Page 5 - ZVPlasty - Hensler Technique Guide 2021
P. 5

ST-007 rev-4



             •  Table 2 gives the maximum recommended inflation
               pressure  and  volume  values  in  constrained  and
               unconstrained  conditions  for  10G,  11G,  and  13G.   UNCONSTRAINED TEST CONDITION
               Also included are the pressure and volume values at            Max.  Recommended    Max.   Recommended
               burst in constrained and unconstrained conditions for   Catalog No.   Inflation Pressure   Inflation Volume
               guidance.                                        VCF-1000-10       6.5 ATM                4 ml

         Inflated Balloon                                       VCF-1000-15       6.5  ATM               4 ml
         Dimensions 10G
                                                                VCF-1000-20       6.5  ATM               6 ml
         Catalog No.:    VCF-         Inflated Dimensions
                         1000-10
         Size (Deflated
         Balloon Length):   15 mm   Volume   Diameter   Length   CONSTRAINED TEST CONDITION (Please note that the Inflation volume
         Max. Inflation   4 ml   2 ml      10 mm    12 mm       required to achieve a desired pressure in a constrained condition will vary during
         Volume:                                                product use due to local variation in bone structure )
                                 4 ml      16 mm    17 mm                     Max.  Recommended    Max.   Recommended
                                                                Catalog No.
                         VCF-                                                  Inflation Pressure   Inflation Volume
         Catalog No.:                 Inflated Dimensions
                         1000-15                                VCF-1000-10       27 ATM                 4 ml
         Size (Deflated
         Balloon Length):   15 mm   Volume   Diameter   Length   VCF-1000-15      27 ATM                 4 ml
         Max Inflation
         Volume:         4 ml    2 ml      9 mm     15 mm       VCF-1000-20       27 ATM                 6 ml

                                 4 ml      14 mm    21 mm
                                                                •   Inflating the vertebral balloon beyond the maximum recommended inflation
                         VCF-                                      volume  may  cause  the  balloon  to  rupture  before  reaching  the  maximum
         Catalog No.:                 Inflated Dimensions
                         1000-20                                   inflation pressure and
         Size (Deflated   18 mm   Volume   Diameter   Length    •   Inflating the vertebral balloon beyond the maximum recommended inflation
         Balloon Length):                                          pressure  may  cause  the  balloon  to  rupture  before  reaching  the  maximum
         Max Inflation                                             inflation volume.
         Volume:         6 ml    2 ml      8 mm     18 mm
                                 4 ml      12 mm    24 mm
                                 6 ml      16 mm    29 mm

                                                               UNCONSTRAINED TEST CONDITION

         Inflated Balloon                                                    Max.  Recommended    Max.   Recommended
         Dimensions 11G                                        Catalog No.    Inflation Pressure    Inflation Volume

         Catalog No.:    VCF-         Inflated Dimensions      VCF-1100-10       6.5 ATM                4 ml
                         1100-10
         Size (Deflated                                        VCF-1100-15       6.5  ATM               4 ml
         Balloon Length):   15 mm   Volume   Diameter   Length
         Max. Inflation   4 ml   2 ml      10 mm    12 mm      VCF-1100-20       6.5  ATM               6 ml
         Volume:
                                 4 ml      16 mm    17 mm
                                                               CONSTRAINED TEST CONDITION (Please note that the Inflation volume
                         VCF-
         Catalog No.:                 Inflated Dimensions      required to achieve a desired pressure in a constrained condition will vary during
                         1100-15                               product use due to local variation in bone structure )
         Size (Deflated   15 mm   Volume   Diameter   Length
         Balloon Length):                                      Catalog No.   Max.  Recommended    Max.   Recommended
         Max Inflation                                                        Inflation Pressure    Inflation Volume
         Volume:         4 ml    2 ml      9 mm     15 mm      VCF-1100-10       27 ATM                 4 ml
                                 4 ml      14 mm    21 mm
                                                               VCF-1100-15       27 ATM                 4 ml
                         VCF-
         Catalog No.:                 Inflated Dimensions
                         1100-20                               VCF-1100-20       27 ATM                 6 ml
         Size (Deflated   18 mm   Volume   Diameter   Length
         Balloon Length):                                      •   Inflating the vertebral balloon beyond the maximum recommended inflation
         Max Inflation   6 ml    2 ml      8 mm     18 mm         volume  may  cause  the  balloon  to  rupture  before  reaching  the  maximum
         Volume:
                                                                  inflation pressure and
                                 4 ml      12 mm    24 mm      •   Inflating the vertebral balloon beyond the maximum recommended inflation
                                                                  pressure  may  cause  the  balloon  to  rupture  before  reaching  the  maximum
                                 6 ml      16 mm    29 mm         inflation volume.



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