Rigel MULTI-FLO User manual

Innovating Together
RIGEL MULTI-FLO
infusion pump analyser
Copyright © 2016SEAWARD GROUP
Last Update: 25th May 2016
Instruction Manual
385A550 Revision 2.7

i
Rigel Medical 24 Month Warranty Statement
Rigel Medical provides a standard 12-month manufacturer’s warranty against breakdown
during normal use. This warranty can be upgraded to a 24-month warranty (terms and
conditions apply*). Problems caused through misuse, damage, fair wear & tear,
consumables and accessories are excluded from standard warranty. Such components
found to be being used in excess of their manufacturer’s operating recommendations are
also excluded. Shipping to an authorised service center is the responsibility of the
sender.
*Terms and Conditions of 24 Month Warranty
The Rigel product must be registered with Rigel Medical within 30 days of purchase to
be eligible for the extended 24-month warranty. Instruments must be returned to an
authorised service center complete with proof of purchase within 13 months of purchase
for calibration at the current rate. Any items returned for calibration outside of the 13
month period stated above may not be eligible for the second 12 month section of
warranty. The second 12 month section of the warranty begins at the expiry of the initial
12 month period, not when the unit is calibrated.
Details correct at time of going to print. The manufacturer retains the right to make
amendments to the above terms and conditions without prior notice.
Calibration Statement
The Rigel Multi-Flo Infusion Device Analyser is fully calibrated and found to be within the
specified performance and accuracy at the time of production. The Seaward Group
provides its products through a variety of channels; therefore it may be possible that the
calibration date on the provided certificate may not represent the actual date of first use.
Experience has indicated that the calibration of this instrument in not effected by storage
prior to receipt by the user. We therefore recommend that the recalibration period be
based on a 12 month interval from the first date the unit is placed in to service.
Date received into service; / / .

ii
© Copyright 2016
All rights reserved. Nothing from this edition may be multiplied, or made public in any
form or manner, either electronically, mechanically, by photocopying, recording, or in any
manner, without prior written consent from the SEAWARD GROUP. This also applies to
accompanying drawings and diagrams.
Due to a policy of continuous development the SEAWARD GROUP reserves the right to
alter the equipment specification and description outlined in this publication without prior
notice and no part of this publication shall be deemed to be part of any contract for the
equipment unless specifically referred to as an inclusion within such contract.

iii
Disposal of old product
The Rigel Multi-Flo has been designed and manufactured with high quality materials and
components, which can be recycled and reused.
Please familiarise yourself with the appropriate local separate collection system for
electrical and electronic products or contact your local supplier for further information.
Please dispose of this product according to local regulations. Do not dispose of this
product along with normal waste material. By offering your old products for recycling,
you will help prevent potential negative consequences for the environment and human
health.

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Statement of Conformity
This product is manufactured by:
Seaward Electronic Ltd, Bracken Hill, South West Industrial Estate, Peterlee, County
Durham, SR8 2SW, UK
As the manufacturer of the apparatus listed, we declare under our sole responsibility that
the product:
Rigel Multi-Flo (1,2 and 4 channel) –Infusion Pump Analyser
Conforms with the relevant Directives and conformity is indicated by the symbol , i.e.
“Conformité Européenne”
Seaward Electronic Ltd. is registered under BS EN ISO9001 Certificate No.: Q05356.
A copy of the Declaration of Conformity and a copy of our ISO certificate are available in
the Support & Resources area of the Seaward website www.seaward.co.uk".

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Index
Introduction................................................................................................................4
Rigel Multi-Flo Design Philosophy .......................................................................................4
Unpacking the Multi-Flo .....................................................................................................5
Warnings and Cautions ...............................................................................................5
User Notes .........................................................................................................................6
Safety Notes.......................................................................................................................6
Multi-Flo Overview .....................................................................................................7
1Getting Started ....................................................................................................8
1.1 Before you switch On! .............................................................................................8
1.2 Turning the Multi-Flo On and Off .............................................................................8
1.3 Home screen ...........................................................................................................8
1.4 Connecting to your Multi-Flo Analyser .....................................................................9
1.5 Priming the Channels.............................................................................................10
1.6 Draining the Channels ...........................................................................................11
2Manual Mode ....................................................................................................12
2.1 Flow Rate / Volume Test .......................................................................................14
2.2 Occlusion Test.......................................................................................................17
2.3 Patient Controlled Analgesia (PCA) Test .................................................................20
2.4 Saving Manual Results...........................................................................................22
3Auto Mode.........................................................................................................24
3.1 Abort/Failure Menu ..............................................................................................27
3.2 Test Sequences .....................................................................................................28
4Remote Control Mode ........................................................................................36
5Data ..................................................................................................................38
5.1 View Data .............................................................................................................38
5.2 Transfer Data ........................................................................................................39
5.3 Download Data (Export) ........................................................................................41
5.4 Upload Data..........................................................................................................45

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5.5 Transfer Test Sequences ........................................................................................46
6Bluetooth Favourites ..........................................................................................48
7Setup .................................................................................................................50
7.1 Time / Date...........................................................................................................51
7.2 Test Sequences .....................................................................................................52
7.3 Memory Options ...................................................................................................52
7.4 Pressure Measurement Unit ..................................................................................55
7.5 Languages .............................................................................................................56
8About Menu.......................................................................................................57
9Maintaining the Rigel Multi-Flo..........................................................................59
9.1 Cleaning the Analyser............................................................................................59
9.2 User Maintenance.................................................................................................59
9.3 Firmware Upgrade ................................................................................................60
9.4 Return Instructions................................................................................................63
9.5 Optional Accessories .............................................................................................63
9.6 Replacement Spare Parts.......................................................................................63
10 Specifications..................................................................................................64
10.1 Technical Specifications.........................................................................................64
10.2 General Specifications ...........................................................................................65
10.3 Environmental Conditions .....................................................................................65
11 Support ..........................................................................................................66
11.1 Contact Us ............................................................................................................66

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Introduction
Rigel Multi-Flo Design Philosophy
The Rigel Multi-Flo Infusion Device Analyser provides accurate and fast analysis of the
performance of all common infusion devices. The Multi-Flo’s instant flow measurement
allows for high resolution flow and pressure analyses and provides a highly accurate
calibration method for proving the correct function of all infusion devices.
Infusion devices can be tested under positive and negative pressure settings whilst
bolus and PCA tests are conducted with the highest possible resolution.
Measuring flow rates, volume and pressure, the Multi-Flo is available in 1, 2 and 4
channel configuration which can be upgraded in the future to include additional channels
up to a maximum of 4 channels. The Multi-Flo will ensure it meets your current and
future requirements.

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Unpacking the Multi-Flo
Carefully unpack all items from the box and ensure the following items are included:
Rigel Multi-Flo Infusion Device Analyser
Mains Power Lead
Multi-Flo Quick Start Guide
Utilities Disc
USB Cable

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Warnings and Cautions
User Notes
Ensure that the Multi-Flo is operated with the distilled or de-ionised water only.
The following symbols are used throughout this Instruction Manual;
Warning of electrical danger! Indicates instructions must be followed to avoid
danger to persons.
Important, follow the documentation! This symbol indicates that the operating
instructions must be adhered to in order to avoid danger.
Safety Notes
Users - The Rigel Multi-Flo Infusion Device Analyser is designed for use by
adequately trained technical personnel only.
Operation - The Rigel Multi-Flo Infusion Device Analyser is designed for use
within the published specifications. Any application outside of these
specifications or any unauthorised user modifications may result in hazardous
conditions or improper operation.
Operation - Refer to the Device Under Test (DUT) manufacturer operating
instructions to ensure safe operation whilst analysing the DUT.
Safety - Ensure that only accessories supplied by the manufacturer or
accessories that meet the manufacturer’s specification are used.
Safety - Where safe operation of the Multi-Flo is no longer possible it should be
immediately shut down and secured to prevent accidental operation.
It must be assumed that safe operation is no longer possible:
If the instrument or leads show any sign of damage or
The instrument does not function or
After long periods of storage under adverse environmental conditions.

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Multi-Flo Overview
KEY
1
Large colour graphic display.
2
ON/OFF button
3
Function keys F1 - F4
4
Start button
5
Rotary encoder
6
Stop/End button.
7
Channel inlet connectors.
8
Channel drain connectors.
9
Folding legs
10
Type A USB connection
11
Type B USB connection
12
IEC mains power lead connection
13
Auxiliary output connection
1
2
3
6
8
4
5
7
9
13
12
10
11

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1 Getting Started
1.1 Before you switch On!
Ensure that the Multi-Flo is operated with the distilled or de-ionised water only.
The Rigel Multi-Flo has two legs on the front base of the unit. These are designed to
raise the front of the unit to improve the viewing angle of the colour graphic display.
1.2 Turning the Multi-Flo On and Off
To turn the Multi-Flo ON, press the orange I/O key so it is in the in
position.
To turn the Multi-Flo OFF, press the orange I/O key so it is in the out
position.
1.3 Home screen
Upon power up of the Rigel Multi-Flo, the display will be showing the HOME SCREEN.
ON / OFF
button
F1
F2
F3
F4

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1.4 Connecting to your Multi-Flo Analyser
The Rigel Multi-Flo is a high precision instrument that can provide real-time and high
accurate flow measurements subject to following the procedures advised below;"
To obtain the highest level of accuracy, we calibrate our Multi-Flo infusion pump
analysers using the following practices and procedures;
1. Ensure that the measurements done by the Rigel Multi-Flo are done using
distilled or de-ionised water only.
2. To prevent the formation of microscopic air bubbles in the pump chamber, keep
the Multi-Flo unit primed unless draining is absolutely necessary.
3. If the Multi-Flo has been drained, to clear any microscopic air bubbles in the
pump and pipework that could affect results, prime with 25ml Isopropyl Alcohol,
followed by 50ml deionised water to flush the alcohol from the system.
4. Due to fluid dynamics the inlet and outlet pipe length, diameter and material can
affect the results. For best results, avoid any in-line valves or other constrictions
and use 1000mm of 1/4” OD/ 1/8” ID tubing on the inlet and 300mm on the outlet.
Semi-flexible tubing, such as Tygon, will provide the best results. See setup
diagram below;
Infusion
pump
Collection
vessel
Fluid
reservoir
1000mm 1/4" OD 1/8" ID
Tygon tubing or similar
300mm 1/4" OD 1/8" ID
Tygon tubing or similar
Inlet
Outlet
NB: Tubing should not drop below
level of work surface
Syringe Driver
Method 1
Device under test
Method 2
Device under test
Ensure the flow direction is as per diagram above. The flow inlet is the top connection
whilst the flow outlet is positioned below the inlet for each channel.

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Ensure that the internal diameter of the outlet tubing is 3.2mm or greater.
Ensure that the length of outlet tubing is kept as short as reasonably practicable.
1.5 Priming the Channels
Upon power-up the Multi-Flo is in automatic priming mode however, should priming be
required at any stage, select PRIME F2 from the Main Menu;
Prime the system until the drain tubing is clear of air bubbles. Press to return to the
Main Menu.

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1.6 Draining the Channels
From the Main Menu, select DRAIN F3. This will take you to the Drain function screen.
Either select the individual channel to drain or select Drain All using the rotary encoder.
Once the fluid has been drained, press F1 to stop the draining process and return
to the Main Menu.
Warning; Once the fluid is drained, do not leave the drain pump facility
running longer than necessary.

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2 Manual Mode
To access tests in Manual Mode select TEST F1 from the Main Menu. Highlight the
required channel and then select MANUAL F4. Here you can access the Test Setup
Menu for each individual channel. (chapters 2.1, 2.2 and 2.3 will go through each
individual test in more detail)
Highlight TEST TYPE and push the rotary encoder to select. This will allow you to toggle
between Flow / Volume Test, Occlusion Test and PCA Test.

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Once the test is set up press to advance to the test screen for the test selected or
to exit without saving and go back to the test summary screen.
Once a test has finished the ELAPSED time will indicate COMPLETED in blue.
Press F1 to go back to the Test Summary screen where the final results and time
should be indicated and Duration set to READY in black for the next test.

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2.1 Flow Rate / Volume Test
The Rigel Multi-Flo is capable of measuring the instantaneous flow at a resolution of
10µl/hr. In addition, the flow rate can be viewed based over an average period (user
selectable) as well as detecting peak and minimal flow rates.
From the Main Menu, select TEST F1. This will take you to the Test Summary Screen
for all individual channels.
Active channels will indicate READY under the Duration column and inactive channels
indicate N/A in the Type column.
Highlight the required channel using the rotary encoder and select either MANUAL F4 to
enter the manual test setup menu or AUTO F3 to select automode to save results in the
database.
Once in the Test Setup screen Highlight TEST TYPE and press the rotary encoder to
confirm. Using the rotary encoder select FLOW/VOLUME and press to confirm. This will
take you to the Flow/Volume Test Setup screen.

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Use the rotary encoder to determine the;
Back Pressure
Sampling Window
Duration
Error Type (instant flow, average flow or expected volume)
Upper and Lower Limits
Press the rotary encoder to select the field and then move the encoder to increase or
decrease the value required and then press the encoder again to confirm the selection.
A USB keyboard can also be used to enter values.
NOTE: To change the pressure unit measurement please refer to Chapter 7.4
NOTE: Upper and lower limits will appear in the graph view provided the limits are
greater than 0 or 0%.
Once the test has been setup successfully press F4 to save and advance to the
Flow/Volume Test screen, or to exit back to the Summary Test screen.
Setup your infusion device to the same settings as entered into the Multi-Flo and start
the infusion. Press the green START button on the Multi-Flo to begin the test.

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During the Flow/Volume Test
Use the rotary encoder during the test, to change the highlighted (blue) field holding the
main measurement parameters:
Mean ml/h
Peak ml/h
Error (Instant Flow, Average Flow or Expected Volume)
Instant Flow ml/h
Volume ml
Min ml/h
Pressure (default mmHg)
Select GRAPH F2 to view the available graphs for this test, SETUP F3 enables the
user to see the original Test settings and CH F4 switches between channels which
can be run simultaneously.
Safety - Press the red STOP button at any time to stop the test.
Viewing the Flow Graph
During the flow/volume test select GRAPH F2 to view the graph of the real time results.
The red lines depict the set minimum and maximum limits.
The graph can switch between flow and volume against time by pressing the TYPE F3
button
Pressing CH F4 enables the user to switch between channels which are running
simultaneously.
NOTE: The GREEN and RED buttons on the Multi-Flo are inactive when on
the Graph screen.