Biorep Technologies PER-5.2 User manual

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PERFUSION APPARATUS
MODEL No: PER-5.2
______________________________________________________
USER MANUAL
______________________________________________________

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TABLE OF CONTENTS
1GETTING STARTED.......................................................................................................................... 3
1.1 SYMBOLS USED IN THIS MANUAL ................................................................................................... 3
1.2 MACHINE INFORMATION ................................................................................................................. 3
1.3 CONTACT INFORMATION ................................................................................................................. 3
1.4 SAFETY INFORMATION .................................................................................................................... 4
1.5 SITE PREPARATION.......................................................................................................................... 5
1.6 UNPACKING INSTRUCTIONS............................................................................................................. 5
1.7 PACKING LIST ................................................................................................................................. 5
2INTRODUCTION................................................................................................................................ 6
3MACHINE PARTS IDENTIFICATION ........................................................................................... 7
3.1 FRONT VIEW ................................................................................................................................... 7
3.2 REAR VIEW ..................................................................................................................................... 8
3.3 RIGHT VIEW .................................................................................................................................... 8
4ACCESSORIES.................................................................................................................................... 9
4.1 PERFUSION TRAY ............................................................................................................................ 9
4.2 DISPOSABLE TUBING SET WITH COIL (PER05-TUBHC-01) ..........................................................10
4.3 BIOREP THERMOPROBE (TC-01) ....................................................................................................10
5PERFUSION MACHINE SET-UP....................................................................................................11
5.1 TUBING SET-UP ..............................................................................................................................11
5.2 HEATER SET-UP..............................................................................................................................13
6PERFUSION APPARATUS OPERATION......................................................................................14
6.1 POWER-UP.....................................................................................................................................14
6.2 POWER-UP PAGE ............................................................................................................................15
6.3 LOGIN PAGE ...................................................................................................................................15
6.3.1 Add Users ..............................................................................................................................15
6.4 MAIN MENU...................................................................................................................................16
6.5 MANUAL MODE .............................................................................................................................16
6.5.1 Experiment Data....................................................................................................................16
6.5.2 Control Panel ........................................................................................................................17
6.6 DATA-VIEWER MODE ....................................................................................................................19
6.6.1 Experiment Playback.............................................................................................................20
7TROUBLESHOOTING......................................................................................................................21
7.1 SAFETY ALARMS............................................................................................................................21
7.1.1 Temperature Alarms..............................................................................................................21
7.1.2 Hazardous conditions............................................................................................................21
7.1.3 Malfunctioning hardware......................................................................................................21

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1 Getting Started
1.1 Symbols Used in this Manual
The lightning flash with arrowhead symbol, within an equilateral triangle, is intended to
alert the user to the presence of dangerous voltage within the machine’s enclosure that
may be of sufficient magnitude to constitute a risk of electric shock.
The exclamation point within an equilateral triangle is intended to alert the user to the
presence of important information in the literature that accompanies the device.
This symbol warns of moving parts may cause personal injury.
This symbol is used when two people are needed to do the task.
1.2 Machine Information
In the spaces provided below, record the Model and Serial No. located on the rear panel of this
machine.
Model No. __________________ Serial No.______________________
Retain this information for future reference.
1.3 Contact Information
Biorep Technologies, Inc.
3225 NW 112th Street
Miami, FL 33167
[e-mail]
www.biorep.com
Tel: [phone]
Fax: [phone]
WARNING:
Please, read this section before unpacking,
installing or operating this machine.

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1.4 Safety Information
PLEASE READ AND OBSERVE ALL WARNINGS AND INSTRUCTIONS GIVEN IN
THIS USER’S MANUAL AND THOSE MARKED ON THE UNIT.
RETAIN THIS BOOKLET FOR FUTURE REFERENCE.
DO NOT REMOVE THE MACHINE’S COVER OR YOU MAY BE EXPOSED TO
DANGEROUS VOLTAGE. REFER SERVICING TO QUALIFIED PERSONNEL ONLY.
TO REDUCE THE RISK OF FIRE OR ELECTRIC SHOCK, DO NOT EXPOSE THIS
DEVICE TO RAIN OR MOISTURE. DANGEROUS HIGH VOLTAGES ARE PRESENT
INSIDE THE ENCLOSURE.
READ AND UNDERSTAND HOW MOVING PARTS ARE CONTROLLED BEFORE
OPERATING THE MACHINE. KEEP YOUR FINGERS AWAY FROM MOVING
PARTS; NEGLECTING TO DO MAY CAUSE PERSONAL INJURY.
READ AND FOLLOW THESE INSTRUCTIONS:
1. Keep these instructions for future reference and heed all warnings stated in this manual.
2. Do not block any ventilation openings. Install the machine in accordance with the
manufacturer’s instructions. See Site Preparation in section 1.5 for details.
3. Do not defeat the safety purpose of the polarized or grounding-type plug. A polarized
plug has two blades with one wider than the other. A grounding-type plug has two blades
and a third grounding prong, which is provided for your safety. If the provided plug does
not fit into your outlet, consult an electrician for replacement of the obsolete outlet or
contact Biorep Technologies, Inc. at [phone].
4. Protect the power cord and the plug from being damaged. Avoid walking on or pinching
the cord or plugs.
5. Refer all servicing of the machine to qualified personnel. Servicing is required when the
apparatus has been damaged in any way, for example: the power-supply cord or plug is
damaged, liquid has been spilled or objects have fallen into the apparatus, or if the
apparatus has been exposed to rain or moisture, has been dropped, or does not operate
normally for any reason.
WARNING:
IT IS IMPORTANT TO READ THIS SECTION.

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1.5 Site Preparation
This machine is intended to be used in a controlled laboratory environment. Please refer to the
figure below for proper installation of the machine. The machine has one ventilation opening in
the rear. A 15 inches clearance is recommended between the back of the machine and the wall.
Figure 1: Dimensions of the Perfusion Apparatus 5
1.6 Unpacking Instructions
Remove the top 2 pieces of blue foam and the items that are located on top of the
machine. Then, carefully remove the foam that surrounds the machine.
It is suggested that the machine be removed from the box by two people, one on
each side. To lift the Perfusion Apparatus, place your hands underneath the
machine and remember to bend at the knee. Please, keep the box and all the foam
pieces in storage, in case the machine needs to be shipped in the future.
1.7 Packing List
The following items are included with the purchase of a Perfusion Apparatus:
Qty
Reference
Description
1
PER-05-115
Perfusion Apparatus
1
PER05-TUBHC-01
Disposable Perfusion Tubing Set with Coil (Sterile)
1
PERTRAY-MABS-01
Disposable Perfusion Tray (Sterile)
1
TC-02
Biorep Thermoprobe
1
86610610
Medical-Rated Power Cord
1
PER05-UM
User Manual
1 PER05-DAQ CD with Software & User Manuals
15 Inches

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2 Introduction
This manual is intended to be used by doctors, researchers, and technicians who have already
been trained in islet isolation procedures and technologies. This document contains the
necessary information for unpacking, installing, and operating the machine.
The Perfusion Apparatus has been developed to assist in and allow automation of the pancreas
perfusion step of the islet isolation process. The machine accurately regulates flow, pressure, and
temperature in two separate perfusion loops. In addition, the machine has the ability to store a
time-lapse record of every parameter during the procedure. The Perfusion Apparatus enables the
researcher not only to analyze each perfusion, but to refine the procedure into a repeatable and
efficient protocol by creating custom recipes for the machine to execute automatically.
The apparatus consists of two pumps, two pressure sensors, one heater, and one touch screen.
This apparatus is used in conjunction with the Biorep Perfusion Tray (PERTRAY-MABS-01), the
Biorep Thermoprobe (TC-02), and the disposable perfusion tubing set (PER05-TUBHC-01). One
of each is included with your new Perfusion system, and replacements are sold separately.
The Perfusion Apparatus is used to automatically distend the organ by pumping fluid at a
constant regulated pressure. The machine automatically adjusts the flow rate to maintain a
constant pressure, therefore minimizing the risk of tissue damage.
Figure 2: Perfusion Machine in the Islet Isolation Process

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3 Machine Parts Identification
3.1 Front View
Figure 3: Front View
Touch Screen
Automatic Heater
Infrared
Thermocouple
Pressure sensor (B)
Pump A
Pressure sensor (A)
Tray t/c
Input
Pump B
Transducer Protector
Holder
Transducer Protector
Holder
Aux t/c
Input

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3.2 Rear View
Figure 4: Rear View
3.3 Right View
Figure 5: Right Side View
ID
Plate
Vent
USB Port 1
USB Port 2
LAN Port 1
Power Entry Module
LAN Port 2

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4 Accessories
The following disposable accessories are included with the Perfusion Apparatus. For ordering
information, please consult our webpage www.biorep.com or contact one of our sales
representatives at [phone].
4.1 Perfusion Tray (PERTRAY-MABS-01)
The Perfusion tray has a removable mesh. Below the mesh, the tray has a funnel shape to
direct all the fluid to the Enzyme Port. The Thermoprobe Port, is used to attach a Biorep
Thermoprobe to monitor the enzyme temperature. The two horizontal ports on the opposite side
are available to re-circulate cold water or a suitable coolant to cool the enzyme if desired.
The Perfusion Tray is available in disposable and autoclavable versions. The included disposable
plastic tray is made from ABS plastic, and it is intended to be a single use disposable device.
Note that use of alcohol based coolants may promote crack formation on the ABS. The
autoclavable perfusion tray is made of stainless steel.
To lower the enzyme temperature, connect 0.25” ID (6.3mm) tubing to the cooling ports and re-
circulate cold water. Do not restrict flow on the coolant output port as this may cause damage to
the tray.
Figure 6: Disposable Perfusion Tray
Thermoprobe Port
Enzyme Port
Cooling Ports
Screen

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Transducer
Protector A
Transducer
Protector B
Heating
Coil
Luer
Connectors
4.2 Disposable Tubing Set with Coil (PER05-TUBHC-01)
For information about how install the tubing set please refer to Section 5.1.
Figure 7: Perfusion Apparatus Tubing Set (PER05-TUBHC-01)
Important:
If silicone tubing remains inside a closed peristaltic pump head
for extended periods, there may be permanent tubing profile deformation.
4.3 Biorep Thermoprobe (TC-02)
The Biorep Thermoprobe is a sterile, disposable type-T Thermocouple. It has a universal mini-
plug connector that measures temperature at the site of any female Luer connection.
Directions: Connect the Thermoprobe to the Perfusion Tray Thermocouple Port (see
Figure 6) and use it to measure the collected perfusion fluid temperature inside the
perfusion tray.

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Figure 8: Biorep Thermoprobe
5 Perfusion Machine Set-up
5.1 Tubing Set-up
Figure 9: Tubing Set Installation
Tubing Set-up Directions (also see photograph on the following page):
1) Place the heating coil inside the automatic heater. Make sure there is good contact
between the stainless steel coil and the aluminum arms. Also, make sure there is good
contact between the coil and the spring loaded thermocouple. See Heater Set-up (5.2).
2) Connect tube “C” to the Enzyme port on the perfusion tray.
C B
A
Transducer
Protector B
Transducer
Protector A
Heating Coil
Luer
Connectors
(To Organ)
D
E
F

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3) Place tube sections “D” and “E” in the appropriate peristaltic pump. Make sure the tubing
is not being pinched on the inlet or outlet.
4) Connect Tubes “A” and “B” to the appropriate pressure sensor fittings.
5) Secure both “Transducer Protector A” and “Transducer Protector B” to their respective
holders.
6) Use both Luer connections for the catheters that go to the pancreas.
Tubing Set and Tray Installation
Figure 10: Tubing Set and Tray Illustration

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5.2 Heater Set-up
A heating element is a coiled stainless steel tube. It has a large heating surface area to provide
precise and non-localized heat to the fluid that circulates through it. The temperature of the fluid is
constantly being monitored and controlled by the Infrared Thermocouple immediately after the
heater’s outlet. Follow the instructions below and see the figure below to properly connect the
Heating Element.
Loosen the thumbscrews to open the clamps enough to fit the heating element’s ends into the
contact grooves.
The heating element terminations (A and B) are different. Identify each one by their shape. Be
sure that end Bof the heating element is inserted into the contact groove on the left, and that end
Afits completely into the thermocouple groove on the right. Then, tighten the thumbscrews.
Close the heater cover carefully. The heating element must not touch the heater cover. If the coil
touches the cover, loosen the thumbscrews and adjust the heating element as necessary.
If the heating coil is not properly connected, and the heater is ENABLED, an
audible alarm will sound. The error message “Check Heating Coil Connections” will
appear. Verify all steps above.
Figure 11: Heater Set-up

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IMPORTANT: At least one peristaltic pump has to be ON (flow rate > 15ml/min), AND the
heater cover needs to be closed for the heater to operate.
6 Perfusion Apparatus Operation
The main operation of the Perfusion Apparatus is done through the touch-screen interface. This
type of interface eliminates the need for an external keyboard or mouse device and provides a
visual and intuitive interaction with the user. The operator should familiarize himself/herself with
the different screens, features, and controls of the interface before attempting to operate the
machine during an actual isolation.
Anyone who will operate and/or supervise the use of this machine should read and
understand this section in its entirety.
This machine has been designed with alarm features that will help the user identify
and correct potential problems. Alarm messages will be displayed at the bottom of
the screen.
Close the protective covers of the peristaltic pumps while working. The
moving rollers that are beneath the covers can cause injuries.
ICON/BUTTON CONVENTIONS. The touch-screen interface of this machine has virtual buttons,
represented by icons, to activate and deactivate the different features of the machine. Care was
taken at the time of designing these icons, so that there is minimal ambiguity between on and off
states (active and inactive). However, to avoid confusion please read this section of the manual
carefully. Every button icon has two display states: a “gray-scale” state and a “colored” state.
When the button icon is “gray-scale” it represents an inactive or “OFF” condition. When the icon is
colored, it represents an active or “ON” condition. If a “gray-scale” icon is pressed, the icon will
change to “colored” icon and the controlled feature will turn on. If a colored icon is pressed, the
controlled element will turn off and the icon will be grayed out.
6.1 Power-Up
The machine’s main power switch is located in the right side of the machine, above the power
entry module. Connect the power cord to the power entry module and then plug it into a 115 or
230 VAC outlet (check voltage rating on red window).
Figure 12: Power Entry Module
Power Entry Module
Machine Voltage
Power switch
Cable Connector

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6.2 Power-up Page
This will be the first page that appears after the system has completed
the boot-up process. In this page you will be prompted to touch
anywhere to begin. Do not touch the screen or enter any commands
via keyboard or mouse until you see this screen.
6.3 Login Page
The Login Page allows you to Log into your password
protected user account. The user account saves the
preferences of your experiments, and saves time by
pre-filling some frequently used fields during the
experiment process and during reporting.
The first step is creating a user account. To create a
new user account, press the Add User Button.
6.3.1 Add Users
When the “Add User” button is pressed, the “New
User Account” fields on the right of the screen will be
enabled. Upon clicking on any field a pop-up
keyboard will appear. Enter a unique username and
password using the keyboard and press “Accept”.
Click Save to create the user.
Now you will be able to find your User name on the
drop down list at the top left. The next time you do a
perfusion experiment, just select your user from the
list, enter your password and press “Login”.

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6.4 Main Menu
Once logged in, you will arrive at the Main Menu
page. On this page you can select the operation
mode of the machine.
“Manual Mode”will take you to a control panel
interface where you can manually manipulate
the machine parameters during an experiment
session. These sessions can be recorded for
later analysis, reporting or playback in the “Data
Viewer”mode. You can think of Manual Mode
as the experiment “composer”, and the data
viewer as the experiment “player/editor”.
On the Data Viewer mode, you can monitor the
various parameters of a perfusion session, and
re-create or edit previous sessions step-by-step.
In this page you will also see the User account, the Software Version installed in your perfusion
machine, and the machine Status Bar at the bottom. The Status Bar will display any alarms or
important messages related to the function of the machine.
You can also end the session from this page either by logging out of your user account or by
turning the system off. PLEASE DO NOT TURN THE MACHINE OFF FROM THE POWER
ENTRY MODULE BEFORE BEING PROMPTED TO DO SO.
6.5 Manual Mode
6.5.1 Experiment Data
Selecting manual mode will take you
to the screen below, where you will be
required to fill out a form type page
with all the relevant data of the donor,
the organ and the Operator. Most of
the fields include drop-down menus for
quick selection. The drop down list can
be edited to include any other options
not in the default list.
Once the data is filled, you can
continue to the Control Panel by
clicking the NEXT arrow on the bottom
right.

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6.5.2 Control Panel
All the controls required to operate the machine during a Manual Mode experiment are located in
this single interface. In this control panel you will be able to change the Temperature parameters,
the Flow/Pressure parameters and control the recording of your experiment for use in the Data
Viewer mode. For reference, the term “indicator” will be used for fields that are “read-only”. This
means that they are not editable, and only provide measurement data or other information to the
user. A “control” is the term used for a field that is editable by clicking. These are usually
variables set by the user to control the machine.
6.5.2.1 Temperature Control
The temperature control section of the
control panel has the following functionality:
The icon on the left is the Heater ON/OFF
button. The TRAY PV is an indicator of the
temperature “Present Value” measured by
the perfusion tray thermoprobe. The AUX PV
is also an indicator of temperature measured
by the auxiliary thermoprobe. The SP stands
for “Set Point”. The SP is a control of the
target temperature you want your system to
reach and maintain. When the heater is
turned ON, the heater will gradually heat the
fluid up to the SP you specify. You will get
constantly refreshing temperature readings
from both TRAY and AUX PV indicators.

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6.5.2.2 Flow control
There are two independent flow loops labeled
LOOP A and LOOP B. Both loops operate the
same way, so we will describe the controls in
LOOP A only.
The “drop” icon on the top left is the ON/OFF
button for the peristaltic pump.
The AUTO button on the bottom left toggles the
pump operation between two modes: Flow and
Pressure control.
The default mode (Auto OFF) is a “Flow” control
mode, in which the user determines the exact flow delivered by the pump in mL/min. The user
sets the desired flow rate by clicking on the Flowrate control field. The pump will maintain that
flow regardless of the pressure (within safety limits); the pressure will be displayed on the
Pressure PV indicator. Pressure SP is disabled.
When the Auto mode is activated, the pump will enter a “Pressure” control mode, in which the
user determines the pressure to be maintained in the system in mmHg. The user sets the desired
pressure by clicking on the Pressure SP field. The machine will automatically regulate flow to
reach and maintain the specified pressure in the loop. The loop pressure is constantly measured
and displayed by the Pressure PV indicator. In Auto mode the Flowrate field on the bottom
becomes an indicator of the current flow rate and can’t be edited.
6.5.2.3 Data-Logging
The Data logging section records your perfusion
experiment for later analysis, reproduction or edition in the
Data Viewer mode.
Press the Record button at any point during your
experiment to start logging all the parameters and their
changes over time. You can use the Pause button to
suspend the data-logging in case you want to make a
change or two “off-the-record”.
When you want to stop logging, just depress the Record
button. The session will be added to the end of the
Reports list in the Data-Viewer section.
6.5.2.4 Taskbar
The taskbar at the bottom of the screen has the following functions: On the left, the Biorep Logo
is a shortcut to the Main Menu screen. On the right, there will be navigation arrows that will take
you to the next or previous screens when applicable. The most important feature is the Status
Bar on the center, which provides the user with visual feedback on any errors or important
messages from the system. A more detailed discussion on errors is found in section 7.

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6.6 Data-Viewer Mode
The Data Viewer screen is where all recorded experiments can be analyzed, replayed or deleted.
Each experiment recording is called a Report. A list of all reports can be found in the first tab of
the Data-Viewer page. They are listed in chronological order, so the last experiment will be found
last on the list. Click on an experiment to select it. All data displayed on the following tabs will
relate to the selected experiment.
You can export all experiments of a particular user to an external device by selecting your user
account from the Operator drop down and selecting Export Data. A windows explorer pop-up
will appear. Navigate to the folder you want to save the data to and click on “Current Folder”. The
file will be saved with the name: ManualReports.tdms. This file can then be opened in your
personal PC with the supplied report reader application.

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You can delete a report from the list by highlighting it and clicking on Delete. All deleted reports
can be found on the last tab “Deleted Reports” and can be recovered from there.
The most valuable feature of the Data-Viewer is the ability to replay an experiment. To do this,
select the experiment you wish to replay and click on Playback.
6.6.1 Experiment Playback
Playback mode will provide you with an interface in which you can replay a previously recorded
experiment; you can also make modifications on-the-fly if required. All the steps of the experiment
are listed in a tabular manner. The beginning of a step is defined as the moment where the user
changes any variable of the experiment. The end of a step is when the next change occurs, which
also marks the beginning of the next step and so on. The time completion bar at the bottom
shows you the experiment elapsed time in relation to the total time of the experiment.
To begin replaying the selected experiment press the Play icon on the top. The experiment will
start and continue through the steps as recorded. To pause and un-pause the experiment press
the Play button.
If you need to perform an on-the-fly modification of any of the parameters, click the Manual Mode
Override button. This will bring you to the manual Control Panel (see Section 6.5.2). In here you
can make all necessary adjustments. When ready to resume your experiment, press the Back
button and you will return to the Playback Screen. Once in the playback screen, press the Play
button to resume where you left off.
The Restart button is the circular arrow button to the right of the Play button. Pressing it will reset
the experiment from the beginning.
To return to the Playback main screen press the Back button.