IFU-01, Rev. A Page 6 of 20
VitalConnect Sensor is tested by UL for electrical safety in accordance with IEC 60601-1-1
VitalConnect Sensor is tested by UL for electromagnetic compatibility in accordance with
IEC 60601-1-2
Vital Connect Sensor complies with the Essential Performance defined in 60601-1,
amendment 1: “performance of a clinical function, other than that related to BASIC
SAFETY, where loss or degradation beyond the limits specified by the MANUFACTURER
results in an unacceptable RISK”, either with applicable testing or via user
documentation.
VitalConnect system is tested by UL for FCC in accordance with ANSI C63.10-2009, FCC
CFR 47 Part 2, FCC CFR 47 Part 15, RSS-GEN Issue 3, and RSS-210 Issue 8.
Electronic components are RoHS compliant.
Patch top layer and adhesive is medical grade.
Software failure, firmware failure or battery failure has no adverse effect on the end-
user. The failure would vital data collection and transmission. In the event this occurs,
the end-user or service provider will be notified as applicable.
VitalConnect Sensor is:
o Type BF applied part
o Not reusable
o IPX4, protected against water spray
o IPX7, protected against water submersion
No installation or maintenance is required.
The patch is intended for a one-time use, for up to 3 days.
The battery is not rechargeable. It’s intended for a one-time use for the life of the patch
which is up to 3 days.
The system does not display any messages
Start-up process is not included in this manual. This IFU is not intended for the end-user.
Shutdown procedure is not included in this manual. This IFU is not intended for the end-
user.
No cable or physical connection required. The only connection is the Sensor Module to
the Patch (as shown in General Description below.
Vital Connect Sensor should not be used adjacent to or stacked with other equipment
and that if adjacent or stacked use is necessary, Vital Connect Sensor should be observed
to verify normal operation in the configuration in which it will be used.
Packaging label is legible within 90 degree viewing angle of the label.
Packaging label is legible within distance of 50 cm (20 inches)
Packaging label is legible within 500 lux – 1000 lux lighting (i.e. foot-candles)
To Next Page
Loading...
