fasciotens Abdomen Instructions For Use Manual
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fasciotens Abdomen Instructions For Use Manual

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Summary of Contents for fasciotens Abdomen

  • Page 1 Instructions for use www.fasciotens.de...
  • Page 2 Introduction Dear customer, Thank you very much for choosing fasciotens®Abdomen, the innovative therapy option in the treatment of the open abdo- men. fasciotens® products provide the highest quality, safety and state-of-the-art technology. Medical necessity dictated the development of this product, and it was practising surgeons who accomplished this innovation.
  • Page 3 Introduction Video tutorial https://www.fasciotens.de/wl-abdomen-ifu-video-en The user must view the video tutorial in full before using the product. Instructions for use...

  • Page 4: Table Of Contents

    Product design Preparing the patient Surgical access to fascia Placement of surgical mesh and suture material Product assembly and attachment Pre-assembly of fasciotens®Abdomen Optional length and height adjustment Application of fasciotens®Abdomen Adjusting the tensile force Procedure for surgical revision Disassembly in daily care and emergencies...

  • Page 5: For Your Safety

    Prior to use, the product is to be inspected to ensure it is intact and not damaged in any way. The warranty and liability conditions of the terms and conditions of sale and delivery of fasciotens GmbH are not extended by any previous or subsequent references.

  • Page 6: Intended Purpose, Indications And Contraindications

    Intended purpose, indications and contraindications Intended purpose The intended purpose of fasciotens®Abdomen is to prevent fascial retraction in the open abdomen and to stretch the abdominal wall/fascia in the case of current or previous loss of abdominal wall/fascial tissue. fasciotens®Abdomen is a medical device belonging to class Is (sterile) and is intended exclusively for human medical purposes.

  • Page 7: Product Design

    Product design Intended patient population Critically ill adult patients requiring open abdomen treatment due to underlying septic/non-septic abdominal conditions; critically ill primarily means ICU patients with a long duration of treatment. Intended users • Surgeons with experience in abdominal surgery (e.g. general, visceral, vascular and trauma surgery) •...

  • Page 8: Preparing The Patient

    Preparing the patient Preparing the patient fasciotens®Abdomen should be ready for use when planning to create a laparostoma, e. g. in the case of confirmed abdominal compartment syndrome.Likewise, fasciotens®Abdomen should be available in the event of an intraoperative decision to create a laparostoma.
  • Page 9 The visceral organs and the wound are covered according to the instructions of the treating physician. After assembling the fasciotens®Abdomen, which is described in the following section, sutures should be introduced and fixated to the suture retention frame. We recommend leaving sutures about 25 cm in length at first and then shortening them after fixation in the side bar, as appropriate.

  • Page 10: Product Assembly And Attachment

    Product assembly and attachment Product assembly and attachment Prior to using fasciotens®Abdomen, if the sterile packaging is noticeably damaged, please ensure that the product is not used any further. Contact the manufacturer. fasciotens®Abdomen consists of the following modules. Module 1:...

  • Page 11: Pre-Assembly Of Fasciotens®Abdomen

    Product assembly and attachment Pre-assembly of fasciotens®Abdomen The pre-assembly of the product and the suture retention frame to the stand can be carried out on the sterile instrument table or in the ICU. It is important that the surgical precautions necessary for assembly have been carried out as described in the “Pre-operative planning”...
  • Page 12 Product assembly and attachment 3. Screw the anchor screws into the supporting foot until these are secure. The plates are now securely connected with the supporting foot. 4. Erect the stand. You can now rotate the traction controller 180 degrees. The emergency release with the red lever must now point downwards.
  • Page 13 Product assembly and attachment 5. Place the stand on the support surfaces. Secure the support pads so that they do not come off when transferring the assembly! Secure the suture retention frame with one hand when engaging the red locking bolt. 6.

  • Page 14: Optional Length And Height Adjustment

    Product assembly and attachment Optional length and height adjustment Height adjustment is loosened or locked by turning the side thumb screws. Both supporting feet can be individually adjusted in terms of their height. When making a height adjustment, the corresponding side should be secured to the product with one hand.

  • Page 15: Application Of Fasciotens®Abdomen

    The product should never be placed on the genitals. The suture retention frame must always be aligned parallel to the laparostoma. 1. Now place fasciotens®Abdomen on the thorax and the anterior pelvic ring. Instructions for use...
  • Page 16 Product assembly and attachment 2. The traction sutures stitched into the meshes may now be fixed to the suture retention frame as follows: a. Guide the doubled traction sutures upwards and insert them from the outside into the open slot of the fixing clip. b.
  • Page 17 Product assembly and attachment 3. Then attach the remaining traction sutures and set them to roughly the same basic tension. Check all traction sutures have similar basic tension. If necessary, re-tension the individual traction sutures. To do so, please follow the above procedure. If too much tension (above 4 on the scale) is built up when tensioning the traction sutures, the tensile force cannot be readjusted using the black screw head.

  • Page 18: Adjusting The Tensile Force

    Product assembly and attachment Adjusting the tensile force The tensile force applied to the abdominal wall/fascia is adjusted by turning the black screw head. It takes several turns of the black screw head to reach the recommended tensile force. A scale serves as an adjustment aid for the tensile force. It is recommended to adjust the tensile force in the range between 6-8 (corresponds to approx.
  • Page 19 Product assembly and attachment The abdominal wall/fascia is now brought to tension ventrally. Do a final check on the tension applied to each traction suture. The suture retention frame must not be in contact with the wound area or the abdominal organs! When positioning a patient, in particular changing the position of the thorax in relation to the pelvis, attention must be paid to possible changes in tensile force and direction of pull.

  • Page 20: Procedure For Surgical Revision

    Procedure for surgical revision Depending on the course of therapy, follow-up operations and revisions may be necessary. In this case, disassembling fasciotens®Abdomen is simple and fast. Please always remember that the product is no longer sterile during surgical revision procedures and must be removed from the patient before starting the sterile procedure.
  • Page 21 Procedure for surgical revision If the edema of the abdominal organs decreases and the attending physician decides to close the abdominal wall promptly, the tension sutures can be pulled in a diagonal direction. For this purpose, the traction sutures are tensioned crosswise in the suture retention frame.

  • Page 22: Disassembly In Daily Care And Emergencies

    Disassembly in emergency Disassembly in daily care and emergencies The product can be disassembled quickly as part of daily care or in emergency situations. 1. Hold the suture retention frame firmly with one hand. 2. Retract the red locking bolt and rotate it 90°. 3.

  • Page 23: Cleaning And Disposal

    Cleaning and disposal Cleaning and disposal Cleaning fasciotens®Abdomen must be cleaned and disinfected in the following cases: • Before each re-attachment during surgical revisions • In the case of heavy soiling during use on a patient fasciotens recommends for cleaning and disinfecting fasciotens®Abdomen: •...

  • Page 24: Warranty

    GmbH. Support If you have any issues or questions, please contact our Customer Support team by email (support@fasciotens.de) or call us on +49 (0)221 17738 500. Instructions for use...

  • Page 25: Symbols Used

    Symbols used Symbols used Labelling Symbols Labelling in accordance with the standard ISO 15223-1. Symbol for “Product number” Labelling in accordance with the standard ISO 15223-1. Symbol for “Batch code, lot” Labelling in accordance with the standard ISO 15223-1. Symbol for “Name and address of the manufacturer” Labelling in accordance with the standard ISO 15223-1.

  • Page 26: Glossary Of Warnings

    Braided suture material (USP 2) must be used to ensure that the sutures are securely retained in Preparing the patient the suture retention frame. Prior to using fasciotens®Abdomen, if the sterile packaging is noticeably damaged, please ensure Product assembly and that the product is not used any further. Contact the manufacturer.
  • Page 27 Damage resulting from improper use, external mechanical impacts, transport damage, applications that do not comply with the intended purpose, or applications carried out by non-authorised persons is not covered by this warranty, nor is it covered by the liability of fasciotens GmbH. Instructions for use...
  • Page 28 Company address: fasciotens GmbH, Moltkeplatz 1, D-45138 Essen, Germany 0044 Tel. +49 (0)201 99 999 630, Fax +49 (0)201 99 999 639, Email: info@fasciotens.de Instructions for use...

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