Storage, Transport And Disposal; Emc Guidance And Declaration - aptus Heli-FX Instrucciones De Uso

12.0 STORAGE, TRANSPORT AND DISPOSAL

Follow local governing ordinances and recycling plans regarding disposal or recycling of device
components. Do not incinerate the Heli-FX Applier unit, as the enclosed batteries may explode
at excessive temperatures.
Environmental Conditions:
• Storage Conditions: Keep dry
• Operating Conditions: (10 – 40°C)(30 – 75% RH)
• Transportation Conditions: (- 18° – + 60°C)(15 – 90% RH)(700 – 1060 hPa)

13.0 EMC GUIDANCE AND DECLARATION

This equipment has been tested and found to comply with the EMC limits for the Medical Device
Directive 93/42/EEC (EN 55011 Class B and EN 60601-1-2). These limits are designed to provide
reasonable protection against harmful interference in a typical medical installation. The equipment
generates, uses, and can radiate radio frequency energy and, if not used in accordance with the
instructions, may cause harmful interference to other devices in the vicinity. However, there is no
guarantee that interference will not occur in a particular setting.
Table 6: Guidance and manufacturer's declaration – electromagnetic emissions
The Heli-FX Applier is intended for use in the electromagnetic environment specified below.
The customer or the user of the Heli-FX Applier should assure that it is used in such an environment.
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
Flicker emissions
IEC 61000-3-3
Heli-FX® EndoAnchor® System
Compliance
Group 1 The Heli-FX Applier uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
Class B The Heli-FX Applier is suitable for use in all establishments, including
domestic establishments.
Not Applicable
Not Applicable
Electromagnetic environment-guidance
EN
20