Leveraging Springs to Optimize Surgical Instrument/Orthopedic Device Cleanability & Functionality

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
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1014 BA Amsterdam, The
Netherlands
Phone: +31 20 638 6523
FAX: +31 20 625 6018
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Tower
178 Gloucester Road, Wanchai,
Hong Kong
Telephone +852 28681860
Fax +852 22956753