Manual - Rigel Medical
Contents
1. Large colour graphic display ON OFF button Function keys F1 F4 Start button Rotary encoder Stop End button Channel inlet connectors Channel drain connectors Folding legs Type A USB connection Type B USB connection IEC mains power lead connection Auxiliary output connection 13 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 Multi Flo To turn the Multi Flo ON press the orange I O key so it is in Ca the in position __ To turn the Multi Flo OFF press the orange I O key so it is in ion the out position 1 3 Accessing the Multi Flo Tests From the main menu use the rotary encoder to highlight Manual mode Press the rotary encoder to enter manual mode E JE NRO Tia i ayy Oe ie ha CH Type Volume Pressure Flow Duration EEEE rT ere IEEE ELECTRIC reer rrr iret irre ree rrr ere RRA EA ARA A RARA O A rrr er rer eer rrr ee rr rrer tree err rer rer errr A rrr A RSS RS ARA SR tr tree OR ORM AR Automatic mode 7 Flow 0 00 3 0 000 Ready Select data gt Flow 000 O 0 000 Ready Setup About 3 NA 12 11 14 pm 30 07 2012 4 NIA EE ere E STOP ALL SETUP AUTO PRIME DRAIN ABOUT 7 Pag2. Rale VOIIME SL seir adiado vida ais oia erais 15 2 6 Draining the Channels eee ERA EREA DERA EREA arara narrar 16 3 Maintaining the Rigel Multi Flo assaassssesdsaa anads aa bi cs os Do soaddcaa 18 3 1 GI GA A PADRE DDR A PR semuetanenvecass 18 de USerMANENANCO ian aa r TA TU ATADA 18 339 IRSIUNTINSIFUCIUIONS cuada dacid nissan tenro raia eia a Sina 19 OR a cia rane asa ss EA A E E e beber A ad AS duda E 20 41 Optional ACCOSSONOS see tera aio atan caida aria Hio alia di 20 4 2 Replacement Spare Paris e RED ERE EDADE RR ED REDE Da ED aa DE Da a DOA 20 SS LEO eee ener eee een a Cele een eee or er earn en en see ee ere eer 21 5 1 Technical Specifications ccccceccccceeeeeseeeeeeeeeeeseeeeeseeeeeeeeeeseseeesseeeesneeeeeeas 21 de General SPSCMICATONS sessie rekene nE ENERE ERES ENEE e 22 53 Environmental COMGIIONS isesi e ada EE 22 DE RAE tenia EIE NEA enact EENI AE OIEA AT E EETA T E 23 6 1 Contact US nian ida cida A e AA AA AA ins eeie inis 23 1 Page Rigel Medical Multi Flo user Manual V1 0 Introduction 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 pos
3. indication of the correct safety settings of an infusion device From the main menu select Manual mode This will take you to the channel summary screen Main menu Summary CH Type Volume Pressure Flow Duration Automatic mode Grow 000 3 0 000 Ready Select data gt Flow 000 O 0 000 Ready Setup About 3 NA SS E 12 11 14 pm 30 07 2012 4 NIA E Er AUTO PRIME DRAIN ABOUT Highlight the required channel and press SET UP Use the rotary encoder to highlight Test type press the encoder to access the sub menu The Test type box will now be highlighted in white Use the rotary encoder to select PCA test and St chamas 1 press the rotary encoder to confirm The PCA Setup screen will now be displayed Test type Basal Flow Rate mih Total Volume mi 0 00 11 Page Rigel Medical Multi Flo user Manual V Use the rotary encoder to edit the basal flow rate bolus volume total volume and test duration NOTE The basal flow rate setting is used to determine the additional volume being delivered ie the BOLUS Therefore an incorrect setting of the basal flow rate will lead to an inaccurate BOLUS detection Press aS to save and advance to the PCA test summary screen or to exit without saving 2 PCA Basal fow mlh 0000 Elapsed Ready Total volume mi 000 Remaining 00 15 00 Bolus Mean Volume m
4. Mains fuse 20 x 5mm T3 15A 250V 20 Page Rigel Medical Multi Flo user Manual V1 0 5 Specifications 5 1 Technical Specifications Flow Measurement Test Duration Programmable up to 24 hours for memory storage Display range Max display resolution Measured range Accuracy Volume Flow update rate Occlusion back pressure measurement Pressure measurement range Back pressure setting range Unit selection Accuracy Max resolution PCA Bolus measurements Volume Display Range Measuring Range Accuracy Max resolution Basal flow rate Pressure 21 Page 0 010 ml h to 1500 ml h 10 ul h 0 500 ml h to 1450 ml h 1 of the reading after 100ul volume at O mmHg backpressure applied 0 001 ml to 9999 ml 1 Hz 500 to 2500 mmHg 200 to 600 mmHg Bar PSI mmHg mmH2O 1 of the reading up to 1500 mmHg 1 mmHg 0 1 ml to 100 ml 0 5 ml to 100 ml 1 of the reading 0 01 ml 1 ml to 30 ml h Max 2500 mmHg Rigel Medical Multi Flo user Manual V1 0 5 2 General Specifications Dimensions Weight Mains supply Mains cable Storage environment Operating conditions Environmental protection PC Communication Keyboard Communication Display 5 3 Environmental Conditions 300mm x 204mm x 150mm 5kg 1 channel 6kg 2 channel 8kg 4 channel 90 264 VAC 50 60 Hz 60W Standard IEC 10A connector 0 C to 50 C 15 C to 40 C IP40 USB B USB A LCD colour graphic display 7 4
5. RIGEL gt MEDICAL GI nt_rge Rnecrf cp ALLO o Gdagnm Bct c _ jwocp Copyright 2012 SEAWARD GROUP Instruction Manual Last Update 5th July 2012 385A550 Revision 1 0 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 amp tear consumables and accessories are excluded from standard warranty Such componenis 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 a
6. VGA The Rigel Multi Flo has been designed to perform tests and measurements in a dry environment Maximum barometric elevation for making measurements is 2000m Protective system IP40 according to IEC 60529 Electromagnetic compatibility EMC conforming to IEC 61326 1 Interference immunity and emitted interference Operating temperature range of 15 C to 40 C without moisture condensation The Multi Flo can be stored at any temperature in the range 0 C to 50 C 22 Page Rigel Medical Multi Flo user Manual V1 0 6 Support 6 1 Contact Us Rigel Medical Contact details Sales and Delivery enquiries Tel 44 0 191 587 8730 Fax 44 0 191 586 0227 Email sales rigelmedical com Technical enquiries Tel 44 0 191 587 8701 Email support rigelmedical com CalibrationHouse Contact details service Calibration and Repair Tel 44 0 191 587 8739 Fax 44 0 191 518 4666 Email info calibrationhouse com Part of SEAWARD Rigel Medical Address details Rigel Medical 15 18 Bracken Hill South West Industrial Estate Peterlee County Durham SR8 2SW United Kingdom CalibrationHouse Address details CalibrationHouse 11 Bracken Hill South West Industrial Estate Peterlee County Durham SR8 2SW United Kingdom 23 Page Rigel Medical Multi Flo user Manual V1 0
7. avoid Important follow the documentation This symbol indicates that the operating AN danger to persons 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 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 A instructions to ensure safe operation whilst analysing the DUT 4 Page Rigel Medical Multi Flo user Manual V1 0 lt must be assumed that safe operation is no longer possible e if the instrument or leads show any sign of damage or e the instrument does not function or e after long periods of storage under adverse environmental conditions 5 Page Rigel Medical Multi Flo user Manual V1 0 Multi Flo Overview RIGEL 1 2 4 5 i 5 8 10 11 6 Page Rigel Medical Multi Flo user Manual V1 0 KEY
8. board to enter data Press 12 24 to toggle between 12 and 24 hour clock mode Press Format to toggle between DDMMYYYY and MMDDYYYY date format Press Mio save the changes then CEE to exit 8 Page Rigel Medical Multi Flo user Manual V1 0 1 5 Displaying the Multi Flo Information Main menu RIGEL Manual mode MEDICAL Automatic mode Select data ES 44 0 181 587 8701 info RigelMedical com 12 15 02 pm 30 07 2012 Details Calibration ia AUTO PRIME DRAIN ABOUT From the main menu press the About function key The main About screen displays telephone email and website information for the equipment manufacturer Calibration Details Details Version 0152 Channel Cal Date Channal Firmware Ver Hardware Ver Senal no 1 5 07 30 424 Vo0 0000 ao SOMA VoOo0 0000 WA WA 1 2 5 We We 4 Calibration po qe des Details This product is manufactured and inspected by Seaward Electronic Ltd In case the product requires calibration or service please contact us to find out your nearest authorised service centre Seanad Elaa ono Lid tal e a apa FARE Service Dear tne ee eS 5162060 11 Bracken Hill Ac itarvard CO uk South ess industrial Este a Engin dea Details catibration Press Details to view the firmware version hardware version and serial no for the Multi Flo unit and each individual ins
9. e Rigel Medical Multi Flo user Manual V1 0 Here you can access the test menu for each individual channel Flow Test Setup PCA Setup Selected Channel 1 Selected Channel 1 Tira Fows Volume test ba Selected Channel Flow Rate 100 00 min ater PCA teat a Lx Test type a id ae Back pressure O mmHg Basal Flow Rate 10 00 a Bolus 0 00 a se mih LY Volume L x Infusion pump type Sampling window 30 sec T f z Total Volume m 0 00 gt A As A Duration Ohr 15min Osec x x x Duration thr s Omin Osec E ss A 5 j ra mar g Ko Alle Mil e Highlight the required channel and press SET UP or push the rotary encoder Highlight the Test tyoe menu and push the rotary encoder This will allow you to toggle between PCA test Occlusion test and Flow Rate Press af to save or CEE to exit without saving 1 4 Setting the Time Date From the main menu use the rotary encoder to highlight Setup Press the rotary encoder to enter the setup menu Time and Date Manual mode Automatic mode Select data 2 30 45 pm Date 30072012 12 14 42 pm 30 07 2012 AUTO PRIME DRAIN ABOUT 4m 12 24 Format Highlight the part of the time date you wish to change using the rotary encoder and push to enter Use the rotary encoder to increase or decrease the value then push again to confirm Alternatively use a USB key
10. i 0 00 Flow mlh 0 000 Duration Sec O ue Graph Setting CH Press the green START button to begin the test N Safety Press the red STOP button at any time to stop the test 2 4 Occlusion test The Occlusion test simulates an obstruction in the infusion process Most infusion devices have the ability to detect this obstruction and provide an occlusion alarm The occlusion test is able to test this alarm feature in infusion devices From the main menu select Manual mode This will take you to the channel summary screen Highlight the required channel and press SET UP This will take you to the Occlusion Setup screen 12 Page Rigel Medical Multi Flo user Manual V1 0 Main menu Volume Pressure Flow Duration Automatic mode haa 000 3 0 000 Ready select data setup About 0 00 E 0 000 Ready 12 11 14 pm 30 07 2012 AUTO PRIME DRAIN ABOUT Selected Channel 1 Test type Cecusion test Infusion pump type Manual Use the rotary encoder to select Occlusion test and press the rotary encoder to confirm The Occlusion Setup screen will now be displayed Infusion Pump Type The manual pump setting refers to an infusion device that does not provide for an automatic back off of pressure As such the green button available during the test must be pressed as soon as the occlusion alarm sound The automatic pump setting
11. itive 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 Note This version of the manual V1 0 describes the manual function of the Multi Flo only Software upgrades available by the end of 2012 will activate the automatic testing sequences remote PC control data storage and download Register your product asap to receive notification of the free firmware upgrade To register your product please visit www rigelmedical com register produci 2 Page Rigel Medical Multi Flo user Manual V1 0 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 Multi Flo Quick Start Guide Utilities Disc USB Bluetooth Adaptor Calibration L D Cerificate SLA 3 Page Rigel Medical Multi Flo user Manual V1 0 RIGEL 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
12. n switch between instantaneous flow and volume by pressing the TYPE button 2 6 Draining the Channels From the main menu select DRAIN This will take you to the Drain function screen E O por ce aaa Automatic mode Channel 2 Select data Channel 3 Setup Channel 4 About Drain All 12 11 14 pm 30 07 2012 Either select the individual channel to drain or select Drain All 16 Page Rigel Medical Multi Flo user Manual V1 0 Draining All Channels e Once the fluid has been drained press to stop the draining process Warning Once the fluid is drained do not leave the drain pump facility running longer than necessary 17 Page Rigel Medical Multi Flo user Manual V1 0 3 Maintaining the Rigel Multi Flo 3 1 Cleaning Ensure that the Multi Flo is operated with the distilled or de ionised water only Always ensure you drain the Multi Flo after use to avoid build up of contamination of the internal flow channels Clean the external case of the Rigel Multi Flo with a clean dry cloth Avoid using solvents and abrasive scouring agents to clean the external case of the Rigel Multi Flo If the Multi Flo is subject to liquid ingress in a manner other than intended the unit should be returned for repair stating clearly the cause for repair 3 2 User Maintenance The Rigel Multi Flo is a rugged quality instrument However care should always be taken when using transporting and storing this type of equi
13. nd 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 1 O Copyright 2012 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 Disposal of old product The Rigel Multi Flo has been designed and manufactured with high q
14. p Use the rotary encoder to select Flow Rate and press the rotary encoder to confirm Flow Test Setup 4 Flow Rate Mean mi h Selected Channel 1 Elapsed Ready Test type Flow Volume test Remaining 00 15 00 0 i 0 0 O Flow Rate 100 00 mih a Mean mih 0 000 Back pressure fa mmHg 2 Peak min ES Error a 100 0 Sampling window 30 sec Inst Flow mh 0 000 Volume mi 0 00 Duration Ohr S 15min S ose H Min muh PmmHg 0 an Graph e JH The Flow Test Setup screen will now be displayed Press MV to save and advance to the Flow Rate test summary screen or E to exit without saving Press the green START button to begin the test Use the rotary encoder during the test to change the highlighted blue field holding the main measurement parameter 15 Page Rigel Medical Multi Flo user Manual V1 0 N Safety Press the red STOP button at any time to stop the test Viewing the flow graph 4 Flow Rate Mean mish Elapsed 00 01 49 Remaining 00 13 11 200 972 Mean ml h 200 972 Channel 1 qa Peak mbh 240 000 Error a 19 Inst Flow mih 203 864 Volume mi 6 09 Min milih 191 992 PmmHg 1 From the summary screen select Graph to view the graph of instantaneous flow rate against time The graph ca
15. pment Failure to treat the product with care will reduce both the life of the instrument and its reliability Always check the Multi Flo and all accessories for damage and signs of wear before use Do not attempt to open the Multi Flo Maintenance should only be carried out by authorised personnel The Multi Flo contains no user serviceable parts Keep the Multi Flo and accessories clean and dry The recommended calibration period for this unit is 12 months 18 Page Rigel Medical Multi Flo user Manual V1 0 3 3 Return Instructions For repair or calibration of the Multi Flo please contact Calibration House Calibration House 11 Bracken Hill Southwest Industrial Estate Peterlee County Durham SR8 2LS United Kingdom Tel 44 0 191 587 8739 Fax 44 0 191 518 4666 Email info calibrationhouse com Prior to returning your unit please contact Calibration House to obtain a RMA By obtaining a RMA your service request can be booked in advance allowing for a quicker turnaround time of your equipment Please have your instrument make model and serial number available 19 Page Rigel Medical Multi Flo user Manual V1 0 4 Accessories 4 1 Optional Accessories The 1 and 2 channel Multi Flo configurations are field upgradeable to a maximum of 4 channels e USB keyboard e USB download lead e Med eBase PC download and remote control software 4 2 Replacement Spare Parts 44B122 IEC mains lead 2 B044
16. refers to infusion devices that do provide an automatic pressure back off function The Multi Flo will detect the occlusion alarm when the line pressure decreases after alarm 2 Occlusion ati Time 00 00 00 Manual Reri Pump type Manual Current mmHg 0 0 Peak mmHg 0 0 Back off mmHg E Bolus Volume ml 0 0 h 4 Graph Setup CH 13 Page Rigel Medical Multi Flo user Manual V1 0 Press aS to save and advance to the Occlusion test summary screen or GEE to exit without saving Press the green START button to begin the test Use the rotary encoder during the test to change the highlighted blue field holding the main measurement parameter Safety Press the red STOP button at any time to stop the test 14 Page Rigel Medical Multi Flo user Manual V1 0 2 5 Flow Rate Volume test The Rigel Multi Flo is capable of measuring the instantaneous flow at a resolution of 10ul 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 Manual mode This will take you to the channel summary screen Summary Volume Pressure Flow Duration Automatic mode mi Flow 0 00 3 0000 Ready Select data low 0 00 O 0 000 Ready Setup About 12 71 14 pm 30 07 2012 l ES ei ters AUTO PRIME DRAIN ABOUT um stopaut setu
17. talled channel Press Calibration to view the calibration data of the installed channels Press gt lt to view the Service and Calibration contact information 9 Page Rigel Medical Multi Flo user Manual V1 0 2 Analysing an Infusion Device 2 1 Connecting an Infusion Device to the Multi Flo Outlet 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 N Ensure that the internal diameter of the outlet tubing is 3 2mm or greater AN Ensure that the length of outlet tubing is kept as short as reasonably practicable 2 2 Priming the Channels Upon power up the Multi Flo is in automatic priming mode however should priming be required at any other stage select the PRIME from the main menu 10 Page Rigel Medical Multi Flo user Manual V1 0 Main menu Prime system connect infusion pump and prime the system until air in the drain disappears Automatic mode Select data Setup About 12 11 14 pm 50 07 2012 AUTO PRIME DRAIN ABOUT Prime the system until the drain is clear of air bubbles Press lt to return to the main menu 2 3 Patient Controlled Analgesia PCA test The PCA test determines the additional volume delivered on top of the basal flow rate set by the user The additional volume or sometime referred to as BOLUS is an
18. uality materials and components which can be recycled and reused When this symbol is attached to a product it means the product is covered by the European Directive 2002 96 EC 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 Certificate of Conformity Manufactured by Seaward Electronic Ltd Bracken Hill South West Industrial Estate Peterlee County Durham SR8 2SW England As the manufacturer of the apparatus listed declare under our sole responsibility that the product Rigel Multi Flo Infusion Device Analyser To which the declaration relates are in conformity with the relevant clauses of the following standard BS EN 61010 1 2010 Safety requiremenis for electrical equipment for measurement control and laboratory use Part 1 General requirements BS EN 61326 2006 Electrical equipment for measurement control and laboratory use EMC requirements Performance The instrument operates within specification when used under the conditions in the above standards EMC and Safety Standards The product identified above conforms to the req
19. uirements of Council Directive 2004 108 EC and 2006 95 EC This Conformity is indicated by the symbol Ce i e Conformit Europ enne Seaward Electronic Ltd is registered under BS EN 1509001 2000 Certificate No Q05356 aa Toei a EA E E AA DAS 2 Design Philosophy isso grp id 2 Unpacking the Multi Flo ssecusanecasieeznanasadiaosa seis puddao Dead ED RAEE E EDAR A EDADE sda dades aid irc ress 3 Vamos and Src 6 5 Seen ena enone ee eee a ee ee eet eee nen etn erent ada eee 4 EIS IN ONG Si 4 Sal INOS are stars pe nessa a A Marne dA S 4 PAGADO IVO os edic ori anii nate ena ene RES 6 1O CORD O a care ss seein een a datas aa 7 1 1 Belore you SWIC O serasa gastas dd asa ainda aclare denun dindo 7 1 2 Turning the Multi Flo On and Of aa aa ae aa Ea Ea a DERA ED aa E EDADE aa Ea a ae Rea DD nOn 7 1 3 Accessing the Multi Flo Tesis era ree arena ERRADO 14 Setting he TMG DAC siiciciccicnssuttodanarurdiateriedeasinetivsactbinntonadaeushelua AD Giane paga 8 1 5 Displaying the Multi Flo Information eee 9 2 Analysing an Infusion Device usisamaisancs does aa aa aa aa a DER nd einen a 10 2 1 Connecting an Infusion Device to the Multi Flo i ii 10 2 2 Priming the Channels cccccccsececeeeeeeeeeeeeeeeeeeeseeeeeseeeeeseeeeeeeeetseueeeseeeeeees 10 2 3 Patient Controlled Analgesia PCA test erram 11 2A OCCIISIOM MCSE usada dan a de ida A ea ea rey ana 12 25 FIOW
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