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Summary of Contents for Adaptec Sensica UO
- Page 1 NSTRUCTIONS FOR 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 P/N 005-0175 Rev A © 2018 Adaptec Medical Devices, LLC...
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Page 2: Table Of Contents
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™... - Page 3 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 P/N 005-0175 Rev A Adaptec Medical Devices...
- Page 4 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 P/N 005-0175 Rev A Adaptec Medical Devices...
- Page 5 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 P/N 005-0175 Rev A Adaptec Medical Devices...
- Page 6 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™...
- Page 7 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 P/N 005-0175 Rev A Adaptec Medical Devices...
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Page 8: Introduction
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. -
Page 9: Table 1: Tasks To Be Completed By Administration Before First System Use
Barcode Settings Setup for entering patient demographics scanning is desired (Chapter 17) Appendix A contains the Guidance and Manufacturer’s Declaration tables for electronic medical equipment regulatory compliance. Appendix B provides the system specifications. P/N 005-0175 Rev A Adaptec Medical Devices... -
Page 10: Part I - Sensica™ Uo System For Icu Overview
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. -
Page 11: Sensica Uo System For Icu Hardware
Sensica™ UO System for ICU Instructions for Use, Model No. SCCS-1001, ver. 1001 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. -
Page 12: Sensica™ Uo Patient Ring Kit: Sensica™ Uo Ring (Single Patient Use)
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. -
Page 13: Sensica™ Uo Patient Kit: Sensica™ Uo Tube Band With Measuring Strip
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. -
Page 14: Sensica™ Uo Software/Icu: User Interface
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. -
Page 15: Bag Level Fullness
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. -
Page 16: On-Screen Keyboard And Calculator
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”... -
Page 17: Urine Specific Gravity Feature Option
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. -
Page 18: Snapshot Screen
Sensica™ UO System for ICU Instructions for Use, Model No. SCCS-1001, ver. 1001 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. -
Page 19: Operating Environment
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™... -
Page 20: Chapter 2. Labeling Symbols
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 P/N 005-0175 Rev A Adaptec Medical Devices... - Page 21 Recyclable lithium-ion (Li-ion) battery Independently-tested and certified by TÜV Rheinland to meet minimum electrical safety standards in U.S. and Canada Humidity limits Handle with care Read Instructions for Use Manual Tripping hazard Dropping hazard P/N 005-0175 Rev A Adaptec Medical Devices...
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Page 22: Chapter 3. Indications For Use And Target Population
SE AND ARGET OPULATION The Sensica UO System for ICU is an automated urine meter system for continuous monitoring of urine output (UO). Target Population: The Sensica™ UO System for ICU, Model No. SCCS-1001, is intended for bedside monitoring of urine output by any patient with an indwelling, urological catheter, drainage tubing and collection bag, typically in critical care settings or where close monitoring of urine output is desired. -
Page 23: Chapter 4. Warnings And Precautions
Portable and mobile RF communications equipment can affect MEDICAL CAUTION ELECTICAL EQUIPMENT. The Sensica UO System for ICU should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Sensica UO CAUTION System for ICU should be observed to verify normal operation in the configuration in which it will be used. - Page 24 Use caution not to drop unit on foot while moving system. Take care not to trip over the Sensica UO System for ICU or the Sensica UO power cord to avoid user injury or accidentally pulling out the indwelling CAUTION catheter.
- Page 25 System for ICU. This will generate a system alarm, and could cause erroneous UO readings. Do not sterilize any component of the Sensica UO System for ICU. To clean the display touch screen, wipe with a soft cloth or use a germicide wipe such as “Sani-Cloth.”...
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Page 26: Part Ii - Sensica™ Uo System For Icu Instructions For Use
If the Sensica™ UO System for ICU shipment container or contents are damaged, notify the carrier and Adaptec Customer Service. DO NOT USE the system until Adaptec personnel or authorized representatives have verified that the system is fully functional. Keep the shipping materials for the carrier’s inspection. -
Page 27: Power And Initialize System
Figure 17: Sensica™ UO System for ICU Initialization Screen 5.2.3 New Patient and Settings Selections This screen provides operator access to setting up a new patient and administrator access to system settings. For initial setup by the administrator, see Part IV. P/N 005-0175 Rev A Adaptec Medical Devices... -
Page 28: Figure 18: New Patient And Settings Selection Screen
Sensica™ UO System for ICU Instructions for Use, Model No. SCCS-1001, ver. 1001 Figure 18: New Patient and Settings Selection Screen P/N 005-0175 Rev A Adaptec Medical Devices... -
Page 29: Chapter 6: New Patient Setup
Patient ID, which will appear on the monitor display. No other patient identifiers are on the standard viewing screen. Once desired data is entered, touch “Submit.” A screen will appear with the submitted data for confirmation that the patient information is correct. Figure 20: New Patient Entry Screen P/N 005-0175 Rev A Adaptec Medical Devices... -
Page 30: Entering Patient Weight For Aki Diagnostic Data Information (Optional)
“Action” button (Chapter 8). Note: It has been shown that changes in urine specific gravity do not significantly alter hourly AKI diagnostic calculations (low volume of urine). For more information, please contact Adaptec Customer Service. P/N 005-0175 Rev A... -
Page 31: Scan Barcode Option
Note: In order to use this feature, the Administrator must first enter the appropriate bar code settings as part of the initial system setup, see Barcode Settings Setup (Chapter 17). Figure 23: Barcode Scanner Screen P/N 005-0175 Rev A Adaptec Medical Devices... -
Page 32: Session Start Up: Attaching Single Patient Use Ring And Tube Band
After catheterizing patient, make note of the initial urine, if desired. Attach the Sensica UO tube band to the drainage tubing as described in 6.3.2.1. Then hang the bag on the Sensica UO ring. Next, align the tube band with the tube holder window and insert the tubing into the tube holder (closest to the patient’s head). -
Page 33: How To Attach The Tube Band To The Drainage Tubing
Discard strip. (Note: It is not necessary to drain the initial urine output before hanging the bag on the ring.) Figure 26: Placing the tube band on drainage tubing and aligning with tube holder window P/N 005-0175 Rev A Adaptec Medical Devices... -
Page 34: Chapter 7: Uo Monitoring Display Features
Figure 27: Sensica UO™ Monitor Standard Display Screen with call outs 7.2 Night View mode option Touching the “Day View” window will change the display to “Night View.” The Night View mode produces less light, which may be desirable during sleep hours. Touching the “Night View” window will return the viewing screen to “Day View.”... -
Page 35: Bag Level Display
To remove the quarter-hour clock, double-tap the box once more. Figure 30: Quarter-hour UO measurement display P/N 005-0175 Rev A Adaptec Medical Devices... -
Page 36: Uo Measurement History Scroll Bar
To show quarter-hour view of any hour, simply double tap that box. To return to the current display, touch the arrow on the right-hand side of the screen. Figure 31: UO measurement history scroll bar P/N 005-0175 Rev A Adaptec Medical Devices... -
Page 37: Chapter 8: Special Actions
(See Figure 31.) This can be used when a catheter is replaced or to change the Catheter Use Time if Sensica UO monitoring has begun after the catheter has been in place for a period of time. P/N 005-0175 Rev A... -
Page 38: Action Selection: Add/Subtract Fluid
Type in the desired amount to either add or subtract from the current volume. When one of the calculators is selected, the other one will “gray out.” Figure 34: Add/Subtract Fluids calculator screen P/N 005-0175 Rev A Adaptec Medical Devices... -
Page 39: Action Selected: Edit Patient Weight
Note: For the most accurate urine volume recording for all types of patients, the default specific gravity in the Sensica™ UO System for ICU is 1.015. Touch “Set to Default” to return to this value. P/N 005-0175 Rev A Adaptec Medical Devices... -
Page 40: Figure 36: Edit Patient Weight And Specific Gravity Action: Pop Up Screens
Sensica™ UO System for ICU Instructions for Use, Model No. SCCS-1001, ver. 1001 Figure 36: Edit Patient Weight and Specific Gravity Action: Pop Up Screens P/N 005-0175 Rev A Adaptec Medical Devices... -
Page 41: Chapter 9: Uo Monitoring Alerts And Warnings
ONITORING LERTS AND ARNINGS All Sensica UO System for ICU alerts and warnings are non-audible. Most system alerts are generated according to administrator settings. Modal alarms occur when there is a danger of interrupting the UO monitoring session. 9.1 System alerts System alerts appear under the bag level indicator. -
Page 42: System Modal Warnings
Ring is disconnected. UO recording Discharge To end patient monitoring session, touch “Discharge.” disconnected. has stopped. Discharge patient and end Reconnect To continue patient monitoring recording. session, reconnect ring and touch “Reconnect.” Reconnect to restart recording. P/N 005-0175 Rev A Adaptec Medical Devices... - Page 43 If problem persists, call Adaptec 4) If warning comes up again, Customer Service. attach new ring and touch “Fix.” 5) If problem persists, call Adaptec Customer Service. Tube band Drainage tubing not inserted Insert tubing into tube holder with the not inserted properly into tube holder.
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Page 44: Chapter 10: Sensica™ Uo System For Icu Data Screens
Figure 39: Data Button drop-down menu selections 10.1 Data Screen Selections The Sensica UO System for ICU provides historical UO output data in three forms: 1) Bar Graph, 2) Table by Date, and 3) Table by Shift. The shift parameters are set by the administrator. (See Chapter 15.) -
Page 45: Figure 40: Data Screen: Bar Graph Screen Example
Patient Weight Entry Screen. (See Figure 20.) The screen can be scrolled up and down using the arrows on the left-hand side of the screen. Figure 41: Data Screen: Table by Date Screen example P/N 005-0175 Rev A Adaptec Medical Devices... -
Page 46: Snapshot Screen
Figure 42: Data Screen - Table by Shift Screen example 10.2 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. -
Page 47: Chapter 11: Ending Patient Monitoring
“No” to continue monitoring. After touching “Yes,” the system will erase all patient data from the Sensica UO system. To completely turn off the system, touch the power icon on the New Patient and Selections Screen. Remove the used Sensica UO patient ring using a counter- clockwise twisting motion, and dispose of the ring in an appropriate bio-waste container. -
Page 48: Part Iii - Sensica™ Uo System For Icu Care And Warranty
Table 7. Sensica™ UO System for ICU Cleaning Information Component Cleaning Method • Touchscreen display Power OFF the Sensica UO System, if possible. • Rub a soft cloth (such as a microfiber cloth) in a circular motion to remove smudges. •... -
Page 49: Chapter 12: Storage
Before storing the Sensica™ UO System for ICU, power OFF the system and clean the system, if needed, according to the instructions in Chapter 11. Store the system in a way that prevents contamination or damage. The environmental temperature for storage and transport of the Sensica UO System for ICU are as follows: •... -
Page 50: Chapter 13: Replacement Parts
HAPTER EPLACEMENT ARTS If a Sensica™ UO System for ICU is missing or damaged in any way, contact Adaptec Customer Service at 1-888-441-1525. Refer to Table 8 for the device model numbers when ordering new parts. Table 8. Sensica™ UO System for ICU Parts List... -
Page 51: Chapter 14: Warranty And Service
CAUTION: There are no user serviceable components in the Sensica UO System for ICU. The user or unauthorized party should not attempt to open control covers or repair the Sensica UO System for ICU components. - Page 52 The customer is responsible for any loss or damage that may occur during shipping. • Use the shipping label provided by Adaptec Customer Service on the outside of the package. • Ship the system to the location specified on the shipping label.
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Page 53: Part Iv -Sensica™ Uo System For Icu Administration
To access the administrator settings screen, touch the “Settings” screen from the New Patient and Settings Selection Screen. (See Figure 17.) The Administrator PIN entry screen will appear. Enter the factory default PIN provided by the Adaptec Medical Devices Sales Representative and touch “Submit.”... -
Page 54: Chapter 15: Facility Preferences Settings
15.2 Date Display Format Select between US or International Date display formats. The default is US. 15.3 Language Current selection option is English. 15.4 Shift Type Select between 12-Hours or 8-Hours shifts. The default is 12-Hours. P/N 005-0175 Rev A Adaptec Medical Devices... -
Page 55: Shift Start Time
2) Access the “Alerts Settings Screen” from the Actions drop down selection on the standard viewing screen (See Chapter 8); and 3) Clear alerts and warnings when they appear on the display screen. P/N 005-0175 Rev A Adaptec Medical Devices... -
Page 56: Chapter 16: Alerts Settings
The default setting is greater than 400ml urine output over a two-hour period (i.e., more than 200ml/hr average for two hours). Selection values for UO are: 100, 200 ,300, and 400 mls. Selection values for hours are: 1, 2, 3 and 4 hours. P/N 005-0175 Rev A Adaptec Medical Devices... -
Page 57: Sudden Increase Alert Setting
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. -
Page 58: Chapter 17. Optional Barcode Settings
‘{‘and ‘}’. The following table describes the tokens used to instruction the barcode parser where items of data are located within an input text stream from a barcode scanner: P/N 005-0175 Rev A Adaptec Medical Devices... -
Page 59: Table 9. Barcode Parser Tokens
Instructs the parser to begin at the current index and skip all space characters until the next alphanumeric character is encountered. {SKIP} Instructs the parser to being at the current index and skip all non- alphanumeric characters until the first alphanumeric character is encountered. P/N 005-0175 Rev A Adaptec Medical Devices... -
Page 60: Parser Examples
Patient Data Extracted: ID = XYZ123, last name = Smith, first name = John, middle initial = H, date of birth = December 12 1980, admission date = January 1 2000, gender = male P/N 005-0175 Rev A Adaptec Medical Devices... -
Page 61: Chapter 18. Ehr Settings
Touch the “EHR” button to access the EHR Setting Screen. This screen allows the necessary information to be entered in order to facilitate the automatic transfer of data to a facility’s EHR system. Adaptec Medical Devices Technical Support is available to work with a facility’s IT department to properly set up the wireless connection. -
Page 62: Mc Server Status
ICU to a facility’s EHR system through middleware products, using the circular jack (for a serial port cable assembly) located at back of the system base. (See Figure 5.) This requires additional software. Please contact your Sensica™ UO System representative for more information. P/N 005-0175 Rev A Adaptec Medical Devices... -
Page 63: Chapter 19: System Information And Remote Support Access
Sensica™ UO System for ICU software and hardware, which is used for product tracking and servicing by Adaptec Medical Devices manufacturing operations. A Remote Support session can also be initiated through this screen, once prompted by an Adaptec Technical Support representative. -
Page 64: Other Button - System Info Tab
Sensica™ UO System for ICU Instructions for Use, Model No. SCCS-1001, ver. 1001 19.2 Other Button – System Info Tab This tab provides additional information for tracking and servicing the Sensica UO system. Figure 52: Administrator Settings - System Information, System Info Screen example... -
Page 65: Appendix A Guidance And Manufacturer's Declarations
Harmonic Class A buildings used for domestic purposes. emissions IEC 61000-3-2 Voltage Complies fluctuations/flicker emissions IEC 61000-3-3 P/N 005-0175 Rev A Adaptec Medical Devices... -
Page 66: Table 11. Guidance And Manufacturer's Declaration - Electromagnetic Immunity - For All Medical Electrical Equipment And Medical Electrical Systems
IEC 61000-4-8 commercial or hospital environment. NOTE: U is the a.c. mains voltage prior to application of the test level. P/N 005-0175 Rev A Adaptec Medical Devices... -
Page 67: Table 12. Guidance And Manufacturer's Declaration - Electromagnetic Immunity - For All Medical Electrical Equipment And Medical Electrical Systems That Are Not Life-Supporting
If the measured field strength in the location in which the Sensica™ UO System for ICU is used exceeds the applicable RF compliance level above, the Sensica UO System for ICU should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Sensica UO System for ICU. -
Page 68: Equipment And The Sensica™ Uo System For Icu - For Medical Electrical Equipment And Medical Electrical Systems That Are Not Life-Supporting
The Sensica™ UO System for ICU is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Sensica UO System for ICU can help prevent electromagnetic interference by maintaining a minimum... -
Page 69: Appendix B Instrument Specifications
Accuracy (bench testing) Volume using water 0-508ml ± 2 ml 509-2030ml ± 1% Dimensions Height 28.0in Width of monitor 12.5in Base depth 11.5in Base width 12.5in Weight Shipping Weight 19.5lb In use weight 12.0lb P/N 005-0175 Rev A Adaptec Medical Devices... - Page 70 Sensica™ UO System for ICU Instructions for Use, Model No. SCCS-1001, ver. 1001 Revision History Revision Date Description of Changes Author ECR#/PCR# Rev A Initial Release P/N 005-0175 Rev A Adaptec Medical Devices...
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