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Sensica™ Sensica™ Urine Output Monitor

Sensica™ Urine Output System

The Sensica™ Urine Output System is an automated urine output monitoring system for bedside monitoring of any patient with a standard Bard™ Foley catheter and drainage system. The system continuously monitors urine output and core bladder temperature when connected to a temperature sensing Foley catheter and can automatically transmit data into the patient's electronic medical record (EMR). This capability is subject to the Sensica™ Urine Output System being connected to the EMR via BD’s EMR Interoperability solution which is available for an additional fee. The touch screen display contains features such as trended data graphing, customizable patient settings, Foley duration tracking and default weight normalized urine output alarms that align with internationally recognized Acute Kidney Injury identification guidelines.

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Overview
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Features and Benefits
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References
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Specification

GTIN - each

00801741215773

1


Country of Manufacture

United States

CE Marking

No


Quantity - Each

1 System


EMR Connectivity

Wireless with CCE

Urine Output Accuracy

±2mL or 5% (whichever is greater)

Temperature Accuracy

±0.2°C

AC Power Input

100-240Vac, 1.4A, 50/60Hz

DC Power Supply Rating

AC to DC Power Supply Medical Grade Class I Power Supply ALM65US12

Medical Electrical Classifications

Product Safety Classification: Class I ME Equipment Applied Part: Type BF

Operating Temperature Range

15°C - 30°C (59°F - 86°F) (at 30-85% Relative Humidity)

Transport Temperature Range

5°C - 45°C (30-85% Relative Humidity)

Atmospheric Pressure Limitation

830hPa to 1030hPa


Temperature Conditions

5°C - 45°C (45-85% Relative Humidity)

GTIN

GTIN - each 00801741215773 1

Manufacturing

Country of Manufacture United States
CE Marking No

Packaging

Quantity - Each 1 System

Product Basic Specification

EMR Connectivity Wireless with CCE
Urine Output Accuracy ±2mL or 5% (whichever is greater)
Temperature Accuracy ±0.2°C
AC Power Input 100-240Vac, 1.4A, 50/60Hz
DC Power Supply Rating AC to DC Power Supply Medical Grade Class I Power Supply ALM65US12
Medical Electrical Classifications Product Safety Classification: Class I ME Equipment Applied Part: Type BF
Operating Temperature Range 15°C - 30°C (59°F - 86°F) (at 30-85% Relative Humidity)
Transport Temperature Range 5°C - 45°C (30-85% Relative Humidity)
Atmospheric Pressure Limitation 830hPa to 1030hPa

Storage and Handling

Temperature Conditions 5°C - 45°C (45-85% Relative Humidity)
References
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Resources
References
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Frequently Asked Questions
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Related Products
RELATED PRODUCTS NOT AVAILABLE
References
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Product Complaints
North American Regional Complaint Center
1-844-8BD-LIFE (1-844-823-5433)
Things to Consider

If you are a patient or end user, you can contact us yourself, or you may have your caregiver or your physician do that for you. To help us process your
information quickly and effectively, please contact our customer complaints
team.

To better facilitate our investigation, please include the following information in your reporting:


  • Product Name and/or Catalog Number
  • Lot Number or Serial Number
  • Any injuries and/or Harm?
  • What is the issue you experienced?
  • Is the actual sample or sample representative available? (If possible, please send affected sample)
  • Contact name and phone number
Product Recalls
Recall Notifications
These recall notices provide current information on medical device recalls.
Learn more
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