Urisys 1100 Operator’s Manual ®
The packaging material, the identification plate on the instrument and the manual may contain the following symbols or abbreviations: Please consult instructions for use ! Caution (refer to accompanying documents). Please refer to safety-related notes in the manual accompanying this instrument. Store at Manufacturer rEF IVD Catalogue number For in vitro diagnostic use This product fulfils the requirements of Directive 98/79/EC on in vitro d iagnostic medical devices.
Table of Contents Page 1. Introduction 1 2. System Description 2 2.1 Measuring Principle 2 2.2 Components and Functions 3 3. Software 3 3.1 Overview 3 3.2 Menu Structure (Flowchart) 4 3.3 Menu Functions 6 3.4 Default Settings 7 3.5 Results Table 8 4. Installation 9 4.1 Unpacking 9 4.2 Installation and Power-On Procedure 10 4.3 Modification for Chemstrip® 5 OB and Chemstrip® 7 Urine Test Strips 12 5. Calibration 13 6. Reading Test Strips 14 6.
1. Introduction Manual version Software version Revision date Amendments 03 6.x June 2008 Operator ID, limited lock-out function, Device ID, compatibility of barcode reader, ASTM protocol The Urisys 1100® Urine Analyzer (Cat. No. 3617556) is a reflectance photometer designed to automatically read and evaluate the results of Chemstrip® 10 MD*, Chemstrip® 7 and Chemstrip® 5 OB Test Strips from Roche Diagnostics.
2. System Description 2.1 Measuring Principle The test strip is placed on a sliding tray, and a stepping motor moves it under the reading head, which remains stationary. The analyzer reads the reference pad, followed by each of the test pads on the strip. The reading head contains LEDs that emit light at various wavelengths.
2.2 Components and Functions 1 2 4 3 5 6 7 8 Component Function 1. Printer cover Flips up for insertion of printer paper Program Chip Contains software needed to operate the analyzer and interpret results (under printer cover) 2. Display/keypad LCD display and three function keys for menu-driven operation and interfacing with the user 3. Test strip tray Holds and anchors the strip 4.
3.2 Menu Structure (Flowchart) The flowchart below provides a visual display of the menu structure and how to access the various instrument settings and functions. Pressing the START button confirms the setting, closes the submenu, and resumes Ready-to-Measure status. 1/1 SW 6.x (US Version) SELF CHECK OpID=ON Operator: ……. Enter OpID! Password: Enter password! AUTH=ON OpID=OFF AUTH=OFF No.: … Insert strip! Calibr.
Menu Structure (continued) Pressing the START button confirms the setting, closes the submenu, and resumes Ready-to-Measure status. 1/1 SETUP1 Modes Strip SW 6.x (US Version) Setup2 SETUP2 Date/Time STRIP SETTINGS Type Units Setup3 DD.MM.YYYY hh:mm Sequence 12/24 Set DD.MM.YYYY <<<< + hh:mm - STRIP TYPE:CHEMSTRIP10 CHEM10 CHEM7 CHEM5 UNITS: CONVENTIONAL Conv. SI Arb. SETUP3 Language Device ID Op.ID LANGUAGE: ENGLISH Other OPERATOR ID: ON On Auth. Off OPERATOR ID: AUTH.
3.3 Menu Functions Self Check: During Self Check at power-on, the analyzer automatically checks that the program chip, tray transport mechanism, printer connection and optical system are all operating properly. The tray type is checked (see Sections 4 and 7.1) to ensure that it correctly matches the test strip type selected in the menu. Calibration: For requesting calibration with Chemstrip Calibration Strip (see Section 5). Linefeed: Causes paper to advance.
Units: Options are: • Conventional units (mg/dL) • SI units (mmol/L) • Arbitrary units (+, ++, +++, ++++) The operator selects the units in which the results are to be stored, printed and/or transferred to a computer. After a new unit setting has been selected, the repeat printout (activated by “Print Results”) and all following printouts and/or data transfer (activated by “Send Results”) will be in the newly chosen units. Language: This enables the display language to be set.
3.5 Results Table Urine test strip measurement values can be reported in either conventional units, SI units, or arbitrary units. The following table lists the levels of concentration that are reported for each format. Parameter Specific Gravity (SG) pH LEU (Leukocytes) NIT (Nitrite) PRO (Protein) GLU (Glucose) KET (Ketone) UBG (Urobilinogen) BIL (Bilirubin) BLD (Erythrocytes) 8 Conv. 1.000 1.005 1.010 1.015 1.020 1.025 1.030 5 6 6.
4. Installation ! Please read the Urisys 1100® Urine Analyzer Operator’s Manual carefully before installation, to ensure proper operation of the analyzer. 4.1 Unpacking Carefully remove the contents of the Urisys 1100® Urine Analyzer box and check for the following items: Contents: 1. Urisys 1100® Urine Analyzer 2. AC adaptor (100 V - 240 V, 50/60 Hz ) 3. Power cord 4. Roll of printer paper 5. Test strip tray, Type C, for reading Chemstrip® 10 MD* Test Strips 6.
4.2 ! Installation and Power-on Procedure Set-Up (1) Place the Urisys 1100® Urine Analyzer on a stable, level surface. To ensure accurate readings, please take the following environmental precautions: • Do not set the analyzer in close proximity to devices that create high-frequency fields, as they may interfere and produce false results. Such devices include; walkie-talkies, mobile telephones, microwave ovens and diathermic equipment.
Paper Installation (4) Release the printer paper cover by pressing the area immediately below and to the right of the printer paper slot (see Figure 3). The cover can then be lifted back. Place the paper roll in the compartment and pull out the first few inches of paper to just beyond the edge of the compartment. The thermosensitive side of the paper (the outer surface of the paper roll) should be facing downwards (see Figure 4). Close the cover again by pressing until it locks audibly into position.
4.3 Modification for Chemstrip 5 OB and Chemstrip 7 Urine Test Strips For readings with Chemstrip 5 OB or Chemstrip 7 Test Strips, the Type N test strip tray is required to accomodate the shorter test strips. It is necessary to modify the “strip type” setting on the analyzer to either “Chem 7” or “Chem 5” as appropriate. To do this, press START and use the function keys to select “Menu”, followed by “Setup 1”, “Strip”, and then “Type”. Select the appropriate strip type from the menu.
5. Calibration The following section only applies when the Urisys 1100® Urine Analyzer is used with Chemstrip 10 MD* Test Strips. When using Chemstrip 5 OB or Chemstrip 7 Test Strips, the calibration procedure described below is not necessary (see Section 4.3). Overview The Urisys 1100® Urine Analyzer is calibrated before leaving the factory. When installed, it must be recalibrated with a Chemstrip Calibration Strip before the first samples are read, and thereafter every seven days.
Calibration printout If the new calibration results are within the acceptable range, the message “CALIBRATION O.K.” is displayed. Results are stored in memory and automatically printed along with time and date. A list of reflectance values for measuring positions 1–11 for the orange LED are printed in the middle column and for the green LED in the right column. (See Figure 8).
6.3 Routine Urine Testing ATTENTION: To ensure that urinalysis is carried out correctly, read the package insert included with the test strips. The Urisys 1100® Urine Analyzer is ready to read when the display shows a sample number and “INSERT STRIP !”. Procedure 1. Dip the test strip briefly (one second) in the urine sample. Draw the long edge of the strip along the rim of the specimen container to remove excess urine.
3. Press the START button (see Figure 12). An acknowledging beep sounds. The tray advances slightly, the retaining bar closes, and the gray reference pad on the tray is read (see Figure 13). Figure 12 Figure 13 4. If the test strip is not correctly located in the middle of the tray, move it gently to the side until it is properly aligned (see Figure 14). Be careful not to move the tray. 5. Seventy seconds after the START button is pressed, all test strip pads are read.
! Thermal printing paper is sensitive to light and subject to fade with prolonged exposure to bright light. Patient reports should be kept in a place away from direct light. For anticipated storage beyond 5 years it is recommended that reports are photocopied for storage. 6.5 Strip Measurement Error If “STRIP MEASUREMENT ERROR !” appears, the test strip and/or analyzer have probably been incorrectly used. Refer to Section 8 for details. 6.
6.7 Data Transmission to a PC or Host Computer In unidirectional mode, the results are transmitted immediately with the sequence number, Patient ID (if entered), date and time. In bidirectional mode, transmission can only be accomplished by using the “Send” function when “MEMORY” is displayed. If a bidirectional PC/host communication link cannot be established, the Urisys 1100® Urine Analyzer aborts transmission after several attempts and r eports an “INTERFACE ERROR !” (see Section 8).
7. Cleaning and Maintenance The Urisys 1100® Urine Analyzer is designed for nearly maintenance-free operation. Protect the instrument from extremes of temperature and high atmospheric humidity (see Section 10), and keep it out of bright light (direct sunlight, spot lamps, etc.). Maintain hygiene by keeping the exterior parts and surfaces of the instrument clean. For cleaning we recommend applying a solution of either 70% alcohol or 10% bleach with a moist cloth.
6. Install the test strip tray by holding the tray opposite the end with the gray reference pad and inserting the tray into the slot below the function keys. ATTENTION: Be careful not to touch the gray reference pad. Contamination of the reference pad may impair the quality of the results obtained. 7. If you wish to proceed with the next readings directly after cleaning the test strip tray, switch the analyzer on again.
E6 CHIP ERROR ! Cause: The program chip on the right of the analyzer underneath the printer cover is missing, is not making contact, is defective or contains an old software version. Action: Switch off the Urisys 1100® Urine Analyzer. Insert the program chip and switch the instrument on again. If “CHIP ERROR” appears again, contact Roche Diagnostics Technical Service at 1-800-428-4674. E7 MISSING TRAY ! Cause: No tray inserted or tray not inserted far enough to be engaged by the motor.
E14 INTERFACE ERROR ! Cause: Fault in data transfer to PC or host in bidirectional or ASTM mode. Action: Check the data cable. Verify that the PC or host is ready to receive data. Use the “Send” function to transfer data or press “Home” to resume Ready-toMeasure status. E17 INVALID PASSWORD! Cause: The entered password doesn’t match. Action: Enter an correct password. E18 INVALID OP.ID! Cause: The entered Operator ID is not valid. Action: Enter a valid Operator ID.
When the interface is set for unidirectional communication, the data is sent as an ASCII file and can be received via a terminal program. The entered Patient ID appears in the Urisys 1100® Urine Analyzer display window and is also printed and/or sent to the PC/host along with the test results (see Section 6.6).
10. Technical Information and Notices 10.1 Instrument Specifications Dimensions: Width: Depth: Height: approx. 150 mm approx. 290 mm approx. 95 mm Weight: < 0.8 kg Power supply: External mains adapter, Model SA 125A-0735U-S (Sino-American Switching Adapter) Input: 100 - 240 V AC, 50-60 Hz, 800 mA Output: 7.5 V DC, 3000 mA + Polarity: – Consumption: Operating: Standby: System description: max. 15 W 1.3 W Type: Light source: Wavelengths: Reader head: Measuring cycle: Max.
10.2 Safety Notices This analyzer was designed and manufactured to comply with following international regulations, “Safety requirements for electrical equipment for measurement, control and laboratory use” and left the factory in a safe condition. In order to keep the instrument in a perfect and safe condition, it is up to the user to observe all instructions and warnings included in this manual. This product fulfils the requirements of Directive 98/79/EC on in vitro diagnostic medical devices.
11. Ordering Information and Replacement Parts The analyzer, consumables, replacement parts and accessories are: Catalogue No. 3617556 3260763 1008552 1893467 418007 Urisys 1100® Urine Analyzer Contents: Power Supply with AC Adaptor and US Power Cord, Program Chip, Test Strip Trays (Type C and N), Printer Paper, Operator’s Manual with Policies and Procedures CD, Quick Reference Guide, and User Training CD.
12. Contact Information Address Roche Diagnostics Corporation 9115 Hague Road PO Box 50457 Indianapolis, IN 46250-0457 USA Phone Numbers Main switchboard: 317-521-2000 Customer Service: 800-428-5076 Technical Service: 800-428-4674 Websites www.poc.roche.com www.diavant.
Roche Diagnostics Corporation 9115 Hague Road Indianapolis, IN 46256 www.poc.roche.com www.diavant.com 03617599001 (03) 2008-06 Cat. No.
