Adaptec Sensica UO User manual

P/N 005-0175 Rev A © 2018 Adaptec Medical Devices, LLC
FOR ICU
INSTRUCTIONS FOR USE
Sensica™ UO System for ICU, Model No. SCCS-1001
Software Version 1.0
Manufactured by:
Adaptec Medical Devices, LLC
90 Weathers St.
Youngsville, NC 27596
[phone]

Sensica™ UO System for ICU Instructions for Use, Model No. SCCS-1001, ver. 1001
P/N 005-0175 Rev A Adaptec Medical Devices 1
Table of Contents
Introduction...................................................................................................................................... 7
Part I –Sensica™ UO System for ICU Overview .............................................................................9
Chapter 1. Device Description......................................................................................................9
1.1 Sensica UO System for ICU Hardware............................................................................. 10
1.1.1 Sensica™ UO System for ICU Stand with Attached Monitor...................................... 10
1.1.2 Sensica™ UO Patient Ring Kit: Sensica™ UO Ring (Single Patient Use).................. 11
1.1.3 Sensica™ UO Patient Kit: Sensica™ UO Tube Band with Measuring Strip ............... 12
1.2 Sensica™ UO Software/ICU: User Interface .................................................................... 13
1.2.1 Touch Screen Display................................................................................................ 13
1.2.1.2 Bag Level Fullness ................................................................................................. 14
1.2.1.3 Catheter Use Time.................................................................................................. 14
1.2.2 System Alerts ............................................................................................................ 14
1.2.3 Administrator Settings Screens.................................................................................. 14
1.2.4 On-Screen Keyboard and Calculator ......................................................................... 15
1.2.5 AKI Diagnostic Data Feature Option.......................................................................... 15
1.2.6 Urine Specific Gravity Feature Option........................................................................ 16
1.2.7 Data Button Selections.............................................................................................. 16
1.2.7.1 Data Screens.......................................................................................................... 16
1.2.7.2 Snapshot Screen.................................................................................................... 17
1.2.7.3 Summary Report .................................................................................................... 17
1.3 Operating Environment..................................................................................................... 18
1.4 Automatic Data Transmission to EHR .............................................................................. 18
Chapter 2. Labeling Symbols .................................................................................................... 19
Chapter 3. Indications for Use and Target Population .............................................................. 21
Chapter 4. Warnings and Precautions....................................................................................... 22
Part II –Sensica™ UO System for ICU Instructions for Use.......................................................... 25
Chapter 5. Initial Device Inspection and Setup.......................................................................... 25
5.1 Initial Device Inspection Procedure................................................................................... 25
5.2 Sensica™UO System Setup Procedure ........................................................................... 25
5.2.1 Plug System into Wall Supply –Charge Battery ........................................................ 25

Sensica™ UO System for ICU Instructions for Use, Model No. SCCS-1001, ver. 1001
P/N 005-0175 Rev A Adaptec Medical Devices 2
5.2.2 Power and Initialize System....................................................................................... 26
5.2.3 New Patient and Settings Selections ......................................................................... 26
Chapter 6: New Patient Setup.................................................................................................... 28
6.1 Operator PIN Entry (Optional) .......................................................................................... 28
6.2 New Patient Entry Screen................................................................................................. 28
6.2.1 Entering Patient Weight for AKI Diagnostic Data Information (optional)..................... 29
6.2.2 Entering Patient Urine Specific Gravity (optional) ...................................................... 29
6.2.3 Scan Barcode Option................................................................................................. 30
6.3 Session Start Up: Attaching Single Patient Use Ring and Tube Band .............................. 31
6.3.1 STEP ONE: Attaching Sensica™ UO Collection Bag Ring ........................................ 31
6.3.2 STEP TWO: Attaching Sensica™ UO Band and Hanging Bag .................................. 31
6.3.2.1 How to attach the tube band to the drainage tubing................................................ 32
Chapter 7: UO Monitoring Display Features............................................................................... 33
7.1 Standard Display Screen.................................................................................................. 33
7.2 Night View mode option.................................................................................................... 33
7.3 Bag level display .............................................................................................................. 34
7.4 Quarter-hour urine output feature..................................................................................... 34
7.5 UO measurement history scroll bar .................................................................................. 35
Chapter 8: Special Actions......................................................................................................... 36
8.1 Action button drop down selections.................................................................................. 36
8.1.1 Action Selection: Set Patient Alerts............................................................................ 36
8.1.2 Action Selection: Discharge Patient........................................................................... 36
8.1.3 Action Selection: Edit Catheter Use Time.................................................................. 36
8.1.4 Action Selection: Add/Subtract Fluid.......................................................................... 37
8.1.5 Action Selected: Edit Patient Weight.......................................................................... 38
8.1.6 Action Selected: Edit Specific Gravity (optional) ........................................................ 38
Chapter 9: UO Monitoring Alerts and Warnings.......................................................................... 40
9.1 System alerts.................................................................................................................... 40
9.2 System modal warnings ................................................................................................... 41
Chapter 10: Sensica™ UO System for ICU Data Screens.......................................................... 43
10.1 Data Screen Selections.................................................................................................. 43
10.1.1 Bar Graph................................................................................................................ 43
10.1.2 Table by Date.......................................................................................................... 44

Sensica™ UO System for ICU Instructions for Use, Model No. SCCS-1001, ver. 1001
P/N 005-0175 Rev A Adaptec Medical Devices 3
10.1.3 Table by Shift........................................................................................................... 45
10.2 Snapshot Screen............................................................................................................ 45
Chapter 11: Ending Patient Monitoring....................................................................................... 46
Part III - Sensica™ UO System for ICU Care and Warranty.......................................................... 47
Chapter 11: Cleaning................................................................................................................. 47
Chapter 12: Storage................................................................................................................... 48
Chapter 13: Replacement Parts................................................................................................. 49
Chapter 14: Warranty and Service ............................................................................................. 50
14.1 Factory Warranty............................................................................................................ 50
14.2 Technical Support .......................................................................................................... 50
14.3 Remote Support for Software Problems ......................................................................... 50
14.4 Defective Patient Kit Replacement Service..................................................................... 50
14.5 Hardware Repair............................................................................................................ 50
Part IV –Sensica™ UO System for ICU Administration.................................................................. 52
Chapter 15: Facility Preferences Settings................................................................................... 53
15.1 Time Display Format ...................................................................................................... 53
15.2 Date Display Format....................................................................................................... 53
15.3 Language....................................................................................................................... 53
15.4 Shift Type....................................................................................................................... 53
15.4 Shift Start Time............................................................................................................... 54
15.5 Rate Meter Update Interval............................................................................................. 54
15.6 Allow Specific Gravity Adjustment .................................................................................. 54
15.8 Set Date and Time.......................................................................................................... 54
15.9 Change Settings PIN...................................................................................................... 54
15.10 Change Operator PIN................................................................................................... 54
Chapter 16: Alerts Settings ........................................................................................................ 55
16.1 Urine Output Low Alert Setting ....................................................................................... 55
16.3 Sudden Increase Alert Setting........................................................................................ 56
16.4 Bag Full Alert Setting...................................................................................................... 56
16.5 Catheter Time Reminder Setting .................................................................................... 56
16.5 Require Operator PIN Setting......................................................................................... 56
Chapter 17. Optional Barcode Settings...................................................................................... 57
17.1 Barcode Setting Overview.............................................................................................. 57

Sensica™ UO System for ICU Instructions for Use, Model No. SCCS-1001, ver. 1001
P/N 005-0175 Rev A Adaptec Medical Devices 4
17.2 Barcode Parser Tokens.................................................................................................. 57
17.3 Parser Examples............................................................................................................ 59
Chapter 18. EHR Settings.......................................................................................................... 60
18.1 EHR Connection Type.................................................................................................... 60
18.2 Volume Observation ID .................................................................................................. 60
18.3 AKI Observation ID......................................................................................................... 60
18.4 Update Interval............................................................................................................... 60
18.5 MC Server Status........................................................................................................... 61
18.6 MC Server Button........................................................................................................... 61
18.7 Send Test Message Button ............................................................................................ 61
Chapter 19: System Information and Remote Support Access................................................... 62
19.1 Other Button –Versions Tab.......................................................................................... 62
19.2 Other Button –System Info Tab ..................................................................................... 63
Appendix A Guidance and Manufacturer’s Declarations................................................................. 64
Appendix B Instrument Specifications............................................................................................ 68
Tables
Table 1: Tasks to be Completed by Administration Before First System Use................................... 8
Table 2. KDIGO AKI Staging Criteria ............................................................................................. 16
Table 3. Sensica™ UO System for ICU Operating Environment ................................................... 18
Table 4. Sensica™ UO System for ICU Labeling Symbols............................................................. 19
Table 5. Sensica™ UO System for ICU Alerts................................................................................ 40
Table 6. Sensica™ UO System for ICU Modal Warnings............................................................... 41
Table 7. Sensica™ UO System for ICU Cleaning Information ........................................................ 47
Table 8. Sensica™ UO System for ICU Parts List.......................................................................... 49
Table 9. Barcode Parser Tokens.................................................................................................... 58
Table 10: Guidance and Manufacturer's Declaration - Electromagnetic Emissions –for all Medical
Electrical Equipment and Medical Electrical Systems..................................................................... 64
Table 11. Guidance and Manufacturer's Declaration - Electromagnetic Immunity - for all Medical
Electrical Equipment and Medical Electrical Systems..................................................................... 65
Table 12. Guidance and Manufacturer's Declaration –Electromagnetic Immunity –for all Medical
Electrical Equipment and Medical Electrical Systems that are not Life-Supporting......................... 66
Table 13. Recommended Separation Distances between Portable and Mobile RF Communications
Equipment and the Sensica™ UO System for ICU - for Medical Electrical Equipment and Medical
Electrical Systems that are not Life-Supporting.............................................................................. 67

Sensica™ UO System for ICU Instructions for Use, Model No. SCCS-1001, ver. 1001
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Figures
Figure 1: Sensica™ UO System for ICU with disposable ring .........................................................9
Figure 2: Drainage tubing tethered to Sensica™ UO Stand .......................................................... 10
Figure 3: Sensica™ UO System for ICU without ring .................................................................... 10
Figure 4: Back view of Sensica™ UO System for ICU Stand base................................................ 11
Figure 5: Sensica™ UO Ring, front and back................................................................................. 11
Figure 6: Clockwise twist-lock connection of Sensica™ UO Ring to stand ..................................... 12
Figure 7: Using Sensica™ UO Tube Band to place tubing in Sensica UO tube holder .................. 12
Figure 8: Move system using crossbar handle ............................................................................... 13
Figure 9: Sample Sensica™ UO System for ICU display screen ............................................. 13
Figure 10: Sensica™ UO System for ICU blue and red alert examples.......................................... 14
Figure 11: Administrator set up screen example ........................................................................... 15
Figure 12: Sensica™ UO System for ICU display on-screen keyboard and calculator .................. 15
Figure 13: Sensica™ UO Display with data screen examples ....................................................... 16
Figure 14: Sensica™ UO Display with Snapshot screen example................................................. 17
Figure 15: Summary Report example............................................................................................. 17
Figure 16: Sensica™ UO System for ICU Relay Software ............................................................. 18
Figure 17: Sensica™ UO System for ICU Initialization Screen...................................................... 26
Figure 18: New Patient and Settings Selection Screen ................................................................. 27
Figure 19: Operator PIN Entry Screen .......................................................................................... 28
Figure 20: New Patient Entry Screen ............................................................................................ 28
Figure 21: Patient Weight Entry Screen ......................................................................................... 29
Figure 22: Specific Gravity Entry Screen........................................................................................ 30
Figure 23: Barcode Scanner Screen.............................................................................................. 30
Figure 24: Session Start Up Wizard STEP ONE: Attaching Ring ................................................... 31
Figure 25: Session Start Up Wizard STEP TWO: Attaching Tube Band and Hanging Bag............. 32
Figure 26: Placing the tube band on drainage tubing and aligning with tube holder window........... 32
Figure 27: Sensica UO™ Monitor Standard Display Screen with call outs ..................................... 33
Figure 28: Sensica™ UO Monitor Screen in optional Night View mode.......................................... 33
Figure 29: Bag level display........................................................................................................... 34
Figure 30: Quarter-hour UO measurement display......................................................................... 34
Figure 31: UO measurement history scroll bar............................................................................... 35
Figure 32: Actions button drop down menu selection..................................................................... 36
Figure 33: Edit Catheter Use Time Screen..................................................................................... 37
Figure 34: Add/Subtract Fluids calculator screen........................................................................... 37
Figure 35: Subtracting exogenous fluid using Subtract calculator................................................... 38
Figure 36: Edit Patient Weight and Specific Gravity Action: Pop Up Screens................................. 39
Figure 37: System alert display format........................................................................................... 40
Figure 38: Modal warning display format........................................................................................ 41
Figure 39: Data Button drop-down menu selections....................................................................... 43
Figure 40: Data screen: Bar Graph Screen example...................................................................... 44

Sensica™ UO System for ICU Instructions for Use, Model No. SCCS-1001, ver. 1001
P/N 005-0175 Rev A Adaptec Medical Devices 6
Figure 41: Data Screen: Table by Date Screen example................................................................ 44
Figure 42: Data Screen - Table by Shift Screen example............................................................... 45
Figure 43: Snapshot Screen example and data sent as text message........................................... 46
Figure 44: Discharge patient screen............................................................................................... 46
Figure 45: System shut down button.............................................................................................. 46
Figure 46: Administrator Level PIN Entry Screen........................................................................... 52
Figure 47: Administrator Settings - Facility Preferences Screen..................................................... 53
Figure 48: Administrator Settings - Alert Settings Screen............................................................... 55
Figure 49: Administrator Settings - Barcode Settings Screen (optional) ......................................... 57
Figure 50: Administrator Settings - EHR Settings Screen............................................................... 60
Figure 51: Administrator Settings - System Information, Versions Screen example ....................... 62
Figure 52: Administrator Settings - System Information, System Info Screen example................... 63

Sensica™ UO System for ICU Instructions for Use, Model No. SCCS-1001, ver. 1001
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Introduction
This manual provides the indications, contraindications, warnings, precautions, and instructions for
use with the Sensica™ UO System for ICU. Carefully read this manual in its entirety before
using the Sensica UO System for ICU. Failure to follow these instructions may result in
improper use of this device. Contact Adaptec Medical Devices at [phone] with any
questions about the information contained in this manual or about the operation and safety of the
Sensica UO System for ICU.
Both User and Administrator functionality of the Sensica UO System for ICU are described in this
manual:
Part I –Sensica™ UO System for ICU Overview, describes the basic functionality of the system
hardware, single patient use products, and user interface.
Part II –Sensica™ UO System for ICU Instructions for Use, contains information regarding the
proper procedures for operating the Sensica UO System for ICU.
Part III - Sensica™ UO System for ICU Care and Warranty, provides information on properly
maintaining and servicing of the system.
Part IV –Sensica™ UO System for ICU Administration, contains information regarding the initial
setup and administration of the system, along with the default settings.
Prior to initial use of the Sensica UO System for ICU, the Administrator should follow the
instructions in Part IV for proper device setup. Table 1 identifies the setup tasks an
Administrator can perform prior to first use of the device.

Sensica™ UO System for ICU Instructions for Use, Model No. SCCS-1001, ver. 1001
P/N 005-0175 Rev A Adaptec Medical Devices 8
Table 1: Tasks to be Completed by Administration Before First System Use
Task
Recommended for Device
Use
Reference
Create Administrator and Operator Personal
Identification Numbers (PINs)
Optional but
Recommended
Facility Preferences Setup
(Chapter 15)
Configure the current date, time, and display
formats
Required for accurate
display
Facility Preferences Setup
(Chapter 15)
Configure alert settings
Optional but
recommended to review/
alter default settings
Alerts Settings Setup
(Chapter 16)
Configure the system to gain access to the
wireless network for transmitting UO data to
Electronic Health Record (EHR) system
Required for automatic
date/time updating and
for using EHR feature
EHR Settings Setup
(Chapter 18)
Configure the system to accept barcode scan
for entering patient demographics
Required if barcode
scanning is desired
Barcode Settings Setup
(Chapter 17)
Appendix A contains the Guidance and Manufacturer’s Declaration tables for electronic medical
equipment regulatory compliance. Appendix B provides the system specifications.

Sensica™ UO System for ICU Instructions for Use, Model No. SCCS-1001, ver. 1001
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Part I –Sensica™ UO System for ICU Overview
Part I Chapters:
•Device Description (Chapter 1) including components and principle of operation
•Labeling (Chapter 2) includes a symbol table explaining the international symbols used in
Sensica UO System for ICU labeling and packaging
•Indications for Use and Target Population (Chapter 3)
•Warnings and Precautions (Chapter 4)
CHAPTER 1. DEVICE DESCRIPTION
The function of the Sensica™ UO System for ICU is to continuously monitor urine output (UO). It is
an automated urine meter system for bedside monitoring of patients with any standard indwelling,
urological catheter and drainage system.
The most likely locations for patients to be monitored are critical care units of hospitals, or any
patient care setting where close monitoring of urine output by patients with indwelling catheters is
desired.
Monitoring of continuous UO data can be accomplished on the bedside system display screen. In
addition, the Sensica UO System for ICU can be configured to automatically transmit UO data via
the Sensica™ UO Relay Software to a facility’s HL7 server, where the data is subsequently verified
and entered into the patient’s electronic health record (EHR) by the appropriate medical personnel.
The Sensica™ UO System for ICU consists of:
•Sensica™ UO Stand and attached Sensica™ UO Display Monitor
•Sensica™ UO Patient Ring Kit (for single patient use), including the Collection Bag Ring and
one Tube Band with Measuring Strips
•Sensica™ UO System for ICU software, including the Sensica™ UO Relay Software for
optional transmission of data to an EHR system
Figure 1: Sensica™ UO System for ICU with disposable ring
Sensica UO
Collection
Bag Ring