Anspach eMax 2 Manual De Instrucciones página 6

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Warnings
• ∆ Always use continuous irrigation to prevent heat build-up. Irrigation is necessary for proper performance.
• Surgeon is responsible for learning proper techniques in use of equipment; improper use may cause serious injury to user
or patient or damage to system.
• Instrument operator and all operating room personnel must wear eye protection.
• Visually inspect for damage before using; do not use if damage is evident.
• Do not use if the product sterilization barrier or its packaging is compromised.
• Do not use, or discontinue use of powered equipment exhibiting excessive temperatures that can cause patient injury
(necrosis) and/or user discomfort.
• Use of damaged or improperly maintained power equipment and/or misused powered equipment can result in excessive
temperatures.
• Use caution to avoid cutting or tearing gloves while handling dissection tools.
• Dissection tools must be adequately retained within attachment to prevent distal migration, which may cause injury.
Confirm attachment is proper size for dissection tool and that it is secure.
• Gently pull on dissection tool shaft to ensure it is fully seated and properly installed.
• Only cut visible areas unless an image intensifier is utilized.
• Delicate structures in proximity to dissection must be thoroughly protected to prevent injury.
• Maintain firm control of instrument at all times.
• Do not bend or use as a lever.
• Use a gentle tapping motion or side-to-side motion and let instrument do cutting.
• Do not use excessive force.
• Forceful side loading of dissection tool may cause fracture of dissection tool, which may cause injury.
• Dissection tools are disposable and intended for single patient use only. Do not re-sterilize and/or re-use dissection tools.
Reuse and/or re-sterilization of these devices could result in reduced performance, material degradation and/or patient
contamination
• Use standard protocol for disposal of sharp instruments.
• Continuous extreme cutting at or near stalling conditions will quickly overheat handpiece.
• Do not operate in an explosive flammable environment.
• Do not modify ground or power cord.
• Do not allow liquid into console.
• Do not use a craniotome in conjunction with Hand Control. Excessive rotational force on hand control may move it, thus
shutting handpiece down.
• Use of accessories or cables other than those provided by DePuy Synthes Power Tools and specified for use with the
eMax 2 or eMax 2 Plus System may result in increased emissions or decreased immunity.
• The eMax 2 or eMax 2 Plus should not be used adjacent to or stacked with other equipment and that if adjacent or stacked
use is necessary, the eMax 2 or eMax 2 Plus should be observed to verify normal operation in the configuration in which it
will be used.
• Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided in this accompanying documentation.
• Portable and Mobile RF communications equipment can affect Medical Electrical Equipment.
• Power source should comply with applicable IEC, CEC, and NEC requirements. Grounding reliability can only be achieved
when this equipment is connected to a receptacle marked "HOSPITAL GRADE."
• Do not use in oxygen rich environment.
• No modification of this equipment is allowed.
• Do not modify. Modifications could result in loss of electrical safety.
• Dispose of items contaminated with body fluids with other biohazardous waste.
• At end of life recycle or dispose of device in accordance with local and national regulations.
• To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. The
use of Accessories, transducers, and cables other than those specified, with the exception of transducers and cables sold
by the Manufacturer of this device as replacement parts for internal components, may result in increased Emissions or
decreased Immunity of the eMax 2 or eMax 2 Plus System.
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