The Purpose of This Study is to Verify the Performance of the Neutral Electrode (NE) Adhesives in Accordance With the Testing Specified in IEC 60601-2-2:2017, Section 201.15.101.7, Pull Test.
Conditions: Adhesion of the Neutral Electrode 21pad
Sponsor: Medline Industries

 
 
 
 
   
July 1, 2022 
 
 
 
Medline Industries, LP 
Three Lakes Drive 
Northfield, IL  60093 USA 
ATTN: Jeanine Hembd 
 
Reference: Report Number F2P27778-01S-R1 
Subject:  Test Results for Adhesion testing – pull test 
 
Dear Ms. Hembd: 
 
We have completed our evaluation of your Split Universal Grounding Pad, model number PAD9165L, specifically 
Lot # ZX20200431 to the following standard(s): 
 
• 
Medical Electrical Equipment – Part 2-2: Particular Requirements for the Basic Safety and Essential 
Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories; IEC 60601-
2-2, Clause 201.15.101.7 – Pull Test 
 
Testing began on 2022-05-30 and was completed on 2022-06-10 at the F2 Labs’ facility. 
 
This report package completes all work associated with F2 Labs’ project number F2P27778.  Should you have any 
further questions regarding this letter, please feel free to contact me at 301-253-4500. 
 
Prepared by: 
 
 
 
 
 
Reviewed by: 
 
 
 
Oscar P. Fuster 
 
 
 
 
 
Adam Black 
Project Engineer  
 
 
 
 
Safety Technical Manager 
F2 Labs  
 
 
 
 
 
F2 Labs 
 
 
 
 
 
 
 
 
 

 
Protocol Number: F2P27778 
 
Page 2 of 10 
Test Report Number: F2P27778-01S-R1 
 
Test Engineer:  Oscar Fuster 
 
 
Reviewed by:  Adam Black  
 
 
Testing Summary: 
 
Test 
Clause 
Result 
Pull Test 1 
Clause 201.15.101.7 
Pass 
 
 
 
 
Test Equipment Used: 
 
Asset No 
Description 
Calibration Date 
Calibration Due 
0515 
Scale 
                 2021-09-27 
2022-09-27 
1278 
Humidity/Barometer/Data Reader 
2021-07-22 
2022-07-22 
1298 
Tape Measure 
2022-01-07 
2023-01-07 
1324 
Stopwatch 
2022-01-07 
2023-01-07 
1327 
Stopwatch 
2022-01-07 
2023-01-07 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Protocol Number: F2P27778 
 
Page 3 of 10 
Test Report Number: F2P27778-01S-R1 
 
Test Engineer:  Oscar Fuster 
 
 
Reviewed by:  Adam Black  
 
 
MEDLINE NE PAD ADHESION TESTING 
 
Protocol #:  F2P27778 
 
Purpose 
The purpose of this study is to verify the performance of the neutral electrode (NE) adhesives in 
accordance with the testing specified in IEC 60601-2-2:2017, section 201.15.101.7, pull test. 
 
Background 
Testing the NE in accordance with IEC 60601-2-2:2017, section 201.15.101.7, is required to confirm the 
shelf life. 
 
Participant Screening 
After informed consent has been obtained, participants will be screened for the following inclusion and 
exclusion criteria.  
 
 
Inclusion Criteria: 
• 
Participants must be willing to comply with all study procedures 
• 
Participants must be willing to shave, or to have shaved, the sites where the neutral 
electrodes will be placed. 
Exclusion Criteria 
• 
The participant has any skin conditions (e.g. eczema, sensitivities, allergies to adhesives, 
sunburn, etc.) at the application sites that might be adversely affected by the application 
of an adhesive pad. 
• 
The participant is pregnant or breastfeeding. 
 
Risks and Benefits 
Possible risks associated with these tests could be an unknown sensitivity to the adhesive components. 
There may also be discomfort from the pulling of the pads during the Pull Test. Participants will be 
monitored during the testing for any adverse events.  
 
There are no benefits to participants participating in this study. 

 
Protocol Number: F2P27778 
 
Page 4 of 10 
Test Report Number: F2P27778-01S-R1 
 
Test Engineer:  Oscar Fuster 
 
 
Reviewed by:  Adam Black  
 
Regulatory and Ethical Considerations 
Participant confidentiality and privacy will be kept confidential per HIPAA requirements. The study 
protocol, documentation, data, and all other information generated will be held in strict confidence. No 
information concerning the study or the data will be released to any unauthorized third party. All study 
data will be identified with an anonymous participant number, and all CRFs and other documents 
containing data will have the participant number and no identifiable information. One master list linking 
participant numbers to participant name and other contact information will be maintained by the staff in 
the event identification of a participant is necessary. This is the only documentation that will link 
participant name and participant number. 
 
Study staff will ensure all source documents for data collection are completed in accordance with Good 
Documentation Practices (GDP) in order to ensure accurate interpretation of data. 
 
All study records will be maintained for a minimum of two years following study closeout; records will be 
maintained for a longer period of time as required by IRB or other regulations. 
 
 
 
Deviations 
It is the responsibility of the PI and study staff to use continuous vigilance to identify and report 
deviations on a routine basis. All deviations must be addressed in study source documents, and reported 
to Medline Industries, LP.  Protocol deviations must be sent to the reviewing Institutional Review Board 
(IRB) per their policies. The site investigator is responsible for knowing and adhering to the reviewing IRB 
requirements. 
 
Device Under Test Description  
 
Model:  
 
 
PAD9165L, Lot # ZX20200431 
Pad, Grounding, Split, 15’ Cord 
 
 
Dimensions: 
 
 
12.0cm x 13.4cm 
Total area:  
 
 
160.8 cm2 
Total conductive area:  
 
96.2– 3.03* = 93.17 cm2 
                                 
 
 
*inside dimension of non-conductive area per photo 
 
Photo of Pad: 
 
 

Protocol Number: F2P27778 
 
Page 5 of 10 
Test Report Number: F2P27778-01S-R1 
 
Test Engineer:  Oscar P. Fuster 
 
 
Reviewed by:  Adam Black  
 
Medline’s Split Universal Grounding Pads are intended for use in monopolar electrosurgery to 
complete the electrosurgical circuit between the generator, the active electrode, and the patient. 
The pads are single use, non-sterile, dispersive electrodes with or without a pre-attached cord. The 
surface of the conductive area is covered with a soft, conformable hydro-gel conductive adhesive. 
The pad also has a nonwoven backing and a non-conductive border adhesive surrounding the 
entire conductive surface area to isolate the conductive area from surgical fluid. The Universal 
Pads are designed for use in duty cycles of 50% or less (e.g. 20 sec on followed by 20 sec off).  
 
 
Instructions for Use 
 
Select an Appropriate Site  
To reduce the risk of burns and pressure necrosis:  
 
Select a smooth, well-vascularized, muscular area close to surgical site that allows full 
Universal Pad-to-skin contact.  
 
Site must be clean, dry, and free of hair. Remove hair at application site.  
 
Locate Universal Pad closer to the surgical site than to the ECG electrodes.  
 
Remove metal jewelry.  
 
Avoid placement over bony prominences, metal prostheses, or scar tissue.  
 
Avoid placement such that current flows through a metal prosthesis or 
conductive implant. For patients with   
implanted electronic devices, contact device manufacturer for precautions to avoid 
interference.  
 
Do not apply Universal Pad where fluids may pool.  
 
Do not apply Universal Pad over injection site.  
 
Select a suitable site remote from any warming device.  
4. 
Pad Application  
To reduce the risk of burns and pressure necrosis:  
 
Inspect Universal Pad, cord, and cable. Do not use if cut, modified, or damaged. 
 
Remove clear liner from Universal Pad before applying to patient.  
 
Apply one end of Universal Pad and smoothly press to the other end. The entire 
surface of the pad should be in contact with the patient. Avoid air entrapment.   
 
Avoid stretching or folding either Universal Pad or patient’s skin.  
 
Do not wrap Universal Pad completely around a limb. Do not overlap.  
 
Do not attempt to relocate Universal Pad after initial application. If patient is 
repositioned, confirm full pad-to-skin contact and integrity of all connections.  
 
Do not use electrode gel.  
 
Do not place cable clamp under patient.  
 
Do not coil or wrap cord or cable around limb or metal object.  
 
Do not place compression stocking or device over grounding pad.  
 

 
Protocol Number: F2P27778 
 
Page 6 of 10 
Test Report Number: F2P27778-01S-R1 
 
Test Engineer:  Oscar Fuster 
 
 
Reviewed by:  Adam Black  
 
 
 
Figure 1 – NE Pad 
 
 
NE Pad, dimensions 12.0cm x 13.4cm 
xy plane is skin surface 
Point A (0,0,0) is NE Cord connection point 
x-ray direction for pull test 
y-ray direction for pull test 
 
 

 
Protocol Number: F2P27778 
 
Page 7 of 10 
Test Report Number: F2P27778-01S-R1 
 
Test Engineer:  Oscar Fuster 
 
 
Reviewed by:  Adam Black  
 
IEC 60601-2-2 Clause 201.15.101.7 NE Adhesion – Pull Test 
Test Method:  At least two samples of the NE under test are applied to convenient locations on at least 10 male 
and 10 female human subjects, according to instructions for use. After application, NEs are allowed to remain 
undisturbed for 5 min to 10 min. For NEs intended for use on adult PATIENTS, the attached NE cord is subjected for 
10 min to a 10 N force directed along each of two orthogonal axes in a plane parallel to the skin surface at the NE 
cord connection point. One of the axes shall consist of the minor dimension of the NE at that point. No more than 
5 % of the NE adhesive area shall separate from the skin surface in at least 90 % of the tests. 
 
Figure 2, Test Setup: 
 
 
 
 

Protocol Number: F2P27778 
 
Page 8 of 10 
Test Report Number: F2P27778-01S-R1 
 
Test Engineer:  Oscar P. Fuster 
 
 
Reviewed by:  Adam Black  
 
Preparation for testing 
Sanitize participant area at least ½ hour before the arrival of any study participant.  
Ensure all equipment to be used is calibrated or verified before using.   
For NE placement, remove all hair from these locations if not already done. Then clean and dry the sites 
thoroughly. 
Cut the cables of the neutral electrodes (NEs) at a point at least 20cm from the NE. Then tie a loop in the cables for 
connection to the cords.  
Apply two NEs on the ventral surfaces of the upper leg of the participant, in a sitting position, such that the edge of 
the NE with the cable exit is aligned along the midline of the upper leg and parallel to the floor (with the upper leg 
approximately parallel to the floor). When applying NEs apply one end and smoothly press to other end. The entire 
surface of the NE should be in contact with the participant. Avoid air entrapment under NE.  
Have the participant sit still, with the NE undisturbed, between 9 to 10 minutes.  
 
Pull test instructions, see Figure 1 and Figure 2 
Record Participant number. 
Record Sample number. 
At Point A where the NE connects to the pad, connect a cord to pull on the cable as indicated in figure 2 below. Pull 
for 10 to 10.25 minutes, in a plane parallel to the NE pad and in a direction away from the center of the pad, with 
10 to 11N (1.02 to 1.12kg) of force in the direction along the minor dimension of the pad. Set the height of the 
pulley so that the direction of pull shall be approximately co-planer with the plane of the connection point of the 
NE. The pull shall be performed by a cord connected to the NE at the cable connection point. See Figure 2 for the 
pull set up. The weights provide the required pull force. 
Start timer. 
At 10 mins, change direction of pull to y direction by rotating the pulley system 90 degrees as shown in Figure 2 – 
apply 10 to 11 N force at Point A in direction of y ray which is in a plane parallel to the pad. 
Start timer. 
At 10 mins: 
photograph NE pad 
 record the % of the NE adhesive area that has separated.  
 
Repeat the above steps on a second NE pad for each Participant (these tests could be done in parallel if desired 
with duplicate setup). 
 
 

Protocol Number: F2P27778 
 
Page 9 of 10 
Test Report Number: F2P27778-01S-R1 
 
Test Engineer:  Oscar P. Fuster 
 
 
Reviewed by:  Adam Black  
 
 
Pull Test 
Participant 
# 
Leg 
applied 
to 
Sample 
# 
Room 
Temperature
, C  
Room Humidity, 
% 
Time elapsed 
(undisturbed), 
min sec 
% of NE Pad 
separated, % 
Verdict 
(Pass/ 
Fail) 
1 
Left 
S6 
22.6 
56.6 
9:23 
0 
Pass 
1 
Right 
S20 
22.6 
56.6 
9:58 
0 
Pass 
2 
Left 
S31 
20.1 
53.8 
9:15 
0 
Pass 
2 
Right 
S32 
20.1 
53.8 
9:45 
0 
Pass 
3 
Left 
S37 
23.6 
45.2 
9:01 
0 
Pass 
3 
Right 
S22 
23.6 
45.2 
9:38 
0 
Pass 
4 
Left 
S13 
24.8 
50.4 
9:39 
0 
Pass 
4 
Right 
S12 
24.8 
50.4 
9:11 
0 
Pass 
5 
Left 
S10 
23.6 
47.0 
9:50 
0 
Pass 
5 
Right 
S11 
23.6 
47.0 
9:12 
0 
Pass 
6 
Left 
S8 
23.6 
47.3 
9:33 
0 
Pass 
6 
Right 
S9 
23.6 
47.3 
9:58 
0 
Pass 
7 
Left 
S21 
22.8 
56.2 
9:31 
0 
Pass 
7 
Right 
S19 
22.8 
56.2 
9:52 
0 
Pass 
8 
Left 
S4 
22.5 
60.1 
9:05 
0 
Pass 
8 
Right 
S3 
22.5 
60.1 
9:32 
0 
Pass 
9 
Left 
S1 
22.5 
60.1 
9:18 
100, pad 
separated at 2:29 
of x direction (Y -
axis could not be 
done) 
Fail 
9 
Right 
S2 
22.5 
60.1 
9:49 
0 
Pass 
10 
Left 
S7 
22.6 
56.6 
9:30 
0 
Pass 
10 
Right 
S5 
22.6 
56.6 
9:52 
0 
Pass 
11 
Left 
S23 
20.9 
57.7 
9:21 
0 
Pass 
11 
Right 
S24 
20.9 
57.7 
9:51 
1.8 
Pass 
12 
Left 
S25 
20.9 
57.7 
9:04 
0 
Pass 
12 
Right 
S26 
20.9 
57.7 
9:28 
0 
Pass 
13 
Left 
S28 
22.1 
51.2 
9:50 
0 
Pass 
13 
Right 
S27 
22.1 
51.2 
9:25 
0 
Pass 
14 
Left 
S29 
22.1 
51.2 
9:42 
0 
Pass 
14 
Right 
S30 
22.1 
51.2 
9:15 
0 
Pass 
15 
Left 
S14 
24.3 
49.1 
9:01 
0 
Pass 
15 
Right 
S15 
24.3 
49.1 
9:33 
0 
Pass 
16 
Left 
S16 
24.3 
49.1 
9:45 
0 
Pass 
16 
Right 
S17 
24.3 
49.1 
9:14 
0 
Pass 
17 
Left 
S39 
24.3 
49.1 
9:15 
0 
Pass 
17 
Right 
S40 
24.3 
49.1 
9:20 
0 
Pass 
18 
Left 
S18 
24.3 
49.1 
9:51 
0 
Pass 
18 
Right 
S38 
24.3 
49.1 
9:22 
0 
Pass 
19 
Left 
S34 
23.3 
54.8 
9:01 
0 
Pass 
19 
Right 
S33 
23.3 
54.8 
9:33 
0 
Pass 
20 
Left 
S35 
23.3 
54.8 
9:15 
0 
Pass 
20 
Right 
S36 
23.3 
54.8 
9:52 
0 
Pass 

Protocol Number: F2P27778 
 
Page 10 of 10 
Test Report Number: F2P27778-01S-R1 
 
Test Engineer:  Oscar P. Fuster 
 
 
Reviewed by:  Adam Black  
 
Pull Test 
Pass/Fail Criteria:  No more than 5% of the NE adhesive area shall separate in at least 90% of the tests. 
Test Summary: 
Total Tests: 40 
# Tests where no more than 5% of the NE adhesive area separated:    39                                   
% of Total tests where no more than 5% of the NE adhesive area separated:     97.5%                   
 
Result:  PASS                                                                                                                                              
 
 
Supplementary information:(assets per test): 1298, 1324, 1327, 1278, 0515 
 
Photo of Sample S24 with 1.8 % Separation: