Aquamantys System

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 surface.
• 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.

W19

Do not use any parts other than Medtronic system components as damage or substandard performance could result.

W20

Always inspect the components before and after use for any damage. If damage is observed, do not use damaged part until it is repaired or replaced. Damaged parts may deposit metal shavings on surgical site.

W21

When precise location of blade tip is required, engage the rotation lock on the handpiece, then calibrate and verify the blade tip on Image Guided Surgery (IGS) system. Always lock M4 handpiece when driving non-rotatable blades to maintain their IGS calibration.

W22

Employ visualization, including use of imaging techniques (e.g., fluoroscopy, image guided surgery) when using rotating powered accessories. Discontinue powered application in the event of lack of visualization of surgical site.

W23

Midas Rex^® Variable Exposure attachments
Surgeons should familiarize themselves with the performance of dissecting tools before use, and should explore the effect of various levels of tool exposure on dissection stability. If the tool exhibits excessive chatter, vibration, or movement, decrease the tool exposure.

W24

Motors and attachments may fail due to extended use and allow a component to detach and fall from the motor or attachment, causing patient injury.

W25

Electrical contacts must be dry prior to use.

W26

Heavy side loads and/or long operating periods may cause the device to overheat.

W27

Do not use an overheated device, as it may cause thermal injury to the patient or operator.

W28

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.

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 Microdebrider, Straightshot Magnum^® II Microdebrider, Straightshot III Microdebrider, Midas Rex^® SC1, Visao^®, or Skeeter^® handpieces and the Multi Function Foot Control Unit.

W80

Sterilize and dry reusable device before storing the system. Decrease likelihood of cross-contamination with timely sterilization.

W81

After each procedure, properly clean all reusable system components.

W82

Auxiliary Power Outlet with protective cover is for use with the Hydrodebrider™, or Bone Mill consoles only.

W1

It is important that the IPC^® operator be familiar with the system User’s Guide, its precautions, procedures and safety issues.

W2

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

W6

To avoid the risk of electrical shock, achieve electrical grounding reliability with proper connections. Connect the IPC system to hospital grade receptacles only.

W7

This medical device complies with EN60601-1-2 safety standard for electromagnetic compatibility, requirements and test. However, if this equipment is operated in the presence of high levels of electromagnetic interference (EMI) or highly sensitive equipment, interference may be encountered and the user should take whatever steps are necessary to eliminate or reduce the source of the interference. Diminished performance may lengthen operating time for anesthetized patient.

W8

Medical Electrical Equipment needs special Precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this Guide.

W9

Portable and mobile RF communications equipment can affect Medical Electrical Equipment.

W10

Do not operate the IPC POWEREASE system in the presence of Magnetic Resonance Imaging devices.

W11

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

W12

The IPC system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the IPC system should be observed to verify normal operation in the configuration in which it will be used.

W13

Do not attempt to run the IPC™ 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 surface.
• W15c - Protect the wound site from metal debris.
• W15d - Use a clamp or grasping device to control loose fragments during transection of any metal component.

W16

Do not operate the IPC POWEREASE system without eye protection.

W17

All service must be performed by Medtronic qualified personnel only.

W18

Repair and/or modification to the IPC system by anyone other than qualified service personnel may significantly compromise the unit's ability to perform effectively and/or void the equipment warranty

W19

Do not use any parts other than Medtronic system components as damage or substandard performance could result.

W20

Always inspect the components before and after use for any damage. If damage is observed, do not use damaged part until it is repaired or replaced. Damaged parts may deposit metal shavings on surgical site.

W21

When precise location of blade tip is required, engage the rotation lock on the handpiece, then calibrate and verify the blade tip on Image Guided Surgery (IGS) system. Always lock M4 handpiece when driving non-rotatable blades to maintain their IGS calibration.

W22

Employ visualization, including use of imaging techniques (e.g., fluoroscopy, image guided surgery) when using rotating powered accessories. Discontinue powered application in the event of lack of visualization of surgical site.

W23

Midas Rex^® Variable Exposure attachments. Surgeons should familiarize themselves with the performance of dissecting tools before use, and should explore the effect of various levels of tool exposure on dissection stability. If the tool exhibits excessive chatter, vibration, or movement, decrease the tool exposure.

W24

Motors and attachments may fail due to extended use and allow a component to detach and fall from the motor or attachment, causing patient injury.

W25

Electrical contacts must be dry prior to use.

W26

Heavy side loads and/or long operating periods may cause the device to overheat.

W27

Do not use an overheated device, as it may cause thermal injury to the patient or operator.

W28

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 mains with protective earth.

W44

Keep NIM® Muting Probe cable away from IPC® system cables.

W45

Verify reusable device was sterilized prior to use. If not sterilized, do not use.

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 Microdebrider, Straightshot^® Magnum^® II Microdebrider, Straightshot^® III Microdebrider, Midas Rex^® SC1, Visao^®, or Skeeter^® handpieces and the Multi Function Foot Control Unit.

W80

Sterilize and dry reusable device before storing the system. Decrease likelihood of cross-contamination with timely sterilization.

W81

After each procedure, properly clean all reusable system components.

W82

Auxiliary Power Outlet with protective cover is for use with the Hydrodebrider™, or Bone Mill consoles only.