| Details of Equipment: |
 |
| Product Type: |
Diagnostic Ultrasound System |
| Brand Name: |
GE Healthcare |
| Model Number: |
Vscan Access |
| NCA Equipment No.: |
2R9-1H-7E0-0D0 |
| Product Name: |
Vscan Access |
| Intended Use: |
This device is a diagnostic ultrasound system |
| Additional Details for Radio Equipment: |
| Frequency Range: |
2400-2483.5MHz |
| RF Output Power Radiation: |
2400-2483.5MHz: 11dBm |
| RF Output Power Conducted: |
|
| RF Channel Spacing: |
Bluetooth v4.0 LE: 2 MHz |
| RF Output Impedance: |
|
| Type Of Modulation: |
GFSK |
| Bandwidth: |
|
| Software Version: |
|
| Antenna Type: |
Integral |
| Antenna Gain: |
|
| Technical Variants: |
|
| Details of Certificate of Compliance: |
| Issuing Body: |
GE Medical Systems (China) Ltd. (R&TTE Self-Declaration of Conformity form) |
| Issuing Date: |
06/30/2016 |
| Validity: |
Indefinite |
| Standards: |
| EMC: |
EN 55011:2009 +A1:2010
EN 61000-3-3:2013
ETSI EN 301 489-1: V1.9.2: 2011
ETSI EN 301 489-17: V2.2.1: 2012
EN61000-4-2: 2009
EN61000-4-3:2006+A2:2010
EN61000-4-4:2004+A1:2010
EN61000-4-5:2006
EN61000-4-6:2009
EN61000-4-8:2010
EN61000-4-11:2004
EN 60601-1-2:2007+AC:2010
EN 60601-2-3-37:2008
EN 61000-3-2:2006+A2:2009 |
| Radio: |
ETSI EN 300 328 V1.8.1 (2012-06)
|
| Health And Safety: |
IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1
(2012) or IEC 60601-1: 2012 |
| Manufacture's Information: |
| Name Of Manufacturer: |
GE Medical Systems (China) Ltd. |
| Address Of Manufacturer: |
No. 19 Changjiang Road, Wuxi National High Tech Dev-Zone, 214028 Jiangsu, China |