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Primetech iPRECIO SMP-300 User Manual

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Summary of Contents for Primetech iPRECIO SMP-300

  • Page 2: Introduction

    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 www.iprecio.com...
  • Page 3 ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO 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.

  • Page 4: Table Of Contents

    ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO Table of contents INTRODUCTION ....................2 TABLE OF CONTENTS ..................4 ® ABOUT IPRECIO ....................6 ’ ........6 HE WORLD S FIRST IMPLANTABLE PROGRAMMABLE INFUSION PUMP ® PRECIO ..................7 ENEFITS OF I ..................
  • Page 5 ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO 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 ........................

  • Page 6: About Iprecio

    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.

  • Page 7: Roduct Omponents

    ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO ® 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...

  • Page 8: System: Smp-300/Ucd-300

    ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO ® Structure of the iPRECIO System: SMP-300/UCD-300 Top view Bottom view Number name ① Septum Port ② Outlet tube ③ Wire Antenna ④ Reservoir ⑤ Micro Cam ⑥ Pump ID label ⑦ Power Switch ⑧...

  • Page 9: Workflow

    ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO 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 ®...
  • Page 10 ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO 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.

  • Page 11: Product Warranty

    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™...

  • Page 12: Infusion Volume/Battery Life Guideline

    ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO 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.

  • Page 13: Detect And Programming Time Guidance

    <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.

  • Page 14: Installation Of Management Software

    ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO 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 ...
  • Page 15 ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO 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>...
  • Page 16 ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO 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.

  • Page 17: Cable Connection Of Data Communication Device: Ucd-300

    ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO 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.

  • Page 18: Tcp/Ip Connection Between Data Com Unit And Control Pc

    ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO 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.

  • Page 19: Software Set-Up

    ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO 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.

  • Page 20: User Registration

    ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO 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>.

  • Page 21: Enable Access Control

    ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO 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>...

  • Page 22: Customize Information

    ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO Customize information Pull down menu for registration and management for Study Information, Keep Vein Open (KVO) flow-rate default setting. Modify default setting if required. 1. Open customize window from “Customize (Z)” menu in the tool bar. 2.

  • Page 23: Start Study

    ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO Start Study Start New Study ® iPRECIO Management software has a function to abort individual animals/pumps during KVO and also during administration phase. For example, it is possible to exclude animal(s) from a study by using <abort> for that animal(s). Also, during Administration phase it is possible to deselect individual animals for any reason.
  • Page 24 ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO 1. Click <New> from the File Menu Bar. 2. Study Header window opens. (*) marked items are mandatory. 3. After filling required information, click <Next>. 4. Pumps and Animals setting window opens. Input the required number of animals (pumps) for the study in the Number of Animals and click <Set>.

  • Page 25: Catheter Connection And Pump Activation

    ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO Catheter connection and Pump activation. Add/cut catheter to length, fill, and activate the pump by switching ON pump. Once pump is on and activated, communications are enabled. Default setting on Power ON <1 minute> communications availability. iPRECIO Pumps are delivered with all fingerpins down to facilitate filling where air escapes through open catheter.
  • Page 26 ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO 4. Firmly hold pump down with finger(s). Then, press down firmly to Power ON pump. If the pump moves/rocks during this process, solution will be pushed out of the reservoir. A blunt pointed tool like forceps is ideal. Take care not to damage silicon coating.

  • Page 27: Pump Detection

    ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO Pump detection 1. Place the pumps and data com device, UCD-300, within 1 m range. 2. Enter <Number of Animals> or number of pumps for the study. 3. Click <Detect> to start detecting pumps. Progress bar is displayed and will continue until all pumps detected.

  • Page 28: Kvo Setting, Dead Volume Setting, Start And Complete

    Important Note. Primetech recommends that the KVO and flushing steps are included within <Infusion Profile>/Group ID to allow full pump programming prior to implantation. Note that it is important to review this section to understand the concept behind KVO, dead volume and flushing durations.
  • Page 29 ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO 3. Input the required information for dead volume calculation and click OK button. To use <Dead Volume Setting> correctly, make sure the <Enable> checkbox is selected and the information is accurately filled. If not accurately filled, the dead volume calculation will not be correct and this will impact when the Drug or Test Article(TA) hits the animal.
  • Page 30 Important Note. Primetech recommends that the KVO and flushing steps are included within <Infusion Profile>/Group ID to allow full pump programming prior to implantation. See < There are two options for KVO settings> later. If KVO function used, KVO flow-rate/duration, and dead volume flushing will consume battery power.

  • Page 31: Create / Group Id

    ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO Create <Infusion Profile> / Group ID The <Infusion Profile> / Group ID will define the iPRECIO Micro Infusion Pump infusion protocol. The pumps will infuse/administer test article (TA) or vehicle/saline in the reservoir according programmed <Infusion Profile>.
  • Page 32 ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO shown in elapsed time with all the steps (including Repeat if used) accumulating in duration. The battery life shown in the bottom of window indicates the expected battery life for a new pump (new battery). It will help to create an <Infusion Profile>/Group ID.
  • Page 33 <Repeat End>. Number of steps in the <Infusion Profile>/Group ID will define the number of pump logs created. See Appendix D under section <iPRECIO SMP-300 pumps has an internal memory to hold a maximum of 28 logs>.

  • Page 34: There Are Two Options For Kvo Settings

    ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO There are two options for KVO settings 1. <KVO> with <Dead Volume Setting> enabled (described in a previous section and briefly again hereafter) 2. Programming KVO, exchange and dead-volume flushing within <Infusion Profile/Group ID>. Refer also to Workflow Guide provided separately and Important Notes on page 36 ◆...
  • Page 35 ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO If an additional catheter is used, the volume should be entered. Alternatively, Use Application software to calculate based on Diameter of Additional Catheter and length. Unless Total Dead Volume is accurately filled/calculated, the dead volume flushing step will not be accurate.
  • Page 36 ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO ◆ Preprogrammed KVO with <Dead Volume Setting> KVO, exchange stop time and dead volume flushing programmed within <Infusion Profile/Group ID> Refer also to Workflow Guide provided separately and Notes below Pros 1. KVO, exchange time stop, flushing and <Infusion Profile/Group ID> in one programming step 2.
  • Page 37 ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO Step1. KVO infusion flow-rate and duration Step2. Exchange time 0 flow-rate and duration Step3. Infusion flushing rate and duration Step4 – Step15. Administration Please calculate the dead volume using <Dead Volume Setting> in application ...

  • Page 38: Infusion Protocol Setting

    ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO Infusion Protocol setting Following KVO function (if used), click <Next>. If KVO function not used, click <Infusion Protocol> to skip KVO function and dead volume flushing options. 1. Group information window appears. 2. Choose infusion Group ID (Infusion Profile) from Group ID pull down menu and set Administration Start Time.

  • Page 39: Start Infusion Protocol

    ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO Start Infusion Protocol See Table on Page 13 for Detect and Programming Time Guidance to allow sufficient time to program the pumps. If insufficient time is given, infusion profiles may start with a delay and the only way to correct for this is to abort and re-start the study. 1.
  • Page 40 ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO o Light Green <Programmed> - Pumps will start infusing as programmed with <Communication Availability> not finalized yet. o Dark Green (Green) <Administrating> Pumps will start infusing as programmed with <Communication Availability> finalized. o Dark Blue (Blue) <Administrating> - Pumps started infusing with delay with <Communication Availability>...

  • Page 41: Monitor The Pump Status

    ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO 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.
  • Page 42 ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO 2. Upper part of window shows Study Name, Group and Animal. Select Group ID from pull down menu in Group column and Animal ID from Animal column. 3. There is a <Refill Log Table> in the Right side. First input the Test Article or saline refill time and volume, then click <Calculate>...

  • Page 43: Replace And/Or Refill The Test Article

    ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO Replace and/or Refill the test article 1. Open Monitor (M) window. 2. Verify the estimated remaining volume in the bottom area of window. 3. Anesthesia the animal with isoflurane or fast acting anesthesia. 4. If required, extract and measure the remaining volume in the reservoir with a 27G needle syringe through the septum port and then refill using the same syringe.

  • Page 44: End Of Study

    ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO End of Study After all infusion protocol finished, click <Study End>, Data from the study are automatically saved. If the study needs to be cancelled before the end, click <Abort All> then click <Study End>. Make sure <Study End> is clicked before closing software to save all data collected.

  • Page 45: Reviewing Saved Study Data With Monitor Function

    ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO Reviewing saved Study Data with Monitor function After the study, previous study data can be reloaded. This is done using the Monitor function. This can be done only if there is no study running or open. Click on <Monitor>...
  • Page 46 ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO When all the logs were not collected due to overwriting of the logs (logs skipped), Communication Availability, Wireless conditions etc., a yellow rectangle/box will be displayed. The yellow box will start from the last received log until the next log (received log).

  • Page 47: How To Re-Program A Pump

    ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO How to Re-Program a Pump When you want to change the infusion profile after the original protocol is complete or after aborting the study, iPRECIO software allows you to change the status of the pumps to re-program them.
  • Page 48 ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO <Recommended Procedure for re-using the pumps> 1. Open Utility Pump BaseStation Manager and click <Connect> and <GetPumpList>. 2. Click <Delete All> or <Delete> only the pumps which will no longer be used. *If the old pumps’ IDs are left in UCD-300, communication time will be assigned for all the pumps in memory.

  • Page 49: Product Specifications

    ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO Product Specifications ® Micro infusion pump for small laboratory animal iPRECIO （Model:SMP-300） Administration method Rotary finger type (Patented: Peristaltic mechanism) Reservoir 130μL Built-in reservoir: (Material) Medical grade SIBS The Maximum capacity is 130 μ L. ± 5% flow accuracy when reservoir is filled between 30 to 130μL.
  • Page 50 ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO Data com unit (Model UCD-300) Interface with control PC LAN ( Cross type cable with ferrite core) Control through Ethernet by setting fixed IP address to the Data com unit. Wireless Communication FCC: 916.15 MHz – North America CE: 864.35 MHz –...

  • Page 51: Appendix A: Table Of Commands

    ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO Appendix A: Table of Commands List of the active commands for IMS-300 software; their (1) Actions (2) Limitations and (3) Comments summarized. Comments/ Action Limitations Recommendations Continue to search for the number If pump not found, will continue Detect of pumps entered until found.
  • Page 52 ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO Comments/ Action Limitations Recommendations No positive confirmation from Will attempt to abort all pumps pump(s) and pump(s) will across all groups. No positive continue to infuse until aborted, UCD-300 will send the Administration confirmation to software from protocol complete or out of battery abort signal until <Abort All>...

  • Page 53: Appendix B: Modify The Ip Address Of Data Communication Device

    ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO Appendix B: Modify the IP address of Data Communication Device Factory Default Network Settings Factory Default Settings of UCD-300 Management Device is below: Headings Default Settings IP address 192.168.1.10 Network mask 255.255.255.0 Default Gateway 192.168.1.1 User Name admin...
  • Page 54 ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO Modify the IP address of Data Communication Device Manually Input a different IP address 1. Uncheck the check box of the ‘use DHCP’ on the Network Settings Screen. 2. Input the IP address other than 192.168.1.10. (e.g. 192.168.1.12/ 192.168.1.15 etc) 3.

  • Page 55: Appendix C: How To Confirm If The Ucd-300 Is Working Correctly

    ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO Appendix C: How to Confirm if the UCD -300 is Working Correctly Green Light On: UCD-300 is correctly plugged with power supply Green Light Off: UCD-300 is not plugged correctly or UCD-300 is not working Orange Light On: If the orange light is on for more than 5 mins, the UCD-300 is not working properly.

  • Page 56: Appendix D: Communication Availability

    ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO Appendix D: Communication Availability Communication Availability <Comms Avail.>: The figure below shows how Communication Availability works for programming and logs. Programming includes detecting, KVO, Flushing, Administrating, Abort etc. For <Every Minute> setting the system has the highest responsiveness where the ...
  • Page 57 3 hour window following <Completion of Programming of each pump> Following this 3 hour window, Communication Availability cycle starts. iPRECIO SMP-300 pumps has internal memory to hold a maximum of 28 logs. If an <Infusion Profile/Group ID> will create more than 28 logs, then it will be possible that some of the logs are overwritten.
  • Page 58 2. The log before the aborted step will not be available also. 3. Logs do not affect pump performance. See appendix E for example logs. For additional information refer to FAQ or contact Primetech Corporation or Authorized Distributor. www.iprecio.com...

  • Page 59: Appendix E: How To Use The Log Data

    ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO Appendix E: How to use the Log Data csv log data may be exported during or after the study. All data collected will be exported. Data including all study parameters and logs<when the pump received the study schedule>, <start of infusion>, <when the study aborted from the log data>...
  • Page 60 ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO <Group Information>> In this section, Group ID, Compound ID, Concentration and Weight Range are recorded. <Animal Information> In this section, individual animal information such as Animal ID, Group ID, Weight, Sex, Age, Species etc. are recorded <Infusion Schedule>...
  • Page 61 ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO <KVO> In this section, actual KVO start/ end time and calculated dead volume and flushing duration etc. There is no information about KVO flow rate in here, details are in <Basic Information> or <KVO log> section. <Infusion Log>...
  • Page 62 ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO <2015/02/03 13:09:23 : Received a Schedule> When pump programmed <2015/02/03 13:09:29 : 10.0[ul/hr] Pump started at 2015/02/03 13:09:29 with a flow-rate of 10ul/hour <2015/02/03 14:14:00 : 0.0[ul/hr] Pump stopped infusion at 10ul/hour at this time and started with a flow-rate of 0.0ul/hour <2015/02/03 14:44:00 : 10.0[ul/hr] Pump stopped infusion at 0ul/hour at this time and started with a flow-rate of...
  • Page 63 ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO <KVO Log> In this section, the exact time of KVO start/ end and KVO flow-rate are recorded. Same nomenclature as <Infusion Log> <KVO Refill Log> In this section, refill logs during KVO are recorded. If data not filled during study, in the application software, no data will be available.

  • Page 64: Appendix F: Pump Status: Example In Infusion Protocol Setting Window

    ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO Appendix F: Pump Status: Example in Infusion Protocol Setting Window Detailed explanation in Appendix G for advanced users. Pump Status Brief Details Programmed Pumps(s) will start as programmed but awaiting positive confirmation for <Communication Availability> programming Light Green Administrating Pump(s) may be implanted...

  • Page 65: Appendix G: Detailed Pump Status

    ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO Appendix G: Detailed Pump Status Towards the end During Pump Status of Infusion Detailed Explanation Programming Duration At start time, pump will start as programmed but no positive confirmation from <Received a schedule> Even if pump started and in absence of Pumps will finish <Received a schedule>, Status will show as on time or finished...
  • Page 66 ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO Towards the end During Pump Status of Infusion Detailed Explanation Programming Duration Within 1-2 minutes of being programmed, pump will start but no positive Pumps will finish confirmation from <Received a schedule> after study Even if pump started and in absence of duration <Received a schedule>, Status will show as...
  • Page 67 ® SMP/UCD-300 User’s Manual ver.2.2.4.e iPRECIO Towards the end During Pump Status of Infusion Detailed Explanation Programming Duration Dark blue means <communication Pumps will finish availability> confirmed. <Received a Administrating Pumps started (xx after study schedule> received. (xx delay with delay) with xx duration Pump will finish after study duration...

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