B.I.A IMPEX PRODUCT SPECIFICATION & USAGE DATA SHEET

TECHNICAL SPECIFICATION:
Product Packaging & labeling: The product is packaged in a polythene bag to maintain cleanliness and must be Autoclaved prior to use ( Except Footswitches & Plate cables). The label has the Stock code,
Description, batch no. and supplier details for identification.

Contacts:

Nickel-plated brass or 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 is pushed fully home into its socket prior to switching on. Always make sure adhesive plate connections are sound and secure to prevent any chance of burns in this area.

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:

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: -

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.