Part I - Sensica™ Uo System For Icu Overview; Chapter 1. Device Description; Figure 1: Sensica™ Uo System For Icu With Disposable Ring - Adaptec Sensica UO Instructions For Use Manual

Sensica™ UO System for ICU Instructions for Use, Model No. SCCS-1001, ver. 1001
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)
C 1. D
HAPTER EVICE
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
Sensica UO
Collection
Bag Ring
Figure 1: Sensica™ UO System for ICU with disposable ring
P/N 005-0175 Rev A
D
ESCRIPTION
Adaptec Medical Devices 9