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
can be determined by turning the equipment off and on, the user is encouraged
to try to correct the interference by one or more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which
the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.
Limited by local law regulations, version for North America does not have region
selection option.
To satisfy FCC RF exposure requirements, a separation distance of 20 cm or more
should be maintained between the antenna of this device and persons during device
operation.
To ensure compliance, operations at closer than this distance is not recommended.
IC Compliance
This device contains licence-exempt transmitter(s)/receiver(s) that comply with
Innovation, Science and Economic Development Canada’s licence-exempt RSS(s).
Operation is subject to the following two conditions:
1. This device may not cause interference.
2. This device must accept any interference, including interference that may cause
undesired operation of the device.
L’émetteur/récepteur exempt de licence contenu dans le présent appareil est
conforme aux CNR d’Innovation, Sciences et Développement économique Canada
applicables aux appareils radio exempts de licence. L’exploitation est autorisée aux
deux conditions suivantes:
1. L’appareil ne doit pas produire de brouillage;
2. L’appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage
est susceptible d’en compromettre le fonctionnement.
This equipment complies with radio frequency exposure limits set forth by the
Innovation, Science and Economic Development Canada for an uncontrolled
environment.
This equipment should be installed and operated with a minimum distance of 20 cm
between the device and the user or bystanders.
This device must not be co-located or operating in conjunction with any other
antenna or transmitter.
Cet équipement est conforme aux limites d'exposition aux radiofréquences définies par
la Innovation, Sciences et Développement économique Canada pour un environnement
non contrôlé.
30 MAC
™
7 Resting ECG Analysis System 2109599-003 A