5
Patient Safety
The KTC Nurse Call Systems are designed to comply with the international safety standard requirements for
medical electrical equipment with UMDNS code 15614.
KTC Medical Basic Nurse Call System is categorized as “ Low Risk” or “Type I “ ( EU, Canada, USA) or “
Type A” ( CHTF) device in IAF Medical Devices Risk Classification.
KTC Medical Basic Nurse Call System is in Compliance with IEC 60601-1 standard ( Basic safety and essential
performance requirements of medical electrical equipment).
According to IEC 60601-1 standard:
•KTC Medical Basic Nurse Call System is evaluated as “Type II” in Electric Shock criteria and Type “B”
in safety of applied parts as there is no floating contact to the patient.
•Operation in Oxygen-rich and in the vicinity of flammable anesthetics for KTC Medical Basic Nurse
Call System is considered as Not Applicable.
•The sterilization of KTC Medical Basic Nurse Call System modules can be done using Gamma Ray
when applicable ( Please check chapter 09 of this manual).
•KTC Medical Basic Basic Call System has “Fixed” installation and “ Permanent” mode of usage and
“Continuous” Mode of operation .
Moreover, KTC Medical Basic Nurse Call System has compliance with IEC 60601-1-2 ( collateral standard
applying to electromagnetic compatibility of medical electrical equipment and medical electrical systems
specifying general requirements and tests for electromagnetic compatibility) and UL-1069 ( UL Standard for
Safety of Hospital Signaling and Nurse Call ) standards.
