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iPrecio SMP-300 Micro Infusion Pump for Mouse Animal Model Infusion
SMP-300
SMP-300 structure

Primetech iPRECIO SMP-300 - Implantable Micro Infusion Pump

The World's First Totally Implantable, Programmable Micro Infusion Pump for Mouse Animal Model Infusion
Code
iPRECIO SMP-300

Primetech iPRECIO SMP-300 - Implantable Micro Infusion Pump


This implantable infusion pump uses a patented, microprocessor controlled peristalsis mechanism for accurate controlled flow. It is the only implantable and programmable pump for mice . iPRECIO® can infuse fluids continuously at accurate low flow rate via software programming and it can be refilled via a percutaneously accessible port.

SMP-300 Key Features

o   Accurate patented Rotary Finger Method

o   Every pump is factory tested and calibrated

o   Better than +/-5% accuracy

o   0 µl/hour to 10.0 µl/hour in 0.1μl/hour steps

101 discreet infusion flow-rates

o   Programmable infusions protocols (simple and complex)

o   Totally implanted in subcutaneous space

o   Refillable (reservoir) percutaneously via refill port with re-sealable septum

o   With iPRECIO® catheters, test your drug's effects nearly anywhere

o   Easy to use state of the art software for infusion protocol programming using profiles.

SMP-300 Pump's Structure

Implantable

The pump can be completely implanted in small laboratory animals subcutaneously. Thus, the animal moves freely without any restrain (i.e. tethering) during drug infusion. Additionally, infection risk is reduced, and the animal is likely to be significantly less stressed than in a tethered infusion model.

Refillable

You can replenish any medical fluid in the pump via percutaneous access to the pump refill septum and reservoir after implantation of the pump. Therefore, long-term drug infusion can continue until the installed battery life has run out. The reservoir is elastic and configured in such a geometry as to allow gentle palpation to confirm an approximate level of fluid in the reservoir.

Programmable

Using the easy to use state of the art iPRECIO® software, header information along with infusion profile details are entered and ultimately downloaded to the pump's flash memory. Start Time, End Time, Flow-rate (0.0µl/hour to 10.0µl/hour), and infusion profiles maybe programmed. These profiles include sustained release, modified release, chrono release and pulsatile release. A total of 15 steps with repeat function allows both complex and simple infusion profiles to be programmed.


A recovery period may also be programmed using the Keep Vein Open Function (KVO) where saline is initially filled in the reservoir. A dead volume flushing function also ensures that the test article (TA) hits the animal at the programmed time point.The programmable feature will make iPRECIO® pumps indispensable for applications where accurate flow infusion, recovery/washout periods, constant/variable dose or complex circadian infusion studies are necessary.In-vivo (re)programming allows refinement and adjustments to be made after initial effects are measured/detected.*subject to battery life

15 steps for flow rate or dose programming : 0.0 - 10.0 ul/hr

infusion unit Each flow profile may contain up to 15 doses or flow rate steps. A single step would mean a fixed continuous dose or flow-rate for the study duration. (unless re-reprogrammed in-vivo) A more complex infusion profile will contain more than 1 step and may contain up to 15 steps.

group profile

In addition to the 15 steps, Repeat Mode may be used. Repeat Mode allows more complex infusions like circadian rhythm, modified release, chrono release and pulsative release to be programmed for daily/weekly/etc repeats.
group profile
circadian protocol

Keep Vein Open (KVO) Function

A recovery period maybe programmed using the KVO function where saline or vehicle is infused to ensure patency of the catheter. During this time, the animal recovers from the implant surgery.

When using KVO mode, a function of the software allows to calculate the total dead volume of the catheter and pump to ensure that the test article (TA) or drug hits the animal at the programmed start time. Flushing of the dead volume maybe programmed by the user and the software automatically calculates when to exchange saline/vehicle to TA/drug.



Programming Workflow

Step1

Start of Study Design:
Study name, ID , user and date are input and saved.

Step2

Pumps and Animal Setting:
Here, total number of animals for study are entered and associated with an animal ID. Information including weight, sex, species, strain, administration site may be entered and saved.

Step3

Keep Vein Open (KVO) Setting
When requiring a recovery period following surgery, KVO setting maybe used to maintain catheter patency and also program a dead volume flush as a next step.

Step4

Infusion Protocol Setting
This is to program the TA or drug administration start time. It also includes the parameters for flushing the dead volume.

Communications Available (Comms Avail) is programmed in Group Prole/Infusion Protocol.

Monitoring Function

Monitor Function allows the user to follow the infusion profile in detail. Refill dates/exchange dates and alarms are also managed and displayed here.



Battery Life

The battery life is up to 52 days at a flow rate of 0.1μL/hr continuously. Battery life is calculated and estimated in iPRECIO® Software and this is dependent on pump switch on date, KVO duration, infusion profile and communication availability selected. These specications are subject to change for product improvements. Exact durations and calculations will be managed by the iPRECIO® Software. When used in preprogrammed (None/0 communication) mode battery life is maximized. When communications availability is set to 1 minute, maximum responsiveness is selected and this gives the lowest battery life.   
Communications availability does not mean that there will always be data or connection every minute.

Actual data will be dependent on wireless environment and infusion protocol.

Communication
availability/
Logging interval

Per minute

Every 2 hours

Every 6 hours

Flow rate
µL/hr

Drive time(hours)

Driving days(days)

Drive time(hours)

Driving days(days)

Drive time(hours)

Driving days(days)

0.1

403

16

907

37

1025

42

1.0

352

14

681

28

745

31

5.0

243

10

362

15

379

15

10.0

169

7

218

9

224

9


Communication
availability/
Logging interval

Every 24 hours

None


Flow rate
µL/hr

Drive time(hours)

Driving days(days)

Drive time(hours)

Driving days(days)

0.1

1104

45

1139

47

1.0

785

32

803

33

5.0

389

16

394

16

10.0

227

9

228

9

∗ Depending on wireless environment, infusion protocol programmed, communication availability/logging interval, pump logs maybe overwritten before being collected.
∗∗ Table above outlines the maximum battery life for the programmed protocol and pump switch on time. Exact battery life will be dependent on pump switch on time, programmed infusion protocol, and selected communication availability. iPRECIO Management software helps the user calculate battery life for selected programming.

Wireless

SMP-300 Micro Infusion Pump allows in-vivo re-programming for maximum exibility. If no effect is detected, pump may be re-programmed to infuse at a higher flow rate. A higher concentration drug/TA may also be used.

Communications Availability (Comms Avail) of SMP-300 may be programmed to maximize battery life or maximum responsiveness. Options are provided in both KVO setting and Group Prole (Infusion Protocol) setting.


Precision

The technology driving the infusion is a patented "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. The accuracy of iPRECIO is +/-5%.



Specifications

Micro Infusion Pump iPRECIO®

Infusion Method Rotary Finger Method (patented peristalsis)
Reservoir 130μL Built-in Elastic Reservoir (Medical Grade SEBS)
Tubing
Inner Tubing : (Material)Medical Grade SEBS
Outer Tubing : (Material)Medical Grade SEBS (3Fr)
(Size) Inner Diameter :0.55mm / Length :approx. 140mm
Refill Port φ2mm refill port is on the top of the pump.
Data Communication
Wireless (Frequency : 916.15 MHz *North America / FCC)
             (Frequency : 864.35 MHz *Europe / CE)
Communication Distance :
3 meter radius of transmitter (This is based on open field condition)
Antenna A wire anntena attached to the pump (length: approx. 50mm, not removable) *Material of Wire anntena: Titanium (φ0.1mm), Coated by 1.2 Fr Polyurethane Tubing
Range of Flow Rate(FR) 0.0 - 10.0µL/hr (Resolution:0.1µL/hr)
*discharge volume by 1 time rotation of the cam:3.4µL
Accuracy ±5% (under 0 - 80cmH2O pressure)
Battery Life Continuous driving life : FR 0.1µL/hr:47 days、FR 10.0µL/hr:9 days for Comms Avail of 0 (none).
FR 0.1ul/hr 16 days and 10ul/hr 7 days for Comms Avail of 1 minute.
Activation Method Pump is activated by pressing down the power button placed on the bottom of the pump. On only. Cannot be switched OFF.
Size 24.8(L) x 15.0(W) x 7.2 (H) mm
(not including outer catheter and wire anntena)
Weight 3.3g (including outer catheter and wire anntena)
Volume 2.15cc
Type of Usage Disposable
Package EO Sterilized blister package (5pcs/box)
sterilization 2 years

iPRECIO® Management System

Data Communication Device
Interface Ethernet(crossed cable)
Operates via intranet/internet by setting fixed IP address with the data communication device.
Communication with Pump Wireless (Frequency: 916.15 MHz *North America / FCC)
             (Frequency:864.35 MHz *Europe / CE)
(Not broadband, individual communication between data communication device and pumps.)
Power Supply AC Adaptor and cable inclued. [Weight] 73g [Length of cable] 1.85m
[I/P] 100-240V 50/60Hz 25VA [O/P] DC 5V 2A
Size / Weight 120(L) x 77 (W) x 31(H) mm / 167g
Accessories included 1 Ethernet cable(3m)

Management Software
Study Management Study Information, Animal Information, Group Information
User Account Register, manage user account name and password,
Administrator Information
Automated Recognition of Pump Pump's ID and Calibration Factor are recognized by wireless data communication.
Pump Programming via Software
> Programmable Parameters Start day / time, Flow rate or Dose Setting, Duration of infusion
> Programming Infusion Steps You can configure in maximum 16 steps of flow rate (or volume) as needed. Also grouping of multiple steps and repeating such groups are available.
> Auto Calculation of Battery usage and infusion duration
When you input infusion protocol, it shows automatically remaining battery(time) and infusion duration (start and end time of each steps) on the window.
> Dead Volume Setting Using value calculated by catheter size(diameter) and length or input measured actual volume.
> Flushing Setting Available KVO Setting (Flow Rate : xx μL/hr, Duration :xx days)
You can load preset default values or set dead volume and flow rate for each study.
Monitoring, Management of infusion shcedule Manage infusion volume and schedule, Checking and record refill and replacement of infusate timing, Setting threshold of remaining volume in the reservoir, Showing alart inside the window
Log After infusion , you can export study data and infusion log in CSV format. Infusion log is transfered to the software in order by wireless data communication during infusion.
PC OS compatible Windows 7, 8, 8.1 (32 bit and 64 bit)
Japanese and English Language with major PC manufacturer


Data Communication Device (UCD-300) Management Software


*iPRECIO® Management System is sold as IMS-300 which consists of data communication device (UCD-300) and Management Software, User Manual.