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LABORIE Solar Blue, Service & Installation Manual

The LABORIE Solar Blue product comes with a comprehensive Service & Installation Manual for easy setup and maintenance. Users can download the manual for free from manualshive.com to ensure smooth operation and maximum efficiency. Get your hands on the detailed instructions to make the most of your solar-powered device.

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© 2008 

– 2020 by MMS B.V. 

Index 

Reset to factory defaults (Solar Blue module) ...................................................................................... 67 

Rotation direction pump ........................................................................................................................ 56 

S

 

Safety information ......................................................................................................................... 10, 139 

Safety module 

install ................................................................................................................................................. 26 

technical specifications ................................................................................................................... 130 

Second flowmeter .................................................................................................................................. 81 

Software 

install Bluetooth software ........................................................................................................... 29, 30 

install MMS software .................................................................................................................. 29, 30 

overview ............................................................................................................................................ 13 

trouble shooting ................................................................................................................................ 41 

Solar blue 

safety module .................................................................................................................................. 130 

Solar Blue 

accessories ......................................................................................................................................... 11 

intended use ...................................................................................................................................... 10 

introduction ......................................................................................................................................... 9 

repairs ................................................................................................................................................ 11 

safety information ..................................................................................................................... 10, 139 

technical specifications ................................................................................................................... 125 

Solar Blue module 

block diagram .................................................................................................................................... 58 
Bluetooth LED’s ............................................................................................................................... 53 
cleaning ............................................................................................................................................. 72 

connect power adapter ...................................................................................................................... 50 

control panel ...................................................................................................................................... 52 

download software ............................................................................................................................ 61 

EMG connection ............................................................................................................................... 55 

EMG test ........................................................................................................................................... 65 

hardware status .................................................................................................................................. 67 

hardware test ..................................................................................................................................... 59 

install ................................................................................................................................................. 48 

install pump head .............................................................................................................................. 49 

install pump tube ............................................................................................................................... 56 

introduction ....................................................................................................................................... 47 

maintenance ...................................................................................................................................... 72 

MMS bus receptacles ........................................................................................................................ 53 

pressure connections ......................................................................................................................... 53 

pressure test ....................................................................................................................................... 62 

pump calibration ............................................................................................................................... 61 

pump test ........................................................................................................................................... 60 

receptacles ......................................................................................................................................... 53 

remote control test ............................................................................................................................. 66 

Summary of Contents for Solar Blue

Page 1: ......

Page 2: ...Solar BlueTM Service Installation Manual MMS Medical Measurement Systems B V Colosseum 25 7521 PV Enschede Netherlands Phone 31 53 480 37 00 Fax 31 53 480 37 01 Internet www laborie com...

Page 3: ...Email usmarketing laborie com LABORIE Europe P O Box 580 7500 AN Enschede The Netherlands Tel 31 53 480 3700 Fax 31 53 480 3701 Email info laborie com Medical Measurement Systems B V Colosseum 25 7521...

Page 4: ...lar Blue Table Top 22 2 4 Solar Blue on Investigation Chair 23 2 5 Solar Blue on Pole 24 2 6 Solar Blue on Pole with Integrated Laptop 25 2 7 Safety Module 26 2 8 Pressure Transducer Holder 28 3 Compu...

Page 5: ...n 55 4 2 9 Install the pump tube 56 4 3 Block Diagram 58 4 4 Hardware Test 59 4 4 1 Introduction 59 4 4 2 Pump Test 60 4 4 3 Pressure test 62 4 4 4 EMG test 65 4 4 5 Remote control test 66 4 4 6 Hardw...

Page 6: ...lable 91 6 5 2 Flowmeter not displayed in HW test program 92 6 5 3 Flowsensor does not function respond 92 6 5 4 Generated values are too low 93 6 5 5 Values are not within limits 93 6 6 Cleaning and...

Page 7: ...113 8 Luna Wireless Module 115 8 1 Introduction 115 8 2 Safety Information 115 8 3 Installation 117 8 3 1 Install the Luna wireless module 117 8 3 2 Install the battery 118 8 3 3 Set the investigation...

Page 8: ...2008 2020 by MMS B V 7 Appendix D Electro Magnetic Compatibility 165 Appendix E Solar Blue Safety Barriers 173 Appendix F Software Messages 175 Warranty for Solar Blue System 185 Index 189...

Page 9: ...8 2008 2020 by MMS B V...

Page 10: ...Blue table top LABORIE systems catalogue code U3 1 Solar Blue Laptop integrated LABORIE systems catalogue code U3 3 The Solar Blue measurement system is a prescription device to be used only by physic...

Page 11: ...h specific area General indications for use include use for patients with lower urinary tract voiding or incontinence problems and for patients with anorectal dysfunction More specifically for inconti...

Page 12: ...ot described or if you are not able to solve the problem with the descriptions please contact your LABORIE representative 1 6 Repairs All repairs which are not performed by LABORIE are for the respons...

Page 13: ...to the local authorities having jurisdiction 1 8 Warranty At the end of this manual you will find warranty information Additional warranty information is described below Flowsensor In case of a flowse...

Page 14: ...ailable patient information investigations reports and memos are stored Selection of a patient will give easy access to all information for that patient Measurement program This program is started fro...

Page 15: ...nual provides you with detailed information about the Solar Blue measurement system setup the installation of software and hardware trouble shooting the hardware test diagnostic program preventive mai...

Page 16: ...re used in a list A round bullet is used for an item of a list A square bullet is used for a step of a procedure This bullet is used for a step in the trouble shooting procedure Numbering You will fin...

Page 17: ...button Figure 1 4 Screen Choose Report Print report means that you must click Report on the menu bar and choose Print report Press a button means pressing the button on the remote control e g the Star...

Page 18: ...ch malfunctions include device malfunction device failure damage to the device or damage to other property NOTE The note sign appears when it is important to read the information Feedback on the manua...

Page 19: ...18 2008 2020 by MMS B V Chapter 1...

Page 20: ...ngle The Solar Blue module is powered by a standard delivered power supply No safety module is needed if the printer and computer are positioned outside the patient vicinity Take note of the system se...

Page 21: ...or a USB cable Integrated in the module are the following items a 4 roller pump to fill the bladder 4x Lemo 4 pressure connectors 1x DIN 5 EMG connector Infrared receiver for remote control Luna wire...

Page 22: ...owmeter can be connected to the Solar Blue module via the digital MMS bus cable Bluetooth puller Mk III The puller withdraws the catheter with a constant speed during UPP investigations The puller has...

Page 23: ...nstall the LABORIE software see the software installation manual document code 0075 MAN 092 EN Assemble and install the Solar Blue module see chapter 4 If applicable install the safety module see 2 7...

Page 24: ...sion pole as supplied with the investigation chair The installation procedure is as follows Install the LABORIE software see the software installation manual document code 0075 MAN 092 EN Assemble and...

Page 25: ...document code 0075 MAN 092 EN Assemble the Solar pole 38mm Assemble and install the Solar Blue module see chapter 4 Mount the Solar Blue module to the Solar pole 38mm CAUTION When mounting the Solar...

Page 26: ...ble and install the Solar Blue module see chapter 4 the Solar pole and the laptop The assembly instructions for the Solar Blue module and the laptop integrated on the Solar pole 38mm can be found in a...

Page 27: ...a Safety module is required Please contact your LABORIE representative Figure 2 5 Safety module On the safety module you will find 1 AC input C14 socket 4 AC outlets 4 x C13 sockets 2 fuses On Off sw...

Page 28: ...nal area of at least 0 75 mm Cu per conductor The maximum cord length is 4m One end of the mains cable must be an IEC60320 type C13 appliance coupler to be connected to the safety module The other end...

Page 29: ...r to the pressure transducer pole see the Solar Blue Assembly instructions laptop integrated set up 0075 MAN 099 If necessary you can change the clamp Figure 2 6 Transducer holder pole for water trans...

Page 30: ...system you must install the software and the USB key properly Installation of the Bluetooth software and the Bluetooth dongle may be necessary for using the Bluetooth devices Solar Blue module Flowmet...

Page 31: ...used to activate the software Note that you install the LABORIE software first then you can install the Solar Blue USB key Figure 3 1 USB key Act as follows Install the software see 3 2 Restart the c...

Page 32: ...wsensor is connected to the power supply you do not need batteries Otherwise you must place the four batteries in the compartment You have 15 minutes to register the Bluetooth devices if needed you ca...

Page 33: ...nd the Bluetooth sign in this window When a module is not presented please check if the module s is on and if Bluetooth is activated For the Luna module Bluetooth can be activated by pressing the Urge...

Page 34: ...enance on the Solar Blue module and all connected modules wireless or by USB cables Information about the connected computer laptop can also be found WARNING Do not connect a patient to the measuremen...

Page 35: ...tarted the screen shows all Bluetooth modules which have already been registered in the measurement program in 3 4 you can read more information about how to register the modules in the measurement pr...

Page 36: ...st Solar USB In the database program choose Utilities Hardware test Solar USB to test the modules connected with USB cables To test the Solar Blue module make sure that the Solar Blue module is connec...

Page 37: ...le button you want to test i e the Solar Blue module Further instructions can be found in the following paragraphs To test the Solar Blue module see 4 4 To test the remote control see 5 3 To test the...

Page 38: ...ore system information can be found in the Hardware test program USB This information can be useful to yourself or your LABORIE representative when you have problems with your system System informatio...

Page 39: ...e following pages Summary This page contains a summary of the most important information System IPL status information about the U2M and the devices connected Bluetooth information and information abo...

Page 40: ...driver information MMSUSB inf MMSUSB sys and information about the connected devices 3 5 6 Download software The Solar Blue module and most of the other devices are provided with a feature to replace...

Page 41: ...you can download the software in all connected modules at the same time The list you will see all connected modules which support downloading of software Default the latest software version will be do...

Page 42: ...er After starting the measurement program a message like Software serial number 970348 SN key is displayed Check if the software serial number indicated on the diskette label is the same as your syste...

Page 43: ...ed If they are not select the port s and click the Remove button After removing exit the program Start the LABORIE software again The software may display the message New hardware found Check in the d...

Page 44: ...k on Yes if you want to delete the investigation with the wrong patient 3 6 8 Messages during the investigation One of the messages Protocol could not be found Settings file not present is displayed R...

Page 45: ...tester Check all devices modules on availability You can use the graphic representation in the hardware test program Check all USB devices on availability for example the USB key and printer Test if...

Page 46: ...network or CD ROM You can make a back up in different ways Back up all patients via Utilities Archive all patients for more information see the separate Database manual in PDF format which can be ope...

Page 47: ...46 2008 2020 by MMS B V Chapter 3...

Page 48: ...upply The pump unit is integrated in the Solar Blue module The pump can be used to fill the bladder with saline during urodynamic investigations A pump tube is connected to a bag of saline and positio...

Page 49: ...and wireless setup Connect the power supply see 4 2 3 Register the Solar Blue module see 3 4 Install the pump tube see 4 2 9 Connect the pressure transducers and catheters see 4 2 7 Connect the EMG c...

Page 50: ...ed Attach the pump head to the Solar Blue module as follows Remove any protection label on the shaft entry of the pump head Please note that the entry is greased Align the male shaft end module with t...

Page 51: ...Detach the pump head Detach the pump head as follows Press the plastic release button on the right side of the pump head Twist the pump head counter clockwise Release the pump head 4 2 3 Connect the p...

Page 52: ...onnect the Solar Blue module to the computer via a USB cable Figure 4 6 USB interface The cable between the Solar Blue module and the computer is used when modules like the flowmeter or the puller are...

Page 53: ...Blue module directly to a USB connection on the computer not via a USB HUB Figure 4 7 Connect the Solar Blue module directly to the computer 4 2 5 Control panel The control panel is used to indicate t...

Page 54: ...bus receptacles The Solar Blue module is equipped with two MMS bus receptacles These receptacles can be used to connect the following modules Flowmeter Puller wired The MMS bus receptacles can only be...

Page 55: ...nd external pressure transducers DT XX DT NN or Sensonor Memscap you need a transducer holder mounted on a pole see also 2 8 With DT XX or DT NN pressure transducers you need interface cables to conne...

Page 56: ...integrated DIN 42 802 and 3 electrodes with press studs 180 cm EMGC TP SUR guarded EMG lead wires with press studs and DIN 42802 set of 3 to be used with EMGC D5 TP guarded EMG cable for 3 electrodes...

Page 57: ...gnal Black Reference Green Yellow 4 2 9 Install the pump tube The pump has four rollers and the rotation direction is predetermined counter clockwise The rotation and flow direction is indicated by th...

Page 58: ...ularly via the hardware test program see 4 4 2 Install the pump tube as follows Open the pump cover Unpack the pump tube and stretch the silicon part of the tube once to improve its flexibility Put th...

Page 59: ...58 2008 2020 by MMS B V Chapter 4 4 3 Block Diagram The figure below shows the block diagram of the Solar Blue module Figure 4 18 Block diagram Solar Blue module...

Page 60: ...Figure 4 19 Hardware test Solar Blue module In case no Bluetooth connection is used choose Utilities Hardware test Solar USB to perform the hardware test Make sure that the Solar Blue module is conne...

Page 61: ...used or Connect the flowmeter via a wired connection to an MMS bus receptacle when the hardware test Solar USB is used Make sure the power adapter is connected to the Solar Blue module in this case Pl...

Page 62: ...advises NOT to calibrate the pump when the pump is performing well within acceptable ranges When the pump performance deviates we recommend to find the cause of the problem first for example the fill...

Page 63: ...the water container which is positioned on the flowsensor Click the Calibrate pump button You will see the progress bar Busy calibrating The pump stops automatically after 5 minutes When there is no...

Page 64: ...The expected reading is 50 cmH2O The maximum deviation may be 2 cmH2O plus the deviation of the pressure transducers in accordance to the manufacturer s specifications Check if the channels display t...

Page 65: ...r Blue module a selection of these transducers or the complete catheter with all transducers based on a catheter definition Pressure unit The pressure values can be shown in four pressure units cmH2O...

Page 66: ...gure Strain your arm muscles and check if the EMG value increases The EMG signal should be approximately 200 You can change the EMG scale by using the Up Down key The values are 1 2 5 10 20 50 100 200...

Page 67: ...66 2008 2020 by MMS B V Chapter 4 4 4 5 Remote control test Choose the TAB Test remote control unit to test the remote control Figure 4 24 Test the remote control For more information see 5 3...

Page 68: ...rdware status Solar Blue Packet info and Sample rate Click the Packet info button to display module information about the received and missed packets and the selected and effective sample rate Click o...

Page 69: ...8 2008 2020 by MMS B V Chapter 4 4 5 Troubleshooting 4 5 1 Registering Bluetooth Solar Blue is not possible The menu item Register Bluetooth devices is not available Contact your LABORIE representativ...

Page 70: ...in the System information Contact your LABORIE representative 4 5 3 H2O pump icon is not displayed during investigation The H2O pump is not shown in the top left corner during the pre test and the inv...

Page 71: ...rect Check if one of the cables plugs or connectors is damaged Check if one or more transducers are defective using the pressure transducer test Contact your LABORIE representative 4 5 7 One pressure...

Page 72: ...he anus The earth cable should be connected to a ground earth electrode on the leg or abdomen of the patient Male patients should preferably be shaved before placing the electrodes Check also if the e...

Page 73: ...a moisturized cloth The urine container and the funnel should be rinsed with water and cleaned with detergent Remove water from the flowsensor and the flow stand with a soft dry cloth Remove water fr...

Page 74: ...and clean the pump rollers one by one with a moisturized cloth Check also if there is nothing around the spindle of the roller that causes the friction like a hair or something Test the pump with the...

Page 75: ...74 2008 2020 by MMS B V Chapter 4...

Page 76: ...he remote control in the direction of the infrared receiver while pressing a key Before working with the remote control make sure that you remove the plastic insulator RC 1200 keys The RC 1200 contain...

Page 77: ...program see 5 6 5 2 Install the Battery The remote control is powered by one button cell battery CR2025 Replace the battery at least every 6 months to avoid leakage The operational distance between re...

Page 78: ...1 and finger nail 2 Insert the new battery in the compartment as shown in the pictures below the battery fits in only one way Figure 5 5 Insert battery in compartment Insert the battery compartment i...

Page 79: ...ware test program Choose Diagnose Test remote control to start the test The following window will be displayed Figure 5 6 Hardware test remote control Point the remote control to the infrared receiver...

Page 80: ...e proper operation and to avoid leakage If the distance at which the remote control works properly is getting shorter than usual it is recommended to replace the batteries immediately 5 6 Virtual Remo...

Page 81: ...80 2008 2020 by MMS B V Chapter 5...

Page 82: ...olar Blue module by using a digital MMS bus cable Three conditions must be met the Solar Blue module is connected to the computer with the USB cable the Solar Blue module is powered by the external po...

Page 83: ...onth on a single set of batteries Optionally the Bluetooth flowsensor can be powered by the power adapter Install the Bluetooth flowmeter as follows Fasten the flow stand pole 7 on the flow stand foot...

Page 84: ...h as an indication that the flowsensor is powered Register the Bluetooth flowmeter in the LABORIE software see 3 4 Test the Bluetooth flowmeter in the hardware test see 6 4 Enable the Bluetooth flowme...

Page 85: ...uter not via a USB HUB Figure 6 3 Connect the Solar Blue module directly to the computer Pick up the flow stand The best way to pick up the flow stand is to take the flow stand arm on which the funnel...

Page 86: ...h communication flowsensor powered by power adapter Green blinking long periods off Bluetooth communication flowsensor powered by batteries Red blinking Low battery message place new batteries in the...

Page 87: ...protocol Click the Connections button Default the Solar Blue measurement system will use all connected or registered flowmeter s with the automatic selection setting You can also select one specific...

Page 88: ...le click on the LABORIE Database button Click on the New investigation button Select one investigation in which the Bluetooth flowmeter is enabled The pre test of the investigation is started and the...

Page 89: ...bus interface is used for the wired data and power connection with Solar Blue module The MMS bus interface socket can also be used for an external power adapter Bluetooth module only Standard for the...

Page 90: ...llowing window Figure 6 7 Hardware test Flowmeter Packet info and Sample rate Click the Packet info button to display module information about the received and missed packets and the selected and effe...

Page 91: ...ou can check the recording Place the urine container on the flowsensor and start the voiding simulation In the window you will see the flow in ml s To exit the test click on the Close button Allowed l...

Page 92: ...2008 2020 by MMS B V 91 6 5 Troubleshooting 6 5 1 Registering Bluetooth Flowmeter is not available The menu item Register Bluetooth devices is not available Contact your LABORIE representative...

Page 93: ...program Select the TAB USB in the System information Contact your LABORIE representative 6 5 3 Flowsensor does not function respond At the start of the investigation only the empty urine container an...

Page 94: ...but when the weight on the flowsensor is increased and the displayed value is not increasing at a certain weight value anymore 2000 gram check the following If the field Weight absolute in the diagnos...

Page 95: ...not use chloride based solutions for cleaning the flow stand Check that the solution does not affect stainless steel AISI304L Clean the flow stand if it was contaminated with urine On a daily base cle...

Page 96: ...ller Figure 7 1 Bluetooth puller The catheter puller communicates through a wireless Bluetooth connection with the computer The puller is powered by four AA type rechargeable batteries NiMH or the sup...

Page 97: ...theter in and out of the patient The catheter can be attached to the slider by means of a spring clamp This clamp is affixed to the slider and consists of a rubber compression piece under which the ca...

Page 98: ...puller see 3 4 Place the guider 10 in the puller enclosure and use the lock screw 14 to secure the guider Do not screw the guider too tight Place the slider 7 in the puller enclosure as shown in figu...

Page 99: ...arts can be replaced quickly and easily Cleaning instructions can be found in 7 6 7 2 2 Control panel The control panel of the Bluetooth puller contains three LED s for Bluetooth and status indication...

Page 100: ...the puller and charging the batteries Orange blinking The batteries are almost depleted please connect the power adapter within 5 minutes Red blinking The batteries are depleted You can connect the p...

Page 101: ...rs This depends on the capacity of the batteries They will obtain their maximum capacity after a few charge discharge cycles If the power adapter is connected and has fully charged batteries inside th...

Page 102: ...Completely depleted batteries will shorten the life span The procedure is as follows Connect the power adapter to the DC receptacle see figure 7 2 2 Make sure that the Bluetooth puller is connected t...

Page 103: ...on one of the protocols and choose Edit protocol Figure 7 4 Edit protocol For each investigation in the selected protocol you can enable the Bluetooth puller Select the TAB with the investigation nam...

Page 104: ...button to return to the investigation protocol In the measurement program you can start an investigation and test the Bluetooth puller 7 2 6 Test the Bluetooth puller The Bluetooth puller can be test...

Page 105: ...uble shooting see 7 5 During the pre test and the investigation it is not possible to move the slider forwards or backwards manually The slider is locked in the puller enclosure and controlled by the...

Page 106: ...of the pulling distance the slider will be equipped with a very small magnet 3mm x 1mm A small hall sensor will result in a shutdown of the motor and if necessary a notification The catheter puller wi...

Page 107: ...witched on when the motor current is required The puller will be equipped with three LEDs and one button A tri color LED will indicate the status of the puller A blue LED will indicate an operational...

Page 108: ...ality press the Unlock slider button on the control panel of the puller until the blue light lights up shortly In the hardware test program click on the Bluetooth puller module button to display the f...

Page 109: ...ting point by clicking the Auto return puller button The puller should stop near the first pencil line Over a distance of 100 mm the measured puller distance may deviate 2 mm maximum clearance of the...

Page 110: ...uetooth puller is not displayed in the hardware test program 4 4 In case you use the hardware test program Bluetooth Register the Bluetooth puller in the hardware test program Bluetooth 3 5 2 7 5 3 Th...

Page 111: ...ftware cannot recognize this situation nor compensate it during the analysis The slider is blocked cannot move freely Reposition the slider You can also clean and check the functioning of the pinion T...

Page 112: ...arge the batteries Replace the batteries Check the range of the Bluetooth puller Check the Bluetooth dongle Contact your LABORIE representative 7 5 10 End of slider detected The Bluetooth puller has s...

Page 113: ...puller battery is depleted The puller has stopped and the message Puller has stopped Puller battery is depleted is displayed during the pre test or the investigation The batteries are depleted Connec...

Page 114: ...s access to the plastic pinion that drives the slider This pinion is limited in torque and poses no threat to fingers or other body parts LABORIE recommends to clean the following parts On a daily bas...

Page 115: ...esentative Some mechanical parts need to be replaced after intensive use for example the plastic pinion and the slider and its parts Contact your LABORIE representative for more information The cathet...

Page 116: ...investigations to start with a stationary urodynamic investigation and to continue with the ambulatory urodynamic investigation 8 2 Safety Information In this paragraph you will find safety informati...

Page 117: ...rating safety transformer or an additional protective earth may be necessary CAUTION Change the battery only when the patient is disconnected from the Luna system unplug catheter and all patient leads...

Page 118: ...una as described in 3 4 In the figure below you will see the back side of the Luna with its connectors Figure 8 2 Luna connectors 1 Lemo 3 EMG channel 4 Lemo 4 pressure channel Pabd 2 Lemo 3 conductan...

Page 119: ...hours in the Luna the software will display the following text If you want to continue with an ambulatory investigation after the stationary investigation change the battery now When the battery is lo...

Page 120: ...3 Luna P3 EMG1 Luna EMG Conductance1 Luna Conductance 8 3 4 Connect the catheter Solid state or air charged transducers with Lemo 4 plug can be connected to the Lemo 4 inputs for measuring pressures...

Page 121: ...It is possible to measure EMG using surface electrodes EMG cable and electrodes The recommended EMG cable to use with the Luna is the UD 597 A6 guarded EMG cable for 3 surface electrodes with press st...

Page 122: ...lation To PC LEMO 5 connector LEMO 3 connector LEMO 3 connector RS485 interface 8Mbyte flash 8Mbyte flash optional Flowsensor no USB Pressure max 2 ch Pressure max 2 ch Pressure max 2 ch EMG 1 ch 1Mby...

Page 123: ...at atmospheric pressure simultaneously You can also zero the individual channels by clicking the 0 button behind the pressure channels Lower the catheter to 100 cm below the water surface of the water...

Page 124: ...ce measured by the rings is now shown in the window as a value and as a horizontal bar In the air the value is 0 When you put the catheter in saline the value will increase Test EMG Connect the EMG ca...

Page 125: ...top of the computer You can also connect the Bluetooth dongle to a free USB port on the front side of the computer The pressure transducer measurement is not accurate Check step by step the following...

Page 126: ...gram Liverpool nomogram Miskolc nomogram Composite nomogram Detrusor flow plots in accordance to ICS Sch fer Blaivas Griffiths optional W F optional UPP analysis accordance to Eberhard optional Patien...

Page 127: ...EC 60601 1 2 2014 MDD Medical Device Directive 93 42 EEC Class IIa medical device ANSI AAMI ES60601 1 2005 C1 2009 A1 2012 A2 2012 CAN CSA C22 2 No 60601 1 2014 SGS contract no 710253 Site Requirement...

Page 128: ...y 5 uV V mmHg Pole for Argon or Memscap transducers optional Holder for Argon or Memscap transducers optional Argon transducers through interface cables optional Receptacles 4x Lemo 4 Connector type L...

Page 129: ...hrough USB not via wireless Bluetooth connection Solar Blue power supply is necessary IR receiver Receiving distance at least 4m Receiving angle 30 degrees in respect to focus center line Solar Blue p...

Page 130: ...Mk IV one piece pole Length 85 cm 34 Diameter 38 mm 1 5 Material Stainless Steel Weight approximately 3 kg Hook integrated in Solar Blue clamp Laptop shelf pivot on top of pole Base box Material Steel...

Page 131: ...specifications visible after installation 9 4 Flowmeter Mk III General Applied part N A Degree of ingress protection IPX1 Flowsensor Digital weight sensor measures voided volume and calculates flow Ca...

Page 132: ...ameter 262 mm Urine container Material PP Polypropylene Volume 1000 ml Flow Accuracy 1 ml s 1 0 Resolution 1 ml s Range 1 100 ml s Artefact correction Volume Accuracy 1 ml 1 0 Resolution 1 ml Range 0...

Page 133: ...nclosure material Aluminium clear anodized POM Mounting possibilities on spring balanced arm Stroke depending on slider length 150 mm or 400 mm Speed 10 1500 mm min Initial backlash 1 mm Movement accu...

Page 134: ...computer Slider Material Aluminum T shape clear anodized Length 305 mm 150 mm stroke 555 mm 400 mm strike Clamp material stainless steel and silicone tube Disk material Silicone Integrated magnet for...

Page 135: ...drinking urge walking leakage Solid state micro tip catheters air charged transducers catheters water transducers catheters Casing material ABS Computer interface Bluetooth wireless interface Mini USB...

Page 136: ...upled Use a RJ11 adaptor for catheters with a RJ11 connector Receptacle Lemo 3 female type EPG OB 304 HLN pin 1 Not connected pin 2 Sensor ring 1 pin 3 Sensor ring 2 EMG Input range 4 mV Electrodes su...

Page 137: ...mory stick 17 inch color monitor 2 button mouse Printer for integrated laptop setup HP deskjet 210x440x210mm DxWxH with foldable tray and separate external power supply f e D2560 NOTE You will need at...

Page 138: ...2008 2020 by MMS B V 137 APPENDICI WARRANTY AND INDEX...

Page 139: ...138 2008 2020 by MMS B V...

Page 140: ...em must be purchased under the supervision of a physician For US only Caution Federal law restricts this device to sale by or on the order of a physician The Solar Blue measurement system complies wit...

Page 141: ...ity of injury death or other serious adverse reactions associated with the use or misuse of the device CAUTION A caution is a statement that alerts the user to the possibility of a problem with the de...

Page 142: ...he system into operation the system must be allowed to acclimatize to the specified operating conditions for at least 4 hours All repairs which are not performed by LABORIE are for the responsibility...

Page 143: ...stem setup in accordance to the IEC 60601 cannot be guaranteed a safety module is required Please contact your LABORIE representative WARNING If the computer is connected to external devices such as p...

Page 144: ...er the Solar Blue module is powered by the external power supply CAUTION Connect the Solar Blue module directly to a USB connection on the computer not via a USB HUB CAUTION The digital MMS bus cables...

Page 145: ...on via pump bag of saline and pressure cuff for perfusion of Pura WARNING Do not connect the computer laptop to a network without proper safety precautions Take note of the applicable safety standards...

Page 146: ...lephone lines sound systems network video sources display systems and or the equipment is combined with other equipment make sure that all requirements of the applicable safety standards are met WARNI...

Page 147: ...age of the system The input voltage is indicated on the safety module WARNING The mains plug must be inserted in a mains socket provided with a protective earth contact WARNING All devices must be pow...

Page 148: ...and 2 this device must accept any interference received including interference that may cause undesired operation This device contains FCC ID POOWML C40XX WARNING If a safe system setup in accordance...

Page 149: ...pump WARNING If you discover any abnormal behaviour with the pump stop the pump with the remote control or disconnect the catheter from the system WARNING During pump calibration do not touch or dist...

Page 150: ...bances CAUTION Remove the battery when the Luna module is not used for a longer period NOTE Environmental conditions as thick walls doors iron in walls doors may compromise the Bluetooth connection of...

Page 151: ...that the solution does not affect stainless steel AISI304L Clean the flow stand if it was contaminated with urine NOTE Environmental conditions i e thick walls doors iron in walls doors may compromis...

Page 152: ...sducer permanently CAUTION Use rechargeable AA batteries 2300 mAh NiMH of good quality only and replace all four at once CAUTION After low battery indication connect the power adapter within 5 minutes...

Page 153: ...tigation is performed and how the results are interpreted the actual diagnosing remains under all circumstances the responsibility of the clinician physician performing the investigation The descripti...

Page 154: ...terpretation and correct measuring cq displaying of values by third party equipment interfaced with LABORIE is the responsibility of the user Therefore LABORIE recommends to verify proper operation pr...

Page 155: ...ctions can occur in some circumstances Abnormal environmental conditions include but are not limited to any other condition as is specified in the manual electro magnetic fields caused by portable equ...

Page 156: ...ss depending on setup Applied part Ingress protection rate Solar Blue Class II BF IPX1 Luna wireless module BF IP2X Bluetooth flowmeter Mk III Class II if powered by power adapter IPX1 Safety module C...

Page 157: ...156 2008 2020 by MMS B V Appendix A...

Page 158: ...mbol Follow instructions for use Consult operating instructions Caution Federal law restricts this device to sale by or on the order of a physician Triangle with black or red border Caution consult in...

Page 159: ...t ingress of dripping water with harmful effects when tilted 15 IPX1 Protected against dripping water Equipment provided with an enclosure preventing entry of such an amount of falling liquid as might...

Page 160: ...ories Symbol with red border Never put fingers or any other body parts in the pump while it is running Double insulated conform IEC 60601 1 Atmospheric pressure range 700 hPa to 1060 hPa Operating Con...

Page 161: ...g Transport Conditions Temperature range 25 C to 70 C Transport Conditions Relative humidity range 90 non condensing This device uses a RF transceiver for data transfer purposes This product is subjec...

Page 162: ...Symbol with red border Do not push or pull Manufacturer May be combined with manufacturing date Mass including safe working load in kilograms Catalogue number Serial number Quantity symbol Numeral in...

Page 163: ...manufacturing year number F Product group number XXXX 3 or 4 digit unique module abbreviation NNNN 4 digit incrementing unique number Explanation of SN number SN YYXXNNNN SN Serial Number YY 2 digit m...

Page 164: ...le MMS Bus Dedicated software and hardware protocol for communication between investigation modules Pressure Simulator Device to test the Solar Blue module with Lemo 4 connectors RC 1200 Remote contro...

Page 165: ...164 2008 2020 by MMS B V Appendix C...

Page 166: ...the measurement modules digital MMS bus cables should only be replaced with original Laborie types SDC 1 6 SDC 4 SDC 10 Recommendations for actions to assure that the Solar Blue remains safe with reg...

Page 167: ...ome defective Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The Solar Blue uses RF energy only for its internal function Therefore its RF emissions are v...

Page 168: ...act 15 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 1 k...

Page 169: ...100 dip in U for 5 sec Power frequency 50 60 Hz magnetic field IEC 61000 4 8 30 A m 30 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commerc...

Page 170: ...0601 test level Compliance level Electromagnetic environment guidance Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 Vrms 150 kHz to 80 MHz 6Vrms for ISM bands 3 V m 80 MHz to 2 7 GHz 27 V m 3...

Page 171: ...fected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios ama...

Page 172: ...f the Solar Blue system including cables specified by the manufacturer Otherwise degradation of the performance of this equipment could result Rated maximum output power of transmitter W Separation di...

Page 173: ...172 2008 2020 by MMS B V Appendix D...

Page 174: ...2008 2020 by MMS B V 173 Appendix E Solar Blue Safety Barriers...

Page 175: ...174 2008 2020 by MMS B V Appendix E...

Page 176: ...ur LABORIE representative Bluetooth SMART dongle not found Communication problems Contact your LABORIE representative Bluetooth Stack s not initialized File s incompatible Communication problems Conta...

Page 177: ...estarting analysis Do you want to create a separate backup Saving investigation file failed Contact your LABORIE representative Demo file not present Demonstration file is not available Create a demon...

Page 178: ...ve as demo file Error while allocating MPEG4 buffers MPEG4 buffer problem Contact your LABORIE representative Error while allocating video buffers Increase the non paged memory size in Milconfig Error...

Page 179: ...rt the pump If the error remains the system should be sent to MMS for maintenance Restart or Stop and save investigation Perfusion problem Contact your LABORIE representative MMS perfusion pressure to...

Page 180: ...ontact your LABORIE representative The Luna needs new firmware to be used stationary This firmware is not available on your computer Please contact your dealer New firmware version needed Contact your...

Page 181: ...emove profile marker Warning No more Profile markers No more profile markers available Remove profile marker Wireless patient module connection lost Communication problems Contact your LABORIE represe...

Page 182: ...ry again later or call your dealer Closing program Repairing demographics database failed Try again later or contact your LABORIE representative Demographics database is busy Probably a network relate...

Page 183: ...Try again later or call your dealer Closing program Investigation database is corrupted Try again later or contact your LABORIE representative Investigation database is busy and could not be repaired...

Page 184: ...act your LABORIE representative Cannot connect to Device Device text When a Bluetooth device is not found Check the batteries Check the distance between the Bluetooth device and the Bluetooth dongle a...

Page 185: ...sentative Solar Blue is connected via bluetooth USB communication is disabled Communication problems Contact your LABORIE representative Solar Blue is not found Please check the USB and power connecti...

Page 186: ...nd patient should consult state law if there is a question regarding this disclaimer The information descriptions recommendations and safety notations in this Manual are based upon Medical Measurement...

Page 187: ...t to the restrictions above and if the SOFTWARE is not copy protected you may make one 1 copy of the software solely for backup purposes You must reproduce and include the copyright notice on the back...

Page 188: ...ANTY OR IN ANY WAY INCREASE THE SCOPE OF THIS WARRANTY AND YOU MAY NOT RELY ON ANY SUCH INFORMATION OR ADVICE YOU MAY HAVE OTHER RIGHTS WHICH VARY FROM STATE TO STATE THIS WARRANTY SHALL ONLY BE EFFEC...

Page 189: ...2008 2020 by MMS B V Warranty for Solar Blue System...

Page 190: ...olar Blue module 67 Block diagram Bluetooth puller 105 Flowmeter Mk III 88 Solar Blue module 58 Bluetooth dongle 29 Bluetooth Flowmeter Mk III 81 batteries 82 block diagram 88 cleaning 94 flowstand 84...

Page 191: ...r puller Bluetooth 95 Cleaning Bluetooth Flowmeter Mk III 94 Bluetooth puller 113 catheter 72 computer 44 Solar Blue measurement system 12 Solar Blue module 72 Combination Interface Module block diagr...

Page 192: ...Bluetooth Flowmeter Mk III H Hardware test Bluetooth Flowmeter Mk III 89 Bluetooth puller 107 remote control 78 Solar Blue measurement system 33 Solar Blue module 59 Hardware test diagnostic program...

Page 193: ...ctance connector 117 diagnostic program 121 EMG connector 117 install the battery 118 installation 117 label Luna 33 pressure connector 117 safety information 115 set investigation protocol 119 techni...

Page 194: ...ansducer holder 22 24 28 54 Print system information 38 Program versions 39 Protocol settings Bluetooth Flowmeter Mk III 86 Bluetooth puller 102 save 45 Puller Bluetooth See Bluetooth puller Pump rota...

Page 195: ...olar Blue accessories 11 intended use 10 introduction 9 repairs 11 safety information 10 139 technical specifications 125 Solar Blue module block diagram 58 Bluetooth LED s 53 cleaning 72 connect powe...

Page 196: ...e module 127 flowmeter Mk III 130 IR reciever Solar Blue module 128 power supply Solar Blue module 128 pressure interface Solar Blue module 127 pump Solar Blue module 126 remote control 133 safety mod...

Page 197: ...information 36 USB interface Solar Blue module 51 USB HUB 136 W Warranty 185 Water catheters 22 54 Weight Solar Blue 126 Windows 10 Wireless connection Solar Blue module 128 Wireless Flowmeter Mk III...

Page 198: ......

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