EN - Specification - Ziehm 8000
EN - Specification - Ziehm 8000
EN - Specification - Ziehm 8000
• Width: 80 cm
• Length: 162 cm / 184 cm Digital Video Chain
• Height: 174 cm / 216 cm
Digital Video Camera
• Weight C-arm mobile stand (high contrast, non-interlaced)
(weight can vary depending on balancing
• Active pixels: 1,048,576
and configuration): 281 kg ± 2 %
• Camera matrix: 1,024 x 1,024 pixels
Brakes
• Bandwidth of video signal: 20 MHz
• Steering & braking lever, with parallel
• Bandwidth of video amplifier: 50 MHz
movement of the mobile stand in all directions
• Video (monitor): 1,125 lines
• Color-coded brake handles for all movements
• Signal-to-noise ratio: 68 dB
• Control: ADR / AVR
X-Ray Generator
• X-ray tube: stationary anode
• Dual focus: 0.5 / 1.5 mm (IEC 60336)
• Max. anode heat content: 48 kHU / 34 kJ
• Max. anode heat dissipation: 600 W / 51 kHU/min
• 1.14 million HU system heat capacity
• Generator type:
high-frequency generator
frequency: 40 kHz
microprocessor-controlled
• Nominal output (100 kV): 2.000 W
• Maximum output: 2.200 W
Filtration
• Total filtration: ≥ 3.9 mm Al + 0.1 mm Cu
Collimator System
• Collimator rotation: ± 90°
• Iris collimator: 50-230 mm diameter
Operating Values
• Fluoroscopy:
kV range: 40-110 kV
mA range: 0.2-6.0 mA (200-240 V)
• Digital radiography (snapshot):
kV range: 40-110 kV
mA: up to 8 mA (200-240 V)
• Radiography (option):
kV range: 40 -110 kV
mA: up to 20 mA (200-240 V)
Output
• Fluoroscopy: 605 W
• Digital radiography (snapshot): 880 W
Digital Memory
• Storage capacity: 150,000 images
Safety Features
• Digital image processing: 16 bit • Electrical Protection Class I equipment, Type B
(IEC 60601-1)
Data Organization • Security key switch (X-ray)
• Patient-based data management with 16-image • Emergency stop button on the C-arm
mosaic display
Options
• Laser positioning device integrated in I.I. and /or
generator housing
• Skin Cone for the generator: A removable mechanical
extension of the generator cap in order to avoid a focal
spot to skin distance smaller than 30 cm.
• Virtual collimator
• Measured dose area product (DAP) and measured Air
Kerma
• Emergency stop button on the monitor cart
• Handrail around the I.I.
• Connection for external radiation warning lamp
• Additional handrails on the C-arm for orbital rotation
support
• Additional zoom (10 cm mag. I.I.)
• Power-on key switch
Accessories
• Disposable sterile covers for all sizes
• Hand surgery table
• Universal film cassette holder
Regulatory Compliance
Device Classification
• MDD 93/42 EEC, Annex IX: IIb
Compliance to QM Requirements
• EN ISO 13485 certified
• MDD 93/42/EEC, Annex II certified
• MDSAP certified
Australian Therapeutic Good Regulation
Brazil RDC ANVISA n. 16/2013, RDC ANVISA n.
23/2013, RDC ANVISA n. 67/2009
Canada Medical Device Regulations Part 1 – SOR
98/282
Japan MHLW Ministerial Ordinance 169
United States 21 CFR 820
• ISO 14971
• IEC 62304
• IEC 62366
Product Compliance
• IEC 60601-1 and relevant collateral
and particular standards
Ziehm 8000
(C-Arm Mobile Stand 23 cm I.I.)
Ziehm 8000
(Monitor Cart)