Safety Specifications Product Specifications
9 - 24 046-003777-00 A5/A3â„¢ Operating Instructions
9.14 Safety Specifications
Vibration Test: Frequency range: 10 to 2000 Hz
ASD 10 to 100 Hz: 1.0 (m/s
2
)
2
/Hz
ASD 100 to 200 Hz: -3 dB/Octave
ASD 200 to 2000 Hz: 0.5 (m/s
2
)
2
/Hz
Duration: 10 min per perpendicular axis (3 total)
Shock Test:
Peak acceleration: 150 m/s
2
(15 g)
Duration: 11 ms
Pulse shape: half-sine
Number of shocks: 3 shocks per direction per axis (18 total)
Drop: Complies with the requirements of clause 15.3.5 in IEC 60601-1.
Spillage and Harmful
Ingress of Water:
Complies with the requirements of clause 11.6.3 in IEC 60601-1 and also the
requirements in IEC 60529 for protection against vertically falling water drops
equipment (IPX1).
Surface Temperature: Complies with the requirements of clauses 11.1 in IEC 60601-1.
Mechanical Stability: Complies with the requirements of clause 9.4 in IEC 60601-1.
Incompatibility with
External Connectors:
Complies with the requirements of clause 15.4 in IEC 60601-1.
Enclosure Rigidity and
Strength:
Complies with the requirements of clauses 15.3.2, 15.3.3, 15.3.6, and 15.3.7 in
IEC 60601-1.
Impairment of
Cooling:
Complies with the requirements of clause 13.2.7 in IEC 60601-1.
Leakage Current: Complies with the requirements of clause 8.7 in IEC 60601-1.
Earth leakage current:
• Normal condition ≤ 500 A
• Single fault condition ≤ 1000 A
Enclosure leakage current:
• Normal condition ≤ 100 A
• Single fault condition ≤ 300 A
Patient leakage current:
• Normal condition ≤ 100 A
• Single fault condition ≤ 500 A
Patient auxiliary current DC:
• Normal condition ≤ 10 A
• Single fault condition ≤ 50 A
Patient auxiliary current AC:
• Normal condition ≤ 100 A
• Single fault condition ≤ 500 A
Patient leakage current (applied part plus mains voltage):
• Single fault condition ≤ 5000 A
Dielectric Strength: Complies with the requirements of clause 8.8.3 in IEC 60601-1.
Mains supply to earth (A-a1): 1500 VRMS, 1 min
Mains supply to applied part (B-a): 4000 VRMS, 1 min
Applied part to earth (B-d): 1500 VRMS, 1 min
Isolation at network port: 1500 VRMS, 1 min
TABLE 9-32 Safety Specifications