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
Equipment Identification
Symbol Description
Follow Instructions For Use
Read and understand the operator's manual before using the device or
product.
As a mandatory action sign, this symbol is identified by a blue background
and white symbol.
This Way Up
Indicates the correct upright position of the package.
Keep Dry
Indicates that you need to keep the container away from rain and other
sources of moisture.
Can Be Recycled
Indicates you may recycle this material or device. Recycle or dispose of in
accordance with local, state, or country laws.
Temperature Limits
Indicates the upper and lower temperature limits for the transportation
and handling of this package. They are indicated next to the upper and
lower horizontal lines.
Humidity Limits
Indicates upper and lower humidity limits for the transportation and
handling of this package. They are indicated next to the upper and lower
horizontal lines.
Atmospheric Limits
Indicates the upper and lower barometric pressure limitations for the
transportation and handling of this package. They are indicated next to the
upper and lower horizontal lines.
Defibrillation-proof Type CF Applied Part
Identifies a defibrillation-proof type CF applied part on medical equipment
that complies with IEC 60601–1.
This device meets the requirements for protection against electric shock for
an earth-free (floating) applied part (one intended for contact with patients)
for cardiac application.
No User– or Field-serviceable Parts
Do not open or disassemble the device for any reason.
Protective Earth (ground)
Identifies the terminal of a protective earth (ground) electrode or any
terminal that is intended for connection to an external conductor for
protection against electric shock in case of a fault.
20 MAC
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7 Resting ECG Analysis System 2109599-003 A