electrocardiogram (ecg) training – eli150c...• obtain and complete paper ecg submission form for...

© 2013 BioClinica, Inc. – Proprietary and Confidential

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© 2013 BioClinica, Inc. – Proprietary and Confidential

Electrocardiogram (ECG) Training –ELI150c

© 2013 BioClinica, Inc. – Proprietary and Confidential© 2013 BioClinica, Inc. – Proprietary and Confidential 2

Welcome

Thank you for entering the BioClinica online training and resource module for the

Biota BTA51-350-201 study. This module is your first resource for answers to many

questions you may have regarding the ELI150c device and software.

Your BioClinica Project Team contact information is also listed. BioClinica is

available at your convenience, so please contact us if you have any questions,

comments, or concerns.

At the conclusion of the training module, you will be required to complete a 10

question assessment of the information provided in order to be certified for

ELI150c operation for this protocol.

Good Luck!


The Training Manual - Introduction

• Site Contact Information

• Equipment Packing List

• Training Verification Form

• Test ECG procedure – recorded and transmitted


BioClinica Contacts

• Please see your study manual for details.

Primary Project Leader:

Claudia Castro

Direct line: +1 301 795 2540

Mobile phone: +1 240 646 2052

Back Up Project Leader:

Christine (Becky) Levinton

Direct line: +1 301 795 2486

Mobile phone: +1 240 277 8424

Project Manager:

Keith Klinger

Direct line: +1 301 795 2522

Mobile phone: +1 240 646 2053

Back Up Project Manager:

Leann Milford

Direct line: +1 301 795 2549

Mobile phone: +1 301 256 5830

STUDY FAX:

STUDY EMAIL:

+1 240 238 9825

[email protected]

24 HOUR SUPPORT NUMBER*

CoreLab Partners Business Hours:

8:30 a.m. to 5:30 p.m. EST

+1 301 795 2500 (USA Office)

+1 800 333 6460 (Toll Free USA Only)

+49 2173 3949 241 (Germany Office)

+800 1234 5640(Toll Free EU Only)


Site Contact Information (Send to BioClinica)

• Located in your study training manual

and on portal

• Must be completed and email/faxed to

BioClinica

• Make sure to add full details for:

• Principal Investigator

• Primary Contact

• Third Contact, if applicable

• Preferred method of communication

• CRA contact details

• Fill out site info

• Print name

• Sign and date


Training Verification Form (Send to BioClinica)

• Located in your study training manual and

on portal

• Must be completed at the end of the

training and e-mailed or faxed to

BioClinica.

• Ensure that all areas are completed before

sending:

• PI last name

• Names and signatures of all staff

completing this training

• Name of trainer (If applicable)

• Indicate training method

• Date test data was successfully

submitted


Equipment Packing List (Send to BioClinica)

• Located in your study equipment box.

• Must be completed and e-mailed or

faxed to BioClinica upon receipt.

• By sending in this form to BioClinica,

you confirm that all equipment listed is

delivered and can be accounted for

during the course of the study and at

study closeout.

• If there are any discrepancies, please

contact your BioClinica Project Team

immediately.


Before we start…

Please note: In order to transmit ECG test or stud y data, it is important to have access to an internet line.

• For this training, you will need the following materials/equipment:

– ELI150c (ECG Unit)– Power Cord– Subject Cable (Lead Wires) (apply

alligator clips)– Network (Internet) Cable– ECG Paper– CoreLab Partners Training Manual


Training Agenda

• Protocol Specifications

• Technical Descriptions

• Date/Time Check

• Subject Preparation

› Skin Prep

› Lead Placement

› Artifact Reduction

• Entering Subject Demographics

• Recording ECG

• Transmitting Data

› Internet Transmission

› Alternative/Back Up Method

• Volunteer Recording

• Frequently Asked Questions

• Conclusion


Protocol Specifications

• Formatting Subject Demographics

• Screening # (XXXXXX)

• Initials (ABC or A-C)

• Gender (F or M)

• DOB (DD.MM.YYYY)

• Visit Code (see codes below)

• Randomization # (XXXX)

• Visit Schedule and Description

• SCR (Screening)

• DAY1 POST (Day 1 Post-dose)

• DAY3 (Day 3)

• DAY15 (Day 15)

• DAY29 (Day 29)

• ET (Early Termination)

• UNS (Unsheduled)

• One 12-lead ECG taken at each time point


Technical Description - ELI 150c

1

2

543

Parts and Accessories

N# Description

1 Subject Cable (Lead Wires)

2 Paper Tray Cover

3 Internet Port

4 Memory Stick Port

5 Power Cord/Socket

ELI150c – back side Power cable, Ethernet cable, memory stick (USB) and ECG cable are connected.


Technical Description – ELI150c

Keys and Indicators – Leads OFF (Main) screen


Setting Date and Time

Step 1. Press F6 on the Main screen.Step 2 . On the Select Application by Number screen press F5 on the keyboard.

Step 4 . Press F6.Step 3. IF necessary, correct Date/Time settings.Use F1 and/or F2 buttons to go up or down.Press F5 to save new settings.

Date and Time should be set

according to local time zone .


Changing the ECG Paper

The ECG will not print if the paper door is not securely closed.

Step 1.1 Press a latch up.

Step 1.2 Pull the cover to left.*The latch will “click” in the end.

Step 1 . Open the paper tray cover.

Step 2 . Load paper. Step 3 . Close the cover tightly.

Step 3.1 Push the cover to right.


Subject Preparation

• Identify electrode lead placement locations• Use prep supplies to shave and clean as necessary• Apply electrodes• Connect subject lead wires• Check ECG display to verify presence of ECG rhythm

for each lead• View all leads and adjust, if needed, for best quality

The chest electrode application points are as follows:Lead V1 (C1): 4th intercostal space at the right border of the sternumLead V2 (C2): 4th intercostal space at the left border of the sternumLead V3 (C3): midway between locations C2 and C4Lead V4 (C4): At the mid-clavicular line in the 5th intercostal spaceLead V5 (C5): at the anterior axillary line on the same horizontal level as C4 and C6Lead V6 (C6): At the mid-axillary line on the same horizontal level as C4


Entering Subject Demographics

• Ensure subject preparation is complete and lead wires are properly

connected.

• From the Main screen, press F1 to enter the subject information menu.

• Enter subject demographics according to protocol specifications.

• Press F1 or F2 to navigate on the screen.

•Verify that all information was entered correctly and press F6.

ECG Field Name Format

Screening # XXXXXX

Initials XXX or X-X

Gender F or M

Date of Birth DD.MM.YYYY

Age Calculated from DOB

VISIT Code Refer to table of visit codes

Randomization # XXXX

ELI150c Demographic Field Format:


Recording an ECG

• Ensure the ECG unit is connected to the power outlet and switched ON.

• Allow completion of self test.

• Verify date and time and update if necessary.

• Have the subject lie down and make sure they remove their cell phone

• Prep subject and place lead wires.

• Enter subject demographics.

• Verify signal for each lead.

• Press ECG key to record an ECG.

• Allow ELI150c to print two (2) pages and save recording before pressing

any keys.

The ECG machine will store up to 150 ECGs.

If the memory is full, the oldest ECG will be deleted automatically to

save a new one.

Make sure to transmit ECGs immediately to prevent data loss.


Transmitting Data – Automatically via Ethernet

Make sure that an internet line is connected to ELI150c.From the main screen press the SYNC key on top of the keyboard.

If transmitting more than one ECG recording , press F1 for batch transmission. There will be a series of messages, the ELI150c will automatically transmit data. Wait until the transmission is completed and press Stop .

A confirmation message will appear specifying the amount of ECGs transmitted if the transmission was successful. Example: 1 of 1 ECG transmitted

If transmission FAILED, please proceed with instructions for the Alternative method via USB.


Transmitting Data – Alternative Method via USB

If transmission via Ethernet is not successful, please proceed with the electronic alternative transmission and save ECG(s) to memory stick USB provided. Disconnect the Ethernet cable and connect memory stick USB on designated port on the back of the machine (this thumb-drive should lite up upon successful connection). From the main screen press the SYNC key on top of the keyboard.

If saving more than one ECG recording , press F1 for batch transmission. There will be a series of messages, the ELI150c will automatically save the data to the USB and provide a confirmation as a successful transmission to the device. Wait until the transmission is completed and press Stop .

Once successful confirmation is received, remove memory stick USB from ECG machine.Insert USB on a site computer with Ethernet capability. Locate the drive and open content of memory stick USB. A file(s) with a “.uni” extension as a file type should be present (please do not attempt to open or rename the file(s)Attach file(s) and send via email to: [email protected] to include your protocol and site number on the subject line of the email communication. Upon receipt, BioClinica will import the data in the system.


Transmitting Data – Back Up

In the event automatic or alternative USB transmission is not successful, contact your Projec t Leader immediately for assistance.• Obtain one of the original ECG hardcopy printouts.• Confirm all subject demographics are visible and accurate.• Verify acquisition date and time stamps.

�Update, if necessary, and initial and date.• Obtain and complete Paper ECG Submission form

for each hardcopy ECG to be submitted.• Obtain appropriately addressed courier envelope and airbill

provided in the initial shipment.• Arrange for pick up and send to BioClinica.

Note: Only original ECG printouts can be digitized. Faxed, scanned, Xeroxed or e-mail copies will not b e processed .


Transmitting Data – Back Up: originals via Courier

• General requirements:• Original hard copy, good quality • All 12 lead tracings should be on a single page in landscape orientation.• ECG tracing and grid lines must be clearly visible.• Calibration marks must be available for each lead/tracing.• The actual ECG tracings should be darker than the background grid.

• Preferred ECG printout formats (in order of preference): • 12x1 - One column of 12 leads aligned in 10 second rows • 6x2 - Two columns of 6 leads aligned in 5 second rows, with a 10 second rhythm strip • 3x4 - Four columns of three leads aligned in 2.5 second rows, with one or more 10 second rhythm

strip/s• All other formats require approval

• Grid Size:• Each ECG grid box should be 5mm in width and height.

• Paper Speed (X axis):• The following speeds are supported:

• 25 mm/s (preferred)• 50 mm/s• The ECG must have the paper speed clearly recorded on the printout.

• Voltage/Gain (Y axis):The follow gains are supported:• 10 mm/mV (most common)• The ECG must have the gain clearly recorded on the printout.

• Tracing must be clean: no spill marks, folds, holes or fading.

Required Paper ECG format:


Volunteer Test Procedures

In order to demonstrate understanding of device operation, a volunteer test recording is required. Please complete the following steps and program the ELI150c device with the following test demographics. Transmit test to BioClinica when completed.

1. Connect ECG components and check date/time

2. Enter the following demographics- Screening # = 999999- Initials = ABC or A-C- Gender = F or M- DOB = 01-01-1970- Visit Code = T1 or TEST- Randomization # = 9999

3. Record ECG on a volunteer

4. Transmit


Frequently Asked Questions

How do I make sure the ECG has the correct date and time?• Keep the ECG unit charged at all times and check the date/time stamps prior to each new

recording. When should I transmit recorded ECGs?

• ECGs should be transmitted as soon as possible after recording to ensure successful data transfer and reports are submitted in a timely manner.

How many ECGs does the ELI150c store?• The ELI150c is designed to store up to 150 ECG recordings. Once the unit has reached its full

capacity, the oldest stored ECG will automatically be deleted to make room for the new recording.I’ve pressed the ECG button to record, but the reco rding has not started yet?

• Check the ECG display for any printer errors. • Make sure the paper tray cover is closed.

Why are there two ECG print outs?• The ECG prints two copies of each ECG so one can be maintained on site if we need to collect a

hard copy due to transmission issues.How do I reprint an ECG recording?

• On the Main Screen press F6 then 1 on keyboard. • Locate the procedure you would like to print and press F3. • Press F4.

ECG recording are faded. Do I need another ink car tridge?• No. The ECGs are printed on thermal paper and do not use ink. If the ECG looks faded check the

paper tray cover to be sure it is completely closed and re-print.


Frequently Asked Questions

How do I obtain the System Setup password?• Contact your BioClinica Project Leader.

Can a copy of the recording be faxed or scanned and e-mailed for processing? • No. The ECGs must be sent electronically or a hard copy must be mailed to BioClinica for digitization.

I entered the subject demographics wrong. How do I make a change?• If the ECG has not been recorded press the F1 button and go back to the field that needs correcting

and make the change. • If ECG has already been printed and transmitted please send a completed Data Correction Request

form to the BioClinica Project Leader or contact your Leader to issue a DCF.Multiple ECGs were taken to minimize artifact. Can I delete the ones I do not want?

• No. We ask that you keep all ECGs recorded and transmit them to BioClinica. A DCF will be issued to confirm the ECG data that is not to be used for study purposes.

How do I minimize artifact?• Be sure to properly prep the electrode placement area by shaving, abrading, and cleaning with

alcohol before placing the electrode. Check the leads on the ECG display before recording to make sure no adjustments are necessary.


Review – Additional Reference Materials

• Full PDF of Training Manual

• BioClinica Full Contact Details

• Regulatory Documents

• Data Correction Request Form

• Quick Reference Guide

• Equipment Request Form

• Paper ECG Submission Form


Conclusion

Congratulations!You’ve completed the ECG training module.

In order to receive your Training Verification Memo please follow these next steps:

Next Steps•Complete e-signature for presentation and assessment on SiT•Review reference materials available on SiT•Complete and Transmit Volunteer Test(s)•Send Regulatory Documents to BioClinica

• Equipment Packing List• Site Contact Information• Training Verification Form

•Print, Complete, Submit and Pass (70% or above) Assessment