Disposable Bladed Laparoscopic Trocars For Laparoscopic Surgery
Disposable Bladed Laparoscopic Trocar
Introduction:
For passive medical device, describe working principle, function mechanism (if applicable), structural composition (including accessories used cooperatively), main raw materials, and contents differing from characteristics, etc. of other similar products; provide graphic illustration when necessary.
Working principle
During use, the Disposable laparoscopic puncture establishes pneumoperitoneum in advance, and makes a proper incision at a proper position on the abdomen. Fix the Trocars on the abdomen raised by pneumoperitoneum at a proper angle by hand. Insert the Trocars into the skin incision, and pull out the Trocars cone to form a work channel for observation and operation with the laparoscope/device.
Structural composition
Disposable laparoscopic puncture design and development of the company (hereinafter referred to as the Trocars device) is mainly composed of a Trocars Cannula and Trocars core, Trocars cannula mainly comprises a sealing cover, injection valve and choke valve, sleeve etc.
Main raw materials
Table 1 Material Requirements of Main Parts
Part Name | Material Designation | Standard No. |
Trocars Core,Trocars Cannula | PC | EN ISO 7391-1:2006 |
Trocars core fixed seat | ABS | ENISO 19062-1:2015 |
Trocarse core tube | 12Cr18Ni9 | EN ISO 7153-1:2016 |
Contradiction
Disposable Trocar is not intended to be used when endoscopic techniques generally are the contraindications.
Basic size as well as model and specification comparison table
The basic size of the Trocars shall conform to the provisions in Table 1.
Table 1 Basic Size of Trocars in mm
Trocars Specifications | Trocars core outer diameter(D) | Cannula length(L) | Trocars cannula inner diameter(d) | |
Basic size | Limit deviation | |||
PC5S | 5.8±0.8 | 77±2 | 6 | +0.3 0 |
PC5M | 102±2 | |||
PC5L | 152±2 | |||
PC10S | 10.8±0.8 | 77±2 | 11 | |
PC10M | 102±2 | |||
PC10L | 152±2 | |||
PC12S | 12.8±0.8 | 77±2 | 13 | |
PC12M | 102±2 | |||
PC12L | 152±2 | |||
PC15S | 15.8±0.8 | 77±2 | 16 | |
PC15M | 102±2 | |||
PC15L | 152±2 |
Cautions
1. Check the package before using. Don't use if the package is damaged.
2. This product is for single patient use only. Do not reuse.
3. Make sure the product is within the expiry date. It is strictly prohibited to use the product beyondthe expiration date.
4. Endoscopic surgery should be performed by surgeons who are familiar with endoscopic techniques.Reference to medical literature relative to technique, complication and other risks is necessary.
5. Failure to establish and maintain appropriate pneumoperitoneum in laparoscopic surgery may reduce the working space, it may increase the risk of injury to internal structure.
6. Verifying the compatibility with trocar before using the instruments and accessories from different manufacturers.
7. Always inspect the operative site for hemostasis when removing trocar from the abdominal or chest cavity. Bleeding can be controlled by electrocautery or manual sutures.
8. Closure of the fascia is up to the surgeons' discretion. Fascia layer may be sutured to reduce the risk of incisional hernia
FAQ
1. Q:Are you a factory or trading company?
A: We are a factory, we have rich experience for manufacturing Medical Device more than 10 years.
2. Q:Where is your factory located? How can i visit there?
A: Our factory is located in Jiaxing city, Zhejiang Province, China.
It is about more than 1 hours from Shanghai.
2. 3.Q:Can you make samples?
A: Yes, we can make samples for you.
4. Q:How does your factory do as quality control?
A: Quality is the lift of our factory. We have inspector in different post, and there are three inspectors before packing to get best quality products.
5. Q: How is your post market service ?
A: If any damaged rings in the course of carriage, with the checking it's our mistake, we will take full responsibility to compensate the customers.
6. Q:Can you do OEM for us?
A: Certainly. We also can build the moulding for our new customer.
7. Q:Does the price include freight?
A: No, please choose the express service provider or negotiate with us.