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March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be
reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal
Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY
and products may not be manufactured, or caused to be manufactured, by any other party.
Leveraging Springs to Optimize Surgical
Instrument/Orthopedic Device Cleanability
& Functionality
www.balseal.com
Slide 2
March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be
reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal
Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY
and products may not be manufactured, or caused to be manufactured, by any other party.
Surgical Instruments/Orthopedic
Devices
• Types:
 Surgical
instruments
 Extractors
 Retractors
 Cutters
 Debridement tools
 Orthopedic devices
 Fusion & fixation
systems
 Joint replacement
systems
Slide 3
March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be
reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal
Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY
and products may not be manufactured, or caused to be manufactured, by any other party.
Surgical Instruments/Orthopedic Devices Must …
• Withstand repeated exposure to
gamma and electron-beam
radiation, autoclave, gas, other
sterilization methods
• Be made from biocompatible
materials like stainless steel,
MP35N or titanium (exposure to
saline, blood, tissue, bone)
• Provide reliable, repeatable
service over thousands of cycles
• Offer haptic and audible
connection feedback, for end-user
confidence
Slide 4
March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be
reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal
Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY
and products may not be manufactured, or caused to be manufactured, by any other party.
Surgical Instruments/Orthopedic Devices
•Engineering challenges:
 Enable surgeons to mate parts
accurately and reliably while
meeting strict FDA
requirements for
cleanability/reusability
 Simplify designs – do more
with less
Slide 5
March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be
reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal
Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY
and products may not be manufactured, or caused to be manufactured, by any other party.
Fasteners
Types • Ball detents
• Collet locks
• Clips
• Other technologies
Goals • Physically connect &
& align
• Allow for
insertion/removal
with consistent,
repeatable forces
• Fit within space
budget
• Meet FDA
cleanability
requirements
Critical Components: Fasteners
• Eventually, all
surgical/orthopedic
equipment designers
need to:
 Latch
 Lock
 Hold
• Choosing the right
fastening components
for the job can improve
cleanability, as well as
functionality
Slide 6
March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be
reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal
Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY
and products may not be manufactured, or caused to be manufactured, by any other party.
Fasteners: Canted Coil Spring
• Precisely controllable insertion
& removal forces
 Latches, locks, holds
• Compact, space-saving footprint
• Replaces complex components,
simplifies assembly and
maintenance
Slide 7
March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be
reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal
Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY
and products may not be manufactured, or caused to be manufactured, by any other party.
Canted Coil Spring: Deflection
Linear springs
Canted coil springs
Deflected ID
Relaxed ID
Slide 8
March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be
reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal
Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY
and products may not be manufactured, or caused to be manufactured, by any other party.
Canted Coil Spring: Application Examples
Tibial Trial Spinal Fixation Device Surgical Retractor
Slide 9
March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be
reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal
Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY
and products may not be manufactured, or caused to be manufactured, by any other party.
Spring Design Considerations
• Geometry
 Can be engineered to deflect in either
an axial or radial orientation
 Sizes available in welded rings from
0.020 in (0.51 mm) to 300 in (7620
mm)
• Force
 Near constant deflection force
 Usable force is created by
compressing coil height
 Flat spring force curve over wide
deflection range
• Tolerances
 Spring allows for up to 5° angular
misalignment (vs. 2° with other
technology)
Radial
Axial
Slide 10
March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be
reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal
Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY
and products may not be manufactured, or caused to be manufactured, by any other party.
90°
F90
F0
F0
F30
F30
F90
30° F60
F60
60°
Spring Groove Geometry
• Can be engineered to …
 Control contact angle
 Provide low insertion, high
removal forces
• Groove type informs
function
 Hold
 Latch
 Pre-load
 Lock
 Lock & quick release
(LQR®
)
Minimum
Force
Very High Force
(Spring Damage)
Force
Contact Location Angle with
Relative to End of Coil Height
60°
30°
0° 90°
Slide 11
March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be
reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal
Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY
and products may not be manufactured, or caused to be manufactured, by any other party.
Spring Cleanability: Testing
• Bal Spring® canted coil
springs (manufactured by
Bal Seal Engineering) were
tested to meet
requirements of AAMI
TIR30:2011*
 Fully immersed in blood soil
for a minimum of 15
minutes
 Dried at room temperature
for a minimum of 1 hour
*Results excerpted from independent test
report. Tests conducted by Nelson
Laboratories, May 12, 2017
Slide 12
March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be
reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal
Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY
and products may not be manufactured, or caused to be manufactured, by any other party.
Spring Cleanability: Test Conditions
• Manual cleaning
 Rinsed under cool, running tap water
 Soft-bristled brush used to scrub
 Soak in Enzol enzymatic detergent
for a minimum of 1 minute
 Brushed with a pipe cleaner for a
minimum of 1 minute
 Rinsed under running, warm tap
water
 Dried with a clean, soft, lint-free
cloth and pressurized air
• Automated washer
 Dunnage devices added to washer to
simulate a maximum load
 Prewash (cold water), enzyme wash
(Enzol), wash (Prolystica), rinse
(purified distilled water) dry
Slide 13
March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be
reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal
Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY
and products may not be manufactured, or caused to be manufactured, by any other party.
Automated Hemoglobin Test: The limit of Detection (LOD) for the method was calculated to be 0.50 µg/mL. This
value was used in the calculations for test articles with results below the detection limit. The Limit of Quantitation
(LOQ) for the method was calculated to be 1.6 µg/mL. If the µg/mL value was between the LOD and the LOQ, the
calculated results are estimates. The hemoglobin concentrations are the average of three replicates.
Identificatio
n
Article Number µg/mL µg/article µg/cm2 Sponsor
Performance
Criteria
Ported
1 0.63 5.7 0.77 Met
Negative Article 0.62 5.6 0.76 N/A
Positive Device
Control
230 2,100 280 N/A
Solid
1 <0.50 <0.45 <0.64 Met
Negative Article 0.65 6.0 0.84 N/A
Positive Device 230 2,000 290 N/A
Spring Cleanability: Hemoglobin Results
Manual Hemoglobin Test: The limit of Detection (LOD) for the method was calculated to be 0.16 µg/mL. This value
was used in the calculations for test articles with results below the detection limit. The Limit of Quantitation (LOQ) for
the method was calculated to be 0.5 µg/mL. If the µg/mL value was between the LOD and the LOQ, the calculated
results are estimates. The hemoglobin concentrations are the average of three replicates.
Article Number µg/mL µg/article µg/cm2
1 <0.16 <3.2 <0.37
2 0.18 3.6 0.42
3 0.34 6.8 0.79
Negative Article 1.3 25 2.9
Positive Article 2.4 4,800 560
Slide 14
March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be
reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal
Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY
and products may not be manufactured, or caused to be manufactured, by any other party.
Automated Micro BCATM Protein Test : The limit of Detection (LOD) for the method was calculated to be 1.1 µg/mL.
This value was used in the calculations for test articles with results below the detection limit. The Limit of
Quantitation (LOQ) for the method was calculated to be 2.0 µg/mL. If the µg/mL value was between the LOD and
the LOQ, the calculated results are estimates. The hemoglobin concentrations are the average of three replicates.
Identificatio
n
Article Number Net µg/mL µg/article µg/cm2 Sponsor
Performance
Criteria
Ported
1 <1.1 <9.9 <1.3 Met
Negative Article <1.1 <9.9 <1.3 N/A
Positive Device
Control
850 7,700 1,000 N/A
Solid
1 <1.1 <9.9 <1.4 Met
Negative Article <1.1 <9.9 <1.4 N/A
Positive Device 710 6,400 910 N/A
Spring Cleanability: Micro BCATM Protein Results
Manual Micro BCATM Protein Test: The limit of Detection (LOD) for the assay was calculated to be 1.1 µg/mL. This
value was used in the calculations for test articles that had absorbances below the detection limit. The Limit of
Quantitation (LOQ) for the assay was calculated to be 2.0 µg/mL. If the µg/mL was between the LOD and the LOQ,
the calculated results are estimates.
Article Number Net µg/mL µg/article µg/cm2
1 <1.1 <22 <2.6
2 <1.1 <22 <2.6
3 2.3 46 5.3
Negative Article 1.4 28 3.2
Positive Article 590 12,000 1,400
Slide 15
March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be
reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal
Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY
and products may not be manufactured, or caused to be manufactured, by any other party.
Canted Coil Spring: A 3-in-1 Solution
Canted coil springs,
with their ability
mechanically
connect, conduct
power AND shield
against EMI, can help
boost performance
while simplifying
device design and
maintenance.
Slide 16
March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be
reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal
Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY
and products may not be manufactured, or caused to be manufactured, by any other party.
Summary & Recommendations
• To eliminate costly mistakes and delays,
consider fastening, requirements as part
of overall instrument/device design
• Choose a component that’s tested and
proven to meet FDA cleanability standards
• In early design stages, collaborate with
Bal Seal Engineering to:
 Get consultative engineering advice
 Review hardware design
 Engage in collaborative spring design
discussion
 Custom design a spring solution that
meets all your system/application
requirements
 Determine recommended test failure
criteria
 Produce high-quality prototypes
 Scale up to full production
Slide 17
March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be
reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal
Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY
and products may not be manufactured, or caused to be manufactured, by any other party.
Resources & Contact Information
solutions@balseal.co
m
www.balseal.com +1 949.460.2100 Design request form
Americas
Bal Seal Engineering
19650 Pauling, Foothill Ranch, CA
92610-2610
Telephone +1 949 460 2100 or
Toll Free +1 800 366 1006
Fax +1 949 460 2300
Europe, Middle East, Africa
Bal Seal Engineering Europe BV
VIDA Building, 1st Floor
Kabelweg 57
1014 BA Amsterdam, The
Netherlands
Phone: +31 20 638 6523
FAX: +31 20 625 6018
Asia Pacific
Bal Seal Engineering
Suite 901, Chinachem Century
Tower
178 Gloucester Road, Wanchai,
Hong Kong
Telephone +852 28681860
Fax +852 22956753

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Springs for Optimized Cleanability & Functionality - 03-23-23.pptx

  • 1. March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party. Leveraging Springs to Optimize Surgical Instrument/Orthopedic Device Cleanability & Functionality www.balseal.com
  • 2. Slide 2 March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party. Surgical Instruments/Orthopedic Devices • Types:  Surgical instruments  Extractors  Retractors  Cutters  Debridement tools  Orthopedic devices  Fusion & fixation systems  Joint replacement systems
  • 3. Slide 3 March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party. Surgical Instruments/Orthopedic Devices Must … • Withstand repeated exposure to gamma and electron-beam radiation, autoclave, gas, other sterilization methods • Be made from biocompatible materials like stainless steel, MP35N or titanium (exposure to saline, blood, tissue, bone) • Provide reliable, repeatable service over thousands of cycles • Offer haptic and audible connection feedback, for end-user confidence
  • 4. Slide 4 March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party. Surgical Instruments/Orthopedic Devices •Engineering challenges:  Enable surgeons to mate parts accurately and reliably while meeting strict FDA requirements for cleanability/reusability  Simplify designs – do more with less
  • 5. Slide 5 March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party. Fasteners Types • Ball detents • Collet locks • Clips • Other technologies Goals • Physically connect & & align • Allow for insertion/removal with consistent, repeatable forces • Fit within space budget • Meet FDA cleanability requirements Critical Components: Fasteners • Eventually, all surgical/orthopedic equipment designers need to:  Latch  Lock  Hold • Choosing the right fastening components for the job can improve cleanability, as well as functionality
  • 6. Slide 6 March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party. Fasteners: Canted Coil Spring • Precisely controllable insertion & removal forces  Latches, locks, holds • Compact, space-saving footprint • Replaces complex components, simplifies assembly and maintenance
  • 7. Slide 7 March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party. Canted Coil Spring: Deflection Linear springs Canted coil springs Deflected ID Relaxed ID
  • 8. Slide 8 March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party. Canted Coil Spring: Application Examples Tibial Trial Spinal Fixation Device Surgical Retractor
  • 9. Slide 9 March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party. Spring Design Considerations • Geometry  Can be engineered to deflect in either an axial or radial orientation  Sizes available in welded rings from 0.020 in (0.51 mm) to 300 in (7620 mm) • Force  Near constant deflection force  Usable force is created by compressing coil height  Flat spring force curve over wide deflection range • Tolerances  Spring allows for up to 5° angular misalignment (vs. 2° with other technology) Radial Axial
  • 10. Slide 10 March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party. 90° F90 F0 F0 F30 F30 F90 30° F60 F60 60° Spring Groove Geometry • Can be engineered to …  Control contact angle  Provide low insertion, high removal forces • Groove type informs function  Hold  Latch  Pre-load  Lock  Lock & quick release (LQR® ) Minimum Force Very High Force (Spring Damage) Force Contact Location Angle with Relative to End of Coil Height 60° 30° 0° 90°
  • 11. Slide 11 March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party. Spring Cleanability: Testing • Bal Spring® canted coil springs (manufactured by Bal Seal Engineering) were tested to meet requirements of AAMI TIR30:2011*  Fully immersed in blood soil for a minimum of 15 minutes  Dried at room temperature for a minimum of 1 hour *Results excerpted from independent test report. Tests conducted by Nelson Laboratories, May 12, 2017
  • 12. Slide 12 March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party. Spring Cleanability: Test Conditions • Manual cleaning  Rinsed under cool, running tap water  Soft-bristled brush used to scrub  Soak in Enzol enzymatic detergent for a minimum of 1 minute  Brushed with a pipe cleaner for a minimum of 1 minute  Rinsed under running, warm tap water  Dried with a clean, soft, lint-free cloth and pressurized air • Automated washer  Dunnage devices added to washer to simulate a maximum load  Prewash (cold water), enzyme wash (Enzol), wash (Prolystica), rinse (purified distilled water) dry
  • 13. Slide 13 March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party. Automated Hemoglobin Test: The limit of Detection (LOD) for the method was calculated to be 0.50 µg/mL. This value was used in the calculations for test articles with results below the detection limit. The Limit of Quantitation (LOQ) for the method was calculated to be 1.6 µg/mL. If the µg/mL value was between the LOD and the LOQ, the calculated results are estimates. The hemoglobin concentrations are the average of three replicates. Identificatio n Article Number µg/mL µg/article µg/cm2 Sponsor Performance Criteria Ported 1 0.63 5.7 0.77 Met Negative Article 0.62 5.6 0.76 N/A Positive Device Control 230 2,100 280 N/A Solid 1 <0.50 <0.45 <0.64 Met Negative Article 0.65 6.0 0.84 N/A Positive Device 230 2,000 290 N/A Spring Cleanability: Hemoglobin Results Manual Hemoglobin Test: The limit of Detection (LOD) for the method was calculated to be 0.16 µg/mL. This value was used in the calculations for test articles with results below the detection limit. The Limit of Quantitation (LOQ) for the method was calculated to be 0.5 µg/mL. If the µg/mL value was between the LOD and the LOQ, the calculated results are estimates. The hemoglobin concentrations are the average of three replicates. Article Number µg/mL µg/article µg/cm2 1 <0.16 <3.2 <0.37 2 0.18 3.6 0.42 3 0.34 6.8 0.79 Negative Article 1.3 25 2.9 Positive Article 2.4 4,800 560
  • 14. Slide 14 March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party. Automated Micro BCATM Protein Test : The limit of Detection (LOD) for the method was calculated to be 1.1 µg/mL. This value was used in the calculations for test articles with results below the detection limit. The Limit of Quantitation (LOQ) for the method was calculated to be 2.0 µg/mL. If the µg/mL value was between the LOD and the LOQ, the calculated results are estimates. The hemoglobin concentrations are the average of three replicates. Identificatio n Article Number Net µg/mL µg/article µg/cm2 Sponsor Performance Criteria Ported 1 <1.1 <9.9 <1.3 Met Negative Article <1.1 <9.9 <1.3 N/A Positive Device Control 850 7,700 1,000 N/A Solid 1 <1.1 <9.9 <1.4 Met Negative Article <1.1 <9.9 <1.4 N/A Positive Device 710 6,400 910 N/A Spring Cleanability: Micro BCATM Protein Results Manual Micro BCATM Protein Test: The limit of Detection (LOD) for the assay was calculated to be 1.1 µg/mL. This value was used in the calculations for test articles that had absorbances below the detection limit. The Limit of Quantitation (LOQ) for the assay was calculated to be 2.0 µg/mL. If the µg/mL was between the LOD and the LOQ, the calculated results are estimates. Article Number Net µg/mL µg/article µg/cm2 1 <1.1 <22 <2.6 2 <1.1 <22 <2.6 3 2.3 46 5.3 Negative Article 1.4 28 3.2 Positive Article 590 12,000 1,400
  • 15. Slide 15 March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party. Canted Coil Spring: A 3-in-1 Solution Canted coil springs, with their ability mechanically connect, conduct power AND shield against EMI, can help boost performance while simplifying device design and maintenance.
  • 16. Slide 16 March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party. Summary & Recommendations • To eliminate costly mistakes and delays, consider fastening, requirements as part of overall instrument/device design • Choose a component that’s tested and proven to meet FDA cleanability standards • In early design stages, collaborate with Bal Seal Engineering to:  Get consultative engineering advice  Review hardware design  Engage in collaborative spring design discussion  Custom design a spring solution that meets all your system/application requirements  Determine recommended test failure criteria  Produce high-quality prototypes  Scale up to full production
  • 17. Slide 17 March 23 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party. Resources & Contact Information solutions@balseal.co m www.balseal.com +1 949.460.2100 Design request form Americas Bal Seal Engineering 19650 Pauling, Foothill Ranch, CA 92610-2610 Telephone +1 949 460 2100 or Toll Free +1 800 366 1006 Fax +1 949 460 2300 Europe, Middle East, Africa Bal Seal Engineering Europe BV VIDA Building, 1st Floor Kabelweg 57 1014 BA Amsterdam, The Netherlands Phone: +31 20 638 6523 FAX: +31 20 625 6018 Asia Pacific Bal Seal Engineering Suite 901, Chinachem Century Tower 178 Gloucester Road, Wanchai, Hong Kong Telephone +852 28681860 Fax +852 22956753

Editor's Notes

  1. Accomplishing these things requires engineers to examine everything about these robots - from motors, sensor & servo systems & even plastic wrapped around them. BUT often components that seal, connect, conduct and shield are secondary design considerations – that AT BEST, don’t enhance performance or WORSE, detract from your well thought out design (e.g. resulting in excess friction in system, tolerance stack issues &/or reduced tool life). The good news is, selecting the right kind of seal, contact & conducting solution can actually ENHANCE system performance! AND, at some point, everyone has needed to consider these issues with their robot, right? Pictures below represent some tools of the trade… SEALS: Polymer & metal. Within polymer generally Elastomeric, Teflon: -Metal vs. polymer: Metal typically used at very high pressures & temps (e.g. well north of 30 KSI & 600 deg. F.) – AND tend to be more $$. Based on my understanding, most surgical robots don’t see such pressures & temps. - Within polymer E & T: Generally speaking elastomeric seals have1.) higher friction but are also more elastic. That means have shorter life, but stretch for easy installation but is prone to taking a set. MECHANICAL fasteners: Depending on solution, can be 1.) bulky, 2.) complicated (consisting of multiple components), 3.) prone to contamination & 4.) have inexact or non repeatable forces (insertion / removal). Conducting solutions: - Many options available, can vary based on your specific need for 1.) footprint (axial & radial), 2.) # of insert/removal cycles & related 3.) conductivity & heat rise Shielding: - xxxxxxxxxx
  2. Explain we engineer no std springs but oval shaped CC springs with coils under special inclination That have different features and benefits Force/Deflection Main take aways for rest Spring features: Unique force vs deflection curve Working deflection up to 35% Coils flex independently Multiple contact points Coil spacing affords for heat and media flux
  3. Latching, changing tip heads. Latching of camera assembly to rod heads – positioned and held firmly with preload so cant be bumped and knocked out of position. And easily detach to clean after surgical procedure. (after x # of cycles for a wipe down) Grounding spring closer to end effector. Slip ring, oscillate slowly. (its effectively a slip ring)…. Energy not very high…. Disposable or reusable part…
  4. These are the groove types, but we take your application into consideration. For example, if space is extra tight, we have grooves that will be maximized to decrease the space. If it’s electrical, we have special grooves to increase electrical conductivity.
  5. PURW – Sterile purified water
  6. Hemoglobin Level should be <2.2ug/cm^2 Protein Level should be <6.4ug/cm^2
  7. Hemoglobin Level should be <2.2ug/cm^2 Protein Level should be <6.4ug/cm^2