Alerta De Seguridad para Acuity Central Physiological Monitoring Station with the following software versions: (1) 4.03.00, (2) 4.03.01, (3) 4.03.02, (4) 4.03.03, (5) 4.03.04, (6) ) 4.03.05; (7) VHF / UHF protocol, wireless, telemetry units.

Safety alert

305

2001-10-05

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

These central monitoring stations installed with one of the software versions mentioned above and used with the above listed telemetry units operate inconsistently with the documentation found in the acuity system reference guide when the reset function is activated during the equipment's alert state . by activating the reset function during the machine's alert period, the border and icon on the screen will turn green. they should be blue. the manufacturer initiated the correction by letters dated march 13, 2001 and june 18, 2001, as well as by telephone dated june 18, 2001.

Check for letters and response cards dated March 13 and June 18, 2001, and the call dated June 18, 2001 from manufacturer Welch Allyn. Identify and isolate all affected products in inventory. Welch Allyn recommends the following: (1) Do not activate the reset function during the machine's alert period. Do not activate the suspend alarm function, which will cancel the buzzer for 90 seconds. (2) Check patient and activity, confirming patient position and cause of equipment alert period. (3) Indicate the cause of loss of communication (eg change the battery). (4) Disconnect all patients before they leave the monitoring area (for example: "net-off" or disconnect the telemetry). (5) Follow the instructions associated with remote control monitoring in the Acuity System Reference Guide (PN # 810-0961-00, Rev A, 2/98) and the Telemetry, Telemetry, Wireless, Reference (PN # 810-0548-02, Rev A, 10/96). Welch Allyn will provide an upgrade of the software at no charge. With it, when the reset function is activated, the audible alarms will be permanently suspended and a blue icon representing the disconnected patient will be generated. The blue icon and border will then change to green when data transmission is restored. Fill out and mail the reply card to Welch Allyn at the address mentioned in the mail. For more information, contact your local representative or directly with the technical service department from 8:00 a.m. to 5:30 p.m. by calling 1 (503) 526-8500 (in the United States).