PRODUCT: 6500033V      A10009-100



Application
Product Line:
SilveRest™

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


Product Information
Shape:
Circular
Size (excl. grip):  
1.375 in 34.925 mm
Sensor (Eyelet) Diameter:
0.42 in 10.592 mm
Substrate Thickness (adapter excluded):
0.006 in 0.152 mm
Total Product Surface Area:
1.4828 in2 37.6632 mm2
Gel Area:
0.3068 in2 7.7927 mm2
Adhesive Area:
1.176 in2 29.8705 mm2
Integrated Lead Wire (length):
N/A in
Integrated Lead Wire (color):
N/A

Materials
Substrate Material:
Vinyl Tape
Adhesive:
Acrylic, Medical Grade
Adhesive Strength:
Regular
Gel Type:
Conductive Wet Gel
Foam (Sponge) Material:
Polyurethane Reticulated Foam
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:
26 Ohm
DC Offset Voltage :
0.39 mV
SDR Slope @30 Sec int.:
0.06 mV/sec

ACZ impedance repeat:
21 Ohm
COIIN:
6 µV
Bias Current Tolerance:
6 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):
9 x 13 in 22.86 x 33.02 cm
Department Packaging - Box (Size / Qty):
n/a in n/a cm
Transport Packaging - Carton (Size / Qty):
14.5 x 10.875 x 6.75 in

36.83 x 27.623 x 17.145 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):
18 Months


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