Data Sciences 02DSI Implant for Research Applications User Manual Transmitter User Guide

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Date Submitted	2002-09-02 00:00:00
Date Available	2002-10-11 00:00:00
Creation Date	2002-08-12 11:07:36
Producing Software	Acrobat PDFWriter 5.0 for Windows NT
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Document Title	Transmitter User Guide
Document Creator	Transmitter User Guide.doc - Microsoft Word
Document Author:	DSI Technical Services

Telemetry Transmitters
User Manual
Copyright 2002 Data Sciences International St. Paul, MN 55126-6164
Dataquest, the Data Sciences logo and PhysioTel are registered trademarks of Data Sciences International in the
United States and certain other foreign countries.
Multiplus is a trademark of Data Sciences International.
All other trademarks are the property of their respective holders.
Telemetry Transmitters User Manual
All Rights Reserved
Printed in U.S.A.
Issued January 2002
Part Number: 000380-001 Revision A
Data Sciences International
4211 Lexington Ave. N. Suite 2244
St. Paul, MN 55126-6164 U.S.A.
Telephone: 1( 651) 481-7400
Fax: 1 (651) 481-7404
www.datasci.com
Telemetry Transmitters User Manual
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Table of Contents
Device Operation
Storage of Transmitters
Storage of Resterilized Transmitters
Considerations With Pressure Transmitters
Checking Accuracy Prior to Implantation
Checking Accuracy at Explantation
Regelling Pressure Transmitters
Precautions Against Blown Sensors
On-Site Resterilization of Transmitters
Temperature Transmitters
Biopotential Transmitters
Pressure Transmitters
Multiplus Transmitters
Refurbishment of Transmitters
Benefits of Refurbishment During Warranty Period
Telemetry Transmitters User Manual
10
Page 3 of 10
TX FCC ID MHA02DSI
These devices comply with part 15 of the FCC rules. Operation is subject to the following two conditions: (1) This
device may not cause harmful interference, and (2) this device must except any interference that my cause undesired
operation.
Caution
Changes or modifications not expressly approved by the party responsible for compliance could void the users authority to operate the equipment.
Device Operation
All transmitters have two operational modes: On and Off. Transmitters are shipped in the Off mode, with the
batteries not activated. When switched to the On mode, the transmitters begin to sense and transmit data. The switch
to change modes is magnetically activated. Some transmitters have an additional Battery mode. This mode allows
the Dataquest ART software to determine the precise amount of battery life left towards the end of the transmitter’s
battery life. Refer to your transmitter label to determine if your model has the Battery mode.
All transmitters should be turned on 24 hours before use to allow the electronics to stabilize. The data from the
transmitters may not be completely accurate until this has occurred. For pressure implants, this can have an effect on
the pressure offset measurement; please see the section “Checking Accuracy Prior to Implantation” for more
information. For details on switching operational modes, please refer to the appropriate section of your surgical
manual.
Storage of Transmitters
It is crucial that transmitters be stored properly to avoid damage or unnecessary loss of battery life. These
instructions include the proper storage technique for both new and resterilized transmitters.
All transmitters should be carefully examined when they arrive at your facility. Remove the transmitters from the
shipping boxes. Save the shipping boxes and foam liners for returning used transmitters.
Inspect the transmitter package for signs of damage. Using your AM radio, confirm that the transmitter is turned off.
Although each unit is checked just before shipping, it is possible that the transmitter may have been exposed to stray
magnetic fields during shipment. This can cause the unit to be turned on unintentionally. All transmitters are sterile
upon arrival. If the package remains undamaged, this sterility is warranted according to the information on the
package label. Transmitters in the Off mode may lose up to 10% of the battery life within 12 months after the
manufacture date.
Transmitters should be stored in a cool (between 10 and 25 degrees Celsius), dry area away from exposure to static
discharge and magnetic fields. They should never be exposed to temperatures above 60 degrees Celsius, as this will
void all warranties. It is also important to store them in an area where they will not be accidentally dropped or have
items placed on top of them. Storage in a refrigerator does not provide significant benefit in terms of battery life. If
the implants are to be stored for an extended period of time, Data Sciences International (DSI) recommends periodic
checks with an AM radio to ensure the transmitters are still turned off.
Transmitters should be turned on 24 hours before use to allow the electronics to stabilize. Zero offset should be
checked on all pressure transmitters just prior to use to verify stability.
Storage of Resterilized Transmitters
DSI supports a method for on-site resterilization of transmitters. For transmitters used in short-term studies, this
allows multiple uses from a single unit before it is necessary to return it for refurbishment. Occasionally there may
be a delay between removal from the first animal and implantation in the next. Proper storage of the resterilized
transmitter is necessary to assure that the unit will function properly.
Following explantation, each transmitter should be thoroughly cleaned and resterilized according to DSI
resterilization procedure (please see the section on resterilization). Using your AM radio, each transmitter should be
Telemetry Transmitters User Manual
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checked to assure that it is properly turned off before storage. If the original transmitter package was saved, place
the transmitter into the plastic packaging. This will help to identify the transmitter and the calibration values
associated with it. There is no effective way to maintain unit sterility during storage, therefore each unit will require
sterilization again at the time of use. Sterilization prior to storage is necessary to prevent spread of bacteria during
handling.
Considerations With Pressure Transmitters
When measuring blood pressure telemetrically, it is essential to verify that the measurements are accurate, since a
small percentage of these devices exhibit long-term drift. Verification can be done in a variety of ways, including
pressure chambers, arterial cannulation, comparison to a mercury manometer, etc. Arterial cannulation is normally
used only if it is necessary to check the accuracy of the device at a time other than at implantation or explantation.
For most protocols this is not necessary. Since those devices that exhibit long-term drift while implanted almost
always drift toward lower pressure, validation of accuracy at implantation and explantation can provide a simple and
reliable method for assuring that the measurements obtained during the course of the study are accurate. The
following procedure will determine if the pressure transmitter is reading zero prior to implantation or if there is a
deviation (zero offset).
Checking Accuracy Prior to Implantation
All DSI transmitters are carefully calibrated and tested prior to being shipped. However, we strongly recommend
that all pressure devices be checked immediately prior to surgery. The following protocol will allow you to verify
that the pressure transmitter is functioning normally prior to surgical placement in an animal.
To check offset, turn the transmitter on approximately 24 hours prior to surgery. This will allow the electronics time
to stabilize. The calibration information from each transmitter should be entered into the Configuration Program of
Dataquest and each transmitter should be assigned to a receiver. It is important that the Dataquest Acquisition
Program be running and that at least one ambient pressure sample is recorded prior to checking zero offsets.
Just prior to surgery the transmitter should be placed on its assigned receiver in the sterile pack. It is very important
that the catheter tip be level with the body of the transmitter. If the catheter is above or below the level of the
transmitter body, the measured values will be affected by this "head pressure" and will not be accurate. Usually, if
the transmitter is checked while it is still in the sterile pack, the unit is held in the proper position for zero offset.
The value being measured by the transmitter can now be visualized using Waveform Trace in the Acquisition
Program. By right-clicking the mouse you can select tracking. This will bring up a dialogue box that shows x values
and y values. By moving the mouse on the waveform, you will be able to see where the offset lies. For units
manufactured within the previous three months, this value should be within 3 mmHg of zero to comply with
manufacturer specifications. Units older than three months may experience a larger offset. If desired, right clicking
the mouse and selecting Print can make a hard copy of a trace. This should be kept with study data as verification of
initial accuracy. Another accuracy verification option is to collect the pressure "waveform" or offset in the same way
you would sample from the animal, using the Save and Trace option in the Acquisition Program. This procedure
would save the pressure offset data in the same file with the animal's data, permanently associating the offset value
to the animal.
If the value of offset is outside ±3mmHg, contact your DSI Service Representative for further instructions. If your
transmitters have been on the shelf for an extended period of time and they have an unacceptable zero offset, it may
be possible to adjust calibration values to compensate for the offset. If you are routinely experiencing offsets prior
to implantation greater than ±3 mmHg, your ambient pressure monitor (APR-1) may require recalibration.
If your experimental protocol or quality standards (such as FDA GLP) require that transmitter accuracy be checked
more thoroughly, we recommend placing the transmitter in a chamber that can be pressurized using a mercury
manometer and verifying the accuracy of the device at several pressures (e.g., 0, 100, and 200 mmHg). Such a
chamber can be fabricated by your mechanical shop or purchased from DSI.
Telemetry Transmitters User Manual
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Checking Accuracy at Explantation
It is also valuable to check the zero offset of the transmitter at the end of the experiment. If the device was accurate
prior to implantation and at explantation, it is safe to assume that the measurements were also accurate in between.
To do a post implantation offset, the transmitter should be carefully removed from the animal. If it is necessary to
cut the catheter, this should only be done using a new scalpel blade at a 45° angle to the catheter. Using scissors to
cut the catheter will ruin the sensor.
Gently clean the catheter to remove any blood or tissue debris from the tip. It is essential that the temperature of the
transmitter be stable while the offset is checked. This can be done by placing it in a beaker of water at 37° Celsius
immediately upon removal from the animal. The water in the beaker should be just barely deep enough to cover the
body of the implant to avoid any affect of head pressure on the offset measurement. Alternately, the transmitter may
be left at room temperature for 1 to 2 hours, but maintaining the temperature close to 37° Celsius is preferable.
Once the temperature of the transmitter has stabilized, the unit should be placed on its receiver and the value
recorded as described above. Refer to product literature or contact DSI for drift specifications. If you are
experiencing excessive drift, please contact your DSI Service Representative for assistance.
By checking the zero offset before and after implantation, you can be confident that the data being collected are
accurate. If accuracy needs to be verified during the experiment, there are various methods for achieving this.
Contact DSI for more information on these techniques.
Regelling Pressure Transmitters
Because of the small diameter of the catheter tip, transmitters can be difficult to reuse in the event that the first
implantation is not successful. Try to insert as much of the catheter into the vessel as possible. This will allow it to
be reused by leaving the residual glue outside of the vessel with each successive use. Cleaning the tip of the catheter
and replacing lost gel can be difficult with pressure transmitters. However, the following guidelines will greatly
increase your success with this procedure.
The tip of the catheter will probably need to be re-gelled in the event that the animal dies while the transmitter is still
implanted. When the transmitter cools from body temperature to ambient temperature, the fluid in the catheter
typically recedes due to thermal expansion and blood products are drawn into catheter tip. The most important factor
in removing this material is to flush it out before it solidifies. A stream of warm saline from a syringe can be used to
gently flush debris out of the catheter tip prior to regelling.
Make sure the transmitter is turned on and you have your AM radio close by. This allows you to audibly monitor the
amount of pressure you are exerting during the procedure. Expel a small amount of gel before entering the catheter
tip to prevent introduction of air bubbles into the catheter tip. With the radio turned on to monitor applied pressure,
carefully insert the tip of the gel syringe into the lumen of the catheter tip past the foreign material. Be sure not to
insert the gel syringe tip beyond the interface of the distal gel plug and the catheter fluid. This interface is sometimes
difficult to see, but the gel plug never extends beyond 1.5 mm from the distal tip of the catheter.
With the gel syringe in place, firmly apply pressure to the plunger of the syringe, which will back-fill the catheter tip
and slowly force the foreign material out the distal tip. Don't rush this procedure; it is a slow process due to the
viscosity of the gel and the small ID of the syringe needle.
In the event that you are unable to remove all foreign material from the catheter tip using the above method, there is
a more risky maneuver. If performed incorrectly, excessive pressure can be applied to the pressure sensor and
destroy the transmitter! Do not attempt this procedure without monitoring applied pressure with an AM
radio!
As a last resort, you can gently squeeze the catheter tip with clean, gloved, fingers to expel contaminants from the
distal end. Start by grasping the stem material at the proximal aspect of the thin walled section. Pressure can then be
progressively applied in a proximal to distal direction. This motion will expel tip contents without applying
excessive pressure to the transmitter. The pitch emitted by the transmitter will change is you squeeze the catheter; if
the pitch changes rapidly, relax your grip on the catheter and proceed more slowly. The expelled material can be
wiped away with wet gauze. Before releasing the pressure, apply a drop of gel to the distal tip and allow the gel to
Telemetry Transmitters User Manual
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be drawn into the catheter tip as you slowly release the pressure. Gently clean the tip and the transmitter is ready for
reuse.
The gel is sterile, but the syringe tip may become contaminated after use. The gel syringe may be reused by
expelling a small amount of gel, then disinfecting the tip.
Precautions Against Blown Sensors
The pressure sensors in DSI blood pressure implants are extremely sensitive; and can be easily damaged. Therefore,
it is necessary to use proper care when handling the transmitters. The following are preventative measures to
observe when handling blood pressure transmitters.
Handle the device with care and make sure not to drop it.
Do not produce any situations where more than 20 lbs per square inch of gauge pressure (approx. 1000 mmHg) are
applied to the sensor.
Take care to grasp the catheter with a proper tool so that the lumen of the catheter does not collapse. DSI
recommends the use of vessel cannulation forceps.
If it is necessary to cut the catheter, do not use a pair of scissors. Catheters should always be cut with a new scalpel
blade at a 45° angle at no less than 3cm from the body of the transmitter. DSI recommends removing the entire
implant and catheter assembly intact whenever possible to avoid damage to the sensor.
Make sure to notice where you are gripping the protective tip cover of the catheter. If the protective cover is gripped
too close to the catheter, it could collapse the lumen of the catheter. This causes a sharp increase in pressure.
Snapping the protective tip cover off can cause a sharp change in pressure as well.
Be sure to monitor the amount of pressure being applied with an AM radio while regelling the implant. For further
instructions on regelling, see the “Regelling Pressure Transmitters” section of this Guide or contact DSI Technical
Services.
When shipping the transmitters for refurbishment, make sure to properly package the implant to reduce the chance
of damage during shipping. DSI recommends using the original shipping container to return the transmitters.
Replacement of a blown pressure sensor may require a fee in addition to the standard implant refurbishment charge.
Telemetry Transmitters User Manual
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On-Site Resterilization of Transmitters
This procedure will increase the number of times an investigator can use each transmitter before returning it to DSI
for refurbishment.
Supplies Needed:
1. Bio- or enzymatic detergent
These are available from most hospital supply companies. They are generally labeled for use on fabrics or surgical
equipment/instruments; check to be sure they are considered safe for these applications. The purpose of the
detergent is to remove blood, serum proteins, and tissue debris from the surface of the transmitter. Some brand
names that have been used successfully are: Kleer-o® (Ulmer Pharmaceuticals), Haemo-sol® (Curtin Matheson),
Medizyme® (Whitley Chemical), and Terg-A-Zyme® (Alconox, Inc.). If you are unsure that your current enzymatic
detergent is safe for use on your transmitters, please contact Data Sciences’ Technical Support for assistance.
2. 2% Activated Glutaraldehyde
This is also available from most hospital supply companies. It is considered a chemical disinfectant and is effective
against most agents commonly encountered in a research environment. One commonly found brand is Cidex
(Surgikos). Follow the manufacturer’s instructions for use. Gluteraldehyde is also available in concentrate that can
be diluted to 2%. It is important to note that 2% glutaraldehyde is an unstable solution with a shelf life of 14 days.
3. Sterile Saline
Provides a rinse for the sterilized transmitter to remove all traces of the glutaraldehyde prior to implantation. Also
can be used to temporarily store (< 4 hours) the transmitter aseptically until surgical implantation. See section on
transmitter storage if you need to store the transmitters for longer than a few hours.
Temperature Transmitters
Following removal from the animal, the transmitter should be rinsed to remove gross contamination from blood and
tissue. The transmitter can then be placed into the enzymatic detergent and allowed to soak in the detergent for at
least 30 minutes to allow breakdown of the surface contaminants. The transmitter should then be removed and
examined. If traces of blood or tissue remain, use gauze to wipe the surface until it is clean. Transmitters with the
thermistor probe option may require gentle manual abrasion to remove tissue. Rinse the transmitter in tap water
thoroughly.
Place the transmitter into fresh 2% activated glutaraldehyde (shelf life of 14 days). The transmitter should be left in
the glutaraldehyde for at least 4 hours. For the best results, we recommend overnight (12 hours).
Place the transmitter into sterile saline for 15-30 minutes to rinse away the glutaraldehyde. We recommend at least
two separate rinses. Following the final rinse, the transmitter can be left in the saline until ready for implantation.
Biopotential Transmitters
Following removal from the animal, the transmitter should be rinsed to remove gross contamination from blood and
tissue. Care should be taken to clean the suture ribs and remove any suture material that may be present. The
transmitter can then be placed into the enzymatic detergent and allowed to soak in the detergent for at least 30
minutes to allow breakdown of the surface contaminants. The transmitter should then be removed and examined. If
traces of blood or tissue remain, use gauze to wipe the surface until it is clean. Rinse the transmitter in tap water
thoroughly. Prior to cold sterilization, use a piece of suture to tie off the ends of the biopotential leads. This will
prevent any leakage of the gluteraldehyde into the lead, where it could cause tissue damage in the next implanted
animal.
Place the transmitter into fresh 2% activated glutaraldehyde (shelf life 14 days). The transmitter should be left in the
glutaraldehyde for at least 4 hours. For the best results, we recommend overnight (12 hours).
Place the transmitter into sterile saline for 30-60 minutes to rinse away the glutaraldehyde. We recommend at least
two separate rinses. Following the final rinse, the transmitter can be left in the saline until ready for implantation.
Prior to implantation the suture sealing the lead material should be cut off.
Telemetry Transmitters User Manual
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Pressure Transmitters
Following removal from the animal, the transmitter should be rinsed to remove gross contamination from blood and
tissue. Carefully remove any residual tissue adhesive from the surface of the catheter. Remove any suture material
present. If there is blood in the tip of the catheter, remove as much as possible by directing a stream of saline at the
tip to flush it out. The transmitter can then be placed into the enzymatic detergent and allowed to soak in the
detergent for at least 30 minutes to allow breakdown of the surface contaminants. The transmitter should be
removed and examined. If traces of blood or tissue remain, use gauze to wipe the surface until it is clean. The
catheter should be wiped very carefully using wet gauze. Do not try to wipe the thin-walled section. Rinse the
transmitter in tap water thoroughly.
Place the transmitter into fresh 2% activated glutaraldehyde (shelf life of 14 days). The transmitter should be left in
the glutaraldehyde for at least 4 hours. For the best results, we recommend overnight (12 hours). Place the
transmitter into sterile saline for 15-30 minutes to rinse away the glutaraldehyde. We recommend at least two
separate rinses. Following the final rinse, the transmitter can be left in the saline until ready for implantation. The tip
of the catheter should be filled with replacement gel at the time of surgery. This should be done aseptically to
prevent contamination
Multiplus Transmitters
For transmitters with multiple sensors, follow the instructions for the most delicate sensor on the transmitter
(typically pressure).
Refurbishment of Transmitters
The following instructions are provided to answer any questions you have about returning any items to DSI. If you
follow these procedures, we will know the exact reason the products are being returned as soon as they arrive and
can begin processing them immediately. Please contact your DSI representative if you have any additional
questions.
1)
Explanted transmitters may constitute a biohazard! To prevent delays, follow cleaning & disinfection
instructions carefully.
a.
Clean explanted transmitter using an enzymatic detergent to remove ALL blood, tissue debris, suture
material, etc.
b. Soak clean transmitters in a 2% solution of hospital disinfectant such as glutaraldehyde for at least 20
minutes. Rinse and allow to air dry.
c.
Place disinfected transmitters into the zip-lock bag provided by DSI before shipping as indicated in
number five (5) below.
d. Shipments that have obviously not been cleaned and disinfected will be rejected and sent back to the user
at their expense plus a $25 handling fee.
2)
Obtain a purchase order prior to returning the goods. Many companies and institutions will issue blanket
purchase orders that will cover several shipments. One of the most common reasons for delays in returning
devices is the lack of a purchase order. Having a blanket purchase order will save you time and the difficulty
of having to obtain a new purchase order each time you return implants for refurbishment and allow us to serve
you better.
3)
Fill in the Returned Materials Form you received with your implants and fax the form to DSI at
(1-651) 481-7404 prior to returning any products to us for refurbishment, repair, or return of items on loan. A
copy of the RMA form MUST accompany your shipment.
4)
Please indicate on the RMA form the serial number of any device that exhibited performance problems and
the type of problems you noticed. Please also identify any products that had been loaned to you.
Telemetry Transmitters User Manual
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5)
Pack the products carefully for return shipment in the foam-lined box you received with your implants.
Place implants in the original package or in the zip-lock bags provided in the RMA kit you received with your
implants. Please do not place implants alone in a box full of packing material since small implants can easily
be lost. Place the zip-lock bags or packaged implants in a box with adequate packing material to prevent
damage during shipment. Return your products to the USA shipping address listed on the RMA form.
Include your name, Customer Service Number and telephone number on the RMA form. Check the
contents of the box to assure that it matches the information you provided on the RMA form.
6)
Make a copy of the RMA form for your own records, and put the original in the pouch on the zip-lock bag
with the goods being returned.
Benefits of Refurbishment During Warranty Period
When an implant is refurbished, the warranty period for that implant is automatically renewed. This renewal
warrants all transmitters for an additional 24 months from the time of refurbishment. Transmitter circuitry is
typically not repairable. If a transmitter is returned for refurbishment within the warranty period and fails to
perform within specification, it is replaced with a new unit. If a transmitter is returned outside of the warranty
period and does not pass our quality assurance tests the transmitter cannot be refurbished. The transmitter can,
however, be replaced by purchasing a new unit. Replacement of damaged sensors incurs a charge that is in addition
to normal refurbishment charges.
Telemetry Transmitters User Manual
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