CPI Alio Vend Panduan Teknisi - Halaman 4

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Safety and Compliance

Pacemaker guidance: potential interference

Radiofrequency energy (RF) from cell phones can interact with some electronic devices. This type of interference is called

electromagnetic interference (EMI). For this reason, the FDA helped develop a detailed test method to measure EMI of

implanted cardiac pacemakers and defibrillators from cell phones. This test method is now part of a standard sponsored by the

Association for the Advancement of Medical Instrumentation (AAMI). This standard will allow manufacturers to ensure that

cardiac pacemakers and defibrillators are safe from cell phone EMI.

The FDA continues to monitor the use of cell phones for possible interactions with other medical devices. Should harmful

interference occur, FDA will conduct testing to assess the interference and work to resolve the problem.

For more information reference sources for pacemakers can be found at the US Food and Drug Administration web site:

https://www.fda.gov / Radiation-Emitting Products / cell phones / potential-cell-phone-interference-pacemakers-and-other-

medical-devices.

Laser SAFETY CONSIDERATION

The Alio Vend card reader includes a laser emitter and corresponding drive circuitry. The laser output is designed to remain

within Class 1 laser safety limits under all reasonably foreseeable conditions, including single faults, in compliance with IEC

60825-1:2014 (Third Edition).

The laser output will remain within Class 1 limits if the CPI recommended device settings (API settings) are used and the

operating conditions specified are respected.

The laser output power must not be increased by any means and no optics should be used with the intention of focusing the

laser beam.

The laser does not require any control, adjustment or maintenance.

Caution: Use of controls or adjustments or performance of procedures other than those specified herein may result in

hazardous radiation exposure.

Laser characteristics. This device emits pulsed laser radiation with a period of 16.7 nanoseconds and 5 nanoseconds on

time, resulting in a duty cycle of 30%. The wavelength is 945 nm.

Compliance statement for Laser Notice 56. Complies with 21 CFR 1040.10 and 1040.11 except for conformance with IEC

60825-1 Ed. 3., as described in Laser Notice No. 56, dated May 8, 2019.

Published by CPI

Alio™ Vend Card Reader

01_CPI_Alio Vend Technician Guide_V1.0_EN