Form 2
The Patents Act, 1970
(39 of 1970)
Provisional / Complete Specification
(see section 10)

Title of the invention
Repeat the columns (a) to (c) if there are more than one applicant.

1-A 3 Way Stopcock Skin
Fixator / Holder, 2.(a) 1 Dr. Philip George

Insert the name In full.
The family or principal name in
the beginning if the applicant is a
natural person.
insert the complete address
including postal index number /
code, State and country.
Insert the nationality. INDIAN.
Strike out in case of provisional
specification.
Description of the invention,
inapplicable in case of
procisional specification.
To be signed by the applicant or his authorized registered patent
Name of the natural person who has signed.
(a) Not applicable in case of provisional specification.
(b) Separate sheet to be used for this column.
/

c

(a) 1 Dr. Philip George
113, Vardhaman industrial Estate, Old Agra, Gokul Nagar, Thane (W). Maharashtra 400 601. INDIA. The following specification
(particularly) 6. describes 6
The nature of the invention and the manner in which it is to be performe 6...-REFER ANNEXURE. IMA.
3, 7 REFER ANNEXURE.
i/We claim 8...
Dated this 30th day of May 1
2002 signature 9.

( ) 10.
Dr. Phinp George 11..
Abstract of the invention. To
i he Controller of Patents The Patent Office, At lower Parei, Mumbai. INDIA.

a) In our endeavour to develop a fully indigenous product for the healthcare industry, we have designed and developed a new product called '3D - Fix1.
b) This concept of '3D - Fix' was introduced based on the following observation during use of a stopcock during infusion therapy.
c) Whenever a 3 way stopcock is connected in line with the I. V. set and the I. V. Cannulae, during infusion, the Nurse is unable to fix the stopcock to the patient's skin because of its three dimensional shape and protrusions.
d) To fix the stopcock, a cluster of tapes is fixed onto the I. V. Cannulae and the I. V. line.
e) This is highly obstructive and disadvantageous since constant manoeuvres of the stopcock are needed regularly. The tapes often tend to shift and the I. V. Cannulae within the patient gets dislodged easily causing trauma to the patient.
f) To tackle this ongoing problem, for the Doctors and the paramedical staff, we put all our efforts in this direction to design a fixator and permanently solve this situation by designing the Worlds 1st Stopcock skin fixator - The '3D - Fix'.
g) The '3D - Fix' is a small plastic medical disposable item made of a soft flexible polymer and is supplied with its own sticking plaster.
h) An important feature of the '3D - Fix' is a small 'well' on its top surface onto and inside which the base of the stopcock can be press fitted.
i) The bottom surface of the '3D - Fix' is anatomically contoured to fit the natural curvature of the patient's body.
j) The '3D - Fix', once placed between the I. V. Cannulae and the I. V. Line with the bottom of the 3 way stopcock firmly locked on to it, the Doctors / Nurses can then fix the required I. V. line to the free ports of the 3 way stopcock.
k) The (3D - Fix3 provides enormous benefits to the Doctors and the patients.
I) Attached are the 1) Pack Insert and 2) Brochure of the '3D - Fix' giving more details on its function, use and benefits.
Enclosed: 1) Pack Insert of '3D - Fix'
2) Product Brochure of '3D - Fix'

3P-FIX |
3 Way Stopcock with Skin Fixator
BRIEF DESCRIPTION:
3D-Fix is a sterile packed assembly of 2 individual products ; a 3 way stopcock and a Base Fixator unit for the stopcock along with adhesive tape wings.
MATERIALS USED:
Polymers of their respective food / medical grades of Polycarbonate and Polyethelene. Medical grade adhesive tapes and for the blister pack, food grade PVC and medical grade lidding paper, sterilised by ETO gas.
INDICATED FOR:
1, Stabilisation of the I. V. Line System - To be used when the need for a 3 way stopcock is indicated, especially when it has to be fixed in its position and place. Furthermore to prevent dislodgement of the connected I. V. Catheter and the I. V. Line, etc.
2, Extending the patency and indwelling time of the I. V. Catheter - By preventing the dislodgement of the inserted I. V. Catheter, early thrombus formation and / or subsequent / independent blockage of the I. V. Catheter is prevented, thus extending the patency and indwelling time of the inserted I. V. Catheter.
3, Easy operation / manoeuverability of the 3 way stopcock - Once the 3 way stopcock is fixed to the 'Fixator', taped to the patient's skin, it becomes easy for the doctor / nurse / technician to single handedly manoeuver the distributor tap of the stopcock without the need to hold the stopcock body with the other hand.
4, Maximum patient comfort.
CONTRAINDICATIONS:
Product should not be used in patients with known hypersensitivity to any of the materials used.
INSTRUCTIONS FOR USE: t Visual Inspection
• Visually inspect the integrity of the unopened package and product.
• Carefully peel the lid away from the blister tray under aseptic conditions and take out the '3D-Fix'.
II Venipuncture
• After a successful venipuncture is completed, prepare the access port of the I. V. Catheter
ready for connection to the 3 way stopcock.
III Skin Preparation
• Clean the area surrounding the hub of the I. V. Catheter with isopropyl alcohol to prepare the
skin for the adhesive tape.
IV Priming of the 3 Way Stopcock
• Make sure that the 3 way stopcock is in the 'Off position and prime the stopcock with the I.V. Fluid, with the preprimed I. V. Line, attached to one of the female ports of the stopcock.
• Then open the clamps of the t. V. Infusion line and displace the air entirely from within the 3 way stopcock.
• Rotate the tap to a closed position.
V Connecting the 3 Way Stopcock to the I. V. Catheter
• Without separating the 3 way stopcock from its base plate, connect the male luer end of the
stopcock to the female port of the I. V. Catheter and tighten the connection using the male luer
lock nut of the stopcock.

VI Fixing of the adhesive tape
• After confirming a safe and secure connection, peel off the backing paper from under the adhesive tape of the 'Fixator. Carefully apply the adhesive type over the skin witth adequate stretching during application, in order to remove its slackness and to ensure a firm fit over the patient's skin.
• Rotate the 3 way tap to the desired position to direct the flow of the i v fluid
VII NOTE
• The 3 way stopcock can be lifted out of the Base Fixator with a firm pull and can be fixed backk
in its position with a firm push back onto its base plate in an/ required direction of position.
Warnings:
• The use of this product is restricted to a qualified Doctor or a Paramedic.
• Read instructions before use !
• Important: Refer to the separate, detailed instruction manual on usage of the 3 way stopcock.
• 'George Philips* disclaims "ANY RESPONSIBILITY FOR POSSIBLE CONSEQUENCES RESULTING FROM IMPROPER USE".
• Visually inspect and check the product and packaging befofe use- Improper transport and

• The product is guaranteed non-toxic, sterile and non-pyrogenis if the package has not been opened or damaged.
• Do not clean, resterilize or reuse. For single use only !
• Change the 3 way stopcock and its Fixator plate every 48 houfs eartier of f the area becomes contaminated with blood / I.V. fluids.
• Do not attempt to change the supplied adhesive tape. This Will reduce the efficiency of the product.
• Check and confirm that the 3 way stopcock is firmly fixed onto its pase if the foment is loose, then change the assembly unit and ensure a firm locking fit of the stopcock onto the base unit.
• STORAGE: Do not expose to heat or direct sunlight. Store in a cool and dry plack
• The product should be used immediately after opening the pack

SYMBOL REFERENCE

ORDERING INFORMATION

mi /Ch.-B
I STERILE JEQI
A

Lot Number / Batch Number Date Of Manufacturing , USE By / Expiry Date Do Not Reuse
Sterilised by Ethylene Oxide See Instructions For Use

PRODUCT COPE
GENERIC NAf*e
BRAND NAME
SHIPPER Q*V

rr-ic
3WayStcpock with Skin Fixator 3D-Fix 500 ffs

GEORGE PHILIPS MEDICAL ENGlNEEf**NG PVT- LTD
113. Vardhaman Industrial Complex, Old Agra Road, Thane (Wast) 100 e01- Maharashtra, INDIA.
Phone: + 91 22 5971265 Telefax: + 91 22 5971266
EmarS: qpmQeth. net, qeorgephilrpsfildishnetd^U^
Website: www.qeDrqepNlips.com
'THE POWER OF ENGINEERING EXCELLENCE'


3D-Fix
3 Way Stopcock with Skin Fixator

THE FIRST AMONGST EQUALS !!!
A REVOLUTIONARY NEW PATENTED PRODUCT, DESIGNED TO HELP FIX THE WAY STOPCOCK ONTO A PATIENT'S SKIN.
THE POWER OF ENGINEERING EXCELLENCE1

3D-Fix

ITS AS EASY AND SIMPLE AS 1, 2, 3.

'3D - Fix5 FEATURES :
Base Unit
• Made from soft, flexible, food grade virgin polymer.
• Bottom surface curved anatomically to snugly conform to the body contours.
• Top well has a universal dimension permitting positioning and holding of any standard stopcock in any direction of placement.
3 way stopcock
• Individually tested upto 4
bar pneumatic pressure.
Adhesive tapes
• Made of medical grade
adhesives & materials.
'3D - Fix' BENEFITS :
• Stabilises the I. V. line.

• Prevents dislodgement of the (. V. Catheter, preventing its early blockage thereby extending its indwelling time.
Offers maximum patient comfort.
User friendly and permits single handed operation of the 3 way stopcock.

ORDERING INFORMATION :
PRODUCT CODE GENERIC NAME BRAND NAME SHIPPER QTY.
IT- 1c 3 Way Stopcock with Skin Fixator 3D - Fix 500 #

GEORGE PHILIPS NTEDICAL ENGINEERING PVT. LTD.
113, Vardham'an Industrial Complex, Old Agra Roadjhane (West) 400 601, Maharashtra, Phone: + 91 22 5971265 Telefax: + 91.22 5971266 Email : qpmffjem.flet, qeoraephilips@dishneldsl.ne
Website: www.qeoraeohiliDS.com
THE POWER OF ENGINEERING EXCELLENCE'


A _ Well for fixing stopcock
B _ Adhesive tape
C _ Fixator with contoured base surface
D _ Stopcock fixed onto the Fixator
E _ Patients Hand
F _ I.V.Line
G _ Fixator
H _ Stopcock
I _ I.V.Catheter