Bard Site-Rite 6 - Compliance Standards

34
Site~Rite
*
6 Ultrasound System
Internal Battery Pack Specifi cations
Battery Chemistry: Lithium Ion
Nominal Output Voltage: 10.8 VDC
Base Power Unit Specifi cations(Allbasepowerunitsexcept9760035)
Input Voltage: 15 VDC
Input Current (Max): 6 Amps
Nominal Battery Output Voltage: 10.8 VDC
Base Power Unit Specifi cations (Base power unit part number 9760035)
Input Voltage: 100-240 VAC, 50/60 Hz
Input Current (Max): 1.7 Amps
A/C Adapter Output Voltage: 15 VDC
A/C Adapter Output Current: 7 Amps
Run and Change Times
System Without Base Power Unit: Run TIme: 1 Hour
Charge TIme: 2 Hours
System With Base Power Unit: Run TIme: 3Hours
Charge TIme: 4 Hours
13 Standards Information
The Site~Rite* 6 Ultrasound System is designed to comply with applicable sections of the following Interna-
tional Standards:
 -UL60601-1:2003,MedicalElectricalEquipment,Part1:GeneralRequirementsforSafety
-CAN/CSA-C22.2No.601.1-M90,MedicalElectricalEquipment-Part1:GeneralRequirementsforSafety
 -IEC60601-1:1988,MedicalElectricalEquipment-Part1:GeneralRequirementsforSafety
 -EN60601-1:1990,IncludesAmendmentsA1:1993,A11:1993,A12:1993,A2:1995andA13:1996,MedicalElectrical
Equipment - Part 1: General Requirements for Safety
- IEC 60601-1-1: 2000, Medical Electrical Equipment - Part 1-1: General Requirements for Safety - Collateral Standard:
Safety Requirements for Medical Electrical Systems
- IEC 60601-1-2: 2001, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard:
Electromagnetic Compatibility - Requirements and Tests
 -IEC60601-2-37:2004,MedicalElectricalEquipment-Part2-37:ParticularRequirementsfortheSafetyofUltrasonic
Medical Diagnostic and Monitoring Equipment
- IEC 60601-1-4: 2000, Medical Electrical Equipment - Part 1-4: General Requirements for Safety - Collateral Standard:
Programmable Electrical Medical Systems
- NEMA UD-2: 2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
 -NEMAUD-3:2004,StandardforReal-TimeDisplayofThermalandMechanicalAcousticOutputIndicesonDiagnostic 
Ultrasound Equipment
 -EN55011:1998,Group1,ClassA-Industrial,Scientific,andMedical(ISM)Radio-FrequencyEquipment-Radio
Disturbance Characteristics-Limits and Methods of Measurement
Output Current (Max): 6 Amps
Output Power (Full Charge): 52 Wh
Battery Output Current (Max): 6 Amps
Battery Chemistry: Lithium Ion
Output Power (Full Charge): 95Wh
Nominal Battery Output Voltage: 10.8 VDC
Output Power (Full Charge): 95Wh
Battery Output Current (Max): 6 Amps
Battery Chemistry: Lithium Ion