Pacesetter™ Reusable Ligating Clip Applier with Replaceable Cartridge - China Suppliers & Factory Solutions
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 |
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| Product structure and composition | Composed of a proboscis, a joint and a handle. |
| Precautions |
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| 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 (FAQ)
What is the primary use of this multiple clip applier?
It is used for delivering and clamping non-absorbable polymer ligating clips through a specific size of trocar during laparoscopic surgery.
What materials are used to manufacture the device?
The device is constructed using high-quality Stainless Steel, PEEK, and Silica Gel.
Has the product undergone safety and biocompatibility testing?
Yes. It has undergone simulated use extraction studies to ensure low safety risks from leachables. Biocompatibility testing includes cytotoxicity, sensitization, intracutaneous reactivity, pyrogen, acute systemic toxicity, genotoxicity, subchronic systemic toxicity, and implantation experiments.
Does the device need to be disassembled for cleaning and sterilization?
No, the product can be directly cleaned and sterilized after use without requiring disassembly, which makes processing more convenient.
What are the storage conditions required for this device?
It should be stored at room temperature in a clean room with relative humidity of no more than 80%, and in an environment free of corrosive gases.
How often should the device undergo professional maintenance?
In addition to daily inspections of the jaw and delivery trigger for smooth movement, it is recommended to send the device to the manufacturer for maintenance once a year.