Test and Inspection Matrix 5: Performance Verification
159
NOTE: When recording test results, separate results within a test by slashes (/); separate tests by semicolons (;);
and use no empty spaces.
V:x;OC:x;EL:x;C:x;DP:x;F:x;Pr:x;USB:x;NC:x;E:x;SP:x;NM:x;SC:x;P:x;DA:x;DB:x;D:x;Pa:x;
S1:x/aaa/bbbb;S2:x/cc/ddd;S3:x/ee/ff/gg/hh/ii/jj/kk/ll/mm/nnn/ooo/ppp
For example: V:p;OC:p;EL:p;C:p;DP:p;F:p;Pr:p;USB:p;NC:p;E:p;SP:p;NM:p;SC:p;P:p;DA:p;
DB:p;D:p;Pa:p;S1:p/9/49/49/9/49/49/9/49/49/99/499/499
Defibrillator
Disarm Test
(D)
Run the “Defibrillator Disarm Test” on
page 169.
Verify that the device is disarmed
Verify that the charge tone stopped
then the Defibrillator Disarm test passes.
D:x
Example D:p
Paddles Safety
Check (Pa)
Perform “Paddles Safety Check” on
page 171.
If PCI flashes as expected, then Paddles test
passes.
Pa:x
Example Pa:p
Safety Tests Using a Safety Analyzer
NOTE: All leakage current tests include both Normal and Reverse Polarity Conditions. Report worst case values.
AC Mains
(S1)
Earth Leakage Current NC (Normal
Condition). See “AC Mains (Ground
Leakage)” on page 172 — aaa
If Normal Condition Maximum leakage
current:
< 300 μA (UL, 120 VAC)
< 500 μA (IEC, 240 VAC)
S1:x/aaa/bbbb
Example:
S1:p/125/800
Earth Leakage Current
SF (Single Fault, open neutral) — bbbb
If Single Fault Maximum leakage current:
< 1000 μA,
then Earth Leakage Safety test passes
Chassis
Leakage (S2)
Use ECG Out (Sync) jack as ground NC
(Normal Condition). See “Chassis
(Enclosure) Leakage” on page 173 — cc
If Normal Condition Maximum leakage
current:
< 100 μA
S2:x/cc/ddd
Example:
S2:p/99/299
Single Fault condition
— ddd
If Single Fault Maximum leakage current:
< 300 μA (UL)
< 500 μA (IEC)
then Chassis Leakage test passes.
Patient Lead
Leakage (S3)
(see “Patient
Lead
Leakage” on
page 173)
ECG Patient Cable / Pads / SpO
2
Cable
(as applicable)
• Source (Normal cond.) — ee / hh / kk
• Source (Single Fault condition — open
earth, open neutral) — ff / ii / ll
• With Mains on applied part (Single
Fault condition) — gg / jj / mm
If readings are as expected:
• < 10 μA
• < 50 μA
• < 50 mA
then Cable Leakage test passes
S3: x/ee/ff/gg/
hh/ii/jj/kk/ll/mm/
nnn/ooo/ppp
Example:
S3:p/9/49/49/
9/49/49/
9/49/49/
99/499/499
Paddles Cable
• Source (Normal Condition) — nnn
• Source (Single Fault Condition — open
earth, open neutral) — ooo
• With Mains on applied part (Single
Fault condition) — ppp
If readings are as expected:
• < 100 μA
• < 500 μA
• < 500 μA
then Paddles Cable Leakage test passes
Table 37 Test and Inspection Matrix (Continued)
Tes t Gro up
Name
Test or Inspection to Perform Expected Test Results Data to Record
x = p (pass)
or f (fail)
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