2014 Cold Chain Hand Sampling TMD (Temperature Monitoring Device) Replacement Program FIS Process Cold Chain Equipment Field Installation Qualification Form Installation Process Dos and Don’ts

Cold Chain Hand Sampling Field Equipment Each Sales Professional in the CCHS Program has been provided equipment to maintain product integrity. You will be dealing with the following equipment: 1. Sample Refrigerator 2. Temperature Monitoring Device installed on the refrigerator Transmitter on top of refrigerator Temperature Probe inside refrigerator

Sample Refrigerator . TMD Transmitter (top of refrigerator)

Temperature Monitoring Device (TMD) TMD Transmitter is located on top of refrigerator TMD Temperature Probe is located inside the refrigerator New TMD In box

Instructional Video Please watch this instructional video, the process will differ only slightly because you will be completing a replacement of an expiring TMD, not an initial installation. http://www.brainshark.com/buzzeopdmainc/vu?pi=zFvzSQEv3zhbLz0&intk=957662113 We recommend watching the video again, just prior to your appointment.

Field Installation Form Sales Professional Contact Information Section – sales professionals must verify this information is accurate. Any changes will need to be done using Good Documentation Practices Information must be entered exactly as it appears on the equipment. Helpful hint the TMD Transmitter ESN # will always begin with “2132…….” You must write out the word Pass or Fail a “P” or “F” will not be accepted. The date must contain the month, date, and year or the form will not be accepted. Both you and the sales professional must print, sign and date the form.

Field Installation Qualification Form Confirm Name, NM#, Storage address and Mobile # are correct. If during scheduling the rep provides you with a storage address that does not match what Buzzeo provided you, you may not schedule the swap. Contact your coordinator with the new address and wait for instruction. Confirm Serial Numbers for the Refrigerator, Expiring TMD & Probe are correct. This info will already be pre-populate on your form. If there is an error, make the correction to the form neatly. Document the serial numbers for the new TMD and probe and the expiry date of the new probe. Please document this information as neatly as possible. Legibility is crucial to the success of this program.

Field Installation Qualification Form cont… Read and Complete each line item You Must write out the complete word Pass or Fail. P Or F is not acceptable. Explain responses marked Fail, as indicated, at bottom of section You will initial and date each step, not the rep. You and the rep will Print name, sign and date where indicated. Any corrections must be done using Good Documentation Practices (Single line cross out, initial and date and reason for correction; write-overs and white out are not acceptable).

Location of Equipment Serial Numbers TMD Transmitter ESN Number (top of refrigerator – bottom of TMD) Refrigerator Serial Number (inside refrigerator on left) Temperature Probe Serial Number and expiry date

Installation Process Verify that there aren’t any samples in the refrigerator. You may not proceed if the rep has samples in their possession.  Remove TMD from refrigerator. Ask rep for the box containing the new temperature monitoring device (TMD). The new probe will come encased in a plastic bag and cannot be removed until the installation is completed (image below) The TMD installation kits will all contain the following: -Installation Putty -TMD -Tie Wraps -Adhesive Anchors Document/verify all serial numbers on the IQ form before the install.  

Installation Process cont… Installation of the Probe Open refrigerator, you may remove the middle self to make it easier to reach inside. But be sure not to move the shelf holders, as they are placed at specific heights. Move refrigerator away from the wall, you may need to unplug it. The refrigerator may not be plugged into an extension cord, refrigerators may be unplugged to perform the installation however they must be plugged directly into an outlet once the installation is completed. You will now install 2 of the sticky backed pieces with the zip ties threaded loosely through them, onto the left wall toward the back corner, inside the refrigerator. The loop of the zip ties should sit horizontally. The first one will go 10 inches from the bottom of the refrigerator. The second one will be placed 20 inches from the bottom of the refrigerator. Now affix 3 zip ties, evenly spaced reaching, on the rear left of the top shelf. The ties should only go up to the middle of the shelf. Leave about 1-2 inches of slack in the zip tie loops. Locate drain tube in the bottom left corner of the refrigerator. You will need to access it through the back/bottom of the outside of the refrigerator.

Installation Process cont… Take the probe and feed it through the same hole that the previous one was in. The probe should be fed through all 5 zip ties you have affixed. You will leave about 24 inches of slack from the top of the probe to the zip tie in the middle of the shelf. Tighten all the zip ties. Remove the putty from the bag; it will be used to seal the hole in the bottom of the refrigerator where the port has been fed through. Installation of the Cellular Device Make sure the top of the refrigerator is clean from any dust or debris. You will place the new TMD where the Velcro is already located on the refrigerator. Not all reps have the TMD located in the same location and have worked with the vendor to obtain stronger signal service from the device. Secure the cord from the device to the foam covered tube running down the back of the refrigerator, using 3 evenly space zip ties. You should also loop and secure the gray cord from the probe up into a zip tie, so that it will not drag on the ground and get caught. Once the cords have been secured you may plug in the power supply to the power outlet. The light should come on, on the front of the cellular device.

Installation Process cont… Last Steps Move the refrigerator back to its original location. You should leave at least 4 inches of space between the back wall and the rear of the refrigerator. And 3 inches of clearance on the sides. Make sure the refrigerator is level. Replace the Middle shelf to its original location, if you removed it. Remove the clear plastic protective cover from the probe. Make sure the Field Installation Qualification Form has been completed. You will take the old expiring TMD with you when you leave, to return to the client.

Dos and Don’ts Do – confirm that all samples have been returned or dispersed and the rep is in receipt of their new temperature monitoring device when confirming the appointment 24hrs prior. Do Not-Schedule the inventory if the rep provides a storage location other than what you were provided by Buzzeo. Do notify Jessica if the rep is unavailable to schedule during the allotted time frame. Do bring multiple copies of the IQ form incase of errors. Do write as neatly and legibly as possible. Do – Confirm, confirm, confirm Do Not – Provide instruction on CCHS policies Do take the old expiring TMD with you when you leave, to return to the client. Do – Submit your paperwork to Jessica within 24 hrs. of completion (fax or scan)

Thank You Training Test Please click the link below to take the required training test: https://secure.testcraft.com/buz254/assess.aspx?aid=SANOFITMD2013&apass=BUZZEO Thank You