Instructions for Use - ARMO

Instructions for Use
Reusable Surgical Instruments (Stainless Steel)

We recommend these instructions for use for the following instruments:
▪ Artery Forceps
▪ Biopsy Instruments
▪ Dilators
▪ Eye & Nasal Specula
▪ Forceps
▪ Hooks
▪ Laryngoscopes
▪ Ligators
▪ Mirrors
▪ Needle holders
▪ Plaster Instruments
▪ Podiatry Clippers
▪ Probes
▪ Ring Cutters
▪ Ring Towel Clips
▪ Ronguers & Rasps
▪ Scalpels
▪ Scissors
▪ Stainless Hollowware
▪ Suction & Irrigation
▪ Vaginal Specula

Introduction
This document provides guidance for the safe use, handling, cleaning, sterilization, and maintenance of reusable surgical instruments made from stainless steel, titanium, and related materials.
ARMO surgical instruments are supplied NON-STERILE. Clean, disinfect and sterilize before first use.
Inspect instruments for damage (cracks, nicks, pitting, etc.) prior to each use.
Do not use damaged instruments.

Intended Use
These instruments are designed for use in surgical, dental, and ophthalmic procedures. The clinician is responsible for selecting the appropriate instrument and ensuring staff are adequately trained.

General Instructions
Inspection - Check for damage before use. Do not use damaged instruments.
Handling - Avoid excessive force or twisting.
Risks - Injury, bleeding, infection possible.
Storage - Store clean, dry, protected.

Reprocessing Instructions
Pre-treatment - Remove debris immediately. Prevent drying by soaking or spraying with an enzymatic cleaning solution.
Preparation - Disassemble and open instruments.

Cleaning 
Use enzymatic/neutral detergents.
Separate dissimilar metals (stainless steel, chrome plated, copper) for cleaning.
All instruments with hinges, locks, ratchets, etc. must be processed in an open position.
Do not let sharp instruments touch each other during the cleaning process
Do not use steel brushes or abrasive materials
If you use an ultrasonic cleaner, remove instruments immediately and rinse with demineralized water.
Avoid the following when cleaning:
▪ Saline
▪ Hydrogen peroxide
▪ Solutions with high alkalinity
▪ Oxygenated water
▪ Abrasive materials & detergents
Rinsing - Thoroughly rinse with demineralized water to remove residues.
Inspection - Visually inspect for cleanliness, function and condition

Washer–Disinfector Processing (EN ISO 15883)
Pre-treatment - Remove gross contamination immediately after use.
Preparation - Disassemble, open hinges, flush lumens.
Loading - Ensure spray access, avoid overloading.
Pre-rinse - Cold water rinse.
Cleaning - 40–60°C with detergent.
Rinse Remove detergent residues (Residue left on
the instruments can cause staining)
Disinfection Thermal disinfection per ISO 15883.
Final Rinse - Use purified water.
Drying - Automated drying or sterile air.
Inspection - Check cleanliness and function.

Sterilisation
Steam sterilization 
Sterilize instruments only after they have been cleaned and disinfected
Place instruments in suitable sterilization packaging or reusable containers according to ISO 11607
Temperature and Time It is recommended to sterilize instruments
in a steam sterilizer at a temperature of 134℃ for 7 minutes at a pressure of 310 kPa.

Storage
Store instruments in a clean, dry environment. Protect delicate parts and avoid exposure to chemicals.

Maintenance
Inspection - Perform regular Inspections checking function, cracks, knicks, pitting etc.
Stain remover - If the instruments are stained, treat the instrument with a stain remover. This should be done to rejuvenate the passivation layer on the instrument
Lubricate - Lubricate Joints and hinges with instrument lubricants. If a stain remover has been used, then it is essential to relubricate the instrument

Disposal
Dispose of instruments according to local regulations if no longer usable.

Warranty
ARMO Instruments have a lifetime warranty for workmanship and Materials. Warranty is void if the instruments have been misused or Instructions for Use have not been followed.