Sensic Software Users Guide Sw Ver 1.4

Sensic Software User’s Guide

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Sensic Software User’s Guide Copyright © 2011 Mediwatch UK Ltd. All rights reserved. The contents of this manual are the property of Mediwatch UK Ltd. Any reproduction in whole or in part is strictly prohibited. At the time of printing or transference to a CD-ROM, this manual correctly described the system and its functions. However, as modifications may have been carried out since the production of this manual, the system package may contain one or more addenda to the manual. This manual including any such addenda must be thoroughly read, before using the system. The following situations void any guarantee(s) and obligations for Mediwatch UK Ltd:  The system is not used according to the enclosed manuals and other accompanying documentation  The system is installed or modified by persons other than Mediwatch UK Ltd service technicians Sensic™ is a trademark of Mediwatch.

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Sensic Software User’s Guide

Table of Contents Table of Contents ... 4 Figure ... 5 General Information ... 6 Indications for Use ... 8 Contraindications ... 8 Connections ... 8 Changing Security Values ... 9 General Warnings ... 9 Introduction to Sensic™ ... 11 What is Sensic... 11 Types of Procedures... 11 Uroflowmetry... 11 Cystometry... 11 Two Urethral Pressure Profile Protocols ... 12 Quick Start ... 13 Entering and Editing Patient Data... 15 Entering Patient Data ... 15 Editing Patient Data ... 17 Deleting Procedures and Patient Data... 20 Preparing Transducers and Pumps... 23 Preparing Water Filled Transducers... 23 Air Charged Transducers... 25 Solid State Transducers ... 25 Prepare the Pump ... 25 Calibrating Equipment ... 26 Establishing Bluetooth Connection ... 29 Uroflowmetry Procedure ... 30 Cystometry Procedure ... 32 Cystometry: Preparations ... 32 Cystometry: Filling Phase ... 34 Cystometry: Voiding Phase ... 37 Cystometry: Leak Point Pressure Procedure ... 38 Single Channel UPP Procedure ... 41 UPP Procedure – Resting UPP / Stress UPP ... 43 Video Studies... 45 Using Video ... 45 Configuring Video... 48 User configurable options... 49 Storing Video... 50 Editing Charts... 51 Tools for Looking at the Chart ... 51 Editing a Procedure... 52 Editing Events and Markers... 53 Displaying the Value Line ... 54 Modifying the Channels ... 55 Viewing and Customising Reports ... 57 Customising Reports ... 57 Archiving the Data... 59 Retrieve Archived Studies ... 62 Page 4 of 72

Sensic Software User’s Guide Backing Up the Data ... 63 Glossary... 65 Index ... 68

Figure Figure 1: System Verification Screen ... 13 Figure 2: Sensic Home Screen ... 14 Figure 3: Patient Screen ... 15 Figure 4: Patient Files Screen... 17 Figure 5: Patient Editing Screen... 19 Figure 6: Delete patient from database ... 20 Figure 7: Delete the current day’s study... 21 Figure 8: Delete a single procedure from today’s study... 22 Figure 9: Connecting a Transducer... 23 Figure 10: Water Filled Transducers Connections... 24 Figure 11: Pressure Connection Box and Corresponding Connections on Transducer Holder... 24 Figure 12: Connecting the Transducers' Cables with Extension Cables... 24 Figure 13: Air Charged Transducers Connections... 25 Figure 14: Correct Flow of Liquid Through Pump... 26 Figure 15: Configuration Screen ... 27 Figure 16: Calibrate Equipment Screen ... 28 Figure 17: Wireless Devices Screen ... 29 Figure 18: Uroflowmetry Screen... 30 Figure 19: Voiding Analysis Header Bar and Patient Position Pop-up ... 31 Figure 20: Voiding Results ... 31 Figure 21: Cystometry Screen... 32 Figure 22: Crosshatch Marks Indicating Data Is Not Being Recorded ... 33 Figure 23: Procedure Settings... 33 Figure 24: Cystometry Filling Phase... 34 Figure 25: Pump controls ... 35 Figure 26: Event buttons ... 35 Figure 27: Cystometry Filling Events... 35 Figure 28: Comment Pop-up... 36 Figure 29: Cystometry Filling Information Window ... 37 Figure 30: Cystometry Voiding Information Window... 38 Figure 31: LPP Menu ... 39 Figure 32: LPP Information Window... 40 Figure 33: Procedures Menu... 41 Figure 34: Single Channel UPP Information Window ... 42 Figure 35: Procedures Menu... 43 Figure 36: Video Recording ... 46 Figure 37: Video Reviewing ... 47 Figure 38: Video Settings... 48 Figure 39: Report Setup... 49 Figure 40: Patient Files ... 52 Figure 41: Procedure View... 53 Figure 42: Channel Scale alteration ... 55 Figure 43: Channel size alteration... 56 Figure 44: Patient Files ... 57 Figure 45: Report Settings Screen ... 58 Figure 46: Database and disk space use Message ... 59 Figure 47: Configuration Screen ... 60 Figure 48: Auto-Archive Setup Screen ... 60 Figure 49: Patient Files Screen with Archived Studies ... 62 Figure 50: SQL Service Manager... 63

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Sensic Software User’s Guide

General Information The Sensic system (“Sensic” or “the system”) is a combination of the Sensic urodynamics software application running on a Mediwatch urodynamics hardware platform. The Sensic system has been designed and tested in accordance with IEC 60601-1 safety standard for medical electrical equipment. To ensure safe operation and to keep the system in safe condition, read and understand the information and warnings contained in this manual. This system is intended to be used by qualified medical personnel, who are knowledgeable about urodynamics. WARNINGS:  The Sensic system must not be used for intensive care monitoring. The Sensic system is not intended for use with or nearby anaesthetic gases due to the danger of electrical ignition of these gases.  The Sensic system is not designed for use in an MRI magnetic field.  Do not use the Sensic system’s integrated computer equipment for anything other than the manufacturer’s intended use, i.e., maintaining patient information with the Sensic software application, executing urodynamic testing on patients, and generating test reports.  Electrical equipment for medical use requires special electro-magnetic compatibility (EMC) precautions and needs to be installed and serviced according to the EMC documentation. If any of the warnings in this manual are ignored, Mediwatch UK Ltd assumes no responsibility for any intentional or unintentional consequences or damage to the Sensic system equipment, nor loss of the equipment efficacy with regards to the manufacturer’s intended purpose, nor compromises to user or patient safety.

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Sensic Software User’s Guide CAUTIONS:  U.S. federal law restricts sale of the Sensic system to physicians and licensed practitioners.  Radio frequency communication equipment and other generators of electromagnetic waves can adversely affect many types of medical electrical equipment, including urodynamics systems. Take steps to minimise these transmissions sources within the facility. For example, require that cell phones be turned off, provide adequate shielding of MRI rooms, etc.  To avoid loss of patient data, it is critical that the data generated by Sensic be backed up on an adequately scheduled basis. The backup copies must be kept in a safe and dry environment.

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Sensic Software User’s Guide

Indications for Use Sensic is intended to assist urologic physicians and licensed practitioners in executing specific urodynamics test protocols, collecting data during protocol execution, analysing collected data, preparing written reports, and archiving patient and testing information. General indications for use include patients with lower urinary tract voiding or continence problems and, more specifically, incontinent patients, patients with bladder outlet obstructions, patients with neurogenic bladder dysfunction, and some children with complex voiding/incontinence problems.

CAUTIONS:  For use under constant control by an operator on patients who are not anaesthetised.  Not intended for intravenous pumping.

Contraindications Sensic should not be used for patients with urinary tract infection.

Connections Insert the power plug into a mains power socket outlet that includes a properly grounded protective earth contact. Do not use an extension cord to make this connection. Note: To meet classifications, approvals, safety compliance, and performance specifications, use only notebook computers and personal computers sold or specified by Mediwatch UK Ltd.

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Sensic Software User’s Guide

Changing Security Values WARNING: Carefully consider all the potentially injurious consequences before changing the security values for a procedure. The maximum bladder pressure is set to 150 cmH2O, and the pumps are calibrated to stop when the infused volume has reached 1000 ml.

General Warnings Connections Warnings  Service must be referred to Mediwatch UK Ltd authorised service personnel, except for specific operations described in this manual, which can be performed by the operator.  Any interruption to the protective earth conductor (earth ground) inside or outside the system or disconnecting or disabling the protective earth connector is likely to endanger the operator and patients of this system. Interruption of the protective earth conductor path is prohibited. The protective earth conductor should be checked regularly.  When connecting medical equipment whose power is supplied from an outlet located in a room not used for medical purposes or when connecting non-medical electrical equipment to this device, adhere to the IEC 606011 and IEC 60601-1-1 safety requirements standards for medical electrical systems. Failure to do so could endanger the operators and patients of this system.  When Sensic is connected to a mains supply, connectors may be live. Removing covers or parts may expose electrically live areas of the system with dangerous or fatal levels of voltage. Therefore, these areas of the system should not be exposed or removed except by Mediwatch UK Ltd authorised service personnel.  Make sure that only fuses with the required rated current and of the specified type are used for replacement. The use of makeshift fuses and the short-circuiting of fuse holders are prohibited.  If more than one piece of equipment is connected to a patient, attention must be paid to the collective sum of patient leakage currents (total amount of electric current flowing through the patient).

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Sensic Software User’s Guide Damaged Equipment Warnings  If there is any possibility that the equipment has been damaged or that its safety systems have been impaired, the system must be made inoperative and be secured against any unintended or uninformed operation until the equipment in question has been properly repaired or replaced by Mediwatch UK Ltd authorised service personnel. If protection has been impaired, have Mediwatch UK Ltd authorised service personnel repair the equipment. The equipment or safety systems may need repair or inspection by Mediwatch UK Ltd authorised service personnel if, for example, any part of the system:  Shows visible damage  Fails to perform its intended function(s)  Has been jarred, dropped, or subjected to severe transport stresses  Carefully check the catheters and transducers for mechanical damage before use.

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Sensic Software User’s Guide

Introduction to Sensic™ What is Sensic The Sensic software application (Sensic™) along with Mediwatch hardware constitute a complete functional diagnostic system that provides advanced urodynamics testing in both clinical and laboratory environments. The Sensic system puts all standard urodynamics tests at your fingertips. It is intended to assist practitioners in diagnosing urological disorders. Some of the special features of Sensic include:  Edit study traces and monitor real-time pressures simultaneously. Sensic lets you freeze and review study traces while monitoring real-time pressures and traces in another window.  On-screen analysis at a glance. At any time during the study, you can get study analysis information by simply touching a colour analysis bar (if you have purchased the touch screen option) or moving the mouse cursor over the bar.  Customised reports. Customise your reports with your clinic’s information and logo.

Types of Procedures Sensic provides you with standard urodynamic procedures that are adaptable to your requirements: Uroflowmetry Uroflowmetry measures the flow rate of the external urinary stream by volume per unit time in millilitres per second (ml/s). The urinary flow reflects the final result of the micturition process consisting of: detrusor function, bladder neck opening, and urethral conductivity. Cystometry Cystometry is the process of recording the relationship between pressure and volume in the bladder during the filling phase. This procedure provides information about the way the bladder accommodates increasing volume, central nervous system control of the detrusor reflex, sensory qualities, muscle coordination, and strength during micturition. Page 11 of 72

Sensic Software User’s Guide Sensic’s cystometry procedure investigates both filling and voiding phases as well as leak point pressure (LPP) measurements, if desired. LPP may be used to document stress urinary incontinence or to assess the risk of obstructive uropathy. Two Urethral Pressure Profile Protocols Recording the urethral pressure profile (UPP) during the storage phase permits evaluation of pressure distribution throughout the urethra. Sensic provides two ways to perform a UPP:  Single Channel UPP. This method uses the Pves catheter and a manual catheter pull technique to measure the resting urethral pressure and length. To perform the study either a puller unit (profilometer) or a beep puller (a software tone sounded at regular intervals) is required.  Advanced UPP. With this method, the resting urethral pressure and length is measured using an automated puller arm (profilometer), which pulls the catheter out at a specific rate (for example, 1mm per second).

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Sensic Software User’s Guide

Quick Start Note: The instructions in this guide have been written to accommodate both operators who have the optional touch screen and those who are using only a mouse. In instances where the mouse is a better option, the instructions specify to use the mouse. To start a procedure: 1 Select the Sensic icon on the Windows desktop:

The System Verification screen is displayed only when the PC has been restarted:

Figure 1: System Verification Screen

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Sensic Software User’s Guide 2 The System Verification makes sure that all components related to Sensic are installed and running correctly. The Sensic Home screen is displayed:

Figure 2: Sensic Home Screen

3 If the patient has not been entered into Sensic yet, select the New Patient button. or To either perform an examination of a patient who has already been set up in Sensic or to review past patient information, select the Patient Files button.

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Sensic Software User’s Guide

Entering and Editing Patient Data This section explains how to enter data for new patients and enter data about the current urodynamic study. All the entered data appears in the printed report.

Entering Patient Data To enter patient information: 1 From the Sensic Home screen, select New Patient. The Patient screen is displayed:

Figure 3: Patient Screen

2 In the Patient Demographics section, enter data into the fields as follows: ID # / Social Security Enter the patient’s identification number used in your facility.

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Sensic Software User’s Guide Date of Birth Month / Day / Year

Enter the patient’s birth date. Make sure to use all four digits for the year. Hint: Use the Tab key to move from field to field. The screen may display Day/Month/Year depending on Windows regional settings.

First Name / Last Name Enter the patient’s first and last names. Address

Enter the patient’s mailing address.

Sex

Select Male or Female from the drop-down list.

3 In the Current Study section, which is indicated by the current date, enter data into the fields as follows: Technician / Physician / Referring Physician

Either select a name from the drop-down list or type the name into the field.

Diagnosis

Enter the diagnosis by either typing it into the field or right-clicking in the field, and then selecting an item from the list displayed.

Comments

Enter any information you want recorded, for example, you can enter observations or comments about the patient (“Patient has spina bifida.”) or a suggested plan for future analysis or treatment (“Suggest cystoscopy in general anaesthesia.”) Either type directly into the field or right-click in the field and select an item from the list displayed.

See Technical Reference Guide p27 for how to create the lists for Diagnosis & Comments. The Patient Age is automatically supplied by the system based on the birth date provided in the Patient Demographics section.

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Sensic Software User’s Guide

Editing Patient Data Use this procedure to edit existing patient studies or add a study to existing patients. To edit patient data: 1 Display the Patient Files screen either from the Home screen or from the Patient screen.

Figure 4: Patient Files Screen

Note: Sensic automatically sorts the data using the Last Examined column. However, you can select the headings of either the Patient Name or Patient ID columns to sort the data according to these columns. Select the heading again to sort in the opposite order (ascending versus descending order).

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Sensic Software User’s Guide 2 Select the name of the patient from the list shown on the left. or If there is a long list of names, you can search for the patient by entering any of the patient’s demographics or the technician’s, physician’s, or referring physician’s first or last name into the Search field, and then select the Search button. When the name or list of names is displayed, select the name of the patient. To return to the complete list of names simply clear the search box. 3 To edit demographic data, select Edit in the Patient Demographics section (on the right). or To edit data about a specific day’s study, select Edit in the line for the date you want to edit. Note: You can review the procedures and reports for a particular study by selecting the button next to the procedure or report. The Patient Editing screen is displayed (in this example the demographics data is being edited):

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Sensic Software User’s Guide

Figure 5: Patient Editing Screen

4 Edit any of the fields displayed on the left of the screen. 5 When you are done editing, either edit another part of the patient’s data (by selecting Edit for that data), select Record Data for this Patient to return to the Patient screen, or select a procedure for editing. See Editing Charts on page 51.

Note: Any changes you make are automatically saved when you select another option.

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Sensic Software User’s Guide

Deleting Procedures and Patient Data Sensic allows you to delete patients, the current day’s study, and one or more procedures from the current day’s study. To delete a patient from the database: 1 Display the Patient Files screen either from the Home screen or from the Patient screen.

Figure 6: Delete patient from database

2 Use the mouse to right-click on the name of the patient.

The Delete pop-up window is displayed:

3 Click Delete. The patient is deleted from the list and from the database. Page 20 of 72