- ページ 17

医療機器 Allied Healthcare EPV200のPDF ユーザーマニュアルをオンラインで閲覧またはダウンロードできます。Allied Healthcare EPV200 20 ページ。 Portable battery powered ventilator with oxygen source required

ページを印刷する

Applicable Standards

This equipment has been tested and found to comply with the EMC limits for the Medical Device

Directive 93/42/ECN (EN 55011 and EN 60601-1-2). These limits are designed to provide

reasonable protection against harmful interference in a typical medical installation. There is no

guarantee that interference will not occur in a particular installation. If this equipment does

cause harmful interference with other devices, which 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 device

 Increase the separation between the equipment

 Connect the equipment into an outlet on a circuit different from that which the

other device(s) is connected.

Consult the manufacturer or field service technician for help

The EPV200 is intended to provide emergency respiratory support for children and adults. The

product is intended to meet the following safety and performance standards:

Performance and Safety Requirements

 ASTM F920 – Performance and Safety Requirements for Resuscitators Intended for Use

with Humans

 ISO 10651-3 – Lung Ventilators for Medical Use – Particular Requirements for

Emergency and Transport Ventilators

Electrical Safety Requirements

 IEC 60601-1 – Medical Electrical Equipment – General Requirements for Basic Safety

and Essential Performance

Transportation and Storage Requirements

 MIL-STD-810E – Shock, Vibration and Storage Requirements

The above listing of standards is not intended to be a complete listing of standards reviewed and

tested during the development of this product. It also may not reflect latest versions, as

standards change. Allied Healthcare Products, Inc. regularly reviews the standards and updates

the products to ensure compliance as necessary.

For the latest revision of the instruction manual, please refer to the company website at

www.alliedhpi.com

This manual is also available in other languages. Please call 314-771-2400 for more

information on obtaining this manual in other languages.