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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

Ordinary Equipment

Harmful Ingress
Water:

Watertight Equipment

(IP57)

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 oxygen 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 presence 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

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.