Broadley James SingleSense SU100 User manual

Operation Manual
SingleSense™Single-Use
Gas Well
Model SU100/SU110

Purpose, Scope, and Disclaimers
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Purpose
This manual provides instructions on how to operate Models SU100/SU110 SingleSense™ gas wells for use
with a bioprocess container (BPC).
Scope
This manual is for customers who purchase and use Models SU100/SU110 SingleSense™gas wells.
Precautions
This product is intended for professional use only. Follow your standard operating procedures when using this
product. Do not use the product if it is broken, defective, or visually damaged.
Disclaimers
Read all instructions prior to installing or operating this product. Save this manual for future reference.
If the instructions in this manual are unclear, contact Broadley-James. If this instruction manual is not for the product ordered, call [phone].
Follow all warnings, cautions, and instructions marked on and supplied with the product.
To ensure proper performance, use qualified personnel to install, operate, update, calibrate, and maintain the product.
This product is designed for single-use.
Third Party Content
The manual uses the trademarks and names of third parties, including Eldon James Corporation. Broadley-James Corporation and users agree that the third parties are not affiliated or partnered with Broadley-James Corporation. The mention of third parties is not an endorsement of any business offering, products, or services. Broadley-James Corporation is not liable for any products or services
of mentioned third parties or any transactions or decisions that may arise from the mention of third parties in this manual for any reason.
Model SU100/SU110 SingleSense™Gas Wells
Operation Manual

Compliance Information
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Compliance
Broadley-James Corporation confirms Models SU100/SU110 SingleSense™gas wells meet the following regulatory
and compliance standards:
CE Compliant Yes
RoHS Compliant Yes
REACH Compliant Yes
CFR 21-11 Compliant Not applicable
BSE/TSE/ADI Compliant Yes
USP Class VI Compliant Yes, all wetted parts
FDA Material Compliant Yes, all wetted parts
Wetted Materials
PEEK: USP Class VI, ADI-Free | Dimethyl Silicone Rubber: Pt Cure, USP Class VI, ADI-Free
Extractable and leachable test data based on BPOG extractable protocol and USP 665 available upon request.
Model SU100/SU110 SingleSense™Gas Wells
Operation Manual

Product Description and Symbol Definitions
Product Description
The SU100/SU110 SingleSense™gas wells are gamma sterilizable and designed for use with a BPC.
Definition of Symbols
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Catalogue number
Serial number
CE marking
Use by date
Temperature limit
Quantity
Caution
Model SU100/SU110 SingleSense™Gas Wells
Operation Manual

Table of Contents
Operation Overview 6
Step 1: How It Works 7
Step 2: Operation 11
Step 3: Post-operation Inspection 17
Appendices 29
Appendix A –Dimensional Drawing of Gas Well
Appendix B –Dimensional Drawing of Installed Gas Well
Appendix C –Dimensional Drawing of Installed Gas Well and Sensor
Appendix D –Purchasing Sheets
Appendix D –Specification Sheets
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Model SU100/SU110 SingleSense™Gas Wells
Operation Manual

Step 1
How It Works
Step 2
Operation
Step 3
Post-operation Inspection
•Essential Terms and Definitions
•Gas Well Description
•How It Operates
•Sequence of Operation
•Remove Red Safety Zip Tie and
Shipping Insert
•Insert Sensor Into Gas Well
•Inspection Checklist
Operation Overview
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Model SU100/SU110 SingleSense™Gas Wells
Operation Manual
Operation Steps

Step 1: How It Works
•Essential Terms and Definitions
•Gas Well Description
•How It Operates
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Model SU100/SU110 SingleSense™Gas Wells
Operation Manual

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1.1 Essential Terms and Definitions
The table outlines terms important to know for the operation process. See the next slide for their location on
the gas well.
1.0 How It Works Model SU100/SU110 SingleSense™Gas Wells
Operation Manual
Term Definition
Barbed feature Section of the gas well body that is used to create a seal with the silicone tube and barbed port
Eldon James barbed port A common type of industry port; the gas well is designed for use with this brand or an equivalent
Gas well body Where the sensor will be inserted
Gas well membrane Reinforced gas permeable membrane inside the gas well
Internal Pg13.5 socket Standard receptacle for a wide variety of sensors
Port gasket Creates a seal with the well to prevent dead space
Protective end cap Protects the end of the gas well during shipment
Removable red safety zip tie Keeps the shipping insert in place
Shipping insert Protects the inside of the gas well during the shipping process
Silicone tube Connects the gas well and barbed port and ensures their barbed features remain in contact
Zip Tie Secures silicone tube to barbed feature of the gas well and barbed port

1.2 Gas Well Description
Figure 1. Gas well description
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1.0 How It Works Model SU100/SU110 SingleSense™Gas Wells
Operation Manual
Note: This manual uses images of the SU100. The content in this manual is applicable to both models.
SU100 Gas Well
Gas well
body
Barbed
feature
Shipping
insert
Removeable red safety
zip tie
Zip ties

1.3 How It Operates
Figure 2. Gas well operation
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Sensor Inserted
Gas Well in Operation Mode
When a sensor is inserted into the gas well body, the steel mesh reinforced
membrane provides a sterile and gas-permeable barrier.
1.0 How It Works Model SU100/SU110 SingleSense™Gas Wells
Operation Manual
Sensor inserted into gas well
Process solution
Reinforced
membrane
Enlarged image showing reinforced membrane
The SU100 and SU110 are operated identically.
In this manual, the SU100 is shown.

Step 2: Operation
•Sequence of Operation
•Remove the Red Safety Zip Tie and Shipping Insert
•Insert Sensor Into Gas Well
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Model SU100/SU110 SingleSense™Gas Wells
Operation Manual

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2.0 Operation
2.1 Sequence of Operation
Sequence of
Operation
1. Remove the red
safety zip tie and the
shipping insert.
2. Insert your
sensor and
tighten it down.
3. Connect your
sensor to the BPC
control system.
4. Calibrate your
sensor per your
standard operating
procedures.
Model SU100/SU110 SingleSense™Gas Wells
Operation Manual

2.2 Remove and discard the red safety zip tie.
Figure 3. Removal of red safety zip tie
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2.0 Operation
Note: Remove and discard any remaining packaging material that may be wrapped around the gas well.
Model SU100/SU110 SingleSense™Gas Wells
Operation Manual
As-received SU100 with
simulated BPC
Pull red safety zip tie
in opposite directions
as shown.
Red zip tie separates along
a prescored line.

2.4 Remove and discard the shipping insert from the gas well body.
Figure 4. Shipping insert removal
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2.0 Operation
Shipping
insert
Eldon James
barbed port
installed on a
simulated BPC
(partially shown)
Model SU100/SU110 SingleSense™Gas Wells
Operation Manual
The gas well is
internally threaded
to accept a Pg13.5
threaded retainer
fitting.

2.5 Prepare a sensor for insertion.
Figure 5. Sensors compatible with SU100 series gas wells
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2.0 Operation Model SU100/SU110 SingleSense™Gas Wells
Operation Manual
•Only the following Broadley-James sensors
are compatible with the gas wells:
•Polarographic DO Sensor Model D1030
•Optical DO Model B2030
•CO2Sensor Model C3030
To ensure proper fit into the gas well, do
not install the sensor with an o-ring or
spacer. If installed, remove the o-ring and
spacer.

2.6 Insert the sensor into the gas well body.
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2.0 Operation
Figure 6. Sensor insertion into gas well body
Model SU100/SU110 SingleSense™Gas Wells
Operation Manual
Once a sensor is inserted, thread the
Pg13.5 retainer fitting and turn until
fully engaged.
Connect the sensor to the BPC control
system and calibrate per your standard
operating procedure.

Figure 7. Operational SU100
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2.0 Operation
The gas well is now operational.
Model SU100/SU110 SingleSense™Gas Wells
Operation Manual

1
Step 3: Post-operation Inspection
•Inspection Checklist
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Model SU100/SU110 SingleSense™Gas Wells
Operation Manual

3.0 Post-operation Inspection
3.1 Inspection Checklist
1. Is the Pg13.5 retainer fitting threaded down completely?
2. Is the sensor cable securely connected?
3. Is the sensor tip angled down at a 15°angle?
1
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Figure 8. Inspection checklist
Model SU100/SU110 SingleSense™Gas Wells
Operation Manual

1
Appendices
•Appendix A –Dimensional Drawing of Gas Well
•Appendix B –Dimensional Drawing of Installed Gas Well
•Appendix C –Dimensional Drawing of Installed Gas Well and Sensor
•Appendix D –Specification Sheets
•Appendix D –Purchasing Sheets
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Model SU100/SU110 SingleSense™Gas Wells
Operation Manual