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February 20 © 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.
Using Canted Coil Springs to Improve
Cleanability & Functionality in
Surgical Instruments/Orthopedicdevices
David Fogel
Business Development Director
Bal Seal Engineering
www.balseal.com
Slide 2
February 20 © 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
February 20 © 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
February 20 © 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
February 20 © 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
February 20 © 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
February 20 © 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
February 20 © 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
February 20 © 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
February 20 © 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
February 20 © 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
February 20 © 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
February 20 © 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.
Identification Article Number µg/mL µg/article µg/cm2 SponsorPerformance
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 Control 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
February 20 © 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.
Identification Article Number Net µg/mL µg/article µg/cm2 SponsorPerformance
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 Control 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
February 20 © 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
February 20 © 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
February 20 © 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
marketing@balseal.com www.balseal.com +1 949.460.2100 Design request form
David Fogel
Director of Business
Development
Bal Seal Engineering
+1 949.460.2241
dfogel@balseal.com

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Using Canted Coil Springs to Improve Cleanability & Functionality in Surgical/Orthopedic Instruments

  • 1. February 20 © 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. Using Canted Coil Springs to Improve Cleanability & Functionality in Surgical Instruments/Orthopedicdevices David Fogel Business Development Director Bal Seal Engineering www.balseal.com
  • 2. Slide 2 February 20 © 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 February 20 © 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 February 20 © 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 February 20 © 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 February 20 © 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 February 20 © 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 February 20 © 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 February 20 © 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 February 20 © 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 February 20 © 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 February 20 © 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 February 20 © 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. Identification Article Number µg/mL µg/article µg/cm2 SponsorPerformance 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 Control 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 February 20 © 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. Identification Article Number Net µg/mL µg/article µg/cm2 SponsorPerformance 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 Control 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 February 20 © 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 February 20 © 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 February 20 © 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 marketing@balseal.com www.balseal.com +1 949.460.2100 Design request form David Fogel Director of Business Development Bal Seal Engineering +1 949.460.2241 dfogel@balseal.com