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fasciotens Carrier HC010 Instructions For Use Manual

Abdominal wall solutions
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Summary of Contents for fasciotens Carrier HC010

  • Page 1 Carrier Instructions for Use www.fasciotens.de Carrier...
  • Page 2 SOPs and all relevant regulatory requirements. We will not assume liability for any damage arising from improper use or use contrary to its intended purpose or incorrect handling. Any significant incidents occurring in connection with the product must be reported immediately to fasciotens GmbH and the responsible national authority.

  • Page 3: Table Of Contents

    Table of Contents Table of Contents For your safety ...................................................................... Intended purpose and indications ........................................................Contraindications ................................................................... Component definitions ................................................................Product structure (HC010) Carrier ................................................Assembly (HC010) Carrier ......................................................Product structure (HC020) Carrier ................................................Product assembly (HC020) Carrier ............................................... Combination with Hernia ....................................................

  • Page 4: 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 5: Intended Purpose And Indications

    Intended purpose and indications / contraindications / component definitions Intended use and indications Intended use Carrier The intended use for is as a holding device for fasciotens products, before, during and after surgical proce- Carrier dures. is a class I medical device. Carrier The product is intended exclusively for human medical purposes and is used during surgery.

  • Page 6: Product Structure

    Product structure Carrier HC010 Product structure HC010 Carrier The figure below shows how is used in combination with Hernia Carrier (HC010) consists of the following modules: Carrier Crossbar Post with bracket and retaining bracket must be sterilised before use by the CSSD according to the processing instructions. Carrier may only be used in a sterile condition.

  • Page 7: Assembly

    Assembly Carrier HC010 Assembly of the product can be attached to all operating tables that have a standard rail. The post is mounted on the sterile cover Carrier on the operating table. The position of the post can be determined by the user, but should not obstruct the surgeon. Make sure that the product has been sterilised according to the processing instructions.
  • Page 8 Assembly Carrier HC010 4. Open the eccentric handle by flipping the clamping lever. The word "open" will now be visible. Make sure that the locking device on the eccentric handle engages correctly. 5. Move the eccentric handle on the post up or down to position the product based on how corpulent the patient is.
  • Page 9 Assembly Carrier HC010 The crossbar has an individually adjustable angle, which can be set by means of a rotary wheel in front of the ball holder. Before each use, check that the product is intact and make sure that the post and the crossbar are attached in a secure and sterile manner.

  • Page 10: Product Structure

    Product structure Carrier HC020 Product structure HC020 Carrier The figure below shows how is used in combination with Hernia Carrier (HC020) consists of the following modules: Carrier Post HC021 Crossbar HC022 must be sterilised before use by the CSSD according Carrier to the processing instructions.
  • Page 11 Assembly Carrier HC020 Assembly of the product can be attached to all operating tables that have a standard rail. The post is mounted on the sterile cover Carrier on the operating table. The position of the post can be determined by the user, but should not obstruct the surgeon. Make sure that the product has been sterilised according to the processing instructions.
  • Page 12 Assembly Carrier HC020 6. Guide the handwheel extension (P3) with the opening onto the post extension and connect both parts of the post by turning the handwheel. Check that both components are firmly locked. 7. Guide the eccentric handle (P4) onto the top of the post extension and move it to the desired position.
  • Page 13 Assembly Carrier HC020 9. Align the crossbar over the patient based on the defect and the abdominal circumference. 10. Secure the crossbar in the eccentric handle by flipping the clamping lever. The word "closed" will now be visible on the eccentric lock. The post and the crossbar can cause pressure damage.

  • Page 14: Combination With

    Combination with Hernia Combination with Hernia To combine with , release the lock on the ball holder of the crossbar by pressing the push button on the Hernia clamping lever and opening the clamping lever at the same time. can now be inserted into the ball holder from above. Hernia Fasten the ball adapter by inserting it into the retaining bracket and closing the clamping lever.

  • Page 15: Service Life

    Processing Carrier Processing Carrier Service life is a reusable medical device. Its service life depends on how much wear and damage it encounters. Fre- Carrier quent processing has no effect on the performance of the product. A passive coating forms on the instruments over time. This is influenced by factors such as material composition, surface condition and processing conditions.

  • Page 16: Carrier (Hc020)

    Processing Carrier 1. Release the lock on the ball holder of the crossbar by pressing the push button on the clamping lever and pulling the clamping lever at the same time. 2. Turn the handwheel counterclockwise back to the furthest possible position Avoid long waiting times before wet or dry processing (e.g.
  • Page 17 All articulated parts must be dried after cleaning. Inspect parts for damage that could impair their function- ality. Damaged and defective instruments must be identified and replaced. Instruments to be returned to fasciotens GmbH for repair must also be sterilised beforehand (individual packaging, see section Sterilisation). Please use the template for returns from your AEMP/ CSSD folder for this purpose.
  • Page 18 (form) provided at the end of the Instructions for Use and attach it to the return documents or the return shipment. fasciotens GmbH has determined that the instructions for the preparation of the instruments are suitable for processing. Additional reference material: •...
  • Page 19 Template For returns: Please note! back Carrier Return for repair This confirmation must be enclosed with the return shipment Carrier We hereby confirm that the enclosed instrument set has been correctly disinfected, cleaned and sterilised. Instrument set Confirmation/sticker Hospital (address) Department Responsible Person Date, stamp, signature...
  • Page 20 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. Support If you have any issues or questions please contact our Customer Support team (support@fasciotens.de)

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Carrier hc020

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