Healthcare Professionals

Midas Rex Microsaws

Indications, Safety, & Warnings

Midas Rex Microsaws

Midas Rex Legend electric handpieces, Midas Rex Microsaws, the Triton electric high-torque handpiece, and the Midas Rex Spine Shaver SC1 handpiece are all powered by the Integrated Power Console (IPC).

Indications

The IPC is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial) Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.

Contraindications

The IPC system is contraindicated for arthroscopic microdiscectomy in individuals with the following:

  • Severe/progressive neurological deficits
  • Cauda equine syndrome
  • Active infection

Arthroscopic microdiscectomy is not indicated for individuals with sequestered disc fragments, discogenic pain, internal disc destruction, or lumbago.

Warnings

System Warnings
W1 It is important that the IPC system operator be familiar with the system User’s Guide, its precautions, procedures and safety issues.
W2 Do not use the IPC POWEREASE system in the presence of flammable anesthetics. Avoid potential ignition or explosion of gases.
W3 When not operating handpiece, eliminate accidental foot control activation. Control energy to and through the handpiece to prevent unintended tissue, bone, or nerve resection.
W4 Disconnect power to the IPC system before cleaning the unit to avoid electrical macro shock.
W5 Do not attach unapproved components to the IPC system to avoid electrical macro shock.
W6 To avoid the risk of electrical shock, achieve electrical grounding reliability with proper connections. Connect the IPC system to hospital grade receptacles only.
W7 This medical device complies with EN60601-1-2 safety standard for electromagnetic compatibility, requirements and test. However, if this equipment is operated in the presence of high levels of electromagnetic interference (EMI) or highly sensitive equipment, interference may be encountered and the user should take whatever steps are necessary to eliminate or reduce the source of the interference. Diminished performance may lengthen operating time for anesthetized patient.
W8 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 Guide.
W9 Portable and mobile RF communications equipment can affect Medical Electrical Equipment.
W10 Do not operate the IPC POWEREASE system in the presence of Magnetic Resonance Imaging devices.
W11 Use of accessories and cables other than those specified and sold by Medtronic may result in increased emissions and decreased immunity of this unit.
W12 The IPC system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the IPC system should be observed to verify normal operation in the configuration in which it will be used.
W13 Do not attempt to run the IPC POWEREASE system handpiece immediately after autoclaving. Allow an adequate "cool down" period (Typically 1 hour).
W14 Consult the Legend Bone Mill product insert before use with the Integrated Power Console system.
W15 For metal transection, observe the following safety precautions:
W15a Eye wear protection is essential.
W15b Irrigate well to cool the cutting surfaces.
W15c Protect the wound site from metal debris.
W15d Use a clamp or grasping device to control loose fragments during transection of any metal component.
W16 Do not operate the IPC POWEREASE system without eye protection.
W17 All service must be performed by Medtronic qualified personnel only.
W18 Repair and/or modification to the IPC system by anyone other than qualified service personnel may significantly compromise the unit's ability to perform effectively and/or void the equipment warranty.
Component Warnings
W19 Do not use any parts other than Medtronic system components as damage or substandard performance could result.
W20 Always inspect the components before and after use for any damage. If damage is observed, do not use damaged part until it is repaired or replaced. Damaged parts may deposit metal shavings on surgical site.
W21 When precise location of blade tip is required, engage the rotation lock on the handpiece, then calibrate and verify the blade tip on Image Guided Surgery (IGS) system. Always lock M4 handpiece when driving non-rotatable blades to maintain their IGS calibration.
W22 Employ visualization, including use of imaging techniques (e.g., fluoroscopy, image guided surgery) when using rotating powered accessories. Discontinue powered application in the event of lack of visualization of surgical site.
W23 Midas Rex Variable Exposure attachments. Surgeons should familiarize themselves with the performance of dissecting tools before use, and should explore the effect of various levels of tool exposure on dissection stability. If the tool exhibits excessive chatter, vibration, or movement, decrease the tool exposure.
W24 Motors and attachments may fail due to extended use and allow a component to detach and fall from the motor or attachment, causing patient injury.
W25 Electrical contacts must be dry prior to use.
W26 Heavy side loads and/or long operating periods may cause the device to overheat.
W27 Do not use an overheated device, as it may cause thermal injury to the patient or operator.
W28 Use adequate irrigation. The use of a tool without irrigation may cause an inordinate amount of heat buildup resulting in a thermal injury to tissue. Depending on the amount of irrigation used, the drill bits and saw blades can achieve temperatures in excess of 50°C.
W29 Do not attempt to change a dissecting tool, saw blade, or attachment while the motor is running, or when the motor or attachment is in an overheated state.
W30 Do not immerse the system components, except as noted.
W31 Do not place motor, attachment and tool on the patient or in an unsecured location during surgery.
W32 A system that is not functioning properly should not be used until all necessary repairs have been made and the unit is tested to ensure that it is functioning in accordance with Medtronic specifications.
W33 Match the nomenclature and color code on the tool packaging to the same nomenclature and color code on the Attachment.
W34 Make sure that the attachment is still in the locked position after each adjustment of the tool exposure, as attempting to increase the tool exposure too far, may result in the attachment accidentally being unlocked.
W35 Midas Rex Legend EHS Motor and Midas Rex Legend EHS Stylus Motor should only be operated when the attachment is in the locked position. Attempting to operate the Midas Rex Legend EHS Stylus Motor when the attachment is in the unlocked position may result in the motor stalling.
W36 Smoke and/or excessive heat may be generated if attachment is not in the fully locked position. This may result in thermal injury to the surgeon or staff.
W37 The Indigo and Legend EHS motors will not run properly unless the attachment is in the locked position.
W38 DO NOT change accessory with handpiece running to prevent laceration of user and cross-contamination through compromised glove.
W39 Remove Legend Footed Attachments cautiously and slowly as per instructions to avoid injury to the operator.
W40 DO NOT modify accessories used with the handpiece. Performance could be diminished with modified accessories.
W41 The safe use of the Endo-Scrub 2 System in procedures where surgical lasers are also employed has not been clinically demonstrated.
W42 In order to ensure compliance with requirements of IEC 60601-1, use a Medtronic approved power cable.
W43 To avoid the risk of electric shock, this equipment must only be connected to a supply main with protective earth.
W44 Keep NIM Muting Probe cable away from IPC system cables.
W45 Verify reusable device was sterilized prior to use. If not sterilized, do not use.
Disposable Warnings
W46 Tools are available for resection of soft tissue and bone for surgical procedures. Use of tools depends on the intended application and patient needs. Sharp-cutting powered tools induce bleeding and removal of significant tissue and bone.
W47 Use methods at the operative site to control bleeding that do not compromise patient safety during at-risk surgery.
W48 Always keep the cutting area of the tool/saw blade away from fingers and loose clothing. Prevent laceration of user and cross-contamination through compromised glove.
W49 Operate the tool only after the appropriate anatomical landmarks and the intended surgical site have been confirmed.
W50 Use care in application of the moving cutting end to only appropriate anatomical landmarks and the intended surgical site when using powered accessories.
W51 Insertion of metal objects in accessory tip may cause the accessory to break leaving fragments in the wound. The fragments may be difficult to remove, causing irritation, inflammation and foreign-body response at surgical site.
W52 Bending or prying may break the accessory, causing harm to patient or staff.
W53 Do not use excessive force to pry or push bone with the attachment, tool or blade during dissection.
W54 A tool's size and geometry may create excessive vibration at certain speeds. Increase or decrease speed on console. Change to a new tool to prevent unintended tissue removal from patient.
W55 Test for wobble at desired speed prior to use. Discontinue use of accessory if tip begins to wobble and replace accessory to prevent unintended tissue removal from patient.
W56 Eccentricity of the tool can cause tool vibration and may result in excess tissue and bone destruction and hearing damage.
W57 Excessive noise from the tool when drilling close to the cochlea or ossicular chain may cause hearing damage.
W58 CONSULT the cranial perforator device labeling for the recommended speed specifications.
W59 Tools with "L" identification are longer tools intended for light bone dissection. The increased tool head/stem configuration may affect dissection stability.
W60 Tool flutes and blade teeth are sharp and may perforate surgical gloves. Tools/blades may be grasped with a hemostat to aid in installation and removal.
W61 DO NOT attempt to resharpen used tools. Worn tools should be replaced with new ones frequently to ensure effective cutting and control.
W62 Carefully inspect tool both prior to and following each use for signs of excessive wear, fragmentation, eccentricities or other defects. Replace any suspicious tools with a new one prior to use.
W63 Excessive pressure applied to bur may cause bur fracture. Should a tool fracture in use, extreme care must be exercised to ensure that all fragments of the tool are retrieved and removed from the patient. Unremoved tool fragments may cause tissue damage to the patient.
W64 Do not use metal-cutting tools on bone.
W65 Use only rotary tools specifically designed for use with this drill system.
W66 When using non-rotatable tools, ensure rotation lock is engaged to prevent inadvertent rotation.
W67 The use of powered reciprocating instruments may result in vibration / related injury.
W68 Powered blades should be operated in the oscillate mode only. Operating in the forward mode may cause damage to the blade.
W69 Do not attempt to sterilize disposable devices. The disposables are packed sterile and are not intended for repeat use. To prevent contamination, use only once.
W70 Any tubing or other tip protectors used during shipping must be removed prior to cleaning and sterilization.
W71 Do not use accessory if package is opened or damaged. Broken seal offers no protection against cross-contamination.
W72 Properly dispose of single-use devices removed from sterile packages. Devices lose sterility upon removal from packaging.
W73 Do not use dull, damaged or bent tools. Use of dull tools can reduce handpiece effectiveness and cause the handpiece temperature to increase.
W74 T&A Blades: Gently remove the inner tube from the outer tube. The inner tube may elongate upon removal from the outer tube. If this occurs, the inner tube may not lock properly into the handpiece or the blade may not work properly.
W75 T&A Blades: Rotate the inner tube when removing and inserting it in the outer tubes to prevent damage to the internal seal. If the seal is damaged, the blade will leak at the handpiece.
W76 Always ensure that the drill is securely engaged into the handpiece prior to operating the system.
W77 Always examine operation of each tool in a handpiece before use.
W78 Powered burs and drills should be operated in the forward mode only.
W79 This system requires insulated connectors for the StraightShot M4 Microdebrider, StraightShot Magnum II Microdebrider, StraightShot III Microdebrider, Midas Rex SC1, Visao, or Skeeter handpieces and the Multi-Function Foot Control Unit.
W80 Sterilize and dry reusable device before storing the system. Decrease likelihood of cross-contamination with timely sterilization.
W81 After each procedure, properly clean all reusable system components.
W82 Auxiliary Power Outlet with protective cover is for use with the Hydrodebrider or Bone Mill consoles only.
W83 Place Stylus Touch in safe mode while not in use.
W84 Do not place Stylus Touch handpiece in the proximity of magnetic field, such as magnetic drape and MRI equipment, to avoid inadvertent handpiece activation.
W85 Do not apply excessive side loading. Excessive side loading could cause angled attachments to unlock accidentally from motor.
Triton Handpieces for Cranial, Spinal, and Orthopaedic Surgery

Triton Handpieces for cranial, spinal, and orthopaedic surgery

Triton Handpieces

The Triton® Powered Surgical Instrument System is available as an electric handpiece powered by the IPC® System or as pneumatic handpieces. All Triton attachments and disposables are compatible with both electric and pneumatic handpieces.

Triton Electric Handpiece

Triton Pneumatic Handpieces

See our Product Catalog for more about our electric and pneumatic handpieces.