Given Imaging Limited SMARTPILL ユーザーズマニュアル
Appendix: Electrical Safety
x history of gastric bezoar
x swallowing disorders
x suspected or known strictures, fistulas, or physiological/mechanical GI
x swallowing disorders
x suspected or known strictures, fistulas, or physiological/mechanical GI
obstruction
x GI surgery within the past 3 months
x severe dysphagia to food or pills
x Crohn’s disease or diverticulitis
x implanted or portable electro-mechanical medical device such as a cardiac
x severe dysphagia to food or pills
x Crohn’s disease or diverticulitis
x implanted or portable electro-mechanical medical device such as a cardiac
pacemaker, defibrillator or infusion pump
x younger than 18 years old.
Data transmission from the capsule to the data receiver is influenced by patient BMI.
Significant data dropout can occur in severely obese patients (>40 BMI).
Significant data dropout can occur in severely obese patients (>40 BMI).
Restricted Use
Caution
The SmartPill GI Monitoring System equipment is not suitable for use in the presence of flammable anesthetic
mixture with air or with oxygen or nitrous oxide.
Not for use with oxygen or oxygen-enriched atmospheres.
Storage
Store SmartPill GI Monitoring System components and capsules at ambient room
temperature (-15–40ºC) and humidity (rH 30–90%).
Caution
Do not expose the capsules to UV light. UV light can permanently damage the pH sensor.
Caution
Do not store capsules within 30cm (1 foot) of the activation fixture. The fixture’s magnetic field could
inadvertently activate the capsules.
Power Requirements
System Computer
System Computer
110/220 VAC, 50–60 Hz
May require the use of a
power plug adapter
Docking Station
110/220 VAC, 50–60 Hz
May require the use of a
power plug adapter
Capsule
3.1 VDC self-contained
batteries
batteries
none
Data Receiver
8.4 VDC, self-contained,
none