fasciotens Carrier HC010 User manual

Carrier www.fasciotens.de
Instructions for Use
Carrier

2
Instructions for Use Carrier
Introduction
Dear customer,
Thank you for using
Carrier
. products provide the highest quality, safety and state-of-the-art technology.
This product was developed in partnership with practising surgeons to meet a particular medical need.
To take full advantage of this product’s capability and to ensure its successful application, please read the Instructions for Use
carefully and use the product as instructed. Always follow standard safety precautions for general occupational safety, your
specific 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.
This medical device is reserved for use by medical professionals only. Please make sure that all persons using this
product only do so aer having read and understood the Instructions for Use.
Please keep the Instructions for Use in a safe place; you may want to reread them at a later date.
Simply reading these Instructions for Use is not in itself suicient to start using Carrier immediately .
Additional instruction by an expert in the handling of the product is required.
Company address:
fasciotens GmbH
Aachener Str. 1053-1055
D-50858 Cologne
Tel.: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.fasciotens.de

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Instructions for Use
Carrier
Table of Contents
Table of Contents
For your safety ...................................................................................................................................................................................................................................................................................................................................................... 4
Intended purpose and indications .................................................................................................................................................................................................................................................................................... 5
Contraindications ........................................................................................................................................................................................................................................................................................................................................... 5
Component definitions ........................................................................................................................................................................................................................................................................................................................... 5
Product structure Carrier (HC010) ................................................................................................................................................................................................................................................ 6
Assembly Carrier (HC010) ........................................................................................................................................................................................................................................................................ 7
Product structure Carrier (HC020) ............................................................................................................................................................................................................................................ 10
Product assembly Carrier (HC020) ....................................................................................................................................................................................................................................... 11
Combination with Hernia .................................................................................................................................................................................................................................................................... 14
Processing instructions Carrier .................................................................................................................................................................................................................................................... 15
Service life ......................................................................................................................................................................................................................................................................................................................................................................15
Preparation ..................................................................................................................................................................................................................................................................................................................................................................15
Cleaning ..........................................................................................................................................................................................................................................................................................................................................................................16
Sterilisation ...............................................................................................................................................................................................................................................................................................................................................................17
Final instructions ..............................................................................................................................................................................................................................................................................................................................................17
Storage instructions .....................................................................................................................................................................................................................................................................................................................................18
Maintenance ............................................................................................................................................................................................................................................................................................................................................................18
Repairs ...............................................................................................................................................................................................................................................................................................................................................................................18
Template for returns ................................................................................................................................................................................................................................................................................................................................ 19
Warnings ..................................................................................................................................................................................................................................................................................................................................................................... 20
Warranty ...................................................................................................................................................................................................................................................................................................................................................................... 20
Support .......................................................................................................................................................................................................................................................................................................................................................................... 20

4
Instructions for Use Carrier
For your safety
For your safety
Please observe the Instructions for Use
Any application or handling of the product requires precise knowledge and observation of the Instructions for Use. The prod-
uct may only be used for the purpose described.
Statements of particular importance are flagged as follows in the Instructions for Use:
Liability for proper function and damage
Any liability for damage from using the product is transferred to the owner or operator of the device inasmuch as the product
has been used by persons who do not belong to the relevant professional groups or do not have the qualifications required
when operating the product or have not receive proper training in its use. In addition, liability is transferred to the user in
case of improper use or use that is not within its defined intended purpose.
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.
Please ensure that the Instructions for Use are accessible at all times and that they are read and understood.
Warning!
This is a Warning alerting you to risk situations and dangers.
Ignoring such a warning may lead to life-threatening situations.
Warnings must be observed under all circumstances.
Information!
This is information about specific features that need to be considered under
all circumstances.

5
Instructions for Use
Carrier
Intended use and indications
Intended use Carrier
The intended use for
Carrier
is as a holding device for fasciotens products, before, during and aer surgical proce-
dures.
Carrier
is a class I medical device.
The product is intended exclusively for human medical purposes and is used during surgery.
The product is approved for use in combination with
Hernia .
Indications
• Combination with products
• Combination with operating tables or standard rails
Contraindications
• No suiciently stable fastening rail
Intended purpose and indications / contraindications / component definitions
Components
Handwheel - post
Post
base (P1)
Post
extension (P2)
Handwheel
extension (P3)
Eccentric handle (P4) Crossbar
Crossbar
with bracket
and retaining bracket

6
Instructions for Use Carrier
Product structure
Carrier
HC010
Product structure Carrier HC010
Carrier and Hernia may only be used in a sterile condition. Carrier is sup-
plied in a non-sterile condition by the manufacturer and must be sterilised in the hospital before each use in the
operating room. Please follow the processing instructions. Please follow the storage instructions for the product.
Carrier must be sterilised before use by the CSSD according to the processing instructions.
Post
Crossbar
with bracket
and retaining bracket
Carrier
(HC010) consists of the following modules:
The figure below shows how Hernia is used in combination with Carrier.

7
Instructions for Use
Carrier
Assembly
Carrier
HC010
Assembly of the product
Carrier can be attached to all operating tables that have a standard rail. The post is mounted on the sterile cover
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.
1. Remove the components from the tray and place them on the instrument table. Make sure that the clamp opening at
the lower end of the post is fully open.
2. Place the post on the standard rail of the operating table.
3. Lock the post on the standard rail of the operating table by turning the handwheel clockwise. Make sure that it is firmly
seated on the operating table.
Always hold the eccentric handle with one hand to prevent it from falling suddenly when not locked.
Make sure that the post is properly attached and
that there are no objects in the way which would
make proper attachment impossible (e.g. patient
blanket, catheter, ECG cable).
The operating table cover should have no more
than 2 layers.

8
Instructions for Use Carrier
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. We recommend positioning the ball holder 15-20 cm
above the abdomen.
6. Remove the crossbar from the packaging and insert
the crossbar into the eccentric handle.
7. Move the crossbar in the desired direction to find the optimal setting depending on the location of the defect.
8. Secure the post in the eccentric handle by flipping the clamping lever. The word "closed" will now be visible.
The post and the crossbar can cause pressure damage. Make sure that there is suicient space between the
patient and the crossbar.

9
Instructions for Use
Carrier
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.

10
Instructions for Use Carrier
Product structure
Carrier
HC020
Product structure Carrier HC020
Carrier and Hernia may only be used in a sterile condition. 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. Please follow the processing instructions. Please follow the storage instructions for the product.
Carrier must be sterilised before use by the CSSD according
to the processing instructions.
Post HC021 Crossbar HC022
Carrier
(HC020) consists of the following modules:
The figure below shows how Hernia is used in combination with Carrier.