ASK-T898-03-7600 Siemens Medical Systems, EM-PCS Danvers 57
7k9kXLSM.c4.CD_ROM.fm/04-99/kaupp
NOT A CONTROLLED DOCUMENT
Chapter 4: Functional Verification and Calibration
1Introduction
Calibration required for proper operation of SC 7000 and SC 9000XL
Patient Monitors have been programmed into the software for the monitor.
An adjustment potentiometer, however, permits calibration of the NBP
transducer in the field, if required following a calibration check. Specific
calibration and adjustment procedures needed in routine operations of the
monitor are detailed in the User Guide for the installed software version,
and are required to be performed only when directed to do so by a message
in the message field on the monitor display.
If specific reading of a patient parameter is suspect, Siemens recommends
functional verification for that function. Siemens recommends a full
functional verification for all patient parameters, including an NBP
calibration check, a pneumatic leakage check, a Temperature calibration
check and a leakage current check be performed in accordance with local
regulations or at least annually. In addition, re-characterization should be
performed at least every two years. Refer to Section 4.7.4 in Chapter 3.
Note: Re-characterization and calibration checks for NBP and
Temperature should be performed by only qualified personnel with the
necessary equipment.
Regulations in some national jurisdictions
may place specific requirements on who may perform these
functions
This chapter describes functional verification procedures, calibration check
procedures, and NBP calibration procedures for monitors in the field. The
procedures assure proper operation of the monitor, using industry-standard
patient simulators and test equipment, to verify that the monitor properly
processes and reports patient physiological parameter signal inputs.
Record results of functional verification testing in a copy of “Appendix D:
Functional Verification Checklist”.
Software and certain of the monitor’s hardware components are continually
checked, first during power-up and later during on-line self-tests. All
monitor functions that are tested are performing in accordance with design
specifications if no error messages exhibit.
Perform all functional verification and calibration procedures with the main
battery installed, and the monitor off-line if mounted on a docking station
and powered by a CPS or IDS. Disconnect all patient parameter signal
inputs from the monitor, and plug in signal inputs from patient simulators
and industry-standard test equipment only as instructed to do so.
To
assure that the monitor is off-line, unplug network cable from, IDS,
CPS, or monitor (if monitor functioning in DirectNet mode).
If the monitor fails to perform as indicated for any specific function during
functional verification procedures, troubleshoot the monitor using
procedures in “Chapter 5: Troubleshooting” of this Manual and remedy the
malfunction before attempting to complete functional verification.
2 Recommended
Tools and Test
Equipment
Use specified recommended tools and test equipment given in Table 4-1
below, or a known equivalent, when performing functional verification tests.
Substitutions are approved only if an equivalent is listed. Use of other test
equipment and/or accessories could result in inconclusive tests or damage
to system components.
To Next Page
Loading...
Need help?
General
