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Short Instructions for Use for Homecare
®
®
ASSKEA prowound
M and prowound
S
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)
1434
Kurz-GA25 Homecare / Revision A-1 / 2019-08

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Summary of Contents for Asskea prowound M

  • Page 1 Short Instructions for Use for Homecare ® ® ASSKEA prowound M and prowound 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) 1434 Kurz-GA25 Homecare / Revision A-1 / 2019-08...
  • Page 2 ® 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.
  • Page 3: Table Of Contents

    ® 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...
  • Page 4: Information For The User

    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.
  • Page 5: Display

    1.2.3 Display Symbol Meaning Battery full Battery weak Battery empty 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.
  • Page 6: Glossary

    The processing procedure must only be performed by ASSKEA GmbH or an authorized service partner of ASSKEA GmbH. Abbreviation for second Wound exudate The term wound exudate denotes all collecting liquids and particles that may be formed or present in a wound.
  • Page 7: Intended Use

    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.
  • Page 8: Basic Safety Instructions

    The use of accessories and spare parts other than those recommended by CAUTION! 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.
  • Page 9: User Requirements

    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 M and prowound S! The separation distance `d´...
  • Page 10: Product Description

    Product Description 2.1 Whole View ® 2.1.1 ASSKEA prowound Fig. 1: Disposable exudate canister with integrated aspiration tube Locking mechanism (On) and (Off) buttons Display arrow buttons ® ASSKEA prowound M device Receptacle for power supply unit ® 2.1.2 ASSKEA prowound Fig.
  • Page 11: Operation Of The Asskea Prowound M And Prowound S

    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 ® and one backup “OneWay” aspiration bag for the ASSKEA prowound...
  • Page 12: Connecting The Asskea Prowound

    Remove the disposable exudate container (Fig. 3 (A)) from the packaging. ® Slide the container on the guiding rails (Fig. 3 (E)) of the ASSKEA prowound until the disposable exudate container clicks into place in the locking mechanism (Fig. 3 (B)).
  • Page 13: Connecting The Asskea Disposable Exudate Container System To The Asskea Prowound S

     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”.
  • Page 14: Connecting A Wound Drainage System

    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 Connect the vacuum port of the device with the corresponding vacuum port of the outer “Bag”...
  • Page 15: Replacement Of The Disposable Exudate Container

    Close the tubing clamp of the wound drainage system (Fig. 3) to maintain the vacuum in the wound. ® Switch the ASSKEA prowound M off. Separate the aspiration tube from the wound drainage system and seal the Luer connector with a protective cap.
  • Page 16: Starting And Ending The Therapy

    3.3 Starting and Ending the Therapy ® Press the button for 1-2 seconds to switch on the ASSKEA prowound M or ® prowound S. The following start screen is displayed: After 5 seconds an overview screen is displayed that shows the most recent therapy parameter settings.
  • Page 17: Troubleshooting

    -Device is still in the Setup -Finalize the selection (please refer mode 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. Page 17 of 23...
  • Page 18: Error Messages

     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...
  • Page 19 Beeper on. Pump Internal error. Shortly plug in the off. power supply unit and unplug again. If the error reoccurs 60 seconds after restarting, contact ASSKEA GmbH! Beeper on. Low battery charge Press the button to level. confirm the error Current operating message.
  • Page 20: System Specifications

    System Specifications ® 6.1 ASSKEA prowound Suction performance of the unit max. 8 l/min max. -200 mmHg; Pressure Conversion factor: 1 kPa ~ 7.5 mmHg Container Disposable exudate container (250 ml) Suction tube Aspiration tube: PVCnoDEHP tube, 4mm (internal) Power supply unit...
  • Page 21: Asskea Prowound ® S

    ® 6.2 ASSKEA prowound Suction performance of the unit max. 8 l/min max. -200 mmHg; Pressure Conversion factor: 1 kPa ~ 7.5 mmHg Disposable exudate container system “Bag” and Container “OneWay” (1000 ml) Various aspiration tube types (depending on the...
  • Page 22: Disposal

    (RoHS), the device must not be disposed of in domestic waste.  The device and accessories may be disposed of via ASSKEA GmbH or the service partner.  Outside of the EU: Follow the disposal requirements of your country! This short Instructions for Use does not contain all information.
  • Page 23: Contact Information

    Contact Information Created and published by: ASSKEA GmbH Haßlocher Straße 9 99189 Gebesee Contact: Telephone: +49-36201-5797-0 Fax: +49-36201-5797-33 Email: info@asskea.de www.asskea.de Page 23 of 23...

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