Orthosensor ORTHOSNSR5 Verasense User Manual

Orthosensor, Inc Verasense

User Manual

Download: Orthosensor ORTHOSNSR5 Verasense User Manual
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Document ID2144722
Application IDHaN7HcHX91n9k623VbsZMg==
Document DescriptionUser Manual
Short Term ConfidentialNo
Permanent ConfidentialNo
SupercedeNo
Document TypeUser Manual
Display FormatAdobe Acrobat PDF - pdf
Filesize135.87kB (1698421 bits)
Date Submitted2013-12-17 00:00:00
Date Available2013-12-19 00:00:00
Creation Date2013-08-22 20:26:55
Producing SoftwareMac OS X 10.8.4 Quartz PDFContext
Document Lastmod2013-10-02 14:35:16
Document TitleLB-03000-012 Rev 1 - OrthoSensor Verasense Knee System Instructions for Use - need ISO font-1-1 (3)
Document CreatorWord
Document Author: Martha Garay

OrthoSensor,	
  Inc	
  
th
1560	
  Sawgrass	
  Corporate	
  Pkwy,	
  4 	
  Floor	
  
Sunrise	
  FL,	
  33323	
  
www.orthosensor.com	
  
  
  
  
  
  
  
ORTHOSENSOR VERASENSE™ KNEE SYSTEM
INSTRUCTIONS FOR USE
DESCRIPTION
The	
  OrthoSensor™	
  VERASENSE™	
  Knee	
  System	
  provides	
  a	
  means	
  to	
  dynamically	
  balance	
  the	
  knee	
  during	
  Total	
  Knee	
  
Arthroplasty	
  (TKA).	
  
  
The	
  VERASENSE	
  Knee	
  System	
  device	
  is	
  an	
  intelligent	
  disposable	
  tibial	
  insert	
  that	
  measures	
  dynamic	
  loads	
  in	
  the	
  medial	
  and	
  
lateral	
  compartments	
  of	
  the	
  knee	
  and	
  wirelessly	
  transmits	
  the	
  measured	
  load	
  data	
  to	
  the	
  OrthoSensor	
  LinkStation	
  for	
  surgeon	
  
visualization.	
  	
  Individual	
  VERASENSE™	
  devices	
  are	
  packaged	
  sterile,	
  for	
  single	
  patient	
  use	
  with	
  a	
  Shim	
  Set	
  for	
  thickness	
  
adjustments.	
  
  
The	
  OrthoSensor	
  LinkStation	
  and	
  VERASENSE	
  Knee	
  System	
  Software	
  Application	
  are	
  required	
  for	
  use	
  of	
  the	
  VERASENSE	
  Knee	
  
System	
  device.	
  	
  The	
  LinkStation	
  contains	
  a	
  computer	
  and	
  all	
  peripheral	
  equipment	
  required	
  to	
  display	
  the	
  measured	
  load	
  data	
  
by	
  providing	
  a	
  graphical	
  and	
  numerical	
  presentation	
  of	
  the	
  loads	
  in	
  both	
  the	
  medial	
  and	
  lateral	
  compartments	
  of	
  the	
  knee.	
  	
  	
  
  
VERASENSE	
  Knee	
  System	
  devices	
  are	
  implant	
  system	
  specific	
  due	
  to	
  variations	
  in	
  implant	
  design.	
  
  
INDICATIONS
The	
  OrthoSensor	
  VERASENSE	
  Knee	
  System	
  device	
  is	
  an	
  intelligent	
  disposable	
  tibial	
  insert	
  trial	
  for	
  the	
  adjustment	
  of	
  the	
  femoral	
  
knee	
  implant	
  to	
  reduce	
  instability	
  from	
  flexion	
  gap	
  asymmetry.	
  	
  The	
  VERASENSE	
  Knee	
  System	
  device	
  is	
  sterile,	
  for	
  single	
  patient	
  
use.	
  
  
CONTRAINDICATIONS
• Any	
  active	
  or	
  suspected	
  latent	
  infection	
  in	
  or	
  about	
  the	
  knee	
  joint.	
  
• Refer	
  to	
  Knee	
  System	
  IFU	
  for	
  additional	
  contraindications.	
  
  
PRECAUTIONS
• Read	
  and	
  follow	
  instructions	
  for	
  proper	
  use	
  and	
  interpretation	
  of	
  force	
  data	
  displayed.	
  
• Strict	
  adherence	
  to	
  the	
  indications,	
  contraindications,	
  precautions	
  and	
  user/patient	
  safety	
  for	
  this	
  product	
  is	
  essential.	
  
• Refer	
  to	
  appropriate	
  Knee	
  System	
  IFU	
  for	
  additional	
  precautions.	
  
• Data	
  from	
  the	
  VERASENSE	
  Knee	
  System	
  is	
  for	
  reference	
  purposes	
  only	
  and	
  should	
  not	
  be	
  the	
  sole	
  basis	
  for	
  surgical	
  decisions.	
  
• VERASENSE	
  Knee	
  System	
  device	
  internal	
  components	
  are	
  non-­‐sterile.	
  	
  Immediately	
  discontinue	
  use	
  of	
  device	
  if	
  any	
  cracks,	
  
damage,	
  or	
  internal	
  fluid	
  is	
  observed.	
  	
  Failure	
  to	
  observe	
  these	
  warnings	
  may	
  expose	
  patient	
  to	
  non-­‐sterile	
  material.	
  
• The	
  Verasense™	
  Knee	
  System	
  device	
  consists	
  of	
  sophisticated	
  calibrated	
  internal	
  microelectronics.	
  	
  Avoid	
  direct	
  impact	
  with	
  
mallet	
  or	
  other	
  instruments	
  when	
  possible.	
  
• Handle	
  VERASENSE™	
  Knee	
  System	
  device	
  with	
  care	
  when	
  inserting,	
  adjusting	
  shim	
  size	
  or	
  removing	
  from	
  tibial	
  tray.	
  
• Do	
  not	
  forcibly	
  impact	
  femoral	
  implant	
  trial	
  onto	
  the	
  VERASENSE	
  Knee	
  System	
  device	
  placed	
  in	
  tibial	
  tray.	
  	
  	
  
• Do	
  not	
  attempt	
  to	
  use	
  the	
  VERASENSE	
  Knee	
  System	
  device	
  without	
  selection	
  and	
  use	
  of	
  proper	
  shim	
  and	
  appropriate	
  sized	
  
tibial	
  tray.	
  
• When	
  attaching	
  Shim	
  to	
  the	
  VERASENSE	
  Knee	
  System	
  device,	
  take	
  care	
  and	
  caution	
  to	
  properly	
  slide	
  shim	
  onto	
  device	
  by	
  
engaging/snapping	
  components	
  together.	
  	
  When	
  detaching	
  a	
  Shim	
  from	
  the	
  VERASENSE	
  Knee	
  System	
  device,	
  detach	
  anterior	
  
lip	
  first,	
  do	
  not	
  pry	
  off	
  posterior	
  edge.	
  	
  	
  
  
USER/PATIENT SAFETY
• VERASENSE	
  Knee	
  System	
  device	
  and	
  Shim	
  Sets	
  are	
  supplied	
  as	
  single-­‐use	
  sterile.	
  Do	
  not	
  reuse	
  or	
  re-­‐sterilize.	
  
• If	
  VERASENSE	
  Knee	
  System	
  device	
  or	
  Shim	
  Set	
  packaging	
  is	
  open	
  or	
  damaged,	
  do	
  not	
  use	
  and	
  immediately	
  return	
  to	
  
OrthoSensor.	
  	
  
• Do	
  not	
  use	
  VERASENSE	
  Knee	
  System	
  device	
  after	
  the	
  expiration	
  date	
  on	
  the	
  package	
  labeling.	
  
• Do	
  not	
  use	
  the	
  VERASENSE	
  Knee	
  System	
  device	
  in	
  a	
  tibial	
  tray	
  without	
  a	
  Shim	
  attached.	
  
• The	
  measurement	
  load	
  range	
  of	
  the	
  VERASENSE	
  Knee	
  System	
  device	
  is	
  5	
  to	
  40	
  pounds	
  per	
  condyle.	
  	
  Contact	
  OrthoSensor	
  for	
  
additional	
  data	
  regarding	
  device	
  accuracy.	
  	
  
• Maximum	
  safe	
  allowable	
  load	
  for	
  the	
  VERASENSE	
  Knee	
  System	
  device	
  is	
  70	
  lbs	
  per	
  compartment.	
  
  LB-­‐03000-­‐012	
  Rev	
  1	
  
August	
  2013	
  
For	
  further	
  information,	
  contact	
  the	
  OrthoSensor	
  Customer	
  Service	
  Center	
  by	
  phone	
  at	
  954-­‐577-­‐7770	
  or	
  by	
  e-­‐mail	
  at	
  
customerservice@orthosensor.com	
  or	
  go	
  to	
  www.orthosensor.com.	
  
  
  
OrthoSensor,	
  Inc	
  
th
1560	
  Sawgrass	
  Corporate	
  Pkwy,	
  4 	
  Floor	
  
Sunrise	
  FL,	
  33323	
  
www.orthosensor.com	
  
  
  
  
  
  
  
• If	
  maximum	
  safe	
  allowable	
  load	
  of	
  70	
  lbs	
  is	
  reached	
  in	
  either	
  compartment,	
  the	
  VERASENSE	
  Knee	
  System	
  device	
  must	
  be	
  
removed	
  from	
  the	
  knee	
  joint	
  and	
  “re-­‐zero’d”	
  by	
  holding	
  down	
  the	
  “CONTROL”	
  key	
  and	
  pressing	
  the	
  letter	
  “Z”	
  key	
  on	
  the	
  
OrthoSensor	
  LinkStation	
  keyboard	
  to	
  recalibrate	
  the	
  device.	
  	
  
• If	
  the	
  physician	
  perceives	
  a	
  difference	
  between	
  the	
  loads	
  displayed	
  on	
  the	
  screen	
  and	
  the	
  physical	
  feel,	
  the	
  physician	
  should	
  
either	
  replace	
  the	
  device	
  or	
  continue	
  the	
  procedure	
  using	
  their	
  standard	
  instrumented	
  trial	
  technique	
  and	
  best	
  clinical	
  
judgment.	
  	
  
• Do	
  not	
  load	
  the	
  VERASENSE	
  Knee	
  System	
  device	
  at	
  its	
  edges.	
  
• Do	
  not	
  subject	
  VERASENSE	
  Knee	
  System	
  device	
  or	
  Shims	
  to	
  loads	
  beyond	
  the	
  maximum	
  allowable	
  load.	
  	
  
• Do	
  not	
  impact	
  /	
  hit	
  the	
  VERASENSE	
  Knee	
  System	
  device	
  or	
  any	
  objects	
  in	
  contact	
  with	
  the	
  device	
  as	
  this	
  may	
  result	
  in	
  damage	
  
to	
  its	
  exterior	
  casing.	
  
• Do	
  not	
  use	
  a	
  prying	
  device	
  during	
  surgical	
  procedure	
  while	
  the	
  VERASENSE	
  Knee	
  System	
  device	
  	
  is	
  in	
  place	
  as	
  this	
  may	
  result	
  
in	
  damage	
  to	
  the	
  exterior	
  of	
  the	
  device.	
  
• The	
  VERASENSE	
  Knee	
  System	
  device	
  contains	
  non-­‐sterile,	
  non-­‐medical	
  grade	
  internal	
  components.	
  If	
  the	
  device	
  housing	
  is	
  
damaged	
  or	
  cracked	
  during	
  the	
  procedure,	
  take	
  appropriate	
  steps	
  to	
  promote	
  patient	
  safety.	
  
• Do	
  not	
  disassemble	
  or	
  otherwise	
  modify	
  the	
  VERASENSE	
  Knee	
  System	
  device	
  or	
  Shims.	
  	
  
• Do	
  not	
  use	
  VERASENSE	
  Knee	
  System	
  device	
  if	
  it	
  appears	
  to	
  be	
  functioning	
  improperly.	
  
• Observe	
  all	
  warnings	
  and	
  alarms	
  generated	
  by	
  the	
  OrthoSensor	
  LinkStation.	
  	
  
• Federal	
  law	
  restricts	
  this	
  device	
  to	
  sale	
  by	
  or	
  on	
  the	
  order	
  of	
  a	
  licensed	
  physician.	
  
  
INSTRUCTIONS
1. Determine	
  the	
  specific	
  size	
  VERASENSE	
  Knee	
  System	
  device	
  required.	
  	
  Remove	
  pouched	
  Shims	
  and	
  device	
  from	
  the	
  
box	
  and	
  put	
  on	
  the	
  shelf	
  of	
  the	
  OrthoSensor	
  LinkStation.	
  DO	
  NOT	
  OPEN	
  POUCH	
  SEALS.	
  
2. Record	
  VERASENSE	
  Knee	
  System	
  device	
  serial	
  number	
  (S/N)	
  onto	
  patient	
  and	
  hospital	
  records	
  as	
  required.	
  
3. To	
  activate	
  the	
  VERASENSE	
  Knee	
  System	
  device:	
  
a. Locate	
  the	
  VERASENSE	
  icon	
  on	
  the	
  screen	
  of	
  the	
  LinkStation	
  and	
  double	
  click	
  the	
  icon	
  to	
  activate	
  the	
  
VERASENSE	
  Software	
  Application.	
  
b. With	
  the	
  product	
  still	
  in	
  the	
  sealed	
  pouches,	
  place	
  the	
  device	
  directly	
  over	
  the	
  magnet	
  on	
  LinkStation	
  shelf;	
  
an	
  orange	
  LED	
  light	
  will	
  illuminate	
  on	
  the	
  articulating	
  surface	
  of	
  the	
  device.	
  Do	
  not	
  move	
  the	
  device	
  until	
  
you	
  observe	
  the	
  following:	
  	
  	
  
i. LED	
  turns	
  off	
  after	
  approximately	
  four	
  (4)	
  seconds.	
  
ii. VERASENSE	
  Knee	
  System	
  User	
  Software	
  launches.	
  
iii. Initialization	
  progress	
  bar	
  appears	
  and	
  completes.	
  
iv. Prompt	
  to	
  select	
  left	
  or	
  right	
  leg	
  appears	
  
c. Device	
  may	
  now	
  be	
  removed	
  from	
  magnet.	
  
4. The	
  VERASENSE	
  Knee	
  System	
  Software	
  will	
  automatically	
  prompt	
  selection	
  of	
  left	
  or	
  right	
  leg.	
  Select	
  appropriate	
  leg.	
  
5. Zero	
  Device	
  
  
a. Follow	
  on	
  screen	
  instructions	
  to	
  zero	
  the	
  VERASENSE Knee	
  System	
  device.	
  
6. With	
  the	
  VERASENSE	
  Knee	
  System	
  device	
  now	
  activated,	
  pass	
  the	
  sealed	
  pouches	
  to	
  the	
  nurses	
  within	
  the	
  sterile	
  field	
  
of	
  the	
  OR.	
  
7. Open	
  double	
  sealed	
  pouches	
  per	
  hospital	
  protocol	
  (VERASENSE	
  Knee	
  System	
  device	
  and	
  Shim	
  Set.)	
  
8. With	
  device	
  and	
  Shims	
  removed	
  from	
  the	
  pouches,	
  apply	
  designated	
  Shim	
  to	
  underside	
  of	
  device.	
  
9. To	
  remove	
  the	
  Shim,	
  or	
  exchange	
  for	
  another	
  size,	
  simply	
  unsnap	
  the	
  anterior	
  lip	
  of	
  the	
  attached	
  Shim	
  and	
  replace.	
  	
  
10. With	
  the	
  VERASENSE	
  Knee	
  System	
  device	
  	
  and	
  Shim	
  attached,	
  physician	
  should	
  manually	
  compress	
  /	
  apply	
  load	
  to	
  the	
  
device	
  and	
  verify	
  the	
  response	
  on	
  the	
  User	
  Interface	
  prior	
  to	
  placing	
  VERASENSE	
  Knee	
  System	
  device	
  into	
  the	
  tibial	
  
tray.	
  	
  
11. Confirm	
  that	
  the	
  VERASENSE	
  Knee	
  System	
  device	
  with	
  Shim	
  is	
  fully	
  seated	
  when	
  placed	
  in	
  the	
  tibial	
  tray.	
  
12. Flex	
  the	
  joint	
  throughout	
  its	
  full	
  range	
  of	
  motion	
  to	
  ensure	
  appropriate	
  response	
  on	
  the	
  User	
  Interface.	
  
13. Proceed	
  with	
  total	
  knee	
  replacement	
  process	
  per	
  physician	
  /	
  hospital	
  protocol.	
  
14. Upon	
  completion	
  of	
  the	
  procedure,	
  deactivate	
  the	
  VERASENSE	
  Knee	
  System	
  Software	
  Application	
  by	
  pressing	
  the	
  
Power	
  Button	
  on	
  the	
  User	
  Interface.	
  
15. Dispose	
  of	
  VERASENSE	
  Knee	
  System	
  device	
  per	
  institutional	
  guidelines	
  for	
  biohazardous	
  medical	
  waste.	
  
  
  
  
  
  
  
  LB-­‐03000-­‐012	
  Rev	
  1	
  
August	
  2013	
  
For	
  further	
  information,	
  contact	
  the	
  OrthoSensor	
  Customer	
  Service	
  Center	
  by	
  phone	
  at	
  954-­‐577-­‐7770	
  or	
  by	
  e-­‐mail	
  at	
  
customerservice@orthosensor.com	
  or	
  go	
  to	
  www.orthosensor.com.	
  
  
  
OrthoSensor,	
  Inc	
  
th
1560	
  Sawgrass	
  Corporate	
  Pkwy,	
  4 	
  Floor	
  
Sunrise	
  FL,	
  33323	
  
www.orthosensor.com	
  
  
  
  
  
  
  
  
  
  
  
VERASENSETM TROUBLESHOOTING
  
Issue	
  
VERASENSE	
  Device	
  LED	
  does	
  not	
  light	
  up	
  
VERASENSE	
  Device	
  not	
  transmitting	
  data	
  
to	
  LinkStation	
  
Cause	
  
VERASENSE	
  Device	
  batteries	
  are	
  dead	
  
VERASENSE	
  Device	
  is	
  out	
  of	
  wireless	
  
range	
  
VERASENSE	
  Device	
  is	
  powered	
  off	
  
VERASENSE	
  Device	
  batteries	
  are	
  low	
  
VERASENSE	
  Device	
  breakage	
  
VERASENSE	
  Device	
  loaded	
  beyond	
  limit	
  
Lag	
  in	
  reported	
  data	
  
Software	
  latency	
  
Solution	
  
Discard	
   VERASENSE	
   Device	
   and	
  
replace	
  
Move	
  LinkStation	
  closer	
  to	
  VERASENSE	
  
Device	
  
Move	
   LinkStation	
   to	
   achieve	
   an	
  
unobstructed	
   line-­‐of-­‐sight	
   to	
   the	
  
VERASENSE	
  Device	
  field	
  of	
  use	
  
Activate	
  with	
  LinkStation	
  magnet	
  
Discard	
   VERASENSE	
   Device	
   and	
  
replace	
  
VERASENSE	
  
Device	
  
internal	
  
components	
   are	
   non-­‐sterile	
   and	
   non-­‐
medical	
   grade.	
   	
   Ensure	
   patient	
   safety.	
  	
  
Discard	
  Device	
  and	
  replace	
  
Maintain	
   knee	
   position	
   until	
   data	
  
settles	
  (approximately	
  5	
  seconds)	
  
  
VERASENSE™ KNEE SYSTEM DEVICE SPECIFICATIONS
This	
  device	
  complies	
  with	
  Part	
  15	
  of	
  the	
  FCC	
  Rules.	
  Operation	
  is	
  subject	
  to	
  the	
  following	
  two	
  conditions:	
  (1)	
  this	
  device	
  may	
  not	
  
cause	
  harmful	
  interference,	
  and	
  (2)	
  this	
  device	
  must	
  accept	
  any	
  interference	
  received,	
  including	
  interference	
  that	
  may	
  cause	
  
undesired	
  operation.	
  
  
This	
   equipment	
   has	
   been	
   tested	
   and	
   found	
   to	
   comply	
   with	
   the	
   EMC	
   limits	
   for	
   the	
   Medical	
   Device	
   Directive	
   93/42/EEC	
   (EN	
  
55011	
  Class	
  B	
  and	
  EN	
  60601-­‐1-­‐2.)	
  	
  These	
  limits	
  are	
  designed	
  to	
  provide	
  reasonable	
  protection	
  against	
  harmful	
  interference	
  in	
  a	
  
typical	
  medical	
  installation.	
  	
  This	
  equipment	
  generates,	
  uses,	
  and	
  can	
  radiate	
  radio	
  frequency	
  energy	
  and,	
  if	
  not	
  installed	
  and	
  
used	
  in	
  accordance	
  with	
  the	
  instructions,	
  may	
  cause	
  harmful	
  interference	
  to	
  other	
  devices	
  in	
  the	
  vicinity.	
  	
  However,	
  there	
  is	
  no	
  
guarantee	
  that	
  interference	
  will	
  not	
  occur	
  in	
  a	
  particular	
  installation.	
  	
  If	
  this	
  equipment	
  does	
  cause	
  harmful	
  interference,	
  which	
  
can	
  be	
  determined	
  by	
  turning	
  the	
  equipment	
  off	
  and	
  on,	
  the	
  user	
  is	
  encouraged	
  to	
  try	
  to	
  correct	
  the	
  interference	
  by	
  one	
  or	
  
more	
  of	
  the	
  following	
  measures:	
  
-­‐
-­‐
-­‐
Reorient	
  or	
  relocate	
  the	
  receiving	
  device	
  
Increase	
  the	
  separation	
  between	
  the	
  equipment.	
  
Consult	
  OrthoSensor	
  for	
  help.	
  
  
This	
   device	
   complies	
   with	
   Part	
   95	
   of	
   the	
   FCC	
   rules.	
   	
   This	
   device	
   may	
   not	
   interfere	
   with	
   stations	
   operating	
   in	
   the	
   400.150–
406.000	
   MHz	
   band	
   in	
   the	
   Meteorological	
   Aids,	
   Meteorological	
   Satellite,	
   and	
   Earth	
   Exploration	
   Satellite	
   Services	
   and	
   must	
  
accept	
  any	
  interference	
  received,	
  including	
  interference	
  that	
  may	
  cause	
  undesired	
  operation.	
  
  
Modification	
  of	
  this	
  device	
  may	
  void	
  the	
  user’s	
  authority	
  to	
  operate	
  the	
  equipment	
  under	
  the	
  FCC	
  rules	
  above.	
  
  
  
  
  
  
  
  
  
  
  LB-­‐03000-­‐012	
  Rev	
  1	
  
August	
  2013	
  
For	
  further	
  information,	
  contact	
  the	
  OrthoSensor	
  Customer	
  Service	
  Center	
  by	
  phone	
  at	
  954-­‐577-­‐7770	
  or	
  by	
  e-­‐mail	
  at	
  
customerservice@orthosensor.com	
  or	
  go	
  to	
  www.orthosensor.com.	
  
  
  
OrthoSensor,	
  Inc	
  
th
1560	
  Sawgrass	
  Corporate	
  Pkwy,	
  4 	
  Floor	
  
Sunrise	
  FL,	
  33323	
  
www.orthosensor.com	
  
  
  
  
  
  
  
  
  
Model:	
   VERASENSE™	
  Knee	
  System	
  
Quantity:	
   1	
  
  
Type:	
   Single	
  Procedure	
  Only.	
  Do	
  not	
  re-­‐sterilize	
  
Sterile:	
   Ethylene	
  Oxide	
  
Device	
  Type:	
   Type	
  BF	
  
  
XNL-­‐ORTHOSNSR1	
  
FCC	
  ID:	
   XNL-­‐ORTHOSNSR2	
  
XNL-­‐ORTHOSNSR3
Operating	
  Range:	
  
6.5 ft [2m] Unobstructed
Mode	
  of	
  Operation:	
   Temporary	
  (single-­‐use)	
  
  
Power	
  Supply:	
   Internally	
  powered	
  at	
  less	
  than	
  3.3	
  VDC	
  
Battery	
  Life:	
   40	
  minutes	
  (approximate)	
  
Temperature:	
  
Relative	
  Humidity:	
  
Operation	
  
15°C
37°C
30%	
  	
  	
  	
  	
  	
  	
  100%,	
  submersion	
  
Storage	
  
0°C
50°C
10%	
  	
  	
  	
  	
  	
  	
  50%,	
  non-­‐condensing	
  
Atm	
  Pressure:	
  
470-­‐1060	
  hPa	
  
360-­‐1060	
  hPa
Rx	
  Only:	
   U.S.	
  Federal	
  Law	
  restricts	
  this	
  product	
  to	
  sale	
  by	
  or	
  on	
  the	
  order	
  of	
  a	
  physician	
  
  
  
  
  LB-­‐03000-­‐012	
  Rev	
  1	
  
August	
  2013	
  
For	
  further	
  information,	
  contact	
  the	
  OrthoSensor	
  Customer	
  Service	
  Center	
  by	
  phone	
  at	
  954-­‐577-­‐7770	
  or	
  by	
  e-­‐mail	
  at	
  
customerservice@orthosensor.com	
  or	
  go	
  to	
  www.orthosensor.com.	
  
  
  
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Description                     : 
Title                           : LB-03000-012 Rev 1 - OrthoSensor Verasense Knee System Instructions for Use - need ISO font-1-1 (3)
Create Date                     : 2013:08:22 20:26:55Z
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Author                          : Martha Garay
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FCC ID Filing: XNL-ORTHOSNSR5

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