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
Product and Packaging Information
Item Label Location Description
7 Shipping Label On the shipping
package
Indicates the shipping address where the device is
delivered.
8 RED Lable On the shipping
package
Contains registration information of Radio Equipement
Directive.
9 Environmental
Symbols
These symbols containing warning and caution
indicators are required for shipping. For a full
description of symbols, see "Symbol Descriptions" on
page 18.
10 Battery Shipping
Label
On the shipping
package
FRAGILE—Lithium Ion batteries can cause fire if
damaged.
16 MAC
™
7 Resting ECG Analysis System 2109599-003 A