User Manual

LBL-xxxx Page 5
Proteus Two-part Patch Technical description Effective: xxXXX2016
Short tern (< 30 days)
Storage/Transportation, Strip +0°C – +40°C - +32°F – 104°F
Humidity
Operating, Patch: 15% - 93% (non condensing)
Storage/Transportation, Pod 15% - 93% (non condensing)
Storage/Transportation, Strip 15% - 93% (non condensing)
Altitude
Operating, Patch 700 hPa – 1060 hPa
7.2. Compliance to IEC 60601-1
The Proteus Two-part Patch has been evaluated and deemed compliant with all the applicable
requirements of:
IEC 60601-1 2005
IEC 60601-1-2 2014
IEC 60601-1-11 2010
Degree of Protection: Type BF applied Part
Protection against Electrical Shock Internally powered medical equipment
Mode of Operation Continuous
Enclosure degree of Ingress Protection IP27 (water proof to 1m – 3.3 feet)
IP27
Essential Performance: The essential performance of this device is defined as
biocompatibility of the patch materials, as established by
compliance to the ISO 10993 series of standards
Use Environment The Proteus Two-part Patch is intended to be used
in the Home Healthcare environment
7.3. Compliance to ANSI/AAMI EC13:2002
The Proteus Two-part Patch has been evaluated and deemed compliant with all the applicable
requirements for heart rate meters of ANSI/AAMI EC13:2002 Cardiac monitors, hear rate meters, and
alarms
Heart Rate range: 30 to 250 bpm
Heart Rate averaging: Averaged over 14 seconds
Heart Rate response time: Up to 5 mins, depending on patch operating mode
Response to Irregular Rythms:
Ventricular Bygeminy (VB) 80 bpm
Slow Alternating VB 60 bpm
Rapid Alternating VB 120 bpm
Bidirectional Systole 90 bpm
Pacemaker pulse rejection Heart rate data may not be accurate for patients with
pacemakers
7.4. Compliance to other Standards
 The Proteus Two-part Patch has been evaluated and deemed compliant with all the applicable
requirements of ISO 10993-1-2009, ISO 10993-5-2009, ISO-10993-10-2010 (Biological
evaluation of medical devices)
 The Proteus Two-part Patch has been evaluated and deemed compliant with all the applicable
requirements of JIS S7200 Pedometers