Currently TP-00473-F2

This would already have been created prior to getting onsite.

Regarding Candida, you should also make certain to use drawer 7 as well to get the ramp rate values for TC2B2.

Currently it is only Bacteria

Belt tensioning should be performed before alignments.

This really needs to be done before you even get onsite so you can order the parts you would need to complete the TSB. We don't carry everything all the time.

Before you restart the instrument, this would be a good time to Configure the T2 for testing. Otherwise you'll be waiting for ever for the instrument to come to a ready state.

I've have yet to find a damaged Gripper compliance mount and the movement is not as easy to verify as the Pipettor. Do you think we could add pictures of what a damaged mount looks like?

In some cases the rails themselves aren't aligned correctly and need to be loosened, realigned and then tightened to correct improper movement. There isn't a procedure for this that I am aware of.

Mounted properly means what? I think all we really try to verify is that the sensor and flag are not damaged and they engage each other correctly (flag is centered).

Is the intent to verify all external ports are functional? 4 USB ports (can be verified with Barcode scanner or flash drives or the printer). The Ethernet connections can be verified with the laptop though I've never tried plugging into the rear port.

Can we reference the "current" printer used here? We actually don't have a true procedure for installing a printer and it can be ever changing as printer models are obsoleted. Perhaps there are generic steps for Windows (either 7 or 10) that can be referenced?

I've had oil tubes left in this module from Manufacturing. Could we mention to check for this, just in case?

Should we also mention the Standard T2Dx Service Kit (BOM) that needs to be ordered here?

We currently order the following:

• 3-Candida cartridges
• 3-Candida reagents
• 4-Candida QCheck Pos
• 2-Candida Qcheck Neg
• 2-Bacteria cartridges
• 1-Bacteria reagents
• 1-Bacteria QCheck Neg

Quantity is missing and what about Bacteria reagents and controls that may need to be cycled for customers interested in processing Bacteria samples?

We also need to include Test Equipment (Voltmeter, Temp meter, etc.).

Does this mean 5 full business days? I don't know if this information is necessary. I would hate to imply it's better to finish in 5 days then being thorough and taking as long as it takes to complete the install.

What conditions (including specific errors) other than temperature instability warrant performing this procedure?

What are the ways to control which bank is used?

If the customer is not processing Bacteria tests, what is the recommended value for the Bacteria ramp rate?

Again it's just easier to show (and use) the actual Search window data.

What do we do if a bank(s) does not pass the criteria?

Is there any chance to get a picture that actually shows the values in the Search area as we taught to locate it on our laptop?

Since 1.5 software (and possibly before), this seems to be the default profile but it is always good to verify.

I don't think this information is on the blue tag but I could be wrong.

Since the instrument is already powered off, I'm not clear how we are going to follow these instructions at this time.

If you are referring to the P&I values, they should be defaulted to 11.0 and 0.75. What actually needs to be changed are the values in the Configurations folder for that particular bank. If not, whatever value is in the file will over right the value on board the module. As long as these values are correct before any verification other than temperature checks, it will be okay.

Regarding the quantity for Consumables, am I correct in assuming we are processing 5 controls now for Thermocycler verification? And yet only 4 cartridges and reagent trays are called out.

For Service Procedures, I would like to see a Purpose statement (why and when you are using this procedure) and Tools/Supplies (specific to that procedure) where not already stated. I would also like to see a reference to placing the instrument into "Development mode" prior to performing the procedure and a reminder to take the instrument out of "Development mode". In addition, are we recommending to disable the upper enclosure fans/heaters when servicing the instrument with the power on? Also in some cases after replacing a module, the first time you power on a Communication error occurs for that module. The reason is the IP address for that module is incorrect. Can we add a statement to the beginning of the Service Procedures section on how to correct this in the event it occurs? Regarding Instrument Verification after module replacement(s), typically we are only required to process 4 controls (2-Neg, 2-Pos).. The PMT is solely for the Pipettor pump and Stress tests are usually used to validate any repair that doesn't influence result recovery.

Just a reminder that this has to be done for all 4 banks.

At what point does this actually occur during the power up sequence? Since the new Thermocycler should come with all the banks P&I values defaulted to 11.0/0.75, I don't think this procedure is necessary.

Where do the quantity values come from for the Consumables? Does the 1-6 reference how many I might use per a specific procedure?

We should be waiting at least 12 hours for temperature equilibration before any attempt to Autotune. I think this should be performed during the Test the MR Reader section.

This isn't necessary at this time until all settings have been properly updated, including gripper alignment. Assuming you are in Development mode, you wouldn't have to worry about the autotune sequence test failing either.

You would not have to remove the Right End Cap cover if you can access the NDX connector from the rear. This would be noticeable after removing the back panel.

You need a reminder to feed the 5V power cable and NDX cable into the entry hole before lowering the module in place.

Better to mention this before you start replacing the module. It could also be mentioned at the beginning of the entire procedure.

Can this link to section 6.13 in WI-00555 instead of the entire document?

repeat the entire procedure.

I believe controls are all that is required unless this is new.

HVO

HVO

You mean HVO.

Updates would also include:

• IP address (communication error if not correct)
• Firmware
• Offsets (Angle and Field Degrees)

This would actually not be an issue in Development mode. Having to wait for the self testing to complete can be very time consuming and should be part of Verification.

You have to be very careful not to damage the wiring for the belt break sensor and LED, located near the top and opposite of each other.

Could be Hex or Philips. Probably just have to state "Remove 4 screws..."

Simply reminding us to move the Pipettor should be good enough. To the right or left depends on the HVO.

Has this procedure become obsolete?

Are there plans to expand this section?

Same as I stated for Bacteria stress tests.

Same as I stated for Bacteria stress tests.

And restart the application. Allow self-tests to complete.

This can also be done on the touchscreen. You need to restart the application either way for the changes to take affect.

Perhaps this could be mentioned in the beginning so you know how many test panels you need. I believe the installation requires 7 and a pump replacement requires 4.

What happens if we don't add these tubes?

I think all the current software out in the field gives you the value without needing to calculate it?

The picture should be the search window not the line by line log data.

Baretail should automatically take you to the most recent log file assuming you're attached to an instrument.

It seems we have already removed the Lid at this point but I'm curious as to how I got it off? A picture and a suggestion would be useful. I also wonder if we should mark both the Case and Lid so we orient them back together correctly?

When removing the Centrifuge, I have always left the Lid attached. Is the goal of this procedure to remove the Lid for cleaning purposes or to repair a Lid component?

Gripper Robot v. Gripper Head. I only have replaced the Gripper Head so I can't really comment on the usefulness of this section. What does the part we are replacing here actually look like?

Perhaps I am missing it, but is there a search tool within the parts list?

What about the swabs?

This would be a great place for a troubleshooting guide.

As part of Pre-Maintenance Setup, I would suggest placing the instrument in "Development mode".

This section assumes I am well versed in log interpretation. I can't speak for everyone else but "logs analysis" continues to be an area I need improvement. Will there be a section in the new FSM to guide us in interpreting and resolving errors?

A level 2 cleaning includes all of a level 1 and the centrifuge. I understand why to do it now but remove the Level 2 reference. Otherwise, I tend to perform the Centrifuge first and then the rest of the instrument. By the time i'm done with the Centrifuge, the other modules are cold enough to clean.

What are we doing about 1.0 instruments?

I think the general consensus is to remove the drawers to clean all relevant sensors and guides. We can certainly help you with the procedure.

Since we are going to verify heater function after the UV bulb replacement, perhaps we could wait to replace the cover until after the heater verification?

Our goal is to complete the entire PM on day 1 and load controls. With the possible addition of TSBs and software upgrades, 2 full days + controls is not out of the question.

Two things. I don't see the verification steps (perhaps they are somewhere else) and since there isn't power supplied to the lamp (lamp is off), do we really have to power off to replace it? I also prefer to use the Service UI to move the drawers.

Later in the procedure the words "Dampen and Saturate" are used. How to we distinguish between the two? Also should there be a reference to swabs and their use?

Is this new to use bleach on the teach tools? Last word was to only use alcohol.

Does this include prep areas and around the instrument? I was not aware we could do this.

A suggestion to be completed before starting TSBs (or Robot Hardware verification) is to "Configure T2Dx Instrument for Testing" by updating the following: EnableDevelopmentMode, AutotuneDurationInHours, DesiredUvSoakTimeMinutes, EnableSelfTest. We would also want a reminder to set these back to their "normal" values. This can be done either via editing the MainController or on board.

Only controls (?).

Only applicable to 1.1 instruments

Unless this is a new requirement, stress test and PMT are not required. Only controls.

What is do be done if all the wells are not in spec?

This procedure is only for 1.1 instruments. 1.0 instruments do not have the extra HVO and a different incubator module.

Could be Philips screws

Perhaps it's me but it seems redundant to use "Manually" when there is no other option with the power off.

When powering off instrument, why was the "customer" option used instead of the "service" option?

Again, only 4 circles. How tight do we want to make these screws?

I only see four orange circles.

I've often wondered if there is a "best" manner in which to remove these screws? Where is the best starting and end point? We should also mention to make certain the Gripper is moved forward to avoid hitting the upper fan cover area of the panel?

Can someone explain to me what a carriage return is?

What do we do if the bucket is not centered?

As with all module replacements, there are times after powering on that a communication error occurs (20006) due to an incorrect IP address. Do we want to mention this here and with all module replacements?

Perhaps this would be better to state after removing the new centrifuge from the box?

Should there be another step to instruct you to power on the instrument?

Inspect all wiring connections and conditions of hardware as Mark mentioned, not necessarily shipping related.

Step 1.5, these screws may be Philips. Depends on age of instrument.

It seems newer instruments are now coming with 2.5mm screws.

When powering off instrument, why was the "customer" option used instead of the "service" option?

When selecting to enlarge the cartridge/tip-tube legend picture, I noticed the top gets cut off.

When selecting to enlarge the cartridge/tip-tube legend picture, I noticed the top gets cut off.