Medtronic 750 Instructions for Use
Simulus™
Ring/Band Accessories
Instructions for Use
Caution: Federal law (USA) restricts this
device to sale by or on the order of a physician.
The following list includes trademarks or registered trademarks of Medtronic in the United States and
possibly in other countries. All other trademarks are the property of their respective owners.
Medtronic, Simulus
Explanation of symbols on package labeling
Refer to the device labeling to see which symbols apply to this product.
Conformité Européenne (European Conformity). This
symbol means that the device fully complies with applicable
European Union acts.
Consult instructions for use
Lot number
Catalog number
For US audiences only
Quantity
Manufacturer
Nonsterile
Authorized representative in the European Community
Manufactured in
3
1 Device description
The Simulus ring/band accessories consist of nonsterile reusable metal
handles, with Nitinol stems that straighten during the steam sterilization
cycle, and clear plastic sizers.
Use the following Simulus ring/band accessories for the Simulus flexible
annuloplasty ring, Model 700FF, and the Simulus flexible annuloplasty
band, Models 700FC and 725FC:
Accessory Model Product Description
750 Simulus flexible ring/band acces-
sory kit
• 9 rigid polysulfone sizers, sizes
23 mm through 39 mm
• 2 standard annuloplasty handles
• 1 sterilization tray
751 Simulus flexible ring/band polysul-
fone sizer set
• 9 rigid polysulfone sizers, sizes
23 mm through 39 mm
755 Simulus flexible ring/band robotic
accessory kit
• 9 polysulfone robotic sizers,
sizes 23 mm through 39 mm
• 1 sterilization tray
Use the following Simulus ring/band accessories for the Simulus semi-rigid
annuloplasty ring, Model 800SR, and the Simulus semi-rigid annuloplasty
band, Model 800SC:
Accessory Model
850 Simulus semi-rigid ring/band
Product Description
accessory kit
4
Accessory Model Product Description
• 9 rigid polysulfone sizers, sizes
24 mm through 40 mm
• 2 standard annuloplasty handles
• 1 sterilization tray
851 Simulus semi-rigid ring/band poly-
sulfone sizer set
• 9 rigid polysulfone sizers, sizes
24 mm through 40 mm
The handles have malleable Nitinol stems that straighten during the steam
sterilization cycle. The handles are available in the following lengths and
quantities:
Accessory Model Length Quantity
752 254 mm 2
2 Indications for use
The sizers are to be used to size a patient’s mitral or tricuspid valve annulus
in order to select the proper size Simulus ring or band.
Do not use other manufacturers’ annuloplasty sizers or sizers from other
annuloplasty products to size the Simulus ring or band. Other sizers may not
indicate the appropriate Simulus ring or band size.
3 Contraindications
The sizers are not intended for use with devices other than the Simulus ring
or band.
4 Warnings and precautions
4.1 Warnings
• The sizers and handles are provided NONSTERILE and must be
thoroughly cleaned and sterilized prior to use.
• Only surgeons who have received appropriate training in valve repair,
including ring implant and sizing techniques, should use this device.
• Correct annuloplasty ring or band sizing is an important element of a
successful valve repair. Undersizing the ring or band can result in:
– valve stenosis
– ring or band dehiscence
– ring or band fracture
5
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