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The Lumax TS Pro™ Fiberoptic Cystometry System User Manual
The Lumax TS Pro™ Fiberoptic Cystometry System User Manual
P/N: 35821, Rev. D
Date: 05/07
Page 1 of 87
The Lumax TS Pro™ Fiberoptic Cystometry System User Manual
1
INTRODUCTION ...6
2
INTENDED USE/INDICATIONS ...7 2.1 2.2 2.3
CONTRAINDICATIONS ...7 WARNINGS ...7 PRECAUTIONS ...7
3
LUMAX TS PRO™ FIBEROPTIC CYSTOMETRY SYSTEM PRODUCT FEATURES...9
4
PRODUCT DESCRIPTION...10 4.1 4.2 4.3
5
THE LUMAX TS PRO FIBEROPTIC CYSTOMETRY SYSTEM ...10 THE LUMAX FIBEROPTIC CATHETER ...10 THE LUMAX EMG MODULE ...10
SETUP / QUICK START GUIDE: ...11 5.1 5.2
6
SETUP WITHOUT THE EMG MODULE ...11 SETUP WITH THE EMG MODULE ...17
QUICK START GUIDE ...27 6.1
7
BEGIN STUDIES...27
SYSTEM OPERATION...29 7.1 7.2
DISPLAY WELCOME SCREEN / WELCOME SOUND ...29 SYSTEM DIALOGS ...29
8
DISPLAY MAIN SCREEN ...32
9
NEW VISIT...33 9.1 9.2 9.3 9.4
PATIENT SETUP ...33 CALIBRATE CATHETERS ...36 STUDY OVERVIEW ...39 STUDY / PROTOCOL SELECTION ...41
10
REVIEW PATIENT VISIT ...56
11
SYSTEM OPTIONS...60
12
PROTOCOL SETUP...61
12.1 13 13.1 13.2 13.3 13.4
SELECT DEFAULT / DEFINE PROTOCOL...61 SYSTEM SETUP ...70 DATE (DAY, MONTH, YEAR) ...70 TIME (HOUR, MINUTE) ...71 SPEAKER...71 HELP...71
14
LANGUAGE SETUP ...72
15
FIELD DIAGNOSTICS ...73
16
SERVICE MODE ...74
17
FOOTSWITCH SETUP...75
18
CLEANING...76
19
SERVICE AND MAINTENANCE ...77
20
TROUBLE SHOOTING GUIDE ...78
P/N: 35821, Rev. D
Date: 05/07
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The Lumax TS Pro™ Fiberoptic Cystometry System User Manual 21
LUMAX TS PRO SPECIFICATIONS ...80
22
LUMAX TS PRO SYMBOLS ...82
23
LUMAX TS PRO EMC COMPLIANCE INFORMATION ...83
24
RECOMMENDED SEPARATION DISTANCE...86
P/N: 35821, Rev. D
Date: 05/07
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The Lumax TS Pro™ Fiberoptic Cystometry System User Manual
CERTIFICATIONS LUMAX TS PRO (MEDICAL EQUIPMENT) WITH RESPECT TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL60601-1, IEC60601-1, CAN/CSA C22.2 No. 601.1 6D33 This marking signifies that the Lumax Fiberoptic Cystometry System model TS Pro has been certified by Underwriters Laboratories (UL) as meeting the current UL, CSA and IEC standards: • • • •
UL Standard 60601-1 IEC Standard 60601-1 CAN/CSA C22.2 No. 601.1 IEC 60601-1-2 for Electromagnetic Compliance
Note: This product has been tested and certified to the requirements of IEC 60601-1-2 for Electromagnetic Compliance. Reasonable protection should be maintained against harmful interference to other devices by this product and interference to this product from other devices. This Product is classified as: Class I Equipment, Type B Applied Part, as defined by UL standard 60601-1.
0086
This CE mark indicates that the Quality System and Technical File have been reviewed and certified by our notified body, British Standards Institute (BSI). Authorized European Representative: Leisegang Fienmechanik GmbH Leibnizstrasse 32 D-10625 Berlin, Germany
P/N: 35821, Rev. D
Date: 05/07
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The Lumax TS Pro™ Fiberoptic Cystometry System User Manual
NOTICE TO USERS OF THE LUMAX TS PRO FIBEROPTIC CYSTOMETRY SYSTEM PRODUCT DESCRIPTIONS NOT INTENDED FOR DIAGNOSTIC PURPOSES. The descriptions and narratives in this User Manual and other written materials provided to Licensee with this Lumax TS Pro Fiberoptic Cystometry System ‘Product’ are intended to provide a foundation for use of the Product along with host computer and software. Actual printout images and any depictions of these images in the User Manual and accompanying written materials are not intended for diagnostic purposes. CHANGES IN SPECIFICATIONS FOR PRODUCT. All specifications for the Product are subject to change without notice. COOPERSURGICAL INC., TRUMBULL, CT 06611 USA. Contents of this User Manual and other written materials provided to Licensee with the Product may not be reproduced by any means whatsoever without prior written permission from CooperSurgical, Inc. All products mentioned in this User Manual and related written materials are trademarked or copyrighted by their manufacturers. All CooperSurgical, Inc., Products are covered by U.S. and other patents and/or patents pending. All product names are trademarks of CooperSurgical, Inc. All trademarks and the rights of the trademarks owned by the companies referred to in this User Manual and other written materials provided to Licensee with the Product are acknowledged. WARRANTY FOR PRODUCT The Product manufactured by CooperSurgical, Inc., is warranted against defects in material and workmanship for twelve (12) months from date of installation. During the warranty period, CooperSurgical, Inc., will repair or replace (at its option) a Product proven to be defective. Warranty repairs may be performed on site, at the factory, or at a CooperSurgical, Inc.,-approved service center without charge, provided the Product was not subjected to misuse, theft, neglect, fire, Acts of God, lightning strikes, or deterioration caused by chemicals that are not used for normal unit operation. Any modifications of the Product in any manner, including but not limited to relocation or installation of the Product without prior CooperSurgical, Inc., Customer Service authorization, shall void all associated warranties or service contracts. Prior to prepaid return of products for repair, the Product must have a Return Authorization Number (obtainable from CooperSurgical, Inc., Customer Service) attached to it. BEYOND THE WARRANTIES STATED ABOVE, THERE ARE NO OTHER WARRANTIES OF ANY KIND, EXPRESS, IMPLIED OR STATUTORY (INCLUDING, WITHOUT LIMITATION, TIMELINESS, TRUTHFULNESS, SEQUENCE, COMPLETENESS, ACCURACY, FREEDOM FROM INTERRUPTION), ANY IMPLIED WARRANTIES ARISING FROM TRADE USAGE, COURSE OF DEALING, OR COURSE OF PERFORMANCE, OR THE IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE. LICENSEE’S EXCLUSIVE REMEDY FOR BREACH OF WARRANTY OR BREACH OF CONTRACT, NEGLIGENCE OR PRODUCTS LIABILITY SHALL BE THE REPAIR OR REPLACEMENT OF DEFECTIVE OR DAMAGED GOODS.
P/N: 35821, Rev. D
Date: 05/07
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The Lumax TS Pro™ Fiberoptic Cystometry System User Manual
1 Introduction The Lumax TS Pro™ Fiberoptic Cystometry System (Lumax TS Pro) utilizes a state-of-the-art fiberoptic pressure transducer technology to measure pressures in the bladder, abdomen and urethra for the diagnosis of urinary incontinence, voiding dysfunction and other bladder disorders. The Lumax TS Pro™ Fiberoptic Cystometry System is comprised of a monitor with a touch-screen interface, volume infused transducer, uroflow transducer, hand-held remote marker, footswitch remote marker, mounting hardware and the appropriate catheters and infusion tubing for urodynamic studies. The system is mounted on an IV pole using custom mounting configurations, which include a mounting tray or hardware to attach directly to the IV pole. The Lumax TS Pro™ Fiberoptic Cystometry System can also be configured with electromyography for additional information regarding motor unit action potential (MUAP) evaluation of the pelvic floor musclulature. This manual provides an overview of the operation and instructions for use for the Lumax TS Pro™ Fiberoptic Cystometry System.
P/N: 35821, Rev. D
Date: 05/07
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The Lumax TS Pro™ Fiberoptic Cystometry System User Manual
2 Intended Use/Indications •
The Lumax TS Pro Fiberoptic Cystometry System is used for the diagnosis of urinary incontinence, voiding dysfunction and other bladder disorders.
•
The Lumax Fiberoptic Catheters are intended to measure physiologic pressures during urodynamic studies, and to infuse fluid into the bladder and drain fluid from the bladder.
•
The Lumax EMG electrodes are intended to measure motor unit action potential (MUAP) activity of the pelvic floor muscles
2.1 Contraindications Do Not Use this product if the patient exhibits infection or any other heightened sensitivity
2.2 Warnings DANGER: Equipment not suitable for use in the presence of flammable anesthetics.
2.3 Precautions Precaution: To ensure ground reliability, attach cord to receptacle marked “Hospital Grade” or equivalent only. Precaution: Electrical shock hazard. Do not remove covers. Refer Servicing to a qualified Service Person. Precaution: Federal Law (USA) restricts this device to sale by or on the order of a physician. Precaution: Operate the Lumax TS Pro Fiberoptic Cystometry System only at 100-240 VAC at 50/60 Hz. Precaution: Do not get fluid into the monitor. Should any liquid or solid object fall into the monitor case, unplug the unit and call CooperSurgical Technical Support at 1-800-444-8546. Precaution: Never lean or place weighted objects on top of unit. Precaution: Do not immerse uroflow transducer in water or cleaning fluids. Uroflow transducer is cleanable (water resistant) and may be rinsed under a faucet. Do not immerse unit under water as this can damage components. Precaution: Do not immerse volume transducer in water or cleaning fluids. Volume transducer may be cleaned by wiping with a slightly damp cloth using mild household detergent. Precaution: Do not use strong solvent such as acetone, thinner, or benzene as they might damage the finish of the monitor. Clean the monitor with a slightly damp cloth. Use a mild household detergent.
P/N: 35821, Rev. D
Date: 05/07
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The Lumax TS Pro™ Fiberoptic Cystometry System User Manual Precaution: Retain the original carton and packing materials for safe transport of this unit in the future. Precaution: Do not install unit in a hot or humid place subject to excessive dust or mechanical vibration. Operate only at +10 to +40 o C (+50 to +100 o F); 30 to 75 % relative humidity (noncondensing). Precaution: Used catheters and EMG electrodes should be considered a biological hazard and should be disposed of according to policy. Precaution: If using an IV pole, the Monitor must be mounted as described in section 1.6 to an IV pole with a base minimum base diameter of 26 inches [66 cm]. Do not attach monitor higher than 5 feet from the floor to ensure proper balancing of the module on the IV Pole. To assure stability during transport, do not tilt the IV Pole with the monitor attached. Precaution: Avoid severe bending or stretching of the fiberoptic catheters. Such use may cause permanent damage to optical components or compromised performance. Precaution: Avoid bumping or moving the connector once the catheter is attached to the receptacle. This action may interfere with accuracy of pressure readings. Precaution: Use only with CooperSurgical EMG Cable P/N 53364 supplied with system unit. Do not use other manufacturers EMG cables as system will not function correctly.
P/N: 35821, Rev. D
Date: 05/07
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The Lumax TS Pro™ Fiberoptic Cystometry System User Manual
3 Lumax TS Pro™ Fiberoptic Cystometry System Product Features • • • • • • • • • •
Records multi-channel cystometrogram (CMG), providing bladder, abdominal and detrusor pressures with uroflow and volumetric data Utilizes fiberoptic pressure catheters for bladder and abdominal pressures Utilizes a touch-screen interface for all operations Has redundant reporting options including thermal paper tracings and the optional The Lumax TS Pro™ Software program with laptop for color reports Advanced help features for added convenience and training Intuitive protocols can be customized for individual users or patients Remote marking system that includes a hand remote and a footswitch marker Advanced diagnostics for system problems Improved accuracy and reliability for the uroflow and volume transducers Electromyography (EMG) can be added for additional capabilities
P/N: 35821, Rev. D
Date: 05/07
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The Lumax TS Pro™ Fiberoptic Cystometry System User Manual
4 Product Description 4.1 The Lumax TS Pro Fiberoptic Cystometry System The Lumax TS Pro™ Fiberoptic Cystometry System is comprised of a monitor with a touch-screen interface, volume infused transducer, uroflow transducer, hand-held remote marker, footswitch remote marker, mounting hardware and the appropriate catheters and infusion tubing for urodynamic studies. The system can be mounted on an IV pole using custom mounting configurations. Studies and their acronyms: Uroflow (Flow) Post Void Residual (PVR) Cystometrogram (CMG or 3-Channel CMG) Valsalva Leak Point Pressure (VLPP) Urethral Pressure Profile (UPP) Maximum Urethral Closure Pressure (MUCP) Pressure Flow (3-Channel CMG with Flow) Electromyography (EMG)
4.2 The Lumax Fiberoptic Catheter The Lumax Fiberoptic Catheter is a flexible tubular device of medical grade polyvinylchloride (PVC) with a fiberoptic pressure sensor housed within the tip. Black markings graduated at 1cm intervals along the distal catheter provide metrics for insertion. Light transmitted down the fiberoptic pathway from the monitor is reflected by a mirror, returned through the fiberoptic pathway to the monitor, where the signal is measured and converted to voltage. The voltage is correlated to a known pressure value. There are three models of Lumax Fiberoptic Catheters: • 10307-010 10 Fr. Bladder Catheter • 10307-005 7 Fr. Bladder Catheter • 10307-009 10 Fr. Abdominal Catheter Note: All Lumax Fiberoptic Catheters are Latex-free. Note: Lumax Fiberoptic Catheters can only be used with the Lumax TS Pro™ Fiberoptic Cystometry System and likewise, competitor catheters cannot be used with the Lumax TS Pro™ Fiberoptic Cystometry System.
4.3 The Lumax EMG Module The Lumax EMG module is an additional hardware and software upgrade to the standard Lumax TS Pro Fiberoptic Cystometry System. It allows for additional EMG channels to include EMG, CMG with EMG and Pressure Flow with EMG. The EMG module can be installed in a customer’s office or prepurchased within the fully configured Lumax TS Pro Elite System. • •
53364 53397
P/N: 35821, Rev. D
EMG Patient Cable EMG Electrodes
Date: 05/07
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The Lumax TS Pro™ Fiberoptic Cystometry System User Manual
5 Setup / Quick Start Guide: The Quick Start Guide is useful for the user who wants to jump into operating the system immediately. The Quick Start Guide will not cover every feature of the product, so care must be taken to review the entire User Manual for additional product information and features. The Quick Start Guide is divided into two sections: Setup and Installation and Quick Start. If you have purchased the EMG Module for your Lumax TS Pro, please refer to section 5.2 for setup instructions.
5.1 Setup without the EMG Module NOTE: The product shown includes the laptop computer. 1. Unpack and setup the IV Pole configuration to include the laptop tray, the monitor tray and the basket. 2. Identify the three thumb screws and two catheter bag hooks. 3. Carefully set the monitor onto the monitor tray and align the two front screws with catheter hooks to the holes at the bottom of the monitor and the third thumb screw (without a catheter hook) into one of the back holes.
4. Tighten thumb screws securely.
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The Lumax TS Pro™ Fiberoptic Cystometry System User Manual
5. Unpack the volume transducer, power cord and 12 V DC power brick, uroflow transducer, handheld remote marker and footpedal and connect the cables to the color-coded and labeled rear monitor panel. Note: Only use the 12 V DC Power Brick [Ault Model No. MW116KA1251F04] supplied with the system.
Volume Infused Transducer Blue Plug to Blue Socket
Uroflow Transducer Yellow Plug to Yellow Socket
USB Connection Foot Switch
Hand Switch 12 V DC Power Supply See Note above
6. Unpack laptop computer and set it onto the laptop tray (there is no mounting mechanism for the laptop computer). 7. Install the USB cable from the laptop to the USB receptacle at the back of the monitor.
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8. Hang the hand-held remote marker to one of the hooks at either side of the monitor. 9. Place uroflow transducer on the floor 10. Hang the volume transducer from the IV Pole crossbar.
11. Secure volume transducer wire to IV Pole (to avoid movement artifact) with Velcro strap.
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Date: 05/07
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The Lumax TS Pro™ Fiberoptic Cystometry System User Manual
12. Unpack thermal paper roll and open printer door at the front of the monitor and then lift the green lever.
13. Place paper roll into groove and carefully thread the paper under the black roller until leading edge of paper appears at the top of the green lever.
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Date: 05/07
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The Lumax TS Pro™ Fiberoptic Cystometry System User Manual
14. Lower the green lever and close the printer door.
15. Remove S-cables from their pouches and secure to S-cable receptacle by aligning the tabs laterally with the single flange on top. Tighten clockwise until snug.
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Date: 05/07
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The Lumax TS Pro™ Fiberoptic Cystometry System User Manual
16. Secure proximal end of S-cable to the S-cable receptacle and tighten.
17. Turn the system on with the power switch at the rear of the monitor.
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Date: 05/07
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The Lumax TS Pro™ Fiberoptic Cystometry System User Manual
5.2 Setup with the EMG Module NOTE: The product shown includes the laptop computer. 1. Unpack and setup the IV Pole configuration to include the laptop tray, the monitor tray and the basket. 2. Unpack Lumax and the EMG Module. 3. Using a Philips screwdriver, remove the (4) rubber feet from the bottom of the Lumax Monitor.
4. Using the (4) screws bundled with the EMG Module, attached the EMG module to the bottom of the Lumax monitor (Rubber feet not shown for illustrative purposes).
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5. Identify the three thumb screws and two catheter bag hooks. 6. Carefully set the monitor onto the monitor tray and align the two front screws with catheter hooks to the holes at the bottom of the monitor and the third thumb screw (without a catheter hook) into one of the back holes.
7. Tighten thumb screws securely.
8. Unpack the volume transducer, power cord and 12 V DC power brick, uroflow transducer, handheld remote marker and foot pedal. 9. Connect the Yellow plug from the EMG Module to the rear of the Lumax monitor in the Yellow Volume Voided socket.
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10. Connect the Yellow plug from the Uroflow Transducer to the Yellow “From Uroflow Transducer (B)” socket on the rear of the EMG Module.
11. Connect the Blue plug from the Volume Infused Transducer to the Blue “Volume Infused” socket on the rear of Lumax.
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12. Connect the Remote Footswitch Plug into the Left Socket on the rear of the Lumax.
13. Connect the Remote Hand switch Plug into the Right Socket on the rear of the Lumax.
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