Table of Contents
Advertisement
Quick Links
Advertisement
Table of Contents
Related Manuals for fasciotens Carrier
Summary of Contents for fasciotens Carrier
- Page 1 Instructions for use www.fasciotens.de...
- Page 3 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 serious incidents that occur in connection with the product must be reported immediately to fasciotens GmbH and the responsible national authority.
-
Page 4: Table Of Contents
Table of Contents Table of Contents For your safety ................................................Intended purpose, indications and contraindications ..............................Component definitions ............................................Product design fasciotens®Carrier (HC020) ................................... Product assembly fasciotens®Carrier (HC020) ..................................Combination with fasciotens®Hernia ......................................Processing fasciotens®Carrier ........................................... Service life ..................................................Preparation .................................................. -
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 use for the fasciotens®Carrier is as a holding device for fasciotens products before, during and after surgical pro- cedures. fasciotens®Carrier is a class I medical device. The product is intended exclusively for human medical purposes and is used during surgery. -
Page 7: Product Design Fasciotens Carrier Hc020
CSSD according to the processing instructions. fasciotens®Carrier and fasciotens®Hernia may only be used in a sterile condition. fasciotens®Carrier is supplied in a non-sterile condition by the manufacturer and must be sterilised in the hospital before each use in the operating room. -
Page 8: Product Assembly Fasciotens®Carrier Hc020
Assembly of the product fasciotens®Carrier can be attached to all operating tables that have a standard rail. The post is mounted above the sterile cover on the operating table. The position of the post can be determined by the user but should not obstruct the surgeon. - Page 9 Product assembly fasciotens®Carrier HC020 6. Guide the screw head extension (P3) with the opening onto the post extension and connect both parts of the post by turning the screw head. Check that both modules are firmly locked. 7. Guide the eccentric handle (P4) onto the top of the post extension and move it to the desired position.
- Page 10 Product assembly fasciotens®Carrier HC020 9. Align the articulated arm over the patient based on the defect and the abdominal circumference. 10. Secure the articulated arm in the eccentric handle by flipping the clamping lever. The word "closed" will now be visible on the eccentric lock.
-
Page 11: Combination With Fasciotens®Hernia
Combination with fasciotens®Carrier Combination with fasciotens®Hernia To combine with fasciotens®Hernia, release the lock on the ball adapter retaining bracket of the articulated arm. To do this, press the pushbutton on the clamping lever and open the clamping lever at the same time. -
Page 12: Processing Fasciotens®Carrier
Processing fasciotens®Carrier Service life fasciotens®Carrier is a reusable medical device. Its service life depends on how much wear and damage it encounters. Fre- quent reprocessing 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 con- dition and processing conditions. -
Page 13: Cleaning
Processing fasciotens®Carrier Avoid long waiting times before processing (e.g. overnight or over the weekend) due to the risk of corrosion and other factors which may make it difficult to clean the instruments. The AKI recommends taking the instruments for sterilisation without them being submerged in liquid. Experience has shown that waiting times of up to 6 hours are unproblematic when the instruments are out of liquid. - Page 14 Processing fasciotens®Carrier Connect hollow-body instruments to the hollow-body rinsing systems of the washer-disinfectors. An alkaline cleaner (pH > 10) should be used according to the manufacturer's instructions for use. Pay attention to the correct dosage! The prod- ucts are approved for alkaline cleaning. Acidic cleaning agents and disinfectants must not be used.
-
Page 15: Sterilisation
Processing fasciotens®Carrier For processing, the medical devices must be sterilised after disinfection (see Sterilisation). Inspect parts for damage that could impair their functionality. Damaged and defective instruments must be identified and replaced. Repairs are to be carried out exclusively by the manufacturer. In this case, the corresponding instruments must be sterilised beforehand (in- dividual packaging, see Sterilisation section). -
Page 16: Final Instructions
55:1244-1310 DOI 10.1007/s00103-012-1548-6 • Processing AKI instruments to preserve their condition, Issue 11 Storage instructions fasciotens Carrier may only be used if sterile. For storage, reprocessing and sterilisation of the system, follow the instructions for use and processing. fasciotens®Carrier must •... -
Page 17: Template For Returns
For returns: Please note! fasciotens®Carrier return Return for repair This confirmation must be enclosed with the return shipment of fasciotens®Carrier. We hereby confirm that the enclosed (leased) instrument set has been correctly disinfected, cleaned and sterilised. Instrument set Proof/Adhesive label... -
Page 18: Repairs
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 19: Symbols Used
Labelling of products placed on the market in accordance with the relevant European legal requirements. Labelling in accordance with standard ISO 15223-1. Symbol for “Keep dry” Labelling in accordance with standard ISO 15223-1. Symbol for “Protect from sunlight” Carrier Instructions for use... - Page 20 Company address: fasciotens GmbH, Moltkeplatz 1, D-45138 Essen Tel. +49 (0)201 99 999 630 Fax +49 (0)201 99 999 639 Email: info@fasciotens.de Carrier Instructions for use...