Asskea ped M Instructions For Use Manual
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Asskea ped M Instructions For Use Manual

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Instructions for Use
ASSKEA ped M and ASSKEA ped S
MEDICAL — GENERAL MEDICAL EQUIPMENT
AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012);
CAN/CSA C22.2 No. 60601-1:14;
IEC 60601-1-6 (2010) + AMD1(2013);
0494
CAN/CSA-C22.2 No. 60601-1-6:11+ Am1: 2015;
ANSI/AAMI/IEC 60601-1- 8 (2006) + Am.1 (2012);
CAN/CSA-C22.2 No. 60601-1-8:08 + Am1:14
GA14-15 / Revision I / 2021-10

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  • Page 1 Instructions for Use ASSKEA ped M and ASSKEA ped S MEDICAL — GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012); CAN/CSA C22.2 No. 60601-1:14; IEC 60601-1-6 (2010) + AMD1(2013);...
  • Page 2 Copyright © 2021 ASSKEA GmbH, Gebesee. The safety of the ASSKEA ped M and the ASSKEA ped S complies with the acknowledged rules of technology and meets the requirements of the German Medical Devices Act. The ASSKEA ped M and the ASSKEA ped S devices bear the CE marking CE0494 in accordance...

  • Page 3: Table Of Contents

    Product properties ........................15 3.3.1 Disposable secretion canister for the ASSKEA ped M ............ 15 3.3.2 Information on the ASSKEA filter system for the ASSKEA ped M ......... 16 3.3.3 Information on the carbon filter ..................17 3.3.4 Secretion canister system for the ASSKEA ped S ............17 3.3.5...
  • Page 4 Disposal of the disposable liner “OneWay” and the suction tube of the ASSKEA ped S ............................... 35 5.1.5 Cleaning / disinfection of the external canister “Bag” of the ASSKEA ped S ....35 5.1.6 Cleaning / disinfection of the holder for the external canister “Bag” ......35 5.1.7...

  • Page 5: Notes On Delivery Damage And Customer Feedback

    The products described in this instruction for use are subjects to constant development and improvement. For this reason, we welcome all customer feedback, comments and suggestions regarding our products and their instruction for use, which contribute to improving the product, service or documentation. Contact: mps@asskea.de Page 5 of 46...

  • Page 6: User Information

    ASSKEA ped S devices for the first time. Please read the safety instructions (Section 2.6) to avoid hazards. These instructions for use are a component of the ASSKEA ped M or the ASSKEA ped S. Keep these instructions for use in an easily accessible place.

  • Page 7: Display

    2.2.2 Display Symbol Meaning Battery full Battery low Battery empty Down OK (On, Enter) Cancel (Off, Back) Power supply unit is connected Filter run time elapsed; replacement of internal filter by service personnel is required! Symbol convention Symbol Meaning • Bulleted list Perform the process in the specified sequence.

  • Page 8: Glossary

    The protection class defines the degree of protection of the device against contact and ingress of liquids. The ASSKEA ped M and ASSKEA ped S devices are protected against solid objects ≥ 2.5 mm diameter and sprays of water from any direction, even if the case is disposed up to 60°...

  • Page 9: Purpose

    The ASSKEA ped M and the ASSKEA ped S are especially designed for secretion aspiration in children and can be used in outpatient and inpatient care (professional healthcare facility environment).

  • Page 10: Basic Safety Instructions - Caution

    • 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 AC. • Only use the power supply unit supplied with the ASSKEA ped M or the ASSKEA ped S (see section 8).
  • Page 11 ASSKEA ped M or the ASSKEA ped S or by improper use. Only connect recommended original parts with the ASSKEA ped M or the ASSKEA ped S. Page 11 of 46...

  • Page 12: User Requirements

    ASSKEA ped M or the ASSKEA ped S prior to startup. Training on how to handle the ASSKEA ped M or the ASSKEA ped S is provided by ASSKEA GmbH or an authorized distribution partner of ASSKEA GmbH. Product training includes an explanation of the design and function of the device, the handling of the device, the cleaning and disinfection as well as the procedure to be followed for each new patient and for disposal.

  • Page 13: Product Description

    ASSEKA ped M device Socket for power supply unit Fig. 1 Fig. 2 3.1.2 ASSKEA ped S with disposable secretion canister system External canister “Bag” and and disposable liner “OneWay” (1 l) Holder for external canister “Bag” Connecting tube Display...

  • Page 14: Asskea Ped S With Reusable Secretion Canister System

    • test report according to IEC 62353 • optional accessories (depending on the order) 3.2.2 Scope of delivery ASSKEA ped S with disposable secretion canister system • the ASSKEA ped S device • disposable secretion canister system (comprising the external canister “Bag”, disposable liner “OneWay”, holder for external canister “Bag”, connecting tube and disposable suction tube (sterile))

  • Page 15: Scope Of Delivery Asskea Ped S With Reusable Secretion Canister System

    (see Section 8 “Technical data”). The ASSKEA ped M or the ASSKEA ped S are operated via the internal battery or via the supplied power supply unit, which can also be used to recharge the battery. The vacuum is generated by a maintenance-free electric motor-driven diaphragm pump.

  • Page 16: Information On The Asskea Filter System For The Asskea Ped M

    Information on the ASSKEA filter system for the ASSKEA ped M The filter system of the ASSKEA ped M consists of the external bacterial filter integrated in the disposable secretion canister and the internal filter installed in the device. The internal filter is a self-sealing bacterial filter and in combination with the filter installed in the disposable secretion canister, is effective against bacteria and viruses.

  • Page 17: Information On The Carbon Filter

    Service life and reuse The carbon filter of the ASSKEA ped M and the ASSKEA ped S 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.

  • Page 18: Information On The Double Filter System For The Asskea Ped S

    3.3.5 Information on the double filter system for the ASSKEA ped S The ASSKEA double filter system DFS® consists of the external bacterial filter integrated in the disposable liner “OneWay” and the external bacterial filter of the reusable secretion canister system installed in the device.

  • Page 19: Information On The Battery

    The charge level of the battery is shown on the display. It is strongly recommended to fully charge the battery prior to first startup of the ASSKEA ped M and the ASSKEA ped S devices and to repeat this after the first uses.

  • Page 20: Warranty

    Warranty Modifications of the ME device are not permitted. The ASSKEA ped M and the ASSKEA ped S 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.

  • Page 21: Operation

    Risk to persons due to improper handling • Please read Sections 4.1 and 4.2 carefully! • The ASSKEA ped M and the ASSKEA ped S may only be operated and used by instructed and appropriately trained personnel. • Use only suitable suction equipment! •...

  • Page 22: Setup And Startup

    Use the socket for the power supply unit of the ASSKEA ped M (Section 3.1.1, Fig. 1/2(G)) or the socket for the power supply unit of the ASSKEA ped S (Section 3.1.2 / 3.1.3, Fig. 3/3-1(G)) to connect the device to the mains power supply via the supplied power supply unit for charging or operation as required.

  • Page 23: Startup

    Positioning of the ASSEKA ped M The ASSKEA ped M can be placed next to the patient bed or attached by means of a variable holder for tube and rail systems. An optional carrying bag is available for portable use. It is, however, up to the physician to decide whether the condition of the patient permits portable use.

  • Page 24: Connection Of The Disposable Secretion Canister Of The Asskea Ped M

    Remove the disposable secretion canister (Fig. 6 (A)) from the packaging. Slide the canister onto the guide rail (Fig. 6 (E)) of the ASSKEA ped M until the disposable secretion canister clicks into place in the locking mechanism (Fig. 6 (B)).

  • Page 25: Connection Of The Disposable Secretion Canister System Of The Asskea Ped S

    • Ensure that the external canister “Bag” is undamaged and the T-piece is firmly attached. The original ASSKEA disposable secretion 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 26 Place the disposable liner “OneWay” in the reusable external canister “Bag”. Press the lid’s edges firmly down to ensure proper sealing. Fig. 9 Attach the pre-assembled connecting tube of the disposable liner “OneWay” to the bottom end of the T-piece located at the external canister. Fig.

  • Page 27: Connection Of The Reusable Secretion Canister System Of The Asskea Ped S

    Ensure that the tube is fixed sufficiently tightly. Fig. 12 4.2.5 Connection of the reusable secretion canister system of the ASSKEA ped S 1. Screw the lid of the reusable secretion canister sufficiently tightly and attach the canister to the device.
  • Page 28 3. Place the gray elbow adapter of the connecting tube onto the connection in the middle of the secretion canister lid (above the overflow protection). Fig. 14 4. Place the suction tube onto the second connection (patient connection). Ensure that the tube is fixed sufficiently tightly.

  • Page 29: Operation Of The Asskea Ped M And The Asskea Ped S

    Operation at startup Press the button for 1-2 seconds to switch on the ASSKEA ped M or the ASSKEA ped S. The following start screen is displayed: After 5 seconds, the following screen is displayed. Two values are shown. (preset of the target...

  • Page 30: Language Selection

    Patient mode The ASSKEA ped M or the ASSKEA ped S enable the selection of patient mode at startup. In patient mode, the patient runtime can be viewed and reset. To select patient mode, follow these steps: Press the button for 1-2 seconds to switch on the ASSKEA ped M or the ASSKEA ped S.
  • Page 31 The authorization code for patient mode may only be passed to specially trained personnel. Training as well as the authorization code can be obtained from ASSKEA GmbH or an authorized service partner of ASSKEA GmbH. Passwords must be treated as confidential information to prevent misuse.

  • Page 32: Canister Replacement

    9. Switch on the ASSKEA ped S. If the ASSKEA ped S is used in combination with the reusable secretion canister system, please follow the instructions regarding cleaning / disinfection in Section 5.1.7. Page 32 of 46...

  • Page 33: Decommissioning

    2. Disconnect the power supply unit from the mains supply (100 V to 240 V AC) and then remove the device plug from the ASSKEA ped M or the ASSKEA ped S. 3. Remove the disposable secretion canister of the ASSKEA ped M as described in Section 4.5.1 up to and including point 5.

  • Page 34: Maintenance

    • Use the disposable secretion canister or the disposable liner “OneWay” for one patient only. • Replace the disposable secretion canister incl. suction tube (ASSKEA ped M) or the disposable liner “OneWay” (ASSKEA ped S with disposable secretion canister system) if it is full, prior to each new patient or weekly at the latest, in accordance with applicable hygiene instructions.

  • Page 35: Cleaning / Disinfection Of The Surface Of The Device

    Dispose of the disposable secretion canister incl. suction tube in a proper manner (see Section 7.3). 5.1.4 Disposal of the disposable liner “OneWay” and the suction tube of the ASSKEA ped Close the tubing clamp on the suction tube. Remove the pre-assembled connecting tube of the disposable liner “OneWay” at the bottom end of the T-piece of the external canister “Bag”.

  • Page 36: Cleaning / Disinfection Of The Reusable Secretion Canister System Of The Asskea Ped S

    Frequent cleaning and disinfection procedures may result in minor discolorations of the holder for the external canister “Bag”. However, these do not affect the function of the device. ASSKEA GmbH recommends replacing the holder for the external canister “Bag” for each new patient.

  • Page 37: Processing / Reuse Of The Device

    Processing / Reuse of the device The ASSKEA ped M or the ASSKEA ped S is suitable for further use. However, prior to passing the device on to other patients or persons, it has to be processed professionally. For this purpose, please hand the ASSKEA ped M or the ASSKEA ped S over to ASSKEA GmbH or to qualified personnel authorized by ASSKEA GmbH.

  • Page 38: Troubleshooting

    2. Start the therapy and allow the device to idle. The alarm “System open” must appear after 60 seconds at the latest. However, if the alarm “Syst. closed – canister full” appears instead, the internal filter of the ASSKEA ped M or the ASSKEA ped S is blocked and should be replaced by service personnel.

  • Page 39: Error Messages

    (for ASSKEA ped S). (for ASSKEA ped S). - External bacterial filter - Replace the external bacterial Pump off. is blocked (for ASSKEA filter (for ASSKEA ped S with Discontinuation of ped S with reusable reusable secretion canister the current operating secretion canister system).
  • Page 40 Back-up mode continues to run in - The device was not - Switch off the device. the background. switched off. Contact ASSKEA GmbH or your service partner if the malfunction cannot be corrected by the described measures. Page 40 of 46...

  • Page 41: Transport, Storage And Disposal

    This ensures that the device is operational at all times. Fully recharge the battery if the ASSKEA ped M and the ASSKEA ped S devices are not used for an extended period of time (approx. 10 months)!

  • Page 42: Technical Data

    Technical data ASSKEA ped M Flow rate* (measuring point at suction max. 8 l/min (low flow) tube nozzle) -60 mbar to -350 mbar (in steps of 5 mbar) (medium vacuum) Vacuum Conversion factor: 1 kPa ~ 7.5 mmHg; 1 kPa ~ 10 mbar...
  • Page 43 ASSKEA ped S Flow rate* (measuring point at suction max. 8 l/min (low flow) tube nozzle) -60 mbar to -350 mbar (in steps of 5 mbar) (medium vacuum) Vacuum Conversion factor: 1 kPa ~ 7.5 mmHg; 1 kPa ~ 10 mbar Disposable secretion canister system (1 l);...

  • Page 44: Electromagnetic Compatibility

    Electromagnetic compatibility The devices ASSKEA ped M and ASSKEA ped S were teste according to EN 60601-1-2:2015 and correspond to the limit values. These limits and test leves are designed to provide reasonable assurance of immunity to electromagnetic interference when the equipment is used in its intended environment. For more information on electromagnetic immunity and electromagnetic radiation, please contact the ASSKEA GmbH at info@asskea.de or download it from ASSKEA GmbH website at...

  • Page 45: Order Information

    ASSKEA ped M Item number Description 100790 disposable secretion canister (250 ml) with step connector 100705-2 variable holder for prowound M, procuff M ped M, 100571 bag prowound M, procuff M, ped M 10.2 ASSKEA ped S Item number Description...

  • Page 46: Publishing Information

    Publishing information Created and published by: ASSKEA GmbH Haßlocher Straße 9 99189 Gebesee GERMANY Contact details: Telephone: +49-36201-5797-0 Fax: +49-36201-5797-33 E-mail: info@asskea.de www.asskea.de Page 46 of 46...

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