LABORIE MMS Solar Blue User Manual Download

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Solar Blue User Manual

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Appendix B

Explanation of Symbols

This appendix provides descriptions of the symbols on the Solar Blue system.

Blue symbol

Refer to instruction manual.

Consult instructions for use.

Caution: Federal law restricts this device to sale by or on the

order of a physician.

Triangle with black or red border: Caution, consult instructions

for use.

Yellow triangle

General warning.

Note that some of the symbols on the measurement system are originally in color.

Summary of Contents for MMS Solar Blue

Page 1: ...Solar Blue User Manual 1 Solar BlueTM User Manual...

Page 2: ...3 4803701 www laborie com MMS is a registered trademark of Medical Measurement Systems BV Enschede the Netherlands All rights reserved IMAGES RENDERINGS OF LABORIE DEVICES IN THIS PUBLICATION ARE PROP...

Page 3: ...nd Select the Patient 22 2 4 Start the Measurement Program 23 2 5 Prepare the Investigation Pre Test 23 2 5 1 Consumables Traceability 23 2 5 2 Pre Test 27 2 5 3 Prepare the pump and pump tube 27 2 5...

Page 4: ...annels 58 4 3 Investigation 58 4 4 Results 59 5 Cystometry 62 5 1 Introduction 62 5 2 Channels 62 5 3 Investigation 62 5 4 Results 63 6 Pressure flow study 69 6 1 Introduction 69 6 2 Channels 69 6 3 I...

Page 5: ...on 109 9 3 1 Water catheters 109 9 3 2 Air charged catheters 110 9 3 3 Solid state catheters 112 9 3 4 Positioning of the catheter 112 9 4 Investigation 113 9 4 1 Introduction 113 9 4 2 Resting pressu...

Page 6: ...iance 139 9 5 16 3D Vector volume plot 140 9 5 17 Rectal volume plot 142 10 Biofeedback 143 10 1 Introduction 143 10 2 Prepare the investigation 144 10 3 Investigation 147 10 4 Analysis 148 10 5 Inves...

Page 7: ...ttings 180 12 5 8 Channel settings 181 12 5 9 Connections Solar Blue 182 12 6 System Settings 183 13 Analysis Program 186 13 1 Introduction 186 13 2 Results 188 13 2 1 Menu overview 188 13 2 2 Display...

Page 8: ...nu overview 205 13 6 2 Channel settings 206 13 6 3 System settings 207 13 7 Export 209 13 8 Report 209 13 9 Configure Button Toolbar 210 Appendix A Safety Information 212 Appendix B Explanation of Sym...

Page 9: ...Laptop integrated LABORIE systems catalog code U3 3 The Solar Blue module can communicate via a wireless connection with the flowmeter puller and computer It receives infrared commands from an optiona...

Page 10: ...measurement system consists of a Solar Blue module and some additional and or optional devices The following table provides an illustration and description of these devices Module Description Solar B...

Page 11: ...used described in the previous version of this manual Wireless flowmeter Mk III The flowmeter can be used to measure voided volume and flow via a wireless connection Under certain conditions a cable...

Page 12: ...tions patients with neurogenic bladder dysfunction and children with complex voiding incontinence problems Contraindication Urodynamics should not be performed in the setting of a symptomatic urinary...

Page 13: ...asy access to all information for that patient Measurement program This program is started from the database The software guides the user through the investigation procedure and saves the measured dat...

Page 14: ...IE assistant Figure 1 6 is an intelligent assistant that can provide helpful advice to you via pop up messages The message and the assistant will disappear when you click the OK button in the message...

Page 15: ...ost important ones Use of bullets Headings The use of the words click press and choose Warnings cautions and notes Use of bullets Bullets are used in a list round bullet Used for an item of a list squ...

Page 16: ...utions to provide patient safety and to prevent damage to the equipment WARNING A warning is a statement that alerts the user to the possibility of injury death or other serious adverse reactions asso...

Page 17: ...Chapters 9 and 10 explain anorectal manometry and biofeedback Chapter 11 explains the Luna module and the procedure to switch from stationary to ambulatory measurement The investigation procedure can...

Page 18: ...Figure 2 1 Login 2 2 1 Administrator Authentication From the Login window Click the button to enter the Administrator Authentication window to manage the User Password Figure 2 2 Administrator Authen...

Page 19: ...location of the files of the LABORIE network software changes you can enter them in the fields Local dir for the location of the locally installed software Network dir for the location of the files on...

Page 20: ...Secure LDAP This sets the default port number to 636 For this option to function correctly the SSL certificate being used on the AD LDAP server needs to be installed on the machine running the Laborie...

Page 21: ...o Any user outside of those groups who attempts to log in will not be allowed to do so 2 2 2 Patient Database From the Login window enter the Username and Password and then click OK to start the pati...

Page 22: ...he mouse Click the OK button to save the information of the new patient The patient is now displayed and selected in the patient list To abort the entry of demographics click the Cancel button The pro...

Page 23: ...easurement program select a new investigation The measurement program shows all available investigations Select the appropriate investigation protocol and then click the investigation name to start th...

Page 24: ...e upper right corner You can reopen it by clicking the RFID button on the toolbar Scanning consumables The Solar Blue software keeps track of your inventory in a repository which is displayed in the C...

Page 25: ...previously used consumables will be preselected and display the suffix reuse Consumable Expiration When consumables are within a month of their expiration date you will be notified and encouraged to u...

Page 26: ...ter an investigation is performed the used consumables will be shown in the database next to the preview of the investigation Figure 2 10 The consumables used during an investigation Consumables in Re...

Page 27: ...formation about installing the pump tube connecting EMG electrodes preparing the flowmeter and preparing the catheter puller In Chapter 3 you will find information about preparing the catheters and th...

Page 28: ...er but do not stretch the pump tube while closing the cover Put the spike of the pump tube into the bag of saline To prevent water spillage put the bag on a table before inserting the spike Make sure...

Page 29: ...LED 3 and the infrared receiver 4 Figure 2 11 The control panel on the Solar Blue module The following table describes what the LED colors and status indicate LED Color Indication Status Green on Gree...

Page 30: ...m for ambulatory urodynamic investigations to start with a stationary urodynamic investigation and to continue with the ambulatory urodynamic investigation The Luna is supplied with a Bluetooth wirele...

Page 31: ...ber of pressures measured two or three The type of investigation Chapter 3 provides detailed instructions about preparing the catheters and transducers 2 5 7 Prepare EMG cables and electrodes EMG of t...

Page 32: ...letely dry the area of any remaining moisture from the alcohol pad o Place the EMG electrode patches directly ON opposing sides of the sphincter The patches should be placed ON the darker skinned area...

Page 33: ...5 connector and integrated DIN 42 802 and three electrodes with press studs 180 cm EMGC TP SUR guarded EMG lead wires with press studs and DIN 42802 set of three to be used with EMGC D5 TP guarded EMG...

Page 34: ...o measure the voided volume and the flow during urodynamic investigations The flowmeter is supplied with wireless Bluetooth technology so that cabling is not required Figure 2 19 Flowmeter The flowsen...

Page 35: ...upply Status LED flowsensor The following table describes what the LED colors and status indicate LED Indication Orange on IPL error Please contact your MMS representative Green on Digital cable is co...

Page 36: ...Wireless catheter puller You can use the puller for the following investigations UPP Urethral Pressure Profile Gynecology study Anorectal manometry The wireless catheter puller communicates through a...

Page 37: ...iece of the spring clamp 9 The control panel of the wireless puller contains three LEDs Bluetooth 1 Status 2 Battery 3 indication and one membrane button 4 to unlock the slider Figure 2 22 Control pan...

Page 38: ...e fully charged Green blinking The power adapter is connected to the puller and charging the batteries Orange blinking The batteries are almost empty please connect the power adapter within five minut...

Page 39: ...and shown immediately The check is OK when there is a minimal 70 amplitude agreement between the Pves and the Pabd signals the smaller spike must be at least 70 of the larger spike If EMG is being me...

Page 40: ...own in the investigation information of the analysis program and in the report 2 7 Perform the Investigation After finishing the pre test you can start the actual investigation Figure 2 26 Pressure fl...

Page 41: ...Biofeedback see Chapter 10 2 8 Print the Investigation Report Double click the Investigation name in the database program to start the analysis program Click the Reporter button to open the Reporter d...

Page 42: ...d be rinsed with water and cleaned with detergent Remove water from the flowsensor and the flow stand using a soft dry cloth Remove water from the Solar Blue module Solar pole and its devices with a s...

Page 43: ...er that complies with all local environmental regulations NOTE For cleaning and sterilization of the catheters or accessories e g EMG needle electrodes see the manufacturer s instructions 2 10 Exit th...

Page 44: ...the database program you can shut down the computer by clicking the Start button of the Windows Start menu Select Shutdown to exit Windows and turn off the system CAUTION Never turn off the computer...

Page 45: ...ters and transducers used and the number of pressures measured For information about how to prepare reusable solid state catheters Figure 3 1 see 3 3 For information about how to prepare air charged c...

Page 46: ...to the filling lumen of the catheter Prepare the EMG cables and apply the electrodes as described in 2 5 7 if applicable Prepare the catheter puller as described in 2 5 9 if applicable Click the Start...

Page 47: ...le position the urethral pressure sensor Pura at the maximum urethral pressure and fix the catheter Insert the rectal catheter into the rectum and fix the catheter Ask the patient to cough to check th...

Page 48: ...e module or Luna as follows Color pressure transducer Solar Blue or Luna Yellow P1 Pves vesical bladder pressure Blue P2 Pabd abdominal pressure Green P3 Pura urethral pressure Place a hook and loop s...

Page 49: ...N position Press the Zero all button to zero all pressures to atmospheric pressure Charge the catheters Figure 3 8 Figure 3 8 Charge catheters Fix the abdominal catheter Withdraw the catheter and loca...

Page 50: ...The catheters are connected to the Solar Blue module or Luna via external pressure transducers In this section you will find instructions and illustrations explaining the setup of single use DT XX pr...

Page 51: ...ay be too high or too low After inserting the catheters the patient is asked to cough to verify the pressure channels If there is no signal check whether the stopcock is open to the catheter and not t...

Page 52: ...t the genital area Insert the bladder catheter and connect the catheter to the pressure transducer P1 Pves Fix the catheter Insert the rectal catheter and connect the catheter to the pressure transduc...

Page 53: ...Set the flow reducer at a flow rate of 60 ml per hour Disinfect the genital area Insert the bladder catheter and locate the vesical sensor Pves and the urethral sensor Pura both in the bladder Connec...

Page 54: ...easuring Pves and Pura For urethral pressure profiles UPP you can use the bladder catheter as displayed and described in 3 5 3 It is not necessary to measure the abdominal pressure see also Figure 3 1...

Page 55: ...isinfect the genital area Insert the bladder catheter and locate the vesical sensor Pves and the urethral sensor Pura both in the bladder Connect the catheter to the pressure transducer P1 Pves and th...

Page 56: ...cer holder is at symphysis pubis level Connect the syringes filled with sterile water to the pressure transducers as displayed in the figure above optionally the LABORIE flush set can be used Push the...

Page 57: ...e patient to cough and check the registration of all pressures The spikes of Pves Pabd and Pura should rise equally in response to the cough and the detrusor pressure Pdet pressure should remain relat...

Page 58: ...estigation Click the Uroflow button to start the pre test Prepare the flowmeter as described in 2 5 8 Place the urine container on the flowsensor Position the patient on the micturition chair or commo...

Page 59: ...ure 4 1 shows the parameters that can be calculated Figure 4 1 Uroflow result selection Some parameters will be calculated after placing the corresponding markers The parameters of the uroflow results...

Page 60: ...ime to Qmax is the elapsed time from the onset of the flow to the peak flow Calculated Time to Qmax C Voided volume The voided volume is the total volume expelled via the urethra Calculated Voided vol...

Page 61: ...ted Qmax is the square root of the voiding volume Calculated Corrected Qmax voided volume Residual urine The residual volume is the volume of urine left in the bladder after micturition This parameter...

Page 62: ...used volume Vin EMG EMG Miction volume Vmic Miction flow Qura During a cystometry investigation the patient should be awake un anaesthetized and neither sedated nor taking drugs that affect bladder fu...

Page 63: ...Enter the residual urine if prompted Remote control buttons Buttons Description Press Shift and Zero all simultaneously to zero the detrusor pressure Pdet during the pre test and if necessary during t...

Page 64: ...he previous investigation Infused volume The infused volume is the volume of the fluid pumped into the patient during an investigation Bladder filling The filling of the bladder at the end of the inve...

Page 65: ...essure is that component of the intravesical pressure that is created by forces in the bladder wall passive and active It is estimated by subtracting abdominal pressure from intravesical pressure Howe...

Page 66: ...investigation by placing two compliance markers The first marker A should be placed just after the start of the filling the second marker B just before the end of the filling see Figure 5 3 The softwa...

Page 67: ...econds to find one or more peak amplitude A cough leak point results table is displayed When no leak point marker is present after the CLPP marker no results are present Leak point only results When a...

Page 68: ...68 Solar Blue User Manual Chapter 5 Other parameters You can find additional explanations about the calculation of other parameters by clicking the Help button in the Results window...

Page 69: ...following channels can be measured during a pressure flow study Vesical pressure Pves P1 Abdominal pressure Pabd P2 Urethral pressure Pura P3 Detrusor pressure Pdet P1 P2 calculated Closure pressure P...

Page 70: ...tion button to mark the first sensation Use this button for all sensation markers When the patient is unable to tolerate further filling or if the bladder is filled sufficiently press the Pump button...

Page 71: ...Valsalva maneuver Click Spontaneous Miction to mark spontaneous miction Press Shift and Leak point to start the Cough Leak Point Pressure CLPP procedure Ask the patient to cough the software will inse...

Page 72: ...user or calculated from the previous investigation Infused volume The infused volume is the volume of fluid infused in the patient bladder during the filling phase of the pressure flow study Bladder f...

Page 73: ...capacity is the maximum infused volume Leak point valsalva and cough results You can find the explanations for the leak point Valsalva and cough results in 5 4 6 4 2 Voiding phase results The voiding...

Page 74: ...alculated Qmax F Time to Qmax The time to Qmax is the elapsed time from the onset of the flow to the Qmax Calculated Time to Qmax C Pdet at Qmax The detrusor pressure at the Qmax Voided volume The voi...

Page 75: ...lling minus the volume lost through leakage and minus the voided volume Note that the amount of urine produced by diuresis during the test is not considered It is assumed that the patient has an empty...

Page 76: ...will be the detrusor pressure at the last third Flow marker Diuresis The diuresis is the amount of urine that is produced by the patient s kidneys during the investigation Diuresis Volume lost throug...

Page 77: ...n Index in 4 4 BVE Bladder voiding efficiency BVE is a product of bladder contractility against urethral resistance and is measured to the degree of bladder emptying The BVE treatment of lower urinary...

Page 78: ...PP study can be performed manually or by using a catheter puller The pull speed can be set in the investigation protocol see 12 5 7 2 Channels The following channels can be measured during a UPP inves...

Page 79: ...ed catheters see 3 4 o Water catheters see 3 5 Do not fix the bladder catheter Locate the vesical sensor Pves and the urethral sensor Pura both in the bladder and watch the graphs carefully Check that...

Page 80: ...the profile Position both sensors Pves and Pura in the bladder Stress profile manual pull Press the Start Pull button to mark the start of the profile note this is an immediate marker The metronome w...

Page 81: ...s profile use the catheter puller Press the Start Puller button to start the puller Ask the patient to cough every two seconds The peaks caused by coughing are used to calculate transmissions An incre...

Page 82: ...is analyzes all profiles found in the investigation It differentiates between rest profiles and stress profiles 7 4 1 Rest profile For each rest profile the following parameters are by default calcula...

Page 83: ...s the length of the urethra along which the urethral pressure exceeds vesical pressure This urethral length is measured in millimeters It is calculated from the puller speed in conjunction with the ti...

Page 84: ...d area related parameters Bladder filling The infused volume in the bladder Average transmission The average percentages of the calculated transmissions Prostatic length Urethral continence zone The p...

Page 85: ...efine how to calculate the Maximum Closure Pressure From the menu choose Settings UPP settings Figure 7 4 MUCP calculation method MUCP Max Pura Pves ura MUCP is the difference between the maximum uret...

Page 86: ...of the puller speed and the time between the profile begin marker and the profile end marker Calculated Profile Length Puller speed Tprofile end Tprofile begin Total profile area The total profile are...

Page 87: ...ncrement in urethral pressure on stress cough as a percentage of the simultaneously recorded increment in vesical pressure For stress profiles obtained during coughing pressure transmissions can be ob...

Page 88: ...stress profiles The software distinguishes between stress and rest profiles by the presence of transmission markers When transmission markers are present the software treats the profile as a stress p...

Page 89: ...Urethral pressure profiles are performed with a partially filled bladder You can repeat this procedure for different bladder fillings The UPP part of the study can be performed manually or by using a...

Page 90: ...uller as described in 2 5 9 if applicable Move the puller clamp to the tip of the puller arm Position the puller in front of the urethra and mount the catheter on the puller clamp Do not fix the bladd...

Page 91: ...e bladder and continue with the filling phase Stress profile manual pull Press the Start Pull button to mark the start of the profile note this is an immediate marker The metronome will help you to pu...

Page 92: ...rt the puller Ask the patient to cough every two seconds The peaks caused by coughing are used to calculate transmissions An increase in urethral pressure Pura indicates that the urethral sensor enter...

Page 93: ...ce the Storage phase marker You can do different tests now to provoke leakage Press the Leak point button to mark leakage Press the Voiding phase button to mark end filling phase The investigation is...

Page 94: ...LPP Ask the patient to cough the software will insert cough markers around the peaks Press Leak point to mark a leak point Click Spontaneous Miction to mark spontaneous miction 8 4 Results In the anal...

Page 95: ...compliance For the anorectal manometry investigation the following tests are available 2 Resting pressure Squeeze Endurance squeeze Cough Push Rectal anal inhibitory reflex RAIR Sensation test Anal re...

Page 96: ...also edit the channels to be measured e g add EMG and the connections Use the Catheter Channels and Connections buttons to set this information Click the More button to see all settings specific to th...

Page 97: ...ex RAIR and sensations Four pressure channels at the same location radial with an angle of 90 degrees and a balloon at the tip to test the anorectal reflex RAIR and sensations Figure 9 2 Anorectal man...

Page 98: ...on puller or the Mark x cm button manual pull If you right click this button the x cm is reset to initial value when a puller is used or the insertion depth is increased with 1 cm when manual pull is...

Page 99: ...he investigation use the U button to move the selected test in the Use column up Use the D button to move it down NOTE Most tests can be combined in one single investigation It is up to the investigat...

Page 100: ...ement setting and the List selection is applicable for the syringe filling method for the Sensation test You can enter the volume increment e g 10 ml or edit a complete list e g 10 10 10 20 20 9 2 5 T...

Page 101: ...the beginning of the investigation 9 2 6 Squeeze Click the More button and then select the Squeeze tab as shown in Figure 9 7 Figure 9 7 Squeeze settings During the squeeze test you can mark the cath...

Page 102: ...e used to withdraw the catheter step wise default 1 cm Balloon filling settings In the Volume section you can set the Initial volume default 10 ml and the Volume increment default 10 ml On the Filling...

Page 103: ...Reflex RAIR test The initial inflation volume is the volume that will be inflated the first time in the balloon to assess the RAIR You can also set the volume increment that will be added to the previ...

Page 104: ...deflate balloon setting For Syringe filling method you can select Ask balloon volume After inserting the RAIR end marker during the test the software will ask to enter the balloon volume 9 2 9 Sensati...

Page 105: ...The setting Display balloon markers can be de selected Balloon filling settings On the Filling tab you can set the filling method For the Syringe filling method you can enter the volume increment e g...

Page 106: ...once and saved if you always use the same type of balloon Use standard balloon calibration Because the balloon has a compliance of its own the calculated compliance should be compensated to obtain th...

Page 107: ...me section you can set the Initial volume default 10 ml and the Volume increment default 10 ml On the Filling tab you can set the filling method For the Syringe filling method you can select Ask ballo...

Page 108: ...c is selected the puller pulls constantly at the set puller speed The recommended speed is 60 mm min The puller is required for continuous longitudinal profile manometry Settings are enabled when a pu...

Page 109: ...cers 4x Interface cables between the Solar Blue module and the pressure transducers 4x Pressure transducer holder Four way catheter flushing set Figure 9 15 Perfusion with pressure cuff The procedure...

Page 110: ...button Keep the catheter horizontal at the level of the pressure transducers to zero all pressures Move the catheter horizontally up to 30 cm above the pressure transducers Check the registration of t...

Page 111: ...t Connect the catheter to the pressure transducers follow the colors Be sure to connect in the OPEN position Calibrate the catheter as instructed by the manufacturer follow the instructions to calibra...

Page 112: ...ess the Zero all button to zero all pressures to atmospheric pressure Gently insert the catheter in the anal canal of the patient and position the balloon in the rectum Ask the patient to cough to che...

Page 113: ...ctal anal inhibitory reflex RAIR Sensation Rectal compliance Anal rest profile Anal squeeze profile Balloon expulsion test During an anorectal manometry investigation the patient should be awake un an...

Page 114: ...f voluntary sphincter capability at one or more levels in the sphincter Press the Next test button until Squeeze is displayed on the left button Ask the patient to squeeze Press the Squeeze button to...

Page 115: ...ce squeeze timer is used see protocol settings Repeat this procedure if necessary 9 4 5 Cough test The purpose of the cough test is to obtain an assessment of voluntary sphincter capability at one or...

Page 116: ...mark the start of the test This is a delayed marker and is used to determine the baseline pressure Press the Balloon x ml button to place a Balloon marker and inflate the balloon Wait for the sphincte...

Page 117: ...filled Press this button when a patient during infusion states a certain sensation The sensation markers are defined in the protocol settings No sensation First sensation First urge Modest urge Inten...

Page 118: ...press the Next test button until No sensation is displayed on the left button or Using the mouse right click this button until the sensation marker you want to insert is displayed 9 4 9 Rest and sque...

Page 119: ...the test The puller automatically returns to its starting position protocol settings or use the puller icon in the software Reposition the catheter and repeat if necessary Press the Next test button...

Page 120: ...y means of the puller or manually In this section you will find a description of the investigation with manual pull When pressures are measured radially throughout the sphincter the software can creat...

Page 121: ...ithdraw the catheter with the speed and distance as displayed setting in the protocol After a short while there should be an increase in the anal pressure The software automatically marks the start an...

Page 122: ...on in the upper left corner of the screen e g 10 ml Connect the syringe to the three way stopcock which is attached to the filling lumen of the catheter Fill the balloon Press the Balloon expulsion bu...

Page 123: ...rtial or Success and then click OK 9 4 12 Rectal compliance The purpose of the compliance measurement is to objectively determine the compliance of the rectum The compliance can be used to determine a...

Page 124: ...ectal pressure with the pressure built up by the balloon If you always use the same balloon catheter you need to determine the balloon compliance only once Measurement The balloon should now be inflat...

Page 125: ...nvestigation To stop the anorectal manometry investigation Press the Stop investigation button to stop the investigation 9 5 Analysis 9 5 1 Introduction Analysis can be performed by inserting channels...

Page 126: ...in the same way you can use these settings again When you performed the investigation with a radial catheter you select all channels for all tests It is always possible to change the settings after y...

Page 127: ...er A drop of pressure after inflating the balloon indicates the internal sphincter In the window channel P3 is defined as IAS This implies that for the RAIR test only channel P3 is analyzed as shown i...

Page 128: ...s The squeeze and cough results are calculated either on channels that are defined as EAS in the channel definition Settings Channel definition or on certain user selectable channels To choose the cha...

Page 129: ...users who are used to it Compliance calculation settings When balloon compliance calibration is performed the compliance calculation will compensate for the obtained balloon compliance If this is not...

Page 130: ...overall resting pressure for the IAS EAS and Anal channels is calculated In the results selection you can choose what results should be displayed for the resting pressure 9 5 7 Squeeze test The squeez...

Page 131: ...re displayed in three tables Resting pressure Maximum squeeze pressure Relative squeeze pressure Results for up to eight channels are displayed and averaged In the result selection the user can select...

Page 132: ...ld be marked with two endurance squeeze markers The first endurance squeeze marker should be placed at the onset of the squeeze The second endurance squeeze marker should be placed at the end of the s...

Page 133: ...utomatically insert two channel markers C and D The first channel marker will be placed on the maximum EAS pressure between marker A and B The second channel marker will be placed at a specified squee...

Page 134: ...an select which of these tables should be included in the results Resting pressure The resting pressure is the pressure at the cough begin marker Maximum pressure The maximum cough pressure is calcula...

Page 135: ...The resting pressure is the pressure at the push begin marker A Residual pressure The residual pressure is the minimum pressure between the two push markers B relaxation The relaxation is calculated a...

Page 136: ...ker B Amplitude of relaxation The amplitude of relaxation is the pressure difference between the resting pressure and the residual pressure of relaxation The of relaxation is defined as the Amplitude...

Page 137: ...he sensation markers or insert new markers if sensations are not marked during the investigation The following sensation results will be calculated Sensation volume Pressure at sensation Sensation res...

Page 138: ...stance C This distance is measured in mm It is calculated as the product of the puller speed and the time between the marker A and the marker B Average internal sphincter pressure in anal zone The ave...

Page 139: ...ion state failed partial or success will be displayed in the marker name Normally the markers are already placed during the investigation You can reposition the balloon expulsion markers or insert new...

Page 140: ...ation marker was placed the sensory threshold will be determined This parameter will be included in the result screen and in the printed reports For each sensation marker placed during the investigati...

Page 141: ...displayed in the left window It can be rotated in any direction by means of the cursor keys or the mouse The 3D plot consists of several segments displayed in different colors These colors have the fo...

Page 142: ...plot button or Choose Options Rectal volume plot to display the Rectal volume plot Figure 9 33 Figure 9 33 Rectal Volume plot when filling with air This plot displays the relation to the balloon volu...

Page 143: ...queeze the pelvic floor until a certain level Feedback to the patient is generated by displaying the measured signal EMG pressure etc by a moving object For example a fish can be displayed in a sea wo...

Page 144: ...rotocol settings are loaded Otherwise the last applied settings for the current patient are displayed You can change the theme challenge time or resting time for more information see 10 5 2 If you wan...

Page 145: ...probe Zero the transducer in open air Insert the catheter probe Ask the patient to cough to check the registration of the pressure Auto scale It is possible to set the scale automatically as follows...

Page 146: ...be toggled on or off for the EMG channel s When the filter is on the software calculates the minimum value over a moving time window of 400 msec Heartbeat filter disabled for the EMG channel Click to...

Page 147: ...investigation you can auto scale toggle curves on or off or toggle heartbeat filter on or off Changes in the settings like challenge time and or resting time can still be done Editing the challenge ca...

Page 148: ...ysis In the analysis program the measurement is shown as conventional graphs Figure 10 5 The challenge markers show the start of a challenge Every time a challenge has changed during the investigation...

Page 149: ...e changes made in the protocol settings and saved by clicking the OK button are stored for the protocol Click the More button to make changes in the Biofeedback settings for more information see 10 5...

Page 150: ...og box 10 5 2 Biofeedback settings You can open the Biofeedback settings dialog box in different ways If you want to save the changes as default protocol settings do the following In the Edit investig...

Page 151: ...iofeedback settings in the protocol The Biofeedback settings dialog box shows a preview of the selected challenge as demonstrated in Figure 10 9 For each channel a preview of the challenge is displaye...

Page 152: ...Biofeedback settings dialog box you can select another theme by clicking the Select Theme button or the image of the theme This is possible only if you enter the settings from the protocol and not du...

Page 153: ...available challenges are shown on the left side The current selected challenge is signified by an orange border The default available challenges are shown at the top the background color is pink and...

Page 154: ...10 12 Edit challenge window Basic edit mode In the basic edit mode you can change the work level or the rest value of a challenge A challenge consists of one or more work levels A work level defines a...

Page 155: ...next work level In the advance edit mode you can add a new part remove parts in the challenge and change levels of each part Figure 10 13 Challenge structure Click the Advanced edit button to enter th...

Page 156: ...shed lines can be moved To add a part right click an anchor To return to the Basic edit dialog box click the Basic edit button In basic edit mode you can save the challenge by clicking the Save button...

Page 157: ...ion The Luna is now recording data and the patient is free to go Stop recording when you want Protocol setting With the protocol settings Enable continuation with ambulatory urodynamics on the General...

Page 158: ...king on it as shown in Figure 11 1 The LCD display shows standby Figure 11 1 Select Luna After a connection between the Luna and the computer had been established the LCD display shows stationary NOTE...

Page 159: ...o stop the investigation Click the Stop investigation button to finish the stationary measurement or use the remote control button Exit the measurement program to enter the database program The measur...

Page 160: ...e database program switch to ambulatory measurement by clicking the New investigation button and then selecting the Luna The following dialog opens Figure 11 3 Continue with an ambulatory investigatio...

Page 161: ...investigation button to proceed with the measurement To change the battery the following window opens Figure 11 5 Change battery Disconnect the catheter and change the battery Figure 11 6 Reconnect ca...

Page 162: ...l for more information and the procedure when the patient returns 11 4 Analysis Two measurements can be analyzed after finishing the investigation the stationary measurement and the ambulatory measure...

Page 163: ...rement system for example the Solar Blue system Figure 12 1 Measurement program The measurement window Figure 12 1 displays nine investigation protocols that can be selected You can find more informat...

Page 164: ...ption of the menu items can be found in 12 4 Bluetooth devices Register Bluetooth modules while installing the system For the registration procedure see the Solar Blue Service Installation Manual Abou...

Page 165: ...and preparation before the actual investigation The preparations depend on the investigation type and the type of catheters being used 12 3 2 Start measurement In the pre test click the Start investig...

Page 166: ...ow During an investigation the status bar is displayed at the bottom of the screen The status bar displays the following information Memory Computer memory available to store an investigation Infused...

Page 167: ...rethral pressure Pura and the vesical pressure Pves Mark spontaneous miction Mark a leak point gynecology test Start and stop the catheter puller wireless during pretest and investigation Move the cat...

Page 168: ...nfrared receiver see 2 5 4 To operate properly point the remote control in the direction of the infrared receiver while pressing a key on the remote control Before working with the remote control make...

Page 169: ...n When you simultaneously press SHIFT you can place delayed markers otherwise immediate markers 9 Pump speed up Change the pump speed during the investigation or the pre test with the up key 10 EMG up...

Page 170: ...o function for Solar Blue 25 Alt To activate alternate functions press this key then press the desired alternate key To deactivate without changes press the ALT key again 26 Shift Press this key toget...

Page 171: ...rtual remote control during the pre test with the stationary software a pop up menu appears You can switch to the old remote control RC 1000 by selecting the remote control from the pop up menu The de...

Page 172: ...ker Coughing or movement by the patient can cause an undesired change in the pressures For that you can place an artefact marker before and after the artefact The data between the two artefact markers...

Page 173: ...e mode During an investigation you can activate the pause mode by clicking the Pause button on the screen This mode can be used when the patient is repositioned In the pause mode the screen continues...

Page 174: ...be started by selecting the investigation name from the Measurement menu in the analysis screen Skip analysis and select a new investigation from the measurement menu Set the field Immediate analysis...

Page 175: ...copied added or deleted as described in the following subsections Edit an investigation protocol Right click the protocol name and then choose Edit protocol Or from the main menu choose Settings Edit...

Page 176: ...col Right click the protocol name and then choose Delete protocol Or from the main menu choose Settings Delete investigation protocol and then select the protocol you want to delete The protocol file...

Page 177: ...of the protocol that you want to edit 12 5 3 General protocol settings Click the General tab to display the general protocol settings as shown in Figure 12 11 Figure 12 11 Edit investigation protocol...

Page 178: ...ambulatory urodynamics when you want to be able to continue the stationary investigation with ambulatory urodynamics without removing the catheter s 12 5 4 LABORIE assistant You can enable or disable...

Page 179: ...rkers on certain events after the investigation In the results which can be printed after the investigation the compliance results will be present 12 5 6 Sensation markers Click the Sensation tab Figu...

Page 180: ...ng on the disk initial pump speed sample rate marker line distance and so on Following are some settings Print report Save report to PDF uroflow only Stop time uroflow only Report graph time base urof...

Page 181: ...the reporter program in the separate Reporter Manual in PDF format which you can open via the Manuals menu in the database program Channels and connections In the protocol you must set the channels fo...

Page 182: ...channel 12 5 9 Connections Solar Blue For each investigation you can set the channel numbers for the channels signal to be measured with the Solar Blue measurement system In the Protocol settings dial...

Page 183: ...flowmeter By 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 flowmeter When a flowmete...

Page 184: ...Investigation settings You can save investigation data at certain intervals during the investigation to secure the data Select the Auto save checkbox and enter during which interval the measurement da...

Page 185: ...s Click the Markers button to change the colors of the available markers General You can set some general settings for example whether hints are shown when the mouse cursor is moved over a button The...

Page 186: ...program In the middle of the screen is a vertical line called the cursor line You can move this through the graphs by moving the mouse In the left column you will see the channel name e g Pves EMG the...

Page 187: ...other parts of the graph drag the scrollbar left or right or use the Page Up Page Down keys on your keyboard Auto scroll You can scroll by using a horizontal scrollbar and with the scroll wheel of th...

Page 188: ...annel information It contains also results of the quality control Investigation memo Open a memo editor The physician who performed the investigation can write down important facts about the procedure...

Page 189: ...you can open via the Manuals menu in the database program 13 2 2 Display results To display study results Figure 13 2 on the menu choose Results Display results or click the Results button You can al...

Page 190: ...gation memo to add comment to the investigation Click Save to PDF to save the results as PDF file Click Print to print the selected results only Click Help to show an explanation of the investigation...

Page 191: ...3 Graph 13 3 1 Menu overview The following menu items are available Menu item Function 100 Display the complete investigation on the screen For more information see 13 3 2 Zoom out Restore the previou...

Page 192: ...oom functions via the 100 screen software button and the keyboard buttons F4 zoom 100 F5 zoom out and F6 zoom in 13 4 Marker 13 4 1 Menu overview The following menu items are available Menu item Funct...

Page 193: ...of a chained marker the next marker in the chain can now be placed by repeating this process Figure 13 4 Insert marker Marker hints When the mouse is moved over the marker label a hint appears showing...

Page 194: ...mple coughing by the patient can cause an undesired change in the pressures Artefact markers can be placed automatically see the protocol settings or afterward in the analysis program Calculation mark...

Page 195: ...to the marker Flow Determine which part of the voiding phase is used for the detrusor flow nomograms Further flow markers influence the way the opening pressures peak flow pressures at peak flow and...

Page 196: ...mogram in a uroflow pressure flow or gynecology study see 13 5 2 Liverpool plot Display the Liverpool flow rate nomogram in a uroflow pressure flow or gynecology study see 13 5 3 Miskolc plot Children...

Page 197: ...t out of bounce Plots in the report By default all detrusor flow plots are enabled in the report Via the edit configuration function you can deselect the plots that you don t want in the report You ca...

Page 198: ...ptions Siroky plot to display the plot as shown in Figure 13 7 Figure 13 7 Siroky flow rate nomogram The results of the Siroky flow rate nomogram are only validated for male patients Read also M B Sir...

Page 199: ...age Men 50 years and older Women Read also B T Haylen D Ashby J R Sutherst M I Frazer and C R West Maximum and average urine flow rates in normal male and female populations the Liverpool nomograms Br...

Page 200: ...ger than 13 Children age 13 or older and younger than 18 Read also L Szabo and S Fegyverneki Maximum and average urine flow rates in normal children The Miskolc nomograms British Journal of Urolygy 19...

Page 201: ...the result is obvious However when the dot is in the Equivocal area the outcome is not clear Read also P Abrams C S Lim The Abrams Griffiths nomogram World journal of Urology volume 13 number 1 1995...

Page 202: ...flow and the detrusor pressure at peak flow determines the classes for the micturition A further explanation about PURR The real pressure flow relations often will show complex patterns but it is eas...

Page 203: ...of North America Vol 17 No 3 August 1990 Miguel Virseda Chamorro et al 1988 Caracterizacion del DURR relacion de resistencia uretral dinamica en el estudio de los sintomas funcionales del tracto urina...

Page 204: ...he maximum detrusor pressure that was measured during the current study The Nomogram is divided into four areas indicating no obstruction or mild moderate or severe obstruction Read also Jerry G Blaiv...

Page 205: ...ese parameters in 6 4 2 Read also P Abrahams Bladder outlet obstruction index bladder contractility index and bladder voiding efficiency three simple indices to define bladder voiding function 13 6 Se...

Page 206: ...he Channel settings dialog box as shown in Figure 13 14 Figure 13 14 Channel settings The channel settings dialog box shows an overview of all available channels For the selected investigation you can...

Page 207: ...gs of the measurement program see 12 6 Display Specific settings for graphs and markers for example how to display a grid and to show the markers as full names If you select Vertical marker names mark...

Page 208: ...a color scheme You can define more than one color scheme so you can quickly change colors Click the button Markers to change the colors of the available markers General You can set some general settin...

Page 209: ...art LABORIE Reporter can be found in the separate Reporter manual in PDF format which can be opened via the Manuals menu in the database program Print PDF JPG report Print or export the report immedia...

Page 210: ...lowing Select a category and then click on a button in the commands list While holding down the mouse button move the mouse cursor to the toolbar Release the mouse button on the spot you want to place...

Page 211: ...Solar Blue User Manual 211 APPENDIXES AND INDEX...

Page 212: ...m 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 with...

Page 213: ...possibility 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 wi...

Page 214: ...ation the system must be allowed to acclimatize to the specified operating conditions for at least four hours All repairs which are not performed by LABORIE personnel are for the responsibility of the...

Page 215: ...ar Blue system to the Multiple Socket Outlet provided on the Separating transformer CAUTION Do not position the Solar Blue system so that it is difficult to operate the disconnection device Installati...

Page 216: ...ole and its devices with a soft dry cloth WARNING The pole clamp for the laptop shelf should be positioned at least 22 cm from the top of the Solar pole III CAUTION Be careful while working with the S...

Page 217: ...ystem requirements should be applied prior to use Solar Blue module The Solar Blue module complies with Part 15 of the FCC Rules Operation is subject to the following two conditions 1 this device may...

Page 218: ...abnormal behavior 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 disturb the flowmeter Leave the system...

Page 219: ...ons 1 this device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired operation The flowsensor contains WML C30 W...

Page 220: ...ck 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 comprom...

Page 221: ...of a pressure transducer as this will damage the transducer permanently CAUTION Use rechargeable AA batteries 2300 mAh NiMH of good quality only and replace all four at once CAUTION After low battery...

Page 222: ...G needle electrodes see the manufacturer s instructions Investigations WARNING Investigation procedures as described in the Solar Blue manuals do not pretend to be complete How an investigation is per...

Page 223: ...ay lose data CAUTION Automatic safeguards built in to the software should be seen as an aid They are not substitutes for careful personal monitoring and an alert investigator CAUTION Do not carry or u...

Page 224: ...ch malfunctions 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 por...

Page 225: ...depending on setup Applied part Ingress protection rate Solar Blue module Class II BF IPX1 Luna wireless module BF IP2X Bluetooth flowmeter Mk III Class II if powered by power adapter IPX1 Safety mod...

Page 226: ...Blue symbol Refer to instruction manual Consult instructions for use Caution Federal law restricts this device to sale by or on the order of a physician Triangle with black or red border Caution cons...

Page 227: ...against 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 a...

Page 228: ...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 Conditio...

Page 229: ...ndensing 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...

Page 230: ...ol with red border Do not push or pull Manufacturer May be combined with manufacturing date Mass including safe working load in kilograms Catalog number Serial number Quantity symbol Numeral in symbol...

Page 231: ...anufacturing year number F Product group number XXXX Three or four digit unique module abbreviation NNNN Four digit incrementing unique number Explanation of SN number SN YYXXNNNN SN Serial Number YY...

Page 232: ...our LABORIE representative Bluetooth SMART dongle not found Communication problems Contact your LABORIE representative Bluetooth Stack s not initialized File s incompatible Communication problems Cont...

Page 233: ...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 234: ...file Error while allocating MPEG4 buffers MPEG4 buffer problem Contact your MMS representative Error while allocating video buffers Increase the non paged memory size in Milconfig Error while allocati...

Page 235: ...e 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 too high The pressu...

Page 236: ...your LABORIE representative The Luna needs new firmware to be used stationary This firmware is not available on your computer contact your dealer New firmware version needed Contact your LABORIE repr...

Page 237: ...ailable Remove profile marker Warning No more Profile markers No more profile markers available Remove profile marker Wireless patient module connection lost Communication problems Contact your LABORI...

Page 238: ...y 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 related...

Page 239: ...be opened Probably due to file corruption Try again later or call your dealer Closing program Investigation database is corrupted Try again later or contact your LABORIE representative Investigation...

Page 240: ...ive System number is incorrect Archive of patient aborted Patient system number is incorrect Contact your LABORIE representative System numbers of databases are not identical Index file is corrupt ple...

Page 241: ...bar 186 system settings 207 Anorectal manometry analysis settings 128 balloon expulsion test 121 cough test 115 edurance squeeze test 114 introduction 95 profiles using manual pull 120 profiles using...

Page 242: ...sducers 50 solid state catheters 46 water catheters 50 water transducers 50 Channel settings 181 206 Cleaning instructions 42 Compliance markers 195 protocol settings 179 Composite nomogram 204 Conduc...

Page 243: ...ormats 209 F Flow markers 195 Flowmeter batteries 34 cleaning instructions 42 introduction 11 prepare 34 status LED 35 Flow reducer set for water catheters 53 G Good Urodynamic Practice GUP 178 Graph...

Page 244: ...4 K Keyboard keys 171 L Leakpoint markers 167 LED Flowmeter 35 LEDs Puller wireless 38 Solar Blue module 29 Liverpool plot 198 Luna wireless module 157 ambulatory measurement 159 Luna wireless Module...

Page 245: ...kers 195 user definable markers 177 Maximum Urethral Closure Pressure MUCP 85 Measurement program buttons in the software 165 166 channel information 165 edit protocol see Protocol settings 174 introd...

Page 246: ...l settings 181 compliance 179 connections Solar Blue 182 copy protocol 174 delete protocol 174 edit protocol 174 general protocol settings 177 Good Urodynamic Practice GUP 178 investigation specific s...

Page 247: ...t results 190 S Safety information 12 212 Sch fer detrusor flow plot 201 Sensation markers 179 Sensonor Memscap pressure transducers 50 Siroky plot 198 Software see MMS software 13 Solar Blue accessor...

Page 248: ...Pressure MUCP 85 rest profile 80 results 82 stress profile 80 Urodynamic catheters 45 Urodynamic transducers 45 Uroflow channel information 58 introduction 58 investigation 58 results 59 V Valsalva m...

Page 249: ...Index Solar Blue User Manual 249 Windows 10 Z Zero water catheters 56...

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