User Manual

Appendix: Electrical Safety
was one additional esophageal retention, eight gastric retentions, four small bowel
retentions and five colonic retentions. These resolved either without intervention or
with endoscopy/colonoscopy.
Patient-Contacting Materials
Patient-contacting materials include polyurethane, a polyurethane-polycarbonate blend,
Teflon coated with polyhema, an ISFET pH sensor, epoxy and UV-cured adhesive.
All patient contacting materials have been tested for biocompatibility and have been
found non-toxic, non-sensitizing, and non-irritating.
The device does not contain natural rubber latex.
Care, Cleaning and Maintenance
Caution
Do not reuse capsules. The capsule is a single-use, disposable item.
Caution
Do not immerse the data receiver in water or other liquids. Immersion damages internal electrical components
resulting in data receiver inoperability.
Caution
Do not immerse the docking station in water or other liquids. Immersion damages internal electrical
components and could result in electrical shock.
Caution
The data receiver, docking station, power supply, and capsule are not user serviceable.
Data Receiver
Clean and disinfect the outside surfaces of the data receiver after each patient use.
1. Turn off data receiver by simultaneously depressing the backlight button and event
button for 5 seconds.
2. Wipe outside surfaces with a cloth dampened (not saturated) with a mild detergent
and water. Suitable detergents include dishwashing detergent (e.g., Joy, Dawn®,
Palmolive®) solutions, or laboratory glassware cleaners such as Alconox®.
3. Wipe dry.
4. Disinfect by wiping outside surfaces with a cloth dampened (not saturated) with
disinfectant. A solution of 10% household bleach can be used as a disinfectant.
5. Wipe dry.
6. Wait at least 5 minutes after cleaning and disinfection before turning the data
receiver on or placing it in the docking station.
7. Conduct a preventive maintenance inspection. Check for cracks or damage. Shake
the data receiver and listen for detached batteries. Do not use the data receiver if
the case is cracked or damaged, or a rattling can be heard.