Complaint
Factory low price disposable cut and coagulation electro surgical pencil
1. The Sterile electrosurgical pencil, DB-01, is a handheld accessory for high voltage high frequency electrosurgical devices. By pressing the yellow and blue buttons on the pencil, it performs its function during the surgical operation to CUT tissue and to COAGULATE tissue to stop bleeding.
2 Construction - The product consists of detachable electrodes, plastic hand piece with two control buttons, 3 meters long cable, 3-pin plug:
3 The pencil is designed to conform the requirements of EN60601-1 and EN60601-2-2 and the following requirements:
MODEL DB-01:
| Sterile Electrosurgical pencil is a monopolar hand-held active electrode intended to produce certain physical effects required in radiofrequency(R.F.) electrosurgery. The R.F. generator generates electricity power and sends power through this accessory for cutting and coagulation. This pencil has two buttons on the hand-piece. The yellow button near to the tip is for "CUT" function and the blue one is for "COAG"coagulation function. They can be used for incision, coagulation or both, in general surgery or a variety of other fields including orthopedics, cardiology, gynecology, urology, neurosurgery, dermatology, otolaryngology, and gastroenterology. Caution: Electrosurgical pencil is forbidden to use on the patient with metal implanted or heart pump. | |
| TECHNICAL FEATURES | ||
| MODEL | DB-01 | |
| DESCRIPTION | Hand control pencil, housing 2.36mm(3/32") with standard hex blade electrode and cable, Sterile | |
| MATERIAL | High resistance ABS plastic. Latex-free | |
| LENGTH | 190±2mm | |
| ELECTRODE | Removable standard hex blade electrode | |
| CABLE | PVC Insulation | |
| CABLE LENGTH | 3meter | |
| CONNECTOR | Tripler universal Valley lab type | |
| STERILISATION | inradial sterilizations | |
| MAX. OPERATING VOLTAGE | 10.8kV peak-to-peak balanced | |
COMPLIANCE TO ELECTRICAL SAFETY STANDARDS | EN 60601-1 EN 60601-2-2 AAMI/ANSI/HF18 | |
| COMPLIANCE TO DIRECTIVE | Directive 93/42/EEC. Class IIB device | |
| PACKAGING | |
| PRIMARY PACKAGING | Singly packaged in sealed paper pouch coupled with polyethylene. |
| Production environment and sterilization | The production and assembly of all product parts and accessories are completed in 100,000 clean workhouses which are in line with the requirements. Inner packing uses paper-plastic bag. And after large packing, all the products are sterilized by ethylene oxide (EO) for single use. |
| STORAGE | Temperature 0 ~ +50 °C Relative humidity: 20 ~ 80% |
| EXPIRY | 5 years from production date if correctly stored |
