Technical Information
Association for the Advancement of Medical Instrumentation (AAMI) Electrode Test Results
Wet Gel Electrode Tests
6% Potassium Chloride Gel
The following products incorporate 6% Potassium Chloride Gel and are tested according to the voluntary Association for the Advancement of Medical Instrumentation (AAMI) standard requirements for electrical performance for disposable ECG electrodes:
|
LL Series
|
LRM Series
|
FO Series |
LLEBL Series
|
LLEBX Series
|
P6
|
Test Results:
|
Lead-Lok Typical
|
AAMI Limits
|
| DC Offset Voltage (mV) |
0.15
|
Not more than 100
|
| AC Impedance @ 10Hz (OHMS) |
51
|
Not more than 2000
|
| DC Offset @ 5 sec after capacitor discharge (mV) |
0.7
|
Not more than 100
|
| Recovery Slope @ 30 second interval (mV/sec) |
0.0
|
Not more than 1.0
|
| AC Impedance after defib (OHMS) |
49
|
Not more than 3000
|
| Noise (uV) |
3
|
Not more than 150
|
| Bias (mV) |
4
|
Not more than 100
|
| Biocompatibility (ISO 10993-1-2003) |
Pass
|
|
| Shelf Life (ASTM F1980) |
18 Months
|
Not more than 24
|
| Adhesive Performance (Duration of use) |
1 Day
|
Up to 3 Days
|
10% Potassium Chloride Gel
The following product incorporates 10% Potassium Chloride Gel and is tested according to the voluntary Association for the Advancement of Medical Instrumentation (AAMI) standard requirements for electrical performance for disposable ECG electrodes:
- Test Results:
|
Lead-Lok Typical
|
AAMI Limits
|
| DC Offset Voltage (mV) |
0.15
|
Not more than 100
|
| AC Impedance @ 10Hz (OHMS) |
50
|
Not more than 2000
|
| DC Offset @ 5 sec after capacitor discharge (mV) |
1.1
|
Not more than 100
|
| Recovery Slope @ 30 second interval (mV/sec) |
0.0
|
Not more than 1.0
|
| AC Impedance after defib (OHMS) |
47
|
Not more than 3000
|
| Noise (uV) |
5
|
Not more than 150
|
| Bias (mV) |
5.2
|
Not more than 100
|
| Biocompatibility (ISO 10993-1) |
Pass
|
|
| Shelf Life (ASTM F1980) |
18 Months
|
Not more than 24
|
| Adhesive Performance (Duration of use) |
1 Day
|
Up to 3 Days
|
Solid Gel Electrodes
All Lead-Lok solid gel electrodes are tested according to the voluntary Association for the Advancement of Medical Instrumentation (AAMI) standard requirements for electrical performance for disposable ECG electrodes and exceed those performance standards.
Stealth Gel Electrodes
The following products are injected with Stealth Gel, Lead-Lok’s proprietary solid gel:
|
SFT Series
|
SFS Series
|
SFL Series |
SFLL Series
|
Test Results:
|
Lead-Lok Typical
|
AAMI Limits
|
| DC Offset Voltage (mV) |
0.12
|
Not more than 100
|
| AC Impedance @ 10Hz (OHMS) |
60
|
Not more than 2000
|
| DC Offset @ 5 sec after capacitor discharge (mV) |
6.5
|
Not more than 100
|
| Recovery Slope @ 30 second interval (mV/sec) |
0.0
|
Not more than 1.0
|
| AC Impedance after defib (OHMS) |
46
|
Not more than 3000
|
| Noise (uV) |
4
|
Not more than 150
|
| Bias (mV) |
2.2
|
Not more than 100
|
| Biocompatibility (ISO 10993-1) |
Pass
|
|
| Shelf Life (ASTM F1980) |
18 Months
|
Not more than 24
|
| Adhesive Performance (Duration of use) |
1 Day
|
Up to 3 Days
|
Pre-Wired Electrodes
The following pre-wired electrodes are laminated with a unique conductive hydrogel:
Test Results:
|
Lead-Lok Typical
|
AAMI Limits
|
| DC Offset Voltage (mV) |
0.51
|
Not more than 100
|
| AC Impedance @ 10Hz (OHMS) |
237
|
Not more than 2000
|
| DC Offset @ 5 sec after capacitor discharge (mV) |
12.8
|
Not more than 100
|
| Recovery Slope @ 30 second interval (mV/sec) |
0.0
|
Not more than 1.0
|
| AC Impedance after defib (OHMS) |
224
|
Not more than 3000
|
| Noise (uV) |
3
|
Not more than 150
|
| Bias (mV) |
4.2
|
Not more than 100
|
| Biocompatibility (ISO 10993-1) |
Pass
|
|
| Shelf Life (ASTM F1980) |
26 Months
|
Not more than 36
|
| Adhesive Performance (Duration of use) |
1 Day
|
Up to 3 Days
|
The following snap electrodes are laminated with a unique conductive hydrogel:
Test Results:
|
Lead-Lok Typical
|
AAMI Limits
|
| DC Offset Voltage (mV) |
0.13
|
Not more than 100
|
| AC Impedance @ 10Hz (OHMS) |
207
|
Not more than 2000
|
| DC Offset @ 5 sec after capacitor discharge (mV) |
12.5
|
Not more than 100
|
| Recovery Slope @ 30 second interval (mV/sec) |
0.0
|
Not more than 1.0
|
| AC Impedance after defib (OHMS) |
220
|
Not more than 3000
|
| Noise (uV) |
3.2
|
Not more than 150
|
| Bias (mV) |
4.9
|
Not more than 100
|
| Biocompatibility (ISO 10993-1) |
Pass
|
|
| Shelf Life (ASTM F1980) |
18 Months
|
Not more than 24
|
| Adhesive Performance (Duration of use) |
1 Day
|
Up to 3 Days
|
Pediatric Electrotherapy Electrodes
All Lead-Lok electrotherapy electrodes are tested according to the voluntary Association for the Advancement of Medical Instrumentation (AAMI) standard requirements for electrical performance for disposable ECG electrodes and exceed those performance standards.
Pre-Wired Electrodes
The following pre-wired electrodes are laminated with a unique conductive hydrogel:
Test Results:
|
Lead-Lok Typical
|
AAMI Limits
|
| DC Offset Voltage (mV) |
0.51
|
Not more than 100
|
| AC Impedance @ 10Hz (OHMS) |
237
|
Not more than 2000
|
| DC Offset @ 5 sec after capacitor discharge (mV) |
12.8
|
Not more than 100
|
| Recovery Slope @ 30 second interval (mV/sec) |
0.0
|
Not more than 1.0
|
| AC Impedance after defib (OHMS) |
224
|
Not more than 3000
|
Snap Hydrogel Electrodes
The following snap electrodes are laminated with a unique conductive hydrogel:
Test Results:
|
Lead-Lok Typical
|
AAMI Limits
|
| DC Offset Voltage (mV) |
0.13
|
Not more than 100
|
| AC Impedance @ 10Hz (OHMS) |
207
|
Not more than 2000
|
| DC Offset @ 5 sec after capacitor discharge (mV) |
12.5
|
Not more than 100
|
| Recovery Slope @ 30 second interval (mV/sec) |
0.0
|
Not more than 1.0
|
| AC Impedance after defib (OHMS) |
220
|
Not more than 3000
|
|
