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LABORIE Urocap IV Owner’s Manual UC4-UM01 

 

53 

APPLICABLE STANDARDS AND DIRECTIVES 

Directive: MDD Directive 93/94/EEC 

Standards: 

•

 

EN 60601-1 

•

 

EN 60601-1-2 

•

 

EN 60601-1-6 

•

 

UL 60601-1 

•

 

ANSI/AAMI ES 60601-1:2005/AS:2010 
 

•

 

EN 62366 

•

 

EN 62304 

•

 

EN ISO 14155 

•

 

EN ISO 15223-1 

•

 

EN ISO 14971 

•

 

CAN/CSA C22.2 No. 601.1 – M90 

•

 

CAN/CSA C22.2 No. 60601-1:08 
ISO 13485 

Table 23 – Applicable Directives and Standards 

Please refer to the EC Declaration of Conformity for latest product related standards. 

APPENDIX B.

 

SYMBOLS AND LABELING 

SYMBOLS GLOSSARY 

 

Authorized Representative in the 

European Community (5.1.2)

1

:

 

Indicates the manufacturer’s device 

representative in the European 

Community. 

 

SGS certification - certified to U.S. 

and Canadian safety standards. 

 

Date of Manufacture  

(5.1.3)

 1

: 

Indicates the date of device 

manufacture. 

 

Manufacturer (5.1.1)

1

: 

Indicates the device 

manufacturer. 

 

Consult Instructions for Use (5.4.3)

1

: 

Manufacturer recommends 

consultation of Instructions for Use. 

 

Lot - Batch Code (5.1.5)

 1

: 

Indicates the batch or lot code for 

identification and tracking purposes. 

 

Catalogue Number (5.1.6)

1

: 

Indicates the device model or 

catalogue number. 

 

Serial Number (5.1.7)

1

: 

Indicates unique device 

serial number for device 

traceability. 

 

Alternating Current (Table D.1, 

1)

2

:

 

Indicates use of Alternating 

Current. 

 

Direct Current 

(Table D.1, 1)

 2

: 

Indicates use of Direct Current. 

 

Non-ionizing electromagnetic 

Radiation (5140)

 4

: 

Radio Frequency (RF) Transmitting 

Device 

Indicates presence of RF transmitters. 

 

Humidity Limitation (5.3.8)

 1

: 

Indicates the humidity range to 

which the medical device can be 

safely exposed. 

 

Temperature Limit (5.3.7)

 1

: 

Indicates the temperature 

limit to which the medical 

device can be safely 

exposed. 

 

Atmospheric Pressure Limitation 

(5.3.9)

 1

: 

Indicates the atmospheric 

pressure range to which the 

medical device can be safely 

exposed. 

 

Not for general waste. This product 

is designated for separate collection 

at an appropriate collection facility 

in accordance with WEE Directive. 

Dispose of in accordance to local 

regulations. 

 

Read Operator’s Manual (M002)

3

: 

Indicates user must refer to 

Owner’s/Operator’s Manual. 

 

Importer (3725)

 4

: 

Indicates the entity that imports 

the medical device. 

 

Do Not Immerse

 

 

Direction of Pump Flow 

 

GS1 DataMatrix for Unique 

Identification 

(01) Global Trade Item Number 

(11) Date of Manufacture 

(21) Serial Number 

1.

 

EN ISO 15223-1 Medical Devices – Symbols to be used with medical device, labels, labelling and information to be supplied – Part 1: General Requirements. 

2.

 

CAN/CSA-C22.2 No. 60601-1:14 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. 

3.

 

ISO 7000:2014 – Graphic Symbols for Use on Equipment – Registered Symbols. 

4.

 

IEC 60417 – Graphic Symbols for Use on Equipment. 

Table 24 – Symbols Glossary 

 

Содержание UROCAP IV

Страница 1: ...LABORIE Urocap IV Owner s Manual UC4 UM01 V13 00 UROCAP IV Owner s Manual Standalone Model...

Страница 2: ...gistered trademark of the Wi Fi Alliance MOTOROLA and product images are trademarks or registered trademarks of Motorola Trademark Holdings LLC ASUS and product images are trademarks or registered tra...

Страница 3: ...Consideration of Waste Disposal 14 4 Device Setup 14 4 1 Perform an Equipment Check 14 4 2 Set Up Equipment 16 4 3 Install Software 16 4 4 Connect Urocap IV to Software 16 4 5 Wireless Printer Setup 1...

Страница 4: ...4 5 Uroflow Options 34 6 5 Options Menu 35 6 5 1 Test Restart 35 6 5 2 Test Playback 35 6 5 3 Uroflow Auto Start 36 6 5 4 Cursor Value Indicator 36 6 5 5 Digital Value Indicator 36 6 5 6 Control Panel...

Страница 5: ...ed in Urodynamic Testing 64 Common Acronyms 65 LIST OF FIGURES Figure 1 Do not immerse the Urocap IV 12 Figure 2 Cleaning the Urocap IV 12 Figure 3 Urocap IV charging port location 13 Figure 4 Urocap...

Страница 6: ...Uroflow Study using Automatic Flow Detection 45 Table 16 Performing the Uroflow Study Utilizing Manual Start 46 Table 17 Troubleshooting Urocap IV Usage 50 Table 18 Troubleshooting Bluetooth Connecti...

Страница 7: ...Throughout the manual you will also find specially marked sections that emphasize important reminders and information to help you understand the features of the system as marked here CAUTION Provides...

Страница 8: ...you with the installation use and operation of the Urocap IV Uroflowmeter For further information or technical service please contact your local LABORIE sales representative or contact LABORIE For wa...

Страница 9: ...ransport storage or handling that could in any way hamper its use DO NOT STAND anywhere on the system or its devices The devices are not designed to support the weight of a person DO NOT immerse the U...

Страница 10: ...and other conductive parts including those connected to protective earth to prevent damage or injury Do not plug or unplug devices or pair or unpair Bluetooth devices while the Urocap IV system is in...

Страница 11: ...ving on to more advanced Urodynamic studies such as Pressure or Micturition The Urocap IV is intended for use in Uroflowmetry studies that measure both flow rate and voided volume and is intended for...

Страница 12: ...le Attention must be paid to prevent damage The Urocap IV should be cleaned using a damp cloth with alcohol soap or disinfectant detergent Figure 1 Do not immerse the Urocap IV Figure 2 Cleaning the U...

Страница 13: ...f misuse abuse or damage is suspected or any form of mechanical damage to the casing is visible discontinue use and contact LABORIE service If there is a sudden change to the battery s ability to hold...

Страница 14: ...ny visible signs of damage or mishandling Notify the carrier immediately if damage has been found Carrying cases and cartons should be saved to provide a convenient and safe way to return the equipmen...

Страница 15: ...Table 1 Standard Equipment EQUIPMENT DESCRIPTION Wireless Printer The wireless printer connects to mobile devicess via WIFI and provides a printout of test results Please speak with a Laborie represen...

Страница 16: ...Urocap IV the beaker the commode chair and funnel can be set up in one room while the laptop and printer can be in another room collecting and printing data 4 3 INSTALL SOFTWARE If not already install...

Страница 17: ...r the system 6 Click Cancel in the Bluetooth Device Server window 7 Click Device Search again 8 Wait for the Urocap to be located When the Urocap is located in the Bluetooth Device Server window highl...

Страница 18: ...or the connection to establish and finalize Table 3 Connecting Urocap IV to the Software When the Urocap IV is connected and functioning the Urocap IV Device Manager window will look similar to this 4...

Страница 19: ...from the Home screen touch Wireless 2 Touch Settings 3 Touch Wireless Setup Wizard or Wi Fi Protected Setup 4 Follow the display instructions to complete the setup If you are already using the printer...

Страница 20: ...Direct password on the printer control panel display from the Home screen touch Wi Fi Direct 4 Proceed to step 5 if the printer has been installed and connected to the computer over a wireless network...

Страница 21: ...s Connect the printer and the computer with a USB cable This USB port is at the rear of the printer Note A USB connection between the computer and printer can only be used if these two devices are iso...

Страница 22: ...ing Green Battery good c Orange Charger plugged in and battery charging d Blinking Orange Low battery time to charge e Light OFF Battery empty 5 2 CONNECTION STATUS Icon indicators in the Urocap IV De...

Страница 23: ...battery is being charged Before complete drainage of the battery power the device s LED lights will flash the battery power status as outlined on page 22 When the battery reaches total power drainage...

Страница 24: ...resolve connection issues Calibration button press to apply settings during the calibration process This behaves in the same way as the Apply button in the software Figure 4 Urocap IV Main Controls 6...

Страница 25: ...o view all tests associated with that particular patient To view a test click on the test name in the lower half of the window and then click Open Selected Test 6 2 2 OPEN FROM DATA FILE Select this t...

Страница 26: ...ins the patient s name comments file date and the procedure date for quick look up The Index file can be re generated by re indexing 6 2 7 ABOUT UDS CLIENT The About UDS Client dialog box displays the...

Страница 27: ...he Channel Title box and type a new channel title name To change the Maximum and Minimum scale click the Scale Min or Scale Max box of a channel and type the desired value for the Min and the Max valu...

Страница 28: ...nformation 4 Click the Add button to add the serial number to the secure list 5 Click Apply to save selections Figure 8 Configuration Window Security Tab Once a UDS test is performed remember to selec...

Страница 29: ...the Event Annotation box 6 3 3 UNLOCK CFG To prevent the accidental overwriting of test configuration files this option will let you lock unlock configuration files All configuration files provided i...

Страница 30: ...ll open click Cancel to continue with the test If a previous patient s information is still visible in this form click New Patient and then enter the necessary information Click OK when complete 6 4 2...

Страница 31: ...rate with Laborie s software and the built in Liverpool Nomograms To view the Liverpool Nomogram click Info X Y Plot Liverpool Nomogram The Liverpool Nomogram contains the graphical representation of...

Страница 32: ...ts by use of the Control Panel event buttons or by right mouse click on the graph window when you want to add the event An event marker will be shown on the Graph window Refer to the following table f...

Страница 33: ...the graph move to the point that corresponds to that particular event Figure 15 Using and Adapting Event Markers If you would like to change the appearance of the Event Summary window contents you can...

Страница 34: ...the voided volume is less than 55 cc and more than 555 cc Parameters of urinary flow were analyzed from 150 curves from subjects between 20 and 40 years old The minimum normal for a given volume appe...

Страница 35: ...tent in definition Normally the default settings for threshold are not changed for performing Uroflowmetry on patients Consult with your LABORIE representative for modifications to default settings TO...

Страница 36: ...s and select Cursor Value Indicator or Press the F9 key on the keyboard 6 5 5 DIGITAL VALUE INDICATOR The Digital Value window displays the data of channels with digital attributes While all channels...

Страница 37: ...tton in the UDS Client screen Enter the name of the function button using the keyboard Repeat until all the function buttons are labeled appropriately Definition of the name on the function button Cli...

Страница 38: ...nnels to zero Patient Info N A Patient Info Opens Patient Info Plot Pre set with the selections made when button is configured Plot Click the plot button to open the Nomograms that are applicable to t...

Страница 39: ...trol Panel Settings 2 Click the drop down button of the Control Panel Set Name box and select the appropriate name 3 Click OK To add a new Control Panel set by duplicating the settings of an existing...

Страница 40: ...ed In our example we will add an image to the Uroflow button 3 In the Properties window click the Browse button in the Image section to locate the image Our picture in this example will be a picture o...

Страница 41: ...Control Panel buttons with the same color and font In the All Buttons section at the bottom of the window select the button property to change and then click the rectangle next to the property to sele...

Страница 42: ...scale value Type the new channel scale value and press Enter on the keyboard Table 11 Modifying Graph Appearance To change the order of the channels 1 Right click directly on the channel area and sele...

Страница 43: ...e double arrow pointer to another position on the graph 4 Left click and then click the Yes button to move the event Table 13 Adjusting Event Marker Location To change one or more fonts for displaying...

Страница 44: ...commode chair and funnel over the Urocap IV and beaker Make sure the beaker and the funnel are aligned but not touching 7 Turn on the computer and then turn on the printer 8 Invite the patient to get...

Страница 45: ...e floor or on an approved Uroflow transducer stand 5 Gently place a graduated beaker on top of the Urocap IV 6 Place the commode chair and funnel over the Urocap IV and beaker Make sure the beaker and...

Страница 46: ...and complete click the Print button on the control panel if auto start Reporter is not active to open and print reports generated with the test data Select the items to include in the printout and cli...

Страница 47: ...listing of the types of reports you can select to view for the particular test file You can also select the report based on the type of test performed The Toolbar contains quick access buttons for fu...

Страница 48: ...ation 7 Click Close when calibration complete Figure 21 Calibrating the Urocap IV with UDS120 10 QUICK REFERENCE AND FAQ How do I check that the Urocap IV is connected You can check equipment connecti...

Страница 49: ...owmeter No power on electrical outlet Plug into a known working outlet Damaged power cord Unplug and contact LABORIE for replacement cord Power cord not connected properly Ensure power cord is secure...

Страница 50: ...ssage on screen reads Calibration Failure Flow out of range Water was poured into beaker too quickly Pour water slowly and at a steady rate More than 500 ml poured into beaker 500 ml must be poured in...

Страница 51: ...too soon after computer was turned on Close the Device Manager software Wait several minutes and re open the software to reconnect Table 19 Understanding Error Messages 11 4 PRINTER SYMPTOM S POSSIBLE...

Страница 52: ...on condensing Pressure 700 hPa to 1060 hPa up to 2000m Table 21 Equipment Specifications CLASSIFICATIONS Table 22 Classification IEC 60601 1 Class I Equipment Type BF Applied Parts Mode of Operation C...

Страница 53: ...rrent Direct Current Table D 1 1 2 Indicates use of Direct Current Non ionizing electromagnetic Radiation 5140 4 Radio Frequency RF Transmitting Device Indicates presence of RF transmitters Humidity L...

Страница 54: ...cs Limits and methods of measurement IEC 61000 3 2 2009 Limits for harmonic current emissions equipment input current 16 A per phase IEC 61000 3 3 2013 Limits Limitation of voltage changes voltage flu...

Страница 55: ...CC Rules Operation is subject to the following two conditions 1 this device may not cause harmful interference and 2 this device must accept any interference received including interference that may c...

Страница 56: ...Electromagnetic environment guidance RF Emissions CISPR 11 Group 1 The Urocap IV uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any i...

Страница 57: ...upply or a battery Power Frequency Magnetic Field 50 60 Hz IEC 61000 4 8 30 A m 30 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial...

Страница 58: ...e frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Table 28 Electromagnetic Environment Immunity Requirements Compliance and Guidance for RF Transmitting Devices IEC 60601 1...

Страница 59: ...facturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by...

Страница 60: ...T Preferences Uroflow Report 1 page voiding study report Preferences UDS Report Full UDS Report Preferences Graph Pages Report Pages Graph pages of UDS report with Report pages Standard Report Prints...

Страница 61: ...id squares Print Range Default Prints test from beginning to end Apply Click this button to set up a default configuration when printing each test Graph Scaling 1 Page Graph Graph page is condensed in...

Страница 62: ...16 4 22 0 16 7 11 4 11 1 7 8 4 6 24 1 17 7 11 4 290 32 9 24 8 16 7 22 3 17 0 11 7 11 2 7 9 4 6 24 4 18 1 18 4 300 33 2 25 1 16 9 22 6 17 3 12 0 11 3 8 0 4 7 24 8 18 4 12 0 310 33 4 25 3 17 2 22 9 17...

Страница 63: ...5 20 4 26 2 20 3 14 4 9 1 6 6 4 1 19 3 14 7 10 0 290 38 8 29 8 20 7 26 5 20 6 14 7 9 2 6 7 4 2 19 7 15 0 10 3 300 39 1 30 0 21 0 26 8 20 8 14 9 9 3 6 8 4 3 20 0 15 3 10 6 310 39 3 30 3 21 2 27 0 21 1...

Страница 64: ...and treatment This group sets standards for Urodynamic testing that all LABORIE training follows lower urinary tract symptoms LUTS these may include frequency urgency incontinence nocturia recurrent u...

Страница 65: ...oftware LPP Leak point pressure LUTS Lower urinary tract symptoms MCC Maximum cystometric capacity MUCP Maximum urethral closure pressure MUP Maximum urethral pressure NGB Neurogenic bladder Pabd Abdo...

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