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NIM

Nerve Monitoring Systems

Indications, Safety, and Warnings

NIM 3.0 Nerve Monitors

Indications for Use

The NIM^® 3.0 is intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots. The APS^® electrode is an accessory intended for providing automatic periodic stimulation to nerves when used with the Medtronic Nerve Monitoring Systems.

Indications for NIM 3.0 EMG Monitoring Procedures include:

Intracranial, Extracranial, Intratemporal, Extratemporal, Neck Dissections, Thoracic Surgeries, and Upper and Lower Extremities

Contraindications

The NIM 3.0 is contraindicated for use with paralyzing anesthetic agents that will significantly reduce, if not completely eliminate, EMG responses to direct or passive nerve stimulation.

Warnings and Precautions

It is important that the NIM-Neuro 3.0 and NIM-Response 3.0 intended operators be familiar with the User's Guide: its Warnings, Precautions, procedures, and safety issues. Disregarding the information on safety is considered abnormal use.

Warnings

System Warnings

W1	After each procedure, properly clean and disinfect all reusable system components.
W2	To avoid the risk of fire or explosion, do not use the NIM System in the presence of flammable anesthetics and/or oxygen rich environment.
W3	Disconnect power to the NIM-Neuro^®/Response^® 3.0 Console before cleaning the unit to avoid electrical macro shock.
W4	Achieve electrical grounding reliability with proper connections. Connect the NIM-Neuro/Response 3.0 Console to hospital grade receptacles only
W5	DO NOT use any parts other than Medtronic Xomed, Inc. components as damage or substandard performance could result.
W6	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
W7	It is important that the NIM-Neuro^®/Response^® 3.0 operator be familiar with this manual, its precautions, procedures and safety issues
W8	To avoid electrical shock, do not attach unapproved components or accessories to the NIM System.
W9	All service must be performed by Medtronic qualified personnel only.
W10	To avoid patient burns: a. Do not activate the electrosurgical instruments while stimulator is in contact with tissue. b. Do not leave stimulating electrodes or probes in surgical field. c. Do not store stimulating electrodes or probes in electrosurgical instrument holder. d. Do not allow a second surgeon to use electrosurgical instruments while stimulator is in use.
W11	Direct stimulator contact may disrupt the operation of active implanted devices. Consult medical specialist before use.
W12	Electrocardiogram monitoring artifacts may be caused by NIM stimulus current delivery or EMG electrode impedance monitoring.
W13	Use of unapproved stimulators, stimulus probes, stimulus dissection instruments or electrodes may result in compromised NIM operation, such as, but not limited to decreased accuracy
W14	Repair and/or modification to the NIM or any accessory by anyone other than qualified service personnel may significantly compromise the unit’s ability to monitor nerve activity and/or void the equipment warranty
W15	The NIM does not prevent the surgical severing of nerves. If monitoring is compromised, the surgical practitioner must rely on alternate methods, or surgical skills, experience, and anatomical knowledge to prevent damage to nerves.
W16	If paralyzing anesthetic agents have been used, patient must regain muscle activity prior to use of the NIM-Neuro/Response 3.0 EMG Monitor.
W17	To avoid the risk of infection while using the NIM Stylus, the user must maintain good sterility practices.
W18	False negative responses (failure to locate nerve) may result from: a. Shorted EMG electrode or cabling (conductive parts of applied needle electrodes or cables contacting each other). b. Patient Interface fuse blown (32 mA, 250V. Xomed Part No.: 8250615). c. Patient Interface defective. d. Inadequate stimulus current. e. Inadequate current for stimulation of nerve through hardware, such as stimulus dissection instruments, may vary based on the physical size, shape characteristics, and design of the hardware and proximity to the nerve. f. Inadvertent simultaneous current delivery from both Stimulator (Patient Interface) probe outputs. This may result in current shunting, division between the stimulator probes. g. Shorted internal amplifier (characterized by baseline activity of < 3 μV p-p).
W19	Stimulator current may cause involuntary patient movement resulting in patient injury.
W20	Anesthetic agents used may have an effect on the EMG amplitude.
W21	Be careful not to damage vascular structures when preparing the nerve for the installation of the APS Electrode
W22	EMG amplitude may be affected by anesthesia regimen used. Consult anesthesiologist if EMG changes are observed.
W23	Electrode integrity should be checked after electrode insertion and before electrode removal to give additional assurance that electrode continuity was maintained throughout the entire procedure. If electrode impedance is very high, discontinue use and replace.
W24	Remove APS electrode from patient prior to using external defibrillator to prevent thermal injury to patient at APS electrode site.
W25	Avoid trans-thoracic stimulation; when possible, maintain anode and cathode stimulating sites in close proximity.
W26	Operation in close proximity to a shortwave or microwave therapy equipment may produce instability in the electrical stimulator output.
W27	Safe stimulus levels are dependent on various conditions including but not limited to: type of excitable tissue, Charge Per Pulse, and Charge Per Unit Area. Waveform morphology, repetition rate, and stimulator effective surface area must be considered. Special operator attention is required for stimulus levels which exceed default settings or conditions resulting in levels higher than 2 mA RMS/cm2.

Precautions

P1. Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the User's Guide.

P2. Portable and mobile RF communications equipment can affect medical electrical equipment.

P3. Use of accessories and cables other than those specified and sold by Medtronic may result in increased emissions and decreased immunity of this unit.

P4. The NIM-Neuro/Response 3.0 should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the NIM-Neuro/Response 3.0 should be observed to verify normal operation in the configuration in which it will be used.

P5. Loud extraneous monitoring noise is caused by activation of electrosurgical unit. Muting Detector must be properly attached to the active electrosurgical lead.

P6. Inability to deliver stimulus current flow may be caused by inadvertent simultaneous current delivery from both STIM 1 probe outputs. This may result in current shunting, division between the stimulator probes.

P7. Avoid accidental contact between 'PATIENT APPLIED PARTS' and other conductive parts, including those connected to protective earth.

P8. The NEW Muting Probe (Ref - 8220325) is compatible with previous versions of the NIM. However, previous versions of the Muting Probe are NOT compatible with the NIM 3.0 System.

Espandi tutto

NIM 2.0 NERVE MONITORS

NIM 2.0 Nerve Monitors

Indications

This device is intended for use in surgical procedures for patient-connected intraoperative nerve monitoring, ie, assisting the surgeon in locating and mapping motor nerves through the use of electromyographic (EMG) signals and electrical stimulus of nerves. This device is indicated for locating and identifying cranial and peripheral motor nerves during surgery.

Contraindications

The use of paralyzing anesthetic agents will significantly reduce, if not completely eliminate, EMG responses to direct or passive nerve stimulation. Whenever nerve paralysis is suspected, consult an anesthesiologist.

Warnings

The NIM-Neuro™ 2.0 does not prevent the surgical severing of nerves. If monitoring is compromised, the surgical practitioner must rely on alternate methods, or surgical skills, experience, and anatomical knowledge to prevent damage to nerves.

To avoid patient burns:

W2a	Do not activate electrosurgical Instrument while the stimulator is in contact with tissue.
W2b	Do not leave stimulating electrodes or probes in surgical field.
W2c	Do not store stimulating electrodes or probes in electrosurgical Instrument holder.
W2d	Do not allow a second surgeon (ie, fat harvesting) to use electrosurgical instrument while stimulator is in use.
W2e	Special operator attention may be required for stimulus currents exceeding 2 mA RMS/cm2. The RMS value of current is generally lower than the stimulator current setting in mA. To calculate RMS current, waveform morphology, pulse width, repetition rate, and the stimulator current delivered must be considered.

While Muting is activated, auditory and visual monitoring are disabled.

To avoid false negative responses, verify stimulator current setting is high enough, and verify stimulus delivery by tone, voice, or display. Low stimulator current may cause a false negative response.

High stimulator current may cause involuntary patient movement resulting in patient injury.

High stimulator current activating of the fifth cranial nerve or Mastication muscles may cause tongue lacerations.

False negative responses (failure to locate nerve) may result from:

W7a	Shorted EMG electrode or cabling (conductive parts of applied needle electrodes or cables contacting each other).
W7b	Patient Interface fuse blown (32 mA, 250V. Xomed Part No.: 8250615).
W7c	Patient Interface defective.
W7d	Inadequate stimulus current.
W7e	Inadequate current for stimulation of nerve through hardware, such as stimulus dissection instruments, may vary based on the physical size, shape characteristics, and design of the hardware and proximity to the nerve.
W7f	Neuromuscular fatigue from prolonged or repeated exposure to electrical stimuli.
W7g	Inadvertent simultaneous current delivery from both Stimulator (Patient Interface) probe outputs. This may result in current shunting, division between the stimulator probes.
W7h	Shorted internal amplifier (characterized by baseline activity of < 3 μV p-p).

Do not power-on the NIM-Neuro 2.0 when the stimulator is in the surgical field.

To avoid eye injury during electrode placement, the electrode needles should be directed away from the globe and adequately secured with tape.

W10

To avoid the risk of fire or explosion, do not use the NIM-Neuro 2.0 in the presence of flammable anesthetics and/or oxygen rich environments.

W11

To avoid electrical shock, do not attach unapproved components or accessories to the NIM.

W12

To avoid the risk of infection while using the NIM-Neuro 2.0 touchscreen stylus, the user must maintain good sterility practices.

W13

Electrocardiogram monitoring artifacts may be caused by NIM-Neuro 2.0 stimulus current delivery or EMG electrode impedance monitoring.

W14

Direct stimulator contact may disrupt the operation of active implanted devices.

W15

While stimulating, it is recommended to use only approved EMG monitor(s) equipped with active audio and/or visual current delivered feedback systems to ensure delivery of current to intended tissues.

W16

Proper handling, insertion, and placement of electrodes and probes is critical for safe and accurate EMG monitoring:

W16a	Improperly placed or bent needles increase the risk of needle breaking off in the patient.
W16b	Do not attempt to straighten bent needles because this may cause stress and weaken device, causing needle to break off in patient.
W16c	Extreme care must be taken when handling instruments with sharp points or edges.

W17

The surgical practitioner must choose the appropriate size electrodes and probes based on the procedure to be performed and the stimulating current necessary for the application.

W18

Avoid trans-thoracic stimulation; when possible, maintain anode and cathode stimulating sites in close proximity.

W19

Reuse of single use electrodes and probes increase the risk of infection and may cause degraded or ineffective monitoring.

Precautions

Special care must be exercised to distinguish between the high-pitched beep of the Event Tones (EMG activity over threshold), and the Stimulus Warble Tone (indicates the set current is being delivered).

When the “Bleedle Alarm” (BLEE-dle-DEET) sounds, the cause must be identified and eliminated immediately.

To avoid loud, extraneous monitoring noise during electrosurgical unit activation, ensure the Muting Probe is properly attached to the active electrosurgical lead.

Inadequate stimulus current flow may be caused by non-flush contact between the stimulating electrode or probe and the nerve, inadequate stimulator probe electrical contact surface area, or high impedance.

Inability to deliver stimulus current flow may be caused by:

P5a	Stimulator return electrode not connected, or other incomplete electrical connection between the NIM-Neuro 2.0, monitoring electrode and stimulator probe.
P5b	STIM 1 (EMG) Patient Interface fuse blown (32 mA, 250 V, REF 8250615).
P5c	Stimulus set to 0.00 mA.
P5d	Defective stimulating electrode or probe.

To avoid false positive EMG events (stimulus artifacts):

P6a	Ensure the recording electrodes and the stimulator (+) or (-) cabling are routed separately and not tangled.
P6b	Ensure EMG ground (green wire) is physically placed between the stimulator return electrode (white wire with red plug) and the EMG channel input electrodes.

Proper placement and setup of the electrosurgical unit away from the NIM-Neuro 2.0 will reduce or minimize unnecessary muting, interference, and offsets.

Use of unapproved stimulators, stimulus probes, stimulus-dissection instruments or electrodes may result in compromised NIM-Neuro 2.0 operation, such as, but not limited to, decreased accuracy.

Electrode integrity should be checked (on the “electrodes” screen) after electrode insertion and before electrode removal to give additional assurance that electrode continuity was maintained throughout the entire procedure. If electrode impedance is very high, discontinue use and replace.

P10

The Patient Interface cable, and Muting Probe cable should be secured to the floor with tape or other nontrip device.

P11

Excessive or insufficient muting may result from improper muting gain. For excessive muting, move the Muting Probe to a Lower jack number. For insufficient muting, move the Muting Probe to Higher jack number. Standard position is number 3.

P12

To avoid excessive muting:

P12a	Do not place the NIM-Neuro 2.0 in close proximity to the electrosurgical unit.
P12b	Do not place Patient Interface or electrode wires in close proximity to the electrosurgical unit or electrosurgical unit wires.
P12c	Avoid high-power electrosurgical unit monopolar settings. Note that muting caused by electrode charging may last several seconds after electrosurgical Instrument use.
P12d	Be aware of external sources that may induce muting including cellular phones, diathermy, electrocautery used in adjacent operating rooms, or other sources of electromagnetic interference.

P13

Avoid accidental contact between connected but unapplied electrodes and other conductive parts.

P14

Contaminated single use electrodes and probes must be disposed of in an appropriate sharps biohazard container in accordance with hospital or other user facilities policy.

P15

For extra-ocular monitoring, it is recommended that electrode placement be done under the direction of a neurologist or ophthalmologist.

P16

The Patient Interface safety fuse used in all NIM Patient Interfaces Boxes for the Stimulator Output are specifically tested for ECU protection. Use Xomed 11270048 Fuse, 5 x20mm, 32mA, 250 V. Order 8250615 Fuse Kit for replacements.

Additional Precautions

AP1	To avoid system damage, do not connect any device other than NIM-Neuro 2.0 Muting Probes into any of the four muting probe inputs on the rear panel of the NIM-Neuro 2.0.
AP2	Disconnect the power of the NIM-Neuro 2.0 or a connected printer before cleaning. To prevent cleaning solutions from seeping into the electronic portions of the instrument, spray cleaner lightly on a cotton cloth, then wipe the instrument with the cloth. Be especially careful around the controls, connectors and panel edges. Do not use abrasive cleaners (especially on the touch screen).
AP3	Repair and/or modification to the NIM-Neuro 2.0, or any accessory by anyone other than qualified service personnel may significantly compromise the units ability to monitor nerve activity and/or void the equipment warranty. For best performance, it is recommended that all service be performed by Medtronic Xomed service personnel. The Manufacturing Test is not intended for end users and is to be used only under the direct supervision of Medtronic Xomed Personnel (see section 7.13).
AP4	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.
AP5	Portable and mobile RF communications equipment can affect Medical Electrical Equipment.
AP6	Use of accessories and cables other than those specified and sold by Medtronic Xomed may result in increased emissions and decreased immunity of this unit.
AP7	The NIM-Neuro 2.0 should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the NIM-Neuro 2.0 should be observed to verify normal operation in the configuration in which it will be used.

NIM TRIVANTAGE EMG ENDOTRACHEAL TUBE

NIM TriVantage EMG Endotracheal Tube

Intended Use

The NIM TriVantage™ EMG Endotracheal Tube is intended for use as a means of providing both an open airway for patient ventilation and for intraoperative monitoring of EMG activity of the laryngeal musculature when connected to an appropriate EMG monitor.

Indications for Use

The NIM TriVantage EMG Endotracheal Tube is indicated for use where continuous monitoring of the nerves supplying the laryngeal musculature is required during surgical procedures.

Contraindications

The NIM TriVantage EMG Endotracheal Tube is not intended for postoperative use. The NIM TriVantage EMG Endotracheal Tube should be removed and replaced with a standard endotracheal tube if ventilation is required beyond the surgical procedure.
The use of paralyzing agents will significantly reduce, if not completely eliminate EMG responses to direct or passive neural stimulation.
The NIM TriVantage EMG Endotracheal Tube is not intended for use in infant and neonatal patients.
Do not use the NIM TriVantage EMG Endotracheal Tube in surgical procedures with flammable gases or high temperature generating devices, such as surgical lasers or cauteries inside the airway, to avoid combustion.

Warnings

Do not use local anesthetic gels or creams to lubricate the tube or apply topical anesthetic sprays on the vocal cords. The use of neuromuscular blocking agents will significantly reduce, if not completely eliminate, EMG responses to direct or passive neural stimulation. Whenever nerve paralysis is suspected, consult the anesthesiologist.
Do not attempt to use a NIM TriVantage EMG Endotracheal Tube without first performing a cuff inflation test. Inflate the cuff with air and visually inspect the cuff for any abnormality. Replace with another NIM TriVantage EMG Endotracheal Tube if any adverse abnormality is found.
Failure to use a NIM stimulating device may result in not identifying the location or detecting injury to the nerve. During EMG monitoring only (passive monitoring), neuromuscular tissue may not elicit a response from sharp dissection or all types of manipulation. Use the stimulating device to confirm location and integrity of the nerve.
Avoid false negative responses (failure to evoke a nerve response), which may be caused by:
- Neuromuscular fatigue from prolonged or repeated exposure to electrical stimuli.
- Deep anesthesia, which may suppress neuroelectrical activity of the recurrent laryngeal nerve.
- Insufficient contact between the electrodes and vocal cords due to misplacement or using a tube size that is too small.
- Displacement during the procedure when rotating, flexing, or extending the patient’s head and neck.
Do not use a NIM TriVantage EMG Endotracheal Tube with a high electrode impedance. This may be due to inadequate electrode continuity. Replace with another NIM TriVantage EMG Endotracheal Tube.
Cuff deflation or diffusion of a gas or gas mixture (nitrous oxide, oxygen, air) might result in cuff pressure and volume variation. Monitor the cuff pressure during the procedure.
Do not over-inflate the cuff. Over-inflation may cause cuff deformation, deflation, or rupture resulting in tube blockage and/ or tracheal damage.
Avoid damage to the trachea, larynx, or vocal cords during insertion by inspecting the tube, cuff, and monitoring connections for damage, which may occur if the cuff is over-inflated during set-up testing.
Do not attempt to manipulate a NIM TriVantage EMG Endotracheal Tube with an inflated cuff after insertion. Manipulating a tube with an inflated cuff may cause partial airway blockage at the tip and/or murphy eye, cuff herniation, or tip deflection. Ensure that the cuff is fully deflated before any manipulation and confirm that the airway is free of any potential occlusion after repositioning.
Do not attempt to remove an inflated cuff from the trachea. This may result in cuff deformation and/or injury of the larynx or vocal cords. If resistance is encountered during removal, ensure that the cuff is fully deflated.
Avoid insertion of a suction tube or stylet in a tube that has been distorted by biting or other forces. This may further damage the tube and block the airway.
Do not attempt to straighten bent needles, which may weaken the metal. Improperly placed, weak, or bent needles increase the risk of the needle breaking off in the patient.
Do not excessively bend or flex the electrodes or the electrical integrity may be compromised. Check electrode integrity after insertion.
Avoid inadequate oxygenation and/or tracheobronchial injury, which may be caused by:
- Excessively bending the tube, causing it to kink, or retracting the tube, which may cause it to crush.
- Placement in the right main bronchus (deep intubation) by confirming the correct positioning after intubation.
- A collapsed or blocked tube after performing a test inflation, by inspecting the inner diameter of the tube for patency after test inflation.
Failure to use a bite block may result in patient injury or damage to the tube. The use of a bite block is essential during transcranial motor-evoked potentials (TcMEP) procedures.
To avoid disrupted air supply, confirm, monitor, and maintain anesthesia gas delivery systems and connections at all times.
Do not perform magnetic resonance imaging (MRI) on a patient with a NIM TriVantage EMG Endotracheal Tube in place.
Do not activate the electrosurgical instruments while the stimulator is in contact with tissue or in the surgical field to avoid patient burns.
Do not connect electrode leads to any other types of equipment or connections than EMG recording/monitoring equipment or electrical shock to the patient or user may occur.
Avoid delivery of current to unintended tissues by using an EMG monitor equipped with active audio and/or visual feedback systems for stimulating.
Do not use if sterile package has been opened or is damaged.
Do not attempt to re-sterilize or reuse single use disposable devices. Re-sterilization or reuse may result in device damage and patient injury.
Avoid injury by disposing of the devices in an appropriate sharps biohazard container.
Avoid injury by using extreme care when handling and cleaning instruments with sharp points or edges.

Precautions

It is strongly recommended that the clinician(s) have a thorough understanding of and experience with intraoperative EMG monitoring prior to using the NIM TriVantage EMG Endotracheal Tube in a surgical procedure. This device is not intended to replace the surgeon’s medical judgment or knowledge of neural anatomy and physiology. It is intended to provide the surgeon with an additional tool with which to make better-informed decisions regarding the surgical procedure.
It is strongly recommended that the surgeon consult with the attending licensed medical practitioner who will be administering anesthesia prior to the use of EMG monitoring to review EMG monitoring techniques, goals, and the effects of the administration of anesthesia on neuromuscular activity.
A patient with an implanted electronic device should not be subjected to electrical stimulation unless specialist medical opinion has first been evaluated.
Proper sizing, intubation, and extubation should be in accordance with accepted medical techniques and expert clinical judgment. A tube that is one size larger than standard selection is recommended whenever possible to improve electrode contact with vocal cords. The proper size tube for the patient should be determined prior to intubation by the anesthesia provider and/or surgeon.
For safe and accurate EMG monitoring, proper handling, insertion, and placement of electrodes and probes is critical. Review the appropriate user’s guide for the monitor being used for the procedure.

Sterility

The needle electrodes are provided sterile and are intended for single patient use only.
Do not resterilize this product. Medtronic assumes no liability for products that have been resterilized.

NIM EMG ELECTRODES AND PROBES (GENERAL)

NIM APS ELECTRODE

NIM APS Electrode

Indications

The electrodes are indicated for intraoperative motor nerve location.

Contraindications

The use of paralyzing anesthetic agents will significantly reduce, if not completely eliminate, EMG responses to direct or passive neural stimulation. Whenever nerve paralysis is suspected, consult anesthesiologist.

Warnings

While stimulating, it is recommended to use only approved EMG monitor(s) equipped with active audio and/or visual feedback systems to ensure delivery of current to intended tissues.

Electrode integrity should be checked (by pressing electrodes check on the NIM^® system) after electrode insertion and before electrode removal to give additional assurance that electrode continuity was maintained throughout the entire procedure. If electrode impedance is very high, discontinue use and replace.

Reuse of single use electrodes and probes increase the risk of infection and may cause degraded or ineffective monitoring.

False negative responses (failure to locate nerve) may result from neuromuscular

fatigue from prolonged or repeated exposure to electrical stimuli.

Proper handling, insertion and placement of electrodes and probes is critical for safe and accurate EMG Monitoring.

Improperly placed or bent needles increase the risk of the needle breaking off in the patient.

Do not attempt to straighten bent needles, this can weaken the metal, causing the needle to break off in the patient.

Extreme care must be taken when handling and cleaning instruments with sharp

points or edges.

To avoid eye injury during electrode placement, the electrode needles should be

directed away from the globe and adequately secured with tape.

To avoid patient burns: Do not activate the electrosurgical instruments while stimulator is in contact with tissue, Do not leave stimulating electrodes or probes in surgical field, Do not store stimulating electrodes or probes in electrosurgical instrument holder, Do not allow a second surgeon to use electrosurgical instrument while stimulator is in use.

Electrode leads must be connected only to EMG recording/monitoring equipment. Electrical shock resulting in patient injury may result if the leads are connected to other types of equipment or connections.

NIM INCREMENTING PROBE

NIM Incrementing Probe

Indications

This device is intended for use in surgical procedures for patient-connected intraoperative nerve monitoring, i.e. assisting the surgeon in locating and mapping motor nerves through the use of electromyographic (EMG) signals and electrical stimulus of nerves.This device is indicated for locating and identifying cranial and peripheral motor nerves during surgery.

Contraindications

Warnings

Electrode integrity should be checked (by pressing electrodes check on the console) aft er electrode insertion and before electrode removal to give additional assurance that electrode continuity was maintained throughout the entire procedure. If electrode impedance is very high, discontinue use and replace. Reuse of single use electrodes and probes increase the risk of infection and may cause degraded or ineffective monitoring.

False negative responses (failure to locate nerve) may result from neuromuscular fatigue from prolonged or repeated exposure to electrical stimuli.

Proper handling, insertion, and placement of electrodes and probes is critical for safe and accurate EMG monitoring:

Improperly placed or bent needles increase the risk of needle breaking off in the patient.

Do not attempt to straighten bent needles because this may cause stress and weaken device, causing needle to break off in patient.

Extreme care must be taken when handling and cleaning instruments with sharp points or edges.

To avoid patient burns:

Do not activate the electrosurgical instruments while stimulator is in contact with tissue.

Do not leave stimulating electrodes or probes in surgical field.

Do not store stimulating electrodes or probes in electrosurgical instrument holder.

Do not allow a second surgeon to use electrosurgical instrument while stimulator is in use.

STIM BUR GUARD

Stim Bur Guard

Indications

The Stim Bur Guard is indicated for nerve monitoring during the incision and removal of soft and hard tissue or bone with a standard bur / blade during otology, neurotology, sinus, laryngeal, nasopharyngeal, head and neck, general and plastic, and orthopedic surgical procedures, including spinal applications.

Contraindications

None.

Warnings

It is important that the Stim Bur Guard operator be familiar with this manual, the NIM^® 2.0 or 3.0 system manual, the bur manual, the XPS^® 3000 BF manual / IPC^® manual, their warnings, precautions, procedures and safety issues.

Four labels are used in this manual to identify important concerns, conditions, or procedures:

Warnings: Describes serious adverse reactions and potential safety hazards that can occur during the proper or improper use of a device.

Precautions: Any special care to be exercised by a practitioner or patient for the safe and effective use of the device.

Additional Precautions: Identifies conditions or practices that could result in damage to the equipment.

Note: Identifies special information or to clarify/emphasize important instructions.

Warning

This device may cause brief ECG interference. If experiencing unacceptable interference, use a NIM^® 2.0 console with software version 2.86 or higher to reduce the occurrence of interference.

Use only Medtronic NIM^® 2.0 or 3.0 with the Stim Bur Guard to ensure delivery of current to intended tissues and adequate audio/visual monitoring.

If using the Stim Bur Guard for nerve mapping, use extreme caution to prevent inadvertent nerve damage.

The clinician(s) must have a thorough understanding of and experience with intraoperative EMG Monitoring prior to using the Stim Bur Guard in a surgical procedure. This device is not intended to replace the surgeon’s medical judgment or knowledge of neural anatomy and physiology. It is intended to provide the surgeon with an additional tool with which to make better-informed decisions regarding the surgical procedure.

Avoid inadvertent activation of the handpiece while in close proximity to nerves.

Minimize guard contact with the patient during prolonged drill on-time to avoid thermal damage to surrounding tissue. The nose section of the Stim Bur Guard may become hot during prolonged on-time.

An appropriate amount of irrigation creates a moist contact point forming a meniscus about the bur head without covering more than 1/2 of the bur head. This moist contact point creates a low resistance connection to the patient while preventing thermal injury to the tissue. Excessive irrigation may prevent adequate current delivery to the tissue due to current shunting.

INTEGRATED POWER CONSOLE (IPC SYSTEM)

Integrated Power Console (IPC System)

Indications

The IPC^® System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and bone, in Head & Neck / ENT (Otologic, Neurologic, Neurotologic, Sinus, Rhinologic, Nasopharyngeal / Laryngeal), Oral / Maxillofacial, and Plastic / Reconstructive / Aesthetic, surgical procedures.

Contraindications

None.

Warnings

System Warnings

W1	It is important that the IPC^® operator be familiar with the system User’s Guide, its precautions, procedures and safety issues.
W2	Do not use the IPC 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™ before cleaning the unit to avoid electrical macro shock.
W5	Do not attach unapproved components to the IPC to avoid electrical macro shock.
W6	To avoid the risk of electrical shock, achieve electrical grounding reliability with proper connections. Connect the IPC 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 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 should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the IPC should be observed to verify normal operation in the configuration in which it will be used.
W13	Do not attempt to run the IPC™ 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.
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 System without eye protection.
W17	All service must be performed by Medtronic qualified personnel only.
W18	Repair and/or modification to the IPC 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 and M5 handpieces 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 can achieve temperatures in excess of 50° C.
W29	Do not attempt to change a dissecting tool 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.
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.
W36	Smoke may be generated if attachment is not in the locked position.
W37	The 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.

Disposable Warnings

W45	Verify reusable device was sterilized prior to use. If not sterilized, do not use.
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 tip of the tool 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 or tool 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 are sharp and may perforate surgical gloves. Tools 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 and M5 Microdebriders, 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.

MIDAS REX LEGEND EHS STYLUS HIGH-SPEED SURGICAL DRILL

Midas Rex Legend EHS Stylus High-Speed Surgical Drill

The Midas Rex^® Legend EHS Stylus^® Surgical Drill is part of the Midas Rex Legend EHS – Electric High Speed – System (Legend EHS System) and the Integrated Power Console (IPC^® System).

Indications

Legend EHS System:

The Midas Rex Legend EHS – Electric High Speed System is intended for use in surgical procedures for the following medical applications:

Neurosurgical
Spine
Orthopaedic surgery
General surgery
ENT
Maxillofacial
Craniofacial

Contraindications

Legend EHS System:

None.

Warnings

Legend EHS System:

DO NOT interchange components of the Legend EHS System with components from the Midas Rex Classic Motor System, the Midas Rex III Motor System or the Mednext^® Bone Dissecting System and their associated attachments and dissecting tools.

DO NOT operate the Legend EHS System in a Magnetic Resonance Imaging Suite.

DO NOT use Legend EHS Motors or Legend Attachments before following proper cleaning and sterilization protocols.

DO NOT dissect bone without adequate irrigation to prevent thermal necrosis.

DO NOT operate the Legend EHS Motors without protective eyewear.

DO NOT attempt to run the Legend EHS motors immediately after autoclaving. Allow an adequate 'cool down' period (Typically 1 hour).

DO NOT use the Legend EHS System in the presence of flammable anesthetics.

DO NOT use Legend EHS System components if damage is apparent or if components do not run properly. The Legend EHS System must be inspected for damage prior to each use.

Conduct a visual inspection of the cables for cracks, tears or corrosion.
Check attachments for proper appearance. Install attachment and dissecting tool, then briefly run motor.
Check motor for overheating.
Check attachment for overheating.
Check dissecting tool for flail.
Check for bent or missing pins in cable connectors

DO NOT attempt to use an overheating motor or attachment.

Consult the Legend Bone Mill product insert before use with the Legend EHS System.

For metal transection, observe the following safety precautions:

Protective eyewear is essential.
Irrigate copiously to cool the cutting surfaces.
Protect the wound site from metal debris.
Use a clamp or grasping device to control loose fragments during transection of any metal component.

Legend EHS Motors or Legend Attachments which fail due to extended use may as a result of such failing allow a component to detach and fall from the motor or attachment and may cause patient injury.

Electrical contacts must be properly dried prior to use.

DO NOT attempt to change a dissecting tool or attachment while the motor is running, or when the motor or attachment is in an overheated state.

DO NOT use a Legend EHS System if the motor continues to run after releasing the foot pedal. If a Legend EHS System requires servicing or refurbishing, return system to Medtronic Powered Surgical Solutions.

DO NOT immerse the Legend EHS System Motor or Cables.

DO NOT place motor, attachment and dissecting tool on the patient or in an unsecured location during surgery.

DO NOT open or disassemble the console. There are no user serviceable parts inside. Refer all servicing to Medtronic Powered Surgical Solutions.

DO NOT immerse the console.

DO NOT sterilize.

DO NOT connect any cables or equipment to the console unless the cables and equipment are approved for use by Medtronic Powered Surgical Solutions as documented in the appropriate Instructions for Use and Classified by UL for use with this system.

DO NOT use a dissecting tool without the appropriate attachment as injury may occur to the patient and/or operator.

DO NOT use a Legend Attachment if any part of the attachment appears to be bent, loose, missing or damaged. If a Legend Attachment requires servicing or refurbishing, return attachment to Medtronic Powered Surgical Solutions.

DO NOT force or modify any attachment or dissecting tool to fit a Legend EHS or Stylus Motor.

Consult the Legend Bone Mill product insert before use with the Legend EHS System.

Heavy side loads and/or long operating periods may cause overheating of the attachment to the point where the attachment is uncomfortable to hold.

Never place an overheated attachment on the patient or patient draping during surgery.
Mitigate the overheating by discontinuing use and rest the attachment by using intermittently, or wrap the attachment interface with a moist sterile towel.
If the attachment is passed off, the receiver of the attachment must handle the attachment cautiously.

Remove Legend Footed Attachments cautiously and slowly as per instructions to avoid injury to the operator.

DO NOT use a dissecting tool without the appropriate attachment as injury may occur to patient, operator and/or operating room staff.

DO NOT use excessive pressure, such as bending or prying, on attachments or dissecting tools. This may cause tool to bend or break and cause injury to patient, operator and/or operating room staff.

DO NOT use an attachment and dissecting tool combination if flail or vibration occurs.

DO NOT use metal cutting dissecting tools on bone.

DO NOT use a twist drill or contra-angle dissecting tool at an operating speed over 62,000 rpm.

DO NOT use a dissecting tool if the sterile packaging is damaged.

If a dissecting tool package is opened, but the tool is not used or contaminated, the tool can be re-sterilized. Remove tool from original packaging and place into an approved autoclave package. Steam sterilize as follows:

High Vacuum Steam 270°F (132°C) for 5 minutes
Gravity Displacement 270°F (132°C) for 15 minutes

The re-sterilized tool must be used promptly following re-sterilization. If rust or corrosion is encountered after re-sterilization, do not use the re-sterilized tool.

Dissecting tool flutes are sharp and can perforate surgical gloves. Always handle with care. Do not spin, twist, or pull a tool by grasping the flutes. Gently pull on dissecting tool shaft to ensure that it is fully seated and properly installed in motor.

DO NOT use the Legend EHS foot control to operate any systems other than Legend EHS.

DO NOT open or disassemble the Foot Control. There are no user serviceable parts inside. Refer all servicing to Medtronic Powered Surgical Solutions.

DO NOT sterilize the Foot Control.

DO NOT use cables with cracks, tears or corrosion.

DO NOT use cables with bent or missing connector pins.

DO NOT kink EHS cables.

DO NOT use power cable with cracks, tears or corrosion.

DO NOT use power cable with bent or missing connector pins.

DO NOT use any other components except for Midas Rex Legend® Attachments, Legend Dissecting Tools, and Legend accessories in combination with Legend EHS Motors. Use of devices other than Legend EHS System or associated parts or components may cause injury to the patient, operator and/or operating room staff. Use of devices other than Legend EHS System or associated parts or components will damage the motor and attachments and will void manufacturer’s limited warranty.

DO NOT use any other components except for Midas Rex Legend® Attachments, Legend Dissecting Tools and Legend accessories in combination with a Legend EHS or Stylus Motor. Use of devices other than Legend EHS Systems or associated parts or components may cause injury to the patient, operator and/or operating room staff. Use of devices other than Legend EHS Systems or associated parts or components will damage the motor and attachments and will void manufacturer’s limited warranty.

DO NOT re-use or re-process a dissecting tool that has already been used. Using a dissecting tool that has already been used may cause injury to the patient, operator and/or operating room staff. Using a dissecting tool that has already been used may affect motor performance and will void manufacturer’s limited warranty.

DO NOT use an attachment and dissecting tool combination if flail or vibration occurs.

DO NOT use a twist drill or contra-angle dissecting tool at an operating speed over 62,000 rpm.

Do not soak/submerge Legend devices.

Do not use ultrasound to clean Legend devices.

Do not use chlorine based or corrosive cleaning agents such as bleach, lye, acetone, sodium hypochlorite/bleach, sodium hydroxide, formic acid, or solutions containing glutaraldehyde.

The use of a washer-disinfector for cleaning may cause a pre-mature degradation in performance.

Allow an adequate cooling period after steam sterilization.

Do not steam or EO sterilize the Legend attachment cleaning nozzle.

Do not use Pana Spray on variable exposure attachments, as it may cause the attachment to overheat.

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.

Dissecting tool size and geometry may contribute to excessive vibration at certain speeds. Increase or decrease speed by adjusting the foot/finger control, or by changing the operating pressure or console speed setting. If necessary, use a different dissecting tool.

Do not use the Variable Exposure Attachment if the TUBE adjustment ring spins freely or fails to click into place with each adjustment, as the exposure may change without warning.

Do not use the end of the tube as a depth gauge or depth stop.

DO NOT use a Legend Attachment if any part of the attachment appears to be bent, loose, missing or damaged. Excessive pressure or improper handling, such as bending or prying, with the attachment or dissecting tool may cause injury to patient, operator and/or operating room staff. If a Legend Attachment requires servicing or refurbishing, return attachment to Medtronic Powered Surgical Solutions.

Remove Legend Footed Attachments cautiously and slowly to avoid injury to the operator.

DO NOT use metal cutting dissecting tools on bone.

For metal transection, observe the following Safety Precautions:

Eyewear protection is essential.
Irrigate copiously to cool the cutting surfaces.
Protect the wound site from metal debris.
Use clamp or grasping device to control loose fragments during transection of any metal component.

Dissecting tool flutes are sharp and may perforate surgical gloves. Dissecting tools for the Telescoping Attachment may be grasped with a hemostat to aid in installation and removal.

CONSULT the cranial perforator device labeling for the recommended speed specifications.

Indications

IPC System:

Contraindications

IPC System:

None.

Warnings

IPC System:

Warnings

System Warnings

W1	It is important that the IPC operator be familiar with the system User’s Guide, its precautions, procedures and safety issues.
W2	Do not use the IPC 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 before cleaning the unit to avoid electrical macro shock.
W5	Do not attach unapproved components to the IPC to avoid electrical macro shock.
W6	To avoid the risk of electrical shock, achieve electrical grounding reliability with proper connections. Connect the IPC 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 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 should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the IPC should be observed to verify normal operation in the configuration in which it will be used.
W13	Do not attempt to run the IPC 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.
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 System without eye protection.
W17	All service must be performed by Medtronic qualified personnel only.
W18	Repair and/or modification to the IPC 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 and M5 handpieces 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 can achieve temperatures in excess of 50° C.
W29	Do not attempt to change a dissecting tool 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.
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.
W36	Smoke may be generated if attachment is not in the locked position.
W37	The 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.

Disposable Warnings

W45	Verify reusable device was sterilized prior to use. If not sterilized, do not use.
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 tip of the tool 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 or tool 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 are sharp and may perforate surgical gloves. Tools 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 and M5 Microdebriders, 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.

VISAO HIGH-SPEED OTOLOGIC DRILL

Visao High-Speed Otologic Drill

The Visao^® High-Speed Otologic Drill is part of the IPC^® System and XPS® 3000 System.

Indications

Integrated Power Console (IPC^® System):

Ear, Nose, and Throat:
The IPC^® is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and bone, in Head & Neck / ENT (Otologic, Neurologic, Neurotologic, Sinus, Rhinologic, Nasopharyngeal / Laryngeal), Oral / Maxillofacial, and Plastic / Reconstructive / Aesthetic, surgical procedures.

Neurologic Technologies:
The IPC System 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

IPC System:

None.

Warnings

IPC System:

Warnings

System Warnings

W1	It is important that the IPC^® operator be familiar with the system User’s Guide, its precautions, procedures and safety issues.
W2	Do not use the IPC 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 before cleaning the unit to avoid electrical macro shock.
W5	Do not attach unapproved components to the IPC to avoid electrical macro shock.
W6	To avoid the risk of electrical shock, achieve electrical grounding reliability with proper connections. Connect the IPC 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 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 should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the IPC should be observed to verify normal operation in the configuration in which it will be used.
W13	Do not attempt to run the IPC 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.
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 System without eye protection.
W17	All service must be performed by Medtronic qualified personnel only.
W18	Repair and/or modification to the IPC 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 and M5 handpieces 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 can achieve temperatures in excess of 50° C.
W29	Do not attempt to change a dissecting tool 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.
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.
W36	Smoke may be generated if attachment is not in the locked position.
W37	The 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.

Disposable Warnings

W45	Verify reusable device was sterilized prior to use. If not sterilized, do not use.
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 tip of the tool 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 or tool 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 are sharp and may perforate surgical gloves. Tools 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 and M5 Microdebriders, 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.

Indications

XPS 3000:

The XPS 3000 is intended for the incision and removal of soft and hard tissue or bone in general otorhinolaryngology, head and neck, and otoneurological surgery.

Otology / neurotology indications include aural atresia, cholesteatoma, cochleostomy, development of a suture tunnel for cochlear implant fixation, drainage of petrous apex cyst from endaural and middle-fossa approach, endolymphatic hydrops, extosis lesion removal, facial nerve decompression, mastoidectomy, mastoidotomy, ossicular chain reconstruction (OCR), otosclerosis, removal of ear tumors including acoustic neuroma, tympanoplasty, and vestibular neurectomy.

Sinus indications include septoplasty, removal of septal spurs, polypectomy, antrostomy, ethmoidectomy/sphenoethmoidectomy, frontal sinus trephination and irrigation, frontal sinus drill out, endoscopic DCR, trans-sphenoidal procedures, maxillary sinus polypectomy, circumferential maxillary antrostomy, choanal atresia, sphenoidotomy, and medial, lateral, and posterior frontal sinusotomy.

Nasopharyngeal / laryngeal indications include adenoidectomy, tracheal procedures, laryngeal polypectomy, laryngeal lesion debulking, surgical management of Recurrent Respiratory Papillornatosis (RRP), tonsillectomy, tonsillotomy and removal of endobronchial lesions.

Head and neck (ENT) indications include soft tissue shaving, rhinoplasty (narrowing of the bony vault and revision of the bony pyramid), removal and shaping of bone during rhinoplasty procedures, removal of adipose tissue (lipo debridement) in the maxillary and mandibular regions of the face, removal of acoustic neuroma, and incision and removal of soft tissue during plastic, reconstructive, and/or aesthetic surgery.

Neurosurgical procedures where removal and aspiration of soft and hard tissue is desired.

The XPS 3000 system using the PowerSculpt handpiece and reciprocating cutting blades / rasps is indicated to cut hard and soft tissue or bone in otorhinolaryngology and head and neck surgery. An integral pump is provided for irrigation, and a second integral pump may be provided for handpiece cooling.

The XPS 3000 system with reciprocating adapter and suction cannula is intended for the removal of soft tissue and fluid during general surgical procedures including suction lipoplasty for aesthetic body contouring.

The XPS 3000 system is indicated for use in orthopedic surgical procedures where the cutting and removal of soft and hard tissue or bone is required. These include spinal and small and large joint arthroscopic procedures.

Contraindications

XPS 3000:

None.

Warnings

XPS 3000:

Always inspect the components before and after use for any damage. If damage is observed, do not use damaged part until it is replaced. Damaged parts may deposit metal shavings on surgical site.
Do not modify accessories used with the handpiece. Performance could be diminished with modified accessories.
Insertion of metal objects in blade or bur tip may cause the blade or bur to break leaving fragments in the wound. The fragments may be difficult to remove, causing irritation, inflammation and foreign-body response at surgical site.
Do not use any parts other than Medtronic Xomed, Inc. system components as damage or substandard performance could result.
Blade and bur accessories are available for resection of soft tissue and bone for surgical procedures. Use of accessories depends on the intended application and patient needs. Sharp-cutting powered accessories induce bleeding and removal of significant tissue and bone.
Do not attach unapproved components to the XPS® 3000 Console to avoid electrical macro shock.
Carefully inspect burs prior to and following each use for excessive wear, fragmentation, eccentricities or other defects. Do not use dull, damanged or bent burs. Use of dull burs can reduce the handpiece effectiveness and cause the handpiece temperature to increase.
Do not attempt to resharpen used burs. Worn burs should be replaced with new ones frequently to ensure effective cutting and control of the drill.
Excessive pressure applied to bur may cause bur fracture. Should a bur fracture during use, extreme care must be exercised to ensure that all fragments of the bur are retrieved and removed from the patient. Unremoved bur fragments may cause tissue damage to the patient.
Test for bur wobble (eccentricity) at desired speed prior to use. Use a bur guard (Xcalibur only) if needed. Select a new bur or reduce speed if wobble is observed.
Test for bur wobble (eccentricity) at the desired speed prior to use. Select a new bur or reduce speed if wobble is observed. Eccentricity of the bur can cause bur vibration and may result in excessive tissue and bone destruction and hearing damage. Always examine the operation of each bur in the handpiece before each use. Operating certain burs at high speed can cause vibration of the bur.
Keep the cooling sleeve irrigated to prevent thermal injury to tissue.
During procedures near nerves, keep bur and bur cannula away from tissue to minimize the potential for thermal injury.
For procedures near nerves, nerve monitoring should be used to alert the user of the potential for injury.
Use care in application of the moving cutting end to only appropriate anatomical landmarks and the intended surgical site when using XPS accessories. The use of powered reciprocating/rotating instruments may result in vibration-related injury. Use appropriate precautions.
Employ visualization when using rotating XPS accessories. Discontinue powered application in the event of lack of visualization of the surgical site.
Use methods at the operative site to control bleeding that do not compromise patient safety during at-risk surgery.
Use lock on Straightshot M4 and M5 handpieces to prevent inadvertant rotation of blade or bur during use.
When precise location of the blade tip is required, engage the rotation lock on the handpiece, then calibrate and verify the blade tip on the Image Guided Surgery (IGS) system. Always lock the Straightshot M4 and M5 handpieces when driving non-rotatable blades to maintain their IGS calibration.
Always keep the cutting tip of the accessory away from fingers and loose clothing. Prevent laceration of user and cross-contamination through compromised glove.
Do not change accessory with handpiece running to prevent laceration of user and cross-contamination through compromised glove.
Bending or prying may break the blade or bur, causing harm to patient or staff.
Discontinue use of curved bur if tip begins to wobble and replace bur to prevent unintended tissue removal from patient.
Do not use burs above the speed indicated on the bur label. Exceeding speed may cause the burs to break.
Disposable devices are for single-use only. Do not attempt to sterilize disposable devices. The disposables are packed sterile and not intended for repeat use. To prevent contamination use only once.
Disconnect power to the XPS 3000 Console before cleaning the unit to avoid electrical macro shock.
After each procedure, properly clean all reusable system components.
Sterilize and dry reusable device before storing the system. Decrease likelihood of cross-contamination with timely sterilization.
Remove and discard accessories following local regulations for proper disposal of contaminated materials.
Properly dispose of single-use devices removed from sterile packages. Devices lost sterility upon removal from packaging.
All service must be performed by Medtronic Xomed-qualified personnel only.

WARNINGS BEFORE SURGERY

Verify reusable device was sterilized prior to use. If not sterilized, do not use.
Do not use accessory if package is opened or damaged. Broken seal offers no protection against crosscontamination.
Do not operate the XPS 3000 System in the presence of flammable anesthetics. Avoid potential ignition or explosion of gases.
Achieve electrical grounding reliability with proper connections. Connect the XPS 3000 Console to hospital grade receptacles only.
Use adequate irrigation from a separate user-provided irrigating source. The use of a bur without irrigation may cause an inordinate amount of heat buildup resulting in thermal injury to tissue.
When not operating handpiece, ensure that handpiece rests on a non-conductive surface that provides containment for handpiece and blade/bur. Avoid unintended thermal injury by an uncontained handpiece.
When not operating handpiece, eliminate accidental foot control activation. Control energy to and through handpiece to prevent unintended tissue, bone or nerve resection.
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.

CURVED BURS

Curved Burs

Indications

The XPS^® Curved Bur is intended for use in an ear, nose, and throat electric or pneumatic surgical drill for incising or removing bone in the ear, nose, or throat area, and is an accessory to the XPS 3000 and IPC^® System.

Contraindications

None.

Warnings

Use adequate irrigation from a separate user-provided irrigating source. The use of a bur without irrigation may cause an inordinate amount of heat buildup resulting in thermal injury to tissue.
Keep the cooling sleeve irrigated to minimize thermal injury to tissue.
Excessive noise from the drill or eccentricity of the drill may cause hearing damage when drilling close to the cochlea or ossicular chain.
During procedures near nerves, keep bur and bur cannula away from tissue to minimize the potential for thermal injury.
For procedures near nerves, nerve monitoring should be used to alert the user of the potential for injury.
Use care in application of the moving cutting end to only appropriate anatomical landmarks and the intended surgical site when using XPS accessories.
The use of powered reciprocating/rotating instruments may result in vibration-related injury. Use appropriate precautions.
Employ visualization when using rotating XPS accessories. Discontinue powered application in the event of lack of visualization of the surgical site.
Always inspect the components before and after use for any damage. If damage is observed, do not use damaged part until it is replaced. Damaged parts may deposit metal shavings on surgical site.
When not operating handpiece, ensure that handpiece rests on a non-conductive surface that provides containment for handpiece and blade/bur. Avoid unintended thermal injury by an uncontained handpiece
When not operating handpiece, eliminate accidental foot control activation. Control energy to and through handpiece to prevent unintended tissue, bone or nerve resection.
Always keep the cutting tip of the accessory away from fingers and loose clothing. Prevent laceration of user and cross-contamination through compromised glove.
Do not change accessory with handpiece running to prevent laceration of user and cross-contamination through compromised glove.
Do not use accessory if package is opened or damaged. Broken seal offers no protection against cross-contamination.
Bending or prying may break the blade or bur, causing harm to patient or staff.
Excessive pressure applied to bur may cause bur fracture. Should a bur fracture during use, extreme care must be exercised to ensure that all fragments of the bur are retrieved and removed from the patient. Unremoved bur fragments may cause tissue damage to the patient.
Test for bur wobble (eccentricity) at the desired speed prior to use. Select a new bur or reduce speed if wobble is observed. Eccentricity of the bur can cause bur vibration and may result in excessive tissue and bone destruction and hearing damage. Always examine the operation of each bur in the handpiece before each use. Operating certain burs at high speed can cause vibration of the bur.
Discontinue use of curved bur if tip begins to wobble and replace bur to prevent unintended tissue removal from patient.
Blade and bur accessories are available for resection of soft tissue and bone for surgical procedures. Use of accessories depends on the intended application and patient needs. Sharp-cutting powered accessories induce bleeding and removal of significant tissue and bone.
Do not modify accessories used with the handpiece. Performance could be diminished with modified accessories.
Do not attempt to resharpen used burs. Worn burs should be replaced with new ones frequently to ensure effective cutting and control of the drill.
Do not use any parts other than Medtronic Xomed, Inc. system components as damage or substandard performance could result.
Disposable devices are for single-use only. Do not attempt to sterilize disposable devices. The disposables are packed sterile and not intended for repeat use. To prevent contamination use only once.
Do not use burs above the speed indicated on the bur label. Exceeding speed may cause the burs to break.

STRAIGHTSHOT M4 AND M5 MICRODEBRIDERS

Straightshot M4 and M5 Microdebriders

The Straightshot M4 and M5 Microdebriders are part of the IPC^® System and XPS® 3000 System.

Indications

IPC System:

The IPC System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and bone, in Head & Neck / ENT (Otologic, Neurologic, Neurotologic, Sinus, Rhinologic, Nasopharyngeal / Laryngeal), Oral / Maxillofacial, and Plastic / Reconstructive / Aesthetic, surgical procedures.

Contraindications

IPC System:

None.

Warnings

IPC System:

System Warnings

W1	It is important that the IPC operator be familiar with the system User’s Guide, its precautions, procedures and safety issues.
W2	Do not use the IPC 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 before cleaning the unit to avoid electrical macro shock.
W5	Do not attach unapproved components to the IPC to avoid electrical macro shock.
W6	To avoid the risk of electrical shock, achieve electrical grounding reliability with proper connections. Connect the IPC 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 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 should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the IPC should be observed to verify normal operation in the configuration in which it will be used.
W13	Do not attempt to run the IPC 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.
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 System without eye protection.
W17	All service must be performed by Medtronic qualified personnel only.
W18	Repair and/or modification to the IPC 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 and M5 handpieces 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 can achieve temperatures in excess of 50° C.
W29	Do not attempt to change a dissecting tool 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.
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.
W36	Smoke may be generated if attachment is not in the locked position.
W37	The 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.

Disposable Warnings

W45	Verify reusable device was sterilized prior to use. If not sterilized, do not use.
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 tip of the tool 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 or tool 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 are sharp and may perforate surgical gloves. Tools 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 and M5 Microdebriders, 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.

Indications

XPS 3000:

The XPS 3000 is intended for the incision and removal of soft and hard tissue or bone in general otorhinolaryngology, head and neck, and otoneurological surgery.

Neurosurgical procedures where removal and aspiration of soft and hard tissue is desired.

Contraindications

XPS 3000:

None.

Warnings

XPS 3000:

Always inspect the components before and after use for any damage. If damage is observed, do not use damaged part until it is replaced. Damaged parts may deposit metal shavings on surgical site.
Do not modify accessories used with the handpiece. Performance could be diminished with modified accessories.
Insertion of metal objects in blade or bur tip may cause the blade or bur to break leaving fragments in the wound. The fragments may be difficult to remove, causing irritation, inflammation and foreign-body response at surgical site.
Do not use any parts other than Medtronic Xomed, Inc. system components as damage or substandard performance could result.
Blade and bur accessories are available for resection of soft tissue and bone for surgical procedures. Use of accessories depends on the intended application and patient needs. Sharp-cutting powered accessories induce bleeding and removal of significant tissue and bone.
Do not attach unapproved components to the XPS 3000 Console to avoid electrical macro shock.
Carefully inspect burs prior to and following each use for excessive wear, fragmentation, eccentricities or other defects. Do not use dull, damanged or bent burs. Use of dull burs can reduce the handpiece effectiveness and cause the handpiece temperature to increase.
Do not attempt to resharpen used burs. Worn burs should be replaced with new ones frequently to ensure effective cutting and control of the drill.
Excessive pressure applied to bur may cause bur fracture. Should a bur fracture during use, extreme care must be exercised to ensure that all fragments of the bur are retrieved and removed from the patient. Unremoved bur fragments may cause tissue damage to the patient.
Test for bur wobble (eccentricity) at desired speed prior to use. Use a bur guard (Xcalibur only) if needed. Select a new bur or reduce speed if wobble is observed.
Test for bur wobble (eccentricity) at the desired speed prior to use. Select a new bur or reduce speed if wobble is observed. Eccentricity of the bur can cause bur vibration and may result in excessive tissue and bone destruction and hearing damage. Always examine the operation of each bur in the handpiece before each use. Operating certain burs at high speed can cause vibration of the bur.
Keep the cooling sleeve irrigated to prevent thermal injury to tissue.
During procedures near nerves, keep bur and bur cannula away from tissue to minimize the potential for thermal injury.
For procedures near nerves, nerve monitoring should be used to alert the user of the potential for injury.
Use care in application of the moving cutting end to only appropriate anatomical landmarks and the intended surgical site when using XPS accessories. The use of powered reciprocating/rotating instruments may result in vibration-related injury. Use appropriate precautions.
Employ visualization when using rotating XPS accessories. Discontinue powered application in the event of lack of visualization of the surgical site.
Use methods at the operative site to control bleeding that do not compromise patient safety during at-risk surgery.
Use lock on Straightshot M4 and M5 handpieces to prevent inadvertant rotation of blade or bur during use.
When precise location of the blade tip is required, engage the rotation lock on the handpiece, then calibrate and verify the blade tip on the Image Guided Surgery (IGS) system. Always lock the Straightshot M4 and M5 handpieces when driving non-rotatable blades to maintain their IGS calibration.
Always keep the cutting tip of the accessory away from fingers and loose clothing. Prevent laceration of user and cross-contamination through compromised glove.
Do not change accessory with handpiece running to prevent laceration of user and cross-contamination through compromised glove.
Bending or prying may break the blade or bur, causing harm to patient or staff.
Discontinue use of curved bur if tip begins to wobble and replace bur to prevent unintended tissue removal from patient.
Do not use burs above the speed indicated on the bur label. Exceeding speed may cause the burs to break.
Disposable devices are for single-use only. Do not attempt to sterilize disposable devices. The disposables are packed sterile and not intended for repeat use. To prevent contamination use only once.
Disconnect power to the XPS 3000 Console before cleaning the unit to avoid electrical macro shock.
After each procedure, properly clean all reusable system components.
Sterilize and dry reusable device before storing the system. Decrease likelihood of cross-contamination with timely sterilization.
Remove and discard accessories following local regulations for proper disposal of contaminated materials.
Properly dispose of single-use devices removed from sterile packages. Devices lost sterility upon removal from packaging.
All service must be performed by Medtronic Xomed-qualified personnel only.

WARNINGS BEFORE SURGERY

Verify reusable device was sterilized prior to use. If not sterilized, do not use.
Do not use accessory if package is opened or damaged. Broken seal offers no protection against crosscontamination.
Do not operate the XPS 3000 System in the presence of flammable anesthetics. Avoid potential ignition or explosion of gases.
Achieve electrical grounding reliability with proper connections. Connect the XPS 3000 Console to hospital grade receptacles only.
Use adequate irrigation from a separate user-provided irrigating source. The use of a bur without irrigation may cause an inordinate amount of heat buildup resulting in thermal injury to tissue.
When not operating handpiece, ensure that handpiece rests on a non-conductive surface that provides containment for handpiece and blade/bur. Avoid unintended thermal injury by an uncontained handpiece.
When not operating handpiece, eliminate accidental foot control activation. Control energy to and through handpiece to prevent unintended tissue, bone or nerve resection.
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.

NIM

Indications, Safety, and Warnings

NIM 3.0 Nerve Monitors

Indications for Use

Contraindications

Warnings and Precautions

Warnings

NIM 2.0 Nerve Monitors

Indications

Contraindications

Warnings

Precautions

Additional Precautions

NIM TriVantage EMG Endotracheal Tube

Intended Use

Indications for Use

Contraindications

Precautions

Sterility

NIM EMG Electrodes and Probes (General)

Indications

Contraindications

Warnings

NIM APS Electrode

Indications

Contraindications

Warnings

NIM Incrementing Probe

Indications

Contraindications

Warnings

Stim Bur Guard

Indications

Contraindications

Warnings

Warning

Integrated Power Console (IPC System)

Indications

Contraindications

Warnings

Midas Rex Legend EHS Stylus High-Speed Surgical Drill

Indications

Contraindications

Warnings

Indications

Contraindications

Warnings

Warnings

Visao High-Speed Otologic Drill

Indications

Contraindications

Warnings

Warnings

Indications

Contraindications

Warnings

Curved Burs

Indications

Contraindications

Warnings

Straightshot M4 and M5 Microdebriders

Indications

Contraindications

Warnings

Indications

Contraindications

Warnings