GE ApexPro TT Technical Manual page 17

2001989-351A
CAUTION
ACCESSORIES (SUPPLIES) —To ensure patient safety, use only
parts and accessories manufactured or recommended by GE.
Parts and accessories used must meet the requirements of the
applicable IEC 60601 series safety standards, and/or the system
configuration must meet the requirements of the IEC 60601 medical
electrical systems standard.
CAUTION
ACCESSORIES (EQUIPMENT) —The use of accessory equipment
not complying with the equivalent safety requirements of this
equipment may lead to a reduced level of safety of the resulting
system. Consideration relating to the choice shall include:
use of the accessory in the patient environment; and
evidence that the safety certification of the accessory has been
performed in accordance to the appropriate IEC 60601-1 and/or
IEC 60601 harmonized national standard.
CAUTION
FDA POSTMARKET SAFETY ALERT—The United States FDA
Center for Devices and Radiological Health issued a safety bulletin
October 14, 1998. This bulletin states "that minute ventilation rate-
adaptive implantable pacemakers can occasionally interact with
certain cardiac monitoring and diagnostic equipment, causing the
pacemakers to pace at their maximum programmed rate."
The FDA further recommends precautions to take into
consideration for patients with these types of pacemakers. These
precautions include disabling the rate responsive mode and
enabling an alternate pace mode. For more information contact:
Office of Surveillance and Biometrics, CDRH, FDA
1350 Piccard Drive, Mail Stop HFZ-510
Rockville, MD 20850
U.S.A.
CAUTION
POWER REQUIREMENTS —If the installation of the equipment,
in the USA, uses 240V rather than 120V, the source must be a
center-tapped, 240V, single-phase circuit.
CAUTION
RESTRICTED SALE —Federal law restricts this device to be sold
by or on the order of a physician.
ApexPro™
Introduction
1-7