Asskea prowound M Instructions For Use Manual Download Page 2

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ASSKEA pro

wound

M and ASSKEA pro

wound

complies with the

acknowledged rules of technology and meets the requirements of the

German Medical Devices

Act

The

ASSKEA pro

wound

M and ASSKEA pro

wound

bear the

CE marking CE1434

accordance with EU Council Directive 93/42/EEC concerning medical devices and meet the
essential requirements of Annex I of this directive.
The

ASSKEA pro

wound

M and ASSKEA pro

wound

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 pro

wound

M and ASSKEA pro

wound

are medical suction devices classified as

class IIa in accordance with EU Council Directive 93/42/EEC, Annex IX.

Errors and omissions excepted.

Summary of Contents for prowound M

Page 1: ...ision 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 ...

Page 2: ...uncil 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 device...

Page 3: ... 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 3 Operation 19 3 1 Set Up and Startup 20 3 1 1 Startup 20 3 1 2 Connecting the AS...

Page 4: ...nd 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 5 Problem Solving 36 5 1 Function Test 36 5 2 Troubleshooting 36 5 3 Error Messages 37 6 Transport Sto...

Page 5: ...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...

Page 6: ...ck 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 ...

Page 7: ...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 ...

Page 8: ...e 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...

Page 9: ...d 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 a...

Page 10: ...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 ...

Page 11: ...ided 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 m...

Page 12: ... 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 depend...

Page 13: ...sing 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 op...

Page 14: ...te 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 prowoun...

Page 15: ...sable 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 T...

Page 16: ...nded 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 ...

Page 17: ...ess 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...

Page 18: ...ated 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 setti...

Page 19: ...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 pr...

Page 20: ...SSKEA 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...

Page 21: ...n of the wound exudate place the ASSKEA prowound M below the wound to be treated It should be noted that the suction tube does not form a dip and is situated at least on patient level 3 1 4 Connecting the disposable exudate canister of the ASSKEA prowound M Fig 5 Connecting the disposable exudate canister A Disposable exudate canister incl suction tube B Locking mechanism for canister C Aspiration...

Page 22: ...the external canister Bag This may lead to the collapse of the disposable liner OneWay Inspect the disposable exudate canister system 1 000 ml to ensure that the lid of the disposable liner OneWay is firmly connected to the external canister Bag Ensure that all connections are firmly attached and properly connected Ensure that the external canister Bag is undamaged and the T piece is firmly attach...

Page 23: ... 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 Fig 9 4 Connect the vacuum connection of the device with the corresponding vacuum connection of the external canister Bag top end of the T piece Use the supplied connecting tube to do so Fig 10 ...

Page 24: ...sable 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 25: ...ns to select the desired language 6 Use the button to confirm your choice 7 Select the prescribed operating mode in the Setup menu 8 Use the button to confirm your choice 9 Perform the desired treatment please refer to chapter 3 2 2 or 3 2 3 10 Switch off the ASSKEA prowound M or ASSKEA prowound S by pressing the button for 3 seconds 3 2 2 Continuous operation In the continuous operating mode the ...

Page 26: ...nfirm the setting by pressing the button The following overview screen is displayed 7 Press the button to start the therapy Default target value 80 mmHg 8 The following screen is displayed for one minute after the therapy has been started The bar symbolizes the tightness of the wound dressing If the bar is in the too tight or not tight range the wound dressing must be adjusted or may need to be re...

Page 27: ...ange from 20 mmHg to 100 mmHg in steps of 5 mmHg The high vacuum can be set in a range from 30 mmHg to 200 mmHg in steps of 5 mmHg The setting of the low vacuum cannot be set higher than the setting of the high vacuum The following values are preset High Vacuum 80 mmHg Low Vacuum 40 mmHg Max Time 4 minutes Min Time 4 minutes 1 Press the button for 1 2 seconds to switch on the ASSKEA prowound M or ...

Page 28: ... Use the arrow buttons to set the prescribed time value for the high vacuum 10 Confirm the setting by pressing the button 11 Use the arrow buttons to set the prescribed time value for the low vacuum 12 Confirm the setting by pressing the button 13 The display shows the set parameters in an overview again 14 Press the button to start the therapy or 15 Press the button to stop the therapy again 16 Y...

Page 29: ... 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 3 Use the arrow buttons to select the Language menu 4 Use the button to confirm your choice 5 Use the arrow buttons to select the desired language 6 Use the button to confirm your choice 3 2 5 Alarm delay at startup At startup of the ASSK...

Page 30: ...nfirm the entry with the button Select the other digits of the code with the arrow button and confirm them with the button as well 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 4 After ...

Page 31: ...w displayed 9 Press the button for 3 seconds to reset the patient runtime to zero 10 Exit the patient mode by pressing the button CAUTION Hazard of persons due to incorrect settings Prior to using the ASSKEA prowound M or ASSKEA prowound S on a new patient it must be verified that the currently set alarm sensitivities are appropriate for this patient The setting of the alarm sensitivities is impor...

Page 32: ... at the wound drainage system 3 4 2 Replacement of the disposable liner OneWay of the ASSKEA prowound S 1 Close the tubing clamp at the suction tube fig 3 and at the wound drainage system to maintain the vacuum in the wound 2 Switch off the ASSKEA prowound S 3 Separate the suction tube from the wound drainage system 4 Separate the pre assembled connecting tube of the disposable liner OneWay at the...

Page 33: ...performed in a proper manner CAUTION Health risks due to the handling of disinfectants The use of appropriate disposable gloves during disinfection is recommended Follow the manufacturer s disinfectant instructions CAUTION Possible bodily injury by electric shock Prior to cleaning disinfection switch off the device disconnect the power supply unit by unplugging it from the power supply and then di...

Page 34: ...r manner please refer to chapter 6 3 It is a single use item 4 1 4 Disposal of the disposable liner OneWay and the suction tube for ASSKEA prowound S 1 Close the tubing clamp at the suction tube fig 3 2 Separate the pre assembled connecting tube of the disposable liner OneWay at the bottom end of the T piece of the external canister Bag 3 Remove the disposable liner OneWay from the reusable extern...

Page 35: ... of 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 Clean and disinfect all accessories prior to returning the device The device itself must be treated with a surface disin...

Page 36: ... System closed must be displayed after no more than 5 seconds If the alarm is not displayed even after repeating the test have the device inspected by a service partner 5 2 Troubleshooting Malfunction Probable causes Remedy Device does not start Battery is empty Device is still in the Setup mode Connect the power supply unit Finalize the selection please refer to 3 2 and start the device No suctio...

Page 37: ...ion Start pump Pump off Discontinuation of the current operating mode Disposable exudate canister or disposable liner OneWay is full Exudate flow obstructed tubing is kinked or stenosis in the tubing If the alarm is displayed even if the canister is not connected the internal bacterial filter is blocked Switch off the device Replace the disposable exudate canister or the disposable liner OneWay Ch...

Page 38: ... background Low battery charge level Connect the power supply unit soon Alarm after 15 minutes The therapy was not initiated The device was not switched off Start therapy Switch off the device Contact the ASSKEA GmbH or your service partner if the malfunction cannot be corrected by the described measures ...

Page 39: ...Store the ASSKEA prowound M and ASSKEA prowound S devices as indicated in the Technical Data chapter 7 The battery of the ASSKEA prowound M or ASSKEA prowound S wound suction device must be charged prior to storage of the device This ensures that the device is operational at all times Fully recharge the battery if the ASSKEA prowound M or ASSKEA prowound S device is not used for a longer period of...

Page 40: ... protection IP code as per IEC 60529 IP22 CE marking CE1434 UL marking Sound emission Operation 35 dB A High priority alarm 52 dB A Low priority alarm 49 dB A Ambient conditions Transport Storage 25 C to 60 C 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 Battery rechargeable 7 4 V 4 4 Ah Lithium ions Charging time if batte...

Page 41: ...rotection IP code as per IEC 60529 IP22 CE marking CE1434 UL marking Sound emission Operation 35 dB A High priority alarm 53 dB A Low priority alarm 51 dB A Ambient conditions Transport Storage 25 C to 60 C 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 Battery rechargeable 7 4 V 4 4 Ah Lithium ions Charging time if battery...

Page 42: ...recommended accessories and spare parts incl transformers and cables in devices other than the ASSKEA prowound M and ASSKEA prowound S may increase the emission of electromagnetic interference or reduce the electromagnetic immunity 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 ...

Page 43: ...poses Harmonic emissions pursuant to IEC 61000 3 2 Class A Voltage fluctuations Flicker emissions pursuant to IEC 61000 3 3 Complies Table 2 Guidance and Manufacturer s Declaration Electromagnetic Immunity The ASSKEA prowound 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...

Page 44: ...ods 5 UT 95 dip of UT for 5s 5 UT 95 dip of UT for period 40 UT 60 dip of UT for 5 periods 70 UT 30 dip of UT for 25 periods 5 UT 95 dip of UT for 5s Main supply voltage should be of the same quality as in a typical commercial living or hospital environment If the user of the ASSKEA prowound M or ASSKEA prowound S requires continued operation during mains power outages it is recommended to power t...

Page 45: ...f 3 V m Portable and mobile RF communications equipment should be used no closer to any part of the ASSKEA prowound M and ASSKEA prowound S incl cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 P d 1 2 P for 80 MHz to 800 MHz d 2 3 P for 800 MHz to 2 5 GHz Where P is the maximum output ...

Page 46: ...wound M and ASSKEA prowound S The ASSKEA prowound M and ASSKEA prowound S devices are intended for operation in an electromagnetic environment in which the radiated 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 RF communications equipme...

Page 47: ...ber Description PU 100419 Power supply unit FRIWO FW 7555M 12 incl all country adapters 1 100000 External canister Bag 1 100002 Disposable liner OneWay 1 000ml 60 100267 Holder for external canister Bag 1 100013 Double filter system replacement set DFS 1 100280 Connecting tube 1 100288 Universal bed holder 1 100346 Variable holder for pipe and rail systems 1 100663 Disposable canister system 1 000...

Page 48: ...e 48 of 48 9 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 ...

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