For in vitro diagnostic use. Instrument VENTANA HE 600 IVD VENTANA® HE 600 INS_4090 06917259001 HE 600 Platform VENTANA HE 600 04015630976010 Instruments Not Available Not Available The VENTANA HE 600 system is intended to automatically stain histologic sections of formalin-fixed, paraffin- embedded (FFPE) specimens on microscope slides, with hematoxylin and eosin. The system fully automates the process of baking, deparaffinization, staining, and coverslipping of specimens on microscope slides. The VENTANA HE 600 system is intended for use in the anatomic pathology (AP) laboratory environment by trained laboratory personnel who are knowledgeable in histology processes and have basic computer operation skills.The VENTANA HE 600 system is intended for in vitro diagnostic (IVD) use. en General characteristics LabelingIVD, CE marked according to European Union Directive 98/79/EC, CSACertificationsEN 61010-1, IEC 61010-2-010, IEC 61010-2-081, EN 61010-2-101, EN 61326-1, EN 61326-2-6, EN ISO 18113-1:2011Fully automatedConsolidates ovens, stainers, and coverslipper into one systemCapacity10 trays = 200 slidesThroughputUp to 200 slides/hrTime to first result40-45 minutes at mid-range protocolsConsumablesNine reagents plus coverslipsSlides25 mm x 75 mm (ISO certified), 26 mm x 75 mm (ISO certified)Coverslips24 mm x 50 mm glass coverslipsDI water supply hook upNot necessaryBarcodesCapable of reading Interleaved 2 of 5, Code 128, Data Matrix, PDF417, QR code, and other symbologiesSpecimen trackingTrack slides from drying to coverslippingConnectivity(Recommended) Standard Category 5, RJ-45 network port located within 4.25 m (14 ft) of the left side of the instrumentAlarmsConfigurable audible and visual alerts availableEnvironmental conditions Temperature15 °C to 32 °C (59 °F to 90 °F)Humidity10% - 80%, non-condensingAltitude305 m below sea level (-1,000 ft) to 1,829 m above sea level (6,000 ft)Electrical specifications Voltage230 +/- 10% nominal AC, 50/60 HzCurrentDedicated/isolated 30 amp circuit requiredUPSHighly recommendedVentilation specifications Flow rate60-70 CFMDuct size7.62 cm (3 inches)Physical characteristics (installed dimensions) ConfigurationFloor modelWidth145 cm / 57 inchesDepth88 cm* / 34.5 inches*Height202 cm, 79.5 inches (without ventilation) 229 cm, 90 inches (with ventilation)Weight621 kg, ~ 1,370 lbs (no waste module) 645 kg, ~ 1,422 lbs (waste module included)* Allows for instrument depth and 7 inches of clearance from the back wallNote: See site requirements for detailed layout of space and load requirementsWaste options* Direct-to-drainDrain must be located within 4.5 m (15 ft) of the right side of the instrumentWaste collection(2) 5.7 L waste containers, can be changed without process interruption * Waste options must be managed in accordance with all applicable local, state, and national regulations. en