Intended Use Indications - Bowa LOTUS Serie Instrucciones De Uso

INSTRUCTIONS FOR USE
EN
LOTUS
Connection combinations
CODE DESCRIPTION
SV3-200 LOTUS Dissecting Shears Straight Transducer Open 200
CV3-400 LOTUS Dissecting Shears Curved Transducer Laparoscopic 400
SV3-500 LOTUS Dissecting Shears Straight Transducer Bariatric 500
ES4-200CT* LOTUS Enhanced Shears Curved Transducer Open 200
ES4-400CT* LOTUS Enhanced Shears Curved Transducer Laparoscopic 400
ES4-500CT* LOTUS Enhanced Shears Curved Transducer Bariatric 500
LR3-200 LOTUS Liver Resector Straight Transducer Open 200
LR3-400 LOTUS Liver Resector Straight Transducer Laparoscopic 400
W3-200** LOTUS Vessel Welder Straight Transducer Open 200
W3-400** LOTUS Vessel Welder Straight Transducer Laparoscopic 400
DB3-400** LOTUS Double Blade Transducer Laparoscopic 400
DB3-100** LOTUS Double Blade Transducer Open 100
* Only for LG4 Series 4 generators with software version issue 6 or later
** Single items may not be available in your country
Medical Devices Directive
This device complies with Directive 93 / 42 EEC regarding medical devices.
Caution: Federal (USA) law restricts this device to sale by or on the order of a
physician.
1 IMPORTANT
1. This Transducer should only be used with a LOTUS generator
2. This document provides instructions for using the LOTUS Ultrasonic Surgical
Systems & Accessories.
It is not a set of instructions for surgical technique.
3. This document should be read in conjunction with the LOTUS Series 4 Ultrasonic
Surgical Systems & Accessories instructions for use.
4. Failure to follow the instructions may lead to serious surgical consequences.
5. The device is not provided sterile and must be washed and sterilized prior to
use.
6. Store packaged devices in a cool dry area.
2 INTENDED USE
INDICATIONS
The LOTUS Ultrasonic Surgical Systems & Accessories are indicated for soft tissue
surgical incisions when bleeding control and minimal thermal injury are important.
LOTUS Series 4 Ultrasonic Surgical System and Accessories may be used as an
adjunct to or substitute for electrosurgery, laser surgery, and traditional scalpels
in general, gynecological, thoracic surgery, and exposure to orthopedic structures
(such as hip joint).
CONTRA-INDICATIONS
The system is not indicated for cardiac surgery. The Handpiece is not indicated for
coagulation and dissection of vessels larger than 5 mm. The device is not indicated
for incising bone. The device is not intended for contraceptive tubal occlusion.
3 DEVICE DESCRIPTION
The LOTUS Transducer Reusable Device is designed to be used with a LOTUS Hand-
piece Single Use Device. When used in combination, the Handpiece and Transducer
form a scissor-like device enabling the user to perform soft tissue cutting of small
vessels whilst controlling bleeding.
8
Transducer Reusable Device
®
COMPATIBLE
WITH
HANDPIECE
DS4-200SD
DS4-400CD
DS4-500SD
DS4-200CD
DS4-400CD
DS4-500CD
LR4-200SD
LR4-400SD
VW4-200SD
VW4-400SD
DB3-400D
DB3-100D