Transcript arab health 2014

www.clearsurgical.com
Oplight180
TM
Oplight180
TM
Oplight180


TM
Illumination of surgical cavities can be provided by:

overhead lamps

headlamps

non-self retaining retractors with fiber optic
cable attachment

theatre staff holding and directing a torch.
Preferred method is fibre optic cable that connects
to a retraction system.
Current
Situation
Oplight180
TM
Current
Situation
Oplight180
TM
Current
Situation

Top down illumination can create shadows within the
cavity.

Light may not reach the deepest part of the incision.

Retractor systems take time to set up.

Extra retractors can clutter the incision area.

Fibre optic cables can clutter the operating field.

Safety implication of the fibre optic cable
Oplight180
TM
Solution

Two functions in a single device

Design of conventional self-retaining retractor with
battery powered light source

Reduce shadowing
 Light

source in both sides
Single use
 Reduces
risk of cross contamination between patients
Oplight180
TM
A single patient use self
retaining retractor with
in-built cold light source.
The Illuminated Retractor
holds open and directly
illuminates a surgical
cavity.
Oplight180
TM
Oplight180
Market sample
TM
Procedure
UK
EU
US
ROW
Breast Axillary
45,000
280,000
220,000
135,000
Hernia
85,000
535,000
500,000
250,000
Fem-Pop
6,500
40,000
35,000
19,000
Appendectomy
40,000
270,000
210,000
130,000
Others- cholecystectomy, splenectomy, pancreatic surgery, pelvic,
colorectal and more
Oplight
TM
180
Design
Development
Oplight
TM
180
Final Design
Comparison
Oplight
TM
Regulatory
180

Apparatus is Class 2a sterile medical device
 ISO13485

Electronics
 Medical

EMC Standard EN60601
LED safety guidelines
 IEC/EN
 ANSI
62471
IESNA RP 27
Cannulated Reduction
Forceps
Clinical Uses
General Trauma Equipment
 Specialist Equipment including Radiolucent
Implants
 Interaction with locking plates
 External Fixation - pin & wire placement
including Circular Frames with ‘Olive’ wires
 Syndesmotic injuries including Endobuttons
 AC joint injuries
 Elective Surgery - Implant alignment

Femur
Hip
Finger