FAQ
NICO Myriad™ Handpiece Instructions for Use
Please read all information carefully. Failure to properly follow these instructions may lead to unintended surgical consequences. Important: This package insert is designed to provide instructions for use for the NICO Myriad handpiece. It is not a reference to surgical techniques.
Indications
For the resection of soft tissue abnormaliti es found in the central nervous system as determined appropriate by the surgeon.
Contraindications
The NICO Myriad System is contraindicated for those pati ents where increased risk or complications may be associated with the removal of tissue based on the physician's judgment. Pati ents receiving anti coagulant therapy or who may have bleeding disorders may be at increased risk.
Warnings and Precautions
  • Removal of tissue using the NICO Myriad System should be performed only by persons having adequate training and familiarity with this procedure. Consult medical literature relati ve to techniques, complications and hazards prior to performance of any minimally invasive procedure.
  • This device should only be used by physicians trained in open or endoscopic tissue removal procedures.
  • The handpiece should not be operated for more than 60 minutes.
  • Minimally invasive instruments and accessories manufactured or distributed by companies not authorized by NICO Corporati on may not be compati ble with the NICO Myriad System. Use of such products may lead to unanti cipated results and possible injury to the user or pati ent.
  • Instruments or devices which come into contact with bodily fl uids may require special disposal handling to prevent biological contaminati on.
  • Dispose of all opened instruments whether used or unused. Do not resterilize the handpiece or any other sterile components off ered by NICO. Resterilizati on may compromise their integrity, which may result in them malfunctioning.
  • The handpiece and other sterile components are intended for single pati ent use and should not be reused. Reuse of these devices may result in pati ent infecti on and/or device malfuncti on.

This symbol indicates that one or more of the materials used for the manufacture of this medical device contain the phthalate DEHP. In accordance with Council Directi ve 93/42/EEC, tissue which is resected from children or pregnant/nursing mothers that comes into contact with materials containing DEHP should not be reinjected into the body for therapeuti c purposes.
Device Description
The handpiece is a sterile, single use, minimally invasive device which is specifi cally designed for the removal of intracranial, skull-base and spinal tissues in human pati ents under direct, microscopic or endoscopic visualizati on.
Instructions for Use – Handpiece
  • The appropriate protocol should be employed to prepare the pati ent for surgery.
  • Prior to use, inspect packaging for damage or gross deformations. If there is any indicati on that sterility or functi onality has been compromised, obtain a new handpiece and contact NICO Customer Service about returning the original handpiece.
  • Remove handpiece from packaging using sterile technique. NOTE: Handpiece tray includes a reservoir which may be used for priming if desired.
  • Pass handpiece connectors into non-sterile fi eld for connecti on to console.
  • Connect blue fl exible sucti on connector to canister. NOTE: If using a specimen collector, this connecti on sequence is diff erent. See “Specimen Collector” secti on of this manual for instructions.
  • Connect blue handpiece connector to blue connecti on port on console
  • To prime handpiece, submerge the aperture at the distal ti p of handpiece (DO NOT SUBMERGE THE ENTIRE HANDPIECE) into the desired sterile priming fl uid and enable prime functi on on console. Prime handpiece unti l soluti on is visible in canister.
  • For working channel handpieces rotate depth-control dial to adjust depth of handpiece during procedure, as clinically appropriate.
  • Perform tissue resecti on using cutti ng and aspirati on as desired. Refer to console Operator’s Manual for more informati on concerning cutti ng and aspirati on functions.
  • Once tissue resecti on is complete, remove handpiece and dispose per appropriate hospital procedure.
Handpiece
Handpiece
Handpiece
Instructions for Use – Handpiece Bending Tool
  • Prior to use, inspect packaging for damage or gross deformations. If there is any indicati on that sterility or functi onality has been compromised, obtain a new bending tool and contact NICO Customer Service about returning the original bending tool.
  • Remove bending tool from packaging using sterile technique.
  • If applicable, remove sti ff ening cannula from handpiece (luer fi tti ng).
  • Align aperture as desired by rotati ng dial.
  • Slide bending tool over cannula of handpiece.
  • Confi rm that the ti p of cannula falls within the range specifi ed in the fi gure on the following page prior to bending.
  • Bend cannula to desired radius. The cannula may only be bent one ti me. Do NOT att empt to bend the cannula more than once. NOTE: Bending tool MUST be used for bending cannula – do NOT bend by any other means. Doing so may result in malfuncti on of the handpiece.
  • Once procedure is complete, discard bending tool per appropriate hospital procedure.
Handpiece Bending Tool
Instructions for Use – Specimen Collector
  • Prior to use, inspect packaging for damage or gross deformations. If there is any indicati on that sterility or functi onality has been compromised, obtain a new specimen collector and contact NICO Customer Service about returning the original specimen collector.
  • Remove specimen collector from packaging.
  • Locate connecti on point on handpiece aspirati on line (see diagram below) and separate blue fl exible sucti on connector from barbed fi tti ng.
  • Connect blue fl exible sucti on connector on handpiece tubing to white rigid connector on specimen collector.
  • Connect blue fl exible sucti on connector on specimen collector to barbed fi tti ng on handpiece tubing.
  • While performing tissue resecti on, monitor level of tissue in specimen collector. If the fi lter element within the specimen collector becomes full, remove and replace fi lter element.
  • Once tissue resecti on is complete, harvest tissue from specimen collector. Then dispose of specimen collector per hospital procedure.
Specimen Collector
Operati ng Conditions
Temperature: +15°C to +40°C
Humidity: 30% to 75%
Shipping Conditions
Temperature: -29°C to +60°C
Humidity: 30% to 85%
Storage Conditions
Temperature: Approximately +20°C to +25°C
Humidity: Ambient Conditions
How Supplied
The handpiece, specimen collector, and bending tool are supplied sterile and packaged for single use. Discard into an appropriate container aft er use.
where to find us
Global Surgical Distribution (GSD)
115 The Promenade, Camp Hill, Queensland, Australia, 4152
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