Giver™ Code Blue Hospital Quality All-Direction Patient Fall and Wandering Alarm with Magnet (AG-PA39-1)

 The Giver™ Code Blue All-Direction Patient Fall Alarm with Magnet (AG-PA39-1) is a tether alarm that is intended to alert a caregiver when the patient extends beyond the range of the cord tether.  

It easily attaches to a bed rail, wheelchair, or arm chair with the included loop.  Simply attach the alligator clip to the patient's clothing, and the other end attaches with a omni-directional magnet.  If the magnet detaches from the alarm, it triggers a user preset caregiver signal (either music or an 115dB emergency alarm).  The alarm features one touch reset button, as well as a high/low volume setting. Standby and low battery lights illuminate the front, and the system is powered by the included 9-volt battery.  A red LED light activates during alert that can visually guide the caregiver to the alarm for night-time monitoring.

• One Touch Reset :  Large front reset button for immediate alarm deactivation
• Activation cord is adjustable from 15" to 36" with perfect tension and immediate activation
• Alarm Settings :  Low and high volume, music or emergency alarm sounds
• Standby mode :  Every three seconds, a dim green LED flashes to let the caregiver know the system is operational
• Low Battery Indicator : A flashing yellow LED will alert the caregiver when it is time to replace the battery
• 10 Second Setup :  Includes circular magnetic activation magnet with 36" long adjustable patient tether and clothing alligator clip
• Powered by one standard 9V alkaline battery (included)

 FDA Classification :  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=PJP

Class 1, Exempt from premarket notification.  This fall-prevention alarm/sensor works only when it is attached to a person. It attaches to a person usually by a clip or belt . A nurse call interface provides dual staff notification or enables the in-room alarm to be silenced.  510(k)-Exempt