Instructions for use: Ikus - Berlin Heart
Instructions for use: Ikus - Berlin Heart
Instructions for use: Ikus - Berlin Heart
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13.2 Technical specifications<br />
Product<br />
Manufacturer and distributor<br />
Classification<br />
Overall system (excluding pump)<br />
Electro-pneumatic ventricular assist <strong>Ikus</strong> EXCOR VAD with<br />
EXCOR stationary Driving Unit <strong>Ikus</strong><br />
<strong>Berlin</strong> <strong>Heart</strong> GmbH<br />
Wiesenweg 10<br />
12247 <strong>Berlin</strong><br />
Germany<br />
Class 3<br />
Ambient operating temperature + 10 to +30 °C, with restrictions up to 35 °C<br />
Ambient temperature in storage and<br />
transport<br />
Max. ambient magnetic field 10 A/m<br />
Relative ambient air humidity 45 to 75%<br />
Ambient atmospheric pressure 900 hPa to 1060 hPa<br />
Pump<br />
Dimensions see product datasheets<br />
- 10 to +50 °C<br />
6 h rest phase after transport be<strong>for</strong>e commissioning<br />
Material Housing and membranes: polyurethane<br />
Driving tube adapter: polyoxymethylene<br />
Connectors: titanium<br />
Coating of the blood contact surfaces Carmeda ® BioActive Surface (CBAS TM )<br />
Ambient temperature of blood pump storage max. +30 °C<br />
Duration of <strong>use</strong> recommended: 1 year; max.: 500 days<br />
Cannulas<br />
Dimensions see product datasheets<br />
Material Silicone; partially textile-rein<strong>for</strong>ced; partially surrounded<br />
by suturable polyester velour; with partial flexible metal<br />
rein<strong>for</strong>cement: wire 2 mm, steel Rd 1.4301; apex cannula<br />
with titanium sheath; mandrin POM<br />
<strong>Ikus</strong><br />
Dimensions (WxHxD) 46 x 95 x 73 cm (with the laptop closed)<br />
46 x 120 x 73 cm (with the laptop open)<br />
Driving tube (red/blue) Recommended lifespan: 1 year; max.: 500 days<br />
Weight 93 kg<br />
Input voltage AC 115 V or AC 230 V (see identification plate)<br />
Power input 575 VA<br />
Mains power f<strong>use</strong> 5 A (115 V) to 3 A (230 V)<br />
External alarm connector Electrical data: max. 24 V /1 A<br />
Insulation data: 2.5mm/ 4 mm strike and creep distance between<br />
alarm contact and 24V safety-low voltage inside the device<br />
(coil side)<br />
Insulation test voltage: 500V<br />
Protection class IPX0 (protection against accidental contact not tested, no water<br />
protection)<br />
Pump frequency 30 to 150 bpm<br />
Systolic pressure 60 to 350 mmHg<br />
Technical specifications<br />
1000002 Rev. 4.9.1 89
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