Device Information - Delsys TRIGNO User Manual

Device Information

Complies with Requirements put forth by the Medical Device Directive
93/42/EEC. Class I device, Annex VII.
Type BF device (IEC 60601-1).
Isolated device, (Class II, IEC 60601-1)
Do not dispose this product with house waste. Contact Delsys Inc. for
instructions on responsibly disposing this device. This product should
not be mixed with other commercial wastes.
Date of Manufacturing (appears on device)
Serial Number (appears on device)
EC
Authorized Representative
FCC ID: W4P-SP-W02 (Trigno Base Station)
FCC ID: W4P-SP-W01 (Trigno Sensor)
IC: 8138A-DST01 (Trigno System)
This device complies with Part 15 of the FCC Rules. Operation is sub-
ject to the following two conditions: (1) This device may not cause
harmful interference. and (2) this device must accept any interference
received, including interference that may cause undesired operation.
This product complies with FCC OET Bulletin 65 radiation exposure
limits set forth for an uncontrolled environment.
Changes not expressly approved by Delsys Inc.could void the User's
authority to operate the equipment
EMERGO EUROPE
Molenstraat 15
REP
2513 BH, The Hague
The Netherlands
DELSYS INC.
650 Beacon St.
Boston MA 02215
USA
Manufacturer
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