Welch Allyn Spot Vital Signs 4400 Service Manual page 14

10 About warnings and cautions
Residual risk information
This product complies with relevant electro-magnetic interference, mechanical safety,
performance, and biocompatibility standards. However, the product cannot completely eliminate
potential patient or user harm from the following:
• Harm or device damage associated with electro-magnetic interference,
• Harm from mechanical hazards,
• Harm from device, function, or parameter unavailability,
• Harm from misuse error, such as inadequate cleaning, and/or
• Harm from device exposure to biological triggers that may result in a severe systemic allergic
reaction.
Adverse Event Reporting Statement (Notice to Users and/or patients)
Notice to Users and/or Patients in EU: Any serious incident that has occurred in relation to the
device, should be reported to the manufacturer and the competent authority of the Member State
in which the user and/or patient is established.