Safety Manual

Regulatory Information
Contraindications
This system is not intended for use in the following manner:
• During patient transport
• With high-frequency surgical units
• As an intra-cardiac application
• As a sole means of diagnosis
• As a vital signs physiological monitor
Prescription Device Statement
CAUTION:
United States federal law restricts this device to sale by or on the order of a
physician.
Classification of Medical Device
The device is classified as follows according to IEC 60601-1.
Table 1: Medical Device Classifications
Category Classification
Type of protection against electrical shock Class I, internally powered
Degree of protection against electrical shock Type CF defibrillation-proof applied part
Degree of protection against harmful ingress of
solids and liquids
The Ingress Protection (IP) code for this device is
IP 20.
Degree of safety of application in the presence
of a flammable anesthetic mixture with air or
with oxygen or with nitrous oxide
Equipment is not suitable for use in the presence
of a flammable anesthetic mixture with air or
with oxygen or with nitrous oxide
Method(s) of sterilization or disinfection
recommended by the manufacturer
Not applicable
Mode of operation Continuous operation
Recording ECGs during Defibrillation
This equipment is protected against the effects of cardiac defibrillator discharge
to ensure recovery, as required by test standards. The patient signal input of the
acquisition module is defibrillation-proof. It is not necessary to remove the ECG
electrodes prior to defibrillation.
2109599-003 A MAC
™
7 Resting ECG Analysis System 5