Related Manuals for LABORIE Flowstar
Summary of Contents for LABORIE Flowstar
- Page 1 FOR DIGNITY. FOR LIFE. Flowstar™ User & Service Manual UROLOGY & UROGYNECOLOGY laborie.com LBL-000986 [D]...
- Page 2 282 Farnborough Road, Farnborough, GU14 7NA Hampshire, UNITED KINGDOM laborie.com Trademarks Flowstar is a registered trademark of Medical Measurement Systems B.V., Enschede, the Netherlands. Document Number: LBL-000986 (0075-MAN-022-EN) Revision: D Release Date: 2024-05 Laborie Medical Technologies Corp. 180 International Drive Portsmouth, NH 03801 USA...
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Page 3: Table Of Contents
Installation and Setup System Overview and Setup Flowstar Flowsensor Power Supply Loading New Paper Controlling the Equipment The Flowstar User Interface Manual or Automatic Operation Conducting an Investigation Automatic Operation Manual Operation Printing a Report Flow and Voided Volume Curves... - Page 4 Uroflow Report Print Orientation Real-Time Graph Printout Reprint Graph Printout Detect Artifacts Appendix A: Technical Specifications Flowstar Flowsensor Thermal Paper Environmental Conditions Configuration and Accessories Appendix B: Symbols Glossary Explanation of SN-number Explanation of PE-number Appendix C: Electromagnetic Compatibility Laborie Flowstar User & Service Manual LBL-000986 [D]...
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Page 5: Introduction
The Flowstar is a standalone system developed by Laborie Medical Technologies Corp. to perform uroflow investigations in hospitals and clinics. The Flowstar is supplied with a built-in printer and is connected to the Flowsensor. The Flowsensor measures flow and volume. The investigation starts automatically when the Flowsensor detects a flow. -
Page 6: Clinical Benefits
Performance Characteristics The Laborie Flowstar uroflowmetry system measures a patient’s urinary flow rate and volume, with the results used to verify or disprove patient symptoms via scientific methodology. Data is acquired by means of an integrated transducer in the Flowsensor and then processed by the Laborie uroflow software application. Results can be printed out in graphical form, including a software-calculated Voiding Summary. -
Page 7: Safety Information
Laborie modules/devices referenced in this document. To ensure safe operation and to maintain the Flowstar in a safe condition, operators of this system should carefully read and follow the instructions, precautions, and warnings in this manual. Therefore, the use of the Flowstar should be restricted to qualified personnel only. -
Page 8: Warnings And Precautions
WARNING No modification of this equipment is allowed. CAUTION Do not position the Flowstar system so that it is difficult to access the power supply plug in the wall socket. Unpacking CAUTION See the packing list to check whether all items are present. -
Page 9: Flowsensor
To prevent damage of the Flowstar measurement system, do not use thinner or similar solvents. To prevent damage to the Flowstar measurement system, do not use excessive amounts of water when cleaning the Flowstar. To prevent damage to the system, never allow water to penetrate the Flowstar or any other part. Investigation WARNING Investigation procedures as described in this manual do not claim to be exhaustive. -
Page 10: Repair
In the event of a suspected Flowsensor malfunction, the customer must return the Flowsensor for Laborie assessment using only the specific Flowsensor box supplied with your Flowstar system, as shown in Figure 1-2. Product warranty may be voided if the Flowsensor is returned in any box other than that which was supplied with your system. -
Page 11: Warranty
Warranty All warranty information is contained within Laborie’s Global Terms and Conditions of Sale, which is available on the Laborie website at www.laborie.com/terms-conditions/. Laborie reserves the right to modify these warranty periods at any time. For the latest warranty information, contact Laborie directly: DISCLAIMER OF WARRANTY ALTHOUGH THE FLOWSTAR SYSTEM, HEREAFTER REFERRED TO AS THE “PRODUCT,”... -
Page 12: Contents Of This Manual
Contents of This Manual This manual is intended for users who perform investigations with the Flowstar system and can be used as a reference. Also provided are instructions and technical specifications for your healthcare facility’s technical service department. The contents of this manual should not be considered to be all inclusive or covering all contingencies. You should direct any questions on the use of this product or interpretation of data acquired from the product to the responsible healthcare professional(s) at your institution. -
Page 13: Accessing Previous Versions Of This Manual
Notes present additional, helpful information about using the device. Accessing Previous Versions of This Manual Previous versions of this and other Laborie user and owner’s manuals and Instructions for Use (IFU) are available on the Laborie website. You can access these documents by visiting the following web address: https://www.laborie.com/document-library... -
Page 14: Installation And Setup
The Flowstar device comprises a membrane-keypad user interface and an integrated thermal printer. Figure 2-1 shows the rear panel of the Flowstar. On the left in the illustration is the power switch. On the right side is the connection port for the Flowsensor and the power supply input plug. - Page 15 Figure 2-2. NOTE The flow stand depicted in Figure 2-2 and described in the setup procedure that follows is available as an optional accessory only. Contact your Laborie sales representative for more information. Flowsensor Flow stand pole* Connector for digital cable to Flowstar...
- Page 16 6. Seat the flow funnel [5] into the holder at the top of the stand. 7. Connect the digital cable to the Flowsensor [2]. 8. Connect the other end of the cable to the weighing scale connector at the back of the Flowstar device. Moving the Flow Stand The best way to pick up and carry the flow stand is to grasp it by the arm on which the funnel is placed, as illustrated in Figure 2-3.
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Page 17: Power Supply
Ensure that the Flowstar is connected to the correct power supply (POW7001) before switching on the device. Do not use a power supply other than that specified and provided by Laborie. Doing so may cause fire, leading to serious consequences. -
Page 18: Loading New Paper
Loading New Paper When the Flowstar is nearly out of paper, red lines will appear on the outer edges of the paper. When the Flowstar is completely out of paper, the PRINT button will illuminate in solid red. The Flowstar uses special-purpose thermal paper (product number UFS-112). - Page 19 Figure 2-7: Open the Printer Cover 4. Place the paper roll on the cover to make feeding easier (see Figure 2-8). 5. Push the tip of the paper into the inlet at the bottom of the paper holder until the autoloader catches the paper and feeds about 10 cm (4") of it through the paper cutter.
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Page 20: Controlling The Equipment
3 Controlling the Equipment The Flowstar User Interface Figure 3-1 presents the user interface for the Flowstar, and Table 3-1 provides descriptions of the function of each user interface button. Figure 3-1: The Flowstar User Interface Table 3-1: Description of the Flowstar User Interface Buttons... -
Page 21: Manual Or Automatic Operation
“Volume Graph on Printout” on page 29). At the end of the investigation, patient information and the results are printed. Optionally, you can print a Siroky plot. You can print Flowstar uroflow reports in landscape or portrait orientation (see the section “Uroflow Report Print Orientation”... -
Page 22: Conducting An Investigation
4. Press the START button to select the Waiting for flow mode. The scales are printed, and the START button will flash green. If there is no flow detected after a certain length of time, the Flowstar stops. This time is the preflow time (see the section "Preflow Time"... -
Page 23: Printing A Report
"Post-Flow Time" on page 28). The Flowstar prints the patient information, results, and the Siroky plot (optionally). The PRINT button changes to flashing green. Wait until the START button is off, before pressing a button. 7. When you want an extra copy of the results and curves, press the PRINT button. Flow scale, volume scale, and Siroky can be changed if necessary, before the button is pressed. -
Page 24: Patient Information
The flow delay is the time from the beginning of the investigation (START button is pressed) to the moment the patient started voiding. During this time the START button is green. Flow delay is only calculated in Manual operation mode. Calculated: Flow delay = [A]. Laborie Flowstar User & Service Manual LBL-000986 [D]... - Page 25 Voiding Time (sec) The voiding time is the total duration of micturition, including the miction interruptions. Calculated: Voiding time = [D]. When voiding is completed without interruption, voiding time is equal to flow time. Flow Time (sec) The flow time is the time over which measurable flow occurs. Calculated: Flow time = [B When voiding is completed without interruption, flow time is equal to voiding time.
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Page 26: Siroky Plot
The method was applied on standing, male patients. The bladder volume is determined by adding the residual urine volume to the micturated volume. NOTE Read also: Siroky MB, Olsson CA, and Krane RJ: The Flow rate nomogram: II. Clinical correlation. The Journal of Urology. 1980; 123. Laborie Flowstar User & Service Manual LBL-000986 [D]... -
Page 27: Maintenance
Cleaning the System Laborie advises that cleaning of the system is performed on a regular basis; for instance, every month. Table 5-1 lists the cleaning instructions for key components of the Flowstar measurement system. To prevent damage to the... -
Page 28: Medical Dishwasher (Instrument Washer)
Monthly Laborie recommends cleaning the Flowstar by wiping it with a soft, dry cloth. If the Flowstar is heavily soiled, wet a soft cloth with mild detergent diluted with water, squeeze it well to remove excess liquid, and then clean the Flowstar. -
Page 29: Testing The Accuracy Of The Flowsensor
The procedure is as follows: 1. Switch off the Flowstar. 2. Press a FLOW button and switch on the Flowstar to print the absolute and relative weight values measured by the Flowsensor. 3. Press a FLOW button to set the relative weight to zero. The relative weight should now read 0 grams, as demonstrated in Figure 5-2. - Page 30 Repeat by placing the other objects on the Flowsensor. 5. Refer to Table 5-3 for the allowed limits. Table 5-3: Allowed Limits for the Flowsensor Used Weight Allowed Limits (Gram) (Gram) (±1%) ±0.5 ±1 ±5 1000 ±10 2000 ±20 Laborie Flowstar User & Service Manual LBL-000986 [D]...
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Page 31: Settings
6 Settings Overview You can adjust the Flowstar user interface settings, and you can activate the Settings menu. Keypad Settings You can set the following functions (the default value is shown): Flow scale 25 ml/s Volume scale 500 ml Siroky plot printout... -
Page 32: Keypad Settings
Preflow Time 30, 60, 120, 180, unlimited (seconds) When in manual operation mode and an investigation is started, the Flowstar waits for a flow. If no flow is detected after the preset time, the investigation stops. Post-Flow Time... -
Page 33: Language
(default), you do not need to press a button. The patient can start voiding directly after switching on the Flowstar. Scales and curves are printed when a flow is detected; in manual mode, you must press the START button first. -
Page 34: Real-Time Graph Printout
Yes, No The Flowstar can detect artifacts such as kicking the urine container. Automatic artifact detection is turned on by default. An artifact is marked with vertical lines on the curves printout. The data of the artifact is not included in the results calculation. -
Page 35: Appendix A: Technical Specifications
Flow stand dimensions: 545 to 710 mm × 365 mm × 360 mm (height × width × depth) • Flow stand weight: 2.5 kg • Funnel material: HDPE (high-density polyethylene) • Funnel diameter: 262 mm • Urine container material: PP (Polypropylene) • Urine container volume: 1,000 ml LBL-000986 [D] Laborie Flowstar User & Service Manual... -
Page 36: Thermal Paper
• Flow resolution: ±1 ml/s • Flow range: 1 to 100 ml/s • Manual scaling on Flowstar: 25 ml/s or 50 ml/s • Preflow time: 30, 60, 120, 180, unlimited (seconds) • Post-flow time: 30, 60, 120, 180, unlimited (seconds) •... -
Page 37: Configuration And Accessories
Configuration and Accessories The following table lists the configuration and accessories that are provided as either standard or optional with the Flowstar system. x = standard o = optional Recording unit with built-in printer... -
Page 38: Appendix B: Symbols Glossary
Authorized Authorized UK responsible person CE marking UKCA marking representative in the representative in European Community Switzerland * Note that some of the symbols on the measurement system can be originally in color Laborie Flowstar User & Service Manual LBL-000986 [D]... -
Page 39: Explanation Of Sn-Number
Explanation of SN-number SN YYXXNNNN Serial Number Two-digit manufacturing year number One- or two-digit product identification number NNNN Four-digit incrementing unique number Explanation of PE-number PEYY-FXXXXNNNN Peripheral Equipment Two-digit manufacturing year number Product group number XXXX Three- or four-digit unique module abbreviation NNNN Four-digit incrementing unique number Appendix B... -
Page 40: Appendix C: Electromagnetic Compatibility
• If the Flowstar is used in a location near (e.g., within 1.5 km) AM, FM, or TV broadcast antennas, it may be necessary to take preventive actions for reducing the EM interfering level (i.e., by shielding the investigation room). - Page 41 Table C-2: Guidance and Manufacturer’s Declaration—Electromagnetic Immunity The Flowstar is intended for use in the electromagnetic environment specified below. The customer or the user of the Flowstar should assure that it is used in such an environment. When the Flowstar is exposed to electromagnetic (EM) disturbances, the device may show abnormal behavior. For instance, the measured traces may be become obscured, the software may crash or, in case of very high-level transient voltage events like for instance ESD, parts of the system may even become defective.
- Page 42 Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Flowstar system, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
- Page 43 FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to Indicates presence of RF fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Flowstar is transmitters.
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