W46
|
Tools are available for resection of soft tissue and bone for surgical procedures. Use of tools depends on the intended application and patient needs. Sharp-cutting powered tools induce bleeding and removal of significant tissue and bone.
|
W47
|
Use methods at the operative site to control bleeding that do not compromise patient safety during at-risk surgery.
|
W48
|
Always keep the cutting area of the tool/saw blade away from fingers and loose clothing. Prevent laceration of user and cross-contamination through compromised glove.
|
W49
|
Operate the tool only after the appropriate anatomical landmarks and the intended surgical site have been confirmed.
|
W50
|
Use care in application of the moving cutting end to only appropriate anatomical landmarks and the intended surgical site when using powered accessories.
|
W51
|
Insertion of metal objects in accessory tip may cause the accessory to break leaving fragments in the wound. The fragments may be difficult to remove, causing irritation, inflammation and foreign-body response at surgical site.
|
W52
|
Bending or prying may break the accessory, causing harm to patient or staff.
|
W53
|
Do not use excessive force to pry or push bone with the attachment, tool or blade during dissection.
|
W54
|
A tool's size and geometry may create excessive vibration at certain speeds. Increase or decrease speed on console. Change to a new tool to prevent unintended tissue removal from patient
|
W55
|
Test for wobble at desired speed prior to use. Discontinue use of accessory if tip begins to wobble and replace accessory to prevent unintended tissue removal from patient.
|
W56
|
Eccentricity of the tool can cause tool vibration and may result in excess tissue and bone destruction and hearing damage.
|
W57
|
Excessive noise from the tool when drilling close to the cochlea or ossicular chain may cause hearing damage.
|
W58
|
CONSULT the cranial perforator device labeling for the recommended speed specifications.
|
W59
|
Tools with "L" identification are longer tools intended for light bone dissection. The increased tool head/stem configuration may affect dissection stability.
|
W60
|
Tool flutes and blade teeth are sharp and may perforate surgical gloves. Tools/blades may be grasped with a hemostat to aid in installation and removal.
|
W61
|
DO NOT attempt to resharpen used tools. Worn tools should be replaced with new ones frequently to ensure effective cutting and control.
|
W62
|
Carefully inspect tool both prior to and following each use for signs of excessive wear, fragmentation, eccentricities or other defects. Replace any suspicious tools with a new one prior to use.
|
W63
|
Excessive pressure applied to bur may cause bur fracture. Should a tool fracture in use, extreme care must be exercised to ensure that all fragments of the tool are retrieved and removed from the patient. Unremoved tool fragments may cause tissue damage to the patient.
|
W64
|
Do not use metal-cutting tools on bone.
|
W65
|
Use only rotary tools specifically designed for use with this drill system.
|
W66
|
When using non-rotatable tools, ensure rotation lock is engaged to prevent inadvertent rotation.
|
W67
|
The use of powered reciprocating instruments may result in vibration / related injury.
|
W68
|
Powered blades should be operated in the oscillate mode only. Operating in the forward mode may cause damage to the blade.
|
W69
|
Do not attempt to sterilize disposable devices. The disposables are packed sterile and are not intended for repeat use. To prevent contamination, use only once.
|
W70
|
Any tubing or other tip protectors used during shipping must be removed prior to cleaning and sterilization.
|
W71
|
Do not use accessory if package is opened or damaged. Broken seal offers no protection against cross-contamination.
|
W72
|
Properly dispose of single-use devices removed from sterile packages. Devices lose sterility upon removal from packaging.
|
W73
|
Do not use dull, damaged or bent tools. Use of dull tools can reduce handpiece effectiveness and cause the handpiece temperature to increase.
|
W74
|
T&A Blades: Gently remove the inner tube from the outer tube. The inner tube may elongate upon removal from the outer tube. If this occurs, the inner tube may not lock properly into the handpiece or the blade may not work properly.
|
W75
|
T&A Blades: Rotate the inner tube when removing and inserting it in the outer tubes to prevent damage to the internal seal. If the seal is damaged, the blade will leak at the handpiece.
|
W76
|
Always ensure that the drill is securely engaged into the handpiece prior to operating the system.
|
W77
|
Always examine operation of each tool in a handpiece before use.
|
W78
|
Powered burs and drills should be operated in the forward mode only.
|
W79
|
This system requires insulated connectors for the StraightShot M4 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.
|
W83
|
Place Stylus Touch in safe mode while not in use.
|
W84
|
Do not place Stylus Touch handpiece in the proximity of magnetic field, such as magnetic drape and MRI equipment, to avoid inadvertent handpiece activation.
|
W85
|
Do not apply excessive side loading. Excessive side loading could cause angled attachments to unlock accidentally from motor.
|