IFU

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🏥 Instructions for Use (IFU) & Care Handling Guidelines

1. Product Description

MADE IN SURGICAL instruments are precision-crafted medical devices manufactured for use in various surgical disciplines including General Surgery, Orthopedic, Neurosurgery, ENT, Gynae/Obstetrics, Laparoscopy, and more. These instruments are made from high-grade surgical stainless steel, titanium, or alloy-specific to the instrument’s intended use.

3. Contraindications

  • Do not use if instrument is damaged, rusted, or has loose/missing parts.

  • Instruments are not intended for non-surgical or non-clinical use.

  • Avoid use in MRI environments unless otherwise stated.

5. Care & Handling Guidelines (Post-Use)

A. Point-of-Use Treatment (Immediately After Use)

  1. Rinse Immediately: Rinse instruments under cool or lukewarm running water. Do not allow blood, body fluids, or saline to dry on the surface.

  2. Do Not Soak in Saline or Disinfectants: Prolonged exposure causes corrosion.

B. Transport

  • Place used instruments in a puncture-resistant tray lined with a moist towel.

  • Transport to CSSD (Central Sterile Services Department) within 30 minutes of use.

7. Inspection & Function Check

  • Check for cracks, corrosion, or pitting.

  • Check alignment, sharpness (scissors/blades), locking mechanisms, and spring tension.

  • Lubricate joints (if required) with surgical-grade lubricant.

9. Sterilization Guidelines

Recommended Method: Steam Autoclaving (Gravity or Pre-Vacuum)

Parameter Gravity Displacement Pre-Vacuum
Temp 121°C / 250°F 132°C / 270°F
Exposure Time 30 minutes 4 minutes
Drying Time 15–30 minutes 20–30 minutes

Important:

  • Do not exceed 137°C (278°F) unless validated.

  • Ensure load is properly dried to prevent corrosion.

11. Shelf Life & Reusability

  • Instruments have an indefinite shelf life if properly maintained.

  • Inspect before each use to determine usability.

2. Intended Use

Surgical instruments are intended to be used by trained medical professionals for diagnostic, therapeutic, or surgical procedures. Reuse is allowed only after proper cleaning, disinfection, and sterilization.

4. Warnings & Precautions

  • Always inspect instruments prior to use.

  • Use appropriate instrument for its specific function.

  • Improper use can cause damage or injury.

  • Discard single-use accessories (e.g., blades, tubing).

6. Cleaning Instructions

A. Manual Cleaning (Preferred for Delicate Instruments)

  1. Disassemble multipart instruments.

  2. Use a pH-neutral enzymatic cleaner.

  3. Scrub with a soft brush to remove visible debris, especially hinges, box-locks, and serrations.

  4. Rinse thoroughly with demineralized or distilled water.

  5. Dry with a lint-free cloth or compressed air.

B. Ultrasonic Cleaning (Optional)

  • Use a validated cycle (4–10 minutes) in a suitable ultrasonic cleaner.

  • Do not overload trays.

  • Follow with final rinse and drying.

8. Packaging for Sterilization

  • Use approved wrap, pouches, or rigid containers.

  • Ensure instruments are dry and open/loose to allow steam penetration.

10. Storage Instructions

  • Store in clean, dry, and well-ventilated conditions.

  • Do not store in saline or disinfectant.

  • Avoid exposure to direct sunlight and moisture.

  • Store in closed, labeled trays or containers.

12. Disposal

  • Dispose of damaged or non-functional instruments according to hospital and local regulatory guidelines for biomedical waste.