Adaptec Sensica UO Instructions For Use Manual

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

(888) 441-1525

Sensica™ UO System for ICU Instructions for Use, Model No. SCCS-1001, ver. 1001

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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

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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

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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

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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

 
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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 

 
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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 

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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 (888) 441-1525 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.

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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.

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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

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The Sensica UO System for ICU is designed to sit on the floor at the patient’s bedside. Any

standard indwelling catheter (“Foley”), drainage tubing, and collection bag may be used with

the system. The drainage tubing is tethered to the stand via the built-in tube holder to ensure

correct operation of the system. The collection bag is hung on the single patient use ring. Once the

bag is hung on the ring, the system begins recording urine output. See Section II, Sensica™ UO

System for ICU Instructions for Use.

Figure 2: Drainage tubing tethered to Sensica™ UO Stand

1.1 Sensica UO System for ICU Hardware

1.1.1 Sensica™ UO System for ICU Stand with Attached Monitor

The Sensica UO System for ICU features: (a) monitor display, (b) a stand with control unit, (c) a

disposable ring interface, and (d) built-in tube holder on left hand side of stand. The power switch

for the display is located on the top of the monitor.

Figure 3: Sensica™ UO System for ICU without ring

a

b

c

d

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Figure 4: Back view of Sensica™ UO System for ICU Stand base

The Sensica UO System for ICU is a DC-powered device that plugs into a medical grade wall

supply via a 19ft power-cord assembly, and sits on the floor at a convenient location near the foot

end of the patient’s bedside. There are two built-in battery backups, one in the base of the system

and one in the monitor. Combined, the two batteries provide approximately twenty hours of use if

the system is unplugged for any reason. The system software will alert the user if the system is

unplugged and provide battery life information. Both batteries re-charge when the system is

plugged into wall power.

1.1.2 Sensica™ UO Patient Ring Kit: Sensica™ UO Ring (Single Patient Use)

The Sensica UO System for ICU is designed for precise measurement using the disposable,

Sensica™ UO Ring, which is a part of the Sensica™ UO Patient Ring Kit. Each time the system is

used with a new patient, a new Sensica UO Ring must be connected to the Sensica UO Stand. The

system software is designed to calibrate each time a new ring is attached to ensure accurate

calculations of urine output volume. Any standard urine collection bag can be hung on the ring.

Figure 5: Sensica™ UO Ring, front and back

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Figure 6: Clockwise twist-lock connection of Sensica™ UO Ring to stand

The Sensica UO ring will provide continuous operation for 336 hours (14 days) when connected to

the Sensica UO System for ICU. If the patient requires longer monitoring than 14 days, a new ring

can be connected to the stand without interrupting data collection or patient history.

1.1.3 Sensica™ UO Patient Kit: Sensica™ UO Tube Band with Measuring Strip

An L-shaped, Sensica UO Tube Band with Measuring Strip is included with the patient kit. This is

used to put a band around the drainage tubing at the correct distance for tethering the tubing to the

tube holder. Once the appropriate length of tubing is measured, the peel-off backing on the band

can be removed to expose glue and the band wrapped around the drainage tubing, creating a

permanent tube band. Then, the perforated measuring strip can be torn off and discarded.

To properly insert the drainage tubing in the tube holder, the tube band is aligned with the tube

holder “window” and the tubing is squeezed into the holder for a secure fit. This ensures accurate,

ongoing UO measurement data. The tube band must be in the tube holder window and the tubing

securely settled into the holder for the system to function correctly.

Figure 7: Using Sensica™ UO Tube

Band to place tubing in Sensica UO tube

holder

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To remove the bag for transporting the patient, turning the patient or any other reason, the drainage

tubing can be removed from the tube holder and the bag lifted off the ring. To resume UO

monitoring after removing the bag, the bag is hung on the ring and the tubing reinserted securely

into the tube holder, the tube band aligned with the tube holder. The system software will run a brief

system check to stabilize the recording. If the volume of urine has changed, the display software will

automatically update the total volume of urine in the bag.

Important: The Sensica UO System for ICU is not designed to be

transported with the patient. To move the system when needed,

pick it up using the crossbar handle at the back of the stand.

Do not lift from the monitor or the front of the system.

Figure 8: Move system using crossbar handle

1.2 Sensica™ UO Software/ICU: User Interface

1.2.1 Touch Screen Display

The monitor display is touch screen operated. Figure 9 shows the Sensica UO Display for ICU in

normal operating conditions with “day” mode selected. The large number is a “live” amount,

updating continuously as urine collects in the bag. The numbers in the light green boxes to the left

of the current hour are UO measurement totals for previous hours, to show data trending. It is

possible to scroll further back in time using the arrow on the left-hand side of the screen.

Crossbar Handle

Figure 9: Sample Sensica™ UO System for ICU display screen

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1.2.1.2 Bag Level Fullness

The monitor display shows how full the bag is, updating continuously along with the current hour

UO measurement. An alert can be set to let the user know when the bag is at a certain level of

fullness (e.g., 50% or 75% full).

1.2.1.3 Catheter Use Time

The monitor display shows how long the indwelling catheter has been in place, since the bag

collection system was first connected to the Sensica UO stand (in Days and Hours). This

information can be used to assist in following facility CAUTI guidelines regarding awareness of

indwelling catheter placement time. If the patient was catheterized prior to entering the unit or if the

catheter is replaced, this time can be changed using the “Actions” button, if desired.

1.2.1.4 Actions Button Selections

The “Actions” button provides a drop-down menu offering the following special functions: 1) Set

Patient Alerts, 2) Discharge Patient, 3) Edit Catheter Use Time, 4) Add/Subtract Fluid, and 5) Edit

Patient Weight. Optionally, “Edit Specific Gravity” can be added to the menu. See Chapter 8 for

more information.

1.2.2 System Alerts

User-defined and informational alerts will appear in a blue box on the upper left-hand side of the

screen. Alerts requiring action will appear in a red box. System alerts will cover the monitoring

screen. Only alerts which affect accurate system functioning include an audible, chirping sound.

Multiple alerts will “tier,” with the most recent alert at the top. To access earlier alerts, tap the down

arrow. (See Chapter 9.)

Figure 10: Sensica™ UO System for ICU blue and red alert examples

1.2.3 Administrator Settings Screens

The Sensica UO System for ICU software provides two levels of password protection for patient

data and user-defined alert setting security: 1) Administrator, and 2) Operator. Administrator level

security can access settings for facility preferences, setting and changing PIN entry access, EHR

configurations, and barcode identification. Both administrator and operator can access settings for

new patient entry and user-defined alerts.

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Figure 11: Administrator set up screen example

1.2.4 On-Screen Keyboard and Calculator

The on-screen keyboard and/or calculator is displayed on all screens that have user input fields or

require data entry.

Figure 12: Sensica™ UO System for ICU display on-screen keyboard and calculator

1.2.5 AKI Diagnostic Data Feature Option

The Sensica UO software includes a unique Acute Kidney Injury (AKI) data set, based on the

commonly accepted criteria for diagnosing AKI. (See Table 2.) This formula assesses urine output

using the formula, ml/kg/hr. The data set is available on the Sensica UO data screens, once the

patient’s weight has been entered into the system. The patient’s weight can be entered or updated

during the monitoring session, using either the “Actions” button (see Figure 9) or on the data

screens (see Figure 13).

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Table 2. KDIGO AKI Staging Criteria

Stage

Urine Output

Serum Creatinine (SCr)

1

<0.5 ml/kg/h for 6-12 hours

1.5-1.9 times baseline or ≥ 0.3 mg/dl (≥ 26.5 µmol/l)

increase

2

<0.5 ml/kg/h for ≥ 12 hours

2.0-2.9 times baseline

3

<0.3 ml/kg/h for ≥ 24 hours

OR Anuria for ≥ 12 hours

3.0 times baseline OR increase in SCr to ≥ 4.0 mg/dl

(≥ 353.6 µmol/l) OR

Initiation of renal replacement therapy OR,

in patients < 18 yrs, decrease in eGFR to < 35

ml/min per 1.73 m

2

Source: Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury Work Group. KDIGO

clinical practice guideline for acute kidney injury. Kidney Inter., Suppl. 2012; 2:1–138. Available online at

http://kdigo.org/home/guidelines/acute-kidney-injury/

1.2.6 Urine Specific Gravity Feature Option

If selected as a default by the Administrator, the individual patient’s urine specific gravity can be

entered into the Patient Data Entry screen at set-up, or using the Actions button. See 6.2.2 for more

information.

1.2.7 Data Button Selections

The “Data” button provides a drop-down menu offering the following selections: 1) Data Screens,

2) Snapshot Screen, and 3) Summary Report.

1.2.7.1 Data Screens

The Sensica UO System for ICU software provides three types of data screens to easily view

the urine output trend over time: 1) Bar Graph, 2) Table by Date, and 3) Table by Shift.

Figure 13: Sensica™ UO Display with data screen examples

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1.2.7.2 Snapshot Screen

The Sensica UO System for ICU software provides a simple way to see and communicate AKI

diagnostic data trends, using the most recent six hour UO recordings. The graphic information

is formatted so it can be photographed and sent via a cell phone as a text.

Figure 14: Sensica™ UO Display with Snapshot screen example

1.2.7.3 Summary Report

The Summary Report shows the Initial Urine Output (if recorded), Volume in Current Shift, Volume

in Last Shift, and Total Volume in Stay.

Figure 15: Summary Report example

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1.3 Operating Environment

Table 2 displays information about the Sensica UO System for ICU operating environment.

Table 3. Sensica™ UO System for ICU Operating Environment

Specification / Classification

Description

Electrical Specifications

AC to DC Power Supply Medical Grade Class II Power

Supply (PMP15M-10-1-BPD):

AC Input - 100-240V ~0.5-0.3A, 50-60Hz

DC Output (input to device) - 6V, 2.5A Max (15W)

Medical Electrical Classifications

Product Safety Classification: CLASS II ME EQUIPMENT

Applied Part: TYPE BF

Environmental Specification

Operating Temperature Range: 15-30

o

C

Storage: 15-30

o

C (at 85% Relative Humidity)

Transport: 5

o

C (at 85% Relative Humidity) to 60

o

C (at

30% Relative Humidity)

1.4 Automatic Data Transmission to EHR

The built-in Sensica™ UO System for ICU Relay Software allows for automatic, wireless

transmission of urine output data to an electronic health records (EHR) system using a certified HL7

protocol with a standard WiFi connection. (Adaptec Technical Support is available to work with a

facility’s IT staff to configure the data transmission for specific EHR software.

The Sensica UO System for ICU administrator will need to set up the communications link for

appropriate transmission of UO data to the EHR. (See Chapter 18.)

Figure 16: Sensica™ UO System for ICU Relay Software

Note: It is possible to transfer urine output data electronically from the Sensica™ UO System for

ICU to a facility’s EHR system through middleware products, using the serial port connection

located at back of the system base. This requires additional software. Please contact your

Sensica™ UO System representative for more information.

Sensica™ UO System for ICU Instructions for Use, Model No. SCCS-1001, ver. 1001

P/N 005-0175 Rev A Adaptec Medical Devices 19

CHAPTER 2. LABELING SYMBOLS

Table 4 provides a description of the symbols used on the Sensica™ UO System for ICU labeling

and documentation.

Table 4. Sensica™ UO System for ICU Labeling Symbols

Label Symbol

Symbol Description

Reference Number

Serial Number

Type BF-applied part

Lot Number

Do not use if package is opened or damaged

Single patient use only. Do not reuse.

CAUTION: Read text before using

CAUTION: Federal (USA) law restricts this device to sale or use by

or on the order of a licensed physician.

Temperature limits

Date of manufacture

Manufactured by

Device transmits radiofrequency (RF) energy

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Adaptec Sensica UO Instructions For Use Manual

Adaptec Sensica UO Instructions For Use Manual

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