User's Manual Part 3

8-1
8. Pre-Use Operator Verification, Troubleshooting and User
Maintenance
8.1. Overview
Check the following items prior to monitoring to ensure completion of all essential preparations.
Items that are broken, missing, plainly worn, distorted, or contaminated must be replaced
immediately. The 3880 system must not be repaired other than in accordance with written
instructions provided by IRadimed. The device shall not be altered without written approval of
IRadimed. The user has the sole responsibility for any malfunction which results from improper
use, faulty maintenance, improper repair, damage or alteration by anyone other than IRadimed
authorized personnel.
! WARNING
• For proper equipment performance, maintenance and service procedures should be
performed at the recommended intervals as described in the monitor’s service manual.
NOTE
• The IRadimed software design controls include performance of a risk analysis using
methods consistent with ISO 14971 Medical devices - Application of risk management to
medical devices. The 3880 system employs watchdog timers, self-monitoring activities
(memory, communication and sensor checks and so on), and power-on self-diagnostics
(for example, memory checksums).
8.1.1. Battery Life Expectancy
Life expectancy of a battery depends on how frequent and how long it is used. For properly
maintained and stored batteries, the life expectancy is about 2 or 3 years respectively. For more
aggressive and non-traditional use models, the life expectancy maybe less.
IRadimed
recommends replacing batteries every 2 to 3 years or when signs of wear or operation are
noticeably different.
To get the most out of your batteries observe the following guidelines:
• The battery performance test must be performed every year, before monitor repairs, or
whenever the battery is suspected as being the source of the problems.
• Take out the battery before the monitor is shipped or will not be used for more than 3
months.
• The shelf-life of a Lithium Polymer battery is about 6 months when the battery is stored
with the battery power being 50% of the total power.