Asskea prowound M User manual

Kurz-GA25 Homecare / Revision A-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)
Short Instructions for Use for Homecare
ASSKEA prowound®M and prowound®S
1434

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Copyright © 2019 ASSKEA GmbH, Gebesee.
The safety of the ASSKEA prowound®M and prowound®S complies with the
established technical standards and directives of the German Medical Device Act.
The ASSKEA prowound®M and prowound®S bear the CE mark CE1434 in
accordance with EU Council Directive 93/42/EEC concerning medical devices and meet
the basic requirements of Annex I of this directive.
The ASSKEA prowound®M and prowound®S have been tested in accordance with IEC
62353.
The quality management system used by ASSKEA GmbH is certified for quality
management based on relevant international standards.
The ASSKEA prowound®M and prowound®S are medical suction devices classified as
Class IIa in accordance with EC Directive 93/42/EEC Annex IX.
Subject to change and error.

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Table of Contents
1Information for the User............................................................................. 4
1.1 How to Use this Instruction Manual ............................................................ 4
1.2 Icons...................................................................................................... 4
1.2.1 General Symbols ................................................................................. 4
1.2.2 Device and Packaging........................................................................... 4
1.2.3 Display ............................................................................................... 5
1.3 Symbol Convention .................................................................................. 5
1.4 Glossary ................................................................................................. 6
1.5 Intended Use .......................................................................................... 7
1.5.1 Essential Features................................................................................ 7
1.5.2 Indications.......................................................................................... 7
1.5.3 Contraindications ................................................................................. 7
1.5.4 Precautions ......................................................................................... 7
1.6 Basic Safety Instructions .......................................................................... 8
1.7 User Requirements .................................................................................. 9
1.8 Information on Product Liability ................................................................. 9
2Product Description .................................................................................. 10
2.1 Whole View............................................................................................10
2.1.1 ASSKEA prowound®M .........................................................................10
2.1.2 ASSKEA prowound®S .........................................................................10
3Operation of the ASSKEA prowound®M and prowound®S ........................ 11
3.1 Set-Up and Startup .................................................................................11
3.1.1 Startup..............................................................................................11
3.1.2 Connecting the ASSKEA prowound®M and prowound®S .........................12
3.1.3 Connecting the disposable exudate container to the ASSKEA prowound®M 12
3.1.4 Connecting the ASSKEA disposable exudate container system to the
ASSKEA prowound®S .........................................................................13
3.1.5 Connecting a wound drainage system....................................................14
3.2 Replacement of the Disposable Exudate Container ......................................15
3.2.1 ASSKEA prowound®M .........................................................................15
3.2.2 ASSKEA prowound®S .........................................................................15
3.3 Starting and Ending the Therapy ..............................................................16
4Troubleshooting ....................................................................................... 17
5Error Messages ......................................................................................... 18
6System Specifications ............................................................................... 20
6.1 ASSKEA prowound®M.............................................................................20
6.2 ASSKEA prowound®S .............................................................................21
7Disposal.................................................................................................... 22
8Contact Information ................................................................................. 23

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1Information for the User
1.1 How to Use this Instruction Manual
Please read this entire short Instructions for Use before operating the
ASSKEA prowound®M or prowound®S device for the first time.
Please read the safety instructions (Chapter 1.6) to avoid hazards.
This short Instructions for Use is a component of the ASSKEA prowound®M and
prowound®S and should be kept in an easily accessible location.
1.2 Icons
1.2.1 General Symbols
Symbol
Meaning
Symbol
Meaning
CAUTION
Warning of possible bodily
injury or health risk.
WARNING
Warning of severe bodily
injury or resulting death.
ATTENTION
Warning of possible property
damage.
NOTE
Note containing useful
information and tips.
1.2.2 Device and Packaging
Symbol
Meaning
Symbol
Meaning
Protect from moisture
This device must not be
disposed of in domestic
waste.
Protection class II
Order number
Air pressure limitation
Serial number
Humidity limitation
Lot number
Follow the Instructions for
Use
Date of manufacture
Protection class: Type BF
(Body Floating)
Manufacturer
Temperature limitation
Do not use if packaging is
damaged!
Power supply unit
Do not reuse

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1.2.3 Display
Symbol
Meaning
Battery full
Battery weak
Battery empty
Up
Down
OK (On, Enter)
Cancel (Off, Back)
Power supply 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!
X / Y
Alarm default settings X = Sensitivity system closed
Y = Check wound dressing sensitivity
1.3 Symbol Convention
Symbol
Meaning
•
Enumeration
1.
2.
Perform the process in the specified order.

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1.4 Glossary
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
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 preparation and rapid reuse of the product.
I
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®S is protected against finger access and
falling water drops at an incline 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.
S
s
Abbreviation for second
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®S device and collected
in the disposable exudate canister.

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1.5 Intended Use
The ASSKEA prowound®M and 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 accelerate 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 including fistula treatment
Exudate management
Facilitation of granulation
Treatment of first and second degree burns
1.5.3 Contraindications
Exposed vessels that may be compressed by the pressure. This also applies to
vascular anastomoses.
Coagulopathy (risk of bleeding)
In acute minor to severe wound hemorrage 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
1.5.4 Precautions
Precautions must be taken in the following circumstances:
Patients who receive anticoagulants and have active hemorrhage
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

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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.
Operate the device with the FRIWO (Type: FW 7555M/12) power
supply unit only.
CAUTION!
Risk of personal injury from improper handling.
Use the device for its intended purpose only.
Never use the device for tracheal aspiration.
Never use the device for thoracic drainage.
When using the power supply unit, make sure the power supply unit
is connected to the mains supply (100V -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 (100V - 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.
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 this 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.

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CAUTION!
Risk of personal injury from strangulation.
People may strangle themselves on the tubing or the power cord.
Ensure during aspiration that no unauthorized/uninvolved personnel is
near the device.
Store the device including accessories in the shipping carton.
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 negatively effect the readability of the display.
ATTENTION!
Risk of damage due to electromagnetic phenomena
Medical electrical equipment is subject to special precautionary measures
regarding electromagnetic compatibility. Wireless communications
equipment such as wireless home network devices, cell phones or
cordless telephones may interfere with the operation of the device. It is
important to maintain a separation distance `d´ to the ASSKEA
prowound®Mand prowound ®S! The separation distance `d´ is
calculated as follows: d = 2.3 √P, where P is the maximum output power
rating of the transmitter in watts (W) . The separation distance is
calculated in meters.
1.7 User Requirements
The ASSKEA prowound®M or prowound®S device must only be operated and used by
instructed patients.
Familiarize yourself with the functions of the ASSKEA prowound®M or prowound®S
device prior to startup.
Training and instructions are provided by your care provider, physician or hospital
medical professional.
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 purpose,
the device is not used in accordance with the Instructions for Use,
the device is opened by unauthorized personnel,
the 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.

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2Product Description
2.1 Whole View
2.1.1 ASSKEA prowound®M
Fig. 1:
A Disposable exudate canister with integrated aspiration tube
B Locking mechanism
C (On) and (Off) buttons
D Display
E and arrow buttons
F ASSKEA prowound®M device
G Receptacle for power supply unit
2.1.2 ASSKEA prowound®S
Fig. 2:
A Disposable exudate container system (“Bag” and “OneWay”)
B Fixture for outer container (“Bag”)
C Connecting tube
D Display
E Control panel
F ASSKEA prowound®S device
G Receptacle for power supply unit

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3Operation of the ASSKEA prowound®M and prowound®S
CAUTION!
Risk of personal injury from improper handling.
Use the device for its intended purpose only.
Read Section 3.1 and 3.3!
ATTENTION!
Malfunction due to aspirated wound exudate.
Ensure that the disposable exudate container of the
ASSKEA prowound®M and prowound®S is replaced on a regular
basis. If the disposable exudate container is full, the integrated
overflow protection system is triggered. This disrupts the aspiration
process.
Switch the device off when replacing the disposable exudate
container.
If an overflow occurred, the device must be properly processed by
ASSKEA GmbH or an ASSKEA GmbH authorized service partner.
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 container for the ASSKEA prowound®M
and one backup “OneWay” aspiration bag for the ASSKEA prowound®S ready, since it
is absolutely necessary for safe operation!
Remove the device and the accessories from the packaging.
Always place the device on a sturdy and flat surface.
Inspect all tubing as well as the power supply unit for damage prior to each
startup of the ASSKEA prowound®M and prowound®S. It is important to
avoid kinking when connecting the tubing. Ensure prior to switching on the unit
that the disposable exudate container is properly connected.
Fully charge the battery prior to initial startup.
Ensure that the device is not placed in direct proximity to devices that emit interfering
signals.
Make sure that the device is not operated if it is on or directly adjacent to devices that
emit interfering signals.

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3.1.2 Connecting the ASSKEA prowound®M and prowound®S
Use the power input receptacle of the ASSKEA prowound®M (Chapter 2.1.1, Fig.1 (G))
or the power input receptacle of the ASSKEA prowound®S (Chapter 2.1.3, Fig.2 (G)) to
connect the device to the mains supply via the supplied power supply unit (Type: FW
7555M/12) for charging or operation as required.
Use the supplied power supply unit only. First connect the power supply unit to the power
input receptacle of the ASSKEA prowound®M or prowound®S and then to the mains
supply.
Fig. 3 Connecting the ASSKEA prowound®M and prowound®S to the patient and accessories
3.1.3 Connecting the disposable exudate container to the ASSKEA prowound®M
Fig.4:
A Disposable exudate container including aspiration tube
B Locking mechanism
C Aspiration port
D ASSKEA prowound®M
E Guiding rail
1. Remove the disposable exudate container (Fig. 3 (A)) from the packaging.
2. Slide the container on the guiding rails (Fig. 3 (E)) of the ASSKEA prowound®M
until the disposable exudate container clicks into place in the locking mechanism
(Fig. 3 (B)).

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3.1.4 Connecting the ASSKEA disposable exudate container system to the
ASSKEA prowound®S
ATTENTION!
Malfunction due to collapsing “OneWay” aspiration bag.
A leak in the “Bag” or at the lid may cause air to flow into the outer “Bag”
container. This may lead to the collapse of the “OneWay” aspiration bag.
Inspect the disposable exudate container system (“Bag” and
“OneWay”) to ensure that the lid of the “OneWay” aspiration bag
is firmly connected to the outer “Bag” container.
Ensure that all connections are firmly attached.
Follow the Instructions for Use supplied by the manufacturer!
The original ASSKEA disposable exudate container system consists of the outer “Bag”
container, the holder for the outer “Bag” container, the “OneWay” aspiration bag and the
connecting tube for “OneWay”.
Port names
A Vacuum port
B Patient port
Please also follow the Instructions for
Use supplied with the disposable
exudate container system (“Bag” and
“OneWay”)!
Fig. 5
1. Remove the “OneWay” aspiration bag from the packaging and fully extend it.
Fig. 6
2. Place the “OneWay” aspiration bag in the reusable outer “Bag” container.
Press the lid’s edges firmly down to ensure proper sealing.

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Fig. 7
3. Attach the prefitted connecting tube of the “OneWay” aspiration bag to the
bottom end of the T-piece located at the outer container.
Fig. 8
4. Connect the vacuum port of the device with the corresponding vacuum port of
the outer “Bag” container (top end of the T-piece). Use the supplied connecting
tube to do so.
Fig. 9
5. Connect the patient port of the “OneWay” aspiration bag (Fig. 5 (B)) to the
aspiration tube.
3.1.5 Connecting a wound drainage system
Connect the aspiration tube of the disposable exudate container to the wound drainage
system.
The aspiration tube must never come into direct contact with the aspiration area.

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3.2 Replacement of the Disposable Exudate Container
3.2.1 ASSKEA prowound®M
1. Close the tubing clamp of the wound drainage system (Fig. 3) to maintain the
vacuum in the wound.
2. Switch the ASSKEA prowound®M off.
3. Separate the aspiration tube from the wound drainage system and seal the Luer
connector with a protective cap.
4. Press on the locking mechanism at the top of the container (Fig. 4 (B)) and keep it
pressed while pulling the disposable exudate container horizontally away from the
device.
5. Dispose of the disposable exudate container and the integrated aspiration tube in a
properly manner. (Please refer to Chapter 7 “Disposal”)
6. Place a new disposable exudate container in the device. Ensure that the disposable
exudate container is properly seated in the device.
7. Connect the aspiration tube to the wound drainage system (Fig. 3).
8. Switch the ASSKEA prowound®Mon.
9. Loosen the tubing clamp of the wound drainage system.
3.2.2 ASSKEA prowound®S
1. Close the tubing clamp of the aspiration tube (Fig. 3) to maintain the vacuum in the
wound.
2. Switch the ASSKEA prowound®Soff.
3. Separate the aspiration tube from the patient port of the “OneWay” (Fig. 5 (B)).
4. Separate the connecting tube of the “OneWay” aspiration bag at the bottom end of the
T-piece of the outer container and attach it to the patient port (Fig. 5(B)).
5. Remove the “OneWay” aspiration bag from the reusable outer “Bag” container.
6. Dispose of the “OneWay” aspiration bag in a properly manner. (Please refer to Chapter
7 “Disposal”)
7. Place a new “OneWay” aspiration bag in the reusable outer “Bag” container as specified
in 3.1.3. Ensure that the lid of the aspiration bag is properly seated on the outer
container and the connecting tube.
8. Attach the aspiration tube to the patient port of the “OneWay” (Fig. 5 (B)).
9. Switch the ASSKEA prowound®Son.
10. Loosen the tubing clamp of the aspiration tube.

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3.3 Starting and Ending the Therapy
1. Press the button for 1-2 seconds to switch on the ASSKEA prowound®M or
prowound®S. The following start screen is displayed:
2. After 5 seconds an overview screen is displayed that shows the most recent
therapy parameter settings.
or
3. Press the button to continue the therapy. The color of the display changes from
orange to green.
or
4. Press the button to stop the pump.
5. Switch the ASSKEA prowound®M or prowound®S off by pressing the
button for 3 seconds.
Additional information on the operation of the devices is provided in the Instructions for
Use of the ASSKEA prowound®M and prowound®S.
5 / 2
5 / 2

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4Troubleshooting
Malfunction
Probable causes
Remedy
Device does not
start
-Battery is empty
- Tubing clamp is closed
-Overflow protection system is
blocked (disposable exudate
container is full)
- Internal filter is blocked
-Device is still in the Setup
mode
-Connect the power supply unit
- Verify proper connection of the
tubing
-Replace disposable exudate
container
- Please contact the physician,
nursing staff or ASSKEA GmbH.
-Finalize the selection (please refer
to 3.2) and start the device.
Contact your physician, the nursing staff or ASSKEA GmbH if the malfunction
cannot be corrected by the described measures.

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5Error Messages
The alarms are solely alarms that are triggered by the system.
Alarm messages of high priority are shown in the display with a red blinking
background and the beeper is sounded (3x, pause, 2x, 3x, pause, 2x) every 3
seconds.
Alarm messages of low priority are shown in the display with a static yellow
background and the beeper is sounded periodically (2x) every 15 seconds.
If the error messages cannot be resolved based on the measures specified in
Chapter 4, contact your physician, nursing staff or ASSKEA GmbH.
Error message
Status
Probable cause
Remedy
Beeper on.
Pump off.
Discontinuation of
the current
operating mode.
Disposable exudate
container is not
connected or not
properly connected.
Press the button to
confirm the error
message.
Check for proper
connection.
Start pump.
Beeper on.
Pump off.
Discontinuation of
the current
operating mode.
Disposable exudate
container is full.
Exudate flow
obstructed.
(tubing is kinked or
stenosis in the
tubing).
If the alarm is
displayed even if the
container is not
connected, the
internal bacterial filter
is blocked.
Press the button to
confirm the error
message.
Switch off the device.
Replace the disposable
exudate container.
Check the tubing and
wound dressing.
Replace the internal
filter.
Beeper on.
Current operating
mode continues to
run in the
background.
Wound dressing is
leaking.
Additional probable
causes: Tube or
container is not
properly connected.
Press the button to
confirm the error
message.
Switch off the device.
Check the wound
dressing and re-apply if
necessary. Switch on
the device.
Check the tube
connection and the
container.
Beeper on. Pump
off.
Discontinuation of
the current
operating mode.
Battery is empty.
Press the button to
confirm the error
message.
Connect the power
supply unit.

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Error message
Status
Probable cause
Remedy
Beeper on. Pump
off.
Internal error.
Shortly plug in the
power supply unit and
unplug again.
If the error reoccurs 60
seconds after restarting,
contact ASSKEA GmbH!
Beeper on.
Current operating
mode continues to
run in the
background.
Low battery charge
level.
Press the button to
confirm the error
message.
Connect the power
supply unit soon.
Beeper on (after
15 minutes).
Current operating
mode continues to
run in the
background.
Pump was not
started, the therapy
was not initiated.
Press the button to
confirm the error
message.
Start pump.

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6System Specifications
6.1 ASSKEA prowound®M
Suction performance of the unit
max. 8 l/min
Pressure
max. -200 mmHg;
Conversion factor: 1 kPa ~ 7.5 mmHg
Container
Disposable exudate container (250 ml)
Suction tube
Aspiration tube: PVCnoDEHP tube, 4mm (internal)
Power supply unit
FRIWO 7555M/12, cable length 4m
Nominal voltage of the power
supply unit
100 –240 V AC primary / 12 V DC secondary
UL listed markets 120V AC primary
Maximum load current
1.25 A
Supply frequency of the power
supply unit
50/60 Hz
Nominal voltage of the circuit
board
12 V DC
Power consumption
15 W
Current consumption
1.25 A at 12 V DC
Battery, rechargeable
7.4 V, 4.4 Ah –Lithium ions
Charging time if battery is
empty
Charging time if battery is
approx. 50% full
6 - 7 hours
3 –3.5 hours
Dimensions (H x W x D) in mm
220 x 165 x 90
Weight (base unit)
1.2 kg
Operating time
Mains: Continuous operation
Battery: approx. 24 –48 hours, depending on the run
time of the motor
Protection class per IEC 60601-
1
Type BF
Risk category per 93/42/EEC, IX
IIa
Protection class per IEC 60601-
1
II
IP protection class
IP22
CE Mark
CE1434
UL mark
Sound emission
Operation:
35 dB (A)
High priority alarm:
66 dB (A)
Low priority alarm:
63 dB (A)
Ambient conditions
Transport/Storage: -25°C to +60°C
with humidity of max. 93%
non-condensing
Operation: +5°C to +40°C
humidity 15% to 93%
non-condensing
Air Pressure: 700 hPa to 1060 hPa
Pressure measurement accuracy
Target pressure > -80 mmHg
max. 5 %
Target pressure < -80 mmHg
max. 10 %
Item number
100514
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)