Description
The Manipler®AZ is a sterile, single use skin stapler designed to deliver 35 stainless steel
staples for routine wound closure.
Indications
The Manipler®AZ skin stapler can be used for routine skin closure in a wide variety of
surgical procedures.
Applications
Prior to using the skin stapler verify compatibility of skin staple remover.
Using sterile technique remove the skin stapler from the package.
With a tissue forceps, pull skin edges together until edges evert (Fig.1)
Position the skin stapler over the center of the everted skin edges (Fig.2)
To form the staple, squeeze the trigger Ðrmly together until the trigger motion is
halted (Fig.3)
Release the trigger (Fig.4)
Move the staple off the incision (Fig.5)
Always verify the correct position of the staple.
Contra-Indications
When it is not possible to maintain at least 5mm distance from the stapled skin to
underlying bones, vessels, or internal organs, the use of staples for skin closure is
contraindicated.
The Manipler®AZ staples contain nickel, which might lead to allergic reactions with
some patients.
Do not reuse or resterilize. This may cause damage on functional capacities of the
product and product and may cause damage or infection in patients.
Adverse Reactions
Adverse effects associated with the use of this device include: wound dehiscence; allergic
response in patients with known sensitivities to metals contained in 316L stainless steel,
(i.e., chromium, nickel and iron) enhanced bacterial infectivity; minimal acute ináammatory
tissue reaction; and pain, edema, and erythema the wound site.
MRI Safety Information
MR Conditional
The Staple of Manipler®AZ is MR Conditional.
A) Non-clinical testing demonstrated that the Staple of Manipler®AZ is MR Conditional.
A patient with this device can be scanned safely, immediately after placement under
the following conditions:
-Static magnetic Ðeld of 3-Tesla or less
-Maximum spatial gradient magnetic Ðeld of 1,500-Gauss/cm (extrapolated) or less
-Maximum MR system reported, whole body averaged speciÐc absorption rate
(SAR) of 4-W/kg for 15 minutes of scanning (i.e., per pulse sequence)
-Normal Operating Mode of operation for the MR system
B) MRI-Related Heating
In non-clinical testing, the Staple of Manipler®AZ produced the following temperature
rise during MRI performed for 15-min of scanning (i.e., per pulse sequence) in a 3-Tesla
MR system (3- Tesla/128-MHz, Excite, HDx, Software 14X.M5, General Electric Healthcare,
Milwaukee, WI):-
•
•
•
Safety instructions
Do not use the Manipler®AZ if the date of expiry has passed.
Store the Manipler®AZ at room temperature and use it directly after the
package has been
opened.
Never use products from open or damaged sterile packaging.
Do not resterilize, as this might impair the functioning of the product and
injure the patient.
Use the Manipler®AZ skin stapler only on one patient.
After using, dispose of the product properly as medical waste.
Sterility
Sterilization is effective until the date of expiry, if the package is stored correctly in a closed and intact
package.
Shelf life is 5 years.
Delivery formats and package sizes
The Manipler®AZ -35W is delivered in a box of 6 units.
Explanation of the symbols on the packaging
C
) Artifact Information
MR image quality may be compromised if the area of interest is in the exact same area or
relativelyclose to the position of the Staple of Manipler®AZ. Therefore, optimization of MR
imaging parameters to compensate for the presence of this device may be necessary. The
maximum artifact size (i.e., as seen on the gradient echo pulse sequence) extends
approximately 15-mm relative to the size and shape of the Staple of Manipler®AZ.
Pulse Sequence T1-SE T1-SE
GRE GRE
Signal Void Size 271-mmâ 175-mmâ 651-mmâ 467-mmâ
Plane Orientation Parallel Perpendicular Parallel Perpendicular
3
Single use
Use by date
Sterilized by ethylene oxide
CE marking and identiÐcation number of notiÐed body. Product conforms
to the essential requirements of the Medical Device Directive 93/42/EEC
Batch code
See instructions for use
Catalogue number Art no. 783100
Staple size 6.9 mm x 4.2 mm
Date of information 03/2017
MR system reported, whole body averaged SAR
2.9-W/kg
Calorimetry measured values, whole body averaged SAR
2.7-W/kg
Highest temperature change
1.8°C
Temperature scaled to whole body averaged SAR of 4
-
W/kg
2.5°C
