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General| Brand | Covidien |
|---|---|
| Model | HawkOne H1-LS-INT |
| Category | Medical Equipment |
| Language | English |
Overview of the HawkOne directional atherectomy system components and function.
Details system compatibility between HawkOne catheter and cutter driver models.
Specifies the intended medical applications for the directional atherectomy system.
Lists conditions or sites where the system must not be used.
Crucial safety precautions and potential risks associated with system use.
Visual guide and labeling of the catheter and cutter driver parts.
Lists possible medical complications from using the device.
Information on how the HawkOne catheter and cutter driver are packaged and provided.
Guidelines for maintaining device integrity and function.
Steps for verifying device integrity before use to ensure safety.
Procedures for readying the HawkOne catheter and system for patient use.
Step-by-step guide for inserting the catheter and performing the procedure.
Details on how to perform the atherectomy procedure on target lesions.
Instructions for safely removing the catheter from the patient.
Procedure for removing excised tissue from the device tip.
Guidelines for the safe and compliant disposal of the device components.
Information on EMC requirements and precautions for the device.
Details on how the device performs in electromagnetic environments.
Guidelines for maintaining safe distances from RF equipment.
Explains the importance of reading and understanding the manual's content.
Information regarding the product's warranty terms and conditions.
