Merit Medical Scion Clo-Sur Plus P.A.D.: инструкция

PLUS

Clo-Sur

P.A.D.™

Antimicrobial Barrier

Instructions for Use

Scion Cardio-Vascular, Inc.

Erika Handler

14256 S.W. 119

th

Avenue

Quinten Matsijslei 32/9

Miami, FL 33186 USA

2018 Antwerpen

Phone: 305-259-8880

Belgium

Toll Free: 1-866-259-8881

Phone: +32 3 233 05 29

Fax: 305-259-8878

Mobile: +32 476 346 154

P/N 00639 Rev. D

Clo-Sur

ENGLISH

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P.A.D.

Antimicrobial Barrier

Instructions for Use

DESCRIPTION:

The Scion Cardio-Vascular Clo-Sur

PLUS

P.A.D. is a soft, non-woven topical hemostasis pad. The Clo-

Sur

PLUS

P.A.D. is designed to provide a barrier to microbial penetration and has demonstrated in-vitro

antibacterial activity that prevents colonization of the dressing. Clo-Sur

PLUS

P.A.D. is packed in a foil

pouch and sterilized by E-beam radiation.

INDICATIONS:

The Scion Cardio-Vascular Clo-Sur

PLUS

P.A.D. is intended for use in the local management of bleeding

wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the

promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on

anticoagulation therapy. The dressing is indicated for the following wounds: skin puncture sites for

vascular procedures, percutaneous catheters or tubes.

CONTRAINDICATIONS:

 No known contraindications.

WARNINGS:

READ ALL INSTRUCTIONS PRIOR TO USE. OBSERVE ALL WARNINGS AND PRECAUTIONS

NOTED THROUGHOUT THESE INSTRUCTIONS. FAILURE TO DO SO MAY RESULT IN

COMPLICATIONS.

 Do not reuse. Discard after one procedure.

 Product reuse is not feasible and could be unsafe due to risk of cross-infection. The pad material

dissolves once it comes in contact with bodily fluids. The product cannot be effectively cleaned,

decontaminated, or reprocessed into its original form after a single application.

PRECAUTIONS:

 Do not use open or damaged packages.

 Product is water soluble. Do not autoclave.

 Do not expose to organic solvents.

STORAGE INFORMATION:

 Store in a temperature controlled environment (15° - 30° C)

 Keep dry, protect from light, and avoid prolonged exposure to high temperatures.

COMPLICATIONS:

Some of the complications are, but not limited to bleeding, hematomas, pseudoaneurysm, rash and

swelling.

PROCEDURE:

1. Apply pressure proximal to treatment area.

2. Verify treatment area is dry prior to applying the P.A.D.

3. Apply the Clo-Sur

PLUS

P.A.D. over the treatment area and place a clean, sterile gauze pad over the

Clo-Sur

PLUS

P.A.D.

4. Gradually release proximal pressure to permit blood to contact the Clo-Sur

PLUS

P.A.D.

5. Reapply proximal pressure, as required, to control bleeding.

6. Verify hemostasis by gradually releasing pressure and checking dressing for additional bleeding. Do

not lift P.A.D. to verify.

7. Once hemostasis is achieved, secure the treatment area with the Clo-Sur

PLUS

P.A.D. left in place using

a dry adhesive dressing.

POST PROCEDURE INSTRUCTIONS FOR Clo-Sur

PLUS

P.A.D.

1. After 24 hours, remove dressing, wet Clo-Sur

PLUS

P.A.D. with water and allow it to dissolve and

remove slowly.

2. Observe treatment area for any signs of infection, including drainage, swelling, redness, increased

pain, etc. Watch for signs of hematoma development, which will be a hard painful bruise at the

treatment area.

3. If a hematoma or bleeding develops, hold pressure at the site, call your physician immediately or go to

the emergency room.

4. Call your physician’s office if you have any problems or concerns.

There is no expressed or implied warranty, including merchantability and fitness for a particular purpose

for the Clo-Sur

PLUS

P.A.D. Under no circumstances shall Scion Cardio-Vascular be liable for any direct,

incidental or consequential damages other than as expressly provided by specific law. No person has the

authority to bind Scion Cardio-Vascular to any representation or warranty except as specifically set forth

herein. Descriptions or specifications are meant to generally describe the Clo-Sur

PLUS

P.A.D. and related

procedures, and do not constitute any expressed warranties or practice.

Clo-Sur

PLUS

P.A.D. is a trademark of Scion Cardio-Vascular, Inc. All rights reserved.

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Clo-Sur

中文

– 4 –

P.A.D.

使用指南

产品简介：

Scion Cardio-Vascular Clo-Sur

PLUS

P.A.D.为一种柔软的非织物局部止血贴。人体试验证实Clo-Sur

PLUS

P.A.D.具有抗菌活性，可防止敷料的细菌移生，Clo-Sur

PLUS

P.A.D.

产品旨在提供一个阻挡病菌侵入的屏障。Clo-Sur

PLUS

P.A.D.

包装在一个箔纸袋子中，并通过电子束照射进行了灭菌处理。

适应症：

Scion Cardio-Vascular Clo-Sur

PLUS

P.A.D.

专门用于出血伤口的局部处理，可给所有患者提供一个屏障，阻止细菌穿过敷料接触伤口，也可用

于患者血液透析后对出血进行快速控制（止血），还可用于进行抗凝血治疗的患者。下列伤口需要

用敷料包扎：血管手术、经皮导管或插管的皮肤针刺部位。

禁忌症：

 目前尚无已知的禁忌症。

警告：

使用前请通读本使用指南。仔细阅读整个使用指南中给出的警告及注意事项部分的全部内容。不

遵守此警告者可导致发生并发症。

 不可重复使用。用完一次后即应丢弃。

 产品重复使用并不可行，而且由于有交叉感染的风险也可能不安全。此贴的材料一旦

与体液接触就会溶解。本产品经过一次使用后将无法有效地清洁、净化或再加工成其

原有形式。

注意事项：

 包装打开或受损的产品不可用。

 产品可溶于水。不可进行高压湿热灭菌。

 不可暴露于有机溶剂。

存放信息：

 存放于温度受控的环境里 (15° - 30° C)

 保持干燥，避免见光，避免长时间接触高温。

并发症：

并发症包括但不局限于出血、血肿、假性动脉瘤、皮疹及肿胀。