acumed Polarus Instrucciones De Uso página 6

US Instructions for use
PROCESSING
Important: Processing personnel must be qualified with suitable training and experience. Use
proper personal protective equipment (PPE) when working with contaminated devices.
IMPORTANT
• Promptly perform the processing steps to limit microbial growth and maximize the effectiveness of
sterilization.
• Inspect implants for contamination by blood or tissue and dispose of them when found. Do not process
contaminated implants.
• Prevent instrument corrosion by minimizing contact with solutions containing iodine, chlorine, and
saline or other metal salts.
• Prevent damage to the protective anodization layer on aluminum instruments by avoiding contact with
solutions < 4 pH and > 9 pH, especially if they contain sodium carbonate or sodium hydroxide.
• Repeated processing of anodized metals may cause colors to fade but this does not affect the function
of the device.
• Avoid cleaning agents containing aldehydes since they can denature and coagulate proteins (fixation).
• Enzymatic detergents are well suited for loosening protein-based contamination.
- Use a neutral pH enzymatic detergent.
- Use a low foaming solution to allow visibility of the device during cleaning.
• Closely follow the manufacturer's instructions for the safety, storage, mixing, water quality, exposure
time, temperature, replacement, and disposal of cleaning agents.
• Devices potentially contaminated with transmissible spongiform encephalopathy (TSE) agents shall not
be processed or reused. These processing instructions are not suitable for inactivation of TSE agents.
Observe hospital procedures, practice guidelines, and/or government regulations for the proper
handling and disposal of devices potentially contaminated with TSE agents.
• Utility water: Refer to AAMI TIR34* when instructed to use utility water. Utility water is typically
municipal or tap water but may require additional treatment to be suitable for use.
• Critical water: Refer to AAMI TIR34* when instructed to use critical water. Critical water is highly treated
and has very low organic and inorganic content with an endotoxin level under 10 EU/mL. Suitable water
may also be specified in national pharmacopeias, national standards, and hospital protocols.
* Association for the Advancement of Medical Instrumentation (AAMI). Water for the reprocessing of
medical devices. AAMI TIR34:2014/(R)2017. Arlington, VA.
MANUAL CLEANING
1. Rinse the contaminated instruments under running cold utility water to reduce heavy surface
contamination.
2. Dispose of any used instruments intended for single use only.
3. Place the contaminated instruments in enzymatic solution* until completely submerged to minimize
the spraying of solution.
4. Actuate all moveable parts to allow detergent to contact all surfaces.
5. Soak for a minimum of ten (10) minutes.
U.S. English – US / PAGE 6