AQUARIUS XT-CT-LT-CTS Owners Manual V12.00 Jan 2018

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. SOMNOtouch is a trademark of SOMNOmedics GmbH. 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: 12.00; Release Date: November 28, 2017; Issued By: R.A.

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 ... 4 AQUARIUS® System ... 4 AnoRectal Manometry (ARM) System ... 4 Spinning Disk Flow Transducer ... 4 Target Users ... 4 Target Population ... 5 Contraindications ... 5 CLEANING AND PREVENTIVE MAINTENANCE ...6 General Cleaning and Preventive Maintenance ... 6 Caring for the Roam™ DX ... 7 Caring for the Urocap V Uroflowmeter... 7 Caring for the Spinning Disk Flow Transducer ... 8 Cleaning... 8 Caring for the UPP Puller ... 10 Cleaning the Mobile Clamp ... 10 Catheter Guide Removal and Replacement... 13 Sterilization ... 14 High-Level Disinfections ... 15 Caring for the Cart and its components ... 15 Caring for the Air-Charged Transducer/Cable ... 16 Battery - Charging and Preventive Maintenance... 16 Charging the Battery ... 16

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Preventive Maintenance ... 18 Computer Virus Protection ... 18 Treating and Disposing of Product After Use... 19 Environmental Consideration of Waste Disposal ... 19 Preventive Maintenance – Checking Calibration ... 19 Check the Flow and Volume of the Urocap™ V Uroflowmeter ... 19 Check the Pump ... 20 Check the EMG ... 20 Check the UPP Puller ... 23 Check Pressure Transducer ... 23 Check the Infusion Transducer... 24 Safely Moving the Cart ... 24 SOFTWARE AND EQUIPMENT ... 26 Standard Equipment and Optional Accessories... 26 Equipment Setup ... 28 Lockable Wheels ... 30 Flowstand ... 30 Reset Button ... 31 Bubble Detector (Optional)... 31 UPP Puller (optional) ... 32 Nose and Motor Body ... 32 Arm and Stand Units ... 33 TRANSDUCER SETUP AND CONNECTION ... 35 Uroflow Transducer ... 35 Pump Setup ... 36 Roam™ DX Setup for Pressure and EMG ... 37 Pressure Transducer Setup for Fluid-based Disposables ... 38 Infusion Volume Transducer (optional) ... 41 CATHETER SETUP ... 42 Fluid-Filled Catheter Setup ... 42 Bladder Catheter Setup ... 42

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Two Catheter Technique ... 42 Abdominal (rectal) Balloon Catheters... 43 T-Doc Air-Charged Catheter Setup... 45 SET UP REMOTE CONTROL (OPTIONAL) ... 48 Part 1: Prepare the Remote Control ... 48 Part 2: Prepare the PC... 49 Part 3: Remote Control Setup ... 53 Part 4: Final PC Setup ... 59 SOMNOTOUCH™ NIBP BLOOD PRESSURE DEVICE SETUP ... 62 EQUIPMENT STATUS AND LIGHT SIGNALS ... 74 Pump Hub ... 74 ROAM™ DX ... 76 Urocap™ V ... 78 UPP ... 79 USING THE MODULE TOUCHSCREEN ... 81 Using the Touchscreen Functions ... 83 How to Add a Device to the System... 83 How to Remove a Device ... 85 How to Connect Devices ... 86 How to Set Up Pump Controls ... 89 CONNECT THE PC/LAPTOP TO THE SYSTEM ... 91 CALIBRATION ... 101 How to Calibrate Flow and Volume ... 101 Calibrate Flow and Volume with the Urocap Uroflowmeter ... 101 Calibrate Flow and Volume with the Spinning Disk Flow Transducer ... 102 How to Calibrate the Pressure and The EMG ... 103 Calibrate Pressure ... 103 Calibrate EMG ... 105

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How to Calibrate the Pump... 106 How to Calibrate the Infusion Transducer ... 110 How to Calibrate the UPP Puller ... 112 SYSTEM STATUS MESSAGES ... 114 SOFTWARE FEATURES AND FUNCTIONS... 117 Dynamic Control Panels ... 118 Zoom Button on Control Panel ... 121 File Menu ... 123 Open ... 123 Open Scheduled Tests (optional – for i-LIST software users) ... 124 Save As ... 125 Print Study... 127 Batch Print... 131 Print Setup ... 133 About UDS Client... 134 Import ASC ... 136 Import ICS... 136 Exit... 136 Edit Menu ... 136 Undo ... 136 Copy ... 136 Mark Block ... 137 Undo Set Zeroes ... 138 Zoom – Selected Area and Back ... 139 Config Menu... 141 Open ... 141 Save As ... 141 Set up/Modify ... 142 Setting up CH5 and EMG1 Channel... 151 UPP Tab ... 152 Pump Tab ... 154 Filter Tab ... 160

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Uroflow Tab... 160 ARM Tab ... 160 Security Tab... 161 i-LIST Events Linking Tab ... 163 Compliance Tab ... 165 Info Menu... 169 Patient Information... 169 History ... 170 Diagnosis ... 171 X-Y Plot ... 171 Event Summary ... 185 Voiding Summary ... 201 UPP Summary... 212 Bladder Compliance (Optional) ... 223 UPP ... 225 ARM 4&8 (optional) ... 234 View Hor. Menu ... 235 Options Menu ... 236 Test Restart ... 236 Test Playback... 236 Uroflow Auto Start ... 237 Cursor Value Indicator ... 237 Digital Value Indicator ... 238 Display Control Panel ... 239 Control PanelSettingsSettings ... 239 Enable Button Sounds ... 258 Remote Control Designer... 259 File Saving Directory... 271 Export Data ... 271 Event Display Options ... 272 Auto Mark Peaks ... 276 Auto Infusion Event... 276 Graph Clipping... 277 Smart Tracing ... 277

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Resize Overflow Screen ... 277 Image Overlay (optional) ... 277 Change Infusion Bag... 277 Audio ... 278 VBN... 279 i-LIST (optional – for i-LIST software users only)... 280 Pump Menu... 281 Configure Pump ... 282 Prime Pump... 283 Slow Fill ... 283 Medium Fill ... 283 Fast Fill ... 283 Stop Pump ... 283 ServerX Menu (OPTIONAL) ... 284 Reset Connection ... 284 Show ServerX Window ... 284 Choose Bluetooth UDS-94... 284 Connection Type ... 285 Video ... 285 Set Zeroes! Menu ... 285 Transducer Type... 286 VBN ... 289 Normal Curve Overlay ... 289 VBN Full and VBN Animation ... 291 VBN Control Panel ... 291 Initialize Default Values... 291 ANORECTAL MANOMETRY (ARM) ... 301 Intended Use ... 301 Target Population ... 301 Contraindications ... 302 System Startup Sequence ... 303 Using ARM with Air-Charged Catheters ... 304

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Using ARM with Fluid-Filled Systems ... 307 Transducer Setup and Connection ... 308 Using ARM with Electronic Catheters ... 311 Catheter Setup ... 311 Performing Tests with the ARM System ... 312 Performing ARM Tests with a Radial Catheter... 314 Starting the ARM Software ... 314 Resting Profile ... 315 Squeezing Profile... 318 Pushing Profile ... 320 Stationary Rest and Squeeze Study ... 322 Stationary Rest, Squeeze, Push Study ... 329 RAIR (Rectoanal Inhibitory Reflex) ... 337 Rectal Volume using Fluid and a Syringe ... 341 ARM 4 and ARM 8 Test Results ... 344 Anorectal Summary... 344 ARM Resting, Squeezing, or Pushing Profile ... 351 Printing ARM Test Results ... 356 Printing Test Results Through the UDS Software... 356 Printing Test Results Through i-LIST Office Reporter ... 361 Comprehensive ARM Reports ... 362 Customizing the ARM Test ... 362 Create Control Buttons for the Mechanical UPP Puller (optional) ... 367 Glossary of ARM 4&8 Control Panel Commands ... 370 SOFTWARE SETUP FOR PEDIATRIC PATIENTS ... 373 PEDIATRIC PATIENT Information... 373 Volume Warning Limit ... 374 RUN UDS TESTS WITH AQUARIUS ... 375 Uroflow Tests ... 375 Run a Uroflow Test Using a Urocap™ V ... 375 Run a Uroflow Test using a Spinning Disk Flow Transducer ... 377 CMG Test or Micturition (Pressure/Flow)... 378

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Run a CMG/Micturition Test with Air-Charged Catheters ... 378 Run a CMG / Micturition Test Using Fluid-Filled Catheters ... 380 UPP Tests ... 381 Run a UPP Test Using AIR-CHARGED Catheters ... 381 Run a UPP Test Using Water-filled Catheters ... 383 TROUBLESHOOT AND SERVICE ... 385 ALL DEVICES ... 385 EMG... 386 PRESSURES ... 387 PUMP ... 387 UROCAP™ V ... 389 BLUETOOTH CONNECTION ... 390 EVENTS ... 390 SOFTWARE ERROR MESSAGES ... 391 PC ... 392 PRINTER... 393 BUBBLE DETECTOR ... 393 CONTROL PANEL ... 393 TOUCHSCREEN ... 395 SOMNOtouch ... 396 END-USER SOFTWARE LICENSE AGREEMENT ... 399 APPENDIX ... 400 Appendix A. System Specifications ... 400 Equipment Specifications... 400 Classifications and Applicable Directives ... 403 Type BF Applied Parts ... 405 Appendix B. Symbols and Labeling ... 406 Product Labels ... 407 Appendix C. Electromagnetic Compatibility (EMC) ... 409 Appendix D. Commonly Used Test Configurations ... 414 Appendix E. Glossary of Terms and acronyms ... 416

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Terms Used in Urodynamics Testing ... 416 Calculations ... 420 Common Urodynamics Acronyms... 421 Appendix F: ARM Values ... 422 Mean Values Range... 422

LIST OF FIGURES

FIGURE 1: DISCONNECTED CATHETER GUIDE ... 10 FIGURE 2: CATHETER GUIDE DISASSEMBLY ... 10 FIGURE 3: MOBILE CLAMP MOVING TOWARD CATHETER GUIDE ... 11 FIGURE 4: MOBILE CLAMP DOWNWARDS ... 11 FIGURE 5: MOBILE CLAMP OFF NOSE TUBE ... 12 FIGURE 6: CATHETER GUIDE REMOVAL - STEP 1 ... 13 FIGURE 7: CATHETER GUIDE REMOVAL - STEP 2 ... 14 FIGURE 8: SAFE MOVEMENT OF CART ... 25 FIGURE 9: UPP CART MOUNT... 32 FIGURE 10: UPP STAND ... 32 FIGURE 11: UPP NOSE UNIT AND MOTOR BODY ... 33 FIGURE 12: UPP ARM AND STAND UNIT ... 34 FIGURE 13: UROCAP V PLACED UNDER COMMODE CHAIR... 36 FIGURE 14: SPINNING DISK FLOW TRANSDUCER ... 36 FIGURE 15: EMG PATCH PLACEMENT. ... 38 FIGURE 16: PRESSURE TRANSDUCER SETUP... 39 FIGURE 17: STOPCOCK POSITIONS ... 40 FIGURE 18: INFUSION TRANSDUCER CONNECTIONS ... 41 FIGURE 19: ABDOMINAL (RECTAL) SINGLE-LUMEN BALLOON CATHETER PRIMING ... 43 FIGURE 20: FRONT OF UROCAP V ... 78 FIGURE 21: BOTTOM OF UROCAP V ... 79 FIGURE 22: PRINT STUDY DIALOG BOX ... 129 FIGURE 23: BATCH PRINT DIALOG BOX ... 132

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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.

•

Do not suspend extra weight from the monitors.

•

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

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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 30. 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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•

The lid of the Urocap V is not removable and attention must be paid to prevent damage to the lid.

•

The Urocap™ V 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™ V is functioning, see page 19.

CARING FOR THE SPINNING DISK FLOW TRANSDUCER On a weekly basis, test the device for proper functioning and inspect all cables and the sensor for cuts and other damages. If in doubt, send the device for service. The device should be cleaned as described below. No additional maintenance is required.

CLEANING The Flow Transducer should be thoroughly cleaned minimum once a week, preferably daily, to avoid deposits and odor. Clean the device as follows: Quick Cleaning (Daily) •

Slowly pour approximately 1L of clean water into the funnel.

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