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
Wireless Regulations
6
Wireless Regulations
The wireless and wired LAN functionality of the MAC 7 is used to retrieve ECG orders
and send ECG reports to an ECG Management System. In addition, the wireless
and wired LAN functionality can be used to interface to other hospital information
systems to provide additional data to the care giver operating the electrocardiograph.
These tasks are an adjunct to the device’s intended use of acquiring, analyzing,
displaying and printing an electrocardiogram. Because the wireless and wired
LAN functionality is not required for the device to fulfill its intended use, network
performance is not critical to the performance of the device. Furthermore, the MAC 7
does not transmit any real-time data or alarm information over the network. Network
Quality of Service (QoS) parameters such as reliability of data transmission, latency,
transfer rate, error rate, and priority levels are not critical to the MAC 7 functionality
and are not specified.
FCC Compliance
This device complies with part 15 of the FCC Rules. Operation is subject to the
following two conditions: (1) This device may not cause harmful interference, and (2)
this device must accept any interference received, including interference that may
cause undesired operation.
CAUTION:
Changes or modifications to this unit not expressly approved by the party
responsible for compliance could void the user's authority to operate the
equipment.
NOTE:
This equipment has been tested and found to comply with the limits for a Class
B digital device, pursuant to part 15 of the FCC Rules. These limits are designed
to provide reasonable protection against harmful interference in a residential
installation. This equipment generates, uses and can radiate radio frequency
energy and, if not installed and used in accordance with the instructions, may
cause harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation. If this
equipment does cause harmful interference to radio or television reception, which
2109599-003 A MAC
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7 Resting ECG Analysis System 29