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Summary of Contents for Asskea prowound M
- Page 1 Instruction for Use ® ® ASSKEA prowound M and ASSKEA prowound AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601-1 (2005), CAN/CSA-C22.2 No. 1434 60601-1 (2008) GA03-04 / Revision C-1 / 2019-08...
- Page 2 ® 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.
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Page 3: Table Of Contents
Product Properties ........................14 ® Disposable exudate canister for ASSKEA prowound M ..........14 2.2.1 ® Information on the ASSKEA filter system for the ASSKEA prowound M ....15 2.2.2 ® Information on the carbon filter of the ASSKEA prowound M ........15 2.2.3... - Page 4 Disposal of the disposable liner “OneWay” and the suction tube for 4.1.4 ® ASSKEA prowound S ......................34 ® Cleaning / disinfection of the external canister “Bag” for ASSKEA prowound S ..34 4.1.5 ® Cleaning / disinfection of the tubing accessories for ASSKEA prowound S ....35 4.1.6...
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Page 5: User Information
User Information 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. -
Page 6: Symbol Convention
1.2.3 Display Symbol Meaning Battery full Battery low Battery empty 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. -
Page 7: Glossary
The processing procedure must only be performed by ASSKEA GmbH or an authorized service partner of ASSKEA GmbH. Wound exudate The term wound exudate denotes all collecting liquids and particles that may be formed or present in a wound. -
Page 8: Intended Use
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. -
Page 9: Precautions
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 ... - Page 10 The use of accessories and spare parts other than those recommended by CAUTION! 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.
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Page 11: User Requirements
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. -
Page 12: Product Description
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”. -
Page 13: Asskea Prowound ® S
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”. -
Page 14: Product Properties
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 The disposable exudate canister consists of a canister with a connected suction tube. -
Page 15: Information On The Asskea Filter System For The Asskea Prowound ® M
(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 ®... -
Page 16: Disposable Exudate Canister System For Asskea Prowound S
(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. page 16 of 48... -
Page 17: Battery
® ® 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. -
Page 18: Warranty
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 : ... -
Page 19: Operation
CAUTION! Read chapter 3.1 and 3.2! Malfunction due to aspirated wound exudate. ® Ensure that the disposable exudate canister of the ASSKEA prowound ATTENTION! ® and ASSKEA prowound S is replaced on a regular basis. If the disposable exudate canister is full, the integrated overflow protection system is triggered. -
Page 20: Set-Up And Startup
„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. -
Page 21: Positioning Of The Asskea Prowound ® M
1. Remove the disposable exudate canister (fig. 5 (A)) from the packaging. ® 2. Slide the canister on the guiding rail (fig. 5 (E)) of the ASSKEA prowound M until the disposable exudate canister clicks into place in the locking mechanism (fig. 5 (B)). -
Page 22: Positioning Of The Asskea Prowound S
Follow the instruction for use supplied by the manufacturer! The original ASSKEA disposable exudate canister system consists of the external canister “Bag”, the holder for the external canister “Bag”, the disposable liner “OneWay”, the connecting tube for the disposable liner “OneWay”... - Page 23 1. Remove the disposable liner “OneWay” from the packaging and fully extend it. Fig. 7 2. Place the disposable liner “OneWay” in the reusable external canister “Bag”. Press the lid’s edges firmly down to ensure proper sealing. Fig. 8 3. Attach the prefitted connecting tube of the disposable liner “OneWay” to the bottom end of the T-piece located at the external canister “Bag”.
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Page 24: Connecting A Wound Drainage System
5. Connect the patient connection of the disposable liner “OneWay” (fig. 6 (B)) to the suction tube. Fig. 11 3.1.7 Connecting a wound drainage system Connect the suction tube of the disposable exudate canister to the wound drainage system. The suction tube must never come into direct contact with the aspiration area. page 24 of 48... -
Page 25: Operation Of The Asskea Prowound ® M And Asskea Prowound ® S
M and ASSKEA prowound 3.2.1 Operation at initial startup ® 1. Press the button for 1-2 seconds to switch on the ASSKEA prowound M or ® ASSKEA prowound S. The following start screen is displayed for 5 seconds: 2. The Setup menu is displayed: 3. - Page 26 ® 1. Press the button for 1-2 seconds to switch on the ASSKEA prowound M or ® ASSKEA prowound S. The following start screen is displayed for 5 seconds: 2. While the start screen is displayed, simultaneously press the arrow buttons. The menu Setup is displayed.
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Page 27: Intermittent Operation
4 minutes Min Time 4 minutes ® 1. Press the button for 1-2 seconds to switch on the ASSKEA prowound M or ® ASSKEA prowound S. The following start screen is displayed for 5 seconds: 2. While the start screen is displayed, simultaneously press the arrow buttons. - Page 28 5. Use the arrow buttons to set the prescribed high vacuum value. 6. Confirm the setting by pressing the button. 7. Use the arrow buttons to set the prescribed low vacuum value. 8. Confirm the setting by pressing the button. 9.
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Page 29: Language Selection
The selected language is stored and automatically loaded at each startup. To customize the language, follow these steps: ® 1. Press the button for 1-2 seconds to switch on the ASSKEA prowound M or ® ASSKEA prowound S. The following start screen is displayed for 5 seconds: 2. -
Page 30: Patient Mode
The authorization code may only be passed to specially trained personnel. You will get the training and the authorization code by ASSKEA GmbH or an authorized service partner of ASSKEA GmbH. Passwords must be treated as confidential information to prevent misuse. - Page 31 Hazard of persons due to incorrect settings. ® ® Prior to using the ASSKEA prowound M or ASSKEA prowound S on a new patient, CAUTION! it must be verified that the currently set alarm sensitivities are appropriate for this patient.
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Page 32: Canister Exchange
18. Loosen the tubing clamp at the wound drainage system. ® 3.4.2 Replacement of the disposable liner “OneWay” of the ASSKEA prowound 1. Close the tubing clamp at the suction tube (fig. 3) and at the wound drainage system to maintain the vacuum in the wound. -
Page 33: Maintenance
S) in accordance to the respectively applicable hygiene instructions, weekly at the latest, prior to each new patient or if it is full. For each new patient, processing by ASSKEA GmbH or an authorized service partner of ASSKEA GmbH is strictly required! ... -
Page 34: Cleaning And Disinfection Of The Surface Of The Device
3. Subsequently rinse the external canister “Bag” thoroughly and allow it to dry. You may also autoclave the external canister “Bag” at 121°C for 20 minutes. ASSKEA GmbH recommends to replace the external canister “Bag” every four weeks at the latest and for each new patient. -
Page 35: Maintenance And Service
ASSKEA GmbH in compliance with the service documentation specified by the manufacturer as well as with technical and hygienic precautionary measures. The device may be sent back for repair to ASSKEA GmbH directly or via the specialty dealer from which the device was purchased. -
Page 36: Problem Solving
Disposable liner “OneWay” is ® (for ASSKEA prowound full) Please contact service. Internal filter is blocked Contact the ASSKEA GmbH or your service partner if the malfunction cannot be corrected by the described measures. page 36 of 48... -
Page 37: Error Messages
Error Messages The alarms are solely system-triggered alarms, since these are identified by the monitoring of device-specific variables. All alarm messages (excepting “Internal error”) must be confirmed by pressing the OK button. 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. - Page 38 The therapy was not Start therapy. minutes) initiated. The device was not Switch off the device. switched off. Contact the ASSKEA GmbH or your service partner if the malfunction cannot be corrected by the described measures. page 38 of 48...
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Page 39: Transport, Storage And Disposal
M or ASSKEA prowound S to other, new users, the devices must be properly processed by ASSKEA GmbH or by an ASSKEA GmbH professional to protect subsequent users. Processing is mandatory in accordance with the German Medical Device Operator Ordinance (MPBetreibV), German Medical Devices Act (MPG) and the manufacturer’s instructions. -
Page 40: Technical Data
Technical Data ® ASSKEA prowound Flow rate max. 8 l/min max. -200 mmHg; Pressure Conversion factor: 1 kPa ~ 7.5 mmHg Canister Disposable exudate canister (250 ml) PVCnoDEHP - suction tube, Ø 4 mm (internal), length Suction tube 150 cm... -
Page 41: Asskea Prowound ® S
® ASSKEA prowound Flow rate max. 8 l/min max. -200 mmHg; Pressure Conversion factor: 1 kPa ~ 7.5 mmHg Canister Disposable exudate canister system (1000 ml) Disposable suction tube, Ø 4 mm (internal), Suction tube length 180 cm, sterile (REF: 100712) -
Page 42: Emc Information
Damage caused by using recommended accessories and spare parts in other devices or by improper use is not covered by warranty in any case. ® Use the accessories and spare parts only with the ASSKEA prowound M and ® ASSKEA prowound S devices. - Page 43 M and ASSKEA prowound S devices are intended for operation in the electromagnetic environment specified below. ® ® The customer or user of the ASSKEA prowound M or ASSKEA prowound S must ensure that it is used in such an environment. Electromagnetic...
- Page 44 Voltage dips, short the user of the 40% U (60% dip 40% U (60% dip ® interruptions and ASSKEA prowound of U ) for 5 periods of U ) for 5 periods voltage variations on ® power supply input ASSKEA prowound...
- Page 45 S devices are intended for operation in the electromagnetic environment specified below. ® ® The customer or user of the ASSKEA prowound M or ASSKEA prowound S must ensure that it is used in such an environment. IEC 60601 test...
- Page 46 RF disturbances are controlled. The ® ® customer or the user of the ASSKEA prowound M or ASSKEA prowound S can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile ®...
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Page 47: Ordering Information
100288 Universal bed holder 100346 Variable holder for pipe and rail systems Disposable canister system (1,000 ml) incl. suction tube with step 100663 connector 100295 Carrying bag for ASSKEA suction devices 100712 Disposable suction tube (sterile) page 47 of 48... -
Page 48: Publishing Information
Publishing Information Created and published by: ASSKEA GmbH Haßlocher Straße 9 99189 Gebesee GERMANY Contact: Telephone: +49-36201-5797-0 Fax: +49-36201-5797-33 E-Mail: info@asskea.de www.asskea.de page 48 of 48...
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