Welch Allyn Hillrom H12+, Руководство пользователя

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USER SAFETY INFORMATION
10
Note(s)
Proper patient preparation is important to proper application of ECG electrodes and operation of the
device.
If electrode is not properly connected to the patient, or one or more of the patient cable lead wires is
damaged, display will indicate a lead fault for the lead(s) where the condition is present.
The device is set to the U.S. Central Time Zone when shipped from the factory. If a change is required,
set the correct date and time prior to using the recorder. Refer to the instructions within this user manual.

The patient cable life expectancy is six months continuous use with proper care.

Complete lead fail will cause a greater draw on battery power which may cause the recording period
to end early due to low-battery voltage.

If during power up the battery voltage is below 1.45V, the recorder will display a low battery message
and will not continue.
The device will automatically turn off (blank screen) if the batteries have been severely discharged.

No preliminary or ongoing scheduled periodic calibration by the user or Welch Allyn personnel is
required. The design for the device is such that the system contains no elements requiring
calibration.

The device conforms to the following standards:
IEC 60601-1: Edition 3.1 2012-08 General requirements for basic Safety and essential
performance
IEC 60601-2-47: Edition 2.0 2012-02* Particular requirements for safety, including essential
performance, of ambulatory electrocardiographic
systems
IEC 60601-1-2: Third Edition 2007-03 Electromagnetic Compatibility
IEC 62304:2006/A1:2015 Software life-cycle processes
IEC 62366:2015 Application of usability engineering
93/42/EEC Medical Device Directive (MDD)
2012/19/EU Waste Electrical and Electronic Equipment
ISO 10993-1:2009/Cor. 1:2010 Biological evaluation of medical devices
*
Pacemaker spikes
<
0.1 milliseconds may not always be detected.

The device is UL classified:
MEDICAL
— PATIENT-MONITORING EQUIPMENT AS TO ELECTRICAL
SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH
ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012), IEC 60601-1 (2012), CAN/CSA
C22.2 No. 60601-1 (2014) AND IEC 60601-2-47 (2012).