GOBY Owners Manual Operation, Care and Maintenance Manual Ver 22.00 Dec 2018

LABORIE USA 400 Avenue D, Suite 10 Williston, Vermont, USA 05495 Tel: 1.800.522.6743 Fax: 1.802.878.1122

LABORIE Headquarters 6415 Northwest Dr., Unit 10 Mississauga, Ontario, Canada L4V 1X1 Tel: 905.612.1170 Fax: 905.612.9731

LABORIE Europe/International Medical Measurement Systems B.V. Colosseum 25 7521 PV Enschede The Netherlands Tel.: +31.53.4803700 Fax: +31.53.4803701

www.laborie.com

Trademarks Goby, Urocap, UDS Roam, Goby Hub, accuTAK, and iLIST Office Reporter are trademarks of Laborie Medical Technologies Canada ULC. T-DOC is a registered trademark of T-DOC Company, LLC, USA. Unisensor is a trademark of Unisensor AG. Windows is a registered trademark of Microsoft Corp. Bluetooth is a registered trademark of Bluetooth SIG. VELCRO is a registered trademark of Velcro Industries B.V. Norton is a trademark of Symantec Corporation or its affiliates in the U.S. and other countries. Other names may be trademarks of their respective owners. Copyright ALL RIGHTS RESERVED. IMAGES/RENDERINGS OF LABORIE DEVICES IN THIS PUBLICATION ARE PROPERTY OF LABORIE AND NO PART OF THIS PUBLICATION MAY NOT BE REPRODUCED WITHOUT THE PRIOR WRITTEN PERMISSION OF LABORIE. © Copyright 2017 LABORIE

Document Number: GOBY-UM02-V22.00 Version: 22.00 Release Date: December 7, 2018

Laborie Medical Technologies Canada ULC 6415 Northwest Drive, Unit 10 Mississauga ON L4V 1X1 CANADA

ii LABORIE Goby Owner’s Manual GOBY-UM02 V22.00

Contents About this manual ... viii Symbols... viii

1

Introduction ... 1 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8

2

Getting Started ... 1 Learning About the Goby™ System ... 1 Caution and Warnings ... 1 Caution... 1 General System Warnings ... 1 Intended Use ... 3 Target Users ... 3 Contraindications... 4

Goby™ System – Care and Maintenance ... 5 2.1 2.2 2.3 2.4 2.5 2.6 2.7

General Care and Preventive Maintenance ... 5 Caring for the UDS Roam ... 5 Caring for the Urocap™ IV Uroflowmeter ... 5 Caring for the Goby™ Hub ... 6 Caring for the Cart and its components ... 7 Caring for the Air-Charged Transducer/Cable ... 7 Battery - CHARGING and Preventive Maintenance ... 7

2.7.1 2.7.2

2.8 2.9 2.10 2.11 2.12

Charging the Battery ... 7 Preventive Maintenance ... 8

Computer Virus Protection ... 8 Treating and Disposing of Product After Use ... 8 Environmental Consideration of Waste Disposal ... 8 Preventive Maintenance – Checking Calibration ... 8 Check the Flow and Volume of the Uroflowmeter... 9

2.12.1 2.12.2

2.13 2.14 2.15 2.16 2.17

3

Check Volume ... 9 Check Flow ... 9

Check the Pump ... 9 Check the EMG ... 9 Check the UPP Puller ... 12 Check Pressure Transducer ... 12 Check the Infusion Transducer ... 12

Set Up Goby™ Equipment and Accessories ...13 3.1 3.2 3.2.1 3.2.2 3.2.3 3.2.4 3.2.5 3.2.6 3.2.7 3.2.8 3.2.9

3.3

Equipment Checklist ... 13 Assemble System Components ... 13 Assemble Goby™ with Cart ... 13 Assemble Goby™ on a Table Top ... 15 Assemble Goby™ on an IV Pole ... 16 Fluid-Filled Pressure Transducer Setup ... 17 Fluid-Filled Pressure Transducer Connections ... 18 T-Doc Catheter ... 19 Set up Infusion Transducer (optional) ... 20 Set up the Pump ... 20 Set up Ambulatory Remote Control (optional) ... 21

Wireless Printer Setup ... 22

iii LABORIE Goby Owner’s Manual GOBY-UM02 V22.00

3.3.1 3.3.2 3.3.3

Before You Begin ... 22 Set Up the Printer on Your Wireless Network ... 22 Print Using Wi-fi Direct... 22

Guidelines For Using Wi-Fi Direct ... 22 To Turn On Wi-Fi Direct ... 23 To Change Connection Method ... 23 To print from a wireless-capable computer (Windows) ... 23

3.3.4

Change the Connection Type ... 23

To change from a USB connection to a wireless network (Windows) ... 23 To change from a wireless connection to a USB connection (Windows) ... 24

Connect Goby™ Devices...25 4

Equipment Status Indicators and Buttons ...28 4.1 4.2 4.3 4.4 4.5

5

Software Features and Functions...32 5.1 5.1.1

5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 5.10 5.11 5.12 5.13

6

LED Lights... 28 Icon Indicators ... 29 Connection Status... 29 Battery Status ... 30 Device Connectors and Buttons ... 30

Dynamic Control Panels... 33 Zoom Button on Control Panel ... 33

Hiding/Showing Channels ... 33 File Menu ... 34 Open ... 35 Open From Data File ... 35 Save As ... 36 File Saving Directory ... 36 Print Study ... 36 Batch Print (optional feature)... 36 Print Setup ... 36 About UDS Client ... 37 Exit ... 37 Ambulatory Configuration Manager ... 37

Config Menu ...37 6.1 6.2 6.3 6.4 6.5 6.6 6.6.1

6.7 6.8 6.9 6.10 6.12 6.13 6.14

Open ... 37 Save As ... 37 Set up/Modify ... 38 Channel Settings ... 38 UPP ... 39 Pump... 39 Volume Warning Limit ... 41

Filter ... 41 Uroflow ... 41 ARM ... 41 Security ... 42 iList™ Events Linking ... 43 Compliance Tab ... 44 Unlock CFG... 44

iv LABORIE Goby Owner’s Manual GOBY-UM02 V22.00

7

Info Menu ...45 7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8 7.9 7.10 7.11

Patient Info ... 46 X-Y Plot... 46 ICS Nomogram (URA)... 46 LinPURR ... 48 Bladder Work Function (WF) ... 50 CHESS ... 52 Siroky Nomogram ... 52 Liverpool Nomogram ... 53 Eberhard Curves ... 53 Event Summary... 54 About the Event Annotation Window ... 55

7.11.1 7.11.2 7.11.3 7.11.4 7.11.5 7.11.6 7.11.7 7.11.8

Add or Change Event Annotation ... 56 Deleting Events from the Event Summary ... 56 Deleting or renaming events – Quick Method ... 56 Selecting/Unselecting Events for Printing ... 56 Permission to Void Event ... 57 Move to Event ... 57 Stress Events ... 57 Area Under Curve ... 58

...58 7.12 7.13

Voiding Summary... 60 Uroflow Options ... 61

7.13.1 7.13.2 7.13.3

7.14

UPP Summary ... 64

7.14.1 7.14.2

7.15

Elements in the UPP Summary ... 66 Re-Marking UPP Segments ... 66

Bladder Compliance (Optional) ... 69

7.15.1 7.15.2 7.15.3

8

Artifact Recognition... 62 Uroflow Auto Recording ... 62 Pediatric Nomogram ... 63

Auto Compliance (optional) ... 70 Auto Compliance by Event ... 70 UPP ... 71

Options Menu ...74 8.1 8.2 8.3 8.4 8.5 8.6 8.6.1 8.6.2 8.6.3 8.6.4

8.7 8.8 8.8.1

8.9 8.10 8.11

Test Restart ... 74 Test Playback ... 74 Uroflow Auto Start... 74 Cursor Value Indicator ... 74 Digital Value Indicator ... 75 Control Panel Settings ... 75 Multiple Control Panel Sets and Hot Key Configuration ... 77 Add an Image to a Control Panel Button ... 77 Customize Colors and Fonts and Adjust Button Size... 78 Types of Control Panel Commands ... 80

Enable Button Sounds ... 82 Event Display Options ... 82 Select Background Colors for Events... 83

Auto Mark Peaks... 83 Auto Infusion Event ... 83 Graph Clipping ... 83

v LABORIE Goby Owner’s Manual GOBY-UM02 V22.00

8.12 8.13 8.14 8.15 8.16

9

Set Zeroes! ... 84 Undo Set Zeroes ... 84 Zoom – Selected Area and Back ... 84 VBN ... 84 Calibration Sets ... 84

Additional Software Features ...85 9.1

Software Setup for Pediatric Patients ... 85

9.1.1 9.1.2

9.2 9.3 9.4 9.5 9.6 9.7

Pediatric Patient Information ... 85 Volume Warning Limit ... 86

Modify Channel Title and Units ... 87 Modify Channel Scales... 87 Channel Value Marker ... 87 Drag/Drop Channel Ordering ... 87 Selecting Graph Segments for iList™ Reports... 88 Setting Up the Remote Control and UDS Roam for Ambulatory Testing (Optional) ... 88

9.7.1 9.7.2 9.7.3

Part 1: Calibrate P4 ... 88 Part 2: Configure File Settings for Remote Detection Algorithm ... 89 Part 3: Configure the Buttons ... 91

9.8

Video ... 92

10 Run a Uroflow Test...93 10.1 10.2

Run a Uroflow Test: Auto Method ... 93 Run a Uroflow Test: Manual Method ... 94

11 Run a CMG/PF Test ...95 11.1 11.2

Run a CMG/PF Test Using Air-charged Catheters... 95 Run a CMG/PF Test Using Fluid-filled Catheters ... 96

12 Run a UPP Test ...98 12.1 12.2 12.3

Run a UPP Test with the UPP Silent Drive Puller ... 98 Run a UPP Test with a Manual Pull... 99 Ambulatory Monitoring During a Test... 100

12.3.1

Additional Notes Regarding Ambulatory Testing ... 103

13 Print a Test... 104 14 Calibration ... 106 14.1 14.2 14.3 14.4 14.5 14.6

Calibrate the Urocap™ IV Uroflowmeter ... 106 Calibrate the Pump ... 107 Calibrate the UDS Roam™ for EMG, Pressure Transducers, Ambulatory Remote, and/or Accutak ... 108 Calibrate the Infusion Transducer ... 109 Calibrate the UPP... 110 Restore Factory Calibration ... 111

15 Quick Reference and FAQ ... 112 15.1 15.2

Equipment ... 112 Software ... 114

16 Help ... 116 vi LABORIE Goby Owner’s Manual GOBY-UM02 V22.00

Appendices... 123 APPENDIX A:

Specifications ... 123

Ambulatory Devices Specifications... 123 Classifications ... 124 Applicable Directives and Standards ... 124

APPENDIX B:

Symbols and Labeling ... 125

Goby™ System Labels Reading Guide ... 127

APPENDIX C:

Electromagnetic Compatibility (EMC)... 127

APPENDIX D:

Print Report Options for UDS120 Goby™ Software ... 131

APPENDIX E:

Nomogram Tables for Uroflowmetry ... 133

APPENDIX F:

Calculations... 135

APPENDIX G:

End-User Software License Agreement ... 135

APPENDIX H:

Glossary ... 135

Terms Used in Urodynamics Testing ... 135 Common Urodynamics Acronyms ... 139

17 References ... 140

vii LABORIE Goby Owner’s Manual GOBY-UM02 V22.00

ABOUT THIS MANUAL SYMBOLS In this manual, you will find important information to help you understand the features and safe use of the device. This important information is highlighted with the following symbols:

CAUTION This is information you need to know to prevent minor injury or product damage

IMPORTANT This is important information about using the device

NOTE This is useful information or reminders about using the device

viii LABORIE Goby Owner’s Manual GOBY-UM02 V22.00

1 INTRODUCTION LABORIE’s Goby™ system is a simple and easy-to-use Urodynamic Analyzer system. With its state-of-the-art technology, Goby™ streamlines testing making the process effortless to perform. Goby™ shortens setup time and gives patients the freedom to move during testing by using fewer cables/wires and smaller testing devices. For warranty information and terms and conditions, visit www.laborie.com

1.1 GETTING STARTED To prepare the Goby™ system before performing any Urodynamics procedures: 1. Set up the system hardware. (see page 13) 2. Configure test files (if necessary). (see page 38) 3. Turn on components and any other accessories. 4. Start the Urodynamics procedure(s).

1.2 LEARNING ABOUT THE GOBY™ SYSTEM To learn about the features and how-to of the Goby™ system, read the following documents or sections of this manual: • Goby™ quick start guide (provided with the equipment shipment and on the software disc.) • Software features and functions (see pages 34 to 84) • How to perform Urodynamics tests with the Goby™ (see pages 93 to 99)

1.3 CAUTION AND WARNINGS

READ CAREFULLY BEFORE USE! 1.4 CAUTION UNITED STATES FEDERAL LAW RESTRICTS THIS DEVICE TO SALE OR USE BY OR ON THE ORDER OF A LICENSED PHYSICIAN.

1.5 GENERAL SYSTEM WARNINGS 1. 2. 3. 4.

DO NOT USE in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide. DO NOT USE electromyography (EMG) simultaneously with high frequency surgical equipment. DO NOT place your fingers inside the pump head when the pump rollers are moving. DO NOT USE the Goby™ in the presence of a magnetic resonance imaging system as it may contain ferromagnetic objects that pose a risk to the patient in the presence of a magnetic core. The strong magnetic field produced by the MRI may cause disruption of the system.

5. DO NOT ATTEMPT TO OPEN OR REPAIR the Goby™ system components by yourself or by an unauthorized party. ONLY Laborie-trained technicians may service the Goby™ system components.

6. Batteries are not operator removable; do not attempt to remove batteries from Goby™ system components. All servicing of Goby™ system, components or attachments to be completed by LABORIE. 7. LABORIE equipment and accessories are licensed by Governments and approved by Safety Agencies to work with each other ONLY.

1 LABORIE Goby Owner’s Manual GOBY-UM02 V22.00

8. LABORIE equipment and accessories are warranted to work with each other ONLY. 9. Exposure to ESD may cause the system to RESET. 10. LABORIE is not responsible for loss of patient files or test data. It is strongly recommended to back up patient data on a regular basis.

11. Ensure all castor wheels are locked during testing procedures to prevent injury to the patient. DO NOT lean anywhere on the system or its devices. The devices are not designed to support the weight of a person. 12. To prevent possible injury to the patient, always use the UPP puller with the UPP puller adaptor. 13. Re-use, reprocessing or re-sterilization of disposables can lead to device failure and create a risk of cross-infection and/or cross transmission of infectious disease(s) from one patient to another. 14. DO NOT immerse the Goby™ equipment or any components in water or any other liquids. 15. Always position GOBY™ to facilitate ease of access to all electrical connections and plugs. Device operator must be able to disconnect device in case of emergency quickly and safely. 16. To avoid the risk of electric shock, only connect this equipment to supply mains with protective earth. 17. Only connect devices specified and approved by Laborie to GOBY™ multiple socket outlets. Connecting any device not approved by LABORIE to the ME system alters the functional integrity of the product creating a safety risk. 18. Avoid altering or adding to GOBY™ medical electrical system. Any alteration to GOBY™ system by an unauthorized party transfers responsibility for meeting ME system requirements from LABORIE to the altering party. Anyone connecting supplementary equipment to medical electrical equipment configures a medical system and is therefore responsible for ensuring that the system complies with the requirements for medical electrical systems, encompassed in the IEC 60601 series. 19. Do not place the printer in the patient environment unless it is powered via the Laborie provided Line Isolation Transformer (Separating transformer). 20. Only connect items that have been approved by Laborie to the system. Any additional connections become the responsibility of the operator and shall tested to meet the IEC 60601-1, ME SYSTEMS requirements. 21. There is the risk of electrical shock if the operator plugs in Non-ME Equipment (i.e. printer or laptop) directly into the MAINS supply that is intended to be powered by a Line Isolation Transformer (Separating transformer) 22. Do not touch the printer/laptop and the patient simultaneously. GENERAL SYSTEM IMPORTANT INFORMATION

23. Use the Goby™ with LABORIE equipment and accessories only. Do not reuse disposable devices. After use, dispose in accordance with local regulations. Do not use if device packaging has been opened, or damaged, or if it presents any fault due to improper transport, storage, or handling that could in any way hamper its use. 24. The built-in pump is designed for use with water, saline or hypaque solutions only. 25. 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. 26. To prevent the IV pole from dropping when mounted on the cart, ensure the pole is installed securely into the pole mount and ensure the locking mechanism is securely fastened in place. 27. Be aware that prolonged use of video capture may result in elevated temperatures at the rear of the AIO PC. 28. Device intended for use in a clinical environment with controlled EMC standards to limit potential interference. GOBY™ may be adversely affected by Bluetooth®, cellular or EMC interference. Minimize interference from other Bluetooth devices by setting up all components of system in proximity to each other.

2 LABORIE Goby Owner’s Manual GOBY-UM02 V22.00

GENERAL SYSTEM SAFETY COMPLIANCE

29. To prevent unexpected exposure to radiation, the device has been tested against EN 60601-1-2 EMC standards.

30. To prevent exposure to potential electric shock, the device meets and exceeds the insulation breakdown specifications for EN 60601-1, EN 60601-1-2 EMC standards & CSA 22.2 medical standards.

31. To prevent patient injury, warning symbols on all labels comply with EN ISO 15223-1 and EN 1041. 32. To prevent external injuries, patients and equipment operators are protected from moving parts of the pump roller head by limiting the torque of the motor. NOTE: local laws take priority over the above-mentioned requirements and warnings; if in doubt, consult your local Laborie representative or the technical service department.

1.6 INTENDED USE The Goby™ system is a Urodynamic Analyzer system that is intended to quantify the pressure, flow and EMG characteristics of the lower urinary tract. Using the available transducers, the system can be used for performing standard Urodynamic tests such as Uroflow, CMG, UPP, and Micturition studies. The major application of Urodynamics is the diagnosis of uncontrolled loss of urine (incontinence), abnormal urinary retention, or neurological cases of Micturition disorder. The device is intended to be used as medical diagnostic equipment.

1.7 TARGET USERS 1. Only technicians and physicians trained in Urodynamics should operate this device. The operator

2.

3.

4.

5.

6.

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 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. 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. Physicians must monitor patients with Autonomic Dysreflexia at least 2 hours after resolution of the episode. To reduce the risk of cross-contamination or urinary tract infection, physicians should be knowledgeable and qualified in applying the appropriate aseptic technique during the intended use of the device. The use of prophylactic antibiotics is at the discretion of the physician and the policies of the institution. 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. Warnings related to Ureteral Catheterization can be referenced within the TDOC IFU (TDOC-UM01).

3 LABORIE Goby Owner’s Manual GOBY-UM02 V22.00

1.8 CONTRAINDICATIONS The Goby is contraindicated for any patient who is not a candidate for Urodynamic testing. Catheters should not be used on patients who suffer from bladder infections or strictures in the urethra. Single-use, disposable catheters provided by LABORIE are “sterile”, unless stated otherwise on the packaging label and instructions. Prior to testing, a urinalysis and urine culture should be considered to rule out the presence of infection. Reusable catheters are cleaned but not sterilized before shipping.

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2 GOBY™ SYSTEM – CARE AND MAINTENANCE 2.1 GENERAL CARE AND PREVENTIVE MAINTENANCE • • •

• •

•

• • •

Always wear protective gloves when cleaning the equipment to prevent biological contamination. The Goby™ system is non-immersible. It should be wiped down with a clean cloth dampened with a cleaning solution such as soap and water or as per hospital cleaning instructions. The Uroflow beaker should be rinsed and dried after use. Soap and water, or a mild detergent solution, can be used for cleaning. NOTE: Although the beaker is reusable, it will discolor over time and may need to be replaced. The EMG electrodes, tubing, disposable catheters, and cartridges are intended for SINGLE PATIENT USE only. Do NOT re-use disposables. Performing regular maintenance will reduce the need for costly repairs. Check the transducer calibration of the Goby™ every 6 months or whenever you suspect the transducers are off calibration. Pay close attention to the LED lights on each device. If they indicate a broken connection and/or low battery, then make sure that the connection is re-established or the battery is fully charged. For information on LED lights, see page 28. 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. The holster can be cleaned with standard hospital wipes. DO NOT STERILIZE the Goby™ system components.

2.2 CARING FOR THE UDS ROAM The UDS Roam is not immersible. Wipe the outside only with soap and water or with a hospitalgrade disinfectant. DO NOT SPRAY CLEANING SOLUTION DIRECTLY ON OR IN THE UDS ROAM. NOTE: It is recommended to charge and use the UDS Roam at least once or twice a year to maintain optimal performance. If it will be placed in storage, make sure it is stored with the battery fully charged.

2.3 CARING FOR THE UROCAP™ IV UROFLOWMETER At times, the Urocap™ IV will become dirty due to urine contamination and cleaning is required. Always wear protective gloves when cleaning the equipment to prevent biological contamination.

IMPORTANT! Do not soak the Urocap™ IV in water! Do not immerse in water or in any other liquids! • The Urocap™ IV Uroflowmeter has an immersion protection rating of IP54 for ingress of water. This means that the enclosure of the Uroflowmeter can handle splashes of water and liquid from any direction, but it is not protected against total immersion into water or any other liquids. This complies with IEC 60529 standards. 5 LABORIE Goby Owner’s Manual GOBY-UM02 V22.00

•

Never soak or immerse the Urocap™ IV in water or any other liquids.

• •

The lid of the Urocap™ IV is not removable. The Urocap™ IV should be cleaned using a damp cloth with alcohol, soap, or disinfectant detergent.

•

It should be stored in a cool and dry area at room temperature.

To check if the Urocap™ IV is functioning, see page 8.

2.4 CARING FOR THE GOBY™ HUB The Goby™ Hub (with pump) is not immersible. It should be wiped using a clean cloth dampened with water and mild detergent. The unit should be stored in a cool and dry area at room temperature. If fluid spills in the pump head, it will need to be cleaned. A mild solution of detergent and water can be used to clean the pump head. The pump head can be removed by turning it counter-clockwise 45° and sliding the pump head forward. Remove the head and tubing from the pump drive and wash them thoroughly.

6 LABORIE Goby Owner’s Manual GOBY-UM02 V22.00

Warning! • • • • • •

Do not use strong detergent agents as they may damage the surface finish of the pump’s metal and plastic casing. Do not immerse the pump drive in a cleaning solution. Do not use excessive force when removing the pump head. Do not drop the pump head on the floor as it may scratch and damage the head. Stop the pump, power off the unit and disconnect the pump cable before cleaning the pump. The tubing set which is used with the pump system during Urodynamic measurements is intended for single use only. It should not be cleaned and reused.

To check if the pump is functioning properly, see page 8.

2.5 CARING FOR THE CART AND ITS COMPONENTS The cart and its components should be wiped down with a clean cloth dampened with a cleaning solution such as soap and water, or as per hospital cleaning instructions.

2.6 CARING FOR THE AIR-CHARGED TRANSDUCER/CABLE The risk of patient to patient cross-contamination with sterile single-use air-charged catheters, using sterile technique, is negligible. However, any procedure in high-risk settings with body fluids and skin-to-skin contact increases the risk of contamination of non-disposable components. The following steps should be performed after each patient use: • Air-charged catheters are single patient use only. Discard after use. • Replace the tethered protective cap to the transducer housing via Luer Lock to protect the transducer. • Spray or wet-wipe the transducer/cable with a hospital-grade, broad-spectrum disinfectant that covers standard potential pathogens as well as HIV, HBV, HCV, VRE, MSRA, MSRE, Pseudomonas and Mycobacterium. • Wipe the transducer/cable until dry.

2.7 BATTERY - CHARGING AND PREVENTIVE MAINTENANCE 2.7.1 Charging the Battery The Urocap™ IV and the UDS Roam each contain rechargeable batteries. The battery status is visible in the Device Manager. For information on battery status messages, see page 29. •

To charge the Urocap™ IV plug one end of the power supply cord into the device and the other end into an electrical outlet. • To charge the UDS Roam, place the UDS Roam securely into the Goby™ Hub. Plug one end of the power supply cord into the bottom of the Goby™ Hub and the other end into an electrical outlet. Switch the Goby™ Hub to ON with the power switch at the bottom. Use Input and Output Cables and Cords provided by LABORIE only. NOTES: 7 LABORIE Goby Owner’s Manual GOBY-UM02 V22.00

• • • •

It will take approximately 5 hours to fully charge the devices. When the LED light on the device is green it is fully charged. The equipment can still be used during charge time. When placed in the Hub the UDS Roam will show an increase in EMG noise.

2.7.2 Preventive Maintenance • Do not step on, drop, drop in water, or puncture the battery. If misuse, abuse, or damage is suspected, or any form of mechanical damage to the casing is visible, then discontinue use and return the battery to LABORIE. • If a sudden change in the battery’s ability to hold a charge or a sudden change in battery life time is noticed, discontinue use and return the battery to LABORIE.

2.8 COMPUTER VIRUS PROTECTION All computers purchased from LABORIE are virus-free before shipment and are installed with the Norton™ Antivirus program. It is the customer’s responsibility to correctly use and maintain the anti-virus program to prevent virus problems. LABORIE is not responsible for any virus related computer problems after point of delivery to the customer.

2.9 TREATING AND DISPOSING OF PRODUCT AFTER USE • • • •

After use, discard the contaminated, plastic, single-use disposables and any packaging according to your institution’s standard operating procedures on medical waste handling. For end of life product, waste electrical and electronic equipment should be collected separately and returned to the designated local recycling service. For end of battery life, disposal must be handled according to local regulations. Packaging waste should be collected separately for available national packaging collection and recycling services.

2.10 ENVIRONMENTAL CONSIDERATION OF WASTE DISPOSAL Due to the fact that the Urocap™ IV is designed to perform Uroflow studies, it is important to dispose of waste (such as urine) properly to prevent environmental pollution. The waste should be disposed of in such a way that will not pollute the fresh water supply system - especially the drinking water system. Normally, this is not an issue in areas that have proper sewage systems with water treatment procedures. In this case, the most convenient way is to use these sewage systems.

2.11 PREVENTIVE MAINTENANCE – CHECKING CALIBRATION Performing regular maintenance will reduce the need for costly repairs. Check the transducer calibration every 6 months or whenever you suspect the transducers are off calibration. If the Uroflowmeter, the pump, the EMG, the UPP puller, the pressure transducers, and/or the infusion transducer appear to be giving incorrect readings, try the following checkups before attempting to calibrate the system.

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2.12 CHECK THE FLOW AND VOLUME OF THE UROFLOWMETER 2.12.1 CHECK VOLUME 1. Open the UDS120 Goby™ software and start a sample Uroflow test. 2. Put an empty beaker on the Uroflow transducer. 3. Select Set Zeroes! 4. Remove the empty beaker. 5. Fill a beaker with 500cc of water and place it on the Uroflowmeter. The volume channel should display a volume of 500ml (+/- 5 ml). If the reading is above or below the 5ml threshold, then calibration is required. Once calibration is complete perform a re-check by following steps 1 to 5 listed here. Contact LABORIE service for assistance if problems continue after the calibration and re-check.

2.12.2 Check Flow 1. 2. 3. 4. 5.

Open the UDS120 Goby™ software and start a sample Uroflow test. Put an empty beaker on the Uroflow transducer. Select Set Zeroes! Fill another beaker with 500cc of water. Slowly and steadily pour the water from the filled beaker into the empty beaker. Try to keep the rate between 25 to 50 ml/second. The volume channel should display a volume of 500ml (+/- 5 ml). If the reading is above or below the 5ml threshold, then calibration is required. Once calibration is complete perform a re-check by following steps 1 to 5 listed here. Contact LABORIE service for assistance if problems continue after the calibration and re-check.

2.13 CHECK THE PUMP Some reminders before pump check-up: • The contrast used for testing procedures should also be used for check-up and calibration procedures. • Use only LABORIE recommended and approved tubing for accurate readings and measurements. 1. Prime the pump tubing. 2. Set up the pump tubing with catheter to pump into an empty beaker. 3. Open the UDS120 Goby™ software and start a sample test. 4. Fill to a volume of 150 cc and stop the test. 5. Measure the volume. The volume channel should match the pump fill volume (+/- 10 ml). If the reading is above or below the 10ml threshold, then calibration is required. Once calibration is complete perform a re-check by following steps 1 to 5 listed here. Contact LABORIE service for assistance if problems continue after the calibration and re-check.

2.14 CHECK THE EMG A reminder before EMG check-up: • EMG leads tend to expire after six months of use; it is recommended that they be replaced every six months.

9 LABORIE Goby Owner’s Manual GOBY-UM02 V22.00

1. Open the UDS120 Goby™ software and start a sample test with an EMG channel. 2. Place two EMG electrodes, 1 inch apart, on your forearm (where the muscle flexes the most) and the third EMG patch on the elbow of the same arm. 3. Keep your arm relaxed, palm open, and fully extended. You will notice minimal EMG activity.

4. Keep your palm open flex the arm slightly until it reached a 45 degree angle. Hold the position to keep it at a constant rate. You will notice an increase in activity on the EMG channel.

at 50% strain

10 LABORIE Goby Owner’s Manual GOBY-UM02 V22.00

5. Keep palm open and flex arm to a 90 degree angle, until it is parallel to the floor. You will notice more activity on the EMG channel.

at 100% strain 6. Keeping your arm in the 90 degree position, clench your fist. You will see an increase in EMG activity on the EMG channel. 7. Unclench your fist and return arm to the fully extended position. 8. Check the EMG channel for activity.

at 100% strain with full contraction A sample reading can be seen here:

extension

50% strain

100% strain

contraction

extension

If the EMG channel does not display any activity, then calibration is required. Once calibration is complete perform a re-check by following steps 1 to 8 listed here. Contact LABORIE service for assistance if problems continue after the calibration and re-check.

11 LABORIE Goby Owner’s Manual GOBY-UM02 V22.00

2.15 CHECK THE UPP PULLER 1. 2. 3. 4.

With a pencil, mark two points 50mm apart along the UPP puller shaft. Open the UDS120 Goby™ software and start a sample UPP test. Move the UPP to the distal (furthest) marker on the puller shaft. Start a timer and then run the puller and measure the time it takes for the UPP puller to move to the proximal (closer) mark on the puller shaft. The puller should stop at the proximal mark after 50 seconds (+/- 3 seconds). If the UPP puller does not move to the proximal mark in the required range of time, then calibration is required. Once calibration is complete perform a re-check by following steps 1 to 4 listed here. Contact LABORIE service for assistance if problems continue after the calibration and re-check.

2.16 CHECK PRESSURE TRANSDUCER 1. Switch the charger on the T-DOC to the OPEN position. 2. Connect the catheter to the charger and gently squeeze the balloon on the catheter to expel any air in the balloon. 3. Switch the charger to the CHARGE position. 4. Fill a standard graduated beaker with 1000ml of water. 5. Open the UDS120 Goby™ software and start a sample test with pressure channels. 6. Click Set Zeroes. 7. Dip the catheter into the beaker until the balloon on the catheter sits just below the water line. Result: The pressure channel should read between 0 and 1 cmH2O. 8. Carefully lower the catheter into the beaker until the tip gently touches the bottom of the beaker. Do not touch the sides of the beaker. 9. Hold the catheter in a steady position and wait for a reading on the pressure channel. The pressure channel should display a reading of 15 cmH2O (+/- 2 cmH2O). If the reading is above or below the 2 cmH2O threshold, then calibration is required. Once calibration is complete perform a re-check by following steps 1 to 9. Contact LABORIE service for assistance if problems continue after the calibration and re-check.

2.17 CHECK THE INFUSION TRANSDUCER NOTE: Make sure the Uroflowmeter is checked and calibrated before checking the infusion transducer. To check the Uroflowmeter, see page 9. 1. Place a full infusion bag on the infusion transducer. 2. Place an empty beaker on the Uroflowmeter. 3. Open the UDS120 Goby™ software and start a sample test with a VH2O channel. 4. Click Set Zeroes. 5. Start the infusion and let it run until the infusion bag is emptied into the beaker on the Uroflowmeter. 6. Read the volume channel. The volume on the channel should match the volume emptied into the beaker. If there is a strong difference (+/- 10 ml) between the volume from the infusion bag and that of the volume displayed on screen, then a calibration is required. Once calibrated, perform a re-check with steps 1 to 6 listed here. Contact LABORIE service for assistance if problems continue after the calibration and re-check.

12 LABORIE Goby Owner’s Manual GOBY-UM02 V22.00