Owners Manual
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AQUARIUS® XT/CT/LT/CTS Owner’s Manual
LABORIE AQUARIUS XT/CT/LT/CTS Owner’s Manual AQS-UM01 V13.00
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LABORIE USA 400 Avenue D, Suite 10 Williston, Vermont, USA 05495 Sales/Marketing: 802.857.1300 Customer Service: 800.522.6743 Technical Support: 800.333.1039 Fax: 802.878.1122 [email protected]
Trademarks AQUARIUS is a registered trade mark of Laborie Medical Technologies Canada ULC, registered mark applies to USA and may not apply to other geographies. Roam DX, Urocap, and i-LIST Office Reporter are trademarks of Laborie Medical Technologies Canada ULC. T-DOC is a trademark of T-DOC Company, LLC. Unisensor is a trademark of Unisensor AG. Windows is a registered trademark of Microsoft Corp. Bluetooth is a registered trademark of Bluetooth SIG Inc. VELCRO is a registered trademark of Velcro Industries B.V. Other names may be trademarks of their respective owners.
LABORIE Canada 2101 Boul. Lapinière Brossard, Québec, Canada J4W 1L7 Montreal: 450.671.5901 Customer Service: 888.522.6743 Technical Support: 800.333.1039 Fax: 450.671.7182 [email protected]
Copyright All rights reserved. IMAGES/RENDERINGS OF LABORIE DEVICES IN THIS PUBLICATION ARE PROPERTY OF LABORIE AND MAY NOT BE REPRODUCED WITHOUT THE PRIOR WRITTEN PERMISSION OF LABORIE.
LABORIE Europe/International Colosseum 25 7521 PV Enschede Netherlands Tel: +31.53.4803700 Fax: +31.53.4803701 [email protected]
© Copyright 2011-2017 LABORIE
Document Number: AQS-UM01; Version Number: 13.00; Release Date: March 1, 2018
LABORIE Headquarters 6415 Northwest Dr., Unit 10 Mississauga, Ontario, Canada L4V 1X1 Customer Service: +1.905.612.1170 Fax: +1.905.612.9731 [email protected]
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CONTENTS ABOUT THIS MANUAL ...XIII Symbols ... xiii Abbreviations ... xiii INTRODUCTION AND GUIDELINES FOR USE ...1 Caution and Warnings... 2 Caution ... 2 Warnings ... 2 Intended Use ... 5 AQUARIUS® System ... 5 AnoRectal Manometry (ARM) System ... 5 Spinning Disk Flow Transducer ... 5 Target Users ... 5 Target Population ... 6 Contraindications ... 6 CLEANING AND PREVENTIVE MAINTENANCE ...7 General Cleaning and Preventive Maintenance ... 7 Caring for the Roam™ DX ... 8 Caring for the Urocap V Uroflowmeter... 8 Caring for the Spinning Disk Flow Transducer ... 9 Cleaning... 9 Caring for the UPP Puller ... 11 Cleaning the Mobile Clamp ... 11 Catheter Guide Removal and Replacement... 14 Sterilization ... 15 High-Level Disinfections ... 15 Caring for the Cart and its components ... 16 Caring for the Air-Charged Transducer/Cable ... 16 Battery - Charging and Preventive Maintenance... 17 Charging the Battery ... 17
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Preventive Maintenance ... 19 Computer Virus Protection ... 19 Treating and Disposing of Product After Use... 19 Environmental Consideration of Waste Disposal ... 19 Preventive Maintenance – Checking Calibration ... 20 Check the Flow and Volume of the Urocap™ V Uroflowmeter ... 20 Check the Pump ... 20 Check the EMG ... 21 Check the UPP Puller ... 24 Check Pressure Transducer ... 24 Check the Infusion Transducer... 25 Safely Moving the Cart ... 25 SOFTWARE AND EQUIPMENT ... 27 Standard Equipment and Optional Accessories... 27 Equipment Setup ... 29 Lockable Wheels ... 31 Flowstand ... 31 Reset Button ... 32 Bubble Detector (Optional)... 32 UPP Puller (optional) ... 33 Nose and Motor Body ... 34 Arm and Stand Units ... 35 TRANSDUCER SETUP AND CONNECTION ... 36 Uroflow Transducer ... 36 Pump Setup ... 37 Roam™ DX Setup for Pressure and EMG ... 38 Pressure Transducer Setup for Fluid-based Disposables ... 39 Infusion Volume Transducer (optional) ... 42 CATHETER SETUP ... 43 Fluid-Filled Catheter Setup ... 43 Bladder Catheter Setup ... 43
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Two Catheter Technique ... 43 Abdominal (rectal) Balloon Catheters... 44 T-Doc Air-Charged Catheter Setup... 46 SET UP REMOTE CONTROL (OPTIONAL) ... 49 Part 1: Prepare the Remote Control ... 49 Part 2: Prepare the PC... 50 Part 3: Remote Control Setup ... 54 Part 4: Final PC Setup ... 60 EQUIPMENT STATUS AND LIGHT SIGNALS ... 63 Pump Hub ... 63 ROAM™ DX ... 65 Urocap™ V ... 67 UPP ... 68 USING THE MODULE TOUCHSCREEN ... 70 Using the Touchscreen Functions ... 72 How to Add a Device to the System... 72 How to Remove a Device ... 74 How to Connect Devices ... 75 How to Set Up Pump Controls ... 78 CONNECT THE PC/LAPTOP TO THE SYSTEM ... 80 CALIBRATION ... 90 How to Calibrate Flow and Volume ... 90 Calibrate Flow and Volume with the Urocap Uroflowmeter ... 90 Calibrate Flow and Volume with the Spinning Disk Flow Transducer ... 91 How to Calibrate the Pressure and The EMG ... 92 Calibrate Pressure ... 92 Calibrate EMG ... 93 How to Calibrate the Pump... 95 How to Calibrate the Infusion Transducer ... 98
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How to Calibrate the UPP Puller ... 100 SYSTEM STATUS MESSAGES ... 102 SOFTWARE FEATURES AND FUNCTIONS... 105 Dynamic Control Panels ... 106 Zoom Button on Control Panel ... 108 File Menu ... 110 Open ... 110 Open Scheduled Tests (optional – for i-LIST software users) ... 111 Save As ... 112 Print Study... 114 Batch Print... 118 Print Setup ... 120 About UDS Client... 121 Import ASC ... 123 Import ICS... 123 Exit... 123 Edit Menu ... 123 Undo ... 123 Copy ... 123 Mark Block ... 124 Undo Set Zeroes ... 125 Zoom – Selected Area and Back ... 126 Config Menu... 128 Open ... 128 Save As ... 128 Set up/Modify ... 129 Setting up CH5 and EMG1 Channel... 138 UPP Tab ... 139 Pump Tab ... 141 Filter Tab ... 147 Uroflow Tab... 147 ARM Tab ... 147
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Security Tab... 148 i-LIST Events Linking Tab ... 150 Compliance Tab ... 152 Info Menu... 156 Patient Information... 156 History ... 157 Diagnosis ... 158 X-Y Plot ... 158 Event Summary ... 172 Voiding Summary ... 188 UPP Summary... 199 Bladder Compliance (Optional) ... 210 UPP ... 212 ARM 4&8 (optional) ... 221 View Hor. Menu ... 222 Options Menu ... 223 Test Restart ... 223 Test Playback... 223 Uroflow Auto Start ... 224 Cursor Value Indicator ... 224 Digital Value Indicator ... 225 Display Control Panel ... 226 Control PanelSettingsSettings ... 226 Enable Button Sounds ... 245 Remote Control Designer... 246 File Saving Directory... 258 Export Data ... 258 Event Display Options ... 259 Auto Mark Peaks ... 263 Auto Infusion Event... 263 Graph Clipping... 264 Smart Tracing ... 264 Resize Overflow Screen ... 264 Image Overlay (optional) ... 264
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Change Infusion Bag... 264 Audio ... 265 VBN... 266 i-LIST (optional – for i-LIST software users only)... 267 Pump Menu... 268 Configure Pump ... 269 Prime Pump... 270 Slow Fill ... 270 Medium Fill ... 270 Fast Fill ... 270 Stop Pump ... 270 ServerX Menu (OPTIONAL) ... 271 Reset Connection ... 271 Show ServerX Window ... 271 Choose Bluetooth UDS-94... 271 Connection Type ... 272 Video ... 272 Set Zeroes! Menu ... 272 Transducer Type... 273 VBN ... 276 Normal Curve Overlay ... 276 VBN Full and VBN Animation ... 278 VBN Control Panel ... 278 Initialize Default Values... 278 ANORECTAL MANOMETRY (ARM) ... 288 Intended Use ... 288 Target Population ... 288 Contraindications ... 289 System Startup Sequence ... 290 Using ARM with Air-Charged Catheters ... 291 Using ARM with Fluid-Filled Systems ... 294 Transducer Setup and Connection ... 295
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Using ARM with Electronic Catheters ... 298 Catheter Setup ... 298 Performing Tests with the ARM System ... 299 Performing ARM Tests with a Radial Catheter... 301 Starting the ARM Software ... 301 Resting Profile ... 302 Squeezing Profile... 305 Pushing Profile ... 307 Stationary Rest and Squeeze Study ... 309 Stationary Rest, Squeeze, Push Study ... 316 RAIR (Rectoanal Inhibitory Reflex) ... 324 Rectal Volume using Fluid and a Syringe ... 328 ARM 4 and ARM 8 Test Results ... 331 Anorectal Summary... 331 ARM Resting, Squeezing, or Pushing Profile ... 338 Printing ARM Test Results ... 343 Printing Test Results Through the UDS Software... 343 Printing Test Results Through i-LIST Office Reporter ... 348 Comprehensive ARM Reports ... 349 Customizing the ARM Test ... 349 Create Control Buttons for the Mechanical UPP Puller (optional) ... 354 Glossary of ARM 4&8 Control Panel Commands ... 357 SOFTWARE SETUP FOR PEDIATRIC PATIENTS ... 360 PEDIATRIC PATIENT Information... 360 Volume Warning Limit ... 361 RUN UDS TESTS WITH AQUARIUS ... 362 Uroflow Tests ... 362 Run a Uroflow Test Using a Urocap™ V ... 362 Run a Uroflow Test using a Spinning Disk Flow Transducer ... 364 CMG Test or Micturition (Pressure/Flow)... 365 Run a CMG/Micturition Test with Air-Charged Catheters ... 365 Run a CMG / Micturition Test Using Fluid-Filled Catheters ... 367
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UPP Tests ... 368 Run a UPP Test Using AIR-CHARGED Catheters ... 368 Run a UPP Test Using Water-filled Catheters ... 370 TROUBLESHOOT AND SERVICE ... 372 ALL DEVICES ... 372 EMG... 373 PRESSURES ... 374 PUMP ... 374 UROCAP™ V ... 376 BLUETOOTH CONNECTION ... 377 EVENTS ... 377 SOFTWARE ERROR MESSAGES ... 378 PC ... 379 PRINTER... 380 BUBBLE DETECTOR ... 380 CONTROL PANEL ... 380 TOUCHSCREEN ... 382 END-USER SOFTWARE LICENSE AGREEMENT ... 384 APPENDIX ... 385 Appendix A. System Specifications ... 385 Equipment Specifications... 385 Classifications and Applicable Directives ... 388 Type BF Applied Parts ... 390 Appendix B. Symbols and Labeling ... 391 Product Labels ... 392 Appendix C. Electromagnetic Compatibility (EMC) ... 394 Appendix D. Commonly Used Test Configurations ... 399 Appendix E. Glossary of Terms and acronyms ... 401 Terms Used in Urodynamics Testing ... 401 Calculations ... 405 Common Urodynamics Acronyms... 406
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Appendix F: ARM Values ... 407 Mean Values Range... 407
LIST OF FIGURES
FIGURE 1: DISCONNECTED CATHETER GUIDE ... 11 FIGURE 2: CATHETER GUIDE DISASSEMBLY ... 11 FIGURE 3: MOBILE CLAMP MOVING TOWARD CATHETER GUIDE ... 12 FIGURE 4: MOBILE CLAMP DOWNWARDS ... 12 FIGURE 5: MOBILE CLAMP OFF NOSE TUBE ... 13 FIGURE 6: CATHETER GUIDE REMOVAL - STEP 1 ... 14 FIGURE 7: CATHETER GUIDE REMOVAL - STEP 2 ... 14 FIGURE 8: SAFE MOVEMENT OF CART ... 26 FIGURE 9: UPP CART MOUNT... 33 FIGURE 10: UPP STAND ... 33 FIGURE 11: UPP NOSE UNIT AND MOTOR BODY ... 34 FIGURE 12: UPP ARM AND STAND UNIT ... 35 FIGURE 13: UROCAP V PLACED UNDER COMMODE CHAIR... 37 FIGURE 14: SPINNING DISK FLOW TRANSDUCER ... 37 FIGURE 15: EMG PATCH PLACEMENT. ... 39 FIGURE 16: PRESSURE TRANSDUCER SETUP... 40 FIGURE 17: STOPCOCK POSITIONS ... 41 FIGURE 18: INFUSION TRANSDUCER CONNECTIONS ... 42 FIGURE 19: ABDOMINAL (RECTAL) SINGLE-LUMEN BALLOON CATHETER PRIMING ... 44 FIGURE 20: FRONT OF UROCAP V ... 67 FIGURE 21: BOTTOM OF UROCAP V ... 68 FIGURE 22: PRINT STUDY DIALOG BOX ... 116 FIGURE 23: BATCH PRINT DIALOG BOX ... 119 FIGURE 24: CONFIGURATION WINDOW ... 130 FIGURE 25: VIEW FROM DISTAL (FURTHEST) END. THE POSTERIOR CHANNEL (P1) IS IN LINE WITH THE BLACK LINE ON THE CATHETER. ... 293 FIGURE 26: IV BAG SETUP FOR 4 PRESSURES ... 296
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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
ABBREVIATIONS Common abbreviations used in this manual: • CHC: Central Hub Computer • CFG: software configuration file • HMI: Human Machine Interface
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INTRODUCTION AND GUIDELINES FOR USE
LABORIE’s Next Generation Modular AQUARIUS® system is a fully wireless system providing mobility and ease-of-use. Procedures can be performed with the mountable modules and controlled by the AQUARIUS® software. Connect to all devices from one central control hub (CHC). The wireless and battery-powered features of each device allow for improved system setup and use.
For warranty information and terms and conditions, visit the following website: http://www.laborie.com/terms-and-conditions/
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CAUTION AND WARNINGS
READ CAREFULLY BEFORE USE! CAUTION UNITED STATES FEDERAL LAW RESTRICTS THIS DEVICE TO SALE OR USE BY OR ON THE ORDER OF A LICENSED PHYSICIAN.
WARNINGS ONLY LABORIE TRAINED TECHNICIANS MAY SERVICE THE UNIT LABORIE equipment and accessories are licensed by Governments and approved by Safety Agencies to work with each other ONLY. LABORIE equipment and accessories are warranted to work with each other ONLY. 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. Ensure all wheels are locked during testing procedures to prevent injury to the patient. Do not lean on the equipment nor hang excessive weighted objects other than LABORIE standard accessories on the platform. Exhibit caution when raising the PC & monitor from its lowest position as the mount may rise abruptly due to the strong springs used to counter-balance the weight. Do not immerse the UDS equipment or any components in water or any other liquids. Do not place your fingers inside the pump head when the pump rollers are moving. LABORIE is not responsible for loss of patient files or test data. We recommend that you back up patient data on a regular basis.
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DO NOT USE in the presence of a flammable anesthetic mixture with air or oxygen or nitrous oxide. DO NOT USE electromyography (EMG) simultaneously with high frequency surgical equipment. Use the AQUARIUS® with LABORIE equipment and accessories ONLY. Do not reuse single-use accessories. After use, dispose in accordance with local regulations. Re-use, reprocessing or resterilization 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. Sterilization failure of reusable items prior to initial use or reuse can result in cross infection and/or crosstransmission of infectious disease from one patient to another. To prevent any risk of damage to the cart: •
Do not lean on trays, accessories, monitors, main tower, or spine of any carts.
•
Monitor should be free of any obstacles. Do not hang anything on the monitor.
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Do not suspend extra weight from the monitors.
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Maximum weight on the work trays should not exceed more than 24 lbs. (11 kg).
DO NOT USE the AQUARIUS® in the presence of a magnetic resonance imaging system as AQUARIUS® 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. Always ensure the Transducer cup drain hole on the Spinning Disk Flow Transducer is unobstructed. If obstructed, clear away the obstruction before use. Be aware that prolonged use of video capture may result in elevated temperatures at the rear of the AIO PC To avoid the risk of electric shock, only connect this equipment to supply mains with protective earth.
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Device intended for use in a clinical environment with controlled EMC standards to limit potential interference. Aquarius 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. Only connect devices specified and approved by Laborie to the AQUARIUS® 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. Avoid altering or adding to AQUARIUS® medical electrical system. Any alteration to the AQUARIUS® 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. Batteries are not operator removable. Do not attempt to remove battery. All servicing of AQUARIUS system, components or attachments to be completed by LABORIE. 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.
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INTENDED USE AQUARIUS® SYSTEM The AQUARIUS® LT, AQUARIUS® CT, and AQUARIUS® XT are diagnostic analyzer systems. The product is a data acquisition system for Urodynamics and peripheral diagnostics that records and displays physiological data from the patient. It is to be used as medical diagnostic equipment. Details are described as follows: • Central Hub Computer: has a touch LCD as a new HMI and collects/synchronizes data from all procedure modules and sends data to PC. It also displays the device status and provides interface for calibration and pump setup. • Pump Module: The pump on the Central Hub is used to infuse a patient’s bladder with saline from an IV bag. • Pressure transducers: These are the sensors for pressure measurement. • EMG: Electromyography (EMG) transducer for measuring the raw and enveloped muscle activity. • Urocap/Uroflow: Load cell transducer to detect volume and flow of liquid into a beaker. • UPP Puller: Retracts a catheter at a constant speed from the patient. • Roam™ DX: Wireless Battery Powered EMG Measurement Device. • PC: Computer which controls the system activity, displays, and stores data.
ANORECTAL MANOMETRY (ARM) SYSTEM •
LABORIE’s ARM system is intended to measure physical parameters such as pressures and EMG of the terminal end of the digestive tract as it relates to Urodynamics, Incontinence, and the Pelvic Floor.
SPINNING DISK FLOW TRANSDUCER The Flow Transducer is intended to sense voiding flow. It is used together with UDS devices for assessing voiding disorders.
TARGET USERS • •
Only medical professionals 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. To reduce the risk of cross-contamination or 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 are at the discretion of the physician and the policies of the institution.
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• • •
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. 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)
TARGET POPULATION •
The major application of Urodynamics is the diagnosis of uncontrolled loss of urine (incontinence), abnormal urinary retention, neurological causes of Micturition disorders, or anorectal manometry.
•
The major application of anorectal manometry (ARM) is to aid in the diagnosis of anorectal disorders and incontinence. ARM has shown applicability in men, women, and children in the diagnosis of these conditions.
CONTRAINDICATIONS The AQUARIUS® system 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 • Strictures in the urethra • Prior to testing, a urinalysis and urine culture should be considered to rule out the presence of infection. Single use, disposable catheters Medical Technologies are “sterile”, unless stated otherwise on the packaging label and instructions. Reusable catheters are cleaned but not sterilized before shipping.
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CLEANING AND PREVENTIVE MAINTENANCE DO NOT IMMERSE THE EQUIPMENT OR DEVICES IN WATER OR ANY OTHER LIQUIDS! GENERAL CLEANING AND PREVENTIVE MAINTENANCE • • • •
The AQUARIUS® 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. Rinse and dry the Uroflow beaker after each 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, optional strap, and cartridges are intended for SINGLE PATIENT USE only. Do NOT re-use disposables. The chair, Flowstand, funnel, and EMG headstage/processor can be wiped clean with a cloth dampened with soap or mild detergent and wiped dry immediately. • •
•
• • • •
The insertion points of the EMG headstage/processor must be kept dry; never immerse the EMG into water or any liquids. When cleaning the funnel, the maximum cleaning temperature should not exceed 80°C (176°F).
For the pressure transducers, clean any fluids or other foreign matter from the external surfaces of the transducer and cable using a slightly damp cloth and a mild detergent solution. Do not immerse. Do not use chlorine-based cleaning solutions/agents. Do not autoclave or EtO sterilize the transducer. Performing regular maintenance will reduce the need for costly repairs. As a necessary step in maintaining optimal system performance check the calibration every 6 months or whenever you suspect the transducers are off calibration. Always wear protective gloves when cleaning the equipment to prevent biological contamination. 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 31. For best performance it is recommended to always charge the devices when alerted to do so by the system.
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CARING FOR THE ROAM™ DX • • •
The Roam™ DX is not immersible. Wipe the outside only with soap and water or with a hospital-grade disinfectant. DO NOT SPRAY CLEANING SOLUTION DIRECTLY ON OR IN THE ROAM™ DX. The optional strap is disposable, non-sterile, and recommended for single-use only. The holster can be cleaned with standard hospital wipes. It is recommended to charge and use the Roam™ DX 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.
CARING FOR THE UROCAP V UROFLOWMETER At times, the Urocap™ V will become dirty due to urine contamination and cleaning is required. Always wear protective gloves when cleaning the equipment to prevent biological contamination.
Do not soak or immerse the Urocap™ V in water! Do not immerse or soak in water or in any other liquids!
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