
8
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.
Connection combinations
CODE
DESCRIPTION
COMPATIBLE
WITH
HANDPIECE
SV3-200
LOTUS Dissecting Shears Straight Transducer Open 200
DS4-200SD
CV3-400
LOTUS Dissecting Shears Curved Transducer Laparoscopic 400 DS4-400CD
SV3-500
LOTUS Dissecting Shears Straight Transducer Bariatric 500
DS4-500SD
ES4-200CT* LOTUS Enhanced Shears Curved Transducer Open 200
DS4-200CD
ES4-400CT* LOTUS Enhanced Shears Curved Transducer Laparoscopic 400 DS4-400CD
ES4-500CT* LOTUS Enhanced Shears Curved Transducer Bariatric 500
DS4-500CD
LR3-200
LOTUS Liver Resector Straight Transducer Open 200
LR4-200SD
LR3-400
LOTUS Liver Resector Straight Transducer Laparoscopic 400
LR4-400SD
W3-200** LOTUS Vessel Welder Straight Transducer Open 200
VW4-200SD
W3-400** LOTUS Vessel Welder Straight Transducer Laparoscopic 400
VW4-400SD
DB3-400** LOTUS Double Blade Transducer Laparoscopic 400
DB3-400D
DB3-100** LOTUS Double Blade Transducer Open 100
DB3-100D
* 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.
INSTRUCTIONS FOR USE
LOTUS
®
Transducer Reusable Device
EN
Содержание CV3-400
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