SALUDA MEDICAL Evoke, Клиническое руководство

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Document Reference: ENG-UMAN-000731 Revision: 5.00 Page 55 of 61
15.5 Evoke CLS
Table 15.4: Evoke CLS.
Materials Case Titanium
Header Epoxy
Seals Liquid silicone rubber
Connector springs Platinum Iridium (24 x connectors)
Set screw Stainless steel
Dimensions 68 mm x 48 mm x 12 mm (2.7 in x 1.9 in x 0.472 in)
Volume 33 cm³ (2 in³)
Weight 50 g (1.76 oz.)
Lead ports 2 Each percutaneous lead is secured by a set screw
at the port entry
Electrodes 25 Port 1: electrodes 1-12
Port 2: electrodes 13-24
CLS case is electrode 25 (recording only)
Stimulation
parameters Current 0 mA – 50 mA (20mA at 750 Ω)
Pulse Width 20 μs – 1000 μs
Frequency
10 Hz – 1500 Hz
Radio
frequency
communication MICS band 403 MHz
Range 1.0 m (3.3 ft.)
Battery Battery type 200 mAh Li-Ion rechargeable battery
Battery life
Greater than 10 years at moderate
settings (current = 5.0 mA, pulse width =
200 μs, frequency = 60 Hz, impedance =
750 Ω, 24hrs/day usage)
Charging Transcutaneous charging using inductive coupling with
an external coil
Implant depth
5 mm to 20 mm (0.2 in to 0.8 in)
Recording
amplifier gain Low: 250x
High: 1000x
Data recording 32 MB, up to 1 year
(Stimulation usage, ECAP amplitude and current
statistics)
Radio opaque
identifier “SME AYY”
Where “SME” is Saluda Medical, “A” is the CLS model
and YY is the two-digit year of manufacture