Welch Allyn CP 200 12-Lead Resting Electrocardiograph - User Manual - Manual (Page 20)

16 Chapter 1 Introduction Welch Allyn CP 200 Electrocardiograph
Using the Electrocardiograph Safely
Before using or servicing the electrocardiograph, you must read and understand the
following safety-related information.
General Warnings
The following warning statements apply to electrocardiograph use in general. Warning
statements that apply specifically to particular procedures, such as connecting the patient
cable or performing an ECG test, appear in the corresponding sections of the manual.
Warning statements indicate conditions or practices that could lead to illness, injury, or
death.
Warnings Related to the Environment
WARNING To ensure patient and device safety, leave 5 feet (1.5 meters) of
open area around the patient.
WARNING To avoid a possible explosion, do not use the electrocardiograph in
the presence of flammable anesthetics: mixtures containing air, oxygen, or
nitrous oxide.
WARNING When transporting the electrocardiograph on a cart, tuck the patient
cable away from the wheels so that it does not present a hazard.
Warnings Related to Accessories and Other Equipment
WARNING For operator and patient safety, peripheral equipment and
accessories that can come in direct patient contact must be in compliance with
all appropriate safety, EMC, and regulatory requirements. See
“EMC Guidance
and Manufacturer’s Declarations” on page 97.
WARNING All signal input and output (I/O) connectors are intended for
connection of only devices complying with IEC 60601-1, or other IEC standards
(for example, IEC 60950), as appropriate to the device. Connecting additional
devices to the electrocardiograph might increase chassis or patient leakage
currents. To maintain operator and patient safety, consider the requirements of
IEC 60601-1-1. Measure the leakage currents to confirm that no electric shock
hazard exists. In the case of a USB printer, the printer (non-medical electrical
equipment) shall be situated outside the patient environment (reference IEC
60601-1-1). The printer used should be approved to the appropriate safety
standard for non-medical electrical equipment (IEC 60950, or its national
variants), and use of an isolation transformer is recommended. If there is a
requirement for the printer to be situated within the patient environment it is the
responsibility of the user to ensure that the system provides a level of safety in
compliance with IEC 60601-1 and 60601-1-1.
WARNING The electrocardiograph has not been designed for use with high-
frequency (HF) surgical equipment and does not protect against hazards to the
patient.