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SleepMed Inc. - Seizures & EEG - DigiTrace Clinical Applications




Patient Instructions For Digital Video System

Click the below link to view the Digitrace Digital Video System Patient Instructions.

M-0001-01 Patient Instructions Rev D.doc

 

Patient Instructions Following Ambulatory EEG Studies   

In addition to providing good instruction to the patient before a home monitoring session, we also find patients appreciate information immediately following their study.  Following is the text that we provide at SleepMed/DigiTrace.  If you would like an electronic version that you can copy onto your own letterhead, please call us.

 

"We hope that your test was as pleasant as possible and that our technologists made sure you were comfortable with all aspects of the testing process.  Now that your test is over, please review the following information regarding further evaluation and treatment of your symptoms.

 

When you get home, please apply hair conditioner to your hair prior to washing. You do not need to wet your hair, simply apply about a handful of conditioner to your hair and work it in.  Let it sit about 5 minutes and using a large toothcomb, comb through your hair. After the 5 minutes, wash your hair and recondition.  Should you find any remaining glue, you can apply a little fingernail polish remover with acetone directly on the glue.  Please make sure you do not get the acetone in your eyes.  You will also want to use some face cream on your forehead and any other place on your face that electrodes were applied.  All of the items used in the testing can dry your skin

 

Your study generates approximately 100-300 pages of data.  This data is collected on the computer, but is analyzed and coordinated with your push button and activity logs by the EEG technologist.  All of this information is detailed in a report and sent to the interpreting physician within 48 hours.  In some cases the interpreting physician is not your physician. 

 

The interpreting physician will review the clinical history, your logs, and all of the data.  The interpreting physician will render a detailed interpretation of the data.  The physician will then dictate the final report, which will be sent to your doctor.

 

Please make sure that you have a follow-up appointment or telephone call scheduled with your physician approximately two weeks after your study.  We recommend that you call your physician's office the day prior to your appointment to verify that the final report is available."

 

 

 

Performing Bio-cals

Thanks to Linda Monroe, R. EEG/EPT, CNIM for providing the bio-cal guidelines she and her staff use at St. Luke's Medical Center, Boise, ID.  To aid the physicians in their interpretations, prior to each DigiTrace study, the technologist will activate the push button and "ask the patient to EO/EC, blink rapidly, chew, and hyperventilate (as appropriate) following hookup."  This information is clearly annotated at the beginning of the study by the technologist and can be referred to as needed to help differentiate events from artifact.

 


 

24-Hour Patient Help Line

Patients like to know they have someone they can talk to should they have questions or problems after they get home with their equipment.  We maintain 24-hour call for patients set up at SleepMed offices or at our hospital or physician collaboration sites.  The Help Line number for your patients to use is (800) 334-3053.  There is no charge for this service for accounts on DigiTrace rental programs, those under warranty or those having service contracts.  Here, from Nancy Foote, our Director of Clinical Services, is how the program works.

 

"The toll-free Help Line is answered by a person, not a machine.  The service we use will ask your patient first if it is a medical emergency.  Should that answer be "yes," they will be instructed to call 911. In most cases it is a question about the test, system or a problem. The answering service will then page the on call technologist. 

 

We maintain a team of 12 highly trained technologists that rotate call. The technologists are all full time SleepMed/DigiTrace employees that are trained on troubleshooting the machines, procedures, and clinical questions.  Once the technologist calls your patient he/she will do everything to fix the problem, encourage your patient to continue the test, help them reapply loose electrodes, re-wrap heads, change batteries, and, when needed, how to remove the electrodes. 

 

As on call technologists we get a wide range of questions and problems such as "I dropped the unit in the toilet",  "my dog bit the cord", "my waist pack is blank ", "the lights aren't flashing", "can I use an extension cord?", "I forgot to plug in", "how do I turn this machine off?"," I had a seizure can I stop now?", "I forgot to push the button", "I just woke up and all my hat came off", "those leads that monitor my heart fell off", and one of my favorites is "my cable TV just went out do you think it is because of this thing on my head?" 

 

With all that said, all our patients are great, and are true sports during the test.  From the electrodes to the gauze caps, they keep their sense of humor (thank goodness).  To better help the patients, it is important that you make sure to go through the instructions carefully.  And, make sure to give them extra supplies in case they need them, especially over a weekend test. 

 

I also suggest that each technologist call the patient several hours after set-up to answer any questions that might have come up when they first arrived home.  I have found this to greatly improve patient compliance and testing.  Please take a moment to review the list of suggested supplies each person should get.  If you put them in zip lock bags the supplies stay clean and, if not needed, can be used for your next patient."

 

Supplies for ambulatory EEG testing for each patient (a must for weekend set-ups):

  1. 2 rolls of gauze - in case we need to rewrap the head.
  2. Tape - to help with the rewrap or the replacement of an electrode
  3. Extra batteries - one for the 1800 and two for the 1800+ (beyond the required 2/24)
  4. 2 ECG pads - in case we need to replace or move the electrodes
  5. Cotton tip stick- for 1800+ units, in case the unit needs to be reset
  6. Extra phone cord- for patients using a Home Computer or video

 

 

Hyperventilation with the DigiTrace System

Several technologists have requested instructions for performing Hyperventilation on the DigiTrace system.  Here are the procedures:

 

1800 Plus instructions:

  1. Using the DigiTrace User Interface (UI) 2.1, set up the recorder and the patient.
  2. Connect the serial cable to the 1800 Plus and from the 1800 Plus set up menu, select Real-time EEG.
  3. Using the 1800 Plus recorder clock, start the patient HV.  At two minutes press the button, and continue HV.   At 3 minutes have the patient stop HV and at 6 minutes press the button again. This will give you a total of 3 minutes of HV and 2 minutes of resting EEG and 8 minutes of continuous EEG recording.  By selecting the real time EEG you can monitor the patient's build up and heart rate.
  4. Once you down load the study, you can use the comment buttons to add your notes, times, and HV performance.  Example:
    • 11:00 start HV
    • 11:02 press the button
    • 11:03 stop HV
    • 11:06 press the button, and disconnect from tower and let patient go home while the remaining two minutes records (remainder of push button event).

 

 

DigiView® Review Software is now available!

DigiView has been designed to be easy to use review software optimized for DigiTrace EEG and video studies.  Menus and icons are user-intuitive and similar to other commercially available on-screen review packages.

 

A popular feature with early DigiView users has been the unique color-coded event files.  This facilitates selecting the files that are most important to the interpreting physician.  The color-coded files have an associated blue bar if video is included in the event.

 

DigiView channel editing features allow the user to adjust individual channel sensitivity, move channels and color-code channels as needed.

 

A time saving feature is the built-in report generator.   DigiView will display patient demographics, system specifications, the types of event files captured and more.  The reading physician can type in the study interpretation or a separate report can be attached.  The report has margins designed to fit most hospital or practice letterhead to ensure a professional presentation.

 

There is much more to like about DigiView.  But, best of all, DigiView is available at no cost to DigiTrace users and interpreting physicians.  Just ask your SleepMed salesperson for your copy or call us at (800) 334-5085.

 

 

 

Time Synchronization- (place under "Technologist Tips")

We have had several questions from reading physicians about why the time on the patient logs do not match the time on the recording.  The answer is that patients often look at their watch, the kitchen clock or the clock radio, none of which are time synchronized to the EEG recording.  The easiest way to solve this problem is to ask the patient to use the clock on the 1800 or 1800 Plus recorder.  The added benefit to using the recorder clock is that your patients can check for low battery levels at the same time.  

 

Using the recorder clock ensures that the interpreting physician will have an easier time correlating the events to the EEG.  So, it's a "win-win" for you and the patient.

 

 

 

Neonatal Monitoring

Periodically we get requests from physicians that we provide a neonatal montage and electrode set in order to monitor these special patients.  The montage is:

 

                                                FP1 - T3                     F7 - FZ

                                                T3 - O1                       FZ - F8

                                                FP1 - C3                     T5 - PZ

                                                C3 - O1                      PZ - T6

                                                FP2 - T4                     LOC - ROC (eyes)

                                                T4 - O2                       Chin EMG

                                                FP2 - C4                     EKG1 - EKG2

                                                C4 - O2                      RP1 - RP2 (respiration)

 

Please call SleepMed/DigiTrace Technical Support for additional information.

 

 

 

 

Digital Video System (DVS) Monitoring of Lenthy Studies

Over 10% of DigiTrace® studies done in our Service Centers and Hospital Collaboration Sites include video.  Following are some suggestions to help you avoid problems with lengthy video EEG studies.

 

Studies lasting more than three days will require that the patient return to your facility so that the electrodes can be re-gelled.  It is not a problem if the patient leaves the video unit at home because the memory in the DVS is far greater than that of the flash card on1800 Plus® or 2700 Plus® recorders.  As part of this process, and after removing the batteries, you should download the data from the flash card then reformat and set up the flash card.  However, DO NOT RESET the recorder.  This is because the recorder is the component responsible for naming the files.  If you reset the recorder, it will re-record over the old patient data (e.g.: there cannot be two "PBTN 001" events in the same record).

 

If the patient does return to the lab with both the DVS and 1800 Plus or 2700 Plus recorder, you can download and reset both units.

 

The chart below shows the difference in capacity between the two records and the DVS.  This is a function of the storage medium used in each unit.  For example, the video unit can record in the continuous recording mode for 13 days due to its large capacity hard drive.  But, depending on the size, the recorder flash card will be full after a few days continuous data.  In the event detection mode, which is most commonly used, you will be able to store more data but this is still subject to the number of pushbutton activations and automatic seizure detections.

 

Multiple day video studies are an easy thing to do and the patient does not need to bring in the video each time that re-gelling is needed.  We encourage physicians to order longer video studies to ensure that we are able to capture events.

 

We are always looking for examples that show how much more valuable information can be obtained through the use of video.  If you have a great video study, please call us.  It may be ideal to share with others as a "Case of the Month" study.  We have the ability to remove the patient name from the record and can assist in addressing confidentiality and consent issues.

 

As always, if you have any questions concerning video studies, please call our Technical Support team at

(800) 334-5085.

 

Data Storage Capacity

 

 

 

Device

1800 Plus

2700 Plus

DVS

18 Channel Event Detection*

24 Days

24 Days

100 Days

27 Channel Event Detection*

NA

17 Days

100 Days

18 Channel Continuous

1.5 Days

1.5 Days

13 Days

27 Channel Continuous

NA

1 Day

13 Days

 

 

 

 

*Numbers determined using a test day of 24 hours, normal time sampling, 10 long seizures, and 4 Push Button Events

 

 

 

Billing 95957 as part of Ambulatory EEG Studies

We have received numerous questions about the validity of billing 95957 ("Digital analysis of EEG") since we provide an automated spike and seizure detection program as part of the DigiTrace System.  We have inquired about this with two of our Medical Directors, Donald Schomer, M.D., Beth Israel Deaconess Medical Center, Boston and Marc Nuwer, M.D., UCLA Medical Center, Los Angeles.  Both Dr. Nuwer and Dr. Schomer have advised us that the 95957 code was not intended for spike and seizure detection since this is considered to be part of the standard billing code for the study.  Rather it was intended for "additional special analysis, such as 3D localization of spike generators that requires averaging spikes and processing with special software."

 

 

 

 

Digital Video System (DVS) Shutdown and Start-Up Procedure 

DigiTrace engineers have added an early warning system to prevent failures of the DVS when using the new DigiTrace User Interface 2.1.  The early warning is active when the unit is shut down properly:

 

  1. When you finish downloading or setting up the DVS with cables still connected shut the unit down using the "stop" icon at the bottom of the set-up menu.  Do not use the "X" at the top right hand corner of the set-up box.
  2. Wait 30 seconds then turn off the DVS at the power switch, and disconnect the cables.

 

If this procedure has been followed, the DVS will automatically run a scan disk when the unit is turned back on, which should be before the patient arrives.  If there is a problem, the scan disk will attempt to correct it.  If the problem cannot be corrected, the system will not boot up, indicating that a problem exists.  Call the DigiTrace Technical Support Department for assistance prior to using the system for a patient study.

 

The DVS uses a Windows® operating system which is why it is possible to corrupt the hard disk if the unit is not properly shut down.  The reason the DVS booting process is 4 minutes long is because each time we boot the system up, the entire windows program is re-installed. In addition to initial start up problems, DVS units that have not been shut down properly have also been prone to shut down after 24-hours of a video study. Should questions arise, call DigiTrace Tech Support at (800) 334-5085..  

 

 

 

Return Materials Authorization (RMA) Procedure

In the event you experience difficulties with your DigiTrace™ hardware or software product, please contact the SleepMed Technical Support Department to resolve the problem. They may be reached at (800) 334-5085, Monday through Friday 8:00 a.m. to 6:00 p.m. Eastern Time.

 

If the technical support person cannot resolve the problem and you want to return the item for repair, a RMA number will be issued.  You will be asked to supply the following information:

 

  • Name of caller requesting RMA.
  • Location of device to be returned.
  • The serial number of the device(s) to be returned. This will be located on a white bar code label applied to the device, approximately 5/8 inch by 1 ½ inch in size.
  • The reason the product is being returned.

 

Prepare the device for shipping:

 

  • Complete a DigiTrace Equipment Report form (copy enclosed).
  • Carefully package the device to be returned to ensure no damage occurs in route.
  • Place the completed DigiTrace Equipment Report form in the box with the return materials.
  • If the device being returned is a DVS unit, pack the DVS to be returned in the original packing material within its carry case. If you do not have the original packing material, call the SleepMed Technical Support Department for instructions. 
  • Write the RMA number clearly on the outside of the box.

 

Return the product to:

 

SleepMed Inc.

Technical Support Department

200 Corporate Place

Suite 5

Peabody MA 01960

 

 

 

 

Upgrading Your Existing DigiTrace Video System

Like you, SleepMed wants to offer the most reliable and clinically useful ambulatory EEG studies possible.  An important aspect of that is to be able to upgrade existing systems to the extent possible.  We are now offering operating system upgrades to the original Digital Video System.  The new Windows 2000 operating system has proven to be much more reliable and more forgiving of minor alterations from patient set-up protocols.  We are continuing to explore other upgrade possibilities including adding a color camera and front-panel LCD screen.  The Windows 2000 upgrade is available at no charge to all rental partners.  Look for updates in future Clinical Application Notes.

 

 

 

 

Reporting EEG Test Days

Our "Per Use" rental programs offer the flexibility of only paying for DigiTrace test days as you use the equipment.  This allows your payments to be tied just to the testing you do and the reimbursements that you will receive as a result.  But, this program requires your cooperation in reporting test days  The report is automatically generated as you do your DigiTrace set-ups either in the DigiTrace User Interface (DigiUI) software or DigiTools.  Here's how to access the report in DigiUI:

 

  1. When you open the DigiTrace User Interface, go to the button that reads "Print EEG Files" (near the bottom of the column).
  2. Click on the "Print EEG Files" button and click on "Activity Report" in the lower left hand corner.
  3. The report will list all the patients that were set-up in the month, the length of the study and whether it was a standard or video study.
  4. Print the page and fax it to us at XXX-XXX-XXXX

The process in DigiTools is as follows:

 

We have also built in a reminder that will appear on your DigiTrace workstation screen at the end of each month. 

 

 

EKG Considerations

Prepping Before Applying an EKG Electrode

Recently we have had several patient complaints about allergic reactions to the EKG patches.  You do not necessarily need to use a pumice-based prep before applying a EKG electrodes.  You can use an alcohol pad to remove oil from the skin.  The alcohol should be given a few seconds to completely dry.  Consider placing EKG patches on the patient's back instead of the chest.  The signal is great, children cannot reach them to pull them off and, if there is a reaction, it is better to be on the back then the chest.

EKG Monitoring with the 2700 Plus

There has been some confusion on EKG monitoring with the 2700 Plus.  The system is designed for EKG leads to be put in A+ to A-.   Jumper cables should be placed in Aux B+ to B-. if you do not have jumper cables you may need to turn the channel off when viewing your study.  Do a patient bio-cal to verify that you have a good signal. 

 

.

 

DigiTrace 1800 Plus and 2700 Plus Battery Questions

DigiTrace maintains a 24/7 patient help line for all patients set up at our service center and DigiTrace partner accounts.  Questions about batteries are very common.  Following is Q&A that may be helpful to you and your patients.

 

Q:    Might the batteries used in the DigiTrace recorder explode or catch fire?

 

A:    There have been documented cases of rechargeable lithium ion batteries that have this problem.  We use lithium batteries for DigiTrace recorders.  Pure lithium batteries, which are not rechargeable, use different chemicals than rechargeable lithium ion batteries.  In our testing we have not been able to cause a fire or explosion or even get them hot enough to melt the battery case.  Thanks to Steve Bild, R. EEG/EP T.,CNIM of Rush University Medical Center for sending in this inquiry.

 

 

 

Q:    How long do the batteries last?

 

A:    The battery life is dependent on the number of channels and event detections.  There is a battery life indicator in the lower right of the DigiTrace recorder LCD.  When the batteries get very low the patient will hear a beeping and will see a "low battery" message on the display.

 

 

 

Q:    How often should batteries be changed?

 

A:    We suggest patients change batteries daily or when the battery display indicates 75% or lower.  It is best to ensure that all EEG data is captured, which can be assured by regular battery changes.

 

 

 

Q:    What if the batteries die?

 

A:    The DigiTrace recorder has non-volatile memory so you and your patients do not have to be concerned about losing data that has been recorded.  If this occurs, despite regular battery changes, it probably indicates that a lot of events occurred and that the referring physician will have plenty of data for interpretation.

 

 

 

Q:    Should I pull the black plastic tops off the Lithium 9V batteries before giving them to my patients?

 

A:    No.  The black plastic tops protect the batteries.  If you give patients extra batteries without the caps and the terminals touch they can short out the batteries.

 

 

 

Q:    What is the correct battery changing procedure?

 

A:    When changing the recorder batteries, instruct your patients to remove them both.  Do not change them one at a time.  Not only is there a chance the patient could get confused or distracted and not recall which battery had been changed but...;

 

 

 

Q:    What if my patient has a problem changing the battery?

 

A:    It is best that you let your patients remove and re-insert the batteries before they leave your lab.  This is especially true of elderly patients who may have difficulty with this task.  A care giver may be able to assist.  Patients and care-givers can always call our Help Line for assistance.  We will be happy to assist.

 

 

 

Q:    Can I get a copy of the Material Safety Data Sheet for my lab?

 

A:    Yes.  Call or email us at eegservices@sleepmed.mdif you would like a copy for your files.

 

 

EKG Monitoring with the 2700 Plus

Aux A should be used for your EKG set-up with the 2700 Plus to ensure it is available upon remontaging. However, if AuxB is used to acquire EKG, it is available only in raw data and not automatically upon remontaging. If you want to look at AuxB upon remontaging, follow these steps:

 

  1. Open referential EEG data (r27 file) and select the montage you want to add the channel to.
  2. Double click on the label "EKG" on the left hand side
  3. Click on insert channel button on the menu that pops up
  4. In the insert channel menu, select Ex1 as Input 1 and Ex2 as Input 2 and name the channel "AuxB"

 

 

 

 

 



DigiTrace Clinical Applications

2003-05 Notes DOC

2003-08 Notes DOC

2003-11 Notes DOC

2004-04 Notes DOC

2005-06 Notes DOC

2006-01 Notes DOC

2007-03 Notes DOC

2007-06 Notes DOC

2007-12 Notes DOC

DPA Brochure TXT

Insomnia Index PDF

Tables of Contents XLS


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