Instructions for Use
Cleaning & Sterilization
Surgical instruments are designed to perform specific functions such as cutting, grasping, clamping, dissecting, probing, retracting, draining, aspirating, suturing, or ligating. Instruments should not be used for anything other than their intended use — devices must be used in accordance with these instructions.
Warning
Read all sections of this insert prior to use. Improper use of these devices may cause serious injury. Improper care and maintenance may render a device non-sterile prior to patient use and cause a serious injury to the patient or healthcare provider.
1. Precleaning
Keep instruments moist and do not allow blood and/or bodily fluids to dry on the instrument. Remove gross contaminants with a steady stream of lukewarm/cool water (below 110°F/43°C). Rinse each instrument thoroughly — do not use saline or chlorinated solutions. Open the jaws of hinged instruments for cleaning, giving special attention to joints and serrations. Instruments with more than one part must be disassembled (if possible) to expose all surfaces to the cleaning process. Separate sharp and delicate instruments from others, and keep ebonized instruments separate from stainless steel instruments to avoid scratching or removal of the ebonized coating.
2. Rinse
Rinse instruments thoroughly under warm distilled or demineralized water.
3. Cleaning
Manual cleaning: to prevent biofilm formation, clean as soon as possible after use. Choose a cleaning solution appropriate for surgical/dental instruments and follow the manufacturer's instructions. Neutral pH detergents are recommended to avoid corrosion, pitting, and breakage. Use a small, clean hand-held brush to remove soil while the instrument is fully immersed. Ultrasonic & mechanical cleaning: follow the manufacturer's concentration and temperature specifications for cleaning agents. Use an ultrasonic cleaner for hard-to-reach areas such as grooves, crevices, and moving parts after gross soil has been removed. Open or disassemble instruments as appropriate, and don't allow ebonized instruments to contact each other or other instruments during ultrasonic cleaning.
4. Rinse and Dry
Rinse all instruments thoroughly with distilled, pyrogen-free water to remove all traces of debris and cleansing agents. Make sure all internal lumens and ratchets are thoroughly rinsed. Instruments must be thoroughly dried and all residual moisture removed before storage. Use a soft, absorbent towel/cloth to dry external surfaces; compressed air may be used to aid drying.
5. Lubricate
Use a water-soluble instrument lubricant compatible with the intended sterilization method before instruments are sterilized. After thoroughly cleaning the instruments, proper application of lubricant to all joints and movable mating surfaces will keep them moving freely and help protect surfaces from mineral deposits.
6. Sterilization
See the parameter table below for validated steam and ethylene oxide (EtO) cycles.
7. Storage
Store sterilized instruments in a manner that maintains sterility until point of use, following standard hospital/clinic protocol.
Sterilization Parameters
| Method | Temperature | Exposure Time | Dry Time |
|---|---|---|---|
| High Vacuum Steam (Pre-vacuum) — Wrapped | 270°F (132°C) | 3 minutes minimum | N/A |
| High Vacuum Steam (Pre-vacuum) — Unwrapped in containers / perforated / solid | 270°F (132°C) | 4 minutes minimum | 20 minutes |
| Gravity Steam — Unwrapped in containers / perforated unstacked | 250°F (121°C) | 45 minutes | 20 minutes |
| Gravity Steam — Wrapped in cassettes | 250°F (121°C) | 30 minutes | 20 minutes |
| Ethylene Oxide (EtO) — Unwrapped in containers / perforated / solid unstacked | 131°F (55°C) | 60 minutes minimum · Concentration 725 mg/l · Humidity 70% | Aeration: 8 hours minimum |
Cautions
- Lapromed surgical instruments are supplied non-sterile, unless otherwise noted, and must be cleaned, lubricated (if required), and sterilized prior to use according to hospital protocol and procedures.
- Inappropriate use of instruments may result in patient injury, damaged, or broken instruments.
- Do not expose instruments to phenols or iodophors.
- Do not use dry heat sterilization for aluminum or plastic-made, black-coated, or ebonized instruments.
- Do not apply excessive stress or strain at joints; misuse will result in misalignment or cracks at the box locks or jaws.
- Wear appropriate protective gloves, eyewear, and clothing when handling biologically contaminated instruments.
- Instruments manufactured from different metals or with special coatings should be processed separately to avoid electrolytic action between the different metals.
- Before use, inspect instruments for possible damage, wear, or non-functioning parts. Damaged or defective instruments should not be used or processed.
Warranty & Returns
Warranty
1-year warranty on stainless steel instruments; 90-day warranty on single-patient-use disposables. Warranty excludes damage from normal wear, misuse, or improper cleaning/sterilization.
Returns
Returns require a Return Goods Authorization (RGA) prior to shipment. A 25% restocking fee applies to returns made within 90 days of purchase; return eligibility and required documentation are determined case by case.