S02 - ATTACHMENT 1 SALIENT CHARACTERISTICS - ACCURYN.docx

STATEMENT OF NEED

Brand Name or Equal: Accuryn Monitor, Accutab System Potrero Medical

PURPOSE: The Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, monitoring of urine output and core body temperature, in degrees Fahrenheit and degrees Celsius; monitoring of intra-abdominal pressure that can be used as an aid in the diagnosis of intra-abdominal hypertension and abdominal compartment syndrome; and acute kidney injury alerts when used with accuTab. These features are crucial in caring for critically patients in MICU and SICU.

SCOPE: C.W. Bill Young VA Medical Center MICU has piloted the use of the Accuryn Monitoring System which meets the physical, functional, and performance of the listed salient characteristics in this section. The equipment feature is essential to the caring of the critically ill patients in MICU and SICU.

PHYSICAL CHARACTERISTICS: Equipment must have the physical characteristics to enable the ICU healthcare providers to perform the capabilities:

Accuryn Monitoring System

· Active Drainline Clearance

· Hourly Urine Output (UO).

· EMR.

· Intra-abdominal pressure (IAP)

· AKI Alerts:

· urine output in 15-minute increments, chart interventions, and run a Furosemide Stress Test. AccuTab allows Accuryn data to be viewed outside the ICU room and on an OR pole.

· Alarm sound level: 62.9 to 71.6 dB

· Dimensions (with floor stand): Accuryn height: 19.5”. width: 13.5”, depth: 7.0”; Accuryn display: LCD touchscreen 4.4”; Accutab display: LCD touchscreen 10.1”; Accuryn monitor only: 10 in length x 3.5 in width x 6 in height, weight 3.1 lbs.

· Urine Volume Measurement: Range 0 to 2000 ml.; +/- 1% at level

· System temperature (rated output range): 32◦C to 42◦C; accuracy: ± 0.3◦ C

· Rated extended output range: 9◦C to 32◦C, 42◦ to 45◦C

· Environmental Use Conditions / Transport Conditions: Ambient temperature: 50°F to 104°F (10°C to 40°C); Relative humidity: 10%-90%, non-condensing; Altitude: 0 to 2000 meters; Pressure: 101 kPa to 81 kPa

· Power supply: 18V±1.8V, DC, 2.2A, EN55011, Class B, FCC Part 15, Class B , EN61000; Full battery – 8-hour capacity; Battery type: Li-Ion

· Pneumatic pump: 3V, 10 inHg vacuum

· Electrical Safety Designations: Class II Medical Equipment, Type BF-Defib Proof Applied Parts FUNCTIONAL AND PERFORMANCE CHARACTERISTICS: Equipment must provide the functional and performance capability as listed in section above.

SOFTWARE: N/A

TRAINING: Government will not require additional training.

WARRANTY OF EQUIPMENT: Government requirement for standard manufacturer industry warranty term. Government does not accept extended warranty, which requires advance payment.