Manufacturer: B.I.A IMPEX Pakistan.
DATE LAST AMENDED: 18 Oct. 2004
DESCRIPTION: ElectroSurgery Monopolar & Bipolar
Forceps - (Reusable and
Disposable)
TECHNICAL SPECIFICATION:
Product Packaging & labeling: The un-sterile
product is packaged in a polythene bag to
maintain
cleanliness and must be Autoclaved prior to use (Except Footswitches & Plate cables). The
Sterile
disposable Forceps are contract packed in clean
room environments. The label has the Stock code,
Description, batch no. and supplier details for
identification. Sterile products also have
expiry date for
usage.
Materials used in Manufacture:
|
|
Connectors: |
Acetal Insulator & stainless steel
(Grade 316) contacts.
|
|
Cable: |
Silicone insulated 3.5mm O/D with 384
strands of 0.05 tinned copper wires. (
Monopolar
Cables)Bipolar Disposable Cable P.V.C.
Insulated 2812X 2x 0.5mm
|
|
Insulation: |
Nylon & Epoxy Polyester, thickness >
0.1mm throughout.
|
|
Contacts: |
Polished Stainless Steel
|
| |
Electrical performance & suitability:
The product has been designed in
accordance with relevant standards
and is suitable for use with all
suitable Electro-Surgery generators and
connective instruments. All products
are latex free in construction. |
GENERAL INSTRUCTIONS FOR USE:
Follow recommended guidelines for power set up &
connection to generator and make sure instrument
ispushed fully home into its socket prior to
switching on. Always make sure adhesive plate
connections are
sound & secure in Monopolar surgery to prevent
any chance of burns in this area. Disposable
Mono &
Bipolar forceps can be used straight from their
packaging as these are supplied sterile.Traceability
The product is batched marked on its packaging
and easily traceable for components & Sterility
record.
Recommended Disposal Method: The product has no
user serviceable parts and should be incinerated
with other medical waste. Every care is taken to
ensure negative toxicity of all materials used
and
prolonged contact with skin will not cause any
adverse reactions.
CLEANING/ STERILIZATION METHOD (Reusable
Instruments only):
Cleaning General: To remove blood & general
grime the product should be cleaned in a mild
detergent
prior to sterilization. DO NOT use solvents of
any as this might affect plastic parts. The
product may be
cleaned using an Instrument cleaner using a 5
cycle process ( Pre-rinse, wash, disinfect, R O
rinse & dry ) if
this is accepted practice.
Autoclaving: Wrapped Sterilization at 115-138°c
for 3-4 minutes with post drying and make sure
heavy
objects are not placed on the product during and
whilst cooling down. Some Autoclaves feature a
Prion
cycle; this may be used if required
Ethylene Oxide: This can be used if all traces
are removed by post drying prior to use.
Radiation:
The product can be exposed to Cobalt 60 Gamma
radiation at up to 4 megarads although a level
of 2-3 is quite sufficient for thorough
sterilization.
PRODUCT LIFE & INSPECTION CRITERIA (Reusable
Instruments only):
The product can be used for a considerable
amount of time if it is routinely
inspected:
A) Check plated metal contacts; these should be
bright without corrosion.
B) Plastic connectors should be free from
imperfection & distortion.
C) Cable insulation must be checked periodically
to make sure the product is safe for use, pay
special
attention to the exit point on the connectors as
excessive bending can cause failure in this
area.
D) All electrical cables and instruments must be
regularly checked for electrical
continuity by the Medical Physics Department to
prevent possible failure whilst being
used in surgery. If this is not possible
continuity testers are available from your
supplier
for on site testing. |
