Implantable Telemetry FAQs

• Where can I find information on the storage and re-sterilization of DSI transmitters?

  You can find this information in the Technical Notes section of our website, or by selecting the appropriate link below.
  
  Cleaning and Re-sterilization Technical Notes: 
  On-Site Cleaning and Resterilization of DSI Transmitters Using Actril 
  On-Site Cleaning and Resterilization of DSI Transmitters Using Cidex/Glutaraldehyde
  Storage of Your Transmitters

• What are the Hydrogen Peroxide, Ethylene Oxide and Gamma Radiation Sterilization Policies for DSI?

  DSI pressure catheters have an anti-thrombogenic film covering them which is designed to prevent overgrowth of tissue on the catheter's surface and by sterilizing other than by the recommended process can potentially destroy the anti-thrombogenic film on the catheter.

  Use of any sterilization procedure outside of the chemicals and procedures listed in the Technical Notes section  will void the warranty of the transmitter.

  On-Site Cleaning and Resterilization of DSI Transmitters Using Actril

  On-Site Cleaning and Resterilization of DSI Transmitters Using Cidex/Glutaraldehyde

• Can I re-sterilize my re-gel syringe(s)?

  DSI doesn’t recommend re-sterilizing re-gel syringes, because the sterilization process (EtO) will change the properties of the gel, which may negatively affect data collection. DSI cannot guarantee successful results if sterilization is attempted.

  The gel used in our pressure transmitters has properties such that no contaminants can be sustained, therefore sterilization is not necessary. In practice, DSI will typically wipe the outside of the re-gel syringe and the needle with an alcohol pad prior to use. Additionally, some customers may choose to have one syringe dedicated for re-gelling immediately after explanting a transmitter, and one syringe dedicated to re-gelling prior to implantation. This may help prevent tissue or other debris from being present in the surgical field at the time of implantation.

• How do I re-gel my transmitters?

  Refer to the following Technical Notes:
  Guidelines for the Re-gel of PhysioTel and PhysioTel Digital Large Animal Transmitters
  Guidelines for the Re-gel of the PA-C40 Transmitter
  Guidelines for the Re-gel of the PA-C10 & HD-X11 Transmitters

• What are the precautions of blown sensors in blood pressure transmitters?

  Please refer the following technical note:
  Precautions of Blown Sensors in Blood Pressure Transmitters

• How do I check the accuracy of Pressure Transmitters?

  Please refer the following technical note:
  Checking the Accuracy of Pressure Transmitters

• Can you use a Defibrillator with DSI Transmitters?

  Although DSI transmitters are not specifically designed with defibrillator protection, we do not expect to see defibrillator use causing any damage to the transmitter nor have we seen damage when defibrillators have been used previously.

  DSI does not guarantee that no damage will occur, but if a transmitter is damaged by defibrillation, it will be replaced under warranty.

  The one exception to this statement is that the defibrillator voltage cannot be applied directly to the leads of a biopotential channel of the transmitter.

• What is the purpose of a biopotential reference lead?

  The purpose of the reference lead is to subtract any common signal between the two or three 'signal' lead pairs from those signals. So the output from the 'signal' leads is the difference= [(its own signal)-(reference lead signal)]. The paired leads for each channel monitor the potential between the two end points. Moving one signal-lead to the site of the reference lead would alter the output of the channel.

• What is the freezing temperature of a pressure catheter?

  The liquid in the pressure catheter freezes at -25° C, so it should be perfectly safe to freeze any model of transmitter in a normal freezer. Therefore, if an animal dies and you don't have time to explant the transmitter right away, it is safe to freeze the transmitter in a normal freezer.

• What happens when a transmitter reaches the end of its battery life?

  When the battery has been depleted, you can ship your transmitters back to DSI to be refurbished.  If the transmitter has not been damaged, it can be exchanged for a refurbished transmitter though our transmitter exchange program: DSI Exchange.

• Can a MRI machine be used with transmitters?

  Athough DSI has not seen any damage to the devices when placed in a MRI machine, the company’s primary concern is that the magnetic field puts significant pull on the transmitter.  This can potentially cause the transmitter to migrate.

• What if I have a cage that allows the animal and transmitter to be farther away from the receiver than the specified range? Do you have any options for that?

  Yes we have basically two options you could consider:

  · Our standard receivers (RMC-1s and RPC-1s) can be grouped together to cover larger areas.  We call this a DRA (Distributive Receiver Array) configuration.  You can use from two to 16 receivers in a DRA depending on the size of the area you need to cover.  In a DRA, the Data Exchange Matrix will automatically select the signal from the receiver that is getting the strongest signal from the transmitter.

  · Repeater Systems are available for large animals (typically dogs and primates) that can increase the broadcast range of a transmitter to up to eight meters.  The Repeater System consists of a Repeater and a Repeater Receiver.  The Repeater receives the signals from the animal’s transmitter, then “rebroadcasts” the signals to the Repeater Receiver having the same frequency.  Repeaters typically attach to a collar or are inserted into a jacket.  The Repeater Receivers are only used with the Repeaters and are available in 12 separate transmission frequencies to allow group housing, and to minimize the possibility of cross talk.

• What if the transmitter has been damaged?

  Transmitters that have been damaged to the extent that the electronic components cannot be salvaged will not qualify for the transmitter exchange program and must be scrapped.  This type of damage is usually the result of the case having been penetrated due to an animal chewing through the case, or as a result of a leak or crack where a catheter or biopotential lead enters the case.  When the case integrity is compromised in this way it will expose the electronics to moisture which can damage the components.  Transmitters with blown sensors must also be scrapped.

• I recently implanted several TA-D70 transmitters. For all of the transmitters, the temperature waveform was steady at about 34 degrees C. This value didn't change at all. Did I do something wrong?

  The transmitters are likely in "reference mode".  The CTA-D70 and TA-D70 have 3 modes in the following order: Off, reference mode, and On.  The reference mode is for factory use only and will normally send out a flat temperature reading. Temperature cannot be recorded in reference mode. 

  Transmitters with battery monitor mode have 3 modes in the following order: Off, On, and battery monitor mode.  The following are DSI transmitters with battery monitor mode: C50-PXT, D70-PCT, D70-PCTP, PA-D70, D70-CCTP, and D70-EEE.

• What if I have reason to believe that a transmitter is not working correctly or has failed prematurely?

  You should contact DSI Technical Support by phone or e-mail and explain the nature and circumstances of the failure.  Our Technical Support Analysts will compile the necessary information to determine if the transmitter should be sent back to DSI for Analysis. If Technical Support feels it is warranted we will send you a Product Investigation (PI) form to include with the transmitter when you send it back to us for analysis.  Our Technicians will inspect and evaluate the transmitter to determine if transmitter will be replaced under warranty.

• How do I monitor transmitters with a Battery Monitor Mode?

  1. Turn on an AM radio and tune it to 455 kHz (the low end of the AM band).

  2. Use the AM radio to listen to the tone of the transmitter. Scan the transmitter with a magnet approximately one inch from the transmitter to change the operating mode to battery monitoring mode. Most transmitters have the following sequence of modes: off, on, battery monitor mode. Refer to the transmitter sterile package for information about the sequence of modes.

  3. If you are not sure if the transmitter is in the battery monitor mode, repeat step 2 and compare the different tones until you are sure you hear a low tone. Repeat steps 2 and 3 for each transmitter to be monitored.

  4. Place the transmitter on its associated receiver.

  5. From the Acquisition program, open the Configuration module and configure each transmitter on a receiver. Refer to Beginning the Configuration Process for more information.

  6. Highlight the animal ID in the Acquisition window, right click and choose Start Sampling - Continuous.... The Start Continuous Sampling window appears.

  7. Select Diagnostic Trace and select the Settings... button to display the Diagnostic Trace Settings window .

  8. Place a check mark in the Enabled column for Battery Life. Remove all other check marks in the Enabled column by clicking on them.

  9.  Change the Upper Limit for Battery life to 15 by clicking in the appropriate cell.

  10. Set the graph length to 10 seconds and select OK to return to the Continuous Sampling window.

  11. Select OK to display the Real-Time Graphs window that contains the battery life signal tracing window.

  If there are more than 14 days of battery life remaining, an alarm window appears indicating the battery is OK and a complete 10 second waveform will not be seen in the Battery Life trace window. Continue to Step 15.

  A complete 10 second waveform in the Battery Life trace window means there are less than 14 days remaining. Continue to Step 12.

  If a waveform does not appear in the Battery Life trace window and the battery OK message was not displayed, check the following:

  • Is the transmitter in Battery Monitor mode? Refer to Step 2.
  • Is the Y axis scale set correctly? Refer to Steps 7-9.
  • Is the word Stopped flashing in the title bar of the Real-Time Graphs window or the Battery Life trace window?
  • Is the animal icon in the Acquisition window blinking and never turning green?

  Answering yes to any of the last three questions indicates a dead battery.

  12.  If a waveform trace is displayed, select Data - Pause after tracing the signal for more than 5 seconds to freeze the battery life waveform.

  13. Click on the Zoom icon (looks like a magnifying glass) located on the toolbar of the Real-Time Graphs window. A Static Graphs window will appear.

  14. Select View - Tracking to change the mouse pointer from an arrow to a + (Clicking on the waveform trace with the left mouse button, and dragging it to another location on the window while holding down the left mouse button will allow you to zoom in on the waveform trace).

  15. Place the pointer on the horizontal waveform line extending across the display from the Y axis. The X and Y axis coordinate values are displayed on the status bar located at the bottom of the Static Graphs window and change according to the location of the pointer on the graph. The Y value indicates the number of days of battery life remaining for the transmitter. Record the number of battery life days remaining on the lab sheet for this Animal ID.

  16. Click the X located in the upper right hand corner of the Static Graphs window to close it and return to the Real-Time Graphs window.

  17. Click the X located in the upper right hand corner of the Real-Time Graphs window. A message will appear stating that by closing this window you will stop all save and trace sampling. Select Yes to return to the Acquisition window.

  18. Repeat Steps 2-17 for each transmitter.

  Notes

  12. The battery monitor mode has a lower tone than the On mode.

  13. The TA11-CTA-D70 and TA10-TA-D70 have 3 modes in the following order: Off, reference mode and On. The reference mode is for factory use only and does not measure battery life. These transmitters cannot record temperature in reference mode

  14. To monitor the battery life of a TL11M3-D70-PCTP, it must be configured as a D70-PCP for the battery monitor mode to be accessible to the Dataquest A.R.T. software.

  15. Plan to perform any end-of-study checks or validations within the indicated remaining battery life. Beyond this time, the transmitter may cease to function or may provide inaccurate data.

• How do I straighten catheters?

  The PA-C20 catheter can become stiff as it returns to room temperature. This may necessitate a need to straighten the catheter for future use. 

  1. Soak the transmitter in an enzyme detergent immediately upon explantation to thoroughly clean and remove any biomaterial. Please refer to the On-Site Sterilization Tech Notes for DSI approved and recommended detergents located on our web site.

  2. Rinse the catheter and re-gel if necessary.

  3. Wet the catheter again and carefully thread it into the beveled end of a 20-gauge syringe needle.

  4. Advance the catheter completely into the needle and place the apparatus on a tray in a warm (40°C) and humid environment for at least one hour, such as a water circulating heating pad.

  5. Cover the tray with wet paper towels (regular tap water is fine). Then cover the whole heating pad with a towel or other covering. Do not exceed a temperature of 50°C while heating.

  6. Rapidly returning the catheter to room temperature will set the catheter in its new configuration.            

  **This same technique can be used for all other DSI pressure catheters however a different needle syringe gauge may need to be used.

Surgical FAQs

• Anesthesia Nosecone for Cannulation in Rodents

  Anesthesia Nosecone for Rodents

• Post-Surgical Complications: Loss of Incision Integrity and Exposure of the Transmitter Body

  Post-Surgical Complications: Loss of Incision Integrity and Exposure of the Transmitter Body

• Critical Factors for Successful Mouse Surgery

  Critical Factors for Successful Mouse Surgery

• Seromas: Cause and Management

  Seromas: Cause and Management

• ECG Lead Placement in Large Quadrupeds

  ECG Lead Placement in Large Quadrupeds

• Blood Pressure Measurement in Less Commonly Used Species (Part 2 -Rabbit, Guinea Pig, Hamster)

  Blood Pressure Measurement in Less Commonly Used Species (Part 2 -Rabbit, Guinea Pig, Hamster)

• Blood Pressure Measurement in Less Commonly Used Species (Part 1 - Mini Pig, Cat and Ferret)

  Blood Pressure Measurement in Less Commonly Used Species (Part 1 - Mini Pig, Cat and Ferret)

• Additional Lab Supplies

  Additional Lab Supplies

• Biopotential Leads: What to Do with Them when Not Being Used

  Biopotential Leads:  What to Do with Them when Not Being Used

Good Laboratory Practice (GLP) FAQs

• Who do I contact if I have a GLP question?

  Please contact the DSI technical support team:
  1-800-262-9687
  1-651-481-7400
  support@datasci.com

• What is a System?

  A “system” is defined as having Software and the operating system, hardware, supporting infrastructure, and SOPs.

• What is included in DSI’s onsite assistance offering for the GLP package?

  DSI’s Onsite Assistance offering is a service to help “jump start” the customer’s validation process. Customers can expect to have a very good understanding of the functions that remain and how to successfully complete their validation once the DSI representative leaves the site. DSI representatives are there to answer questions about the DSI system and products as well as the validation documentation.

• Will DSI complete a customer validation of a system?

  No.  DSI employees cannot perform the validation process for a customer.

• When does a system need to be revalidated?

  A system should be revalidated if any changes to the hardware are made, software upgrades are done, changes to the system’s environment occur, or there are changes to security controls.

• What is validation and why do I need to do a validation?

  Systems used to create, modify, maintain, archive, retrieve or transmit data that supports a GLP study must be validated. The reason systems must be validated is because government agencies rely on the data created from a GLP study to make decisions regarding pharmaceuticals that impact the public well being.  Validation of systems, and therefore, the data generated from these systems must demonstrate safety, efficacy, purity, potency and stability of pharmaceutical.

• What is the PNM-VSP validation package?

  The Validation Service Package (PNM-VSP7) will support functionality of all system types (hard-wired, telemetry, etc.) for the current Ponemah version (and previous versions if requested).

• How long will the validation of a system take?

  The timeline to validate a system is dependent on many variables and can be dramatically different for each customer.

• What is a Vendor Audit?

  Vendor audits are used to assess if a vendor supplying products that will be used in a GLP environment implements a Quality System and complies with documented procedures.

Software FAQs

• How do I enable daylight savings time in Windows? Why do I need to do this?

  Re-enable Daylight Savings Time on your computer. If you don’t do this, the timestamp used in outlook and other programs will be incorrect for half of the year.

• How do I create a Microsoft Diagnostics report?

  In Windows NT:

  From the Start button on the Windows Menu bar, choose Programs - Administrative Tools (Common) - Windows NT Diagnostics. A new window will appear. Go into the File menu and choose Save Report, making sure "All Tabs" is selected for scope and "Complete" is selected for detail level. Choose to save it as a text file.

  In Windows 2000:

  Right-click on the My Computer icon located on the desktop and choose Manage. Open up the System Tools branch and then click on "System Information" so it is highlighted. Right-click on the highlighted folder and choose to save it as a text file.

  In Windows XP

  From the Start button on the Windows Menu bar, choose Run. In the Run window, type msinfo32.exe in the Open field. Highlight System Information and choose File - Export... to save the information as a .txt file.

• Sometimes when I start my Ponemah system I only have the options of File, Setup, Replay and Help, what makes that happen?

  If a user double clicks on the Ponemah icon to start the system more than once multiple instances of Ponemah will attempt to open and you will not have all of the options available. If this happens close all instances of Ponemah and double click only once on the icon to open Ponemah.

• Are there any software applications that are not recommended to use with Ponemah (installing or running with Ponemah)?

  As with any real-time data acquisition system, the Ponemah software can be very resource intensive. As such, it is recommended that other applications running during acquisition be reduced as much as possible. Delaying antivirus scans and reducing network communications can help keep resource available for the software and will help avoid potential conflicts that may interrupt or interfere with data collection.

• Does my software license expire? What is the expiration date listed when I “View License File” in Ponemah.

  No, once a customer purchases a version of the Ponemah software that version does not expire. The expiration date on a License file is set to either 3 months or 12 months from the time it is created. Every system get’s 3 months, if the customer purchases a software enhancement agreement it will be set 12 months after it is created.
  The expiration means they will get any new version released up until that expiration date.

• Can I use Dataquest ART software at the same time I am exporting an analog signal from an Adapter?

  Yes, you can still save data normally in the Acquisition software. You can also choose to just use the analog signal and ignore the computer software.

• Does DSI provide training to learn how to use Ponemah hardware and software?

  Yes. Contacting technical support at support@datasci.com or 1-800-262-3687 option 2 you can set up GoToMeeting^TM, phone meetings, visiting a DSI site, or inquire about a paid training option.

• Why do I have manuals on my Ponemah CD for products I do not have?

  All of the available Ponemah product manuals are available on the CD.

• Where can I find manuals and product release notes for Ponemah?

  Each new release of Ponemah will include the manuals as well as the release notes for that version. If any service packs (SP) are released they will include release notes about the updates.

• Can I use my Software key/license file on multiple computers?

  It is possible, though not recommended. The license file and the UBS software key can be moved from computer to computer; however this process increases the possibility of losing the USB key. If a USB key is lost they can be replaced. Please contact your sales representative for if a replacement key is needed, a quote will be generated for you.

Data Analysis Services FAQs

• Who do I contact if I have a question about Data Analysis Services (DAS)?

  ScientificServices@Datasci.com

• Are there study consultation fees?

  No, DAS is available for consultation at any time.  Consultation can vary in topics and may include study design, what parameters should be reported, and how to best present your data to communicate your results effectively.

• What kind of data can be analyzed?

  DAS can analyze data from a variety of areas in pharmaceutical research.  Some examples of these areas are discovery, safety pharmacology and toxicology.  Our team has expertise in cardiovascular studies, neurological sleep and seizure studies; we do not charge consultation fees so if there are any questions please contact Scientific Services

• How much does DAS cost?

  As each customer’s data set is unique and comes with a range of complexity, data analysis services cannot come with a standard price tag.  The data analysis team will schedule a free scientific consultation with the customer to tailor the data analysis product to each customer’s specifications.

• How long will it take to get results back?

  Due to the uniqueness of each dataset this may vary.  Standard datasets can be put into draft format within 10 working days after receiving the complete dataset

• What acquisition systems can you report data from?

  To produce a report, we can analyze data collected in Ponemah or Dataquest A.R.T.  Other systems may also be possible with prior examination by the Data Analysis team.

• How will the data be secured?

  Immediately after receiving any portion of the data, the data analysis team will transfer all data to the DSI secure network.  The customer will receive documentation of the file list and confirmation of the data security. The secure network is backed up daily. 

• Can DSI analyze data collected in a GLP setting?

  Currently, we are not offering data analysis for GLP studies.

• How qualified are DSI’s analysts?

  Data Analysis Services analysts have backgrounds in scientific research and engineering, including the areas of pharmaceuticals, academia, government and preclinical services.  They have been trained extensively by DSI’s software experts, as well as experts within the cardiology and neuroscience fields.  Experienced in Data Quest A.R.T, Neuroscore and Ponemah, they have the ability and tools necessary to analyze data quickly and reliably.  Our staff has over 40 years of combined experience in scientific research.