Pacesetter™ Reusable Applier with Replaceable Cartridge - China Suppliers & Factory for Ligating Clips

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Place of Origin Made in China
Brand Name Pacesetter(TM) Multiple Ligating Clip Reusable Applier
Certification ISO13485
Model Number MCA-12CL, MCA-10CM, MCA-10CS

Product Detail

Product Features

A simulated use extraction study was conducted to evaluate the safety of its unknown/target leachables, which proved that the target/unknown leachables contained in the product was lower potential safety risk to humans;

Cytotoxicity, sensitization, intracutaneous reactivity, pyrogen, acute systemic toxicity, genotoxicity, subchronic systemic toxicity and implantation experiments were performed. It proved that biocompatibility of the product meets the requirements of expected use and regulations;

Novel and creative.

Product Description

Product Use:	Used for delivering and clamping non-absorbable polymer ligating clip through specific size of trocar in laparoscopic surgery	Product Highlights:	The product can be used for continuous clip application; is reusable; can be converted to install the multiple ligating clip cartridge; can be directly cleaned without disassembly after use.
Device Classification:	[CN] Class II [KR] Class I	Material:	Stainless Steel, PEEK, Silica Gel
Specification Description:	MCA-12CL: Large MCA-10CM: Medium MCA-10CS: Small	Storage Conditions:	Store in a clean room with no more than 80% relative humidity, no corrosive gas, room temperature.

Product Specification

Instructions	Check whether the device is cleaned, sterilized and packaged in good condition before use. Clip application should be performed by experienced medical staff. After using the clip applier, pull the reset button to return it to its original position and press the lock catch to remove the empty cartridge. See the IFU for details.
Product advantages	Multiple ligating clips can be placed continuously to save surgical time; After the ligating clips are used up, reloading is allowed; The product is reusable, which is more convenient and economical.
Product structure and composition	Composed of a proboscis, a joint and a handle.
Precautions	1. The product must be cleaned and sterilized in a timely manner after use, and the device is not required to be disassembled during the cleaning and sterilization process; 2. Avoid using corrosive solution to clean and sterilize the product; Avoid heavy pressure or impact on various components of the device; 3. Please confirm the model and brand of ligating clip and select the appropriate multiple clip applier for use.
Maintenance	Inspect the delivery/clamping trigger for smooth movement and no obvious deformation/defect of jaw before daily use; it is recommended to send it to the manufacturer for maintenance once a year.

Frequently Asked Questions

What is the primary use of this clip applier?

The device is designed for delivering and clamping non-absorbable polymer ligating clips through a specific size of trocar during laparoscopic surgery.

What materials is the product made of, and is it safe?

It is constructed from Stainless Steel, PEEK, and Silica Gel. Biocompatibility tests (including cytotoxicity, sensitization, systemic toxicity, and implantation experiments) and simulated use extraction studies have proven that the device meets regulatory safety requirements and poses a lower potential safety risk to humans.

Does the device need to be disassembled for cleaning and sterilization?

No, the device does not require disassembly during the cleaning and sterilization process. However, you must avoid using corrosive solutions and clean/sterilize the product in a timely manner after use.

What are the storage requirements for this device?

The product should be stored at room temperature in a clean room with no more than 80% relative humidity and free of corrosive gases.

What maintenance is recommended for the product?

Inspect the delivery/clamping trigger daily before use to ensure smooth movement and check that the jaw has no obvious deformation or defects. It is recommended to send the device to the manufacturer for maintenance once a year.