Brand: Swadeshi Instruments (Acrowndentco)Company: The Bizz InternationalRegulatory Classification: Class A (MDR 2017 – India)Status: Non-Sterile, Non-Measuring DeviceHSN Code: 90184900
GENERAL INFORMATION
These medical devices are intended exclusively for dental or surgical use by qualified healthcare professionals.
All instruments are supplied non-sterile and must be cleaned, disinfected, and sterilized before their first use and before each subsequent reuse.
Prior to use, all devices should be inspected for damage, contamination, or deformation caused during transport or handling.
Protective covers, if provided, must be removed before sterilization.
Instruments are designed for specific clinical applications only. Misuse may result in harm to both the operator and the patient.
Reprocessing must be performed by trained personnel assigned to maintain and monitor device integrity and safety.
Damaged, bent, or corroded instruments must not be used and should be properly disposed of or returned to the manufacturer.
Reprocessing life is determined by wear, frequency of use, and reprocessing method; there is no fixed reprocessing cycle limit.
Reprocessing equipment (washers, autoclaves) must be maintained as per manufacturer instructions.
Do not attempt self-repair. All repairs must be done by certified Swadeshi service personnel.
WARNINGS & SAFETY PRECAUTIONS
Always handle sharp and pointed instruments with extreme care.
Do not sterilize mixed metals together (e.g., aluminum with stainless steel).
Do not exceed 134°C in sterilization.
Never use strong alkaline (pH > 9) or acidic (pH < 4) detergents.
Avoid cold sterilization unless validated for specific instruments.
Do not process titanium, anodized aluminum, mirrors, or coated tips in ultrasonic cleaners unless specifically recommended.
Always process jointed instruments in open position.
Follow the exact concentration and exposure time provided by the detergent/disinfectant manufacturer.
Use medical-grade cleaning and disinfecting agents only.
REPROCESSING CYCLE
Step 1: Collection
Collect instruments immediately after use and transport them in a closed, puncture-resistant container to prevent contamination and damage.
Step 2: Decontamination / Pre-Soaking
Soak in approved enzymatic or quaternary ammonium-based solutions (e.g., glutaraldehyde-free, neutral pH detergents).
Follow solution-specific dilution and soaking time instructions.
Step 3: Rinsing
Rinse thoroughly with clean, preferably demineralized water to remove chemical residue.
Step 4: Cleaning
A. Manual Cleaning
Use soft, non-metallic (e.g., nylon) brushes.
Do not use steel wool or abrasive pads.
Clean all surfaces, joints, serrations, and lumens.
Ultrasonic cleaning is recommended for hinged and delicate instruments.
Place instruments in open position and fully submerged.
Avoid overlapping sharp tips and mixing different metals.
B. Automated Washer Disinfectors
Use validated programs that include thermo-disinfection.
Ensure the equipment is properly loaded and maintained.
Step 5: Drying
Dry immediately using lint-free cloths or compressed air.
Do not leave instruments wet, as it promotes corrosion.
INSPECTION & MAINTENANCE
After cleaning, inspect visually and functionally:
Check for cracks, pitting, rust, or deformation.
Test cutting edges, alignment, ratchet function, and joints.
Sharpen cutting instruments (e.g., curettes, scissors) as needed.
Lubricate all metal-to-metal moving parts using medical-grade lubricant (instrument milk) that is autoclave-safe.
Reassemble disassembled instruments before sterilization.
PACKAGING
Use medical-grade sterilization pouches or trays.
Instruments must be dry and in open (unlocked) position.
Protect sharp edges.
Label with sterilization and expiry date, and operator initials.
STERILIZATION
Recommended method: Steam Autoclave (Class B preferred)
Cycle Parameters:
Temperature: 134°C (273°F)
Exposure Time: 5 minutes
Drying Time: 20–45 minutes (varies by device load)
Use only demineralized water.
Flash sterilization and dry heat sterilization are not recommended unless validated for specific devices.
Follow sterilizer maintenance protocols for safe use.
STORAGE
Store in cool, dry, and dust-free environments between 5°C–40°C.
Keep away from direct sunlight and heat sources.
Only store instruments in intact, sealed pouches.
DEVICE-SPECIFIC GUIDELINES
Please refer to product-specific inserts (where applicable) for additional handling guidance on items such as mirrors, coated instruments, titanium tips, scalpel blades, and syringe systems.
SYMBOLS USED
🔄 Reusable
♻️ Medical Device
🧼 Washer Disinfector Safe
💨 Steam Sterilizer Safe
🧽 Ultrasonic Cleaning Allowed
⚠️ Handle With Care
CONTACT INFORMATION
For further assistance, reconditioning service, or spare parts:
