Primetech iPRECIO SMP-300, iPRECIO IMS-300 User Manual
iPRECIO® SMP/UCD-300 User’s Manual ver.2.2.4.e
Introduction
We would like to thank you for purchasing iPRECIO®.
iPRECIO® allows for accurate intracorporeal administrations of small-volumes over
extended durations.
The iPRECIO® User’s Manual for programming and operation of iPRECIO®.
The iPRECIO® is prohibited for human use.
When using iPRECIO® , please follow all appropriate guidelines, processes, and
protocols mandated by the institution at which experimentation is performed.
NOTICE TO THE USER
One or more of the following statements may be applicable for this equipment.
Notice (For Model UCD-300 only)
The provided LAN Cable with a ferrite core shall be used when connecting the UCD-300 to a
PC and do not replace the LAN cable with other LAN cable.
FCC WARNING
FCCID: 2ACHIUCD300/2ACHI300
This device complies 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
accept any interference received, including interference that may cause undesired operation.
Changes or modifications not expressly approved by the manufacturer could void the
user’s authority to operate the equipment.
For more information:
PRIMETCH CORPORATION
TEL：+81-3-3816-0851 E-mail : iprecio@primetech.co.jp
URL ：www.iprecio.com
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iPRECIO® SMP/UCD-300 User’s Manual ver.2.2.4.e
INFORMATION TO THE DIGITAL DEVICE USER REQUIREMENT by FCC
(For Model UCD-300 only)
This equipment has been tested and found to comply with the limits for a Class B digital
device, pursuant to part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential installation. This
equipment generates, uses and can radiate radio frequency energy and, if not installed and
used in accordance with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in a
particular installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off and on, the
user is encouraged to try to correct the interference by one or more of the following
measures:
—Reorient or relocate the receiving antenna.
—Increase the separation between the equipment and receiver.
—Connect the equipment into an outlet on a circuit different from that to which
the receiver is connected.
—Consult the dealer or an experienced radio/TV technician for help.
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iPRECIO® SMP/UCD-300 User’s Manual ver.2.2.4.e
Table of contents
INTRODUCTION ................................................................................................ 2
TABLE OF CONTENTS ......................................................................................... 4
ABOUT IPRECIO® .............................................................................................. 6
THE WORLD’S FIRST IMPLANTABLE, PROGRAMMABLE, INFUSION PUMP .................................... 6
BENEFITS OF IPRECIO® ........................................................................................ 7
PRODUCT COMPONENTS ......................................................................................... 7
STRUCTURE OF THE IPRECIO
WORKFLOW ....................................................................................................... 9
PRODUCT WARRANTY ...................................................................................... 11
INFUSION VOLUME/BATTERY LIFE GUIDELINE ................................................ 12
HOW TO SAVE BATTERY LIFE .................................................................................. 12
DETECT AND PROGRAMMING TIME GUIDANCE ................................................ 13
®
SYSTEM: SMP-300/UCD-300 ......................................... 8
INSTALLATION OF MANAGEMENT SOFTWARE .................................................. 14
PREPARATION BEFORE START ................................................................................... 14
INSTALL IPRECIO
CABLE CONNECTION OF DATA COMMUNICATION DEVICE: UCD-300 ..................................... 17
TCP/IP CONNECTION BETWEEN DATA COM UNIT AND CONTROL PC ...................................... 18
SOFTWARE SET-UP .......................................................................................... 19
RUN THE MANAGEMENT SOFTWARE ............................................................................ 19
USER REGISTRATION ............................................................................................ 20
ENABLE ACCESS CONTROL ..................................................................................... 21
NETWORK SETTING .............................................................................................. 21
CUSTOMIZE INFORMATION ...................................................................................... 22
START STUDY .................................................................................................. 23
START NEW STUDY .............................................................................................. 23
CATHETER CONNECTION AND PUMP ACTIVATION. ........................................................... 25
PUMP DETECTION ................................................................................................ 27
KVO SETTING, DEAD VOLUME SETTING, START AND COMPLETE .......................................... 28
CREATE <INFUSION PROFILE> / GROUP ID ................................................................. 31
THERE ARE TWO OPTIONS FOR KVO SETTINGS .............................................................. 34
INFUSION PROTOCOL SETTING ................................................................................. 38
START INFUSION PROTOCOL ................................................................................... 39
MONITOR THE PUMP STATUS ................................................................................... 41
REPLACE AND/OR REFILL THE TEST ARTICLE ................................................................. 43
END OF STUDY ................................................................................................... 44
SAVE STUDY FILE ................................................................................................ 44
EXPORT STUDY FILE ............................................................................................. 44
®
MANAGEMENT SOFTWARE .............................................................. 14
REVIEWING SAVED STUDY DATA WITH MONITOR FUNCTION........................... 45
HOW TO CHECK IF ALL THE PUMPS LOG DATA WERE COLLECTED ........................................... 45
HOW TO RE-PROGRAM A PUMP ........................................................................ 47
UTILITY SOFTWARE ............................................................................................. 47
CHANGE PUMP CONDITION/ STATUS .......................................................................... 47
PRODUCT SPECIFICATIONS ............................................................................. 49
APPENDIX A: TABLE OF COMMANDS ................................................................ 51
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iPRECIO® SMP/UCD-300 User’s Manual ver.2.2.4.e
APPENDIX B: MODIFY THE IP ADDRESS OF DATA COMMUNICATION DEVICE .... 53
APPENDIX C: HOW TO CONFIRM IF THE UCD-300 IS WORKING CORRECTLY .... 55
APPENDIX D: COMMUNICATION AVAILABILITY................................................ 56
APPENDIX E: HOW TO USE THE LOG DATA ....................................................... 59
APPENDIX F: PUMP STATUS: EXAMPLE IN INFUSION PROTOCOL SETTING WINDOW
....................................................................................................................... 64
APPENDIX G: DETAILED PUMP STATUS ............................................................ 65
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iPRECIO® SMP/UCD-300 User’s Manual ver.2.2.4.e
About iPRECIO®
The world’s first implantable, programmable, infusion pump
iPRECIO® SMP-300 model is the world's first completely implantable, programmable,
wirelessly programmable micro-infusion pump system for experimentation in small
laboratory animals such as mouse. The pump has a built-in microprocessor which can be
programmed to administer small volumes, in vivo, for extended durations. Additionally,
the pump houses a septum designed for percutaneous access, through which filling and
exchange of solutions is made possible. The iPRECIO® system’s highly precise, in vivo
capabilities uses a patented, high accuracy, mechanical pump technology, the “Rotary
Finger Method”. This method is a unique form of peristalsis. The precise “micro-stick”
pushes a rubber tube in the pump in a uniform and sequential manner. This was
developed by Primetech.
SMP-300 pumps are wirelessly programmed using proprietary technologies incorporated
in the UCD-300 programming station, application software and pumps. Using these
technologies, the IMS-300 system, may be programmed to have maximum battery
duration or maximum responsiveness. Maximum battery duration would mean the
pumps would be available less often for re-programming/communicating. Maximum
responsiveness would mean the pumps would be available more often for
reprogramming but battery life significantly reduced. See Table on page 12 and
Appendix D: Communication Availability for more detailed description. Once wirelessly
programmed, the iPRECIO SMP-300 Pumps will infuse as programmed until
completed or aborted.
In addition to infusing independently once programmed, the pumps will also provide logs
to confirm certain operations of the pump. At each event, a log is created with a
Timestamp. These logs include <Received a Schedule>, <Start of Infusion>,
<Flow-rate change>, <Finished>, <Complete> etc. More details can be found in
Appendix D and E. Appendix E: How to use the Log Data shows an example of Log
Data from an infusion.
During the study, these logs may be exported to have a permanent record of the
study as it progresses. See <Export Study File> on page 44.
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iPRECIO® SMP/UCD-300 User’s Manual ver.2.2.4.e
Benefits of iPRECIO®
Highly precise delivery
Unique peristaltic mechanism
Patented Rotary Finger Method
Every pump is factory tested and calibrated
Better than +/-5% accuracy
Totally implantable into subcutaneous space
Programmable (requires Windows 7/ 8/ 8.1 and LAN port)
Refillable percutaneously through a septum
Wireless Communication
Battery life of up to 46 days (with continuous infusion of flow rate as 0.1uL/hr and
communication interval setting as <none>)
Product Components
iPRECIO® system configured with the following parts:
iPRECIO® Micro-Infusion Pump SMP-300
iPRECIO® Management System IMS-300
Data Communication Device UCD-300 (including AC adapter, LAN cable)
iPRECIO® Management Software Installation CD
iPRECIO® User’s Manual
(L) SMP-300 sterile pump 5pcs/box (R) UCD-300 including AC adaptor, LAN cable
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iPRECIO® SMP/UCD-300 User’s Manual ver.2.2.4.e
Number
name
①
Septum Port
②
Outlet tube
③
Wire Antenna
④
Reservoir
⑤
Micro Cam
⑥
Pump ID label
⑦
Power Switch
⑧
LAN cable connect port
⑨
AC Adaptor connect port
⑩
Dual Antennae (full length of antenna 5 cm)
Top view
Bottom view
Structure of the iPRECIO® System: SMP-300/UCD-300
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iPRECIO® SMP/UCD-300 User’s Manual ver.2.2.4.e
Workflow
You should begin implantation of the iPRECIO® according to the following workflow.
Make sure there is sufficient time to fill, activate and program all pumps prior to
implantation.
1. Installing the iPRECIO® Management System
Install the iPRECIO® Management Software that is required for the iPRECIO®
Management System.
LAN Interface Arrangement
Set a connection between the data communication device, UCD-300, and the
software.
User Registration
Certify the system by setting a study director and management software users
upon initial setup of the software.
Software Customization
Customize the Infusion Protocol Setup header screen’s pull-down menus: Section
Name, Animal Species, Animal Strain, and Administration Route by adding or
deleting the default pull-down menu options.
2. Starting a new Study
Input general information about the study
(Study name, animal ID, weight, etc.)
Filling the test article (TA) or saline (MA) into the reservoir and catheter
Fill the TA or MA into the reservoir with 27G syringe.
Activate the Pump
Use blunt-nosed forceps to press down firmly the black power button switch to
switch ON and activate pump
Pump Detection
Click Detect button to detect the pumps.
3. Start Keep Vein Open (KVO) and setup dead-volume protocol
If using KVO, setup infusion flow rate for KVO and <dead volume setting> for
accurate flushing of dead volume and Click <KVO Start>. Use <Skip KVO> if not
required prior to drug infusion.
4. Start Infusion Protocol
Program <Infusion Profile> or choose infusion Group name from Group ID pull
down menu and set the administration start time. Make sure there is sufficient time
to program all the pumps (dark green status (green)) before infusion start time.
Click <Start All> or <Start> for each pump to start the programming process.
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iPRECIO® SMP/UCD-300 User’s Manual ver.2.2.4.e
5. Implantation
Implant pumps only after all the pumps have been completely programmed as
described in step 4. (<Administrating> dark green status)
6. Status Management
The management software will predict the administration schedule based on the
programmed protocol and will suggest when the pump needs refilling.
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iPRECIO® SMP/UCD-300 User’s Manual ver.2.2.4.e
Product Warranty
Primetech Corporation (“Primetech”) warrants to the customer of iPrecio™ products
(including the iPRECIO™Micro Infusion Pump and the iPRECIO™ Management System
and related products) that, for the warranty periods set forth below, the iPrecio™
products that Primetech and its authorized distributors have sold to the customer shall
be free from defects in materials and workmanship. Primetech does not warrant that
its products will meet the customer’s requirements or will operate in the combinations
(including with products not supplied by Primetech) which may be selected for use by
the customer.
Customer’s sole and exclusive remedy under the foregoing limited warranty is that
Primetech will repair or replace, at the Primetech’s option, any iPrecio™ product which
is defective in materials or workmanship during the warranty periods set forth below at
no cost to the customer, so long as such defect is not caused in transit or by customer’s
negligence, alteration, operation contrary to instructions, misuse, abuse, or parts or
accessories not supplied by Primetech. Any defective product must be returned to
Primetech for repair or replacement, transportation prepaid, and must be
accompanied by a returned equipment declaration with RMA number supplied by
Primetech.
Warranty Period:
iPRECIO® Micro Infusion Pump SMP-300: 12 months after manufacture
iPRECIO® Management System IMS-300: 12 months after shipping date
The foregoing limited warranty is in lieu of all other warranties, express or implied, including,
but not limited to, the implied warranties of merchantability and fitness for a particular purpose.
Limitation of Liability
Primetech’s liability for damages to the customers of iPrecio™ products for any cause
whatsoever, regardless of the form of action, whether in contract or tort, including
negligence, shall be limited to the amount the customer paid for the product or
products directly related to or which are the subject matter of the claim for damages.
In no event shall Primetech be liable for any loss or damage resulting in lost profits, or
other consequential, incidental, special or indirect damages of its customers of
iPrecio™ products, even if Primetech has been advised of the possibility of such
damages, or for any claim against its customers of iPrecio™ products by any other
party. This warranty is null, void, and of no effect if the customer, its agents or
employees, or any third party, uses the warranted iPrecio™ product for a use other
than the intended use of that product, which is for use in animals.
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iPRECIO® SMP/UCD-300 User’s Manual ver.2.2.4.e
Comms Avail.
Every Minute
Every 2hrs
Every 6hrs
Every 24hrs
None
Flow Rate
(uL/hr)
Drive Time
(hrs)
Drive Time
(hrs)
Drive Time
(hrs)
Drive Time
(hrs)
Drive Time
(hrs)
0.1
403
907
1025
1104
1139
1.0
352
681
745
785
803
5.0
243
362
379
389
394
10.0
169
218
224
227
228
Infusion volume/battery life guideline
The battery life is up to 42 days at a Flow Rate of 0.1uL/hr with communication
availability of 6 hours. Please refer to the Appendix D for more detail about
communication availability. As a guide, see the table below. The guaranteed battery
life is calculated by Application Software of IMS-300 system when setting up the
<Infusion Profile/Group ID>. When maximizing infusion durations, ensure that
that negative remaining battery is not displayed in the Group Profile. See page
31.
Please note that the conditions below reduce the battery life of pumps:
If you do not use the pump immediately/rapidly after power on.
After power on, internal circuit becomes active and starts to use battery
power by standby power requirement. Comms Avail. default setting is
every minute.
If you do not store under proper conditions. When pumps/batteries
are subject to frequent temperature swings and/or exposed to high
temperatures outside storage temperature range, self-discharge of
batteries are increased.
How to Save Battery Life
It is recommended to use communication availability of <every 24
hours>. This can save the battery life significantly compared to <every
minute>, <every 2 hours>, <every 6 hours> and <every 24hours> will give
almost same duration as <None> setting. This setting also provides the time
for the pump logs to be collected.
The table above and the Application Software <Infusion Profile>/Group
ID function will help the user select based on flow-rate requirements,
required durations and requirements for logs and programming.
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iPRECIO® SMP/UCD-300 User’s Manual ver.2.2.4.e
Detect
(minutes)
Programmed
Pump Status:
<Administrating
(dark green)>
abort
Log
(2 hour
Comms Avail)
1-10 pumps
1 to 10
20 minutes to 2
hours
immediate
1 to 2 hours
11-20 pumps
3 to 20
40 minutes to 3
hours
immediate
2 to 4 hours
21-30 pumps
5 to 30
80 minutes to 4
hours
immediate
4 to 6 hours
31-50 pumps
8 to 50
120 minutes to 6
hours
immediate
6 to 8 hours
Detect and Programming Time Guidance
When the management system is communicating with the pumps, a certain amount of
time will be required to complete the different processes. The exact time would be
dependent on the wireless conditions (noisy or clear), distance of pumps from
management system, number of pumps, the <Infusion Profile/Group ID> etc.
The table below is a theoretical example for a <2 hour communication
availability> with an <Infusion Profile/Group ID> for 5 steps.
In noisy environments and non-ideal conditions, it has taken up to several hours to
program pumps. If this occurs, contact your authorized distributor or Primetech
Corporation. Note that the table below is based both on ideal wireless conditions and
nosier environments.
Pumps to be within 1 meter of UCD-300 and according to recommended orientation
Check for additional guidance documents and/or contact authorized distributor or
Primetech Corp. iprecio@primetech.co.jp or call +81-3-3816-0851
Delete pumps from UCD-300 memory before each new study. Delete all pumps using Utility Pump
BaseStation Manager. See Pg 48 <Recommended Procedure for re-using pumps>.
If detection reliability not good enough, use Faraday Cage. See Troubleshooting in iPRECIO
Installation CD, “Faraday Cage to try to see if interference is the issue to date.pdf”
Pump: wake up 5 sec/min when communicating <Comms Avail>
Management System: 3 sec interval call
Pumps communicating time is automatically staggered to reduce waiting time.
Maximum steps in an <Infusion Profile/Group ID> is 15. If <Infusion
Profile/Group ID> is more than 5 steps, programming will take longer.
Abort does not mean that the pump(s) has stopped.
*UCD-300 will send the abort signal but there is no way to confirm if the pump will
receive the stop signal or not.
*During KVO step, use <Abort All> to go to the next step if required. If <Abort> is
used to stop the pump individually, the pump and log will no longer be available.
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iPRECIO® SMP/UCD-300 User’s Manual ver.2.2.4.e
Installation of Management Software
Preparation before start
iPRECIO® Management software install CD
Windows 7/8/8.1 (32bit or 64bit OS) installed and LAN port ready PC
Data communication unit UCD-300 (data communication unit)
UCD-300
AC adapter
LAN cable (Cross over cable with Ferrite core)
Install iPRECIO® management software
If the Application is closed, PC is switched off, sleeps, LAN disconnected or
power supply to UCD-300 Management System is lost, the Application software
cannot recover to monitor study status. Pumps will continue to infuse as
programmed.
Recommended PC settings:
Please TURN OFF the screen saver.
Go to control panel and change the Power option as “Never Sleep Mode”.
Please set the user account as “Administrators” (see picture below).
Windows Update: Change settings to download updates but let me choose
whether to install them.
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iPRECIO® SMP/UCD-300 User’s Manual ver.2.2.4.e
1. Run the “setup.exe” in an install CD.
2. When the startup window appears, click <Next> and follow instructions. Basically,
following the next feel steps. <Next> at Setup Wizard window.
3. Chose the default program files folder and click <Next> or modify as appropriate.
Subsequently the confirmation screen opens, click on <Next> to start the
installation.
4. When installation complete window appears, click <Close>.
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iPRECIO® SMP/UCD-300 User’s Manual ver.2.2.4.e
5. Click on the start menu <All Programs> <iPRECIO Management Software
IMS-300> to confirm that the following 3 Programs were installed:-
iPRECIO® Management Software IMS-300
Utility Base Station Manager
Utility Pump Database Manager
Usage of 3 Programs will be described within User Manual. All 3 will be required for
correct operation.
6. If installation was successful, all 3 programs will be available in <iPRECIO
Management Software IMS-300>
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iPRECIO® SMP/UCD-300 User’s Manual ver.2.2.4.e
Connect LAN cable to management device and software
installed PC
Plug the AC Adapter to outlet
power source:
100-240V, 50/60Hz
Cable connection of data communication device: UCD-300
Plug the AC Adapter to data communication device. Connect the communication
device and PC with LAN cable. Refer to Appendix C to confirm if the UCD-300 is
working correctly.
Ferrite core attached end must be connected to UCD-300 side.
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iPRECIO® SMP/UCD-300 User’s Manual ver.2.2.4.e
TCP/IP connection between data com unit and control PC
1. Connect data com unit (UCD-300) and control PC with LAN cable
2. Open Network and Sharing Center from control panel.
3. Click Change adapter setting, then right click on the data com Local Area Control
and open Properties.
4. Select Internet Protocol version 4(TCP/IPv4) property and input the following IP
address
IP Address: 192.168.1.11
Subnet mask: 255.255.255.0
Then press “OK”.
The Data communication unit factory default IP address configuration is 192.168.1.10. If IP
address does not work in default configuration due to conflict etc., change the IP address in
accordance with “Appendix B: How to change IP address of the Data communication unit”
5. Once the Data communication device and control PC is connected by Internet
Protocol, network connection <Network Setting> can be made in the management
software.
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iPRECIO® SMP/UCD-300 User’s Manual ver.2.2.4.e
Software Set-Up
Run the management software
Before running the software, put the cursor on the iPRECIO icon and right click to open
below window.
Go to Compatibility to check “use as an administrator” box.
The first time the management software is used, the user registration window will
open automatically. Register user information, user management and access control
as appropriate.
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iPRECIO® SMP/UCD-300 User’s Manual ver.2.2.4.e
User Registration
1. Input required information in the user registration window. The asterisk (*) marked
column must to be filled.
Institution & Department
Administrator
2. In addition, at least one operator registration is required. Input operator’s User
Name, Login ID and Password (Confirmation required), then click on <Add>.
The operator will then be listed in the table. Add as appropriate.
3. To use Access control, check the “Enable Access Control” check box. Detail of
Access Control function, refer to the next page, “Access control of software”.
4. Fill all required information then, click<OK> to finish the registration process.
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iPRECIO® SMP/UCD-300 User’s Manual ver.2.2.4.e
Enable Access Control
When using <Access Control Function>, the administrator can restrict and/or control
user access to the management software. To use this function, check the “Enable
Access Control” in the user registration window.
Once <Access Control Function> is active, Login ID and Password is required every
time the software is used.
Please record Login ID and Password carefully. Without username and
password, access to software will not be possible.
Network Setting
Connects IMS-300 Application Software to UCD-300.
1. Click network setting menu in toolbar.
2. Input default IP address (192.168.1.10) in the Host IP address column for the
data com unit.
3. Click <connect>
4. After confirming Status as <Connected>, close the window.
5. If the status column shows <disconnected>, check the IP address setting. Please
refer the “TCP/IP connection between data com unit and control PC”.
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