Cautions; Contraindications - Signostics uscan User Manual

 Do not incinerate or discard the device in general waste at end of life. The lithium battery is a potential
environmental and fire safety hazard.
 Uscan complies with the requirements of IEC 60601-1:3rd Edition. To avoid the risk of injury or
electrical shock, comply with all safety instruction and warnings.
 Uscan complies with the Electromagnetic Compatibility requirements of AS/NZ CISPR 11:2004 and
IEC 60601-1-2:2007. However, electronic and mobile communications equipment may transmit
electromagnetic energy through air and there is no guarantee that interference will not occur in a
particular installation or environment. Interference may result in artifacts, distortion, or degradation of
the ultrasound image. If Uscan is found to cause or respond to interference, try re-orienting Uscan or
the affected device, or increasing the separation distance between the devices. Contact
customer support or your Signostics distributor for further information
 When using the optional mobile stand, the Uscan system can be susceptible to ESD and may require
manual intervention. If ESD results in an error, unplug the probe and plug back in to restore operation.
 Neurological use on patients with Creutzfeld-Jacob disease must not be performed. The device is
unable to be disinfected after such use.
 The ALARA principle (As Low As Reasonably Achievable) should be employed for all medical
ultrasound exposure

Cautions

 Federal (USA) law restricts this device to sale by or on the order of a physician.
 Ultrasound transducer crystals are fragile and are easily damaged if knocked, dropped or excessively
vibrated.
 Avoid unnecessary bending or winding of the connecting cable.
 The Uscan batteries should be charged every six months at a minimum, even if you are not using your
device. When storing for greater than 3 days, store at ambient or cooler temperature.
 Use only recommended disinfection methods.
 Use abrasive cleaners, isopropyl alcohol or solvents sparingly, and if used immediately clean and
remove residual substances from the Uscan.
 Do not heat sterilize any part of the Uscan device.
 Minimize application of alcohol based disinfectant to colored overmold materials. Long term use may
result in material degradation. If alcohol based disinfectant is applied to the overmold, immediately
remove by wiping with a damp cloth.
 Only operate, charge and store Uscan within the approved environmental parameters.
 Uscan contains sensitive components and circuits. Failure to observe proper static control procedures
may result in damage to the system. Any faults should be reported to
your Signostics distributor for repair.

Contraindications

 The Uscan is designed for percutaneous scanning only. Do not attempt intra-cavity imaging; in
particular, trans-esophageal, trans-vaginal and trans-rectal scans are contraindicated.
 The Uscan is not intended for ophthalmic use or any use causing the acoustic beam to pass through the
eye.
P003948 Uscan User Manual
Signostics
Signostics customer support or
Page | 10