Philips BioTel ELI 150 User manual

ECG Acquisition Guide for
Revolution Medicines RMC-6236-001
(BTR 79602)
Protocol RMC-6236-001
Phase 1/1b Multicenter Open-Label Study of RMC-6236 in Subjects with Advanced Solid Tumors
Harboring Specific Mutations in KRAS
Subjects will receive a triplicate 12-lead ECGs during Non-Food Effect Cohort and Food Effect Cohorts on
a Mortara ELI 150 machine.
Philips BioTel Research, 155 Corporate Woods, Suite 180,
Rochester, NY 14623 USA

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Table of Contents
1.0 EQUIPMENT RECEIPT........................................................................................................................................3
2.0 EQUIPMENT SET-UP .........................................................................................................................................3
2.1 OVERVIEW OF THE ELI 150................................................................................................................3
2.1.1 Front and Side View.........................................................................................................3
2.1.2 Rear View ........................................................................................................................4
2.1.3 Keyboard Overview .........................................................................................................4
2.2 DATE AND TIME VERIFICATION............................................................................................................5
2.3 POWER ..........................................................................................................................................5
2.3.1 Main power .....................................................................................................................5
2.3.2 Battery power..................................................................................................................5
2.3.3 Test ECGs Test ECGs ........................................................................................................5
3.0 SUBJECT IDENTIFICATION NUMBER..................................................................................................................6
4.0 ACQUISITION TIMEPOINTS ...............................................................................................................................6
4.1 NON-FOOD EFFECT COHORT ..............................................................................................................6
4.2 FOOD EFFECT COHORT ......................................................................................................................7
5.0 SUBJECT PREPARATION ....................................................................................................................................8
5.1 SKIN PREPARATION...........................................................................................................................8
5.2 ELECTRODE PLACEMENT ....................................................................................................................9
5.2.1 Quality Checks.................................................................................................................9
6.0 ENTERING SUBJECT DEMOGRAPHICS ON THE ELI 150 MACHINE.....................................................................10
6.1 INITIAL ECG ..................................................................................................................................10
6.2 SUBSEQUENT ECGS........................................................................................................................10
7.0 ECG ACQUISITION AND SUBMISSION .............................................................................................................11
7.1 ACQUIRING THE ECG ON LOCAL EQUIPMENT .......................................................................................11
7.2 ECG TRANSMISSION .......................................................................................................................12
7.2.1 Analog Transmission .....................................................................................................12
7.2.2 LAN/Internet Transmission............................................................................................12
7.2.3 USB Transmission ..........................................................................................................13
7.2.4 Courier...........................................................................................................................13
8.0 SITE QUERIES AND DATA NOTIFICATIONS ......................................................................................................14
9.0 CARDIOPORTAL ..............................................................................................................................................14
APPENDIX 1: CONTACT INFORMATION ................................................................................................................15
PHILIPS BIOTEL RESEARCH CONTACT INFORMATION/CUSTOMER SUPPORT......................................................15
EMAIL CONTACT LIST ............................................................................................................................16
APPENDIX 2: STUDY CLOSE OUT PROCEDURES.....................................................................................................17

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1.0 Equipment Receipt
The ELI 150c machine has been provided to your site for use in this study. Study protocol information has been
pre-programmed into the unit(s) by Philips BioTel Research.
You will receive your equipment and study supplies in one shipment. This will include your ELI 150c machine(s)
and standard supplies such as electrodes, paper, razors, and prep pads.
Please refer to the packing slip sent with the shipment for a detailed inventory of your specific study equipment
and supplies. It is important that you perform a complete inventory and inspect the equipment for any apparent
damage. If you have any problems or discrepancies with the equipment and its accompanying supplies; please
contact Customer Support so that we can rectify the problem immediately.
Please retain all packaging materials received, as they will be used to return the
equipment at the close of the study!
2.0 Equipment Set-Up
You will need to familiarize yourself with the equipment, verify the date and time, understand the power
options, and transmit a pre-loaded Test ECG.
2.1 Overview of the ELI 150
It is important to understand where everything is located on your equipment. Take a few moments to review the
diagrams and locate the buttons and access ports on your equipment.
2.1.1 Front and Side View
Color
View
Screen

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2.1.2 Rear View
2.1.3 Keyboard Overview

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2.2 Date and Time Verification
Verify the date and time for all equipment received from Philips BioTel Research and ensure the times match the
dosing clock exactly. BTR will contact each site when there is an international change in time such as Daylight
Savings Time. Be sure to check the date and time prior to each session.
•Press F6 to open the Application Menu
•Press F5 to select Set Time/Date
•Use F1 and F2 to scroll to desired field
•Use the keyboard to enter the chosen value
•Press F5 to save
•Press F6 to return to the main menu
NOTE: The calendar and clock will reset to the default settings if there is a total
power loss- either manually simulated or complete battery failure!
2.3 Power
The ELI 150 can be operated while plugged into the wall and with battery power (approximately 24 hours of
battery life).
2.3.1 Main power
Plug the power cord into an AC wall outlet and into the back of the device. Press the ON/OFF button located on
the face panel of the device. The battery indicator is clear when charging and illuminates in white when fully
charged.
2.3.2 Battery power
When using battery power, the battery indicator illuminates in green with a 35-100% charge, yellow with a 20-
35% charge and red with a <20% charge. When the battery charge is depleted to its lowest level (10.5V), the
device will automatically power down (you will see the message Battery Low – Charge Unit for 10 seconds prior
to it powering down).
If the device is in ECG acquisition mode when the battery voltage is detected at its lowest level, the message
Battery Low – Charge Unit will appear but the unit will not shut down until the user exits the ECG acquisition
mode. This allows the user to complete an ECG already in progress.
It will take 30 hours without operation to fully recharge a battery from its lowest level.
BEST PRACTICE: Connect the unit to AC power for recharging when not in use!
2.3.3 Test ECGs Test ECGs
Test ECGs ensure the equipment is properly configured and the operator can perform the ECG. Philips BioTel
Research recommends that two test ECGs be transmitted prior to your first subject entering the study.
Test 1 (Required)
•Each machine will arrive with a pre-loaded ECG
•Transmit the pre-loaded TEST ECG to Philips BioTel Research (refer to section 7.2)

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Test 2 (Recommended)
•Record a TEST ECG on a human volunteer and transmit to Philips BioTel Research (refer to section 7.2)
•The demographics for the human test should be:
oSubject ID: SSS-9999 (use your site number for SSS)
oAge: 99
oTimepoint: TE
3.0 Subject Identification Number
Each participant will be uniquely identified by an 8-digit number where the first six digits represent the site number, a
hyphen and the following four digits represent the number assigned to the participant. The example below
represents subject 0001 at site 001.
Example: 001-0001
Enter the 8 digit participant identification number into the ECG machine under Subject ID.
4.0 Acquisition Timepoints
ECGs should be obtained at study specific timepoints as described in the current protocol as shown in this
section. Please note there are different BTR timepoints to be entered depending on if the participant if in a
food effect cohort or not.
4.1 Non-Food Effect Cohort
Non-Food Effect Cohort
Visit Description BTR Timepoint
Screening Day -14 to -1 1 2 3
Baseline C1D1 predose 4 5 6
Baseline C1D1 2 hr post
dose 7 8 9
Cycle 1 C1D15
predose 10 11 12
Cycle 1 C1D15 2 hr
post dose 13 14 15
Cycle 3 C3D1 predose 16 17 18
Cycle 5 C5D1 predose 19 20 21
Cycle 7 C7D1 predose 22 23 24
Cycle 9 C9D1 predose 25 26 27
Cycle 11 C11D1
predose 28 29 30

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Cycle 13 C13D1
predose 31 32 33
Cycle 15 C15D1
predose 34 35 36
Cycle 17 C17D1
predose 37 38 39
Cycle 19 C19D1
predose 40 41 42
Cycle 21 C21D1
predose 43 44 45
Cycle 23 C23D1
predose 46 47 48
Cycle 25 C25D1
predose 49 50 51
Cycle 27 C27D1
predose 52 53 54
Cycle 29 C29D1
predose 55 56 57
EOT
Within 30
days of last
dose
96 97 98
Unscheduled UNS 99
4.2 Food Effect Cohort
Food Effect Cohorts
Visit Description
BTR Timepoint
FE Only
Screening Day -18 to -4 101 102 103
FE Only
Baseline
Day -3
predose 104 105 106
FE Only
Baseline
Day -3 2 hr
post dose 107 108 109
Baseline C1D1
predose 110 111 112
Baseline C1D1 2 hr
post dose 113 114 115
Cycle 1 C1D15
predose 116 117 118
Cycle 3 C3D1
predose 119 120 121
Cycle 5 C5D1
predose 122 123 124
Cycle 7 C7D1
predose 125 126 127
Cycle 9 C9D1
predose 128 129 130

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Cycle 11 C11D1
predose 131 132 133
Cycle 13 C13D1
predose 134 135 136
Cycle 15 C15D1
predose 137 138 139
Cycle 17 C17D1
predose 140 141 142
Cycle 19 C19D1
predose 143 144 145
Cycle 21 C21D1
predose 146 147 148
Cycle 23 C23D1
predose 149 150 151
Cycle 25 C25D1
predose 152 153 154
Cycle 27 C27D1
predose 155 156 157
Cycle 29 C29D1
predose 158 159 160
EOT
Within 30
days of last
dose
196 197 198
Unscheduled UNS 199
5.0 Subject Preparation
Unrestricted access to the skin in the chest area, arms, and lower legs is required to allow for correct placement
of the electrodes. A recumbent position is recommended for the subject and the table should be large enough
to support the body and limbs. Subjects should be supine and resting 5-10 minutes before and during the ECG
acquisition.
•Do not use TV, microwaves, cell phones, smart devices (i.e., smart watches, wireless charging devices),
magnets, computers, electric fans and avoid talking while taking the ECG.
oHigh voltage electrical lines near the area can cause artifacts.
•Ensure room temperature is comfortable for the subject as shivering may lead to artifacts in the ECG.
•Ensure subjects allowed for proper meal planning as hypoglycemia (low sugar in blood, e.g. late to eat
meals) can cause subjects to shiver and artifacts in the ECG.
5.1 Skin Preparation
Skin preparation is required to help produce an artifact-free and accurate ECG.
•The removal of body hair may be required to ensure adequate contact with the skin.
•Exfoliation may be required the provided prep pads specifically designed for this purpose.
•Skin should also be cleaned to remove any oils or lotions.
•Snap electrodes to the lead wires BEFORE adhering to the subject.
•Apply pressure around the outer edge and the inner ring of the electrode to adhere to skin.

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5.2 Electrode Placement
Proper electrode placement is crucial to obtaining a good quality ECG.
Standard 12-Lead Electrode Placement
5.2.1 Quality Checks
After positioning the leads, the waveform and lead quality checks must be performed. Failure to check the
quality of the waveforms or leads may result in loss of data.
Review 12-Leads
•Connect the AM12 (Acquisition Module) to the ECG
connector at the rear of the device. (Until this is connected,
the message “Searching for WAM” will be displayed on the
screen.)
•Press F2 to select Leads
•Keep pressing F2 to scroll through all 12 leads (3 at a time)
•View all twelve leads to check quality of the waveform

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Look for Notifications
•Examine the display for any notification messages
oLeads Off – displays when subject is not connected
oLead Fault – displays faulty leads (re-prep and replace
electrodes as needed to improve recording quality)
oElectrode Wrong Position – displays an error message when
a lead is connected incorrectly or is in the wrong location
(e.g. “Limb leads misplaced?”)
•Re-attach electrodes as needed to improve recording quality
•Unplugging and/or moving the machine to a different room or
location may help improve recording quality and noise reduction.
6.0 Entering Subject Demographics on the ELI 150 Machine
6.1 Initial ECG
Use this process the first time you enter a subject into the equipment.
•Press F1
•The subject information screen will then open and you can
begin to enter the subject demographics. This will include:
oSubject ID
oAge
oGender
oBTR Timepoint
•The Cursor will automatically begin at the Subject ID line
•Enter subject demographics
oPlease note that demographic fields will be customized
per study and may differ in appearance from the
example found here
oPress F2 to move between the demographics
•Press F6 when done
•Wait 10 seconds for the machine to stabilize before acquisition
6.2 Subsequent ECGs
•From the Real-Time View, press F1 to select ID
•Enter in Subject ID (the rest of the subject’s demographics will populate the fields)
•ALWAYS update the timepoint!
•Press F6 to save changes

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7.0 ECG Acquisition and Submission
7.1 Acquiring the ECG on Local Equipment
•Press the ECG button on the ECG equipment or on the AM12 module to acquire an ECG
oThe real time view will change to the acquired ECG view
oA hardcopy ECG automatically prints out
•Press F3 (Print) for additional copies
•Press F4 (Save) if the ECG is of acceptable quality
•Press F6 (Done)
•If F4 (Save) is not selected, a prompt will appear instructing the user to save or delete the record.
oIf Saved, the ECG will be added to the machine directory and will be transmitted with the next
batch transmission
oIf Deleted, the ECG will NOT be added to the machine directory, and the electronic copy cannot
be retrieved. The deleted ECG will need to be repeated using the same BTR Timepoint

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7.2 ECG Transmission
This is the process for transmitting your ECGs to Philips BioTel Research.
•Press SYNC button from the real-time view
•Press F1 (Batch) to send all the ECGs you have recorded since your last transmission
Print the subject directory after each transmission to verify all ECGs were transmitted successfully. Please follow
the instructions below:
•Press F6 (More) from real-time view
•Press 1 for Directory of Stored ECGs
•Press F5 (More)
•Press F4 (Print)
All ECGs should be transmitted the same day as acquisition.
7.2.1 Analog Transmission
The analog method of ECG transmission uses an analog telephone line to transmit ECG data from your provided
ECG machine to Philips BioTel Research. To transmit ECGs using this method, you must use the analog telephone
line the site identified on the Site Information Form. Generally, most fax lines use analog technology and a
common best practice is to use a fax line on-site to transmit ECG data.
•Connect the identified analog telephone line to the back of the ELI150c ECG machine.
oConnect to the modem port.
•Connect the other end of the analog line directly into the connection port (wall) with no devices in
between (i.e. fax, dual port adapters, etc.)
•Press SYNC button from the real-time view
•Press F1 (Batch) to send all the ECGs you have recorded since your last transmission
•Listen for a low dial tone and then the ECG machine dialing a pre-configured telephone number
•Listen for fax-like connection noises, followed by an on-screen confirmation that the ECG machine
is connected and transmitting data.
oObserve a display message that indicates Bytes Transmitted and a series of numbers going
upward.
•Verify a displayed message confirming the number of ECGs transmitted (i.e. 1/1 ECGs
transmitted, or 1/3 ECGs transmitted)
7.2.2 LAN/Internet Transmission
The LAN/Internet method of transmission uses an internet connection to transmit ECG data from your provided
ECG machine to Philips BioTel Research. To transmit ECGs using this method, you must use the provided LAN
cable to connect to the provided ECG machine and internet connection.
•Connect the LAN cable to the back of the ELI 150c ECG machine.
oConnect where the icon displays a small pyramid of squares.

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This connection port is the only connection that will allow for the included LAN cable
to be connected.
•Connect the other end of the LAN cable to the internet port.
oObserve green lights above the connection port on the ECG machine.
•Observe a displayed message,Attempting Network Connection.
•Observe the displayed message,Connected.
•Verify a displayed message confirming the number of ECGs transmitted (i.e. 1/1 ECGs
transmitted, or 1/3 ECGs transmitted)
7.2.3 USB Transmission
USB transmission should be used ONLY in circumstances where an Ethernet or analog line is not available. To
transmit via USB, the equipment must first be configured appropriately. If the Site Information Form initially
indicated an analog or Ethernet line available, the machine will not be configured for the USB transmission
method. Please contact Customer Support if you believe your machine needs to be reconfigured.
Please refer to the USB transmission instruction below to transmit your ECGs using your provided ELI 150c
equipment.
●Connect the USB flash drive to the orange USB port on the back middle of the ECG machine
●Press SYNC to transmit, followed by F1 for batch
●Remove the flash drive from the ECG machine and plug into an open USB port on your computer
●Open the Records folder on the USB stick
●Send the .uni files to Philips BioTel Research using one of the following methods:
a) Attach .uni files to email and with protocol/site in the subject line and send to
[e-mail]
OR
b) After logging in to CardioPortal locate the ELI LINK in the dashboard and proceed to upload
the .uni files.
7.2.4 Courier
Please contact Customer Support (see Appendix 1) if an ECG record needs to be sent to Philips BioTel Research
by courier.

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8.0 Site Queries and Data Notifications
Philips BioTel Research uses a Query Management System (QMS) to communicate issues with submitted data to
selected site personnel. Sites will be emailed login credentials and a link to access the QMS once they have been
final qualified.
A data query or data notification email can be sent for the following reasons:
Data Query: If the data cannot be loaded or analyzed a query will be sent and held open until it is resolved.
Data Notification: If there is a minor discrepancy with the data, an email notification will be sent though the
data will proceed through the process.
Queries will be sent to your site via email within 5 business days of receipt at Philips BioTel Research. We will
follow-up with your site once a week until the queries are resolved. If your site is unresponsive or the issue has
not been resolved after three follow-up attempts, approximately 21 days, the issue will then be escalated to the
Sponsor study team for further direction.
9.0 CardioPortal
Philips BioTel Research ECG reports are posted on CardioPortal after receipt of the ECGs. Reporting can be
delayed due to poor quality of the ECG recording or a pending site query.
At the beginning of the study, the site will receive a Site Information Form that allows them to identify one
person from their site to obtain access to CardioPortal. The identified person will be provided a username,
password, CardioPortal login instructions and a Quick Reference Guide via email. If you have any questions
regarding login credentials, please contact [e-mail].

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Appendix 1: Contact Information
Philips BioTel Research provides full Cardiac Safety services and is pleased to have the opportunity to work
closely with you, to help ensure the success of this study. We have provided the call-in and direct email contact
list to meet all your needs.
Philips BioTel Research Contact Information/Customer Support
Customer Support is available 24 hours 7 days a week. You can contact Customer Support with questions
concerning ECG transmission, ECG inquiries, shipping inquiries and urgent ECG processing. Translation services
are also available for our international customers who do not speak English. For the Toll-Free number in your
region, please refer to the list below:
Country
Toll Free Number
Country
Toll Free Number
Argentina
0800-6662511
Macedonia
800-3704955
Australia
1-800-775704
Malaysia
1-800-880217
Austria
0800-202382
Mexico
01-800-1231654
Belgium
0800-80324
Netherlands
0800-0200942
Brazil
0800-8919925
New Zealand
0508-555621
Bulgaria
00-800-1104455
Norway
800-30823
Chile
12300208426
Peru
0800-77991
China
10811 1 877 324 8326
Philippines
1-800-11102002
Colombia
018005189569
Poland
800-702256
Croatia
0800-222841
Portugal
800-207-437
Czech Republic
800-900-541
Romania
0800-894598
Denmark
80321439
Russia
8-10-800-110-1011 8773248326
Egypt
0800-0000260
Serbia
0800-190007
Estonia
800-0044271
Singapore
1-800-8232243
Finland
0800-97435
Slovakia
0800-005064
France
0805-540365
Slovenia
0800-80899
Germany
0800-0006729
South Africa
800-980411
Greece
00800129251
South Korea
0079844341368
Hong Kong
800-963549
Spain
900-811866
Hungary
0680020934
Sweden
0201701514
India
000800-4401523
Switzerland
0800-001948
Ireland
1800937448
Taiwan
0277374422
Israel
1-809-446-554
Thailand
001800442300
Italy
800-903227
Turkey
00800142030820
Japan
0120-882-689
UK
0800-032-5465
Latvia
800-02613
Ukraine
0800502886 877-324-8326
Lebanon
855-365-8004
USA/Canada
1-877-324-8326
Lithuania
880-090-015
Vietnam
18004924
You can also email the Customer Support Department at BTRsuppo[email protected]m.
Please provide Sponsor Name, Protocol and Site Number associated with your study
for all inquiries

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Email Contact List
Email lists are available depending on the inquiry or form you are submitting to Philips BioTel Research. Please
reference the list below:
Email Contact
Action
[e-mail] Send .uni file via USB drive for ECG processing
[e-mail] Study close out questions, replace shipping box, or return label
[e-mail] Send the Resupply Order Form
BTRsuppor[email protected] Customer support and CardioPortal inquiries

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Appendix 2: Study Close Out Procedures
At the end of the study, please gather all the study supplies.
•Dispose of all open study materials as per your clinic’s policy and/or procedures.
•Unused razors, prep pads, and electrodes should be returned to Philips BioTel Research along with the
equipment.
•Please use the original shipment materials to return the equipment and any unused supplies to Philips
BioTel Research.
•You will be contacted by our returns team via email with instructions for returning all study materials.
If you have any questions regarding the return process, contact [e-mail].