Safety Manual
Table Of Contents
- Table of Contents
- Publication Information
- Regulatory Information
- Intended Use
- Indications for Use
- Contraindications
- Prescription Device Statement
- Classification of Medical Device
- Recording ECGs during Defibrillation
- Modulating Effects in Digital Systems
- Biocompatibility
- Legal Notice
- Responsibility of the Manufacturer
- Responsibility of the Purchaser/Customer
- Warranty Information
- Safety Information
- Product and Packaging Information
- Equipment Identification
- Electromagnetic Compatibility (EMC)
- Wireless Regulations
Safety Information
WARNING:
PERSONAL INJURY - Contact with patients during defibrillation can cause serious
injury or death.
Do not contact patients during defibrillation. Patient signal inputs labeled with
the CF symbols with paddles are protected against damage resulting from
defibrillation voltages. To ensure proper defibrillator protection, use only GE
Healthcare recommended cables and leadwires. Proper placement of defibrillator
paddles in relation to the electrodes is required to ensure successful defibrillation.
CAUTION:
EXPLOSION HAZARD
Do NOT use in the presence of flammable anesthetics vapors or liquids.
WARNING:
INTERPRETATION HAZARD - Results of the automated QT analysis are not
considered a diagnosis.
A qualified physician or cardiologist must review and confirm the measurements
and waveforms recorded by the system. It should be used only as an adjunct to
the clinical history, symptoms, and results of other tests.
WARNING:
INTERPRETATION HAZARD - Computerized interpretation is only significant when
used in conjunction with clinical findings.
A qualified physician must overread all computer-generated tracings.
WARNING:
IMPROPER USE - This is a prescriptive device.
This equipment is intended for use by or under the direct supervision of a licensed
healthcare practitioner.
WARNING:
BATTERY EXPLOSION HAZARD - Batteries may explode in fires.
Do not dispose of the battery by fire or burning. Follow local environmental
guidelines concerning disposal and recycling.
WARNING:
ELECTRIC SHOCK HAZARD/SYSTEM MALFUNCTION - Liquids inside a device can
cause electric shock or system malfunction.
Do not allow liquids to enter the device. If liquids enter the device, turn it off and
inform your service technician. Do not use the device until it is checked by a
service technician.
WARNING:
ELECTRIC SHOCK - Improper connection of this equipment may cause electric
shock.
To avoid risk of electric shock, this equipment must only be connected to a supply
mains with protective earth.
10 MAC
™
7 Resting ECG Analysis System 2109599-003 A