Asskea prowound M User manual

GA03-04 / Revision C-1 / 2019-08
AS TO ELECTRICAL
SHOCK, FIRE AND
MECHANICAL HAZARDS
ONLY IN ACCORDANCE
WITH ANSI/AAMI
ES60601-1 (2005),
CAN/CSA-C22.2 No.
60601-1 (2008)
Instruction for Use
ASSKEA prowound®M and ASSKEA prowound®S
1434

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Copyright © 2019 ASSKEA GmbH, Gebesee.
The safety of the ASSKEA prowound®M and ASSKEA prowound®S complies with the
acknowledged rules of technology and meets the requirements of the German Medical Devices
Act.
The ASSKEA prowound®M and ASSKEA prowound®S bear the CE marking CE1434 in
accordance with EU Council Directive 93/42/EEC concerning medical devices and meet the
essential requirements of Annex I of this directive.
The ASSKEA prowound®M and ASSKEA prowound®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 prowound®M and ASSKEA prowound®S are medical suction devices classified as
class IIa in accordance with EU Council Directive 93/42/EEC, Annex IX.
Errors and omissions excepted.

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Table of Contents
1User Information .................................................................................................................. 5
1.1 Using this Instruction for Use...................................................................................................5
1.2 Icons.............................................................................................................................................5
1.2.1 General Symbols...................................................................................................................5
1.2.2 Device and Packaging ..........................................................................................................5
1.2.3 Display....................................................................................................................................6
1.3 Symbol Convention....................................................................................................................6
1.4 Glossary.......................................................................................................................................7
1.5 Intended Use ..............................................................................................................................8
1.5.1 Essential Features.................................................................................................................8
1.5.2 Indications .............................................................................................................................8
1.5.3 Contraindications .................................................................................................................8
1.5.4 Precautions............................................................................................................................9
1.5.5 Restrictions on use ...............................................................................................................9
1.6 Basic Safety Instructions ...........................................................................................................9
1.7 User Requirements..................................................................................................................11
1.8 Information on Product Liability ............................................................................................11
1.9 Material Compatibility.............................................................................................................11
2Product Description............................................................................................................ 12
2.1 Whole View ...............................................................................................................................12
2.1.1 ASSKEA prowound®M ........................................................................................................12
2.1.2 ASSKEA prowound®M product contents.........................................................................12
2.1.3 ASSKEA prowound®S .........................................................................................................13
2.1.4 ASSKEA prowound®S product contents ..........................................................................13
2.2 Product Properties...................................................................................................................14
2.2.1 Disposable exudate canister for ASSKEA prowound®M ...............................................14
2.2.2 Information on the ASSKEA filter system for the ASSKEA prowound®M....................15
2.2.3 Information on the carbon filter of the ASSKEA prowound®M....................................15
2.2.4 Disposable exudate canister system for ASSKEA prowound®S ...................................16
2.2.5 Information on the double filter system for ASSKEA prowound®S .............................16
2.2.6 Battery..................................................................................................................................17
2.2.7 Pressure settings ................................................................................................................17
2.3 Warranty ...................................................................................................................................18
3Operation ............................................................................................................................ 19
3.1 Set-Up and Startup ..................................................................................................................20
3.1.1 Startup .................................................................................................................................20
3.1.2 Connecting the ASSKEA prowound®M and ASSKEA prowound®S...............................20
3.1.3 Positioning of the ASSKEA prowound®M ........................................................................21
3.1.4 Connecting the disposable exudate canister of the ASSKEA prowound®M...............21
3.1.5 Positioning of the ASSKEA prowound®S..........................................................................22
3.1.6 Connecting the ASSKEA disposable exudate canister system of the
ASSKEA prowound®S .........................................................................................................22
3.1.7 Connecting a wound drainage system ............................................................................24
3.2 Operation of the ASSKEA prowound®M and ASSKEA prowound®S .................................25
3.2.1 Operation at initial startup................................................................................................25
3.2.2 Continuous operation........................................................................................................25
3.2.3 Intermittent operation.......................................................................................................27
3.2.4 Language selection.............................................................................................................29
3.2.5 Alarm delay at startup .......................................................................................................29

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3.3 Patient Mode ............................................................................................................................30
3.4 Canister exchange ...................................................................................................................32
3.4.1 Replacement of the disposable canister of the ASSKEA prowound®M ......................32
3.4.2 Replacement of the disposable liner “OneWay” of the ASSKEA prowound®S ...........32
4Maintenance ....................................................................................................................... 33
4.1 Cleaning and Care....................................................................................................................33
4.1.1 General Information...........................................................................................................33
4.1.2 Cleaning and disinfection of the surface of the device .................................................34
4.1.3 Disposal of the disposable exudate canister incl. the suction tube for
ASSKEA prowound®M ........................................................................................................34
4.1.4 Disposal of the disposable liner “OneWay” and the suction tube for
ASSKEA prowound®S .........................................................................................................34
4.1.5 Cleaning / disinfection of the external canister “Bag” for ASSKEA prowound®S .......34
4.1.6 Cleaning / disinfection of the tubing accessories for ASSKEA prowound®S ..............35
4.2 Maintenance and Service........................................................................................................35
4.3 Testing of the ASSKEA prowound®M or ASSKEA prowound®S..........................................35
5Problem Solving .................................................................................................................. 36
5.1 Function Test ............................................................................................................................36
5.2 Troubleshooting.......................................................................................................................36
5.3 Error Messages.........................................................................................................................37
6Transport, Storage and Disposal....................................................................................... 39
6.1 Decontamination prior to Shipment .....................................................................................39
6.2 Storage ......................................................................................................................................39
6.3 Disposal.....................................................................................................................................39
7Technical Data .................................................................................................................... 40
7.1 ASSKEA prowound®M .............................................................................................................40
7.2 ASSKEA prowound®S...............................................................................................................41
7.3 EMC Information......................................................................................................................42
8Ordering Information......................................................................................................... 47
8.1 ASSKEA prowound®M .............................................................................................................47
8.2 ASSKEA prowound®S...............................................................................................................47
9Publishing Information ...................................................................................................... 48

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1User Information
1.1 Using this Instruction for Use
Please read this entire instruction for use before operating the ASSKEA prowound®M or
ASSKEA prowound®S device for the first time.
Please read the safety instructions (chapter 1.6) to avoid hazards.
This instruction for use is a component of the ASSKEA prowound®M and ASSKEA prowound®S.
Keep this instruction for use in an easily accessible location.
Include this instruction for use when passing the ASSKEA prowound®M or ASSKEA prowound®S
device on to third parties.
1.2 Icons
1.2.1 General Symbols
Symbol
Meaning
Symbol
Meaning
Attention: possible bodily
injury, health risks or possible
property damage.
NOTE
Note containing useful
information and tips.
1.2.2 Device and Packaging
Symbol
Meaning
Symbol
Meaning
Protect from moisture
Order number
Protection class II
Serial number
Humidity limitation
Lot number
Air pressure limitation
Date of manufacture
Follow the instruction 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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1.2.3 Display
Symbol
Meaning
Battery full
Battery low
Battery empty
Up
Down
OK (On, Enter)
Cancel (Off, Back)
Power supply unit is connected
Max pressure / Max time
Min pressure / Min time
Keylock (symbol in display)
Is activated automatically during operation and can be cancelled by
simultaneously pressing the Up and Down buttons.
Filter run time elapsed; replacement of the internal filter by service is
required!
Alarm default settings
X = Sensitivity “System closed”
Y = Sensitivity “Check dressing seal”
1.3 Symbol Convention
Symbol
Meaning
•
Enumeration
1.
2.
Perform the process in the specified order.

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1.4 Glossary
A
approx.
Abbreviation for “approximately”
C
Contamination
Contamination means that bacteria and viruses from the wound exudate have
come into contact with the interior of the device.
D
DFS®
Double filter system (only ASSKEA prowound®S)
The double filter system comprises the external filter and the bacterial filter
integrated in the suction device. 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.
E
e.g.
For example, abbreviation for Latin “exempli gratia”
I
incl.
Abbreviation for “inclusive”
IP22
International Protection / Protection Class
The Protection Class defines the degree of protection of the device against
contact and ingress of liquids.
The ASSKEA prowound®M and ASSKEA prowound®S are protected against
finger access and falling water drops at an inclination of up to 15°.
O
Overflow
Overflow means that the wound exudate is sucked into the interior of the
device.
P
Processing
The processing procedure is required for each new patient. The term
processing denotes the process in which parts coming or potentially coming
into contact with wound exudate are cleaned, disinfected and replaced if
necessary.
The processing procedure must only be performed by ASSKEA GmbH or an
authorized service partner of ASSKEA GmbH.
W
Wound exudate
The term wound exudate denotes all collecting liquids and particles that may
be formed or present in a wound. The wound exudate is aspirated from the
wound using the ASSKEA prowound®M and ASSKEA prowound®S devices
and collected in the disposable exudate canister.

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1.5 Intended Use
The ASSKEA prowound®M respectively ASSKEA prowound®S device is designed for the
aspiration of wound exudate. It is intended for patients who may benefit from vacuum wound
care, especially since it may accelerates wound healing.
1.5.1 Essential Features
Generation of a vacuum
Generation of volumetric flow
Aspiration of wound exudate
1.5.2 Indications
Leg ulcer (venous, arterial, mixed)
Decubitus ulcer
Diabetic food ulcer
Posttraumatic and postoperative wounds
Initially infected wounds after surgical debridement (bite wounds, insect stings, necrotizing
fasciitis)
Soft tissue injuries (lacerated and contused wounds, decollement injury)
Injuries with exposition of bone or bradytrophic tissue
Wound after limb compartment splitting
Status post skin transplantation (e.g. mesh graft, until adequate healing of the transplant on
day 5 or 6)
Sternal wound infections (after surgical debridement)
Open abdominal treatment incl. fistula treatment
Exudate management
Facilitation of granulation
Treatment of first and second degree burns
1.5.3 Contraindications
The ASSKEA prowound®M and ASSKEA prowound®S are contraindicated for the following
applications:
Aspiration in the trachea region
Thorax drainage
Exposed vessels that may be compressed by the vacuum. This also applies to vascular
anastomoses.
Coagulopathy (risk of bleeding)
In acute minor to severe wound bleeding after injury / surgical debridement
Tissue necroses
Unexplored fistulas
Untreated osteomyelitis
Malignant wounds
Exposed organs
Dry wound conditions, e.g. dry or mildly exudating wounds
Third degree burns

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1.5.4 Precautions
Precautions must be taken in the following circumstances:
Patients who receive anticoagulants and have active bleeding
Patients with complicated wound hemostases
Use of the device in direct proximity to blood vessels, organs, muscles and fascias
Irradiated vessels and tissues
Bone fragments
Uncooperative patients
Untreated malnutrition
1.5.5 Restrictions on use
In medical rooms where potential equalization is necessary (e.g. heart surgery)
In hazardous areas
Outside / outdoor
1.6 Basic Safety Instructions
CAUTION!
Health risks due to the handling of infectious liquids or pathogenic germs.
Infectious and pathogenic germs in the wound exudate cause health risks.
Perform wound treatment carefully.
Follow the hygiene, cleaning and decontamination instructions.
WARNING!
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 is designed to operate at
supply voltages of 100-240 V alternating current.
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
alternating current.
Only operate the device with the provided power supply unit (Type: FRIWO
FW 7555M/12).
ATTENTION!
Risk of damage due to electromagnetic phenomena.
Medical electrical equipment is 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 chapter 7.3)

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CAUTION!
Hazard of persons due to improper handling.
Use the device for its intended purpose only.
Never use the device for tracheal aspiration.
Never use the device for thorax drainage.
When using the power supply unit, make sure the power supply unit is
connected to the mains supply (100 V -240 V AC) only after the power cord
plug of the power supply unit has first been connected to the suction device.
The separation of the power supply unit from the mains supply must occur
in exactly the opposite sequence (first separate the power supply unit from
the mains supply (100 V - 240 V AC) and then the power cord plug from the
suction device).
ATTENTION!
Damage to the device due to improper handling.
Never aspirate flammable, corrosive or explosive liquids or gases.
Do not drop the device.
Do not use the device in case of apparent housing damage.
CAUTION!
Safety defects due to improper accessories and spare parts.
The use of accessories and spare parts other than those recommended by
ASSKEA GmbH may compromise the safety and function of the device. Damage
caused by using non-recommended accessories and spare parts or by
improper use is not covered by warranty in any case.
Only use original accessories and spare parts.
ATTENTION!
Damage to the device by ingress of liquids.
Do not use the device near splashing water.
Do not use the device in damp rooms or while bathing or showering.
Do not allow the power supply unit, plug and display film to get wet.
Never submerge the device in water or other liquids (also not while not in
operation).
ATTENTION!
Damage to the device by heat.
Do not cover the power supply unit.
Keep the device as well as the power cord and power supply unit away from
other heat sources.
CAUTION!
Hazard of persons due to strangulation.
People may strangle themselves on the tubing or the power cord.
Ensure that no unauthorized/uninvolved personnel is near the device during
aspiration.
Store the device incl. accessories in the shipping carton.

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ATTENTION!
Known or identifiable conditions for medical care within a domestic
environment
Children and pets must be kept away from the device to ensure that the
device is not knocked over or dropped.
Prior to connecting the power supply unit, ensure that the voltage of the
device corresponds to the domestic power supply.
Do not use the device in damp rooms, baths or showers.
Do not allow the power supply unit, plug and switch unit to get wet.
Never submerge the device in water or other liquids (also not while not in
operation).
Incident light may effect the readability of the display negatively.
1.7 User Requirements
The ASSKEA prowound®M or ASSKEA prowound®S device must only be operated and used by
instructed and trained personnel.
Familiarize yourself with the functions of the ASSKEA prowound®M or ASSKEA prowound®S
device prior to startup.
Training on the operation of ASSKEA prowound®M and ASSKEA prowound®S is provided by
ASSKEA GmbH or an authorized service partner of ASSKEA GmbH. Product training takes
approximately one to two hours and includes an explanation of the design and function of the
device, the handling of the device, the alarm system, the cleaning and disinfection as well as the
procedure to be followed for each new patient and for disposal.
Training should be repeated on a regular basis every 24 months.
Each participant receives a certificate as proof of training.
1.8 Information on Product Liability
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,
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.
1.9 Material Compatibility
ATTENTION!
Aggressive substances may damage the device and the accessories.
Please follow the cleaning and care instructions (chapter 4.1)

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2Product Description
2.1 Whole View
2.1.1 ASSKEA prowound®M
Fig. 1 ASSKEA prowound®M
A Disposable exudate canister (250 ml) with integrated suction tube
B Canister locking mechanism
C (On) and (Off) buttons
D Display
E and arrow buttons
F ASSKEA prowound®M device
G Socket for power supply unit
2.1.2 ASSKEA prowound®M product contents
the device ASSKEA prowound®M
2 x disposable exudate canister (250 ml) with integrated bacterial filter, carbon filter, solidifier
and suction tube
power supply unit (Type: FRIWO FW 7555M/12) incl. country adapter
instruction for use
multilingual charging instructions
“Used Medical Device” label and decontamination certificate
test report according to IEC 62353
instructions for safe handling of battery packs
optional accessories (depending on the order)
A separate Quick Reference Guide for use of the ASSKEA prowound®M in in-home care is
available for download on our internet page (www.asskea.de) under “Download”.

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2.1.3 ASSKEA prowound®S
Fig. 2 ASSKEA prowound®S
A Disposable exudate canister system (1,000 ml)
B Holder for external canister “Bag”
C Connecting tube
D Display
E Control panel ( (On) and (Off) buttons and and arrow buttons)
F ASSKEA prowound®S device
G Socket for power supply unit
2.1.4 ASSKEA prowound®S product contents
the device ASSKEA prowound®S
disposable exudate 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 (Type: FRIWO FW 7555M/12) incl. country adapter
instruction for use
multilingual charging instructions
“Used Medical Device” label and decontamination certificate
test report according to IEC 62353
instructions for safe handling of battery packs
optional accessories (depending on the order)
A separate Quick Reference Guide for use of the ASSKEA prowound®S in in-home care is
available for download on our internet page (www.asskea.de) under “Download”.

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2.2 Product Properties
CAUTION!
Hazard of persons due to improper handling.
Use the device for its intended use only.
Never use the device for tracheal aspiration.
Never use the device for thorax drainage.
ATTENTION!
Damage to the device due to improper handling.
Never aspirate flammable, corrosive or explosive liquids or gases!
Do not drop the device!
Do not use the device in case of apparent housing damage.
The ASSKEA prowound®M and ASSKEA prowound®S devices are lightweight, portable, battery
powered aspirators for stationary and mobile use in the medical aspiration of wound exudate.
They are intended for aspiration in the low vacuum range and can be used in the hospital and
doctor’s office, during patient transport and in in-home care.
The ASSKEA prowound®M and ASSKEA prowound®S devices are operated via the internal
battery or via the supplied power supply unit that also can be used to recharge the battery.
The vacuum is generated by a maintenance free electric motor driven membrane pump. After it
is switched on, the vacuum pump creates a vacuum in the tubing system and disposable exudate
canister, which is used to aspirate wound exudate. The wound exudate is directed away from the
patient and collected in the disposable exudate canister. If the disposable exudate canister is full,
the device triggers the “System closed” alarm via an integrated overflow protection system and
stops the pump.
The ASSKEA prowound®M and ASSKEA prowound®S devices must only be operated with the
supplied disposable exudate canister.
The expected lifetime of the ASSKEA prowound®M and ASSKEA prowound®S is 36 months.
The provided disposable exudate canister for the ASSKEA prowound®M as well as the
disposable liner “OneWay” and the suction tube for the ASSKEA prowound®S are intended for
single use.
2.2.1 Disposable exudate canister for ASSKEA prowound®M
The disposable exudate canister consists of a canister with a connected suction tube. The
disposable exudate canister has an integrated bacterial filter, carbon filter and solidifier. The
hydrophobic bacterial filter integrated in the disposable exudate canister is 99.999% 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” appears on the display. The aspiration process is discontinued. The
disposable exudate canister must be replaced.
The activated carbon filter in the disposable exudate canister reduces the spread of odor.

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Solidifier:
Disposable exudate canisters filled with wound exudate can be transported and disposed of in a
leak-proof manner by using the solidifier. The wound exudate solidifies after an average gelling
time of 2 to 5 minutes (depending on the consistency of the wound exudate), irrespectively of the
aspiration intervals.
The disposable exudate canister incl. the suction tube is intended for single use.
Replace the disposable exudate canister in accordance to the respectively applicable
hygiene instructions, if it is full, prior to each new patient or weekly at the latest.
2.2.2 Information on the ASSKEA filter system for the ASSKEA prowound®M
The filter system of the ASSKEA prowound®M consists of the external bacterial filter integrated
in the disposable exudate canister and the internal filter installed in the device. The internal filter
is a self-sealing bacterial filter and is 99.999% effective against bacteria and viruses in
combination with the integrated filter in the disposable exudate canister.
The ASSKEA filter system effectively protects the interior of the device from
contamination and overflow.
Service life and reuse
The internal filter is not intended for reuse. To ensure consistent performance, the
internal filter must be replaced after contact with the exudate (blocked), after the
filter service life has expired ( symbol in the display) or during maintenance /
repair.
The internal filter must be replaced by ASSKEA GmbH or an authorized service partner of
ASSKEA GmbH.
2.2.3 Information on the carbon filter of the ASSKEA prowound®M
An additional filter in the exhaust air vent of the ASSKEA prowound®M removes undesirable
odor out of the exhaust air of the device. This filter consists of a thin activated carbon coated
nonwoven. The activated carbon in the nonwoven adsorbs the odor particles of the exhaust air
and neutralizes them. Spreading of odor will be effectively reduced.
Service life and reuse
The carbon filter 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.

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2.2.4 Disposable exudate canister system for ASSKEA prowound®S
The disposable exudate canister system consists of the external canister “Bag” and the
disposable liner “OneWay”. 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 99% effective against microorganisms. 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” appears on the display. The aspiration process is
discontinued. The disposable liner “OneWay” must be replaced.
The activated carbon filter in the disposable liner “OneWay” reduces the spread of odor.
Solidifier:
Disposable liners “OneWay” filled with wound exudate can be transported and disposed of in a
leak-proof manner by using the solidifier. The wound exudate solidifies after an average gelling
time of 2 to 5 minutes (depending on the consistency of the wound exudate), irrespectively of the
aspiration intervals.
The disposable liner “OneWay”and the suction tube are intended for single use.
Replace the disposable liner “OneWay”incl. suction tube in accordance to the respectively
applicable hygiene instructions, if it is full, prior to each new patient or weekly at the
latest.
2.2.5 Information on the double filter system for ASSKEA prowound®S
The ASSKEA double filter system DFS®consists of the external bacterial filter integrated in the
disposable liner “OneWay”and the internal filter installed in the device. The filters are
hydrophobic and self-sealing bacterial filters, which, in combination, are 99.999% effective
against bacteria and viruses.
The internal bacterial filter is installed in the ASSKEA prowound®S.
The external bacterial filter is incorporated in the disposable liner “OneWay”.
The ASSKEA double filter system DFS®effectively protects against overflow and
contamination of the interior of the device. It permits fast, simple and cost-effective
processing.
Service life and reuse
The internal filter of the ASSKEA double filter system DFS®as well as the disposable liner
“OneWay”are not intended for reuse. To ensure consistent performance, the internal filter
must be replaced after contact with the exudate (blocked), after the filter service life
has expired ( symbol in 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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2.2.6 Battery
The charge level of the battery is shown in the display.
It is strongly recommended to fully charge the battery prior to first startup of the
ASSKEA prowound®M and ASSKEA prowound®S and to repeat this after the first uses.
The ASSKEA prowound®M and ASSKEA prowound®S are equipped with a lithium-ion battery,
which, unlike traditional types of rechargeable batteries, has a low self-discharge rate.
The ASSKEA prowound®M and ASSKEA prowound®S device 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 a longer period of time (approx. 10
months).
Lithium-ion rechargeable batteries do not have a memory effect. They can, therefore, be
recharged at any time after initial charging.
Only frequent short-time charging should be avoided.
The battery of the ASSKEA prowound®M and ASSKEA prowound®S is protected against deep
discharge, but the charging information listed above must nevertheless be followed. 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 operational service life of the battery is 2 years. According to the manufacturer of the
battery, the battery has a remaining capacity of more than 80% after 300 charge cycles.
2.2.7 Pressure settings
Once the ASSKEA prowound®M or ASSKEA prowound®S has been switched on, the pressure
settings can be individually adjusted by a healthcare professional.
The pressure settings can be adjusted in a range from -20 mmHg to -200 mmHg (in steps of
5 mmHg). The setting of the pressure and time values is described in chapter 3.2.
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 prowound®M or ASSKEA prowound®S it must be
ensured that the device is equipped with a disposable exudate canister.
The wound dressing must be checked if a shift change occurs or every 8 hours. The
wound dressing contracts if a sufficient vacuum is applied and the system is not leaking.

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2.3 Warranty
The devices of ASSKEA GmbH 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 responsible for impacts on safety, reliability and specified performance only if :
original ASSKEA accessories and spare parts are used,
maintenance and repair are performed by professionals authorized by ASSKEA GmbH or by
ASSKEA GmbH itself,
the affected product is used and operated in accordance with the instruction for use and
within its intended use.
ASSKEA GmbH does not warrant accurate function of the devices ASSKEA prowound®M and
ASSKEA prowound®S and is not liable for a loss of property or personal injury in the following
circumstances:
no original ASSKEA accessories or spare parts are used,
using information of this instruction for use are ignored,
installation, settings, changes, upgrades or repairs are not carried out by ASSKEA GmbH or by
professionals authorized by ASSKEA GmbH,
the safety seal is broken or removed.
All warranty claims are voided if the device is opened by unauthorized individuals, the
safety seal is removed / damaged or repairs have been performed by unauthorized
individuals.

page 19 of 48
3Operation
CAUTION!
Hazard of persons due to improper handling.
Use the device for its intended purpose only.
Read chapter 3.1 and 3.2!
ATTENTION!
Malfunction due to aspirated wound exudate.
Ensure that the disposable exudate canister of the ASSKEA prowound®M
and ASSKEA prowound®S is replaced on a regular basis. If the disposable
exudate canister is full, the integrated overflow protection system is
triggered. This disrupts the aspiration process.
Switch the device off when replacing the disposable exudate canister.
If the internal filter of the ASSKEA prowound®M or the DFS®of the
ASSKEA prowound®S is blocked, the device must be properly processed by
ASSKEA GmbH or by an authorized service partner of ASSKEA GmbH!
WARNING!
Hazard of persons due to inadequate monitoring of patient.
A regular adequate monitoring of patient is mandatory in case of intensivly
exuding wounds, wounds with viscous or strongly deposited exudate and
strong bleedings.
Particular attention must be paid to exudate retention in the wound dressing
and the proper seating of the dressing.
The establishment of the monitoring interval must be dependent on the wound
situation, the health of the patient and the settings of the alarm sensitivities.
WARNING!
Hazard of persons due to decreasing the alarm sensitivities.
When strong decreasing the alarm sensitivities, it is not excluded that a
blockage or leakage in the wound and tube system is not detected and thus no
alarm can be triggered.
The devices ASSKEA prowound®M and ASSKEA prowound®S are designed to
build up a vacuum in the wound drainage system and to aspirate the exudate.
The devices are not designed to detect strong bleeding or congaries of blood in
the wound. For this reason you must not rely solely on the alarm system of the
devices ASSKEA prowound®M and ASSKEA prowound®S.
The execution of regular monitoring of the patient and the wound dressing can
reduce a severe deterioration of health of the patient dramatically.
WARNING!
Hazard of persons during operation in a domestic environment.
Due to the increasing mobility of patients in a domestic environment, there is
an increasing risk of forming leaks or blockages in the wound dressing or tube
system.
For this reason, a detailed training and instruction of patients as well as
performing regular monitoring of the wound dressing and aspiration system by
trained personnel is mandatory.

page 20 of 48
3.1 Set-Up and Startup
3.1.1 Startup
It is important to follow the safety instructions in chapter 1.6 prior to initial startup.
Always have one backup disposable exudate canister for the ASSKEA prowound®M and one
backup disposable liner „OneWay“ for the ASSKEA prowound®S ready, since it is absolutely
necessary for safe operation!
Please read this entire instruction for use before operating the ASSKEA prowound®M or
ASSKEA prowound®S device for the first time.
Remove the device and the accessories from the packaging.
Always place the device on a sturdy and flat surface, take care of the correct position of the
device.
Inspect all tubing as well as the power supply unit for damage prior to each startup of the
ASSKEA prowound®M and ASSKEA prowound®S. It is important to avoid kinking when
connecting the tubing. Ensure prior to switching on the unit that the disposable exudate
canister and tubings are properly connected.
Fully charge the battery prior to initial startup.
Perform a function test! (Please refer to chapter 5.1)
3.1.2 Connecting the ASSKEA prowound®M and ASSKEA prowound®S
Use the socket for power supply unit of the ASSKEA prowound®M (chapter 2.1.1, fig.1 (G)) or the
socket for power supply unit of the ASSKEA prowound®S (chapter 2.1.3, fig.2 (G)) to connect the
device to the mains power supply via the supplied power supply unit (type: FRIWO FW 7555M/12)
for charging or operation as required.
Use the supplied power supply unit only. First connect the power supply unit to the socket for
power supply unit of the ASSKEA prowound®M or ASSKEA prowound®S and then to the mains
power supply.
Fig. 3 Connecting the ASSKEA prowound®M and ASSKEA prowound®S to the patient and accessories