INSTRUCTIONS FOR PDO

DESCRIPTION
Polydioxanone Monofilament（PDO）is sterile Absorbable Surgical Suture based on
Polydioxanone. It has been found to be inert, non-antigenic and non-pyrogenic. The
sutures are not braided and are available dyed (coated, violet).Polydioxanone
Monofilament（PDO）complies with the requirements of United States Pharmacopoeia
(USP) for Synthetic Absorbable Surgical Suture.
INSTRUCTIONS FOR USE
This section includes information about description, intended use, introduction for use
and cautions (contraindications, warnings, general precautions) for Synthetic
Absorbable Sutures with/without needles.
INTENDED USE
PDO is indicated for use in general soft tissue approximation and/or ligation
includinguse in plastic surgery; subcuticular; Pediatric; Urology; orthopedics;
gastroenterology;
ACTIONS
Polydioxanone Monofilament（PDO）elicits minimal tissue reaction and ingrowths of
fibrous connective tissue. Absorption of bio-absorbable sutures occurs by hydrolysis
where the Polyglycolic Acid(PGA), Poly(glycolide-co-L-Lactide)(PGLA) and
Polydioxanone Monofilament（PDO）polymer degrades to glycolic acids which are
subsequently absorbed and metabolized in the body. The absorption begins with loss
of tensile strength followed by loss of mass.Absorption through slow hydrolytic
action completed in 200 days approximately.
CONTRAINDICATIONS
Since Polydioxanone Monofilament（PDO）is an absorbable suture, it should not be
used when the tissue support is needed for an indefinite of time.The product can be
used only once, should be used immediately after opening the package and destroyed
afterwards; Strictly prohibit using them if the package is damaged. The product
funked or affected with damp cannot be used. They should locate in the place where is
abstained from high temperature and high humidity, and from caustic gases, and have
good dryness and ventilation. The product must be sterilized by EO. Every test item
must meet with standard before using them.The period of validity is 3 years from the
date of manufacture, must use them in this period.
WARING
Polydioxanone Monofilament（PDO） is sterilized by ethylene oxide gas only for
single use. Do not re-sterilize!Do not use if package opened or damaged! Discard
open unused sutures! Store at room temperature. Avoid prolonged exposure to
elevated temperature and moisture.Polydioxanone Monofilament（PDO）should be
selected and used depending on patient condition, surgical experience, surgical
technique, wound site and wound size. Requirements and techniques vary with these
conditions and indications. Therefore, users should be familiar with surgical
procedures and techniques involving absorbable suture before employing
Polydioxanone Monofilament（PDO）for wound closure, as risk of wound dehiscence
may vary with the site of application and suture material used.Polydioxanone
Monofilament（PDO）may be inappropriate in elderly malnourished or debilitated
patients, or in patients suffering from conditions that may delay wound healing. As
Polydioxanone Monofilament（PDO） is an absorbable suture material, the use of
supplemental non-absorbable sutures should be considered by the surgeon in the
closure of sites which may undergo expansion, stretching, or distention, or which may
require additional support.
PRECAUTIONS
Under certain circumstances, notably orthopaedic procedures, immobilization by
external support may be employed at the discretion of the surgeon.Skin sutures which
must remain in place longer than 7 days may cause localized irritation and should be
removed as indicated.In handling Polydioxanone Monofilament（PDO） or any other
suture material, care should be taken to avoid damage from handling. Avoid crushing
or crimping damage due to application of surgical instruments such as forceps
orneedle holders..Adequate knot security requires the accepted surgical technique of
flat, squareties, with additional throws as warranted by surgical circumstance and the
experience of the surgeon. The use if additional throws may be particulary appropriate
when knotting monofilaments.
ADVERSE REACTIONS
Adverse effects associated with the use of this device include wound dehiscence,
failure to provide adequate wound support in closure of the sites where expansion,
stretching or distension occur, failure to provide adequate wound support in elderly,
malnourished or debilitated patients or in patients suffering from conditions-which
may delay wound healing, wound infection, minimal acute inflammatory tissue
reaction, localized irritation when skin suturesare left in place for greater than 7 days,
calculi formation in urinary and biliarytracts when prolonged contract with salt
solutions such as urine andbile occurs,and transitory local irritation.
STORAGE
Store packed product at temperature below30℃. Avoid from moisture and direct heat.
Do not use after expiry date!
HOW SUPPLIED
Polydioxanone Monofilament（PDO）is supplied as monofilament dyed (coated, violet)
and strands in USP size 6-0 through 2 (metric sizes 0.7 through 5), in variety of
lengths, with or without needles.Polydioxanone Monofilament（PDO） is available in
1 dozen, if export or except the customer has other request.
CAUTION
Restricts Polydioxanone Monofilament（PDO）to sale & distribute and use by or on
the order of a physician
Manufacturer: HUAIAN ANGEL MEDICAL INSTRUMENTS CO.,LTD
19 East Road Zhuhai Huaian ,Jiangsu,China
Tel: +86-517-83717129 Fax: +86-517-83717157
EC Representative: Shanghai International Holding Corp.GmbH (Europe)
Add: Eiffestrasse 80, 20537 Hamburg, Germany
Tel:+49-40-2513175 Fax:+49-40-255726
E-mail:shholding@hotmail.com
USABLE LIFETIME
The usable lifetime of non-absorbable suture is 5 years after it’s sterilization.
Symbol used on the Labels

Symbol Explain

Caution

Date of manufacture

“Use by “expiration date(year-month)

Manufacturer

Lot number(batch)

Code

Single Use

Do not use if package is damaged

Sterile

Serial number

European representative

Consult instructions for use

Method of sterilization - Ethylene oxide

Do not resterilize

Keep away from sunlight

2292 CE-mark

Version Nnumber：ANGEL.IST.(PDO)1th
Issue date: October 30,2017