Data Sciences HD18 Small Animal Implant Transmitter User Manual Getting Started Guide

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Data Sciences International
Getting Started Guide
PhysioTel Hybrid Digital Platform
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Acknowledgments
Dataquest , Ponemah™, the DSI Logo, and PhysioTel are registered trademarks of Data Sciences
International in the United States and certain other foreign countries.
A.R.T.
is a trademark of Data Sciences International.
PhysioTel Hybrid Digital (HD) Platform Getting Started Guide
Copyright
2015 Data Sciences International
All Rights Reserved
Printed in U.S.A.
Part Number 391-0303-001
Rev. 02
Data Sciences International (DSI)
119 14th Street NW • Suite 100 • St. Paul, MN 55112
Telephone: (1-651) 481-7400 • 1-800 262-9687
Fax: (1-651) 481-7417
Website: www.datasci.com
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CONTENTS
Welcome ................................................................................................................................................................................ 5
Telemetry System Overview .................................................................................................................................................. 6
Quick Setup Instructions ........................................................................................................................................................ 7
About the Implant ................................................................................................................................................................ 10
Implant Components............................................................................................................................................................ 12
Understanding Specifications ............................................................................................................................................... 14
Detailed Instructions For Implant Operation ....................................................................................................................... 16
Operational Modes ...................................................................................................................................................... 16
Entering A Pressure Offset .......................................................................................................................................... 16
DSI System Setup.................................................................................................................................................................. 18
Software Compatibility with HD Devices ............................................................................................................................. 28
Appendix A: Care After First Implantation ........................................................................................................................... 29
Appendix B: Quick Reference Specifications ........................................................................................................................ 31
Appendix C: Catheter & Lead Configuration Options........................................................................................................... 36
HD-S10 ............................................................................................................................................................................. 36
HD-S11-F0/HD-S11-F2...................................................................................................................................................... 37
HD-S21 ............................................................................................................................................................................. 38
HD-X10 ............................................................................................................................................................................. 39
HD-X11 ............................................................................................................................................................................. 39
Appendix D: Recommended Supplementary Products And System Components............................................................... 40
Appendix E: Exchange Program ........................................................................................................................................... 43
Appendix F: Returning Product to DSI .................................................................................................................................. 44
Appendix G: Device Warranty .............................................................................................................................................. 45
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WELCOME
DSI recognizes that every lab environment is different. Please contact Technical Support (Support@datasci.com) after
reading this manual with any comments or concerns. DSI partners with our customers to ensure proper validation of a
special product use case. DSI offers many additional tools that can be ordered to complete the solution depending on
the facility needs (see Appendix D).
DSI has also added these Scientific Service offerings:
Surgical Services
o On-site surgical training
o On-site pre-implanted animals
o Surgical videos and manuals
o Surgical training at DSI headquarters
o Rodent pre-implanted animals at DSI headquarters
GLP and Validation Services
o On-site assistance and system setup
o Organization of lab resources
o GLP documentation
Data Analysis Services
o Detection of hemodynamic changes
o ECG evaluation
 Arrhythmia detection
 Interval quantification
o Heart rate variability (HRV)
o EEG analysis
 Sleep scoring
 Seizure detection
o Respiration analysis
This user manual will give basic instructions that are required to be successful with the use of this DSI product. The
manual is written so that users who know very little about telemetry and users who have extensive experience have
a ess to D“I’s e o
e ded telemetry system setup.
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TELEMETRY SYSTEM OVERVIEW
I pla ta le tele et s ste s ha e ee i use si e the
’s. The e a le esea hers to obtain physiological data
directly at the source without restraining the animal physically or chemically. The implant (also called a device,
telemeter or transmitter by different researchers) senses the physiologic data through its internal sensors , transmits the
physiologic signal to the receiver which is pictured under the cages. The receiver acts as an antenna and brings the
wireless signal to the Data Exchange Matrix which filters and assimilates the data before storing it on the computer.
DSI’s soft a e p og a the displa s the a o al ulated ph siologi alues i eal ti e o the o ito a d sa es the
data for viewing and filtering after acquisition. A system diagram is shown below to help illustrate this.
This is a representation of the HD small animal platform used with rats. See the Cagi g a d “hieldi g Re ui e e ts
section or contact Technical Support for more system setup options. The small animal products can also be used with
guinea pigs, rabbits, hamsters and other rodents. The extra small or mini products are mouse sized and are also
available with these platform features. These are smaller and therefore can be used in neonatal rodents >19 grams.
The HD platform mouse sized implants have the same digital features, but may offer less battery life than the small
animal models.
Specialized surgical expertise is required as these devices are implanted much like a pacemaker is for clinical
applications. The implant body is placed subcutaneously or intra-peritoneal (IP) and the biopotential leads and
catheters are then routed to the source of the physiologic signal. Although surgery, once mastered, can be simple and
quick, many surgeons have found that survival surgery requires strict attention to detail as infection or animal
discomfort can impact study results. DSI provides a surgical manual also included on this CD with D“I’s e o
e ded
methods (proven over 30+ years of experience) on how to implant the device depending on the physiologic parameters
of interest. Further hands-o t ai i g D“I’s t ai ed su gi al staff is e o
e ded and has been found to be the most
helpful for DSI customers.
D“I’s e pe ie ed su gi al se i es tea is a aila le to a s e a
uestio s pho e o e ail. In person, hands-on
surgical training is available onsite or at DSI headquarters. Training at headquarters often includes a tour of
a ufa tu i g, as ell as so e ti e ith D“I’s te h i al suppo t fo spe ialized ha ds o soft a e t ai i g and the
opportunity to meet with other DSI employees. DSI also offers high quality pre-implanted animals for any surgical
technique we recommend.
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QUICK SETUP INSTRUCTIONS
In order to ensure success the first time, DSI recommends checking that the system is functioning correctly before
implanting any animals. After the system is set up appropriately, be sure to follow these instructions to prevent
erroneous data. These steps should be treated as a cheat sheet on how to setup the system quickly and can be
printed off as a standard protocol for use in the research lab.
Before Beginning
It is important the device remains in the sterile package or it will need to be re-sterilized before implantation.
For detailed sterilization instructions see Appendix A.
Always check the battery life when the device arrives and pressure offset before surgery to be sure there
has ’t ee a da age i shippi g or long term storage (see step 6 & 7).
If the device has been used already, inspect the device for defects. Make sure it has been properly sterilized
and the explant procedure did not harm the catheter or cut the leads too short.
There are several hardware products that are required to be able to monitor from the new implant. There are four main
components of the acquisition system; the data acquisition computer, the ambient pressure reference (APR), the Data
Exchange Matrix (DEM) and the receivers.
Hardware Setup
1.
Start by connecting the separate pieces as shown in the diagram below:
2.
After connecting the hardware, make sure the receivers have adequate spacing in between them (see
“hielding Recommendations section for more detail).
Configuring the Device
3.
4.
Using the data acquisition software DataquestART or Ponemah (with OpenART) go to Hardware Configuration
and verify the hardware is connected correctl
li ki g Ve if u de Hardware or pressing Ctrl+Y.
When configuring the HD implant the software will include a wizard to assist with device configuration.
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a.
b.
c.
d.
Right click on the receiver to connect the device to this specific receiver
Cli k o Ne T a s itte
When the wizard launches, select the appropriate HD implant model
Follow the outlined steps in the wizard that instruct when to turn the device ON in order to allow for
transmission of the serial number and calibrations. “ee the HD Platfo Featu es se tio to lea
more about the platform’s digital features.
To turn the device on:
i.
ii.
iii.
iv.
e.
Take the implant and place it on top of the receiver (at least within a few inches).
Power on a Short wave radio and tune it to 18MHz
Bring the radio close to the packaged device.
Bring a strong magnet i luded i D“I’s HD “ta te Kit in close proximity to the implant in the
package.
v. A tone should be heard on the radio within two to five seconds of the magnet swipe
indicating that the device has been turned on.
In the final step assign a unique animal ID (alpha or numeric) per local lab requirements and select a
species.
Check Device Functionality: Important!
5.
6.
Check the battery life on-time to be sure the implant did ’t accide tall tur o i shippi g. Refer to the
Batte Life, O Ti e a d Voltage ith Ph sioTel HD T a s itte s to lea ho to he k this alue i
Dataquest ART. In Ponemah the device on time and battery voltage will automatically displa i the “ou e
“tatus pop-up when acquisition is started.
a. D“I’s shippi g p o edu es atte pt to p ote t the de i es but stray magnetic fields exist outside of
D“I’s o t ol so there is always the possibility that the device could potentially turn on in shipping
before it gets to the lab space.
b. Less than 3 days of device on time should not impact the study, however if concerns arise please notify
DSI technical support and if necessary we will advise on how to return the product and receive a new
one. Standard lead times may apply. We will also track this occurrence and use this information to
improve our shipping processes in the future.
Check the pressure offset at ambient pressure and temperature. Always check the pressure offset of an
i pla t upo e eipt a d/o efo e i pla tatio i to a a i al. D“I’s highl sophisti ated test ali atio
equipment ensures that the product will be within specification upon receipt unless the product has somehow
been damaged in shipping. Follow these instructions to learn how to estimate gross pressure offset inside
sterile packaging, in air and at ambient temperature, after initial receipt:
a. Turn on the implant for a minimum of 1-4 hours to let the electrical components stabilize. If this
stabilization exceeds 4 hours contact technical support.
b. Ensure that the APR-1 is connected to the system and has been calibrated within the last 2 years.
c. Start Acquisition of the pressure signal. This assumes the device and study has already been set-up
properly.
d. Check the baseline pressure reading at room temperature (~23C) from the device and compare it to
the APR-1 recording. This is the pressure offset for the implant.
e. Record this value for tracking purposes.
f. If the pressure offset is less than the specified drift at room temperature then the device is safe to
implant.
Deleted: an AM
Deleted: 550 k
Deleted: (the lowest end of the AM
band).
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g.
h.
However, if the offset is greater than the specified drift and is still within the sterile packaging contact
DSI’s te h i al suppo t as the ill help ou dete i e ho to p o eed ith the use of this p essu e
implant.
If the product has been sitting on the shelf for a few months or if it this is a used implant technical
support may recommend entering a pressure offset into the software to account for pressure drift
over time at body temperature. Never enter a pressure offset into the software without checking
the device at the appropriate temperatures. Follo the i st u tio s i the I st u tio s fo I pla t
Use se tio fo the ost a u ate ethod to dete i e the a tual p essu e offset at od
temperature and to learn how to enter the pressure offset into the software platform.
Begin Surgery
7.
8.
Once the device is configured and properly checked for functionality surgery can start.
Remember, for pressure products it is important to hydrate the catheter for a minimum of 15-30 minutes in
sterile saline. Remove the protective tip cover on the catheter before implantation under sterile conditions. If
needed, re-gel the catheter using a re-gel syringe right before surgery. For explicit instructions on how to re-gel
go to D“I’s e site fo a tech note and video or read the surgical manual.
9. Always keep the DSI provided surgical manual nearby to ensure the surgery is being performed correctly as this
is a critical step to the success of the study and to maintain the best care for the animal. Personal on-site
training or surgical courses at DSI are available if a hands-on experience is desired.
10. When the catheters and leads are surgically placed, the physiological signals from the implanted device can be
viewed in the software immediately during acquisition.
11. Give the animal at least 10-14 days to recover from surgery before collecting baseline data. This has been
verified and proof sources are available. Information can be found by searching in the Bibliography section on
our website. Please note DSI expects:
a. Local inflammation, as expected from any surgery, will heal over time.
b. Mean pressure will stabilize over time (approximately 4 hours) as the catheter and implant body
acclimates to the in vivo hydrated and thermal environment. This timing may vary depending on if
heating and hydrating of the catheter was performed before surgery and for how long.
c. If conducting a pair house study, keep the animals apart for at least 10-14 days prior to placing them in
the same cage.
Formatted: Indent: Left: 0.75", No bullets or
numbering
Comment [K1]: Waiting to hear from Heather
regarding this to verify the amount of time is
correct.
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ABOUT THE IMPLANT
Nomenclature
HD sta ds fo H id Digital a d is used to disti guish the platfo f o othe D“I p odu ts. “ee the diag a
for instructions on how to de-code a model name for this platform of devices.
# of Pressure Signals
# of Biopotential Signals Signals
HD – S 1 1 – F 0
Product
Platform
elo
Frequency
F0 = 455kHz
F2 = 18MHz
Animal Size
S= Small
X= Extra Small
Model
Animal Model
Pressure Signals
Biopotential Signals
HD-S21
Rat or similar
HD-S11-F0*
Rat or similar
HD-S11-F2*
Rat or similar
HD-S10
Rat or similar
HD-X11
Mouse or similar
HD-X10
Mouse or similar
*Note that the –F0 represents a 455kHz frequency for the device. The –F2 represents an 18MHz frequency (used for
pair housing studies). The frequencies are the only difference between the HD-S11-F0 and the HD-S11-F2; therefore an
additional naming system was added to distinguish between the two HD-S11 devices.
HD PLATFORM FEATURES
The HD platform digitally transmits the Animal ID, implant ON time and battery voltage with the physiologic signals.
During system setup the HD implant will also transmit the stored factory calibration data to remove human error from
manual entry of these values.
Animal ID
The Animal ID (or serial number) digital feature enables an implant to be specifically linked to the receiver when it is
configured in the software. Ambient electromagnetic noise generated by large power sources and other equipment
(even other telemetry equipment) can impact signal quality. With this device the impact is minimized because the
hardware is intelligent enough to know where the implant signal is coming from. If noise is detected, the signal will
disappear, the theory being researchers would rather have clean data or nothing at all. Shielding from potential noise
sources is important to understand for telemetry studies. See the “hielding Recommendations section to learn more.
Factory Calibrations
Deleted: Pressure
Formatted: Underline
Formatted: Left
Formatted: Font: 12 pt
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When setting up the software the factory calibrations will be auto populated when the device is turned on (see the
Quick Setup I st u tio s section to learn more). The implant sends out these calibration values every time it is turned
on. This may mean there is a slight delay in obtaining physiologic data when the device is in itially turned on as the
s ste is e if i g the de i e’s ide tit . This feature removes human error of placing the wrong animal in the wrong
cage after dosing or behavioral testing, and it means that the calibration values on the label do not need to be tracked
as closely as they are stored digitally in the device itself. However, researchers should still keep the sterile tray the
device comes in if they wish to participate in the DSI Exchange Program as it is used to return product back to DSI. See
Appendix E and www.datasci.com to learn about the DSI Exchange Program and its subsidiary programs which help keep
cost down and drive efficiency for other DSI customers.
Battery Voltage
An alarm in the software will go off when the implant gets close to the end of its life because of the battery voltage
feature. This is important because the measured physiologic parameters may become inaccurate when implants are
used past their warranted battery life e e though the de i e a still ope ate . Implants are calibrated at a certain
battery voltage and as the battery loses life the voltage becomes unstable and this may impact the physiologic signal.
D“I’s a ufa tu i g ali ation systems are state of the art and engineers design with this in mind. However customers
should check calibration values before device implantation to ensure that the product is still accurate especially if
explanted and re-used from study to study. The battery voltage feature gives researchers even more insight into the
calibration accuracy of the device and can be used as a supplement to this information.
Battery on Time
At any point in time, because of the implant ON time feature, researchers can now see how much battery life has been
used. On time is separate from the battery voltage as the on-time is a digital feature calculated off of an internal clock
which is temperature dependent and only records on time correctly at body temperature. The on-time usage is updated
every 16 hours of continuous use. Battery life specifications are stated as warrantied battery life which means duration
of continuous on-time. When the implant is turned off, it is not using battery life and so the implant on time will not be
tracking battery life either.
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IMPLANT COMPONENTS
Drawing of HD small animal implant
IMPLANT BODY
The biocompatible housing that contains:
Pressure sensor: receives pressure fluctuations from the fluid-filled catheter and sends the signals to the
electronics module.
Reusable electronics module: translates the pressure fluctuations and biopotential signal into digitized signals
and transmits them to a receiver. Temperature data is sent digitally. The reusable electronics module also
contains a magnetically activated switch that allows the device to be switched on or off.
Battery: provides the power supply for the electronics module. Battery ON time and voltage parameters are
sent digitally during sampling.
Suture rib: allows the surgeon to suture the device securely in place at the implant site.
SUTURE RIB
On most implants the suture rib is optional and therefore it is important to understand when it is necessary. The suture
rib is recommended for IP placement of the device and should be secured to the abdominal wall to restrict movement.
Subcutaneous placement of the device does not require a suture rib as the connective tissue will hold the implant in
position.
PRESSURE CATHETER
The pressure catheter is made of high performance polyurethane tubing that extends out of the device body and
contains:
Non-compressible fluid: relays pressure fluctuations to the sensor in the device body.
Thin-walled section: tip of the catheter farthest from the device body that senses the dynamic portion of the
pressure wave. It is designed to be completely inserted into the vessel or space where the desired pressure can
be sensed. It contains biocompatible gel at the very tip, which prevents the non-compressible fluid from
leaving the catheter and blood from clotting in the catheter tip.
Tip cover: removable section of silicone tubing that protects the catheter tip until it is actually inserted into the
desired vessel.
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Detailed diagram of catheter components with the tip cover removed
Some catheter components are optional. For example, the ligation aid is offered for catheter placement in the left
ventricle, right ventricle, or bladder. It is a groove between the end of the thin-walled section and the additional thin
band of tubing. This feature can be best described with the image below. It is intended to provide a secure location to
suture which aides in the anchoring of the catheter to the surrounding tissue. This particular feature is only available on
the HD and PhysioTel Digital platforms.
Diagram highlighting the ligation aid option
Many catheter lengths are also available. See the configuration options in Appendix C to learn more about what
features are available and their common surgical placement. “ee the U de sta di g “pe ifi atio s se tio elo to
learn more about the importance of catheter specifications.
BIOPOTENTIAL LEADS
Two leads (clear and pink) extend out of the device body and are made of:
Silicone tubing which provides insulation from external electrical activity
Helix of medical grade stainless steel wire which senses the desired biopotential voltage changes
The leads are designed to be cut to a length suitable for the biopotential signal to be monitored. The clear lead is used
to collect the negative signal of the biopotential and the red lead is used to collect the positive signal. The biopotential
signal monitored could be an ECG, EEG, EOG, EMG, etc. Examine the biopotential specifications listed in Appendix B to
learn more about the product specifications including measurement sensitivity and range. This is especially important
for special applications.
The small animal sized implants come with tip covers (as shown below) to prevent the end of the steel helix from
irritating the surrounding tissue. Mouse sized implants do not come with these as the leads are too small. See the
surgical guide to learn more about how to make tip covers from the existing lead material and for placement of the
leads.
Photo of leads with tip covers placed appropriately
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UNDERSTANDING SPECIFICATIONS
See the quick specification reference in Appendix B for specific specification values for the particular HD implant of
interest. Listed below is more information about certain implant specifications that DSI sees as being the most valuable
for customers to understand. Please contact Technical Support (Support@datasci.com) with any additional questions.
ANIMAL IMPLANTATION RECOMMENDATIONS
The minimum animal size is listed e ause that is the s allest a i al D“I’s su gi al tea feels that this p odu t a e
implanted in without complications. Smaller animals can be used, but concerns about growth of the anim al and surgical
o pli atio s i ease as s alle a i als a e used. Please o ta t D“I’s su gi al se i e tea if the study requires
implantation in smaller animals than DSI recommends as there may be some things we can suggest to ensure success.
The maximum cage size is listed due to the standard recommended DSI configuration setup for the intended animal
model. If a different animal model and/or caging configuration is required, DSI offers some additional hardware options
to make the system more flexible. View the receiver portion of this user manual and the shielding requirements section
to better understand caging restrictions before contacting Technical Support.
DEVICE WARRANTY
D“I’s goal is to a hie e high sta da ds of p odu t elia ilit a d pe fo a e a d ou Li ited Wa a t Poli is
unparalleled in the wireless monitoring industry – this efle ts D“I’s o fide e a d o e
ea s of e pe ie e as ell
as our increasing investments in product design and testing.
The in vivo environment presents significant product reliability challenges, especially for electronic devices used for
chronic applications. Included in our warranty policy is a three-part program covering our implanted devices with
separate warranty durations for (i) battery life, (ii) implant life, and (iii) maximum warranty period. For complete details
on device warranty information and description see Appendix B and Appendix G.
PRESSURE SPECIFICATIONS
Understanding the pressure specifications is key to understanding the accuracy of the data over a long period of
implantation (>1 month).
D“I’s athete s a e filled ith a pate ted o -compressible fluid which is biocompatible and designed for long term
chronic use. Any catheter will have issues with patency over time, but some handle it better than others. Because of
the material selected and after many years of experience, DSI has perfected the technology that ensures the catheter
will stay patent over the warranted implantation duration and over the calibrated temperature range.
As a rule of thumb: the shorter the DSI catheter the better the frequency response. The required frequency response of
the pressure signal depends on the physiologic signal of interest. For most applications, DSI catheters have more than
enough frequency response for the basic physiologic signals being measured in the most common animal models. In
the catheter configuration guide in Appendix C, surgical placement and recommended length for a particular parameter
is identified.
If more information is required or questions arise about this parameter in particular, please contact technical support
for assistance. Please be equipped with what physiologic signal is being monitored, what analysis is required and if
possible the highest frequency component of the signal that is used in this analysis. This only applies if a signal is being
analyzed in a new way or if the device is being used in an untested animal model. Again for basic pressure
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measurements such as heart rate, blood pressure, and pulse pressure the frequency response will be adequate for the
recommended animal models.
The sensor used in this device is a solid state sensor which is protected within the device housing. This sensor has been
characterized for long term use and its pressure drift over time is very low. As with any sensor, the calibration can vary
depending on temperature, humidity, and voltage and may not be consistent over time.
Sensors drift over time due to a variety of fa to s. D“I’s se so s a e solid-state and are protected within the device
body. Because of this, the HD platform has proven to have the lowest pressure drift specifications of all DSI small animal
telemetry devices. This ensures the calibration accuracy of the device is consistent over time and little to no adjustment
needs to be made to the data over the duration of implantation.
BATTERY LIFE
DSI is known for its technical ability to optimize battery life with the smallest devices on the market today. DSI devices
have guaranteed battery life specifications which means that if the product fails prematurely DSI will replace the device
under full warranty. Because of this, customers can have confidence that DSI treats the listed warranted battery life as
the absolute minimum requirement. No maximum battery life is listed so the added battery voltage feature and On
Time counter are much more useful for researchers to use to better plan the study protocols.
Calibrations are dependent on battery voltage and therefore the calibration data ma y be compromised if used past the
warranted battery life. Each battery is different which is why the minimum life is all that is specified. Use past
warranted life is at the discretion of the researcher as eventually the battery will degrade and the impact to the study
calibrations or actual end of life may vary. When considering device re-use, see Appendix A.
The HD implants have an On Time Counter hi h ea s the i pla t is t a ki g ho
u h ti e it’s spe t o . O ti e
increments in 16-20 hour periods (depending on temperature) and so it is accurate to about 24 hours. The software will
also notify the researcher if battery life goes below the recommended battery voltage. Consult the software help menu
or contact technical support if battery voltage as an output is of interest for monitoring end of life manually.
Batte ’s atu all deg ade o e ti e, ega dless of if the a e standard o rechargeable. The batteries in this product
will not last forever. Leaving them unused on a shelf is considered in the shelf life specification. It is not recommended
to use old implants as batteries discharge over time whether they are used or not. The battery life specification will then
be invalid. It would be prudent to send them back to DSI if they have gone past the shelf-life as the battery life and
product calibrations will be compromised. Be ause D“I’s de i es a e ag eti all a ti ated, e su e to o side keepi g
the battery far away from any strong magnetic fields during storage. See Appendix A for more storage tips.
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DETAILED INSTRUCTIONS FOR IMPLANT OPERATION
OPERATIONAL MODES
The HD implants are activated with a magnet, similar to other DSI products. In order to properly activate the implant,
turn on a radio and tune it to the low end of the AM band. Next take a magnet and hold it near the implant for two
seconds before pulling it away. The device is ON when distinct tone is heard from the radio (as opposed to static
noise).
HD implants are equipped with two operational modes: ON and OFF. Implants are shipped in the OFF mode. The
battery in the implant is not activated. When switched to ON, the implants begin to sense and transmit data. The
switch to change between these two modes is in the interior of each device and is therefore not visible. The switch is
magnetically activated and will switch between modes when exposed to a strong magnetic field.
To switch operational modes:
Power on a short wave radio and tune it to 18 MHzi.
Bring the radio close to the device.
Momentarily bring a strong magnet within approximately one inch of the device for two to five seconds.
The order of modes is:
Off (No tone on the radio)
On (Tone on the radio)
ENTERING A PRESSURE OFFSET
Entering an offset in the software will automatically adjust for the initial pressure drift (see specifications for maximum
expected pressure drift). However, entering in an offset is optional and only applies to the studies where absolute
pressures are being compared. Only enter an offset in the software when all of these criteria are met:
The device was used once in an animal and is being re-used or the product has been unused for more than a
month.
The ambient pressure reference has been calibrated within the last 2 years
The pressure offset was taken at over the calibrated range (body temperature)
The pressure offset is within specification (initial pressure offset + monthly pressure drift) at body temperature.
See the warranted product specifications for these precise values.
Entering in an offset value taken at room temperature will compromise the integrity of the calibrations from DSI. If
technical support has recommended it, or if the above criteria are met, use the method below to get the most accurate
pressure offset:
Determining actual pressure offset when hydrated at body temperature before implantation:
1. Ensure the lab has a calibration schedule to ensure all measurement equipment is up to date on its maintenance.
For example, temperature probes may require calibration every year.
2. Ensure that the APR-1 is connected to the system and has been calibrated within the last 2 years.
3. Create a rudimentary water bath:
a. Heat sterile saline (or distilled water if saline is unavailable) in a beaker on a hot plate. Stir the li quid to
create a homogeneous medium.
Deleted: an AM
Deleted: 550 k
Deleted: (the low end of the AM band)
17 | P a g e
b.
4.
5.
6.
7.
8.
9.
Bring the liquid temperature to the calibrated temperature range of the device (see specifications in
Appendix C) to simulate animal body temperature for the most accurate offset reading.
c. Place a calibrated temperature probe or thermometer in the liquid with the device.
d. Hydrate the entire implant, including the catheter, to properly acclimate the device to the simulated in vivo
environment. NOTE: DSI always recommends that the catheter be hydrated in heated sterile saline for at
least 15-30 minutes before every implantation for optimum patency and for signal accuracy.
Turn on the implant.
Start Acquisition of the pressure signal. This assumes the device and study has already been set -up properly.
Watch the pressure and temperature parameters and wait for stabilization. This may take a minimum of 1 hour to
let the electrical components stabilize and acclimate to temperature. If the device has been sitting on a shelf for a
long period of time, it may take up to 4 hours to stabilize (as in the above procedure).
Compare the calibrated APR- e o di g to the i pla t’s p essu e eadi g at od te pe atu e. This is the
pressure offset for the implant.
Record this value for tracking purposes.
Enter the pressure offset in the software only if it has been verified at temperature and after closely examining
the warranted DSI specifications, otherwise the adjustment may actually cause the offset error to be greater once
it is implanted. If there is any doubt about the accuracy of the system, note the offset and account for it outside of
the software in a lab notebook. To enter it in the software follow the steps below:
a. Go to the Ha d a e Co figu atio
i do .
b. Expand the matrix, receiver and implant of interest to see the associated physiologic channels.
c. Right li k o the p essu e ha el of i te est a d go to P ope ties .
d. Go to the Ad a ed ta a d e te i the u e i al offset i the offset field at the otto of the
calibration table.
18 | P a g e
DSI SYSTEM SETUP
There are several components needed to monitor from the new DSI system. There are four main components of the
PhysioTel Hybrid Digital (HD) telemetry system; the data acquisition computer, the Data Exchange Matrix (DEM), the
receivers, and the HD implants. The DEM receives information from the implants through the receiver. Using a
hardware configuration wizard in the data acquisition software, the user chooses a set of implants and assigns them
each to a particular receiver. Up to sixteen receivers can be assigned to one DEM. All DEM’s operate on the same
communication frequency. How to connect the separate pieces is shown in the diagram below and the following
sections will explain the function of each piece of hardware:
If conducting a pair housing study, the Data Exchange Matrix is replaced with the MX2 device which allows researchers
to acquire data from eight animals simultaneously. More information regarding the MX2 device can be found here.
TELEMETRY RECEIVERS
Multiple receiver options exist and selection depends on the implant model and the caging setup. Listed below are the
receivers that support this implant’s transmission frequency (455 kHz or 18MHz). Check the implant’s t a s issio
range listed as the cage requirement in the product specifications (Appendix B). If space is an issue, if a non-standard
cage is being used, or if there is a lot of signal drop out, skip to the shielding section in this document to learn more.
DSI receiver options for HD implants are listed below to assist researchers determine the appropriate telemetry receiver
for specific study needs. Information about maximum receiver range, DRA capability, antenna capability, application
and frequency is detailed for each receiver. DSI does offer servicing for receivers when they are not working properly.
Contact your sales representative to learn more.
Receiver
RPC-1
RPC-3
RSC-1
Maximum
Signal Range*
Sufficient
coverage for up
to 16 in
(or 41cm)
DRA
Capability
Antenna
Capability
Single Internal
Dual Internal
Single Internal or
Auxiliary External
Frequency
Application
455kHz
455kHz &
18MHz
Typical Cage Setup
Multiple implants in the same animal or
paired housing use cases
Supplementary for larger cage sizes or for
unique cage configurations
455kHz
Formatted: Left
19 | P a g e
RLA3000
Axis dependent
Single Internal
455kHz
Operating Room or Special Caging
*Range is highly dependent on telemetry model. The miniature implant size typically has a 20cm range, the small animal implant size
typically has a 25cm range, and the large animal implant size typically has a 1.5m range.
RPC-1
The Receiver Plastic Cage (RPC-1) is used to collect data from any 455 kHz associated PhysioTel implant. The RPC-1 can
pick up the signal from the implant or from a neighboring cage so it is important to put enough distance between them
so the signals do not interfere. PhysioTel 455 kHz implants can be read up to 40-45cm away from the receiver because
of the dual axis antenna located inside the RPC-1 housing. Skip to the shielding section in this document to learn more
about cage requirements. See the schematic of the RPC-1 below to see what the reciever looks like up close.
The RPC-1 specifications are as follows:
Pickup Frequency
Size
Power Requirements
455kHz
12.9 x 8.9 x 1.3 inches
(328 x 227 x 33 mm)
Powered by the DEM
Photo of an RPC-1
Front (top) and back (bottom) of the RPC-1
20 | P a g e
RPC-3
The RPC-3 as desig ed fo D“I’s “ patheti Ne e A ti it “NA o ito i g p odu t the F -W-F2 to be used in
conjunction with a 455 kHz PhysioTel implant (most commonly the PA-C40). However it can be used with HD products
and with the 4ET as well. It contains two antennas and is used to collect signals from 2 animals simultaneously which
are pair housed or from two implants in one animal. One of the signals must be from an 18 MHz PhysioTel implant and
the other from a 455 kHz PhysioTel implant. This is important if the system will use 18MHz frequencies in the future
such as the 4ET or the F50-W-F2.
The RPC-3 can still pick up the signal from the implant or from a neighboring cage so it is important to put enough
distance between them so the signals do not interfere. This receiver is different from the RPC-1 because has additional
antennas that enable it to monitor from two separate frequencies. See the schematic below to see view the front and
back profiles of the RPC-3. The RPC-3 looks similar to the RPC-1 (photo depicted above).
The RPC-3 specifications are as follows:
Pickup Frequency
Size
Power Requirements
18MHz and 455kHz
12.9 x 8.9 x 1.3 inches
(328 x 227 x 33 mm)
Powered by the DEM
Front (top) and back (bottom) of the RPC-3
Deleted: h
21 | P a g e
RSC-1
The Receiver Special Cage (RSC-1) contains the same antenna as the RPC-1 but has a much smaller profile. The RSC-1 is
used in special situations where the RPC-1 is too large or will not fit close to the animal. Applications that are
considered special situations could be adding a running wheel to the existing cage setup, using a metabolic cage or a
large maze. The RSC-1 can be used to supplement an existing system. This device also has been used in larger caging
setups with the DRA function (explained in the software manuals and briefly described below). The RSC-1 also has the
function to attach any external antenna (for example 272-7002Tethe A te a . Speak to DSI technical support if
to learn more about this option for a specific use case. Some researchers may have interest in developing their own
custom antenna. An engineering based manual is available by request to instruct users on how to interface their design
to the RSC-1. The images below are photos of an actual RSC-1.
Photo of RSC-1 as viewed from the front
The RSC-1 specifications are as follows:
Pickup Frequency
Size
Power Requirements
455Hz
3.3 x 1.2 x 5.25 inches
(84 x 30 x 132 mm)
Powered by the DEM
Photo of back of RSC-1
22 | P a g e
RLA3000
The RLA3000 is ideal for an operation room system as it works with all DSI small animal implants, is very portable and
can be easily cleaned. Special situations where the RPC-1 is too large or will not fit close to the anesthetized animal the
RLA3000 or the RSC-1 may be used. This works for short range applications where a wand-like receiver is useful. The
portability of this receiver makes it ideal for spot checking animals and for surgical applications as it can easily be place d
in a sterile filed and cleaned after surgery. It can be used to supplement an existing system, for example it has been
used in marmoset studies to expand the range in a cage as it could be placed on a perch or platform .
The RLA3000 contains a single antenna (so one less than the RPC-1) and has a much different profile from the other
receivers. However because of the single antenna this receiver has better reception depending on the orientation of the
device to the receiver. The RLA3000 is ideal in anesthetized animal use because of this orientat ion limitation. Because
the RLA3000 is an older receiver model it is not automatically recognized by the system like the other receivers so it
must be configured when it is attached to the DEM. The RLA3000 also cannot calculate activity like the other receivers
because of the single antenna. While the receiver can easily be cleaned, please do not submerge it completely as it is
not water tight. Use disinfecting wipes or a cloth instead. This receiver also does not have any indicator lights to notify
the users of its function like the other DSI receivers.
Limitations do apply with this receiver but it can be very useful in specific use cases. Speak to DSI technical support to
learn more about this receiver for a specific use case. The images below are photos of an actual RLA3000.
Photo of RLA3000
The RLA3000 specifications are as follows:
Pickup Frequency
Size
Power Requirements
455Hz
Length: 8 inches
Diameter: 1.7 inches
Powered by the DEM
23 | P a g e
RECEIVER FUNCTIONALITY
The receivers are always powered by the connection with the DEM. When connected, the DSI Dataquest or Ponemah
software will detect the model and serial number and configure the software appropriately for all DSI hardware. All
receivers have similar jacks and indicator lights. This section describes these and what they mean for each receiver.
Jacks
Plug the J output jacks into the DEM to establish a power and data connection. The RPC- has t o J output ja ks
while the RPC-1 and RSC-1 have only one. The RSC- also has a AUX a d a ANT ja k o the a k. The AUX is
used i D“I a ufa tu i g to test the p odu t. The ANT is he e usto e s a plug i a usto a te a ade
DSI or by their own engineers.
Indicator Lights
The power light indicates that the receiver is connected to the DEM and powered appropriately. The light is either on or
off.
The carrier light indicates when the receiver can detect an implant signal. The light is either on or off, so depending on
the quality of the signal users may observe what appears to be blinking if the quality of the signal is poor.
The signal light is available on the RSC-1 only. It has a more gradual transition from off to on which is designed to
indicate when the implant enters the reception range and the strength of the signal. This is useful in tuning remote
antennas for custom antenna work.
Enable Button
The enable button on the front of the RPC-3 allows the user to turn off the receiver. Power will still be provided to the
receiver, it just severs the connection between the receiver and the DEM. This is useful in situations when using a
PhysioTel implant that is not of the HD platform. This feature prevents the receiver from detecting information when an
animal or cage is removed from a rack. Because the receiver is so sensitive, sometimes it will pick up data from other
sources that look physiologic in cases where it is not watching for an encrypted signal like the HD implants use. The
sig al is e a led he the utton is pressed in and the LED light is o . To disa le o dis o e t f o the DEM p ess
the button again and it should pop out with the LED light turned off. The carrier lights will both turn off as well
indicating that the signal cannot be read by the acquisition system.
DRA FUNCTIONALITY
If a cage is being used that is larger than a single RPC-1, the receivers can be arranged in a Distributed Receiver Array
(DRA) mode to cover a larger area. The DRA feature allows groups of 2, 4, 8, or 16 receivers to be used with a single
animal to expand the coverage area and improve signal quality. A single data stream is passed back to the data
acquisition computer based on instantaneous switching to the receiver that has the strongest signal strength.
Unfortunately, the DRA function requires that all receivers within a group are the same receiver model. Please refer to
the software user manual for more information on configuring a DRA setup. The DRA function is also only supported by
Dataquest A.R.T. or Dataquest OpenART versions 4.31 and later.
24 | P a g e
DATA EXCHANGE MATRIX (DEM)
The Data Exchange Matrix is hardwired and connected to the receivers to deliver the transmitted signal to the
computer. The matrix has 4 channels and can transmit data from 4 receivers simultaneously, or it can be configured to
t a s it f o all RPC’s i a s heduled sa pli g ode that otates et ee g oups. The Data Exchange Matrix
performs two tasks:
1) It multiplexes the signals fed into it from any combination of several receivers and sensors and sends this
signal stream to the computer via a Local Area Network (LAN) type cable.
2) It routes power from the power supply to the connected receivers and analog-to-digital adapters
The Data Exchange Matrix also detects changes in signal strength that indicate movement in the animal, and provides
one or more digital pulses to the computer upon each movement. The DEM’s asi specifications are listed to the right.
If additional specifications are of interest, please contact technical support.
Size
Weight
Power Requirements
Maximum Receivers Daisy Chained
Operating Temperature
Operating Humidity
10.0 x 7.0 x 4.25 inches
(254 x 178 x 108 mm)
6.05 lbs.
5 Volts DC @ 1.5A
12 Volts DC @ 35mA
0-38°C
< 70% R.H. non-condensing
A Data Exchange Matrix is comprised of 3 circuit boards contained in a steel housing. The bottom circuit board (labeled
"A" on the rear of the Data Exchange Matrix) is always a MCC-1 Communications Controller. The remaining circuit
boards (labeled "B" and "C") are MMX-1 Receiver Multiplexors. On the front of the DEM there are two columns of
lights, a green indicating power and a red indicating fault for each card. The green light indicates power to each card
and should be continuously lit for all rows in a normally operating DEM.
Front of DSI Exchange Matrix
25 | P a g e
J1-J8 ports on B & C
rows: connect to
receivers
J1-J4 COM ports:
connect to an APR-1
and additional DEMs
Back of DSI Exchange Matrix
COM port connecting
to the PCIe card in
computer
The back of the Data Exchange Matrix has 20 available input jacks. The jacks on card A (MCC card) labeled J1COM
through J4COM can be connected to an APR-1 and additional DEMs. Card A also has a COM port that connects to the
Dataquest Acquisition card in the computer and a round plug for the DEM power supply. Jacks J1 through J8 on cards B
and C are used to connect DSI's receivers and converters. Each Data Exchange Matrix has a unique serial ID number
assigned at the factory that the data acquisition software recognizes when verifying the hardware configuration.
Blinking (Errors)
Blinking red lights indicate a fault or hardware error. There is one light per card. It also lights during system startup and
when the card is reset. Blinking green lights indicate a power failure.
What to look for
What it means
A Red light li ks ui kl o the f o t pa el a d the is off fo a sho t ti e, a d the
pattern repeats. The red led light next to the COM port on the back panel is also
blinking in the same pattern.
No communication from the
DEM to the computer
Blinking Green Light
Power Failure
How to fix it?
Try these few steps as these are the most common failure modes:
1.
2.
3.
Make sure the computer is powered on
Replace the cable between the Data Exchange matrix (DEM) and the computer with a spare or from a
neighboring DEM that is functioning correctly. If the new cable works, the older one is bad and will need to be
replaced.
Re-connect and re-start the system.
If these steps do not fix the issue, please contact technical support. Technical support can answer any questions about
abnormal system behavior.
26 | P a g e
AMBIENT PRESSURE REFERENCE (APR)
The Ambient Pressure Reference, APR-1, is important because it is a special type of barometer that measures
atmospheric pressure providing dynamic corrections via a digital signal to the computer. All local environmental
pressure fluctuations and changes in ambient barometric pressure are automatically corrected again st measurements
obtained by the Dataquest A.R.T. system. Since the PhysioTel implants measure absolute pressure, an APR-1 is
necessary for accurate pressure recordings as it provides dynamic adjustment to changes in ambient pressure.
The APR-1 requires routine calibration to ensure the accuracy of the data. Other pressure monitoring hardware
systems may come with the ambient pressure reference built in to the acquisition hardware. DSI values accuracy and
knows that all sensing equipment will drift over time. Calibrating the system is much more difficult when it is in the
hardware and prefers to have it in its own smaller box for ease of calibration frequency and minimal system downtime.
To learn more about the APR-1 refer to the user manual (to order a new one for free use part number 391-0047-001).
Pressure Accuracy
+/- 1 mmHg
Pressure Range
650-800 mmHg
Pressure Drift
< 1.0 mmHg per year at 20 C-30 C
Size
14 cm x 10.5 cm x 4 cm
Weight
510g
Suggested Calibration Frequency
Every two years
Power Requirements
Powered via DEM connection
Front of APR-1
Back of APR-1
Lights
The green power light means the APR-1 is receiving power from the DEM. The ready light means the device has
connected to the system, has passed the self-test and is actively monitoring pressure. If the ready light does not turn
on the APR-1 should be checked for proper operation. Refer to the APR-1 user manual for more troubleshooting
information.
27 | P a g e
Comment [K2]: Pair house
CAGING AND SHIELDING RECOMMENDATIONS
DSI has experience using the typical shoe box sized cages but more and more customers are finding that lab space is
difficult to come by. Many different configurations are possible depending on the animal model and space available. As
a rule of thumb, always leave at a minimum the distance of one RPC-1 (~12 inches or 31cm) between cages. The best
case situation would be placing each cage two receiver widths (18 inches or 45 cm) away from each other. Excluding
pair housing studies, below is an example of the minimum recommended small animal configuration without any
shielding:
Deleted: This
12 inches
RPC-1
RPC-1
18 inches
RPC-1
RPC-1
RPC-1
RPC-1
RPC-1
RPC-1
As shown above, stagger the cages on a shelf to conserve the most space with this single frequency device. This
illustration represents one implanted animal in each cage paired with another animal that is not implanted, With the
HD-S11-F2 device, it is possible to pair two implanted animals with different frequency implants in the same cage and
gather data simultaneously. The RPC-3 receiver is mandatory for pair housing studies and requires the same amount of
distance between cages as that of the RSC-1 (~12 inches or 31cm).
If the receivers need to be closer together and data loss is prevalent (>5%) implement electromagnetic shielding.
Shielding comes in many forms from sheet metal and chicken wire to high tech clear specifically designed metal mesh.
Locate the source of the noise and enclose that with shielding if possible. For example, the DEM or another implant can
be a source of noise if it is placed too close to the receivers. If problems arise or if you require a list of acceptable
shielding options, technical support is equipped to help determine the best shielding method either remotely or onsite if
necessary.
Deleted: O
Deleted: can be implanted with telemetry, and
Deleted: the other
Deleted: will
Deleted: be
Deleted: (if the study protocol requires paired
housing the animal).
28 | P a g e
SOFTWARE COMPATIBILITY WITH HD DEVICES
This matrix below explains the Dataquest ART, Ponemah and OpenART software versions (and service packs (SP) if
necessary) required for each implant in the HD platform.
Software
Platform
Version
5.0
●
5.1
●
Ponemah
OpenART &
Dataquest ART
HD-S21
5.2
5.6
6.1
4.31
4.32
4.33
4.34
4.36
●
●
●
●
●
●
●
HD-S11-F0
HD-S11-F2
●
(SP1)
●
●
●
●
●
●
●
Implant
HD-S10
Formatted Table
HD-X11
●
(SP2)
HD-X10
●
●
●(SP5)
●
●
●
●
●
●
●
●
●(SP5)
●
Deleted: ¶
Formatted: Left, Space After: 0 pt, Line
spacing: single
Deleted: ¶
Comment [K3]: Talk to Chris
●
GLP REQUIREMENTS
If the lab is GLP certified, or if it aspires to be, DSI implants will work within this environment. However, Ponemah is the
only DSI software that can be validated for GLP compliant labs. Be ause of the HD de i e’s digitall t a s itted a i al
ID, it is easier to track in vivo and verify that the correct animal is being used. Contact Scientific Services for more
information on software validation services and how our experienced team can help save time and reduce costs
associated with computer system validation.
29 | P a g e
APPENDIX A: CARE AFTER FIRST IMPLANTATION
EXPLANTATION
For complete information on device explantation, visit www.datasci.com or contact Technical Support
(Support@datasci.com). When explanting DSI implants that are implanted intra-peritoneally or subcutaneously,
consider the following:
1.
2.
3.
4.
5.
6.
Carefully remove the implant body first.
Be careful not to drop the implant.
Never cut a catheter if the intention is to re-use the implant.
If cutting the catheter is necessary, use only a new scalpel blade to cut the catheter at a 45-degree
angle away from the device body and approximately 3 cm from the implant body.
Do not use any instrument other than a scalpel blade to cut the catheter. Cutting the catheter with a
pair of scissors or any other instrument could cause damage to the pressure sensor and void the
warranty.
If the catheter must be cut, the implant cannot be reused in another animal model. Please send the
device back to DSI for participation in the Exchange Program and the standard Exchange discount on a
new device will apply.
Leads can be cut as there are lead coupler kits available for purchase to extend the length of the leads. Lead
coupler kits may make the leads less flexible over time so try to save as much length as possible during
explantation.
Clean and sterilize the implant with an approved enzyme detergent and sterilant before returning the implant
to DSI or re-using in another animal.
If the animal should die unexpectedly and the implant cannot be explanted immediately, the animal can be
placed in a refrigerator or freezer until the explant can take place. The refrigerator or freezer will not damage
the device, however; storage in a refrigerator will allow for an easier retrieval.
ON-SITE CLEANING AND RE-STERILIZATION
All new and exchanged implants shipped to an investigator are sterile and ready for implantation. In studies where
devices are implanted for short periods at a time, significant battery life may remain at the end of the study allowing
reuse of the implant. DSI has published specifications on the minimum guaranteed hours of battery life. Record the
amount of time the device is on to track use and to calculate the battery life left. The PhysioTel HD platform allows this
tracking to be much easier as the battery voltage and approximate on time is transmitted from the implant when it is in
the ON mode.
DSI has developed detailed procedures for cleaning and sterilizing telemetry implants. These procedures will increase
the number of times an investigator can use each implant before returning it to DSI via the Exchange Program, helping
to reduce overall costs per study. Sterilization procedures are available online at www.datasci.com.
SHELF-LIFE AND STORAGE
New Implants direct from Manufacturing
1.
2.
Carefully examine all implants when they arrive at the facility.
Remove the sterile packages containing the implants from the shipping boxes. All implants are sterile upon
arrival.
30 | P a g e
3.
4.
5.
Save the shipping boxes to use when returning used implants for the Exchange Program.
Inspect each implant’s ste ile pa kagi g fo sig s of damage. If the package remains undamaged, this
sterility is warranted according to the information on the package label.
Confirm that each implant is turned off before storing.
a. Using the AM radio on the low frequency setting, turn each implant on and off by scanning a
magnet across the implant to ensure that none of the implants were damaged during shipping.
b. Although each unit is checked just before shipping, the implant may have been exposed to stray
magnetic fields during shipment. This can cause the unit to be turned on unintentionally.
c. Implants in the OFF mode may lose up to 10% of the battery life within 12 months after the
manufacture date.
Storage of Sterilized Implants
Occasionally there may be a delay between the implant removal from the animal and the beginning of the next
study. Proper storage of the on-site sterilized implant is necessary to ensure that the unit will perform normally during
the next study.
1.
2.
3.
4.
5.
Using the AM radio on the low frequency setting, check each implant to ensure that it is properly turned off.
Thoroughly clean and sterilize each implant according to DSI's On-Site Re-sterilization
procedure. www.datasci.com
If the original implant sterile package was saved, place the implant into the plastic packaging. This will help
to identify the implant and the calibration values associated with it.
a. Do not store implants in saline or other liquid.
Sterilization before storage is necessary to prevent the spread of bacteria during handling.
Each implant will require sterilization again at the time of use as there is not an effective way to maintain
sterility after the sterile package has been opened.
STORAGE LOCATION REQUIREMENTS
The implants should be stored in a cool (between 10 and 25 degrees Celsius), dry area away from exposure to static
discharge and magnetic fields. Never expose them 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 as the catheter could be crushed and the senor damaged. Storage in a refrigerator does not
provide significant benefit in terms of battery life. By following the procedure for storage, the implants should perform
just as well as the day they were shipped.
31 | P a g e
APPENDIX B: QUICK REFERENCE SPECIFICATIONS
Telemetry implants may operate over wider pressure and temperature ranges with reduced accuracy. Please contact
technical support (Support@datasci.com) if the study requires use of products outside the specified range.
Specifications and product performance is only valid for the warranted battery life and when the d ata is recorded using
DSI Software platforms. Use of alternate software platforms or homemade calibration systems may compromise the
integrity of the study.
HD-S10 PART NUMBER: 270-0180-XXX
Total Configuration Possibilities: 5
Measures: Pressure, Temperature & Activity
DIGITAL DATA
Stored Factory Calibrations
Animal ID
Battery ON Time
Battery Voltage
BATTERY LIFE
Min. Warranted Battery Life Period: 5 months
Battery Data Displayed:
Battery Voltage and ON time
ON time accuracy: ± 1 day at 37°C
OPERATING SPECIFICATIONS
Ambient Pressure Range (mmHg): 670 to 800
Maximum Altitude (meters): 625
RF Transmission Frequency (Hz): 455 kHz ± 10
PRESSURE SPECIFICATIONS
Pressure Accurate within Temperatures (°C): 34-41
In vivo:
Range (mmHg): -20 to 300
Initial Accuracy (mmHg): ± 3
Drift (mmHg/month):
< 2.0 Maximum (< 0.25 Average)
In Package:
Pressure Drift over time
At Dry Heat of 37°C (mmHg / per month): ± 1
Pressure Catheter Properties:
Catheter
Frequency
Tip Length
Diameter
Length
Response**
8 cm
6 mm*
0.7 mm
Min 40Hz
8 cm
4.5 mm
0.7 mm
Min 40Hz
8 cm
3 mm
0.7 mm
Min 40Hz
10 cm
6 mm
0.7 mm
Min 40Hz
15 cm
6 mm
0.7 mm
Min 20Hz
No S10 catheter is to be used for dP/dT calculations
*Most common
**With default 50Hz software filter
ANIMAL RECOMMENDATIONS
Min. Animal Weight (g): 175
Max Cage Size (cm): 42 x 42 x 18
PACKAGING
Sterile Shelf Life: 12 months
Sterile Barrier Type: Single Layer
IMPLANT BODY DIMENSIONS
Excluding Suture Ribs:
Shape: Round with flat bottom
Length (mm): 23.4
Width (mm): 13.8
Height (mm): 13.2
Weight (g): 4.3
Volume (cc): 3.0
Outer Material: Silicone Elastomer
Suture Ribs: See configuration table
TEMPERATURE ACCURACY
Calibrated Range (°C): 34-41
Initial Accuracy (°C): 0.1
Resolution (°C): 0.05
Temperature Drift (°C)
Per 6 months: 0.2
WARRANTY INFORMATION
Maximum Warranty Period: 18 months
Warranted Implant Period: 9 months
32 | P a g e
HD-S11-F0/-F2 PART NUMBER: -F0: 270-0193-XXX; -F2: 270-0196-XXX
Total Configuration Possibilities: 10
DIGITAL DATA
Stored Factory Calibrations
Animal ID
Battery ON Time
Battery Voltage
BATTERY LIFE
Min. Warranted Battery Life Period: 2 months
Battery Data Displayed:
Battery Voltage and ON time
ON time accuracy: ± 1 day at 37°C
Measures: Pressure, Biopotential, Temperature & Activity
ANIMAL RECOMMENDATIONS
Min. Animal Weight (g): 175
Max Cage Size (cm): 42 x 42 x 18
PACKAGING
Sterile Shelf Life: 12 months
Sterile Barrier Type: Single Layer
IMPLANT BODY DIMENSIONS
Ambient Pressure Range (mmHg): 670 to 800
Maximum Altitude (meters): 625
RF Transmission Frequency:
455 kHz (HD-S11-F0)
18 MHz (HD-S11-F2)
Excluding Suture Ribs:
Shape: Flat with rounded edges
Length (mm): 34.8
Width (mm): 17.6
Height (mm): 12.0
Weight (g): 8
Volume (cc): 5.9
Outer Material: Silicone Elastomer
Suture Ribs: See configuration table
PRESSURE SPECIFICATIONS
TEMPERATURE ACCURACY
Pressure Accurate within Temperatures (°C): 34-41
In vivo:
Range (mmHg): -20 to 300
Initial Accuracy (mmHg): ± 3
Drift (mmHg/month):
< 2.0 Maximum (< 0.25 Average)
In Package:
Pressure Drift over time
At Dry Heat of 37°C (mmHg / per month): ± 1
Calibrated Range (°C): 34-41
Initial Accuracy (°C): 0.15
Resolution (°C): 0.05
Temperature Drift (°C)
First two weeks: 0.1
Per 6 months after: 0.1
OPERATING SPECIFICATIONS
Pressure Catheter Properties:
Catheter
Frequency
Tip Length
Diameter
Length
Response
8 cm
6 mm*
0.7 mm
Min 100Hz
8 cm
4.5 mm
0.7 mm
Min 100Hz
8 cm
3 mm
0.7 mm
Min 100Hz
10 cm
6 mm
0.7 mm
Min 50Hz
15 cm
6 mm
0.7 mm
Min 20Hz
*Most common and is only catheter recommended for
dP/dt calculation
Deleted: (Hz)
Deleted: ± 10
Formatted: Font: Not Bold
BIOPOTENTIAL SPECIFICATIONS
Bandwidth Range (Hz): 0.1 - 145
Input Voltage Range (mV): ± 5
Biopotential Lead Dimensions
Length (cm): 30cm or 60cm
Outer Diameter (mm): 0.94
Coil Diameter (mm): 0.46
WARRANTY INFORMATION
Maximum Warranty Period: 18 months
Warranted Implant Period: 9 months
Comment [K4]: Perry – does this need a +/- 10
like the 455kHz?
Formatted: Font: Not Bold
33 | P a g e
HD-S21 PART NUMBER: 270-0192-XXX
Total Configuration Possibilities: 17
Measures: Pressure (2), Biopotential, Temperature & Activity
DIGITAL DATA
ANIMAL RECOMMENDATIONS
Min. Animal Weight (g): 175
Max Cage Size (cm): 42 x 42 x 18
Stored Factory Calibrations
Animal ID
Battery ON Time
Battery Voltage
PACKAGING
Sterile Shelf Life: 12 months
Sterile Barrier Type: Single Layer
BATTERY LIFE
Min. Warranted Battery Life Period: 2 months
Battery Data Displayed:
Battery Voltage and ON time
ON time accuracy: ± 1 day at 37°C
IMPLANT BODY DIMENSIONS
Excluding Suture Ribs:
Shape: Flat with rounded edges
Length (mm): 34.8
Width (mm): 17.6
Height (mm): 12.0
Weight (g): 8
Volume (cc): 5.9
Outer Material: Silicone Elastomer
Suture Ribs: See configuration table
OPERATING SPECIFICATIONS
Ambient Pressure Range (mmHg): 670 to 800
Maximum Altitude (meters): 625
RF Transmission Frequency (Hz): 455 kHz ± 10
PRESSURE SPECIFICATIONS
Pressure Accurate within Temperatures (°C): 34-41
In vivo:
Range (mmHg): -20 to 300
Initial Accuracy (mmHg): ± 3
Drift (mmHg/month):
< 2.0 Maximum (< 0.25 Average)
In Package:
Pressure Drift over time
At Dry Heat of 37°C (mmHg / per month): ± 1
Pressure Catheter Properties:
Catheter
Tip Length
Length
8 cm
6 mm*
8 cm
4.5 mm
8 cm
3 mm
10 cm
6 mm
15 cm
6 mm
TEMPERATURE ACCURACY
Calibrated Range (°C): 34-41
Initial Accuracy (°C): 0.15
Resolution (°C): 0.05
Temperature Drift (°C)
First two weeks: 0.1
Per 6 months after: 0.1
BIOPOTENTIAL SPECIFICATIONS
Diameter
0.7 mm
0.7 mm
0.7 mm
0.7 mm
0.7 mm
Frequency
Response
Min 100Hz
Min 100Hz
Min 100Hz
Min 50Hz
Min 20Hz
*Most common and is only catheter recommended for
dP/dt calculation
Bandwidth Range (Hz): 0.1 - 145
Input Voltage Range (mV): ± 5
Biopotential Lead Dimensions
Length (cm): 30cm or 60cm
Outer Diameter (mm): 0.94
Coil Diameter (mm): 0.46
WARRANTY INFORMATION
Maximum Warranty Period: 18 months
Warranted Implant Period: 9 months
34 | P a g e
HD-X10 PART NUMBER: 270-0171-XXX
Total Configuration Possibilities: 4
DIGITAL DATA
Stored Factory Calibrations
Animal ID
Battery ON Time
Battery Voltage
BATTERY LIFE
Min. Warranted Battery Life Period: 6 weeks
Battery Data Displayed:
Battery Voltage and ON time
ON time accuracy: ± 1 day at 37°C
OPERATING SPECIFICATIONS
Ambient Pressure Range (mmHg): 670 to 800
Maximum Altitude (meters): 625
RF Transmission Frequency (Hz): 455 kHz ± 10
PRESSURE SPECIFICATIONS
Pressure Accurate within Temperatures (°C): 34-41
In vivo:
Range (mmHg): -20 to 300
Initial Accuracy (mmHg): ± 3
Drift (mmHg/month):
< 2.0 Maximum (< 0.25 Average)
In Package:
Pressure Drift over time
At Dry Heat of 37°C (mmHg / per month): ± 1
Pressure Catheter Properties:
Catheter
Frequency
Tip Length
Diameter
Length
Response
5 cm
4.5 mm
0.4 mm
Min 60Hz
7 cm
4.5 mm
0.4 mm
Min 40Hz
No mouse catheters are recommended for dP/dt
calculations.
Measures: Pressure, Temperature & Activity
ANIMAL RECOMMENDATIONS
Min. Animal Weight (g): 19
Max Cage Size (cm): 33 x 33 x 14
PACKAGING
Sterile Shelf Life: 12 months
Sterile Barrier Type: Single Layer
IMPLANT BODY DIMENSIONS
Excluding Suture Ribs:
Shape: Tear Drop / Cylindrical
Length (mm): 19.58
Width (mm): 10.67
Diameter (mm): 9.65
Weight (g): 2.2
Volume (cc): 1.4
Outer Material: Silicone Elastomer
Suture Ribs: See configuration table
TEMPERATURE ACCURACY
Calibrated Range (°C): 34-41
Initial Accuracy (°C): 0.15
Resolution (°C): 0.05
Temperature Drift (°C)
First two weeks: 0.1
Per 6 months after: 0.1
WARRANTY INFORMATION
Maximum Warranty Period: 12 months
Warranted Implant Period: 6 months
35 | P a g e
HD-X11 PART NUMBER: 270-0170-XXX
Total Configuration Possibilities: 4
Measures: Pressure, Biopotential, Temperature & Activity
DIGITAL DATA
Stored Factory Calibrations
Animal ID
Battery ON Time
Battery Voltage
BATTERY LIFE
Min. Warranted Battery Life Period: 1 month
Battery Data Displayed:
Battery Voltage and ON time
ON time accuracy: ± 1 day at 37°C
OPERATING SPECIFICATIONS
Ambient Pressure Range (mmHg): 670 to 800
Maximum Altitude (meters): 625
RF Transmission Frequency (Hz): 455 kHz ± 10
PRESSURE SPECIFICATIONS
Pressure Accurate within Temperatures (°C): 34-41
In vivo:
Range (mmHg): -20 to 300
Initial Accuracy (mmHg): ± 3
Drift (mmHg/month):
< 2.0 Maximum (< 0.25 Average)
In Package:
Pressure Drift over time
At Dry Heat of 37°C (mmHg / per month): ± 1
Pressure Catheter Properties:
Catheter
Gel Tip
Frequency
Diameter
Length
Length
Response
5 cm
4.5 mm
0.4 mm
Min 60Hz
7 cm
4.5 mm
0.4 mm
Min 40Hz
No mouse catheters are recommended for dP/dt
calculations.
ANIMAL RECOMMENDATIONS
Min. Animal Weight (g): 19
Max Cage Size (cm): 33 x 33 x 14
PACKAGING
Sterile Shelf Life: 12 months
Sterile Barrier Type: Single Layer
IMPLANT BODY DIMENSIONS
Excluding Suture Ribs:
Shape: Tear Drop / Cylindrical
Length (mm): 19.58
Width (mm): 10.67
Diameter (mm): 9.65
Weight (g): 2.2
Volume (cc): 1.4
Outer Material: Silicone Elastomer
Suture Ribs: See configuration table
TEMPERATURE ACCURACY
Calibrated Range (°C): 34-41
Initial Accuracy (°C): 0.15
Resolution (°C): 0.05
Temperature Drift (°C)
First two weeks: 0.1
Per 6 months after: 0.1
BIOPOTENTIAL SPECIFICATIONS
Bandwidth Range (Hz): 0.1 - 200
Input Voltage Range (mV): ± 2.5
Biopotential Lead Dimensions
Length (cm): 20cm
Outer Diameter (mm): 0.94
Coil Diameter (mm): 0.46
WARRANTY INFORMATION
Maximum Warranty Period: 12 months
Warranted Implant Period: 6 months
36 | P a g e
APPENDIX C: CATHETER & LEAD CONFIGURATION OPTIONS
Many configurations are available to enable flexibility between studies. Configurations that are more common and
therefore have faster lead times are highlighted for convenience. Part numbers may change over time as more options
become available and as more surgical methods are validated due to customer demand.
All listed su gi al app oa hes a e e do sed D“I’s su gi al suppo t staff a d the efo e t ai i g is a aila le for these
methods on-site or at DSI headquarters. The surgical placement may vary depending on the animal model and
experimentation with a non-functional training device is recommended before attempting a survival surgery. Surgical
manuals and videos for each implant are available.
Pape s o poste s e if i g these su gi al ethods a e a aila le ia D“I’s i liog aph s ste fou d o the e site. I
unique applications, DSI may also be able to connect researchers together for further surgical or scientific development.
HD-S10
The X after the Part Number means the pricing reflects participation in the Exchange Program.
Catheter
270-0180-XXX
-001
Length /
Tip
Ligation
Aide?
8cm /
6mm tip
Lead
Length
30cm
Suture
Rib?
•
DSI Endorsed Surgical Approach
Animal
Model
Device Placement
Rabbit
Intra-peritoneal
Intra-peritoneal
Intra-peritoneal
Systemic BP from the
Descending Aorta
Intra-Pleural Pressure
Systemic BP from the Femoral
Artery
Systemic BP from the Femoral Artery
Pulmonary Artery Pressure
Right Ventricular Pressure
Subcutaneous
Systemic BP from the Femoral Artery
Intra-peritoneal
Rat
Subcutaneous
-002
-003
-007
-008
10cm /
6mm tip
15cm /
6mm tip
8cm /
3mm tip
8cm /
4.5mm tip
30cm
•
•
Catheter Placement Options
Rat
30cm
•
Rabbit
30cm
•
Rat
Intra-peritoneal
Bladder Pressure
30cm
•
Rat
Intra-peritoneal
Intra-Cavernosal Pressure
* WARNING: The HD-S10 is NOT recommended for dP/dt analysis
37 | P a g e
HD-S11-F0/-F2
All catheters are High Frequency catheters. They have been redesigned and improved upon from other DSI PhysioTel
models. The X after the Part Number means the pricing reflects participation in the Exchange Program.
-F0:
270-0193-XXX
-F2:
270-0196-XXX
Catheter
Length /
Tip
DSI Endorsed Surgical Approach
Ligation
Aide?
Lead
Length
Suture
Rib?
Animal
Model
Rat
Subcutaneous
Systemic BP from the Femoral Artery
30cm
•
Rat
-002
10cm /
6mm tip
30cm
•
Rat
-004
-005
-006
-007
Rabbit
30cm
Intra-peritoneal
Left Ventricular Pressure
Right Ventricular Pressure
•
30cm
•
Rat
Intra-peritoneal
•
30cm
•
Rabbit
Intra-peritoneal
Right Ventricular Pressure*
30cm
•
Rat
Intra-peritoneal
Intra-Cavernosal Pressure
30cm
•
Rat
Intra-peritoneal
Bladder Pressure
Intra-peritoneal
Numerous Applications
Intra-peritoneal
Numerous Applications
Subcutaneous
Numerous Applications
•
-008
10cm /
6mm tip
60cm
•
-009
15cm /
6mm tip
60cm
•
8cm /
30cm
•
6mm tip
* WARNING: Not recommended for dP/dt analysis in rats
-010
Formatted: Font: +Body, 10 pt, Bold
Intra-peritoneal
Intra-peritoneal
Intra-peritoneal
-001
-003
Catheter Placement Options
Systemic BP from the
Descending Aorta
Intra-Pleural Pressure
Systemic BP from the Femoral Artery
Pulmonary Artery Pressure
Right Ventricular Pressure*
8cm /
6mm tip
8cm /
6mm tip
8cm /
6mm tip
10cm /
6mm tip
8cm /
4.5mm tip
8cm /
3mm tip
Device Placement
Ferret
Rabbit
G. Pig
Ferret
Rabbit
G. Pig
Rat
38 | P a g e
HD-S21
All catheters are High Frequency catheters. They have been redesigned and improved upon from other DSI PhysioTel
models. For any pulse wave velocity analysis the catheter lengths must be equal. The X after the Part Number means
the pricing reflects participation in the Exchange Program. The L after the Part Number is a level pricing option offered
on this product alone. Contact your sales representative to learn more. WARNING: Only the 8cm catheter with a 6mm
tip and ligation aide is recommended for dP/dt analysis in rodents.
Ligation Aide
Catheter 2
Length / Tip
Ligation Aide
270-0192-XXX
Length / Tip
Catheter 1
DSI Endorsed Surgical Approach
Biopotential
Lead Length
Suture
Rib?
Animal
Model
-001
8cm /
6mm
8cm /
6mm
30 cm
•
Rat
-002
8cm /
4.5mm
8cm /
6mm
30 cm
•
Rat
-003
8cm /
3mm
8cm /
6mm
30 cm
•
Rat
-004
8cm /
6mm
10cm /
6mm
30 cm
•
Rat
-005
8cm /
6mm
•
10cm /
6mm
30 cm
•
Rat
-006
10cm /
6mm
•
10cm /
6mm
30 cm
•
Rat
-007
10cm /
6mm
10cm /
6mm
30 cm
•
Rat
8cm /
6mm
15cm /
6mm
60 cm
-008
-009
-010
10cm /
6mm
•
•
10cm /
6mm
15cm /
6mm
60 cm
15cm /
6mm
60 cm
•
•
•
-012
-013
-014
8cm /
6mm
8cm /
3mm
8cm /
6mm
15cm /
6mm
•
•
•
15cm /
6mm
8cm /
4.5 mm
8cm /
6mm
15cm /
6mm
•
Two stomach pressures
Cavernosal pressure
Blood pressure via descending aorta
Bladder Pressure
Blood pressure via descending aorta
PAP or RVP
Blood pressure via descending aorta
LVP
Blood pressure via descending aorta
RVP
Blood pressure via descending aorta
PAP or RVP or Intra-Pleural Pressure
(IPP)
Blood pressure via descending aorta
LVP (if no suture aid is desired)
Blood Pressure via femoral artery
LVP
Blood pressure via descending aorta
PAP or RVP
Blood pressure via descending aorta
PAP
Blood pressure via femoral
LVP
Blood pressure via femoral
Bladder pressures
Cavernosal pressures
Rabbit
Ferret
G. Pig
Rabbit
Ferret
G. Pig
Rabbit
Rat
-011
Catheter Placement Options
60 cm
•
Rabbit
30 cm
•
Rat
30 cm
•
Rat
60 cm
•
Rat
Rabbit
LVP & RVP
Pulse Wave Velocity (equal catheter
lengths required)
39 | P a g e
DSI Endorsed Surgical Approach
Ligation Aide
Length / Tip
Length / Tip
270-0192-XXX
Catheter 2
Ligation Aide
Catheter 1
Biopotential
Lead Length
Suture
Rib?
Animal
Model
Catheter Placement Options
Numerous surgical applications in
rabbits
-015
8cm /
3mm
-017
10cm /
6mm
•
8cm /
3mm
•
30 cm
•
Rat
8cm /
3mm
•
30 cm
•
Rat
Intra-ocular & intra-cranial pressures
Blood Pressure via femoral artery
Bladder Pressure
HD-X10
The 5cm catheter is the same as the one on the PhysioTel PA-C10 model. The 7cm catheter was developed for this
product to enable carotid artery surgery while obtaining core temperature via IP placement of the device body . The X
after the Part Number means the pricing reflects participation in the Exchange Program.
270-0171XXX
Catheter
-001
-002
-007
5 cm
5 cm
7 cm
-008
7 cm
Suture
Rib?
•
•
DSI Endorsed Surgical Approach
Animal Model
Mouse
Mouse
Mouse
Mouse/Juvenile
Rat
Device
Placement
Subcutaneous
Intra-peritoneal
Intra-peritoneal
Subcutaneous
Catheter Placement
Systemic BP from the Carotid Artery
Systemic BP from the Descending Aorta
Systemic BP from the Carotid Artery
Numerous Applications
HD-X11
The 5cm catheter is the same as the one on the PhysioTel PA-C10 model. The 7cm catheter was developed for this
product to enable carotid artery surgery while obtaining core temperature via IP placement of the device body . The X
after the Part Number means the pricing reflects participation in the Exchange Program.
270-0170XXX
Catheter
Biopotential
Lead Length
Suture
Rib?
-001
-002
-007
5 cm
5 cm
7 cm
20 cm
20 cm
20 cm
•
•
-008
7 cm
20 cm
DSI Endorsed Surgical Approach
Animal Model
Mouse
Mouse
Mouse
Mouse/Juvenile
Rat
Device
Placement
Subcutaneous
Intra-peritoneal
Intra-peritoneal
Subcutaneous
Catheter Placement
Systemic BP from the Carotid Artery
Systemic BP from the Descending Aorta
Systemic BP from the Carotid Artery
Numerous Applications
40 | P a g e
APPENDIX D: RECOMMENDED SUPPLEMENTARY PRODUCTS AND SYSTEM COMPONENTS
It is important to practice the surgery with the new implants before the study begins. Every product is different and
each surgical method is different. No matter how experienced the surgeon or researcher may be, it is always a good
idea to e ie the e
ethods i D“I’s su gi al manual. A complete list of all recommended products for a DSI
certified surgery is included in the surgical manual.
D“I’s surgical team is always improving the recommended methods with feedback received from all over the world. DSI
surgeons are available for individualized on-site training at ou fa ilit o at D“I’s fa ilit .
370-0193-0XX
(10 options)
370-0192-0XX
(17 options)
HD-X11
HD-S10
HD-S11-F0/-F2
00608-11
HD-X10
Part
Number
HD-S21
The tools listed below are not required by DSI ut a e offe ed as supple e ta to o plete D“I’s solutio for
physiologic monitoring. The highlighted tools are highly recommended for all researchers, while the rest are
replacement products or only useful in some applications. Speak with your sales representative to learn more.
Item Type
Vessel Cannulation
Forceps
Distributor
Fine Science
Tools
Use Notes
Single most important surgical tool. Required to
properly handle the catheter.
370-0180-0XX
Identical to the corresponding implant part
numbers (replaces the beginning 270 with 370).
Used to practice surgical techniques
Non-Functional
Training Module
370-01XX-0XX
370-0170-0XX
(4 options)
276-0038-001
276-0103-001
SA Catheter
Regel Syringe
Starter Kit
DSI
500+ uses possible. “ee D“I’s egel p o edu e
online for implant reuse.
(1) HD Getting Started Guide
(1) Surgical Manual
(2) Surgical Video
(1) 3ml bottle tissue adhesive (Vetbond)
(1) Trocar/sleeves
(1) Radio w/ batteries
(1) Suture kit 5-0 silk
(1) Magnet
(1) Fiber patch 5x5cm
(2) Needle hypo 14ga .
(2) Needle hypo 22ga .
(2) Needle hypo 20ga .
Formatted Table
276-0019-001
HD-X11
HD-S10
276-0104-001
HD-X10
HD-S11-F0/-F2
Part
Number
HD-S21
41 | P a g e
Item Type
Starter Kit
Distributor
DSI
Crimp Tool
276-0031-001
Lead Coupler Kit
276-0065-001
370-0104-001
370-0104-002
370-0034-001
391-0303-001
391-1007-001
391-1008-001
390-0099-001
390-1000-001
Extra Pins/Sheaths
Extra Magnet
DSI
Used to extend existing leads or add a custom
lead design. Requires a Crimp Tool (order
separately. Includes:
(5) Extra Pins/Sheaths
(6) Tip Covers (276-0031-001 only)
(2) Prepared leads ready to attach (60 or 20cm)
(1) User Manual
Comes in packs of 5 and are included in the lead
coupler kits.
Used to turn on and off the device
HD Getting Started
Guide
This System Setup Guide has all necessary
information including hardware, supplemental
tools and specifications for all HD Implants.
Surgical
Implantation
Manual
Surgical Manual on a CD for Specific Implants
Surgical Video
Surgical Video which shows common techniques
for device implantation with DSI surgical
technicians voice over
(1) HD Getting Started Guide
(1) Surgical Manual
(1) Surgical Video
(1) 3ml bottle tissue adhesive (Vetbond)
(1) Trocar/sleeves
(1) Radio w/ batteries
(1) Suture kit 5-0 silk
(1) Magnet
(1) Fiber patch 5x5cm
(2) Needle hypo 18ga .
(2) Needle hypo 25ga 5/8
(4) Practice catheters
For use with the lead coupler kit(s) which is used
to crimp leads together. Must be ordered
separately.
276-0019-002
Use Notes
Formatted Table
42 | P a g e
Typical Hardware Acquisition System Part Numbers
Hardware Description
Part Number
RPC-1
RPC-3
RSC-1
RLA3000
DEM
272-6001-001
272-6008-001
272-6012-001
272-5007-002
271-0117-001
Depends on Geography
Contact Sales for details
275-0020-001
DEM Power Supply
APR-1
Computer System:
Computer
Monitor
Power Cables
271-0112-005
271-0113-001
Depends on Geography
Contact Sales for details
43 | P a g e
APPENDIX E: EXCHANGE PROGRAM
DSI Exchange allows customers to exchange their used telemetry
implants for replacement implants at a fraction of the original purchase
price.
We ensure that each implant manufactured as part of DSI Exchange
meets or exceeds design expectations for guaranteed performance and
quality. Participating in DSI Exchange contributes to a decrease in the
overall cost of each customer's study.
Construction
Ea h i pla t is ha d asse led D“I’s highl skilled te h i ia s a d
receives 100% inspection to ensure that all components meet our quality standards
A new battery is installed to guarantee functionality over the warranty period
Several steps ensure that a biocompatible device guaranteed to perform to specifications IN VIVO is delivered:
Packaging in a biocompatible housing
Attachment of biopotential leads and catheters to provide signal fidelity
Pre-shipment sterilization
Calibration
Mechanical and electrical testing of all components to guarantee optimal functionality
Full calibration of each physiologic signal followed by testing to ensure accuracy specifications are met or
exceeded when used as intended. Signals include: temperature, pressure, biopotential, and respiratory
impedance
Each implant includes a calibrations label on the sterile package to document that the device has been
calibrated for accuracy
Certification
Each implant shipped from DSI has the same warranty policy and is guaranteed to operate exactly the same every time.
Implants that are received through the exchange program are like a new product. Exchanged implants are purchased
for a fraction of the cost of new devices, which reduces ongoing study costs while maintaining data quality and accuracy.
Already Participating?
DSI now has the option for researchers to pre-pay for their exchanges ahead of time and send implants back to DSI for
exchange right away. This can shorten the internal purchasing order process and ensure that budget dollars are
retained for future telemetry studies. Just give Customer Service a call when the devices are needed and we will
maintain inventory for you. This e a les usto e ’s i te al p o essi g a d lead ti e to e o e sepa ate from the DSI
product lead time so studies can get up and running faster. Giving DSI advanced notice may also decrease lead times on
44 | P a g e
special device configurations. Consider using the Pre-pay Exchange Program or the new Exchange Manager to help
manage telemetry studies.
APPENDIX F: RETURNING PRODUCT TO DSI
A detailed updated procedure for properly returning telemetry products to DSI for product investigation is provided on
our website, www.datasci.com. The following additional considerations should be made:
To e o e ed u de the a ufa tu e ’s a a t , the implants must be returned for exchange within the
warranty period (listed in the implant specifications).
Ensure that the implants are well packed, preferably in their original packaging and boxes.
Return the implants via a traceable shipping method to prevent losses in transit.
Exchange forms are available on our website www.datasci.com
001465-001: DSI Exchange Form USA
001549-001: DSI Exchange Form Europe
004540-001: DSI Exchange Form International
Contact DSI Technical Services with any concerns or comments regarding the performance of the devices upon
receipt and after the first use.
Forms needed for returning products for investigation:
Product Investigation Form (PIF) – printed email sent from Technical Support
45 | P a g e
APPENDIX G: DEVICE WARRANTY
The most up to date DSI Telemetry Products Official Warranty is on the website. A summary is provided here.
Overview
DSI has a broad range of implants for application from mouse to large animal models, and warranty periods vary based
on the implant model and its intended application. DSI also offers warranties on our non-implanted hardware products,
typically of one year duration. This version of the warranty policy will be in effect as of December 1, 2009 and will
supersede any previous warranty policies or references to the warranty in other printed materials.
DSI Implant Excha ge Progra
Warranty Details
When sent back to DSI, each implant’s athete s, leads, atte ies, a d housi g a e epla ed. The sa i gs is i the e -use
of the electronics which are thoroughly tested and calibrated to the same standards as a brand new module. Even the
electronics are replaced (DSI absorbs the cost) if it does not meet DSI specifications. The esult is a good as e
implant with the same warranty coverage as a new implant – but at a much lower price.
The Exchange Program pricing remains available until the implant model goes out of production. The only restriction is
that implants must be carefully handled and returned in visually good condition. Implants with significantly damaged
housings (i.e. beyond normal wear and tear such as animal chewing) will not be available for the Exchange Program.
Implant Warranty Duration Details
DSI warrants to customers that, for each of the warranty periods, DSI implanted implants and other products shall
o fo to D“I’s appli a le pu lished spe ifi atio s i effe t at the ti e of ship e t, a d shall e f ee f o defe cts in
materials and workmanship.
For implanted implants, the Warranted Battery Life Period shall e the agg egate of the pe iods of atte o ti e .
For example, if the battery is turned on for use on January 1 and turned off on March 1 of the same ye ar, the individual
period of battery on time would be two (2) months. If all periods of battery on time exceed the Warranted Battery Life
Period when added together, the device is no longer under warranty. The Warranted Battery Life Period is specified per
implant model.
The Warranted Implant Period is the period of time over which DSI warrants the device to perform in-vivo in
accordance with specifications. For example, if a device is implanted in a research subject on January 1 and later
removed on March 1 of the same year, the individual period of in-vivo use would be two (2) months. If the cumulative
total of all periods of in-vivo use exceed the Warranted Implant Period, the device is no longer under warranty. If
customers implant DSI implantable telemetry devices for longer periods of time than the Warranted Implant Period, the
customers assume all risk of device failure, compromised data quality or other adverse effects. This is because DSI does
not a a t the pe fo a e to D“I’s pu lished spe ifi atio s fo de i es that ha e ee i pla ted lo ge tha the
Warranted Implant Period.
The Ma i u Warra t Period is the continuous period commencing on the date that each product is shipped to the
customer and shall continue for the specified number of months. If implants are returned to DSI beyond this date for
any reason, the product is no longer covered free of charge under warranty and the customer will be charged for a new
device if replacement is required. Even if it is out of warranty it can still be used in the Exchange Program as long as the
product is still in production, but it will not be replaced for free.
46 | P a g e
D“I’s appli a le pu lished spe ifi atio s su h as a u a a d othe pe fo a e pa ameters are valid only within the
shorter of (a) the Warranted Battery Life Period (b) the Warranted Implant Period and (c) the Maximum Warranty
Period. Device operation and data collection outside of warranty is done at the sole discretion and risk of the customer.

---

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