Interrad Medical SecurAcath Instructions for use

International IFU
Instructions for Use - English - EN
Istruzioni per l'uso - Italiano - IT
Mode d’emploi - Français - FR
Gebruiksinstructies - Nederlands - NL
Gebrauchsanleitung - Deutsch - DE
Instrucciones de uso - Español - ES
Brugsanvisning - Danish - DA
Användningsinstruktioner - Swedish - SV
Käyttöohjeet - Finnish - FI
Návod k použití - Czech - CS
Instruções de Utilização - Portuguese - PT
Οδηγίες χρήσης - Greek - EL
Bruksanvisning - Norwegian - NO
‫ﻋﻠﯾت اﻻﺳﺧدام‬- Arabic - AR
MRI Information
Non-clinical testing demonstrated that the SecurAcath Device with Nitinol
Securement is MR Conditional*. A patient with this device can be
scanned safely immediately after placement under the following
conditions:
Subcutaneous Catheter Securement System
Instructions for Use
Product Description
The SecurAcath is a subcutaneous catheter securement system. The device
utilizes a small anchor (securement feet) placed just beneath the skin at the
catheter insertion site and attached to the catheter shaft. The SecurAcath is
designed for round-shaft catheters.
- Static magnetic field of 3-Tesla or less
- Spatial gradient magnetic field of 720-Gauss/cm or less
- Maximum MR system-reported, whole-body-averaged specific
absorption rate (SAR) of 3 W/kg for 15 minutes of scanning.
During testing, the device produced a clinically non-significant
temperature rise at a maximum MR system-reported, whole-bodyaveraged specific absorption rate (SAR) of 3 W/kg for 15 minutes of
scanning. MR image quality may be compromised if the area of interest
is in the exact same area or relatively close to the position of the device.
Therefore, optimization of MR imaging parameters to compensate for the
presence of this device may be necessary.
* MR Conditional as defined in ASTM F 2503-05
Indications
The SecurAcath Device is indicated for short or long term securement of
percutaneous indwelling catheters to the access site by means of a
subcutaneous anchor.
Preparation for Use
Examine the package carefully before opening to confirm its integrity and
that the expiration date has not passed. The device is supplied in a
sterile package and is non-pyrogenic. Do not use if package is damaged,
opened, or the expiration date has passed.
CAUTION: Product cannot be resterilized.
Contraindications, Warnings and Precautions
Contraindications
The device is contraindicated whenever:
• Skin integrity deemed unfavorable by the operator, e.g. friable skin due to
chronic steroid use, presence of cellulitis or rashes at the desired site of
catheter insertion
• Local tissue factors will prevent proper device stabilization and/or access
• The presence of device-related infection, bacteremia, or septicemia is
known or suspected
• The patient’s body size is insufficient to accommodate the size of the
implanted device
• The patient is known or is suspected to be allergic to materials contained in
the device
• Past irradiation of prospective insertion site
1. Place catheter following standard procedure
NOTE: The SecurAcath requires a minimum of 3cm of catheter shaft
exposed above the skin surface. The back end of the SecurAcath
device should not be placed beyond the zero mark on the catheter or
closer than 1cm from the catheter hub.
NOTE: A dermatotomy is not required, however, if performed it should
be less than 3mm.
Warnings
• Intended for Single Patient Use. DO NOT REUSE. Reuse may lead to SAE
and device malfunction
• This product contains nitinol. Do not use in patients with known nickel
allergy
• After use, this product may be a potential biohazard. Handle and discard in
accordance with accepted medical practice and applicable local, state and
federal laws and regulations
Precautions
• Carefully read and follow all instructions prior to use
• Federal (U.S.A.) law restricts this device to sale by or on the order of a
physician
• Only qualified health care practitioners should insert, manipulate and
remove these devices
• Follow universal precautions when inserting and maintaining the catheter
• Do not attempt to remove the catheter when the SecurAcath device is
securing the catheter
• Do not twist or rotate the device after securement
• SecurAcath device should be removed when the catheter is removed
Possible Complications
The potential exists for serious complications including the following:
• Bleeding
• Brachial Plexus Injury
• Catheter Erosion Through the Skin
• Catheter Related Sepsis
• Insertion Site Infection or necrosis
• Hematoma
• Intolerance Reaction to Implanted Device
• Laceration or Perforation of Vessels or Viscus
2. Select the appropriate size SecurAcath device to match the catheter
diameter. If catheter is not a whole French size, use the closest
smaller size SecurAcath (i.e. with 8.5F catheter use 8F SecurAcath)
3. Fold the base downward until eet come together
4. Lift the catheter off the skin surface to visualize the insertion site on
under side of catheter
5. Hold the folded base at an angle,
aiming the tips of the feet at the
insertion site. Insert feet and
advance a few millimeters into the
subcutaneous tissue
NOTE: If the insertion site is not
large enough to insert the feet, use
one hand to stretch the skin or use
the tip of a dialator to widen the
insertion site
6. Orient the base in the direction you
want the catheter to lie. A
maximum angle of 45 degrees in
either direction from center is
recommended. The base should lie
on stable tissue and away from
areas of flexion such as joints.
7. Release the base to allow it to open
8. Unfold the base until it is flat
9. Gently pull the base to be sure the feet
are fully open under the skin
10. If the feet appear to be overlapping
slightly, gently move the base back and forth to allow them to open
fully
11. Align the catheter with the groove in the base.
• Be sure the catheter shaft and base are clean and dry
12. Place the cover on the base by
pressing down on cover while
holding base to affix the device to
the catheter shaft. Visually
inspect the edges of the
SecurAcath to make sure the
cover is fully engaged with the
base. There should be no gap
along the edge of device
Note: Flush the catheter lumens
to assure patency
13. Adjust catheter length (optional)
Remove the cover, adjust
catheter position, replace the cover
14. Record on the patient’s chart the indwelling catheter length as to
centimeter markings on the catheter where it enters the skin.
Frequent visual reassessment should be made to ensure the
catheter has not moved
15. Dress catheter site per hospital protocol
NOTE: Be sure to stabilize catheter hub under the dressing to
prevent pulling or kinking of catheter outside the SecurAcath device.
Do not turn or twist the SecurAcath from its original position. Do not
apply dressing too tightly or it may create pressure on SecurAcath
device which may cause patient discomfort
Removal Procedure
• Remove dressing
• Grip the HOLD tab on SecurAcath
device with thumb and finger of one
hand to stabilize device
• Pry upward at edge of LIFT tab with the
other hand to release the cover from
the base
• Remove the cover completely from the
base.
WARNING: Do not attempt to remove
the catheter when cover is attached and
feet are deployed
• Remove the catheter. Do not use
excessive force
• Hold pressure at the insertion site until hemostasis is achieved and
while removing SecurAcath feet
Cleaning the Insertion Site
• Follow Infusion Therapy Standards of Practice and hospital protocol for
catheter site maintenance
• Use 3ml or larger 2% chlorhexidine gluconate (CHG)/70% isopropyl
alcohol applicator or povidone iodine swabs as an antiseptic solution
• Follow antiseptic solution manufacturer’s labeled directions for
application
• Gently lift the catheter and SecurAcath device to clean around the
catheter insertion site
• Do not twist or rotate the SecurAcath device from its original position
while cleaning the insertion site
• Flood insertion site area and SecurAcath device with antiseptic solution .
Ensure the antiseptic solution is applied to all exterior surfaces of the
device
• Scrub skin around entry site. Use repeated back and forth strokes of
the applicator for a minimum of 30 seconds. Completely wet the area
with antiseptic solution
• Allow area to air dry. Do not blot or wipe away
• Dress catheter site per hospital protocol
NOTE: Be sure to stabilize catheter hub under the dressing to prevent
pulling or kinking of catheter outside the SecurAcath device. Do not
apply dressing too tightly or it may create pressure on SecurAcath
device which may cause patient discomfort
If catheter or securement feet dislodge
If the catheter or securement feet dislodge, do not reinsert the catheter.
Temporarily secure the catheter and assess if catheter must be removed
and replaced.
MR Conditional
Use by date
Single use only
Sterilized by Ethylene Oxide
Refer to IFU for more information
Do not re-sterilize
Note: If site is scabbed or has
adhesions/tissue growth, apply saline
soaked sterile gauze to the site for a
few minutes to ease removal
Prescription Use Only
Authorized Representative in the
EEA
Manufacturer
Option 1—Fold Base
Refer to IFU
• Apply firm pressure at insertion site
with one hand
• Use other hand to fold wings
downward to bring feet together under the
skin. Place a third finger under device to
help begin folding motion
• Hold folded base horizontal to the skin
• Use a swift, deliberate upward motion to
remove following the shape of the feet
USA Clinical Support Line
Not made with Natural Rubber
Latex
Do not use if package is damaged
Batch code
Catalogue number
Interrad and SecurAcath are trademarks of Interrad Medical, Inc.
Patents: securacath.com/patents
© Copyright 2019 Interrad Medical, Inc. All rights reserved .
Option 2—Split Base
• Use a blunt-tip scissors to cut the base
completely in half lengthwise along the
groove
• The flexible feet are shaped like an “L” with
the feet extending 5mm to each side of the
insertion site
• Apply firm pressure at the insertion site
with one hand
• Turn blue edge upward and use a swift,
deliberate upward motion to remove each
foot separately following the shape of the
foot
Interrad Medical, Inc.
181 Cheshire Lane Suite 100
Plymouth, MN 55441
USA
1-866-980-1811
www.securacath.com
Authorized Representative:
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
+49 511 6262 8630
1500-001-rE
•
•
Interrad Medical, Inc.
181 Cheshire Lane Suite 100
Plymouth, MN 55441
USA
1-866-980-1811
www.securacath.com
Rappresentante autorizzato:
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germania
+49 511 6262 8630
1500-002-rE
2.
3.
4.
5.
6.
7.
8.
9.
Interrad et SecurAcath sont des marques de commerce d’Interrad Medical, Inc.
Brevets: securacath.com/patents
© Copyright 2019 Interrad Medical, Inc. Tous droits réservés.
Interrad Medical, Inc.
181 Cheshire Lane Suite 100
Plymouth, MN 55441
États-Unis
1-866-980-1811
www.securacath.com
Représentant autorisé :
MDSS GmbH
Schiffgraben 41
30175 Hanovre, Allemagne
+49 511 6262 8630
2010
1500-003-rF
Onderhuids Katheterbevestigingssysteem
Interrad Medical, Inc.
181 Cheshire Lane Suite 100
Plymouth, MN 55441
VS
1-866-980-1811
www.securacath.com
Bevoegde Vertegenwoordiger:
MDSS GmbH
Schiffgraben 41
30175 Hannover, Duitsland
+49 511 6262 8630
1500-004-rE
Chargencode
Katalognummer
Interrad und SecurAcath sind Marken von Interrad Medical, Inc.
Patente: securacath.com/patents
© Copyright 2019 Interrad Medical, Inc. Alle Rechte vorbehalten.
Interrad Medical, Inc.
181 Cheshire Lane Suite 100
Plymouth, MN 55441
USA
1-866-980-1811
www.securacath.com
Autorisierter Vertreter:
MDSS GmbH
Schiffgraben 41
30175 Hannover, Deutschland
+49 511 6262 8630
1500-005-rE
2.
3.
4.
5.
6.
7.
8.
9.
Interrad Medical, Inc.
181 Cheshire Lane Suite 100
Plymouth, MN 55441
USA
1-866-980-1811
www.securacath.com
Representante autorizado:
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
+49 511 6262 8630
1500-006-rE
Interrad Medical, Inc.
181 Cheshire Lane Suite 100
Plymouth, MN 55441
USA
1-866-980-1811
www.securacath.com
Authorized Representative:
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
+49 511 6262 8630
1500-007-rE
•
•
Interrad Medical, Inc.
181 Cheshire Lane Suite 100
Plymouth, MN 55441
USA
1-866-980-1811
www.securacath.com
Auktoriserad representant:
MDSS GmbH
Schiffgraben 41
30175 Hannover, Tyskland
+49 511 6262 8630
1500-008-rE
Interrad Medical, Inc.
181 Cheshire Lane Suite 100
Plymouth, MN 55441
USA
1-866-980-1811
www.securacath.com
Valtuutettu edustaja:
MDSS GmbH
Schiffgraben 41
30175 Hannover, Saksa
+49 511 6262 8630
1500-009-rE
Interrad a SecurAcath jsou ochranné známky společnosti Interrad
Medical, Inc.
Patenty: securacath.com/patents
© Copyright 2019 Interrad Medical, Inc. Všechna práva vyhrazena.
Interrad Medical, Inc.
181 Cheshire Lane Suite 100
Plymouth, MN 55441
USA
1-866-980-1811
www.securacath.com
Autorizovaný zástupce:
MDSS GmbH
Schiffgraben 41
30175 Hannover, Německo
+49 511 6262 8630
1500-010-rD
Interrad Medical, Inc.
181 Cheshire Lane Suite 100
Plymouth, MN 55441
EUA
1-866-980-1811
www.securacath.com
Representante Autorizado:
MDSS GmbH
Schiffgraben 41
30175 Hannover, Alemanha
+49 511 6262 8630
1500-013-rD
Interrad Medical, Inc.
181 Cheshire Lane Suite 100
Plymouth, MN 55441
USA (ΗΠΑ)
1-866-980-1811
www.securacath.com
Εξουσιοδοτημένος αντιπρόσωπος:
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany (Γερμανία)
+49 511 6262 8630
1500-011-rD
• Hold trykket på innstikkstedet med
den ene hånden
• Bruk den andre hånden til å brette
kantene på ankeret ned under huden.
Plasser en tredje finger under enheten
for å hjelpe brettebevegelsen
• Hold det brettede fotstykket vannrett
med huden
• Bruk en hurtig, og bestemt bevegelse
oppover for å fjerne mens formen til
føttene følges
Interrad og SecurAcath er varemerker for Interrad Medical, Inc.
Patenter: securacath.com/patents
© Copyright 2019 Interrad Medical, Inc. Med enerett.
Interrad Medical, Inc.
181 Cheshire Lane Suite 100
Plymouth, MN 55441
USA
1-866-980-1811
www.securacath.com
Autorisert representant:
MDSS GmbH
Schiffgraben 41
30175 Hannover, Tyskland
+49 511 6262 8630
1500-012-rD
Interrad Medical, Inc.
181 Cheshire Lane Suite 100
Plymouth, MN 55441
SUA
1-866-980-1811
www.securacath.com
Reprezentant autorizat:
MDSS GmbH
Schiffgraben 41
30175 Hanovra, Germania
+49 511 6262 8630
1500-014-rD
‫•‬
‫•‬
‫‪Interrad Medical, Inc.‬‬
‫‪555 Cheshire Lane Suite 577‬‬
‫‪Plymouth, MN 11445‬‬
‫‪USA‬‬
‫‪5-566-957-5555‬‬
‫‪www.securacath.com‬‬
‫נציג מורשה‪:‬‬
‫‪MDSS GmbH‬‬
‫‪Schiffgraben 45‬‬
‫‪37501 Hannover, Germany‬‬
‫‪+49 155 6262 5637‬‬
Sıra numarası
Katalog numarası
Interrad ve SecurAcath, Interrad Medical, Inc.'e ait ticari markalardır
Patentlers: securacath.com/patents
© Telif Hakkı 2019 Interrad Medical, Inc. Tüm hakları saklıdır.
Interrad Medical, Inc.
181 Cheshire Lane Suite 100
Plymouth, MN 55441
ABD
1-866-980-1811
www.securacath.com
Yetkili Temsilci:
MDSS GmbH
Schiffgraben 41
30175 Hannover, Almanya
+49 511 6262 8630
1500-019-rD
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‫خام‪،‬‬
‫اساياو ‪ - 1‬ي اسةاعدت‬
‫•‬
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‫•‬
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‫اساياو ‪ - 2‬ق ا اسةاعدت‬
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‫شوكة ‪.Interrad Medical, Inc‬‬
‫‪ 555‬طيطاي تي ك‪،‬يت ‪ 500‬ر يما‪،‬تأ ‪MN 11445 USA‬‬
‫‪5-566-950-5555‬‬
‫‪www.stucAcuceS.uom‬‬
‫اسممي اسمعدمد‪:‬‬
‫ط ل ‪MDSS CmbH‬‬
‫‪SuSiffgAcbtn 45‬‬
‫‪30571 HcnnovtA, CtAmcny‬‬
‫‪+49 155 6262 5630‬‬
‫‪5100-058-AD‬‬