Mindray BeneVision N1

BeneVision N1 Patient Monitor Operator’s Manual A - 7
A.12 Out-Of-Hospital Transport - Standards Compliance
■ Shock Tests according to IEC TR 60721-4-7, Class 7M3. Test procedure according to IEC/EN60068-2-27
(peak acceleration up to 100g).
■ Random Vibration according to IEC TR 60721-4-7, Class 7M3. Test procedure according to IEC/EN 60068-2-
64 (RMS acceleration 5g).
■ Sinusoidal Vibration according to IEC TR 60721-4-7, Class 7M3. Test procedure according to IEC/EN 60068-
2-6 (acceleration up to amplitude 2g).
■ Bump Test according to IEC/EN60068-2-29 (peak acceleration 15 g, 1000 bumps).
■ Free Fall Test according to EN 60068-2-32 (height 1.2 m).
■ EN 1789:2007+A2:2014 Medical vehicles and their equipment - Road ambulances.
■ EN 13718-1:2008 Medical vehicles and their equipment-Air ambulances-Part 1: Requirements for medical
devices used in air ambulances.
■ IEC 60601-1-12:2014 Medical electrical equipment -Part 1-12: General requirements for basic safety and
essential performance -Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems intended for use in the emergency medical services environment.
■ RTCA DO-160G Environmental Conditions and Test Procedures for Airborne Equipment.
◆ Section 7 Operational Shocks and Crash Safety
◆ Section 8 Vibration (Category S for fixed wing and Category U2 for rotary wing)
■ MIL-STD-810G Environmental engineering considerations and laboratory tests
◆ Method 514.6 Category 13 - Fixed Wing Propeller Aircraft
◆ Method 514.6 Category 14 Category 14 Helicopter, General, UH-60
◆ Method 514.6 Category 20 - Ground vehicles - ground mobile
◆ Method 514.6 Category 24 - Helicopter minimum integrity test
■ Radiated susceptibility 20 V/m according to IEC80601-2-30: 2013 (NIBP), ISO80601-2-55: 2011 (CO
2
),
ISO80601-2-56: 2009 (TEMP), ISO 80601-2-61: 2011 (SpO
2
).
■ Extended radiated susceptibility tests
◆
TETRA 400: 27V/m
◆ GMRS 460; FRS 460; GSM 800/900; TETRA 800; iDEN 820; CDMA 850; LTE Band 5; GSM 1800; CDMA
1900; GSM 1900; DECT; LTE Band 1, 3,4, 25; UMTS; Bluetooth; WLAN; 802.11 b/g/n; RFID 2450; LTE Band
7: 28V/m
◆ LTE Band 13, 17; WLAN 802.11 a/n: 9V/m
■ Magnetic Field emission according to MIL STD 461F, Chapter RE101: Radiated emissions, magnetic field,
30Hz to 100KHz. Limit class: Army.
■ Magnetic Field susceptibility: Radiated susceptibility, magnetic field, 50 and 60 Hz, 30 A/m.