fasciotens gebrauchsanweisung en 04 2019 · 2021. 4. 19. · ©abdomen instructions for use 11....

©Abdomen

Instructions for Use

www.fasciotens.de

©Abdomen

2

Instructions for Use ©Abdomen

Introduction

Dear customer,

thank you very much for choosing fasciotens©Abdomen, the innovative therapy option in the treatment of the open abdomen. fasciotens©products offer highest standards in quality, safety, and advanced technology. Medical necessity dictated the development of this product, and it was practicing surgeons who accomplished this development.

In order to be able to make full use of the capability of this product and for its successful application, please read the instruc-tions for use carefully and operate the product as instructed. Safe operation and product function can only be guaranteed if both the requirements of the Regulations Governing the Installation, Operation and Use of Medical Devices and the gen-eral safety and accident prevention regulations as well as the content of the Instructions for use are being met. We will not assume liability for any damage arising from improper use or use contrary to its intended purpose or incorrect handling.

Use of the medical device is restricted to medical professionals. Please make sure that all persons using this product only do so after having read and understood the Instructions for Use. Moreover, application without prior instruction is not permitted.

Please keep the Instructions for Use in a safe place; you may want to reread it at a later date.

Reading the Instructions for Use alone will not be sufficient for the immediate use of fasciotens©Abdomen Additional hands-on training on the use of the product by a qualified person will be required.

Company address:fasciotens GmbHAachener Str. 1053-1055D-50858 Köln

Tel.: +49 (0)221 17738 500Fax: +49 (0)221 17738 549Email: [email protected]: www.fasciotens.de

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Instructions for Use©Abdomen

Table of Contents

Table of Contents

For your safety 4

Indications 5

Contraindications 5

Design 6

Pre-operative planning 6Surgical access to fascia 7Surgical placement of mesh and suture materials 7

Surgical and mounting procedures 9Pre-assembly of fasciotens©Abdomen 10Optional adaptation of length and height 13Placing fasciotens©Abdomen 14Adjusting traction 17

Surgical revisions 19

Removal in an emergency 22

Cleaning and disposal 23Cleaning 23Reprocessing/sterilization 23Disposal 23

Warnings 24

Warranty 24

Support 24

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For Your Safety

For Your Safety

Please observe the Instructions for Use

Any implementation and handling of the product requires the precise knowledge and observation of the Instructions for Use. The product may only be used for the purpose described.

The Instructions for Use highlight statements of particular importance as follows:

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 circles or do not have the qualifications required when operating the product or did not receive proper training on 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 checked for its integrity and any defects.

The warranty and liability provisions of the Terms and Conditions stipulated by fasciotens GmbH are not being extended by any information that precedes or follows them.

Please make sure that the Instructions for Use are accessible at any time and that they are being 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 points out specific features that need to be considered under all circumstances.

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Indications /Contraindications

Indications

The intended purpose of fasciotens©Abdomen is its use for the prevention of fascial retraction as incurred in an open abdo-men, and for tissue expansion of the abdominal wall/fascia in previous loss of abdominal wall tissue/fascial tissue.

Typically, all indications where applying external tensile force may be an option when a laparostoma was created due to elevated abdominal pressure or other causes. fasciotens©Abdomen is to prevent fascia retraction or – where a loss of fascia/abdominal wall has already occurred – expand and thus recover tissue.

Contraindications

Applicability of the product may be restricted by local factors of the area of application and due to the general health status of a patient!

Local Factors:

• Skin damage or infections in the areas where the support surfaces are to be placed• Application to intact skin not possible• Unstable thorax• Unstable pelvis• Other local impairments to resilience in the areas of the support surfaces• Insufficient clearance between patient and device due to e. g. obesity• Silicone implants in the area of the support surfaces, especially in the female breast

General Factors:

• High-grade heart failure from NYHA III or ejection fraction below 35 %• Pregnancy• Acute impairment of pulmonary function necessitating an 80 % FiO2• Prone position of patient required

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Design

Design

fasciotens©Abdomen

Using fasciotens©Abdomen

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Pre-operative Planning


When creating a laparostoma, e. g. in confirmed abdominal compartment syndrome, fasciotens©Abdomen should be at hand and ready for use. The same applies if an intraoperative decision to create a laparostoma may have to be made for other reasons such as peritonitis or sepsis.

Surgical Fascial Access

In view of the prevailing anatomical situation, extra caution and experience of the surgeon are required when surgically opening the abdomen, and thus creating access to the fascia of the M. rectus abdominis. Laparotomy should follow stan-dardized requirements. Unless previous surgery dictates oth-erwise, midline laparotomy is the preferred approach when opening the abdominal cavity. This access is a suitable pro-cedure when opening the abdomen for the treatment of the abdominal compartment. The incision should be lateral to the umbilicus on either the right or the left side.

Placement of Surgical Mesh and Suture Materials

To spare the structures of the abdominal wall, we recommend to distribute the ventrally applied traction by means of a commercial surgical mesh that is laid flat and stitched in place using conventional techniques. We recommend short-spacing the sutures (small steps/small bites).

Should the fascial edge be used up or necrotic due to preceding interventions, using the anterior or posterior lamina of the rectus sheath and possibly including the cutis, may be an alternative.

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Once the surgical mesh has been placed, a sufficient number of surgical sutures are tied into the mesh at similar distances as shown (Option 1).

As an alternative in long laparotomy incisions, the mesh can be stitched with a long thread which then is guided up in an U bend to be fixed in the clamping device of the thread retainer (Option 2). The visceral organs and the wound are covered according to the instructions of the treating physician.

After mounting fasciotens©Abdomen, which is described in the following section, threads should be introduced in the specific slots of the thread retainer and fixated by the appropriate snap fasteners. We recommend thread ends of about 25 cm in length that may be shortened after fixation in the clamping device, as appropriate. There should always be an excess end of approx. 5 cm, so that length can be adjusted if required.

It is absolutely necessary to use polyfile sutures (minimum thickness 2), to ensure that the threads are securely retained in the thread holders.

Option 1

Option 2

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Surgical and mounting procedures


The following technique describes the alternatives of mounting the product. This product is for use with the following mounting technique only. Use as intended refers to the prevention of fascial retraction under conditions of an open ab-domen and to the expansion of the abdominal wall/fascia in preceding loss of abdominal wall/fascial tissue.

Any application of the product for other anatomical structures or other interventions is contrary to intended purpose.

fasciotens©Abdomen consists of the following modules that are delivered in 3 modules.

Module 1: Support surfaces with support padding

Module 2: Thread retaining frame

Module 3: Stand with anchor screws

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Pre-assembly of fasciotens©Abdomen

Pre-assembling the support surfaces and mounting the thread retainer to the stand can be performed at the sterile instru-ment table while the mesh is sown in. The external system must be mounted under sterile conditions.

Wearing sterile gloves is an indispensable necessity.

Module 1 (support surfaces/support padding) and Module 3 (stand + anchor screws) are required for the procedure and are opened.

1. Remove an anchor screw and insert it through the opening in the support surface.

To protect anchor screws from falling out, always secure them until they are thoroughly fixed in the supporting feet! Use the instrument table to assemble the system!

2. Introduce the anchor screw in the thread of the supporting foot. Again it is helpful to place the stand on the instrument table with the supporting feet pointing up.

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3. Tightly fasten anchor screws in the supporting feet.

4. The support surface is now safely connected with the supporting foot.

5. Repeat this step for the second support surface.

6. Put up the stand on its support surfaces. You may now turn the force measuring device around to stand on its feet.

7. The red lever for emergency release should now point downwards.

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8. Should you prefer to mount the thread retainer frame directly on the patient, you now need to place the support pads under the support surfaces.

Secure the support pads so that they do not come off when transferring the assembly from the instrument table to the surgical table!

9. The thread retainer (Module 2) is introduced in the emergency release from below.

10. It is fastened using the red locking bolt:

The bolt is fixed in the ‘open’ position by retracting it and rotating it by 90°. The thread retainer may now be introduced. When turned back, the bolt will engage in the ‘locked’ position, and the thread retainer is secured. Please check that the thread retaining device is safely attached in the emergency release.


Ensure that the thread retainer is fully inserted into the receptacle and that the locking bolt engages properly.

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11. fasciotens©Abdomen is now ready for use. When transferring it to the patient, please make sure that all parts are fastened tightly and secure the support pads.

Optional adjustment of length and height

Height adjustment is loosened or locked by turning the thumb screws. Both supporting feet can be separately adjusted for height.


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The thumb screws at the top permit to adjust length along the vertical rods.

After adjustment the thumbscrews must be fixed again!

Do not loosen the thumbscrews more than is necessary, to prevent their coming off!

Placing fasciotens©Abdomen

1. fasciotens©Abdomen should now be placed on the thorax and the anterior pelvic ring.

The support pads may only be deployed on intact skin!

Make sure that no other objects, such as cables, are trapped under the support pads. Also, do not apply pressure to the genitals.

Additional cushioning with wrinkle-free dressing material is recommended.


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2. The free-end of the sutures stitched into the meshes may now be fixed to the thread retainer frame as follows:

1. Press a snap fastener on the thread clamping device2. Insert thread through slots in the clamping device3. Let go of the snap fastener

Until at least the four corner threads have been safely attached, an assistant is required to secure the product!

Visual control of the sutures and the intestines is required throughout the application of fasciotens©Abdomen. If necessary, threads must be adjusted or replaced so as to prevent any injuries.


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3. First attach all threads and adjust to achieve a similar baseline strain on all of them.

After all threads have been attached, please check them for their baseline strain. Some threads may have to be adjusted. To do so, please follow the above procedure.

Please note that the basic tension is not too high in the beginning, in order to be able to increase the tension over the black screw head and in particular to be able to reduce it. Ideally, the setting is not yet in the green range after reaching the basic tension of all threads.


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Adjusting traction

The traction applied to the abdominal wall/fascia is adjusted by turning the black screw head.

The end of the black sleeve above the colored sleeves serves as an adjustment aid. This will be explained to more detail in the following. Adjusting traction to a level in the upper light green section, i. e. between 40 and 50 N, is recommended.

When starting the adjusting step, the black screw head may have to be turned upward till the end cap is touched. At this stage, the threaded rod should not protrude from the top of the screw head.

The baseline setting should be in the top light green section, hence between about 40 and 50 N!

Setting traction to the dark green setting range, requires close monitoring of the support surfaces since this results in elevated compressive load!

The tension that is distributed via the threads and meshes leads to a ventral pull on the abdominal wall.


Recommended range of traction

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Do a final check on the strain applied to each thread. It should be similar in all threads.

The thread retaining device must not be in contact with the wound area or the abdominal organs!

For positioning of a patient, in particular changes in the position of the thorax relative to the pelvis, attention must be paid to possible changes in tensile force and direction.


During the ongoing therapy on the ward it is recommended to move the bearing surfaces regularly by longitudinal shifting and/or turning.

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Surgical Revisions

Depending on the treatment outcome, subsequent interventions or revisions may be necessary. In this case disassembling fasciotens©Abdomen will be simple and fast. Since the clamping device can be removed, the suturing material attached may be left in place, and no time is lost on resuturing.

Removal for revision intervention

1. Loosen the overall traction by turning the black screw head until the threaded rod no longer protrudes from the screw head.

2. Loosen locking bolt by retracting and rotating it by 90°.

Surgical Revisions

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Surgical Revisions

3. Remove the clamping devices together with the threads attached by lifting them out of the thread retainer. If necessary, gently press down force measuring device for easy removal.

4. Repeat steps on the other side.

5. The clamping devices may now be placed to the sides of the patient and the remaining system may be removed from the patient in one piece.

Make sure the clamping devices do not touch the skin. No monopolar electric scalpels may be used since heating of the clamping devices cannot safely be excluded and may result in burns. Also, electricity discharged via the clamping devices may lead to burns if grounding occurs and there is skin contact at the same time.

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Surgical Revisions

6. Following the revision the part removed from the product may once more be placed on the patient and the clamping devices attached to the thread retainer. To do so, the clamping devices are fixed in the appropriate position (laterally or centrally) and the locking bolts rotated by 90°, so that they engage and lock the clamping devices.

The setting chosen for traction needs to be checked and adjusted, as required.

Depending on the space required by the prolapsing organs, the clamping devices may either be posi-tioned laterally or centrally. Initially, the clamp-ing devices should be positioned laterally, and changed to the central position as soon as intes-tinal swelling recedes. This means traction shifts from a purely ventral direction to the opposite side thus readying abdominal closure at a later stage. After further decrease of the swelling and immedi-ately prior to closing the abdomen, the thread re-tention may be shifted to the contralateral clamp-ing device. This way traction on either side directs the fascial edges towards each other.

Alternatively, all threads can be cut, which is use-ful, for example, with simultaneous use of negative pressure wound therapy. In this case, to reinstall the system at the revision new threads need to be attached to the mesh.

If contralateral thread retention is introduced too early, this may lead to organ damage due to threads cutting in or due to pressure elevation

Abdominal organs can now be covered either with conventional dressing material or with negative pressure wound therapy as determined by the treating physician.

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Removal in an Emergency


In view of the serious condition that prevails in patients with opened abdomen, emergency situations may occur in the course of the disease and while using fasciotens©Abdomen. In particular, if a patient requires resuscitation and life-saving measures need to be introduced, fast removal of the product is of highest importance.

Moreover, displaying the accompanying Quick Guide near the bed of the patient is recommended.


1. Firmly grasp the thread retainer with one hand. Retract the red locking bolt and rotate it by 90°.

2. This disengages the thread retainer which now can be pulled downward and removed.

3. Remove the stand and its support surfaces from the patient, so that emergency measures can be introduced.

It is recommended to firmly grasp the thread retainer with one hand, so that no force is executed on the opened abdomen.

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Removal in an Emergency/Cleaning and Disposal

If removal by manipulating the locking bolt should not disengage the thread retainer, cut all threads as an alternative solution.

Remounting the device upon completion of resuscitation/emergency measures

After successful resuscitation or emergency measures, remounting the device is fast, simple and does not require much effort.

1. Position stand together with its support pads on patient2. Bring black screw head back into initial position (with threaded rod sunk)3. From below, introduce thread retainer into its recess4. Lock emergency release5. Readjust traction

Cleaning and Disposal

Cleaning

The product may be cleaned from all debris and contamination using conventional disinfectants. Regular wipe-down disinfection is recommended for the stand. Wipe-down disinfection is suitable for all parts of the device. For disinfection the product may be removed from the patient using the emergency release (see Removal/Assembly in an Emergency).

Reprocessing/Sterilization

The product is for single use only, hence it is not suited for resterilization and reprocessing. Reprocessing procedures cannot safely preclude potential adhesions of infectious material and thus patient hazard. For this reason the manufacturers are not able to guarantee the performance and safety of the medical device if used repeatedly.

Disposal

Discard product with hospital waste after use.

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Warning notices/Warranty/Support

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fasciotens GmbH, Aachener Str. 1053-1055, D-50858 Köln Tel.: +49 (0)221 17738 500, Fax.: +49 (0)221 17738 549, Email: [email protected]

Support

For any issues or questions please contact our Support under [email protected] or call us under +49 (0)221 17738500.

Warranty

The legal warranty period of 24 months applies to our products. Should any initial defect occur in your product within this period, please inform our Support immediately.

The product is for singly use only and is labelled accordingly. Any reprocessing or resterilization and subsequent re-use is considered abnormal handling, and in this case all and any guarantee rights, the warranty and liability of fasciotens GmbH are deemed to be null and void.

In case of deficiencies that may imply a hazard for patients, staff or third parties, the device must no longer be used and is to be replaced.

Damage resulting from improper use, external mechanical impacts, transport damage, applications that do not comply with the intended use, or applications carried out by non-authorized persons is not covered by this warranty, nor is it covered by the manufacturers‘ liability.

Warning notices

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fasciotens gebrauchsanweisung en 04 2019 · 2021. 4. 19. · ©abdomen instructions for use 11....

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