Dorado KT Service Manual Ver 9.0 Dec 2010

Dorado KT is a trademark of LABORIE (also known as Laborie Medical Technologies). Unisensor is a trademark of UNISENSOR AG. 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 2010 by LABORIE. All rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior written permission of LABORIE.

MAN575

Table of Contents 1

INTRODUCTION... 1

2

SYSTEM OVERVIEW ... 2

3

TECHNICAL DESCRIPTION ... 3 3.1 3.2 3.3 3.4 3.5 3.6 3.7

4

TRANSDUCER SETUP AND CONNECTION ... 11 4.1 4.2 4.2.1

4.3 4.4 4.5

5

5.6.1 5.6.2 5.6.3

5.7

6.5.1 6.5.2 6.5.3

6.6

Calibrate Volume ... 18 Calibrate Flow ... 19 Calibrate the EMG Unit (optional) ... 20 Calibrate the UPP Puller (optional) ... 20 Calibrate the Pump... 21 Calibrate Pressure Transducers (P1, P2, P3, etc…)... 22 For water-based disposable catheter systems... 22 For air-charged catheter systems ... 23 For Electronic Catheter Systems ... 25

Calibrate the Infusion Transducer (P8) ... 26

Equipment and Accessories ... 27 Preventive Maintenance ... 27 Virus Protection ... 28 Air-charged (T-DOC) Transducer/Cable Cleaning Instructions ... 28 Electronic (Unisensor™) Solid-State Catheters ... 29 Catheter Cleaning ... 29 Disinfection ... 29 Sterilization ... 29

Treating and Disposing of Product After Use ... 30

TROUBLESHOOTING ... 31 7.1 7.2 7.2.1

8

Fluid-Filled Pressure Transducer Connections ... 13

Electronic Catheter ... 14 Infusion Volume Transducer ... 14 EMG Setup ... 17

CLEANING AND PREVENTIVE MAINTENANCE... 27 6.1 6.2 6.3 6.4 6.5

7

Uroflow Transducer ... 11 Fluid-Filled Pressure Transducer Setup ... 12

TRANSDUCER CALIBRATION ... 18 5.1 5.2 5.3 5.4 5.5 5.6

6

System Specifications ... 3 Classifications ... 3 Operating Ranges and Accuracy ... 3 Applicable Directives and Standards... 4 Replacement Accessories ... 4 Peripheral Specifications ... 5 Optional Software Features... 9

Symptoms/Causes/Corrective Actions ... 31 EMG Verification ... 34 Corrective Actions ... 34

ELECTROMAGNETIC COMPATIBILITY (EMC) ... 36

8.1 8.2

9

Emissions ... 36 Immunity ... 36

SYMBOLS ... 38

10 SCHEMATICS - PROPRIETARY INFORMATION ... 39 11 END-USER SOFTWARE LICENSE AGREEMENT... 40

LABORIE

Dorado KT™ Service Manual

1 INTRODUCTION This manual is intended for servicing the Dorado KT™ UDS system manufactured by LABORIE. The UDS94 on the Dorado KT is a data acquisition unit. It collects data from the following devices: • • • • • •

Uroflow Transducer Water Pressure Transducers UPP Puller Electronic Pressure Transducers Infusion Transducer EMG Unit

The information located in this manual is intended for the biomedical departments of hospitals or clinics.

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LABORIE

Dorado KT™ Service Manual

2 SYSTEM OVERVIEW

External Devices and Transducers

Printer

Dorado KT02

Keyboard VGA Monitor

CPU (Motherboard) Mouse

Hard Drive CD-ROM

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Floppy Drive A

LABORIE

Dorado KT™ Service Manual

3 TECHNICAL DESCRIPTION UPON REQUEST, LABORIE will make available to the customer, any circuit diagrams, component part lists, and other technical documentation directly related to the Dorado KT.

3.1 System Specifications Model Dimensions Weight Operating Conditions

Transport and Storage Conditions

Dorado KT™ 22” x 25”(Footprint) X 53”(Cart Height) 56cm x 64cm (Footprint) X 135 cm (Cart Height) 18.2 kg (40 lb) including power supply Temperature: 15ºC to 35ºC (59ºF to 95ºF) Humidity: 30% to 75% relative humidity (non-condensing) Pressure: 700hPa to 1014hPa Temperature: -10ºC to 50ºC (14ºF to 122ºF) Humidity: 20% to 80% relative humidity (non-condensing) Pressure: 700hPa to 1014hPa

3.2 Classifications Class I Equipment Type BF Applied Parts IEC 60601-1 IPX0 Equipment Degree of Protection Against Ingress of Water Continuous Mode of Operation Equipment not suitable for use in the presence of a Flammable Anaesthetic Mixture with Air or Oxygen or Nitrous Oxide.

3.3 Operating Ranges and Accuracy Uroflow Rate Uroflow Volume Pressure EMG† Pump UPP Puller Infusion T-Doc Data Conversion Rate

0 to 50 ml/s 0 to 1100 ml -40 to 350 cm H2O -225 to 225 µV Frequency: 2 to 800 Hz 5 to 140 ml/min * 0.5 to 3 mm/s 0 to 1000 ml -68 to 408 cmH2O Min 10 Hz (min) up to 1000 Hz (optional up to 5000 Hz)

* Maximum pump rate is limited by size of catheter used † Sensitivity Range: +/- 1000 µV; High Pass: 800 Hz; Low Pass: 20 Hz

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LABORIE

3.4

Dorado KT™ Service Manual

Applicable Directives and Standards Directive: • MDD Directive 93/42/EEC Standards: • IEC 60601-1 • IEC 60601-1-1 • IEC 60601-1-2 • IEC 60601-1-4 • EN 60601-1 • CSA 22.2 No.601.1-M90 • UL 60601-1

3.5

Replacement Accessories

Accessory Laborie family of conventional single-use Urodynamic catheters (6fr – 14fr) Laborie family of electronic catheters Laborie family of single use air-charged catheters Pump Tubing set with Infusion Line Urodynamics Measurement Tubing Set Pressure Transducer with Luer Lock Beaker USB Printer Cable for Desktop Printer Accessory Dual Lumen 6 Fr. Catheter or 8 Fr. Catheter Urodynamics Measurement Tubing Set Pump Tubing set with Infusion Line

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Number Model varies Model varies Model varies TUB500 TUB101 DIS130 DIS173 CAB914 Number CAT206 or CAT208 TUB101 TUB500

LABORIE

Dorado KT™ Service Manual

3.6 Peripheral Specifications Dorado KT Urodynamic Processor

Dorado KT I/O

Power Supply

Part Number: PRO493 Individual Parts: Trolley CAR 463 LIT enclosure LIT375 UDS Module mount BRA546 CPU mount BRA546 Printer shelf (small work surface) CAR571 Keyboard shelf (large work surface) CAR570 Medex bracket BRA317 IV hook IVP482 Size {W x H}:560mm x 640 mm x 1350 mm Weight: 18.2 Kilograms Materials: Aluminum, Plexiglas, Acetal (excluding transducers) Data Collection Rate: Variable Rate up to 1000 samples per second all channels (combined). Data rate fixed in multiples of 10/20/30 Computer: Desktop PC Relevant Standards: IEC60601-1, IEC60601-1-1, IEC60601- 1-2, EN60601-1, UL2601-1 Agency: TUV Uroflow: Differential Input EMG: Direct Signal P1/2: Dual Differential Input P3/4: Dual Differential Input Port D: RS232 (adj. settings) Port A: Main RS232 (default 115200, 8, 0, 1, NFC) USB: USB1.1 (used for firmware download, not interface active) Port B: Printer RS232 (default 38400, 8, 0, 1, HWC) Port C: RS232 (adj. settings) UPP: 2 Digital I/O, Speed Control signal Main Power: +12VDC, 5A input

Part Number: POW779 Size {W x D x H}: 129 x 77 x 40 mm, Size {Length}: 1,735 mm Weight: 488 grams Materials: Black, 94VO Polycarbonate Power In: 100-240Vac, 50-60 Hz, 1A Power Out: +12 Vdc, 6.67A

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LABORIE

Dorado KT™ Service Manual

Instruction Manual, Assembly Guides, and Service Manual

LABORIE Software

Part Number: MAN162, MAN156, and MAN575 Size {W x D}: 8½ x 11 inches; 11 x 17 inches Material: PDF and paper

Part Number: LAB783/LAB786 Label Information: Laborie CD Size {Diameter}: 11.9mm Weight: 12 grams CD Software: UDS View, Manuals, Instruction Video, Brochure

UDS Transducers Uroflow Transducer

Part Number: TRA875 Size {Dia x H}: 126 x 112 mm Weight:1068 grams Materials: Aluminum, PVC, nickel plate steel, Acetal Voltage excitation: +/-3.3V Serial Number Format: FUAyyxxxx

Pressure Transducer Plate

Part Number: TRA600(P1)/TRA602(P2)/TRA604(P3)/TRA608(P5)/ TRA610(P6)/ TRA612(P7) Size {W x D x H}: 57 x 24 x 73 mm Weight: 34 grams Voltage excitation: +/-3.3V Serial Number Format: MX960xxxxx

Pressure Cable

Part Number: CAB440(P1/P2)/CAB441(P3)/ CAB444(P5/P6)/CAB443(P7) Size {Length}: 810…890 mm Weight: 68 grams Materials: ABS, Nickel Plate Steel, PVC Serial Number Format: None

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Dorado KT™ Service Manual

EMG Processor & Head Stage

Integrated Pump

Part Number: CAB155 Size {Length}: 1800 mm Weight: 38 grams Materials: ABS Voltage excitation: +/- 5V Serial Number Format: None

Part Number: Integrated into PRO493 Size (W x D x H): 83.97 x 48.42 x 81.10 mm Weight: 320 grams Materials: Polypropylene, IXEF, Nylon, Stainless Steel Serial Number Format: Integrated into 94-R01

Note: Upper limit is dependent on catheter used.

UPP

Electronic Catheter (Single)

T-DOC

Part Number: UPP 715 Size base (Dia x H): 680 x 500mm Size arm (Length): 1000 mm Size puller (W x D x H): 44 x 50 x 77 mm Weight: 1500 grams Materials: Aluminum, Acetal, PVC, Steel Voltage excitation:+12V Serial Number Format: UPByymmzzzz

Part Number: Not Released Size (Length): 10 ft 4 in Weight: 88 grams Materials: Chromium Steel, Polyurethane, Teflon, Silicon Encapsulation Voltage excitation: +/-3.3V Serial Number Format: None

Part Number: CAB665(P1/P2) / CAB666(P3) Size {W x D x H}: 57 x 24 x 73 mm Weight: 183 grams Voltage excitation: +/-3.3V Serial Number Format: TDCxxxxx

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LABORIE

Dorado KT™ Service Manual

Part Number: TRA145 Size (Length): 145 mm Weight: 9 grams Materials: Acetal, Aluminum, Stainless Steel Voltage Excitation: 10V max Serial Number Format: INFyymmzzzz

Infusion Transducer

Laborie Accessories 115V Medical Grade Power Cord

110V Part Number: POW005 Size (Length): 2400 mm Weight: 272 grams Materials: PVC 230V Part Number: POW740 Size (Length): 2490 mm Weight: 266 grams Materials: PVC

Commode Chair

Part Number: CHA171 Size (W x D x H): 432mm x 610mm x 480mm Weight: 6.14 Kg Materials: White PVC tubing Maximum Weight Allowed: 136.4 Kg

Flow Stand

Part Number: STA700 Size (W x D x H): 406mm x 381mm x 559mm Material: Aluminum, Stainless Steel, Acetal Weight: 1.4 Kg

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LABORIE

Dorado KT™ Service Manual

Laborie Disposables Laborie Transducer Cartridge with Luer Lock

Part Number: DIS130 Size (W x D x H): 28.37 x 10.12 x 50.44 mm Weight: 6 grams Materials: Diaphragm: Black Polyurethane DPS Cartridge: Polycarbonate Silicone lubricant: Dow #360 silicone lubricant Protector: White Acrylonitrile Butadiene Styrene ISO Lock Nut: Acrylic ISO Lock Nut Adapter: Polycarbonate Protectors: Low Density Polyethylene

To be used with Logical Pressure Plate Transducers (UDS-D-M-Px).

Urodynamics Measurement Tubing Set

Part Number: TUB101 Weight: 22 grams Materials: Protector: LDPE DOW 640 NT; Stopcock plug: HDPE Quantum LF 6030-00 & DuPont 50006 White Stopcock body: Polycarbonate GE Lexan 144R-112 Tubing: 125 C Kentak 3390 NT Male and female Luer: Polycarbonate GE Lexan 144R-112

To be used with Logical Pressure Transducers Plate (UDS-D-M-Px)

Pump Tubing Set with Infusion Line

To be used with Logical Pressure Transducers Plate (UDS-D-M-Px)

Part Number: TUB500 Weight: 54 grams Materials: PVC Plastic Female Luer taper: C1500-01 Tubing Clamp: C1502-01 Silicone tubing: C1501-01 Male Luer: Polycarbonate GE Lexan 144R-112 Male and female protector: LDPE DOW 640INT Stopcock plug: HDPE Quantum LF 6030-00 & DuPont 50006 White Stopcock body: Polycarbonate GE Lexan 144R-112

3.7 Optional Software Features Feature Batch Printing Adjustable Data Rate Math 1 to Math 4

Item Number FEA125 FEA035 FEA335

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LABORIE

Dorado KT™ Service Manual

Feature Adjustable Display Curve Width Adjustable Printing Curve Width User-Defined Curve Color User-Defined Curve Filling User-Defined Curve Mirror User-Defined Curve Overlay User-Defined Event List Compliance Measurements Auto Compliance Eberhard Curves/Summary URA CHESS Nomogram WF LinPURR Area under curve Click channel titles and units to modify Click channel scales to modify Channel Value Marker User-defined channel font Pediatric Nomogram Data Rate Sampling (Mode I) Data Rate Sampling (Mode II) VBN Animation VBN Full Sound Uropix II Uropix Burst Uropix Smart Capture Saturn Burst Saturn Smart Capture Manual Capture Image Cursor Auto Capture Image Overlay Additional Viewing Key

Item Number FEA040 FEA045 FEA575 FEA605 FEA635 FEA650 FEA665 FEA155 FEA065 FEA255 FEA500 FEA143 FEA725 FEA305 FEA050 FEA150 FEA145 FEA140 FEA515 FEA365 FEA673 FEA669 FEA681 FEA677 FEA470 VID600 VID630 VID615 VID315 VID330 FEA315 FEA290 FEA060 FEA295 FEA485

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LABORIE

Dorado KT™ Service Manual

4 TRANSDUCER SETUP AND CONNECTION 4.1 Uroflow Transducer The first step in performing a test procedure using your Dorado KT is to set up the Uroflow transducer. To set up the Uroflow transducer: 1. Place the funnel on the plastic frame of the commode chair. 2. Carefully place the Uroflow transducer on the floor. 3. Gently place the Uroflow dish on top of the Uroflow transducer. 4. Place a graduated beaker on top of the dish. 5. Place the commode chair and funnel over top of the Uroflow transducer and beaker. Ensure that the beaker and the funnel are aligned. 6. Connect the Uroflow transducer cable to the flow port on the back of your Dorado KT. IMPORTANT! It is critical that: •

The Uroflow dish is properly seated inside the base. Remove the protective sponge spacer if it is still separating the dish from the base.

•

The beaker is well centered and does not touch the funnel during the test.

a.

b.

Uroflow Transducer (a) placed under commode chair (b)

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LABORIE

Dorado KT™ Service Manual

4.2 Fluid-Filled Pressure Transducer Setup Take each pressure cartridge out of its package, and remove protective covers from the back and from the connector ends. 1. Slide a cartridge over each transducer until it clicks in place. 2. Attach pressure measurement tubing, with attached three way stopcock to lower (male) end the pressure cartridge. 3. Attach 10 ml sterile-fluid filled syringe to side port of stopcock. 4. By turning stopcock in appropriate directions, flush fluid from syringe through both the pressure cartridge and the pressure measurement tubing. CAUTION! There should be NO AIR BUBBLES present in the system during testing. NOTE: Be sure that the stopper cap is always securely in place whenever the stopcock position is being changed.

Fluid-Filled Pressure Transducer Setup

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LABORIE

Dorado KT™ Service Manual

4.2.1 Fluid-Filled Pressure Transducer Connections 1. Attach a 3-way stopcock with pressure measurement tubing to the bottom (male) connector of the pressure cartridge. 2. Attach the opposite end if the pressure measurement tubing to the catheter. 3. Attach a syringe filled with water or saline to the stopcock. 4. Turn the “OFF” position of the stopcock down towards the catheter. (see B below) 5. Remove the Luer lock plug from the top (female) connector of the pressure cartridge. 6. Fill the pressure cartridge with water. Reattach the Luer lock plug. 7. Turn the “OFF” position of the stopcock up towards the Luer lock plug (see D below). 8. Prime the pressure measurement tubing and the catheter. 9. Turn the “OFF” position of the stopcock towards the syringe (see A below). The 3-way stopcock should be turned “OFF” towards the syringe to allow pressure recording (A). Off to Syringe

To Transducer Cartridge

To Catheter

Stopcock Positions

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LABORIE

4.3

Dorado KT™ Service Manual

Electronic Catheter

Typical Set up 1.

Connect the cables to the Electronic catheters as follows: P1 – Pves – Blue -> S1 distal of dual catheter P2 – Pabd – Red -> Single catheter P3 – Pura – Black -> S2 proximal of dual catheter

Refer to the following diagram for more information.

Figure 4.1: Electronic Catheter Connections

4.4

Infusion Volume Transducer

1. Place the volume transducer at the top of the IV pole. (see Figure 4.2) 2. Connect the infusion transducer cable to the P8 port of the Dorado KT.

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LABORIE

Dorado KT™ Service Manual

3. Place a 1000 ml bag of sterile saline inside a pressure cuff. Hang the pressure cuff on the hook of the infusion transducer. The IV pole should be at least 60 cm above the patient table. 4. Inflate the pressure cuff to 300 mm Hg (when the red line appears on the pressure cuff gage). 5. Connect an infusion line to the saline bag. Use a basic solution set with a drip chamber. 6. Tape the infusion line to the IV pole between the drip chamber and the flow control valve (roller clamp). Ensure there is excess tubing between the tape and the drip chamber. 7. Connect the other end of the infusion line to the filling port on the catheter.

Important! • Ensure that the infusion line is not pulled or else the transducer reading will not be accurate. • The infusion transducer is calibrated for up to 1000 ml of sterile saline or water. If you are using a different medium, such as hypaque, re-calibration is required. •The infusion transducer for the Dorado KT is compatible with the Aquarius TT™, Triton™, and Delphis™ systems. However, it cannot be used on the Bonito™ systems.

Hint: Use an infusion pressure cuff for faster flow rate.

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LABORIE

Dorado KT™ Service Manual

Figure 4.2: Infusion Transducer Connections

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