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Pacesetter™ Reusable Ligating Clip Applier with Replaceable Cartridge | China Suppliers & Factory Quality
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
Q:What is the primary use of this multiple clip applier?
It is designed for delivering and clamping non-absorbable polymer ligating clips through a specific size of trocar during laparoscopic surgery.
Q:What materials are used to manufacture the product?
The product is constructed using premium, biocompatible materials: Stainless Steel, PEEK, and Silica Gel.
Q:Does the device need to be disassembled for cleaning and sterilization?
No, the device can be directly cleaned and sterilized without disassembly after use. However, you should avoid using corrosive solutions.
Q:What are the storage guidelines for this device?
It should be stored at room temperature in a clean room with no corrosive gas and a relative humidity not exceeding 80%.
Q:What are the key safety and biocompatibility certifications?
The product has undergone simulated use extraction studies to ensure safety from leachables, alongside comprehensive testing for cytotoxicity, sensitization, intracutaneous reactivity, pyrogen, acute systemic toxicity, genotoxicity, subchronic systemic toxicity, and implantation.
Q:How often does the device require professional maintenance?
While daily checks for smooth movement and jaw deformation should be performed before use, it is recommended to return the device to the manufacturer for professional maintenance once a year.