Asskea ped M User manual

GA14-15 / Revision I / 2021-10
MEDICAL —GENERAL MEDICAL EQUIPMENT
AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012);
CAN/CSA C22.2 No. 60601-1:14;
IEC 60601-1-6 (2010) + AMD1(2013);
CAN/CSA-C22.2 No. 60601-1-6:11+ Am1: 2015;
ANSI/AAMI/IEC 60601-1- 8 (2006) + Am.1 (2012);
CAN/CSA-C22.2 No. 60601-1-8:08 + Am1:14
Instructions for Use
ASSKEA ped M and ASSKEA ped S
0494

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Copyright © 2021 ASSKEA GmbH, Gebesee.
The safety of the ASSKEA ped M and the ASSKEA ped S complies with the acknowledged rules of
technology and meets the requirements of the German Medical Devices Act.
The ASSKEA ped M and the ASSKEA ped S devices bear the CE marking CE0494 in accordance
with EU Council Directive 93/42/EEC concerning medical devices and meet the essential
requirements of Annex I of this directive, as well as with Article 120 of Regulation (EU) 2017/745
of the European Parliament and of the Council.
The ASSKEA ped M and the ASSKEA ped S have 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 ped M and the ASSKEA ped S are medical aspirators classified as class IIa in
accordance with EU Council Directive 93/42/EEC, Annex IX.
Errors and omissions excepted.

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Contents
1Notes on delivery damage and customer feedback............................................................5
2User information ......................................................................................................................6
2.1 Using these instructions for use................................................................................................6
2.2 Icons...............................................................................................................................................6
2.2.1 Device, packaging and accessories......................................................................................6
2.2.2 Display......................................................................................................................................7
2.3 Symbol convention......................................................................................................................7
2.4 Glossary.........................................................................................................................................8
2.5 Purpose .........................................................................................................................................9
2.5.1 Intended use ...........................................................................................................................9
2.5.2 Essential functions .................................................................................................................9
2.5.3 Applied parts...........................................................................................................................9
2.5.4 Indications ...............................................................................................................................9
2.5.5 Contraindications ...................................................................................................................9
2.5.6 Restrictions on use.................................................................................................................9
2.6 Basic safety instructions –CAUTION! .....................................................................................10
2.7 User requirements ....................................................................................................................12
2.8 Information on product liability ..............................................................................................12
3Product description................................................................................................................13
3.1 Overall view of the ME system.................................................................................................13
3.1.1 Asskea ped M........................................................................................................................13
3.1.2 ASSKEA ped S with disposable secretion canister system.............................................13
3.1.3 ASSKEA ped S with reusable secretion canister system ................................................14
3.2 Scope of delivery........................................................................................................................14
3.2.1 Scope of delivery ASSKEA ped M .......................................................................................14
3.2.2 Scope of delivery ASSKEA ped S with disposable secretion canister system .............14
3.2.3 Scope of delivery ASSKEA ped S with reusable secretion canister system .................15
3.3 Product properties ....................................................................................................................15
3.3.1 Disposable secretion canister for the ASSKEA ped M ....................................................15
3.3.2 Information on the ASSKEA filter system for the ASSKEA ped M .................................16
3.3.3 Information on the carbon filter........................................................................................17
3.3.4 Secretion canister system for the ASSKEA ped S ............................................................17
3.3.5 Information on the double filter system for the ASSKEA ped S....................................18
3.3.6 Information on the battery.................................................................................................19
3.3.7 Pressure settings..................................................................................................................19
3.4 Warranty......................................................................................................................................20
4Operation.................................................................................................................................21
4.1 Setup and startup ......................................................................................................................22
4.1.1 Connection of the ASSKEA ped M and the ASSKEA ped S..............................................22
4.2 Startup.........................................................................................................................................23
4.2.1 Positioning of the ASSEKA ped M ......................................................................................23
4.2.2 Connection of the disposable secretion canister of the ASSKEA ped M .....................24
4.2.3 Positioning of the ASSKEA ped S........................................................................................24
4.2.4 Connection of the disposable secretion canister system of the ASSKEA ped S.........25
4.2.5 Connection of the reusable secretion canister system of the ASSKEA ped S.............27
4.3 Operation of the ASSKEA ped M and the ASSKEA ped S .....................................................29
4.3.1 Operation at startup ............................................................................................................29
4.3.2 Language selection ..............................................................................................................30
4.4 Patient mode ..............................................................................................................................30
4.5 Canister replacement................................................................................................................32

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4.5.1 Replacement of the disposable canister of the ASSKEA ped M....................................32
4.5.2 Replacement of the disposable liner “OneWay” of the ASSKEA ped S.........................32
4.6 Decommissioning ......................................................................................................................33
5Maintenance............................................................................................................................34
5.1 Cleaning and care ......................................................................................................................34
5.1.1 General information ............................................................................................................34
5.1.2 Cleaning / disinfection of the surface of the device .......................................................35
5.1.3 Disposal of the disposable secretion canister of the ASSKEA ped M...........................35
5.1.4 Disposal of the disposable liner “OneWay” and the suction tube of the ASSKEA ped
S...............................................................................................................................................35
5.1.5 Cleaning / disinfection of the external canister “Bag” of the ASSKEA ped S ...............35
5.1.6 Cleaning / disinfection of the holder for the external canister “Bag” ..........................35
5.1.7 Cleaning / disinfection of the reusable secretion canister system of the ASSKEA ped
S...............................................................................................................................................36
5.1.8 Cleaning / disinfection of the tubing accessories of the ASSKEA ped S ......................36
5.2 Processing / Reuse of the device.............................................................................................37
6Troubleshooting......................................................................................................................38
6.1 Function test...............................................................................................................................38
6.2 Troubleshooting.........................................................................................................................38
6.3 Error messages ..........................................................................................................................39
7Transport, storage and disposal...........................................................................................41
7.1 Transport / Return.....................................................................................................................41
7.2 Storage ........................................................................................................................................41
7.3 Disposal.......................................................................................................................................41
8Technical data .........................................................................................................................42
8.1 ASSKEA ped M ............................................................................................................................42
8.2 ASSKEA ped S..............................................................................................................................43
9Electromagnetic compatibility .............................................................................................44
10 Order information ..................................................................................................................45
10.1 ASSKEA ped M ............................................................................................................................45
10.2 ASSKEA ped S..............................................................................................................................45
11 Publishing information ..........................................................................................................46

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1Notes on delivery damage and customer feedback
Caution!
Please, check consignments for damage immediately upon delivery and remove any packaging.
All damages must be reported within three days. Otherwise they cannot be accepted.
The products described in this instruction for use are subjects to constant development and
improvement. For this reason, we welcome all customer feedback, comments and suggestions
regarding our products and their instruction for use, which contribute to improving the product,
service or documentation.
Contact:
[email protected]

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2User information
2.1 Using these instructions for use
Please read these instructions for use carefully before operating the ASSKEA ped M or the
ASSKEA ped S devices for the first time.
Please read the safety instructions (Section 2.6) to avoid hazards.
These instructions for use are a component of the ASSKEA ped M or the ASSKEA ped S. Keep
these instructions for use in an easily accessible place.
Include these instructions for use when passing the ASSKEA ped M or the ASSKEA ped S device
on to third parties.
2.2 Icons
2.2.1 Device, packaging and accessories
Symbol
Meaning
Symbol
Meaning
Caution: possible bodily injury,
health risks or damage to
property.
NOTE
Note containing useful
information and tips.
Protect from moisture
International Protection:
IP33 (see Section 2.4)
Protection class II
Order number
Humidity limitation
Serial number
Air pressure limitation
Lot number
Follow the instructions for use
Date of manufacture
Follow the instructions for use
Manufacturer
Protection class: Type BF (Body
Floating)
Do not use if packaging is
damaged!
Temperature limitation
Do not reuse
This device must not be
disposed of in domestic waste.
Power supply unit

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2.2.2 Display
Symbol
Meaning
Battery full
Battery low
Battery empty
Up
Down
OK (On, Enter)
Cancel (Off, Back)
Power supply unit is connected
Filter run time elapsed; replacement of internal filter by service personnel is
required!
2.3 Symbol convention
Symbol
Meaning
•
Bulleted list
1.
2.
Perform the process in the specified sequence.

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2.4 Glossary
A
approx.
Aspirate
Abbreviation for “approximately”
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.
C
Contamination
Contamination means that bacteria and viruses from the aspirate have
come into contact with the interior of the device.
D
DFS®
Degree of
protection
Double filter system (only ASSKEA ped S)
An external filter and an internal bacterial filter into the aspirator make up
the double filter system. The double filter system effectively protects the
interior of the device from contamination and overflow. It enables safe
processing and rapid reuse of the product.
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.
E
e.g.
For example, abbreviation for Latin “exempli gratia”
I
incl.
IP33
Abbreviation for “including”
International Protection / protection class
The protection class defines the degree of protection of the device against
contact and ingress of liquids.
The ASSKEA ped M and ASSKEA ped S devices are protected against solid
objects ≥ 2.5 mm diameter and sprays of water from any direction, even if
the case is disposed up to 60° from vertical.
M
ME system
Abbreviation for “medical electrical system”
MRI
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.
O
Overflow
Overflow means that the aspirate is sucked into the interior of the
device.
P
Processing
The processing procedure is required for each new patient. The term
processing means that all parts that have (potentially) come into contact

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with the aspirate must be cleaned, disinfected and replaced, if necessary.
Processing may only be performed by ASSKEA GmbH or by a service
partner authorized by ASSKEA GmbH.
2.5 Purpose
2.5.1 Intended use
The ASSKEA ped M and the ASSKEA ped S are network-independent mobile medical aspirators
for temporary and primarily spontaneous aspiration of aspirate from the trachea. The ASSKEA
ped M and the ASSKEA ped S are especially designed for secretion aspiration in children and can
be used in outpatient and inpatient care (professional healthcare facility environment).
2.5.2 Essential functions
•Generation of a vacuum (medium vacuum)
•Generation of volumetric flow (low flow)
2.5.3 Applied parts
The suction tube is an applied part of type BF.
2.5.4 Indications
•Tracheostomy patients
•Aspiration if respiratory function is impaired
•Aspiration of blood, secretion and food residues from the oral cavity, the pharyngeal zone and
the bronchial system
2.5.5 Contraindications
The ASSKEA ped M and the ASSKEA ped S are contraindicated for the following applications:
•Liposuction
•Gynecology applications
•Dental applications
•Thoracic drainage
•Continuous drainage
•Applications in wound areas
•Pharyngeal aspiration
2.5.6 Restrictions on use
•In medical rooms where potential equalization is necessary (e.g. heart surgery)
•In areas subject to explosion hazards / in the MRI environment
•Outside / outdoors
•In the homecare sector

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2.6 Basic safety instructions –CAUTION!
Risk 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 ped M or the
ASSKEA ped S is suitable for 100 V to 240 V AC and a mains frequency of 50-60 Hz.
•Ensure prior to startup in UL listed markets such as the USA and Canada that the mains
supply is designed to operate at a supply voltage of 120 V AC.
•Only use the power supply unit supplied with the ASSKEA ped M or the ASSKEA ped S (see
section 8).
Health risks due to the handling of infectious or pathogenic germs
Infectious and pathogenic germs in the aspirate cause health risks.
•Always aspirate with a suitable sterile disposable catheter. The suction tube must never come
into direct contact with the aspiration area.
•Follow the hygiene, cleaning and decontamination instructions.
Risk to persons due to strangulation
•Persons may strangle themselves on the tubing or the mains cable, especially if tubes or
cables are excessively long.
•Ensure that no unauthorized / uninvolved personnel are near the device during aspiration.
•Store the device incl. accessories in the shipping carton until the next 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 documentation (see Section 9).
Damage to the device caused by ingress of liquids
The ASSKEA ped M and the ASSKEA ped S devices have the IP classification IP33 in respect of
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.
•Never submerge the device in water or other liquids (including while it is switched off).
Contact of the inner of the device with liquids or solids
If the inner of the device gets in direct contact with liquids or solids the device has to be proofed
by the ASSKEA GmbH or an authorized distribution partner of ASSKEA GmbH.
Risk to persons due to improper handling
•Only use the devices for their intended purpose.
•Never use the devices 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 power supply unit, ensure that it is first connected to the aspirator and then
to the mains supply (100 V to 240 V 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
(100 V to 240 V AC) and then remove it from the aspirator).
•Never touch parts of devices other 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 instructions for use may compromise the
safety and function of the devices. Any warranty is excluded for damage caused by using
accessories and spare parts not recommended or by improper use. Only use the recommended
original accessories and spare parts.

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Damage to the device caused by heat
•Do not cover the power supply unit.
•Keep the aspirators, the mains cable and the power supply unit away from other heat
sources.
Damage to 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 the
event of apparent housing damage.
•Prior to each use, check all components that are subject to wear and damage, to ensure that
these are in a perfect condition and proper operation of the devices is guaranteed. If this is
not the case, replace the parts immediately.
Inspection of the internal power supply
Since the internal battery is not automatically maintained in a fully operational state, it is
necessary to check the charging status regularly and, if necessary, the battery must be replaced
by service personnel. The battery may only be replaced by trained service personnel, since
replacement by inadequately trained personnel could result in a hazard (such as excessive
temperatures, fire or explosion)!
Possible physiological effects and unobvious risks
•To avoid personal injury, select the suction power depending on the respective patient and
the medical indication.
•Always place the device upright on a sturdy, flat, non-sloping base. Ensure that the device
cannot be knocked over or fall in such a way that persons could be hit by the falling device.
•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 soon 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 to contact injuries after prolonged exposure. In such cases, seek medical assistance
immediately.
Warning of safety defects due to improper connections of the ME system
The connection of the ME system with other devices, installations or pieces of equipment not
recommended by ASSKEA GmbH and not specified in the instructions for use may compromise
the safety and function of the ME system. Any warranty is excluded for damage caused by
connecting devices, installations or pieces of equipment not recommended for use with the
ASSKEA ped M or the ASSKEA ped S or by improper use.
Only connect recommended original parts with the ASSKEA ped M or the ASSKEA ped S.

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2.7 User requirements
The ASSKEA ped M and the ASSKEA ped S may only be operated and used by
instructed and appropriately trained personnel. Familiarize yourself with the mode
of operation of the ASSKEA ped M or the ASSKEA ped S prior to startup.
Training on how to handle the ASSKEA ped M or the ASSKEA ped S is provided by ASSKEA GmbH
or an authorized distribution partner of ASSKEA GmbH. Product training 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.
2.8 Information on product liability
The liability for the functioning of the device is transferred to the operator in the following cases:
•the device is used outside its intended use,
•the device is not used in accordance with the instructions for use,
•the device is opened by unauthorized personnel,
•the security seal is removed / broken,
•installation, settings, enhancements, routine maintenance, processings or repairs are
performed by unauthorized personnel,
•original accessories and spare parts have not been used.
Advice for the responsible organization:
The assembly of ME systems and modifications during their expected service life shall be
evaluated based on compliance with the requirements of the applicable standards.

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3Product description
3.1 Overall view of the ME system
3.1.1 Asskea ped M
Fig. 1
Fig. 2
A
Disposable secretion canister with
integrated suction tube
B
Canister locking mechanism
C
(On) and (Off) buttons
D
Display
E
(Up) and (Down) arrow buttons
F
ASSEKA ped M device
G
Socket for power supply unit
3.1.2 ASSKEA ped S with disposable secretion canister system
Fig. 3
A
External canister “Bag” and and
disposable liner “OneWay” (1 l)
B
Holder for external canister “Bag”
C
Connecting tube
D
Display
E
Control panel
( (On) and (Off) buttons and
(Up) and (Down) arrow buttons)
F
ASSEKA ped S device
G
Socket for power supply unit

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3.1.3 ASSKEA ped S with reusable secretion canister system
Fig. 3-1
A
Secretion canister (reusable) with
integrated overflow protection in the lid
(see Fig. 18)
B
Bacterial filter (external)
C
Connecting tube
D
Display
E
Control panel
( (On) and (Off) buttons and (Up)
and (Down) arrow buttons)
F
ASSEKA ped S device
G
Socket for power supply unit
3.2 Scope of delivery
3.2.1 Scope of delivery ASSKEA ped M
•the ASSEKA ped M device
•2 x disposable secretion canister with integrated bacterial filter, carbon filter, solidifier and
suction tube
•power supply unit incl. country adapter
•these instructions for use
•multilingual charging instructions
•“Used Medical Device” label and decontamination certificate
•test report according to IEC 62353
•optional accessories (depending on the order)
3.2.2 Scope of delivery ASSKEA ped S with disposable secretion canister system
•the ASSKEA ped S device
•disposable secretion canister system
(comprising the external canister “Bag”, disposable liner “OneWay”, holder for external
canister “Bag”, connecting tube and disposable suction tube (sterile))
•power supply unit incl. country adapter
•these instructions for use
•multilingual charging instructions
•“Used Medical Device” label and decontamination certificate
•test report according to IEC 62353
•optional accessories (depending on the order)

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3.2.3 Scope of delivery ASSKEA ped S with reusable secretion canister system
•the ASSKEA ped S device
•reusable secretion canister system
(comprising the reusable secretion canister, S6 lid with ball for overflow protection, bacterial
filter, connecting tube, tube mount and disposable suction tube (sterile))
•these instructions for use
•multilingual charging instructions
•“Used Medical Device” label and decontamination certificate
•test report according to IEC 62353
•optional accessories (depending on the order)
3.3 Product properties
The ASSKEA ped M and the ASSKEA ped S devices are lightweight, portable, battery-powered
aspirators for inpatient and mobile use. The ASSKEA ped M and the ASSKEA ped S are especially
designed for secretion aspiration in children and can be used in outpatient and inpatient care
(professional healthcare facility environment).
The ASSKEA ped M or the ASSKEA ped S have a max. flow rate of 8 l/min
(see Section 8 “Technical data”).
The ASSKEA ped M or the ASSKEA ped S are operated via the internal battery or via the supplied
power supply unit, which can also be used to recharge the battery. The vacuum is generated by a
maintenance-free electric motor-driven diaphragm pump.
After it is switched on, the vacuum pump creates a vacuum in the tubing system and secretion
canister system, which is used to aspirate fluids (via a suitable sterile suction catheter). The
aspirate is directed away from the patient and collected in the secretion canister.
If the secretion canister is full, the device triggers an alarm via an integrated overflow protection
and stops the pump. The ASSKEA ped M device must only be operated with the supplied
disposable secretion canister. The ASSKEA ped S device can be operated with the supplied
disposable secretion canister system as well as with the reusable secretion canister system,
which is also available.
The provided disposable secretion canister for the ASSKEA ped M as well as the disposable liner
“OneWay” and the suction tube for the ASSKEA ped S are intended for single use.
3.3.1 Disposable secretion canister for the ASSKEA ped M
The disposable secretion canister consists of a canister with a connected suction tube. The
disposable secretion canister has an integrated bacterial filter, carbon filter and solidifier. The
hydrophobic bacterial filter integrated in the disposable secretion canister is effective against
bacteria and viruses. This integrated filter prevents an overflow in the event of an operational
error or a full canister. If the liquid reaches this filter, aspiration is no longer possible and the
error message “System closed –canister full” appears on the display. The aspiration process is
interrupted. The disposable secretion canister must be replaced.
The activated carbon filter in the disposable secretion canister reduces the spread of odor.

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Solidifier:
Disposable secretion canisters filled with aspirate can be transported and disposed of in a leak-
proof manner by using the solidifier and closing the tube clamp. The aspirate solidifies after an
average gelling time of 2 to 5 minutes (depending on the consistency of the aspirate), irrespective
of the aspiration intervals.
The disposable secretion canister incl. suction tube is intended for single use. Replace
the disposable secretion canister if it is full, prior to each new patient or weekly at the
latest, in accordance with the applicable hygiene instructions.
3.3.2 Information on the ASSKEA filter system for the ASSKEA ped M
The filter system of the ASSKEA ped M consists of the external bacterial filter integrated in the
disposable secretion canister and the internal filter installed in the device. The internal filter is a
self-sealing bacterial filter and in combination with the filter installed in the disposable secretion
canister, is effective against bacteria and viruses.
The ASSKEA filter system effectively protects the interior of the device from
contamination and overflow.
Service life and reuse
The internal filter of the ASSKEA filter system is not intended for reuse. To ensure
consistent performance, the internal filter must be replaced after contact with the
aspirate (blocked), after the filter service life has expired ( symbol on the display)
or during maintenance / repair .
The internal filter must be replaced by ASSKEA GmbH or an authorized service partner of
ASSKEA GmbH.

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3.3.3 Information on the carbon filter
An additional filter in the exhaust air vent of the ASSKEA ped M and the ASSKEA ped S
neutralizes undesirable odors in the exhaust air of the device. This filter consists of a thin
nonwoven material coated activated carbon. The activated carbon in the nonwoven absorbs the
odor particles from the exhaust air and neutralizes them. This effectively reduces the spreading
of odor.
Service life and reuse
The carbon filter of the ASSKEA ped M and the ASSKEA ped S is not intended for reuse. To
ensure consistent performance, the carbon filter must be replaced during maintenance /
repair or after 2 years at the latest.
The carbon filter must be replaced by ASSKEA GmbH or an authorized service partner of
ASSKEA GmbH.
3.3.4 Secretion canister system for the ASSKEA ped S
Disposable secretion canister system:
The disposable secretion canister system consists of the external canister “Bag”, the holder for
the external canister “Bag”, the disposable liner “OneWay”, the connecting tube and the suction
tube. The disposable liner “OneWay” has an integrated bacterial filter, carbon filter and solidifier.
The self-sealing bacterial filter integrated in the disposable liner “OneWay” is effective against
bacteria and viruses. This integrated filter prevents an overflow in the event of an operational
error. If the liquid reaches this filter, aspiration is no longer possible and the error message
“System closed – canister full” appears on the display. The aspiration process is interrupted. The
disposable liner “OneWay” must be replaced.
The activated carbon filter in the disposable liner “OneWay” reduces the spread of odor.
Solidifier:
The disposable liner “OneWay” filled with aspirate can be transported and disposed of in a leak-
proof manner using the solidifier. The aspirate solidifies after an average gelling time of 2 to 5
minutes (depending on the consistency of the aspirate), irrespective of the aspiration intervals.
The disposable liner “OneWay” and the suction tube are intended for single use.
Replace the disposable liner “OneWay” and the suction tube if it is full, prior to each new
patient or weekly at the latest, in accordance with applicable hygiene instructions.

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Reusable secretion canister system:
The reusable secretion canister system consists of a reusable secretion canister, a canister lid
with integrated overflow protection, a suction tube and a connecting tube with external bacterial
filter. The external bacterial filter is effective against bacteria and viruses. It prevents an overflow
in the event of an operational error. If the liquid reaches this filter, aspiration is no longer
possible and the error message “System closed – canister full” appears on the display. The
aspiration process is interrupted. The external bacterial filter must be replaced.
The reusable secretion canister is intended for multiple use. Replace the external
bacterial filter in accordance with applicable hygiene instructions, prior to each new
patient and also in the event of discoloration, contamination or reduced suction power.
3.3.5 Information on the double filter system for the ASSKEA ped S
The ASSKEA double filter system DFS® consists of the external bacterial filter integrated in the
disposable liner “OneWay” and the external bacterial filter of the reusable secretion canister
system installed in the device. The filters are self-sealing bacterial filters which, in combination,
are effective against bacteria and viruses.
The ASSKEA double filter system DFS® effectively protects the interior of the device from
contamination and overflow. It permits fast, simple and cost-effective processing.
Service life and reuse
The ASSKEA double filter system DFS® is not intended for reuse. To ensure consistent
performance, the internal filter must be replaced prior to each new patient, after
contact with the aspirate (blocked), after the filter service life has expired (
symbol on the display) or during maintenance / repair.
The internal filter must be replaced by ASSKEA GmbH or an authorized service partner of
ASSKEA GmbH.

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3.3.6 Information on the battery
The charge level of the battery is shown on the display.
It is strongly recommended to fully charge the battery prior to first startup of the ASSKEA ped M
and the ASSKEA ped S devices and to repeat this after the first uses.
The ASSKEA ped M and the ASSKEA ped S devices should ideally be stored and charged at room
temperature in accordance with the ambient conditions specified in the technical data. Never
store the device incl. battery in a discharged state!
Fully recharge the battery if the device is not operated for an extended period of time (approx. 10
months).
The battery of the ASSKEA ped M and the ASSKEA ped S devices are protected against deep
discharging. The battery is also protected against overheating during charging. If the battery
temperature is exceeded during charging due to improper ambient conditions, charging is
temporarily discontinued to allow cooling. The purpose of this measure is to ensure safe
operation and to protect the battery.
The typical service life of the battery is approx. 300 load cycles, subsequently more than 80 % of
the primary capacity is still available.
3.3.7 Pressure settings
Once the ASSKEA ped M or the ASSKEA ped S have been switched on, the pressure settings can
be individually adjusted by a healthcare professional.
The pressure settings can be adjusted in a range from -60 mbar to -350 mbar (in steps of 5
mbar). The setting of the pressure values is described in Section 4.3.1.
Always use the lowest possible pressure setting. Adjustments to device settings must only
be made if instructed to do so and only by healthcare professionals. Prior to switching on
the ASSKEA ped M or the ASSKEA ped S, it must be ensured that the devices are
equipped with the corresponding secretion canister.

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3.4 Warranty
Modifications of the ME device are not permitted.
The ASSKEA ped M and the ASSKEA ped S are covered by warranty for 2 years. It is neither
extended nor renewed by warranty work.
The battery is covered by warranty for 6 months. Wearing parts are excluded from the warranty.
ASSKEA GmbH is only responsible for impacts on safety, reliability and specified performance if:
•original ASSKEA accessories and replacement parts are used,
•processing and repair are performed by professionals authorized by ASSKEA GmbH or by
ASSKEA GmbH itself,
•the ASSKEA ped M and the ASSKEA ped S are used and operated in accordance with the
instructions for use and for their intended use.
All warranty claims shall be void, if:
•the device is opened by unauthorized personnel,
•the security 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.