Instructions for Use

These instructions are for trained healthcare and reprocessing staff. They do not replace professional training, clinical judgement or your facility's validated procedures and local regulations.

1. Intended use and users

Reusable instruments for cutting, grasping, holding, retracting, dissecting, measuring and other manual tasks in surgical, dental and medical procedures. They are for use only by qualified healthcare professionals, in a suitable clinical setting.

Contraindications: do not use an instrument for a purpose other than the one it was designed for. Instruments are not intended for permanent implantation.

2. Supplied non-sterile

Instruments are supplied non-sterile. Before first use, and before every use after that, they must be cleaned, inspected and sterilised as described below. Remove all protective caps, tubes and packaging first.

3. Warnings and precautions

• Inspect every instrument before each use. Do not use damaged, cracked, corroded or misaligned instruments.
• Do not expose instruments to saline solution, chlorine or bleach, iodine, or strong acids/alkalis; these cause pitting and corrosion.
• Do not use steel wool, wire brushes or abrasive cleaners.
• Process instruments open (hinged instruments unlocked) and take multi-part instruments apart.
• Do not mix stainless-steel instruments with damaged, corroded or chrome-plated instruments, or with other metals, in the same ultrasonic bath.
• Do not exceed 137 °C (279 °F) during sterilisation.
• Use personal protective equipment when handling contaminated instruments.
• Instruments with lumens, cannulas (e.g., liposuction cannulas, suction tubes) or hollow parts need brushing and flushing of every channel.
• Instruments used on patients with known or suspected prion disease (CJD/vCJD) must be handled according to national guidance; they may need to be quarantined or discarded.

4. Reprocessing instructions

4.1 Point of use

Wipe off gross soil with a lint-free cloth moistened with water. Do not let blood or tissue dry on instruments. Begin cleaning within 2 hours, or keep instruments moist (with a pre-cleaning foam or a damp cloth, not saline).

4.2 Containment and transport

Transport used instruments to the reprocessing area in a closed, puncture-resistant container.

4.3 Manual cleaning

1. Rinse under cold running tap water (< 40 °C) for at least 1 minute to remove visible soil.
2. Immerse fully in a neutral or mildly alkaline enzymatic detergent prepared to the detergent maker's concentration, temperature and contact time.
3. Brush all surfaces with a soft nylon brush while immersed, paying attention to serrations, box joints, ratchets, teeth and lumens. Work joints open and closed.
4. Ultrasonic cleaning: with the instruments open and fully immersed, run an ultrasonic cycle in fresh detergent for 5–10 minutes at 35–45 kHz, at no more than 40 °C. Do not use ultrasound for microsurgical instruments or for aluminium, titanium, anodised or plated parts.
5. Rinse thoroughly with purified (demineralised or RO) water, including all channels.
6. Dry immediately with a lint-free cloth or medical-grade compressed air.

4.4 Automated cleaning and disinfection (preferred)

Use a washer-disinfector that meets ISO 15883, with a validated instrument cycle: pre-rinse with cold water, an alkaline or enzymatic detergent wash, neutralisation if needed, a final rinse with purified water, thermal disinfection at 90–93 °C for at least 5 minutes (A0 ≥ 3000), and drying. Load instruments open, on racks, without overlapping. Connect cannulated instruments to the rinsing ports.

4.5 Inspection and function check

Under good lighting (magnification is recommended), check each instrument: - clean and free of visible residues, stains and corrosion; - no cracks, especially at box locks and joints; - jaws and teeth align and close fully; ratchets engage and hold; - cutting edges are sharp and free of nicks (scissors should cut cleanly through thin gauze or test material at the tips); - TC inserts are intact. Re-clean instruments that are not clean. Remove damaged or blunt instruments from service for repair or replacement (see Warranty and Services).

4.6 Lubrication

Lubricate hinges, joints, box locks and ratchets with a water-soluble, steam-permeable instrument lubricant (no silicone or industrial oils). Work the joint to spread it and wipe off the excess.

4.7 Packaging

Package instruments in sterilisation wrap, pouches or rigid containers that meet ISO 11607 and are suitable for steam sterilisation. Keep hinged instruments slightly open (first ratchet position) and protect sharp tips.

4.8 Sterilisation

Moist heat (steam) sterilisation in a steriliser meeting EN 285 / EN 13060, with a process validated to EN ISO 17665-1:

Never exceed 137 °C. Where national guidance requires extended cycles (for example for prion risk), follow that guidance and contact us.

Dry heat (only where steam is not available, all-metal instruments only): 170 °C for at least 60 minutes or 160 °C for at least 120 minutes; never above 177 °C.

Ethylene oxide, hydrogen peroxide plasma and liquid chemical sterilants are not covered by these instructions; contact us before using them. Do not use flash/immediate-use sterilisation for routine reprocessing.

Allow instruments to cool to room temperature before use or storage.

4.9 Storage

Store sterile packages in a clean, dry, dust-free area at room temperature, away from chemicals and direct sunlight. Respect the shelf life defined by your facility's procedures and check the packaging is intact before use.

5. Service life

Repeated reprocessing has little effect on these instruments. The end of service life is determined by wear and damage, not by a fixed number of cycles. Inspect before each use (section 4.5) and retire instruments that fail the check.

6. Disposal

Clean and sterilise instruments before disposal. Dispose of them as metal waste, or as clinical waste where contaminated, according to local regulations.

7. Reporting incidents

Report any serious incident involving an instrument to BusinessMed Instruments ([email protected]) and to the competent authority of the country where it occurred (in the EU, the national competent authority for medical devices).

8. Symbols used on labels (ISO 15223-1)

9. Manufacturer and certificates

Manufacturer: BusinessMed Instruments, Jammu Road, Talwara Mughlan, Sialkot 51310, Pakistan Certificates: Certificates

10. IFU library: download by product

Download our two general documents and the product-specific IFU for each instrument. Search by product name, catalogue number (SKU) or category.

Each product page also has a Download IFU link to its own document.

11. Can't find your IFU? Request it

Need the IFU for a specific instrument, a translated IFU, material test certificates (MTC) or declarations of conformity? Fill in the form and our regulatory desk will reply within 1 business day.

Request an IFU by email

Please include the product name or catalogue number (SKU), your order number if you have one, the country where the instrument is used and the language you need. Do not include patient information.

Or email [email protected] with the subject "IFU request".

Frequently asked questions

Are your instruments supplied sterile? No. All reusable instruments are supplied non-sterile and must be cleaned and sterilised before first use.

Can I autoclave at 121 °C? Yes, in a gravity-displacement cycle at 121 °C with a 30-minute holding time. A pre-vacuum cycle at 134 °C is recommended because it is faster and dries better.

Why are my instruments getting brown stains or rust spots? Usually because of the water quality (chlorides), detergent residues, saline contact, or contact with corroded instruments in the same load. Use purified water for the final rinse and check your detergent. Our team can help: send photos on live chat.

Can I use these instructions for electrosurgical cables or light sources? No. These products have their own IFU. Request it with the form above.

Related: Warranty and Services · Certificates · Support 24/7