User Manual

Device Classifications
SmartPill pH.p Capsule
SmartPill Data Receiver
SmartPill Docking Station
Power:
Internally Powered
Equipment
Internally Powered Equipment
Class I Equipment
Electric Shock
Protection:
Type BF Applied Part
Type BF Applied Part
Ordinary Equipment
Harmful Ingress
Water:
Watertight Equipment
(IP57)
Ordinary Equipment
Ordinary Equipment
Equipment not suitable for
use in the presence of
FLAMMABLE
ANAESTHETIC
MIXTURE WITH AIR or
WITH OXYGEN OR
NITROUS OXIDE. Not
for use with o
xygen or
oxygen enriched
atmospheres.
Equipment not suitable for use
in the presence of
FLAMMABLE
ANAESTHETIC MIXTURE
WITH AIR or WITH
OXYGEN OR NITROUS
OXIDE. Not for use with
oxygen or oxygen enriched
atmospheres.
Equipment not suitable for use
in the pr
esence of
FLAMMABLE
ANAESTHETIC MIXTURE
WITH AIR or WITH
OXYGEN OR NITROUS
OXIDE. Not for use with
oxygen or oxygen enriched
atmospheres.
Mode of
Operation:
Intermittent operation
Continuous Operation
Continuous Operation
Connectivity Restrictions
External equipment intended for connection to signal input, signal output or other
connectors shall comply with IEC 60601 series for medical electrical equipment. In
addition, all such combinations – systems – shall comply with the standard IEC 60601-
1-1, Safety requirements for medical electrical systems. Equipment not complying with
IEC 60601-1 shall be kept outside the patient environment, as defined in the
standard.5
Any person who connects external equipment to signal input, signal output or other
connectors has formed a system and is responsible for the system to comply with the
requirements of IEC 60601-1-1. If in doubt, contact a qualified biomedical
professional or the SmartPill Corporation.
Index
5 The normal distance is at least 1.5 m from the patient or the patient support.