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Safety Information

– 2020 by MMS B.V.

145

Computer (Laptop)

WARNING

The computer and its peripherals, connected to the Solar

system must comply with the latest version of one of the
following standards: the IEC 60950, EN 60950 or UL

60950.

WARNING

The printer may not be connected (wired) to a computer

without a safety module when the Solar Blue module is
connected to the PC via USB. Preferably use a wireless

printer.

WARNING

If the computer is connected to external devices (such as
printer, modem, telephone-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.

WARNING

Do not connect the computer to a network without proper

safety precautions. Take note of the applicable safety
standards.

CAUTION

First install the Solar Blue software and then plug-in the

Bluetooth dongle and the USB key.

CAUTION

Windows has a bug that affects the detection of USB 1.X
devices through a USB2.0 HUB. Unfortunately, all modern

USB HUBs are V2.0 so make sure that USB 1.X devices,
like the Solar Blue module and the printer are connected

directly to a USB receptacle on the computer.

Содержание Solar Blue

Страница 1: ......

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

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

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 198: ......

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