Urocap-III Owners Manual Ver 15 July 2014

TABLE OF CONTENTS 1

INTRODUCTION ...1 Product Overview and Features ... 1 Urocap III Models ... 2 Urocap III Standalone ... 2 Urocap III Wired to PC ... 2 Urocap III Wireless with PC ... 2

2

CAUTIONS AND WARNINGS – PLEASE READ CAREFULLY! ...3 Cautions ... 3 Warnings ... 3 Intended Use ... 6 Target Population ... 6 Contraindications ... 6

3

UNPACKING THE UROCAP III EQUIPMENT ...7 Standard Equipment ... 7 Urocap III Standalone Model ... 7 Urocap III Wired to PC ... 8 Urocap III Wireless with PC ... 8

Optional Accessories ... 8 Retractable Antenna (Urocap III Wireless with PC only) ... 9

4

SETTING UP THE UROCAP III EQUIPMENT... 10 Urocap III Standalone Setup ... 10 Urocap III Wired with PC Setup ... 11 Urocap III with Wireless PC Model Setup ... 11 General Room Setup... 11

5

SOFTWARE SETUP ... 12 Urocap III PC Software ... 12 Microsoft Windows ... 12 Windows Start Menu/Task Bar ... 12

6

USING THE UROCAP III™ - STANDALONE MODEL... 13 Performing a Uroflow Test (Standalone Model) ... 13

7

UROCAP- III - WIRED / WIRELESS PC MODEL ... 15 Logon Screen ... 15 UDS Client Window ... 15 FILE MENU ... 16 Open ... 16 Save As ... 18 Print Study ... 18 Batch Print (Optional) ... 20 Print Setup ... 21 About UDS Client ... 21 Update Fax Cover

22 22

Import ICS ... 22

Import ASC... 22 Exit ... 22

INFO MENU... 23 Patient Info ... 23 X-Y Plot ... 24 Siroky Nomogram ...24 Liverpool Nomogram ...25

Event Summary ... 25 Add an event using a configured Control Panel button during the test ...25 Add an event that is not listed on the Control Panel ...25 View the Event Summary ...26 Add or Change Event Annotation ...26 Deleting Events from the Event Summary ...26 Move Events by Drag and Drop ...26 Customized Event List (Optional) ...27

Voiding Summary ... 28 Uroflow Options ...29

Artifact Recognition ... 31 Pediatric Nomogram ...31

UPP Summary / UPP ... 32 ARM 2 / ARM 4&8 ... 32

OPTIONS MENU ... 33 Test Restart ... 33 Test Playback ... 33 Uroflow Auto Start ... 33 Cursor Value Indicator ... 34 Digital Value Indicator ... 34 Control Panel Settings ... 35 Multiple Control Panel Sets and Hot Key Configuration ...36 To Configure Multiple Control Panel Sets ...36 To Use Another Configured Control Panel Set ...36 To Add a New Control Panel Set by copying another Control Panel Set ...36 To Configure the Hot Keys ...37 To Configure Sound ...37 Add an Image to a Control Panel Button ...38 Customize Colors and Fonts...39 Control Panel Commands ...39

File Saving Directory ... 40 Auto Mark Peaks ... 40 Graph Clipping ... 40 Resize Overflow Screen ... 40 Smart Tracing ... 40 VBN Settings ... 41 VBN - Normal Curve Overlay (Optional) ... 41 iLIST ... 42 Restore Factory Calibration ... 42

Connection Manager (optional) ... 42 ServerX Menu ... 45 Daughter Download ... 45 Pump/Transducer Calibration ... 45 Reset Connection ... 45 Show ServerX Window ... 46 Choose Bluetooth UDS-94 ... 46

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ADDITIONAL SOFTWARE FEATURES ... 47 Title, Numeric, Unit, and Scale Font ... 47 Change Channel Order (Optional) ... 47 Change Channel Titles and Units (Optional)... 48

Change Channel Scales (Optional) ... 49 Video ... 49

PERFORMING A UROFLOW TEST (WITH THE PC MODEL) ... 50

9 10

TRANSDUCER CALIBRATION... 51

Calibrating the Urocap III - Standalone Model... 51 Calibrating the Urocap III - Wired or Wireless PC Model ... 52 Calibration through the Hyper Terminal ... 52 Calibration through the UDS120 Software ... 53 Calibrate Volume ...54 Calibrate Flow ...54

Tips for Better Calibration ... 54

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CLEANING AND PREVENTIVE MAINTENANCE ... 55

Cleaning ... 55 Preventive Maintenance ... 55 Check the Flow and Volume of the Uroflowmeter ... 55 Check Volume ...55 Check Flow 55

Virus Protection (for wired/wireless PC model) ... 56 Treating and Disposing of Products After Use... 56

12

TROUBLESHOOTING ... 57

Troubleshooting for all models ... 57 Troubleshooting for the Urocap III standalone model ... 58 Troubleshooting for the Urocap III wired/wireless PC models ... 58

13

TECHNICAL DESCRIPTION ... 61

System Specifications ... 61 Equipment/Accessory Part Numbers ... 62 Software Features List ... 63 Classifications ... 63 Applicable Directives and Standards ... 63

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ELECTROMAGNETIC COMPATIBILITY (EMC) ... 64

Emissions ... 64 Immunity ... 64

15

SYMBOLS ... 65

16

END-USER SOFTWARE LICENSE AGREEMENT ... 66

APPENDIX... I A B C

Voiding Summary Analysis ... i Nomogram Tables for Uroflowmetry ... ii Accessory Descriptions ... iv

1 INTRODUCTION The Urocap III™ is one of the world’s most compact Uroflowmetry analyzers with built-in comparative studies. These studies, along with other unique features, will deliver highly accurate Uroflowmetry recordings that are easy to produce and interpret. An added feature to the Urocap III is the option of built-in Bluetooth® technology - providing you with the ease and flexibility of wireless connection to perform all your Uroflowmetry procedures. Uroflowmetry (Uroflow) is a standard Urodynamic test, whereby the urine flow rate and volume are measured. Uroflowmetry is used to verify or disprove patient symptoms via scientific methodology. It is a prerequisite for you, as a user of this equipment, to understand the basic measuring principles and techniques of Uroflowmetry analysis. The purpose of this manual is to familiarize you with the installation, use, and operation of the Urocap III Uroflowmetry analyzer. For further information or technical service, please contact your local sales representative or contact LABORIE.

PRODUCT OVERVIEW AND FEATURES The Urocap III uses Uroflowmetry as a form of Urodynamic testing. The urinary flow rate and volume are measured and the results, in general, are used to verify or disprove patient symptoms via scientific methodology. Data acquisition occurs as the transducer collects and processes data. It prints the data in graphical form during the procedure, and is followed by a calculated Voiding Summary.

Some of the features include:  Hardcopy printout of Uroflow report including:  Patient information section  Uroflow graph including Flow and Volume channels  Voiding Summary  Reprint option  Customized Clinic name (optional)  On-site calibration  Software interface with real-time graph scrolling (available with PC option)  Ability to connect wirelessly from one Urocap III to another or one Urocap III to another Laborie UDS system

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UROCAP III MODELS There are three different Urocap III models:   

the Urocap III standalone model the Urocap III wired to PC model the Urocap III wireless with PC model

Urocap III Standalone The Urocap III Standalone model connects to a thermal printer. With this model, the printer is used as the output device of the Urocap III. The procedure starts when the transducer detects the flow signal from the Uroflow transducer, and the results are printed on the serial thermal printer. After a test is complete, you can print an additional copy of the study. This function can be used in cases where the printer has run out of paper or when extra hard copies are required. Chapter 6 further explains the use of the Urocap III Standalone model. Urocap III Wired to PC The Urocap III Wired with PC model connects to a PC through a cable during normal operation. The PC will run UDS software on the Microsoft Windows XP® Professional or the Windows 7® Professional operating system, and all commands to operate the product will be done through the UDS software. Chapters 5 and 7 further explain the use of the Urocap III Wired/Wireless with PC model. Urocap III Wireless with PC This model is similar to the Urocap III wired with PC model with the exception that the connection between the Urocap III and the PC is wireless. The PC will run UDS software on the Microsoft Windows XP® Professional or the Windows 7® Professional operating system. The operation is identical to that of the wired model. Chapters 5 and 7 further explain the use of the Urocap III Wired/Wireless with PC model.

For warranty information and terms and conditions visit www.laborie.com.

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2 CAUTIONS AND WARNINGS – PLEASE READ CAREFULLY! CAUTIONS 1.

UNITED STATES FEDERAL LAW RESTRICTS THIS DEVICE TO SALE OR USE BY OR ON THE ORDER OF A LICENSED PHYSICIAN.

2.

DO NOT USE an AC adapter other than that which is specified. It may negatively affect the protection against electrical shock.

WARNINGS 1.

Only technicians and physicians trained in Urodynamics should operate this device. The operator must read the Owner’s manual entirely and refer to any additional training materials before using the device. Optional In-Service is available from LABORIE. 2. Use the device indoors in a well-lit room only with the following Operating conditions  Temperature: 15°C to 30°C (59°F to 86°F)  Humidity: 30% to 75%, non-condensing  Pressure: 800hPa to 1014hPa And the following Transport and storage conditions  Temperature: -20°C to 60°C (-4°F to 140°F)  Humidity: 20% to 80%, non-condensing  Pressure: 800hPa to 1014hPa 3. DO NOT USE in the presence of a flammable anesthetic mixture with air or oxygen or nitrous oxide. 4. DO NOT USE the unit in the same room as an operating magnetic resonance imaging device (MRI). The strong magnetic field produced during MRI may cause disruption of the system. 5. All transducers should be calibrated prior to use. Calibration should be checked at least every six (6) months or whenever there is a suspicion that the calibration is incorrect. ONLY calibrate the transducer if necessary. 6. Use with LABORIE equipment and accessories ONLY. 7. ONLY Laborie trained technicians may service the unit. DO NOT ATTEMPT TO OPEN OR REPAIR the system by yourself or by an unauthorized party. 8. LABORIE equipment is licensed by Governments and approved by Safety Agencies to work with LABORIE accessories ONLY. 9. LABORIE accessories are licensed by Governments and approved by Safety Agencies to work with LABORIE equipment ONLY. 10. Laborie equipment is warranted to work with LABORIE accessories ONLY. 11. Laborie accessories are warranted to work with LABORIE equipment ONLY. 12. Re-use, reprocessing or resterilization of disposables could lead to device failure and create a risk of cross-infection and/or cross transmission of infectious disease(s) from one patient to another. Result of sterilization failure could lead to cross infection and/or cross-transmission of infectious disease from one patient to another. 13. DO NOT LEAN anywhere on the unit. The unit is not designed to support the weight of a person. 14. DO NOT STEP on the unit. The unit is not designed to support the weight of a person. LABORIE

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15. DO NOT PLACE ANY OBJECTS on top of the transducer when not in use. It may damage the unit. 16. Use the device indoors in a well-lit room only. 17. Use Input and Output Cables and Cords provided by LABORIE ONLY. 18. Exposure to ESD may cause the system to RESET. 19. Do not plug in or unplug any transducers when a procedure is running. Always stop the procedure before plugging in or unplugging transducers. 20. Customers providing their own computer, monitor, or printer for use with the Laborie system may require the use of a Line Isolation Transformer (LIT) to maintain system compliance. In all cases it is advised to check with your local regulations before proceeding. 21. LABORIE is not responsible for loss of patient files or test data. We recommend that you back up patient data on a regular basis. 22. Any additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards (e.g. IEC 60950 for data processing equipment). Any and all configurations shall comply with the requirements for medical electrical systems. Anyone connecting supplementary equipment to medical electrical equipment configures a medical system and is therefore responsible that the system complies with the requirements for medical electrical systems. Attention is drawn to the fact that local laws take priority over the above-mentioned requirements. If in doubt, consult your local Laborie representative or the technical service department. 23. It is recommended to make a photocopy of the printout from a thermal printer on normal paper for longer storage as printouts on thermal paper fade with time. Store thermal printer paper in a cool, dry, and dark room. Keep paper away from direct sunlight. Maintain at a temperature below 25°C (77°F) with a relative humidity between 45% and 65%. 24. The use of cellular phones, smartphones, mobile internet devices, and other portable wireless devices within close proximity of the system is not recommended and may cause artifacts to appear on the channels. 25. The Urocap III is packaged for protection during shipment and transport. Verify that all ordered equipment and accessories have been received. Contact LABORIE should there be any discrepancies between ordered and received equipment. 26. DO NOT LEAN anywhere on the unit. The unit is not designed to support the weight of a person. 27. DO NOT STEP on the unit. The unit is not designed to support the weight of a person. 28. DO NOT PLACE ANY OBJECTS on top of the transducer when not in use. It may damage the unit. 29. The device complies with EN 60601 Safety and EMC Standards. 30. The Uroflowmeter needs to be positioned so that the beaker does not touch the flow funnel during the Uroflowmetry procedure. 31. Ensure the beaker is correctly placed on the Urocap base so that there are no abnormalities displayed in the Uroflowmeter signal. Ensure that the patient remains calm and still during the entire procedure. 32. The device complies with all in-house quality alpha tests and EN 60601-1-6 Usability Checklist to ensure that the occurrence of incorrect flow or misinterpretation of data is significantly low during normal mode function. 33. Device complies with the EN 60601-1-2 EMG test standards. 34. Device complies with in-house quality alpha and EN 62304:2006 to ensure misinterpretation of results / incorrect flow readings during normal mode is significantly reduced. 35. The connection manager feature in the software allows for reconnection of system components and access to transducer calibration if necessary.

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36. The principles of development, product life-cycle, risk management, verification and validation are taken into account through internal software verification and validation procedures. 37. The device is conformant to EN 60601-1 Safety standards (Class I with type B applied parts). 38. User manual states in Caution and Warnings section: “To avoid patient injury, AC-DC power supplies are spaced so that they have short circuit protection and can withstand the DC outputs being short circuited. 39. To reduce the risk of power failure and patient injury, the main power component is conformant to EN 60601-1 Safety standard (Class I with Type B applied parts. 40. To avoid the risk of device connection interruption, reduce the distance between the device and the computer. The maximum distance between the processor and the computer can be up to 10 meters (33 feet). Also, Remove any physical barriers like walls, posts, doors, or people. 41. The device complies with verification tests & the EN 60601-1-6 Usability checklists to ensure that the equipment performs as intended. 42. Device complies with the EN 60601-1 Safety and EN 60601-1-2 EMC Test standards. 43. The device does not emit any EMI radiation that can affect any other CE-marked devices/systems in the immediate area. 44. To reduce the risk regarding improper labelling of connections (for the transducer, input power, and controls) the power connections are separate from other connection types. 45. Device uses the general warning sign/symbol from EN ISO 15223 and ISO 7010. Descriptions of all symbols that appear on the device and the device label can be found at the back of this manual. 46. Device is EN 60601 Safety and EMC compliant. 47. Device is classified as IPX1 Equipment (degree of protection against ingress of water). 48. Do not immerse the UDS equipment or any components in water or any other liquids. 49. Use with LABORIE equipment and accessories ONLY. 50. Laborie will not be responsible for any damages resulting from the use of incompatible devices. 51. To reduce the risk of serious patient injury, it is vital that physicians and clinicians performing Urodynamics studies on patients with a Spinal Cord Injury be prepared to recognize and treat Autonomic Dysreflexia. Proper patient screening before Urodynamics testing and continued monitoring for spikes in blood pressure and pulse during test procedures is also required. If a rise in blood pressure or other symptoms are detected, bladder must be emptied immediately. Raise the patient’s head if not already in a sitting position. Physicians must monitor patients with Autonomic Dysreflexia at least 2 hours after resolution of the episode. 52. To prevent cross-contamination, waist belts and lanyards are made of machine washable materials and should be washed with hot water and dried between uses. 53. To reduce the risk of serious patient injury, it is vital that physicians and clinicians performing Urodynamics studies be prepared to recognize and treat symptoms associated with vasovagal syncope (fainting) during Urodynamics procedures. 54. To reduce the risk of urinary tract infection, the physician should be knowledgeable and qualified in applying the appropriate aseptic technique during the intended use of the device. The use of prophylactic antibiotics are at the discretion of the physician and the policies of the institution. 55. To reduce the risk of invalid test results, catheters should not be used on patients who suffer from bladder infections or strictures in the urethra. 56. Prior to testing, a urinalysis and urine culture should be considered to rule out the presence of infection.

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57. To reduce the potential for discomfort during the procedure and/or transient discomfort, dysuria and hematuria, technicians and physicians should explain any additional risks of the procedure to the patient. 58. To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth. 59. No modification of this equipment allowed. 60. Connecting electrical equipment to a multiple socket outlet effectively leads to creating an a medical electrical system and can result in a reduced level of safety. 61. The UDS system must be positioned in such a way so as to provide unobstructed access to the power cord connector in the event of a required emergency stop.

INTENDED USE The Laborie Urocap III Uroflowmetry analyzer is intended to quantify the flow characteristics of the lower urinary tract. Using the available transducer, the system can perform standard Uroflowmetry studies. Uroflowmetry is a standard Urodynamic test that is often used as a screening test before moving on to more advanced Urodynamic studies such as Pressure or Micturition. The Urocap III is intended for use in Uroflowmetry studies that measure both flow rate and voided volume; and is intended for use by a qualified practitioner only.

TARGET POPULATION The major application of Urodynamics (including Uroflowmetry) is the diagnosis of uncontrolled loss of urine (incontinence) or abnormal urinary retention.

CONTRAINDICATIONS The Urocap III Uroflowmetry analyzer is contraindicated in any patient who is not a candidate for Uroflowmetry testing.

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3 UNPACKING THE UROCAP III EQUIPMENT The Urocap III is packaged for protection during shipment and transport. Verify that all ordered equipment and accessories have been received. Contact LABORIE should there be any discrepancies between ordered and received equipment. Inspect the equipment for any visible signs of damage or mishandling, and notify the carrier immediately if damage has been found. NOTE: Carrying cases and cartons should be saved to provide a convenient and safe way to return the equipment should service be required.

STANDARD EQUIPMENT See page 62 for equipment and accessory part numbers. Part numbers for optional software features and for the Urocap III with PC model can also be found in that location. Urocap III Standalone Model     

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1 Urocap III wired transducer 5 Beakers 1 Commode Chair 1 Uroflow Funnel 1 Thermal printer with Reprint capability

    

Thermal Printer cable 3 Rolls of thermal printer paper 1 Power supply 1 Medical grade power cord Instruction manuals

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Urocap III Wired to PC     

1 Urocap III wired transducer 1 RS-232 cable 5 Beakers 1 Commode Chair 1 Uroflow Funnel

   

Instruction manuals 1 Power supply 1 Medical grade power cord 1 Urocap III CD with software key

   

Instruction Manuals 1 Power supply 1 Medical grade power cord 1 Urocap III CD with software key

Urocap III Wireless with PC     

1 Urocap III wireless transducer 5 Beakers 1 Commode Chair 1 Uroflow Funnel 1 Bluetooth card/USB adaptor

OPTIONAL ACCESSORIES Depending on the setup of your Urocap III system, some of the items listed below may or may not be available as an optional accessory.  Flow stand  Uroflow Funnel  Folding Commode chair  Funnel for folding commode chair

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 Desktop printer with wireless support (for wireless PC models only)  HP Bluetooth® Adapter for DeskJet Printer

RETRACTABLE ANTENNA (UROCAP III WIRELESS WITH PC ONLY) The bottom of the wireless model of the Urocap III contains an antenna that can be extended to provide better Bluetooth signal reception.

RETRACTIBLE WIRELESS ANTENNA

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4 SETTING UP THE UROCAP III EQUIPMENT UROCAP III STANDALONE SETUP 1. Connect the DC power connector and the serial communication connector (DB9) of the printer cable to the thermal printer. 2. Connect the other end of the printer cable to the Urocap III transducer. 3. Connect the power supply to the Urocap III transducer. 4. Connect the power cord to the power supply, and plug the power cord into an electrical outlet. NOTE: All cables must be connected before turning on the Urocap III unit. IMPORTANT! The Urocap-III power supply must be in a dry area at least one (1) metre away from the base of the commode chair.

Figure 4.1: Urocap III Standalone Model Connections and Room Setup

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UROCAP III WIRED WITH PC SETUP 1. Connect the RS-232 cable to the Urocap III transducer. 2. Connect the other end of the RS-232 cable to the COM2 port (or another COM port) of the PC. 3. Connect the power supply to the Urocap III transducer. 4. Connect the power cord to the power supply and plug the power cord into an electrical outlet. NOTE: All cables must be connected before turning on the Urocap III unit. IMPORTANT! The Urocap-III power supply must be in a dry area at least one (1) metre away from the base of the commode chair.

UROCAP III WITH WIRELESS PC MODEL SETUP 1. Connect the power supply to the Urocap III transducer. 2. Connect the power cord to the power supply, and plug the power cord into an electrical outlet. NOTE: All cables must be connected before turning on the Urocap III unit. IMPORTANT! The Urocap-III power supply must be in a dry area at least one (1) metre away from the base of the commode chair.

GENERAL ROOM SETUP When setting up your Uroflow study room, it is recommended that the printer and the power supply be kept away from the voiding area. The printer should be placed on a small table or flat surface away from the voiding area to keep it clean and to prevent any damage due to dirt and fluid. With the wireless model, the Bluetooth technology built into the Urocap III unit provides the patient with a higher degree of privacy during voiding. The transducer, beaker, commode chair, and funnel can be set up in one room while the PC can be in another room collecting the test data.

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5 SOFTWARE SETUP For the Urocap III Standalone model, there is no software to install. Please refer to chapter 6 for more information. For the Urocap III wired to a PC or the Urocap III wireless with PC, the software is installed prior to shipping. Only install the software if it has been accidentally uninstalled or if you are upgrading to a more current version. Follow the instructions in the Software Installation Guide in the Laborie Software CD for your UDS system.

UROCAP III PC SOFTWARE The software is designed and is thoroughly tested to run on the Microsoft Windows XP® Professional or the Windows 7® Professional operating system. NOTE: Some of the software features described may be optional. Please check with your Laborie sales representative for details.

Microsoft Windows Knowing how to use the basic Microsoft Windows features is the first step to the test preparation. Each area and symbol on the screen is significant to the operation of the software. Windows Start Menu/Task Bar The Windows Start Menu is located at the Windows task bar. The Start Menu can be used to open programs, access shortcuts, or shut down Windows. For more information, please refer to your Microsoft Windows manual.

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6 USING THE UROCAP III™ - STANDALONE MODEL For the standalone model of the Urocap III, the testing and calibration procedures are outlined through the instructions provided by the thermal printer’s printouts. The Urocap III thermal printer has a blue- or red-colored button labeled Reprint. The Reprint button is used to print another copy of the procedure stored in memory. It is also used to obtain input during transducer calibration. (For more information on calibration, please see page 51.)

PERFORMING A UROFLOW TEST (STANDALONE MODEL) 1. Place the Urocap III on a flat surface. IMPORTANT! The Urocap-III power supply must be in a dry area at least one (1) metre away from the base of the commode chair.

2. 3. 4. 5. 6.

Place the printer in a desired location preferably away from the voiding area. Verify that all cable connections have been connected. Plug the DC power supply into a wall outlet. Turn on the printer. Verify that the Urocap III is receiving power. Result: The Urocap III Lamp window will blink red. The printer online lamp will light green and the power lamp will blink green. 7. Place a beaker on the Urocap III. Result: The Urocap III Lamp window will blink red faster and then turn solid green after 5 seconds. The printer will print: “Ready…” 8. Position the commode chair and the funnel directly above the beaker on the Urocap III. Make sure the funnel center aligns with the beaker so that the fluid going into the funnel will go straight into the beaker. The funnel must not touch any of the sides of the beaker. Result: If the beaker is knocked out of place and the printer starts to print the procedure, you can reset the system by lifting the beaker off and then placing it back on the transducer. 9. Ask the patient to urinate normally into the funnel. Result: When the patient starts voiding, the printer will start printing the procedure. The Urocap III lamp window will blink green when data is being collected. 10. When the patient finishes voiding, DO NOT REMOVE the beaker. Wait for the printing to complete. (Refer to the sample printout in Figure 6.1 on page 14.) Result: The Urocap III lamp window will turn a solid red. 11. If another printed copy is required, press and release the Reprint button after the printer stops printing and goes online. The data is stored until the beaker is lifted off and replaced. 12. After all the required copies finish printing, empty and clean the beaker and place it back on the Urocap III. 13. Write the information on the printout such as Patient name, doctor name, date, and so on with a pen and file it for your records. Result: After 5 seconds, the printer prints: Ready… You are now ready to start another Uroflow study. Return to Step 5 and follow the instructions to perform a new Uroflow procedure.

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Figure 6.1: Sample Printout

NOTES:    

If the printer runs out of paper while printing the procedure, the printer will go offline. Replace the empty paper roll with a new roll of thermal printer paper. Verify that the paper has been inserted properly because you can only print on one side. Press the printer’s online button to set it back online. The online LED of the printer will light up when ready to print again.

For more information about the thermal printer, please refer to the user manual that was shipped with the printer.

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7 UROCAP- III - WIRED / WIRELESS PC MODEL In the PC Mode of Operation, the study is printed using the default printer in Windows. Please ensure that there is a printer connected and that the correct Windows printer driver is installed properly. Refer to the printer manual for more information on printer driver installation.

LOGON SCREEN Once the UDS120 software starts, you may be asked to enter a user name and password. This logon feature, in accordance to the Health Insurance Portability and Accountability Act (HIPAA) 1996, provides an extra layer of security for testing and when accessing patient test files. Depending on the software configuration used, one of two screens will be visible at startup.

OR The user name and password used for logging on to the computer must be used in this logon screen too. If a password is not available ask your system administrator to provide one for you. A log file is created whenever someone starts the software and opens a file. Note that the software will shut down if an incorrect user name or password is repeatedly entered more than three times.

UDS CLIENT WINDOW The UDS Client is the main window of the UDS Software, which provides the screens necessary for you to perform tests. The UDS system must be connected to the laptop PC and the Software Key must be plugged into a USB port in order to run tests. To open the UDS Client Window:

1. Insert the Software Key in a USB port. 2. Double-click the UDS120 icon on the Windows desktop -ORClick Start > All Programs > Laborie > UDS120. Result: The UDS Client opens with the UROCAP III Welcome Screen.

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FILE MENU The File menu is the first menu located on the menu bar. Open The Open feature on the File menu opens patient tests that have already been created. Before opening a saved data file, be sure that any currently running patient tests are saved. Once the file is saved, opening a saved file automatically closes the old one. To open a saved file:

1. Click File from the menu bar. 2. Select Open. Result: The Open Test File window opens.

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