PRODUCT: 6500066V      A10049



Application
Product Line:
SilveRest™

Duration of Use (Hrs):
24
Application:
Resting ECG


Product Information
Shape:
Rectangular
Size (excl. grip):  
0.813 x 1.75 in 20.650 x 44.45 mm
Sensor (Eyelet) Diameter:
0.42 in 10.592 mm
Substrate Thickness (adapter excluded):
0.063 in 1.588 mm
Total Product Surface Area:
1.1656 in2 29.6063 mm2
Gel Area:
0.1963 in2 4.986 mm2
Adhesive Area:
0.9693 in2 24.6203 mm2
Integrated Lead Wire (length):
N/A in
Integrated Lead Wire (color):
N/A

Materials
Substrate Material:
Polyethylene Foam
Adhesive:
Acrylic, Medical Grade
Adhesive Strength:
Regular
Gel Type:
Conductive Solid Hydrogel
Foam (Sponge) Material:
N/A
Release Liner:
PS
Sensor Polymer:
Ag/AgCl plated ABS
Adaptor / Connector (Stud):
Stainless Steel
Integrated Lead Wire Jacketing:
N/A
Integrated Lead Wire Cord:
N/A


Electrical Performance
(ANSI / AAMI EC12)
ACZ impedance @10 Hz:
57 Ohm
DC Offset Voltage :
0.22 mV
SDR Slope @30 Sec int.:
0.07 mV/sec

ACZ impedance repeat:
47 Ohm
COIIN:
7 µV
Bias Current Tolerance:
4 mV
Picture Not Available

Features
MRI Conditional:
No
X-ray Translucence:
No
Integrated Abrader:
No
Repositionability:
No
Pediatric:
No


Packaging
Product Packaging Material:
Paper/PE/Foil/PE
Resealable Pouch:
Yes
Product Packaging Size (L x W):
8 x 7 in 20.32 x 17.78 cm
Department Packaging - Box (Size / Qty):
9.25 x 8.25 x 6.25 in 23.495 x 20.955 x 15.875 cm
Transport Packaging - Carton (Size / Qty):
18 x 14 x 10 in

45.72 x 35.56 x 25.4 cm


Biocompatibility
ISO 10993:
Passed

Latex Free:
Yes

Environmental
Halogenated Hydrocarbon Content (e.g. PVC):
None
Phthalate Derivatives Content (e.g. DEHP):
None

RoHS Compliant:
Yes
REACH Compliant:
Yes

Shelf Life
Product Shelf Life (in accordance with storage guidelines):
24 Months


Regulatory
Regulatory Status:
CE Mark according to MDD 93/42/EEC CE marked