Precautions For Handling And Operation - NSK Primado2 Manuel D'utilisation

Precautions for Handling and Operation

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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
DANGER
Hazard that could result in personal death or serious injury if the safety instructions are not correctly followed.
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.
● DO NOT use this product in a room where there is a danger of explosion or in the vicinity of flammable substances. It is especially
important not to use this product on a patient to whom a flammable anesthetic agent (dinitrogen monoxide) has been administered.
● Never disassemble or modify the product. Disassembly or modification may cause personal injury or damage to the Motor (including
Motor Cord/Motor Hose) or Attachment.
● This is a medical system; do not allow anybody to use it other than surgeons who are familiar with the procedures. Use this system in
accordance with its indications for use and proper method of use.
● 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.
● Irrigate appropriately while cutting in order to prevent necrosis of bones and tissues.
● Perform inspection before use according to "8 Check before Operation". If abnormal vibration or noise is found, the following issues
are suspected:
– The internal consumables (ball bearings, etc.) are worn or damaged.
– The chuck is open or there is a bad connection of each part.
– System defect due to damaged/deformed Cutting Accessory.
Using the Attachment in these conditions may lead to heat generation causing thermal injury. Perform "11 Troubleshooting" in this
case. If the issue does not improve after troubleshooting, contact your Authorized NSK Dealer.
● DO NOT place the Attachment/Motor (including Motor Cord/Motor Hose) on the patient or the drape covering the patient. Doing so may
cause an accident, injury or thermal injury to the patient and/or surgical staff.
● Prevent any debris or other foreign materials from entering into the Attachment. Failure to do so may lead to heat generation, causing
thermal injury.
● DO NOT allow strong impact on the product for example, dropping the Attachment/Motor on a hard surface. Doing so may cause
personal injury, abnormal heating, fire and/or thermal injury due to product damage.
● After purchase or repair of the Attachment, be sure to clean, lubricate and sterilize the Attachment before use (refer to OM-SZ0911MA
Primado2 REPROCESSING MANUAL).
● DO NOT use bent, damaged or deformed Cutting Accessories. If they are used, the Attachment may not clamp the Cutting Accessory
securely and it may break or cause accidents.
● DO NOT put excessive pressure on the Cutting Accessory. Doing so may bend or damage the Cutting Accessory, or cause excessive
heat generation on the Cutting Accessory, Attachment and Motor, which could lead to thermal injury.
● Avoid continuous use of the product and use it intermittently to prevent excessive heat generation.
In case of heat generation, immediately stop use until the product cools down.
● Be careful not to touch the heated area. Doing so may cause thermal injury.
● When replacing the Cutting Accessory, be sure to slide the Safety Lock on the Hand Switch of the Motor to the OFF position, or
completely take your foot off the Foot Control Pedal to stop the Attachment completely. Otherwise, a patient or surgical staff may be
injured by unintentional movement of the Motor and the Cutting Accessory.
DANGER
WARNING
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