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

Clo-Sur P.A.D.™

Instructions for Use

Scion Cardio-Vascular, Inc.

Exclusively Distributed by:

Medtronic Ireland

Erika Handler

th

14256 S.W. 119

Avenue

Medtronic Inc.

Parkmore Business Park West

Quinten Matsijslei 32/9

Miami, FL 33186 USA

710 Medtronic Parkway NW

Galway, Ireland

2018 Antwerpen

Phone: 305-259-8880

Minneapolis, MN 05532 USA

Phone: 353-91-708000

Belgium

Toll Free: 1-866-259-8881

Phone: 888/283-7868

Fax: 353-91-757524

Phone: +32 3233 05 29

Fax: 305-259-8878

Mobile: +32 476 346 154

P/N 00839 Rev A

PK90432 Rev. 3

Scion Cardio-Vascular, Inc.

Medtronic Ireland

Erika Handler

th

14256 S.W. 119

Avenue

Parkmore Business Park West

Quinten Matsijslei 32/9

Miami, FL 33186 USA

Galway, Ireland

2018 Antwerpen

Phone: 305-259-8880

Phone: 353-91-708000

Belgium

Toll Free: 1-866-259-8881

Fax: 353-91-757524

Phone: +32 3233 05 29

Fax: 305-259-8878

Mobile: +32 476 346 154

Clo-Sur P.A.D.

ENGLISH

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Instructions for Use

DESCRIPTION:

The Scion Cardio-Vascular Clo-Sur

P.A.D.™ is a soft, non-woven hydrophilic wound dressing. Clo-Sur

P.A.D.™ is packed in a foil pouch and sterilized by E-beam radiation.

INDICATIONS:

The Scion Cardio-Vascular Clo-Sur P.A.D.™ is intended for use in the local management of bleeding

wounds such as vascular access sites, percutaneous catheters or tubes, and the promotion of rapid control

of bleeding in patients following hemodialysis and in patients on anticoagulation therapy.

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.

3. Apply the Clo-Sur P.A.D.™ over the treatment area and place a clean, sterile gauze pad over the Clo-

Sur P.A.D.™

4. Apply firm pressure over the treatment area and slowly release proximal pressure to permit blood to

contact the Clo-Sur P.A.D.™.

5. Hold continuous pressure over the treatment area for a minimum of ten minutes, then slowly release.

6. Verify hemostasis; secure the treatment area with the Clo-Sur P.A.D.™ left in place using a dry

adhesive dressing.

POST PROCEDURE INSTRUCTIONS FOR Clo-Sur

P.A.D.™

1. After 24 hours, remove dressing, wet Clo-Sur P.A.D.™ with water and allow it to dissolve and

remove slowly.

2. Do not bathe or swim for 5 days following procedure.

3. Avoid any strenuous activity for at least 72 hours. This includes but is not limited to jogging,

bicycling, climbing stairs, walking long distances or lifting heavy objects.

4. 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.

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

emergency room.

6. 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

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

P.A.D.™ and related

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

Clo-Sur P.A.D.

中文

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使用指南

产品简介：

Scion Cardio-Vascular公司的Clo-Sur P.A.D.™为一种柔软的非织物吸水性伤口敷料。

Clo-Sur 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：

Sc

ion Cardio-Vascular公司的Clo-Sur P.A.D.™

专门用于局部处理出血伤口，例如血管刺入部位、经皮导管或插管，以及快速控制血液透析后患者

和正在接受抗凝血治疗患者的出血。

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。

使用方法：

1. 在治疗部位施加近端压力。

2. 确认治疗部位干燥无液。

3. 将Clo-Sur P.A.D.™贴于治疗部位，并取一片干净的无菌纱布敷于本品上。

4. 在治疗部位施加切实压力，然后慢慢减弱近端压力，让血液接触Clo-Sur P.A.D.™。

5. 在治疗部位保持压力10分钟，然后慢慢放开。

6. 确认已经止血，将Clo-Sur P.A.D.™留在原处，用一片干燥粘性敷料保护治疗部位。

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