Precautions For Handling And Operation - NSK Primado2 Manual Del Usuario

Precautions for Handling and Operation

1
Please read these precautions carefully and use only as intended or instructed.
Safety instructions are intended to avoid potential hazards that could result in personal injury or damage to the device. Safety instructions
are classified as follows in accordance with the seriousness of the risk.
Degree of Risk
Class
Hazard that could result in serious injury or damage to the device if the safety instructions are not correctly
WARNING
followed.
Hazard that could result in light or moderate injury or damage to the device if the safety instructions are not
CAUTION
correctly followed.
NOTICE
General product specification information highlighted to avoid product malfunction and performance reduction.
● If this product is used for a patient with Creutzfeldt-Jakob Disease (CJD) or with suspected CJD, reprocess the product appropriately
in accordance with the regulations or guidelines for CJD of each country.
● Follow the regulations or guidelines of each country.
● Reprocess this product after every surgical operation.
● Do not directly spray detergent/liquid on the LCD Touch Panel of the Control Unit when cleaning the Control Unit. It may cause failure.
● The Irrigation Tube and Cutting Accessory are for single use only.
Do not reuse or resterilize.
● The Cutting Accessory is for single use only. DO NOT reuse or reprocess it. If you reuse or reprocess it, the following risks may occur:
– Infection.
– Personal injury due to damaged Cutting Accessory.
– System defect due to damaged/deformed Cutting Accessory.
● Thoroughly clean the Attachment before autoclave sterilization. Autoclaving the Attachment with blood remaining on it may lead to
sterilization failure, resulting in infection to the patient and/or user or malfunction of the Attachment due to blood coagulation.
● Immediately after use, the Attachment should be cleaned, lubricated and sterilized. Remaining blood in the Attachment may cause rust
due to blood coagulation. Failure to properly maintain the Attachment may lead to overheating, causing thermal injuries or product
failure.
● Do not lubricate the electric Motor. It may result in an abnormal heating and failure.
● Wear Personal Protective Equipment (PPE) to prevent infection.
● NSK has verified the effectiveness of reprocessing using the dedicated cleaning tools.
● Be sure to use the dedicated cleaning tools.
● DO NOT use a lint cloth or metal brush for cleaning.
● When cleaning, use disinfecting ethanol or ethanol with isopropanol added as an alcohol disinfectant (e.g. Meliseptol® rapid) to wipe
down the surface of the product.
● DO NOT use a chlorinated cleaner, benzene or thinner for cleaning to prevent damage to the product.
● Do not soak the Control Unit, Foot Control or Motor in water for cleaning. It may cause failure.
● Do not clean the Control Unit or Foot Control under running water. It may cause failure.
● DO NOT clean the product with an ultrasonic cleaning apparatus to prevent damage to the product.
● The Wire Pin Driver includes aluminum, therefore take special precaution to always use a PH neutral detergent compatible with
aluminum, when washing it.
● When using detergents other than the ones we used for validation, it is necessary to verify the effectiveness based on the information
provided by the manufacturer of the detergent and the information obtained from testing.
● Prepare the detergent according to the instructions of the detergent manufacturer when using the detergent.
● Refer to the operation manual of the washer-disinfector before operating it.
● Be sure to use a disinfector compliant with ISO15883.
● Dispose of the Irrigation Tube and Cutting Accessory after use as medical waste
(refer to OM-SE0021E Primado2 OPERATION MANUAL Control Unit and Foot Controls).
WARNING
CAUTION
2