully!
Only perform aspiration in the respiratory tract after instruction by specialized
personnel!
Only use suitable sterile disposable catheters for aspiration! Commercially
available sterile disposable catheters from CH10 to CH16 that are intended for
the use in the tracheal area can be connected.
If aspiration procedures are carried out too often, slight bleeding may occur.
When using the device for the treatment of children, the vacuum setting `Low´
must be used.
Malfunction due to aspirated secretion
Change the reusable secretion canister when it is half-full to curtail frothing. If
the reusable secretion canister is full, the mechanical overflow protection is
triggered. This disrupts the aspiration process.
Switch off the device when emptying the reusable secretion canister.
If secretion has been aspirated into the device, it must be properly processed
by ASSKEA GmbH or by a service partner authorized by ASSKEA GmbH!
Damage of the device due to insufficient acclimatization
After the device has been exposed to temperatures between -25°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
Known or identifiable conditions for medical care within a domestic
environment
Children and pets should be kept away from the device to ensure that it cannot
be knocked over or dropped.
Prior to connecting the power supply unit, ensure that the voltage of the device
corresponds to the domestic power supply.
The device may not be used in damp rooms, bathrooms or showers. 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).
Check the power supply unit incl. mains cable for potential damages before each
use and replace it if there is any damage.
Use the socket for the 12V power supply unit (fig. 1(D)) to connect the device to the mains power
supply with the aid of the supplied power supply unit to charge or operate it as needed. Make
sure that the device is positioned in such a way that it is possible to easily disconnect it later.

Page 16 of 38
Information on the permissible environmental conditions during operation can be found in
section 7 `Technical data´.
Fig. 2 Connection of the ASSKEA secretion aspirator proVisio®M28 to patient and accessories
Startup3.2
Take the device and the accessories out of the packaging.
Always place the device on a sturdy and flat surface 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 absolutely essential for safe
operation!
Prior to each application, check that the reusable secretion canister is completely clean to
avoid frothing.

Page 17 of 38
3.2.1 Connecting the reusable secretion canister
1. Fold the moving part of the secretion canister lid slightly upwards and place the secretion
canister lid on the secretion canister.
Fig. 3 Fig. 4
2. Fold the moving part of the secretion canister lid downwards so 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 cannot be connected if the
bacterial filter has not been inserted correctly.

Page 18 of 38
4. Insert the secretion canister into the canister fitting provided on the device by guiding it
over the rack on the 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.

Page 19 of 38
Operation
3.3
3.3.1 Control elements and indicators of the ASSKEA secretion aspirator
proVisio®M28
Fig. 11
A
Vacuum setting `High´
B
Vacuum setting `Medium´
C
Vacuum setting `Low´
D
LED status indicator for battery
operation
E
LED status indicator for
mains operation
F
On/off button
Symbol
Description
Meaning of display
button illuminates
continuously green
device is running, vacuum setting `High´ is adjusted
(-0.5bar < vacuum ≤ -0.9bar)
button illuminates
continuously red
canister full/filter blocked
(motor switches off automatically)
button illuminates
continuously green
device is running, vacuum setting `Medium´ is adjusted
(-0.2bar < vacuum ≤ -0.5bar)
button illuminates
continuously 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% to 10%
display illuminates
continuously red
Battery capacity < 10%, connect power supply unit
immediately. Switch off the device after completion of the
aspiration procedure for charging!
display blinks green
Battery is being charged.
display blinks red
Overtemperature protection, interruption of charging
process until battery temperature returns to permissible
range.
Battery defective, operation only possible with connected
power supply unit. Please contact your service partner!

Page 20 of 38
Symbol
Description
Meaning of display
display illuminates
continuously green
Power supply unit is connected, voltage available.
display blinks red
Incorrect power supply unit is connected, no charging of
battery possible!
button illuminates
continuously green
Device is switched on and ready for use.
button illuminates
continuously orange
Device still runs for 30 sec. before it switches off
automatically. Afterwards the button will still be
illuminated for 10 seconds.
button illuminates
continuously red
Internal error, operation is not possible.
Please contact your service partner!
3.3.2 Setting the vacuum
1. Switch on the device by pressing the on/off button (fig. 11(F)).
2. Select the desired vacuum range by pressing the corresponding button (`Low´,
`Medium´ or `High´) on the control panel (fig. 11(A, 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. Control the aspiration procedure and the desired vacuum via the additional air opening
on the fingertip (fig. 12).
3. Decommission the device after the aspiration procedure according to section 3.4.
In any case, please take note of section 2.4 and the important information on the
handling of the bacterial filter! Ensure that the battery has a sufficient capacity
during the aspiration procedure. The battery status display must signalize green or
orange. If the display turns red, the power supply unit must be plugged in
immediately. Only in this case the aspiration can be continued without any
interruption.