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Table of Contents
Related Manuals for Henry Schein Urispec Plus
Summary of Contents for Henry Schein Urispec Plus
- Page 1 User manual...
- Page 2 User manual Urispec Plus ® The Urispec Plus is CLIA waived for Urispec urinalysis reagent strips. ® ® A certificate of CLIA waiver is required to perform the testing in a waived setting. If the laboratory does not have a Certificate of Waiver, the Application for Certi- fication (Form CMS-116), can be obtained at http://www.cms.hhs.goc/clia/.
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Page 3: Table Of Contents
User manual Urispec Plus ® 1. Quickstart ………………………………………………………………………… 5 2. Introduction and intended use ………………………………………………… 7 2.1. Intended Use and Indications for Use ……………………………………… 7 2.1.1. Measuring Principle ……………………………………………………… 7 2.1.2. Functional Principle Urispec Plus ……………………………………… 7 ® 3. Unpacking and Set Up ………………………………………………………… 11 3.1. - Page 4 User manual Urispec Plus ® 10. Equipment Settings ………………………………………………………… 31 10.1. How to modify strip settings ……………………………………………… 31 10.1.1. Units …………………………………………………………………… 31 10.1.2. Order of Parameters ………………………………………………… 31 10.2. How to protect settings from unauthorized access …………………… 31 10.3. How to turn the printer on and off ……………………………………… 32 10.4.
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Page 5: Quickstart
User manual Urispec Plus ® 1. Quickstart Unpack the instrument and place it on an even, hard surface. Connect the pow- er supply and turn the equipment on with the On/Off-switch (Pic. 4-8). After the self test you will be able to select a strip type. Once you select the strip you want to use, or after 15 s, the start screen will appear, Urispec 11-Way INSERT STRIP! - Page 6 User manual Urispec Plus ® After approximately 60 sec the result will be displayed on the screen and trans- ferred to the printer and interfaces. RESULT Seq.No: 0001 ID: 1234567890 2006.02.17 9:47 *BLD 10 ERY/uL NORM *GLU 50 mg/dL 1.005 Display 2: Result By pressing the printer symbol the result can be printed again.
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Page 7: Introduction And Intended Use
User manual Urispec Plus ® 2. Introduction and intended use The Urispec ® Plus is a reflection photometer for the analysis of Urispec ® urine test strips. The measurements are performed under standardized conditions, measured values may be displayed, printed and transferred to a computer. The Urispec ®... - Page 8 User manual Urispec Plus ® in the display. The result is shown on the display, printed out and released via the interfaces after the measurement has been completed. After three minutes the instrument will go to stand-by. Touching the screen will reactivate the instrument. All user inputs are performed via the touch-screen (see 3.7.
- Page 9 User manual Urispec Plus ® 2.1.4. Labels on the device and symbols 5701310 Refl ectance photometer for evaluation of ® Urispec 11-Way, GP+A, 5-Way Plus and 4-Way Contents: 1 unit Rev. Date: 12/2018 Made in Hungary Shelf Box Label for product 5701310 5701309 Refl...
- Page 10 User manual Urispec Plus ® 2.1.5. Symbols explanation Caution: Further information in user manual The medical device that has not been subjected to a steril- ization process. Keep away from sunlight. Keep dry. Temperature limits. Should not be used if the package is damaged. The medical device is intended for one use, or for use on a single patient during a single procedure.
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Page 11: Unpacking And Set Up
User manual Urispec Plus ® 3. Unpacking and Set Up 3.1. List of delivered parts a Urispec ® Plus reflectometer b Power pack 100 - 240 V, 47/63 Hz, 9V c Printer paper + User manual (this booklet) Pic. 2: Content Read the operating manual for Urispec ®... -
Page 12: Description Of Instrument Parts
User manual Urispec Plus ® 3.2. Description of instrument parts Pic. 3: Front view Pic. 4: Backside view Actuator Function 1. Touch-Screen Control of equipment functions 2. Test Strip Slide Test strip retainer and autonomous start of analysis 3. Printer Flap Opening the printer flap for paper replacement 4. -
Page 13: How To Plug The Instrument In
User manual Urispec Plus ® 3.4. How to plug the instrument in Pic. 5: Power pack Pic. 6: DC in An adapter is provided for adapting the power pack to the available mains con- nection. The adapter matching the mains connection is plugged on to the power pack (Pic. -
Page 14: How To Install Batteries (Optional)
User manual Urispec Plus ® Pic. 9: Printer C Pic. 10: Printer D Unroll the paper roll by 5 cm and place the roll in the paper compartment with the end on the lower side. Fix the end of the paper to the housing with your forefinger while closing the flap (Pic. -
Page 15: Use Of The Instrument
User manual Urispec Plus ® 3.7. Use of the instrument All user inputs are done via a touch-screen (touch-display). All functions are activated directly by slight pressure with the finger on explicit pictograms or text representing the menu items. 3.7.1. Buttons Framed areas react to pressure and trigger the action linked to it. The caption of an area describes its function. -
Page 16: Round Buttons
User manual Urispec Plus ® 3.7.3. Round buttons These buttons typically appear on screens that require a selection among serial items. The button with a filled circle is the current selection. Today Date Pressing the circle will activate a selection. Save your selection by pressing . -
Page 17: User Menu
User manual Urispec Plus ® 4. User Menu 4.1. Flow-chart of the Menu Structure Memory List Search Clear Check mode Memory Measurement Settings Strip Type Units Parameter order Password Printer Sound Touch Positive Autostart Battery Backlight Printer Language Date/Time Interface Customisation Print setting Manual Urispec Plus V2.01 HS USA / 04-19 ®... -
Page 18: Description Of The Menu Items
User manual Urispec Plus ® 4.2. Description of the Menu Items • SN: 5.6. Changing the sequence number ("SN") • ID: 5.5. Entering the Patient Identification • (P): Standby • Main menu • Memory: 7. Recall results • Check mode: 9. Quality control testing • Settings: 10.1. How to modify strip settings 10.2. -
Page 19: Analysis Of Test Strips
User manual Urispec Plus ® 5. Analysis of Test Strips Note: The Urispec Plus will perform an automatic calibration each time a test ® is run. 5.1. Select strip The Urispec Plus reader can read different test strips. Upon turning on the ®... -
Page 20: Display Of Results
User manual Urispec Plus ® 5.3. Display of Results The sequence number (Seq.No.) as well as the patient identification (ID) will be displayed with the results. RESULT Seq.No: 0001 ID: 1234567890 2006.02.17 9:47 *BLD 10 ERY/uL NORM *GLU 50 mg/dL 1.005 Display 4: Result Positive findings are clearly marked by an asterisk (*) on the printout and on the display. - Page 21 User manual Urispec Plus ® 1234567890 1234567890 – ABC DEF 123 JKL MNO -(#) PQRS WXYZ Display 5: Entering ID (numerics) Display 6: Entering ID (letter) b) Using a standard PC-keyboard: Connect the keyboard to the USB-jack Type A (Pic. 4 f ) in the backside of the instrument. User inputs on the keyboard will automatically be interpreted as Patient Identifications.
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Page 22: Changing The Sequence Number ("Sn")
User manual Urispec Plus ® 5.6. Changing the sequence number ("SN") Pressing the field in the start menu brings up a numerical pad. Enter a new sequence number using the keys on the pad. All following measurements will now be counted from this number on. Seq.No. -
Page 23: Enter The Main Menu
User manual Urispec Plus ® 6. Enter the Main Menu Pressing on the start screen will bring up the main menu. Urispec 11-Way MENU INSERT STRIP! Memory 0001 Check mode Settings 1025358 Display 8: Start menu Display 9: Main menu From here the other functions e.g. memory (7. Recall results), the test mode (9. Quality control testing) as well as the settings (10. -
Page 24: Recall Results
User manual Urispec Plus ® 7. Recall results The Urispec ® Plus has has an internal memory for storage and recall of mea- surement results. Every result is automatically saved after the analysis. When the memory is full, new data will overwrite the eldest saved dataset. Access the memory by pressing in the Main menu MENU... -
Page 25: How To Find Specific Results (Filtering)
User manual Urispec Plus ® 7.2. How to find specific results (filtering) To find the result you may select the date of the measurement and a specific parameter. SET FILTER PAR. Display 13: Filtering 7.2.1. Selecting the Day By pressing the panel you will reach the menu displayed below. -
Page 26: Selecting Search Criteria
User manual Urispec Plus ® 7.2.2. Selecting Search Criteria Pressing brings up Display 15. SELECT PARAMETER Seq.No. Positive Not printed Not sent Display 15: Select parameter Use the arrow keys to select the desired criteria and confirm with . The filter criteria will be displayed on filter settings screen (Display 16). 7.2.3. Display suitable matches After setting "Day"... -
Page 27: How To Delete Results From Memory
User manual Urispec Plus ® When suitable matches are found, an option will appear, allowing to print the da- tasets , send them to a PC or display them on the screen XX entries found Print Send Display Display 17: Search result If no matching results are found, the equipment returns to the memory menu. -
Page 28: Expected Waiver Performance
User manual Urispec Plus ® 8. Expected waiver performance At 3 sites, 66 untrained users with no laboratory experience tested randomized samples using the Urispec urine test strips and the Urispec Plus Urine Ana- ® ® lyzer. The CLIA waiver study demonstrated that the performance of the Urispec ®... -
Page 29: Quality Control Testing
User manual Urispec Plus ® 9. Quality control testing Test at least one known negative and one known positive specimen or control, whenever a new bottle of strips is first opened, for each new shipment, for each new LOT or at least monthly. Quality control samples should be run like a patient sample. -
Page 30: How To Review Old Qc Measurements
User manual Urispec Plus ® CHECK MODE Negative Positive Display 20: Control sample After pressing the instrument expects the test strip. 9.2. How to review old QC measurements The equipment saves the result of the QC measurements in a seperate mem- ory. -
Page 31: Equipment Settings
User manual Urispec Plus ® 10. Equipment Settings Enter the main menu by pressing the menu key to reach the "SETTINGS" display press MENU SETTINGS Strip Memory Password Printer Sound Check mode Autostart Battery Settings Language Date/Time Interface Display 21: Main menu Display 22: Settings 10.1. How to modify strip settings 10.1.1. Units... -
Page 32: How To Turn The Printer On And Off
User manual Urispec Plus ® PIN and confirm by pressing . The PIN will be asked for upon the next attempt to change the settings. 10.3. How to turn the printer on and off Selecting "Printer" in the settings menu will bring up an option panel. Choose the desired option and confirm. -
Page 33: How To Change The Language
User manual Urispec Plus ® 10.7. How to change the language Select "Language" in the settings menu. The language of the Urispec ® Plus menu can be switched to the following languages using the respective selective list: English, German, Spanish, French, Italian, Portuguese, Polish, Turkish and Hungarian. -
Page 34: How To Change The Text Of The Printout Header
User manual Urispec Plus ® 10.10. How to change the text of the printout header Select "Customization" in the settings menu. The first two lines of the printout may be filled with a user-specific identifier. Each line contains 23 characters. To enter the text an external keyboard or the alphanumerical pad on the dis- play can be used. -
Page 35: Cleaning And Maintenance
User manual Urispec Plus ® 11. Cleaning and Maintenance DANGER: Urine and used test strips bare the danger of infection. Always use protective gloves during handling and disposal. The disposal of used test strips should be performed according to the regulations for the handling of potentially infec- tious material 11.1. How to clean the housing The instrument housing may be wiped with a cloth. -
Page 36: Table Of Results
User manual Urispec Plus ® 12. Table of Results Param. CONV 10 Ery/μL 10 Ery/μL 50 Ery/μL 50 Ery/μL 250 Ery/μL 250 Ery/μL NORM NORM NORM 2 mg/dL 35 μmol/L 4 mg/dL 70 μmol/L 8 mg/dL 140 μmol/L 12 mg/dL 200 μmol/L ++++ 1 mg/dL 17 μmol/L... -
Page 37: Service Menu
User manual Urispec Plus ® 13. Service Menu Urispec ® Plus has a password protected service menu. To enter the service menu press the touch-screen three times during the self test after turning the equipment on. Upon request input the PIN "1111". A selective list with different menu items appears. -
Page 38: Interface Description
User manual Urispec Plus ® 14. Interface Description Urispec ® Plus may be connected to a computer via the RS232 or the USB- interface (Pic. 4) (work station or laboratory information system). 14.1. Serial Interface Protocol RS232, 19200 Baud, 8 bit, no parity Connection plug arrangement: Signal Description... -
Page 39: Error Messages And Fault Clearance
In case an error cannot be cleared using the instructions above, please contact the Henry Schein Pro Repair Service (see 17. Service, page 41). Manual Urispec Plus V2.01 HS USA / 04-19 ®... -
Page 40: Technical Information
User manual Urispec Plus ® 16. Technical Information 16.1. Technical Data Required electric supply Mains transformer: Input 100–240 V Output 9 V = 1.5 A Alternative: battery operation with 6 mignon batteries 1.5 V (AA). Dimensions Height: 7.5 cm (3.0 inches) Width: 16 cm (6.3 inches) Depth: 20 cm (7.9 inches) Weight 720 g (without batteries and power pack) -
Page 41: Service
Phone: 1-800-367-3674 8am – 5pm et www.prorepair.com 17.1. Version history Manual Urispec Plus V1.01 HS USA / 02-13, February 2014 Manual Urispec Plus V1.03 HS USA / 07-14a, July 2014 Manual Urispec Plus V2.00 HS USA / 07-18b, December 2018 Manual Urispec Plus V2.01 HS USA / 04-19, April 2019... -
Page 42: Additional Information On Security Standards
The instrument can be used in all institutions including residential area and ar- eas which are directly con nected to the public power supply, no matter if public power supply supplies buildings for residential purpose. Distributed by: HENRY SCHEIN INC. 135 DURYEA ROAD MELVILLE, NY 11747 USA Manual Urispec Plus V2.01 HS USA / 04-19...