USER SAFETY INFORMATION
• Do not operate the device in conjunction with or in close proximity to other devices such as high frequency
surgical instruments, defibrillators, imaging systems, or other diagnostic or therapeutic devices. Simultaneous
operation may damage the device or lead to erroneous results.
• It is recommended to keep proper functioning backup items such as a spare patient cuff, extension hose,
interface cable, batteries and other equipment on hand to prevent delayed treatment due to an inoperable
device.
• While the Hypertension Diagnostics Suite software can operate in a multi-user networked-environment and
support hundreds of patient records, its performance may degrade with increasing database file size. In such
situations or perhaps on a regular basis, it is recommended that patient records be archived and a new patient
database be created. Refer to the Software Operation section of this User Manual for further information on
how to archive existing and create new databases.
Note(s)
• There is no known safety hazard if other equipment, such as pacemakers or other stimulators, is used
simultaneously with the device; however, disturbance to the signal may occur.
• As defined by IEC 60601-1, the device is classified as follows:
• Class I equipment or internally powered.
• Type BF and defibrillation-proof applied part.
• Ordinary equipment.
• Equipment not suitable for use in the presence of flammable or explosive environments including
anesthetic mixtures.
• Continuous operation.
• This device is intended to be used in an ambulatory setting as prescribed by a licensed physician, and should be
used and stored according to the environmental conditions specified below:
Operating temperature: +5° to +40°C (+41° to +104°F)
Operating humidity: 30% to 95% RH, non-condensing
Atmospheric pressure: 1033 hPa to 550 hPa
Storage temperature: -20° to +55°C (-4° to +131°F)
Storage humidity: 15% to 95% RH, non-condensing
Atmospheric pressure: 1059 hPa to 550 hPa
CAUTION: The device may not provide accurate results or may be damaged if operated or stored
beyond the specifications.
• The device is CSA classified:
WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL
HAZARDS ONLY IN ACCORDANCE WITH UL60601-1, IEC60601-1,
CAN/CSA C22.2 No. 601.1, IEC 60601-1-1, CAN/CSA C22.2 No. 60601-
1-1-02, IEC60601-2-30 AND CAN/CSA C22.2 No. 601.2.30-99
To Next Page
