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IRIS iChem 100 Operator'S Manual Download Page 8

 

 

 

 

 

 

1. Introduction 

Introduction 

Intended Use 

The iChem™100 Urine Chemistry Analyzer is a semi-automated urine 
chemistry analyzer intended for use only with iChem™ 10 SG Urine 
Chemistry Strips for the in vitro measurement of the following analytes in 
urine: glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, 
ketones, nitrite, leukocytes, ascorbic acid, color and user-defined clarity. 
 
This document is the Operators Manual for the iChem100 Urine Analyzer.  It 
is intended to explain system operation in detail and to be used as the 
basis for training new operators.  Retain this manual for future use.  It is 
an information guide and a troubleshooting reference.  It explains 
program settings and gives maintenance instructions. 

 

How to use the Operator’s Manual 

 
This manual contains important information on the functions of the 
iChem100 distributed by Iris Diagnostics.  This manual contains 
instructions for the operation, maintenance and troubleshooting of the 
iChem100.

  

 

Before operating the iChem100, read this manual carefully.  
 
 
 

300-4410 English Rev C 01/2007 

Operators Manual

 

7

 

Summary of Contents for iChem 100

Page 1: ...1 Introduction Operators Manual ...

Page 2: ...1 Introduction Click to select English Deutsch Français Italiano Español Português ...

Page 3: ...mitation of Liability 10 Chapter 2 System Description Theory of Operation 12 Features 12 Test Strips 12 Optics 13 LED Unit 13 CMOS Image Sensor 14 Optics Calibration 14 Measurement 14 Instrument Components 15 Front 15 Back 15 Software 17 Data Entry Fields 17 Toggle Fields 17 Function Keys 18 Menu Diagram 18 Main Menu 18 Worklist Menu 18 Run Patient Menu 19 Results Menu 19 Controls Menu 19 Setup Me...

Page 4: ...y of Microscopic Setup 36 Setting the Test Sequence 37 Setting the Log On Identifiers 39 Adding a New User 40 Editing a User Information 41 Deleting a User 43 Setting Up the Printer 45 Setting Transmitting Results 47 Chapter 4 Specimen Processing Powering the Instrument On 49 Logging On 49 Logging Off 50 Running Single Specimen Analysis 51 Entering Patient Information 51 Sequence Number 51 Specime...

Page 5: ...esults 78 To reject the results 78 Control Results 79 Viewing Control Results 79 Printing Control Results 80 Deleting Control Results 80 Chapter 6 Results Entering Microscopic Results 83 Viewing Results 88 Limiting Result Parameters 88 Printing Results 90 Transmitting Results 92 Deleting Results 93 Chapter 7 Maintenance and Service Maintenance 95 Recommended Maintenance Cleaning 95 Daily Maintenan...

Page 6: ...aintenance Log 111 Chapter 8 Installation Shipping Cartons 113 Unpacking 113 Installation 114 Install the paper roll 116 Appendix Table of Results 118 Bilirubin 118 Urobilinogen 118 Ketones 118 Ascorbic Acid 118 Glucose 118 Protein 118 Blood Hemoglobin 118 Blood RBCs 118 pH 119 Nitrite 119 Leukocytes 119 Specific Gravity 119 Color 119 Clarity 119 Specimen Type 119 300 4410 English Rev C 01 2007 Op...

Page 7: ...use the Operator s Manual 7 Precautions and Warnings 8 Notes 8 Cautions 8 Warnings 8 Biological Warnings 8 Warnings Precautions Limitations 8 Iris Diagnostics Contact Information 9 Warranty 9 Limitation of Liability 10 300 4410 English Rev C 01 2007 Operators Manual 6 ...

Page 8: ...iChem100 Urine Analyzer It is intended to explain system operation in detail and to be used as the basis for training new operators Retain this manual for future use It is an information guide and a troubleshooting reference It explains program settings and gives maintenance instructions How to use the Operator s Manual This manual contains important information on the functions of the iChem100 di...

Page 9: ...Analyzer This information is crucial in preventing instrument damage and maintaining the analyzer CAUTION Laser light caution A laser is used to read the barcodes Protect eyes from the laser light Warnings WARNING Identifies potentially hazardous situations that could result in serious injury to laboratory personnel Biological Warnings WARNING Use care when handling urine samples or used test stri...

Page 10: ...l Inc Iris warrants that the products manufactured by it or its affiliates and sold hereunder shall be free from defects in material and or workmanship under normal use and service for the period expiring twelve 12 months from the completion of installation or upon Purchaser s signature on Iris Diagnostics Warranty Acceptance form or fifteen 15 months from shipment whichever occurs first No warran...

Page 11: ...erms of this warranty IRIS DIAGNOSTICS MAKES NO WARRANTY OTHER THAN THE ONE SET FORTH HEREIN OR THAT WHICH MAY BE PROVIDED IN A SEPARATE WARRANTY COVERING THE APPLICABLE PRODUCT CATEGORY SUCH LIMITED WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES EXPRESSED OR IMPLIED INCLUDING BUT NOT LIMITED TO ANY EXPRESSED OR IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR PARTICULAR PURPOSES AND SUCH CONSTITUT...

Page 12: ...nt 14 Instrument Components 15 Front 15 Back 15 Software 17 Data Entry Fields 17 Toggle Fields 17 Function Keys 18 Menu Diagram 18 Main Menu 18 Worklist Menu 18 Run Patient Menu 19 Results Menu 19 Controls Menu 19 Setup Menu 20 Microscopic Menu 20 Service Menu 20 Specifications 21 Consumables or Part Replacement 22 300 4410 English Rev C 01 2007 Operators Manual 11 ...

Page 13: ...orbic acid for interference detection allows users to correct or compensate for urine discoloration allows batch and stat mode for sample processing Test Strips The test strips have reagent impregnated specialty paper pads to perform hemical analysis of c bilirubin n urobilinoge ketones ascorbic acid glucose protein blood pH nitrite leukocytes specific gravity The advantage of this approach is eas...

Page 14: ...al design the ntire urine test strip is illuminated LED Unit Inside View Side View fo After the test strips are placed on the Test Strip Tray with correct orientation they are automatically transported to the measurement window and the r For the illumination of the measurement a LED Unit with three differen wavelengths LEDs 450nm 530nm and 625nm is used To increase homogeneity the LED s are not pl...

Page 15: ...libration if the one point calibration done before each specimen determination falls outside of the acceptable limits A secondary movable standard is automatically moved into place and readings from it in conjunction with the fixed standard are used to perform a two point calibration No external calibration strips or procedures are required Measurement Once calibrated the urine test strip is seque...

Page 16: ...Paper roll 5 Transport belt opening for placement of strip 6 Clarity and specimen type barcode labels 7 Hand held barcode reader Back 4 5 2 3 1 1 Power switch 2 Keyboard barcode reader cable connection 3 External printer connection 4 RS232 connection 5 Power supply connection 300 4410 English Rev C 01 2007 Operators Manual 15 ...

Page 17: ... used for navigating within a screen between screens making selections and entering data inputs The barcode reader enables you to enter information via barcoded data into selected entry fields e g patient identification specimen identification color clarity etc 300 4410 English Rev C 01 2007 Operators Manual 16 ...

Page 18: ...or or Tab keys then press the Delete key To erase contents from data field one character at a time select the field using the keyboard s or or Tab keys then press the Backspace key The last character in the field will be deleted Toggle Fields Toggle fields are fields setup in a circular fashion allowing you to choose one field out of a series of pre setup fields e g blank trace few moderate many e...

Page 19: ... Main Menu screen is displayed The function keys will only perform the function that is associated with it in the currently displayed screen Menu Diagram Main Menu 03 10 2006 1 50PM MAIN MENU F1 WORKLIST F5 SETUP F2 RUN PATIENT F6 MICROSCOPIC F3 RESULTS F7 SERVICE F4 CONTROLS Worklist Menu WORKLIST MENU F1 CREATE F2 DOWNLOAD F3 VIEW EDIT F4 RUN F5 PRINT 300 4410 English Rev C 01 2007 Operators Man...

Page 20: ...lt SEQ 003 SPEC PAT ID LAST NAME FIRST NAME CLARITY SPC TYPE F1 MAIN MENU Results Menu Controls Menu CONTROLS MENU LOT EXP FILE 1 1212UC2006 03 20 2006 FILE 2 1213UC2006 03 20 2006 FILE 3 FREQ 1O Hours F1 SETP F2 VIEW F3 RUN F4 PRINT F5 DELETE F6 MAIN MENU 300 4410 English Rev C 01 2007 Operators Manual 19 ...

Page 21: ...m Description Setup Menu Microscopic Menu Service Menu SERVICE MENU F1 DATE TIME F4 DIAGNOSTICS F2 PRINTER F5 TRANSMIT F3 LANGUAGE F6 TEST STRIP F7 MAIN MENU 300 4410 English Rev C 01 2007 Operators Manual 20 ...

Page 22: ... requiring confirmatory tests Microscopic examination Abnormal Quality Control results Display LCD backlit 8 lines x 40 characters Printer Thermal built in Interfaces RS 232 parallel printer port 5 pin DIN socket Physical Specifications 19 5 x 10 8 x 9 8 in 49 5 x 27 5 x 25 cm 16 5 lbs 7 5 kg Power 100 to 250 VAC 10 50 60 Hz Operating Range 59 F to 90 F 15 C to 32 C 20 to 80 Relative Humidity Pack...

Page 23: ...r 800 7507 Transport mechanism enclosure 800 7508 Barcode reader and cable 800 7509 Keyboard English 800 7510 Keyboard German 800 7511 3 Rolls of Thermal Paper 800 7014 Incubation Belt 800 7004 iChem 10 SG Urine Chemistry Strips US 800 7005 iChem 10 SG Urine Chemistry Strips Int l 800 3203 Iris System Cleanser 300 4410 English Rev C 01 2007 Operators Manual 22 ...

Page 24: ... L units 29 Qualitative units 29 Customized Units 30 Printing Units 30 Sample Print Layout 31 Setting the Flagging Criteria 32 Microscopic 34 Print a Copy of Microscopic Setup 36 Setting the Test Sequence 37 Setting the Log On Identifiers 39 Adding a New User 40 Editing a User Information 41 Deleting a User 43 Setting Up the Printer 45 Setting Transmitting Results 47 300 4410 English Rev C 01 2007...

Page 25: ...From the Main Menu press the F7 key to access the Service Menu 2 From the Service Menu press the F3 key The Language Setup screen will be displayed 3 Use the or arrow keys to toggle through the six language options 4 Press the F1 key to lock in your selection and return to the Service Menu screen or press the F2 key to lock in your selection and return to the Main Menu screen 300 4410 English Rev ...

Page 26: ... the F7 key The Service Menu screen will be displayed SERVICE MENU F1 DATE TIME F4 DIAGNOSTICS F2 PRINTER F5 TRANSMIT F3 LANGUAGE F6 TEST STRIP F7 MAIN MENU 2 Press the F1 key to display the Set Date Time screen SET DATE TIME DATE FORMAT mm dd yyyy TIME FORMAT am pm DATE 03 23 2006 TIME 10 00 pm F1 FORMAT F2 SERVICE F3 MAIN MENU 300 4410 English Rev C 01 2007 Operators Manual 25 ...

Page 27: ... Use the or arrow keys to toggle through the two time options 24 hour am pm 5 Press the F1 key to return to the Date Time screen Changing the Date and Time 1 From the Date Time screen use the or arrow keys or the Enter key to move to the desired field e g DATE TIME or am pm 2 To enter or change the date select the DATE field and then enter the correct date using the keyboard numeric keys NOTE You ...

Page 28: ...t enter two digits for the hour and the minutes e g 01 01 for 1 01 etc 4 To change the am pm selection if desired select the am pm field use the or arrow keys to select am or pm 5 Press the F2 key to return to the Service Menu screen or press the F3 key to return to the Main Menu screen 300 4410 English Rev C 01 2007 Operators Manual 27 ...

Page 29: ...nal µmol L and mmol L Qualitative Customized a combination of all three 1 From the Main Menu press the F5 key The Setup Menu will be displayed 2 From the Setup Menu press the F1 key The Units screen will be displayed 3 To select either conventional S I or qualitative units exclusively select the desired unit option using the or arrow keys then press the F1 function key 300 4410 English Rev C 01 20...

Page 30: ...Conventional mg dL Units Standard International µmol L units Qualitative units Press the F1 key to return to the Units screen from any of these display screens 300 4410 English Rev C 01 2007 Operators Manual 29 ...

Page 31: ...or arrow keys Once the desired units are displayed press the arrow key or Tab key or the Enter key to move to the next chemistry unit field 3 Continue until all unit selections have been made then press the F1 key to lock in the selections and return to the Units screen Printing Units 1 From the Units screen select the desired units and then press the F2 key The instrument will begin printing the ...

Page 32: ...3 Set Up Sample Print Layout The figure below displays an example of a unit printout 300 4410 English Rev C 01 2007 Operators Manual 31 ...

Page 33: ... key The Flagging Setup screen will be displayed 2 Toggle through the result selections for the first chemistry using the or arrow keys The field will display all positive reportable results for the units selected Once your selection is displayed press the arrow key the Tab key or the Enter key to move to the next chemistry unit field 3 When all flagging selections have been made press the F1 key ...

Page 34: ...will be displayed displays an asterisk after the result displays a number sign after the result 5 Once your selection is made press the arrow key the Tab key or the Enter key to move to the next field 6 When all flagging selections have been made press the F1 key to lock in the selections and return to the Flagging Setup screen Press the F2 key to lock in the selection and return to the Setup Menu...

Page 35: ...microscopic exams anytime this information is altered all existing patient data is deleted to avoid reporting the wrong microscopic information A warning screen will alert you to this prior to allowing you to establish the new microscopic quantifiers 2 From the Microscopic screen press the F2 key to display the following Microscopic Setup screen A series of screens similar to this one provide you ...

Page 36: ...y can be used to delete existing entries in the field allowing the operator to change the information 4 Once you have entered all the quantitative descriptions desired for the current parameter press the F1 key to bring up the next microscopic parameter screen 5 To enter the quantifiers for the next microscopic parameter type the desired information into each of its text fields then press the or a...

Page 37: ... press the F4 key to return to the Main Menu screen Print a Copy of Microscopic Setup 1 From the Microscopic screen press the F3 key to print a copy of the microscopic parameters 2 Press the F1 key to stop printing if desired All printouts will include Header information see Setting Up the Printer The printout identifier Microscopic Setup Each parameter with up to six quantifiers 300 4410 English ...

Page 38: ...ard enter a number from 1 to 11 3 Once your selection is made press the arrow key the Tab key or the Enter key to move to the next field If a test result is not to be displayed or printed do not enter a number next to that test parameter You may not use the same number in more than one field To do so will result in an error when you go to lock in the selections 4 When all test selections have been...

Page 39: ...ult is not to be displayed or printed do not enter a number next to that test parameter You may not use the same number in more than one field To do so will result in an error when you go to lock in the selections 7 When all desired test selections have been numbered press the F1 key to return to the Test Sequence Setup screen displaying the chemistry parameters Press the F2 key to return to the S...

Page 40: ...ed on NOTE A generic Log On will permit operation of the instrument should the operator forget their password 1 From the Setup Menu press F4 to access the Log On Setup screen 2 To require Log On to the iChem100 instrument select Log On Required on the Log On Setup screen 3 Once the Log On Required is highlighted press either F1 or F2 and the instrument will automatically take you to the Enter Log ...

Page 41: ... Press F1 to display the Log On Setup Change or Delete screen 4 Use the arrow key to advance to the first empty position Press F2 to display the Log On ID Setup Add Change screen 5 Enter the operator s last name in the Last Name text field up to 15 alpha characters Press the Enter key or use the or arrow keys to advance to the next field 6 Enter the operator s first name in the First Name text fie...

Page 42: ...he Log On ID being setup F3 disregard and return to the Main Menu without the Log On ID being setup 10 Press the F1 key to return to the Log On Setup screen 11 Press the F2 key to return to the Setup Menu screen or press the F3 key to return to the Main Menu screen Editing a User Information 1 If an operator is Logged On he she must Log Off and log back on a From the Main Menu press F8 to display ...

Page 43: ...F1 key to continue This will display the Log On ID Setup Add Change screen 7 To change any of the information shown use the or arrow keys to move to the desired text field to highlight it 8 Enter the change desired using the keyboard keys NOTE If you make an entry in the Log On ID field you must make the same entry in the Verify Log On ID field 9 Press the F1 key to lock in the changes made and re...

Page 44: ...reen will allow you to delete one or more Log On identifiers 3 Press the F1 key if the desired operator name is not present on this screen This will advance you to the next screen of operator names 4 Use the or arrow keys or the Enter key to select the user 5 If you wish to delete the selected highlighted operator information press the F3 key A message will appear warning that all results will be ...

Page 45: ...ter key to select highlight your choice 9 If you select YES and press the F1 key the instrument will delete the existing operator information and return you to the Log On Setup Change or Delete screen If you select NO and press the F1 key the instrument will return you to the Log On Setup Change or Delete screen without deleting the operator information 300 4410 English Rev C 01 2007 Operators Man...

Page 46: ...al printer that uses letter size paper External A4 printing will be sent to an external printer that uses A4 size paper 3 Use the or arrow keys to toggle through the options then use the or arrow keys or the Enter key to lock in the selection and move to the next field 4 The Print Cycle can be set to print After each Analysis Run printer will print results after each analysis or worklist run Print...

Page 47: ...ame on printout The remaining fields on this screen allow you to create the print header to be displayed and printed when results are sent to the printer 7 Four lines with up to 30 alphanumeric characters each may be entered Once you have entered the desired information use the or arrow keys or the Enter key to lock in the selection and move to the next line 8 Press the F1 key to lock in your sele...

Page 48: ...Run data will be transmitted to the host computer after each analysis run Transmit Function Only data will be transmitted only when the transmit function F3 is accessed from the Results screen 3 To setup the Transmit option use the or arrow keys to toggle through the two options then use the or arrow keys or the Enter key to lock in the selection and move to the next field 4 Press the F1 key to re...

Page 49: ...t ID 51 Last Name 51 First Name 52 Clarity 52 Spec Type 53 Analyzing the Urine 54 Running Batch Specimen Analysis 57 Creating a Worklist 57 Sequence Number 59 Specimen Patient ID 59 Last Name 59 First Name 59 Clarity 59 Spec Type 60 Downloading a Worklist 62 Viewing and Editing a Worklist 63 Running a Worklist 65 Printing a Worklist 67 Running a Stat 68 300 4410 English Rev C 01 2007 Operators Man...

Page 50: ...he Main Menu screen will be displayed NOTE Anytime the transport mechanism enclosure is removed while the instrument is on you will be alerted that it is ajar and you must indicate whether the waste container was emptied or not Once it is back in place the incubation belt will run for approximately 110 seconds to clear any strips that may be on the belts and then the Main Menu screen will appear L...

Page 51: ...4 CONTROLS F8 LOG OFF NOTE If the Enter Log On ID screen reappears with the message Unacceptable Log On re enter your identifier If the Main Menu screen still does not appear refer to Setting Log On Identifiers Logging Off To log off of the instrument from the Main Menu press the F8 key This will log off the current operator and the Enter Log On ID screen will be displayed The F8 LOG OFF does not ...

Page 52: ...all three options Data for only one patient at the time can be entered in this screen Sequence Number The sequence number field is only active for the first specimen run after entering Run Patient Thereafter the sequence number is automatically assigned by the software each time a new patient specimen is analyzed Specimen Patient ID 2 If desired enter specimen or patient ID up to 15 alphanumeric c...

Page 53: ...eader Barcodes are located at the top left of the instrument Using keyboard entry Using barcode entry Options Blank field Clear Hazy Slt Cloudy Cloudy Turbid Bloody Other Options CLEAR SLT CLOUDY CLOUDY BLOODY OTHER Press the or arrow keys until the desired clarity result appears Press the Enter key or use the or arrow keys to accept and move to the next field To select clarity using the barcode r...

Page 54: ...rcode entry Options Blank field Random CL catch Cath Peds First am 24 hours Fasting Gluc tol S pubital Other Options RANDOM CL CATCH CATH PEDS OTHER Press the or arrow keys until the desired type appears Press the Enter key or use the or arrow keys to accept and move to the next field To select specimen type using the barcode reader click the barcode reader over its respective barcode 300 4410 Eng...

Page 55: ...return to room temperature 1 Dip the urine test strip into the urine making sure all the test pads are wet 2 Immediately remove the urine test strip from the urine dragging the edge of the strip against the side of the container as you remove the strip 3 Blot the urine test strip by touching the edge of the strip to a paper towel Do not drag the strip across the paper towel touch the edge only 300...

Page 56: ...urned on along with the green LED light NOTE If you move the strip away from the sensor prior to being transported you will be prompted to remove the urine strip from the transport belt and press the F1 key to continue 5 Approximately two minutes after the urine strip is transported for analysis the printer will print the results unless printing has been set to Print Function Only see Setting up t...

Page 57: ... on the transport belt within ten 10 minutes the screen will return to the Main Menu screen You may return to the Main Menu screen at any time by pressing the F1 key However if the analysis of the strip is not complete a message will appear requesting that you wait for analysis to finish 300 4410 English Rev C 01 2007 Operators Manual 56 ...

Page 58: ...enter missing information before advancing to the next specimen The sequence number field is only active for the first specimen in the Create Worklist option After the first specimen the instrument will automatically advance one sequence number each time a new patient specimen is entered 1 From the Main Menu screen press the F1 key to display the Worklist Menu screen 2 From the Worklist Menu scree...

Page 59: ... to select YES or NO a If you select YES and press the F1 key the instrument will delete the existing worklist and advance you to the Create Worklist screen b If you select NO and press the F1 key the instrument will return you to the Worklist Menu screen 300 4410 English Rev C 01 2007 Operators Manual 58 ...

Page 60: ... move to the next field Last Name 6 If desired enter the patient last name up to 15 characters using the keyboard or the barcode reader Press the Enter key or use the or arrow keys to move to the next field First Name 7 If desired enter the patient first name up to 10 characters using the keyboard or the barcode reader Press the Enter key or use the or arrow keys to move to the next field Clarity ...

Page 61: ...ess the Enter key or use the or arrow keys to accept and move to the next field To select clarity using the barcode reader determine the clarity result and click the barcode reader over its respective barcode Specimen Type 9 You can enter the specimen type by either toggling through the list in the software or by using the barcode reader Barcodes are located at the top left of the instrument 300 4...

Page 62: ...er over its respective barcode 10 Once the desired patient identification information has been entered for the current specimen proceed to the next sample by pressing the F1 key A blank Create Worklist screen will be displayed ready for the next sample The sequence number will automatically advance by one number Repeat this process until information has been entered for all specimens 11 You can re...

Page 63: ...following screen will be displayed 3 If the screen above appears use the or arrow keys to select YES or NO a If you select YES and press the F1 key the instrument will delete the existing worklist and display the Download Worklist screen b If you select NO and press the F1 key the instrument will return to the Worklist Menu screen c If there is no existing worklist the following screen will be dis...

Page 64: ...t information for the worklist is being requested After communication between the computer and instrument is established the worklist transfer begins The instrument can accept up to 100 patient demographics The Worklist Menu screen will reappear when the download is complete NOTE For each sample the instrument must download either a specimen patient ID or patient name last and first If neither is ...

Page 65: ...information 4 To delete the specimen and all associated information from the worklist press the F3 key A confirmation message asking you to confirm the deletion will be displayed Using the Enter key a Select YES and then press the F1 key to delete the specimen b Select NO and then press the F1 key if you do not wish to delete the specimen 5 To move to the next specimen on the worklist press the F1...

Page 66: ...nstrument is activated and waiting for a urine test strip to be placed on the transport mechanism NOTE If the waste container is nearly full 125 strips you must empty it before beginning Run Patient analysis NOTE The urine specimen should be fresh well mixed and un centrifuged If refrigerated allow the specimen to return to room temperature 3 Dip the urine test strip into the urine making sure all...

Page 67: ...with the test pads facing up Slide the strip forward until the strip touches the end stop A sensor will detect the presence of the strip and the red LED light will be turned on along with the green LED light NOTE If you move the strip away from the sensor prior to being transported you will be prompted to remove the urine strip from the transport belt and press the F1 key to continue 300 4410 Engl...

Page 68: ... results for all of the specimens processed from the worklist unless printing has been set to Print Function Only Refer to Setting up the printer Printing a Worklist 1 From the Worklist Menu screen press the F5 key to print a copy of the worklist 2 The screen notifies you that the worklist is being transmitted to and printed by the printer internal or external 3 To stop the printing process press ...

Page 69: ...ing Run Patient analysis 2 To run a stat specimen you can enter patient identification information such as patient ID first and last name or you can use the sequence number assigned by the software NOTE The sequence number assigned to the stat specimen will be the next number following the last patient specimen assigned when you created the current worklist e g sequence number for last specimen cr...

Page 70: ...ging the edge of the strip against the side of the container as you remove the strip 6 Blot the urine test strip by touching the edge of the strip to a paper towel NOTE Do not drag the strip across the paper towel touch the edge only 300 4410 English Rev C 01 2007 Operators Manual 69 ...

Page 71: ...the printer The screen then displays the Stat Interrupt screen ready for another stat specimen 9 To run another stat sample enter the patient information dip the urine test strip then place it onto the transport belt as described previously 10 To return to the worklist interrupted by the Stat from the Stat Interrupt screen press the F1 key to return to the Run Worklist screen 11 If the stat specim...

Page 72: ... File 73 Editing Control File Information 75 Deleting Control File Information 76 Running Controls 77 To accept the results 78 To reject the results 78 Control Results 79 Viewing Control Results 79 Printing Control Results 80 Deleting Control Results 80 300 4410 English Rev C 01 2007 Operators Manual 71 ...

Page 73: ...RINT F5 DELETE F6 MAIN MENU 3 To specify how often a control is to be run enter a number between 1 and 30 in the text field Press the arrow key or the Enter key to move to the right frequency field 4 The right frequency field allows the operator to toggle through the following options Blank entry field Hours Days Weeks Months 5 Use the or arrow keys to select the desired option The entries will be...

Page 74: ... a lot number and expiration date for a specific quality control material 4 Enter the desired lot number in the Lot Number text field up to 12 alphanumeric characters Press the arrow key or the Enter key to move to the next field 5 Enter the desired expiration date in the Expiration Date text field Press the arrow key or the Enter key to move to the next field 6 Press the F1 key to lock in the sel...

Page 75: ...e Refer to Setting units on Chapter 3 Setup A control value that falls outside of the selected values will be flagged with an when the results are displayed or printed 8 Use the or arrow keys to move through the options in each toggle field and select the desired control value for both the upper and lower limit Use the or arrow keys the Tab key or the Enter key to move between fields 9 If desired ...

Page 76: ...ted This screen allows you to Delete Lot and Exp delete the existing lot number expiration date and run data Delete Assay Info Lot and Exp delete all existing file information lot exp date assay information and run data Edit Existing Info leave all existing information intact allowing the editing of desired parameters only such as lot numbers but deleting run data of the selected file Print Existi...

Page 77: ...le number and press the F1 key If File 1 had been selected a screen similar to the following will be displayed FILE 1 CONTROL SETUP WARNING The results of selected file will be deleted Press F1 to delete and continue F1 CONTINUE F2 CONTROLS F3 MAIN 3 Press the F1 key if you wish to carry out the desired deletion The instrument will advance to the File Control Setup screen when finished 4 Press the...

Page 78: ...have its results stored in the selected file The sequence number of the control is displayed at the top of the screen and reflects the number of controls that have been run for this specific control file The instrument has the capability to store up to 100 runs in each file NOTE You cannot run a control material that has not been previously set up in a control file Refer to Setting a Control File ...

Page 79: ...on Only refer to Setting up the printer The instrument will then return the display to the Controls Menu screen where you can select a different control material and repeat this process To reject the results 7 Press the F2 key to reject the displayed results Rejecting the results will remove the results from memory and return the display to the Run Controls screen where the control material may be...

Page 80: ...ameters 3 Use the or arrow keys or the Tab key to select a parameter and then press the F1 key The screen will display a series of screens allowing you to view all the stored results along with flagging for the selected chemistry FILE 1 VIEW QC RUNS Glucose Run Date Time Opr Results 91 03 23 2006 08 25 1 1000 92 03 23 2006 12 30 2 500 93 03 23 2006 22 15 3 500 94 03 23 2006 08 25 21 150 95 03 23 2...

Page 81: ...select the control file to be printed and then press the F4 key All printouts will include Header information Name of file followed by lot number and expiration date All results and flagging for each of the chemistry parameters the date and time of the run and the operator s identifier 3 Press the F1 key to stop printing if desired The printing will stop after print queue is emptied 4 At the end o...

Page 82: ... results from the selected file The screen will return to the Controls Menu screen Press the F3 key to exit the screen without deleting any results from the selected file The screen will return to the Main Menu screen 300 4410 English Rev C 01 2007 Operators Manual 81 ...

Page 83: ...ts 300 4410 English Rev C 01 2007 Operators Manual 82 6 Results Entering Microscopic Results 83 Viewing Results 88 Limiting Result Parameters 88 Printing Results 90 Transmitting Results 92 Deleting Results 93 ...

Page 84: ...ry screen will be displayed 2 Once you have entered the search criteria for the urine specimens you want to access press the F1 key to display the Enter Microscopic screen for the first urine specimen This screen will display the patient s specimen s ID number and last name if entered along with the date and time of the chemistry analysis Microscopic entry is completed exclusively with toggle fiel...

Page 85: ...elials Crystals Tri Phos CaOx Ca Carb Ca Phos Uric Acid Leuc Cyst Tyro Amorph Na Urate AmBiurat Triple phosphate Calcium oxalate Calcium carbonate Calcium phosphate Uric Acid Leucine Cystine Tyrosine Amorphous urates phosphates Sodium urates Ammonium biurate Yeast YeastBud YeastHyp Budding yeast Hyphaed yeast Casts HyalCast Epi Cast WBC Cast Hyaline cast Epithelial cast White Blood Cells cast 1234...

Page 86: ... you wish to change the Bacteria descriptors With the Bacteria identifier field active toggle through the bacteria selections e g BacChain BactCoci or BactRods to access the desired descriptor NOTE The quantifier selections for each of the microscopic parameters can be viewed by printing them out see Print a Copy of Microscopic Setup 5 Once you have made your selection use the or arrow keys or the...

Page 87: ...ext specimen s fields for entering or editing microscopic results will be displayed If there are no microscopic results to be entered or edited for a specimen press the F3 key to advance to the next specimen 1234567890 Johnson 03 23 2006 12 07 Bili Neg Bld Neg Uro Norm pH 7 Ket 100 Nit Pos A Acid Neg Leu 75 Gluc 150 S G 1 015 Prot Neg F2 PREV F3 NEXT F4 MICRO F5 MICROSCOPIC F6 MAIN MENU 8 To view ...

Page 88: ...me specimen s microscopic results again press the F4 key while displaying the specimen s chemistry results This will return you to the first Microscopic Entry screen 10 Press the F5 key to return to the Microscopic Entry screen or press the F6 key to return to the Main Menu screen ...

Page 89: ...ens for one day enter the Start Date and End Date To bring up all specimens for one day during a particular hour enter the Start Date Time and the End Date Time Limiting Result Parameters In addition to viewing complete results from the Results screen it is also possible to limit your results by the following parameters To view results Press the F1 key after doing this by start date enter the desi...

Page 90: ... for each specimen of the search through a combination of two screens one for chemistry results and one for microscopic results 123456789012345 Johnson 0025 03 23 2006 12 07 pm Bili Neg Bld Uro Norm pH 6 Ket Neg Nit Pos A Acid Neg Leu 75 Gluc 1000 S G 1 030 Prot 500 Color Yellow Clarity Slt Cloudy S Type Random F1 MICRO F2 PREV F3 NEXT F4 RESULTS Use the F1 key to toggle between these two screens ...

Page 91: ...h to print by specifying the date specimen or patient ID patient last name or operator number in the search fields 3 Press the F2 key to print results A screen will appear indicating that results are being printed 4 Press the F1 key to stop printing if desired The printing will stop after the print queue is emptied 5 At the end of printing the screen will revert back to the Results screen ...

Page 92: ... Color Amber Spec Type Random Bilirubin Neg Urobilinogen Norm Ketones Neg Asc Acid Neg Glucose 150 mg dL Protein Neg Blood 0 03 mg dL pH 8 Nitrite Pos Leukocytes 75 WBCs uL S Gravity 1 030 RBCs 5 10 HPF WBCs 25 50 HPF BacChain 2 Sq Epi 2 Tri Phos Few YeastBud Moderate COMMENTS Header Information Date and time of analysis Sequence Number Patient First and Last Name if available Specimen or patient ...

Page 93: ...send results to the laboratory information system LIS A screen will appear indicating that results are being transmitted Transmitted results will include Date and time of analysis Sequence number Patient first and last name if available Specimen or patient ID Operator s name if available Specimen type if available Color Clarity if available Chemistry results with flagging Microscopic results if av...

Page 94: ...ber in the search fields 3 Press the F4 key to delete results from patient storage WARNING If no entry has been made into any of the search fields the instrument will delete ALL results from patient storage You will receive a warning message asking for confirmation to delete results Press F1 confirm the deletion and return to the Results screen Press F2 return to the Results screen without deletin...

Page 95: ...ekly Maintenance 96 Emptying Waste Container 96 Cleaning the Belt Assembly 99 Replacing the Belts 101 As needed Replacing the Paper Roll 104 Diagnostics 105 LCD Test 105 Printer Test 105 Load Drive Test 106 Inc Drive Test 106 LED Test 106 RGB Test 107 Mechanical Tests 108 Internal Standard Test 109 Exit Diagnostics 109 Before Calling for Service 110 Maintenance Log 111 ...

Page 96: ...l or computer connection Daily Maintenance Material needed Iris System Cleanser REF 800 3203 1 Power OFF instrument 2 Wipe do not spray surfaces that come in contact with specimens strips with Iris System Cleanser Rinse with water and dry with a soft cloth or paper towel Avoid excess moisture 3 Empty waste container of strips and clean with Iris System Cleanser Rinse with water and dry with a soft...

Page 97: ... Emptying Waste Container Material needed Iris System Cleanser REF 800 3203 1 To empty the waste container slide the transport mechanism enclosure towards you and away from the instrument 2 Set the container on the counter or some other flat surface An error message may be displayed on the screen 3 Remove the lid of the transport mechanism enclosure ...

Page 98: ...iate waste container 5 Clean with Iris System Cleanser rinse with water and dry with a soft cloth or paper towel 6 The entire transport mechanism enclosure can be cleaned with Iris System Cleanser and then rinsed with water and dried or wiped with a damp cloth at this time if needed 7 Replace the waste container in the transport mechanism enclosure and replace the lid ...

Page 99: ...8 8 Slide the transport mechanism enclosure back on the instrument until you hear a click This assures you that it is properly positioned for running 9 Press F2 if you emptied the waste container or press F1 if you did not The instrument will reset the counter when emptied ...

Page 100: ...ument to power the instrument off 2 Remove the transport mechanism enclosure by sliding it towards you and away from the instrument The belt assembly is now visible 3 Gently remove belts from transport and incubation pulleys Wash with soap and water and then dry them with a soft cloth or paper towel NOTE Do not soak the belts 4 Wipe the incubation and transport rollers with Iris System Cleanser an...

Page 101: ...e back on the instrument until you hear a click indicating that it is properly positioned for running 7 Press the power switch located at the back right of the instrument to power the instrument on 8 After replacing the belts and prior to running strips run the Transport F3 and Incubation F4 drives for 1 minute to reseat belts and remove any twists Refer to Load Drive Test and Inc Drive Test ...

Page 102: ... visible 3 Remove the front blue transport belt by sliding it towards you and off of the pulley assembly discard it 4 Repeat this process with the three incubation belts and the last transport belt The belt pulleys are color coded for easy identification and replacement of the belts The grooves of the center transition pulley are colorless for the three 3 incubation belts and blue for the two 2 tr...

Page 103: ...ht pulley Pulling slightly slide the other end of the belt around the middle pulley as shown below 8 Position the belt without twisting it into the clear grooves 9 Repeat steps 7 and 8 for the 2nd and 3rd clear incubation belts 10 Replace the front transport belt last by sliding the belt around the far left pulley then pulling slightly slide the other end of the belt around the middle pulley ...

Page 104: ...ument until you hear a click indicating that it is properly positioned for running 13 Press the power switch located at the back right of the instrument to power the instrument on 14 After replacing the belts and prior to running strips check the belts using the F3 and F4 Diagnostic menu options see Load Drive Test and Inc Drive Test Run the belts for at least one minute to reseat the belts and re...

Page 105: ...er feed 2 Pull out the remaining paper and remove the empty core 3 Feed the paper manually under the printer roller with the inside face of the paper upward and away from you 4 Make sure the instrument is powered on 5 Press the Page Up key until the paper comes through the opening at the top of the instrument as shown above 6 Place the paper roll into the paper holder at the top of the instrument ...

Page 106: ...screen will be displayed NOTE The transport mechanism enclosure can be removed while performing any of the tests LCD Test 1 From the Diagnostics screen press the F1 key to activate the LCD display to perform a number of diagnostic procedures that tests its operational capabilities completely reversed screen clear screen and a screen with alphanumeric characters Press the F1 key until the Diagnosti...

Page 107: ...med after replacing the incubation belts to reseat belts and remove any twists 1 From the Diagnostics screen press the F4 key to activate the incubation belts on which the urine test strips are transported for analysis After one minute press the F1 key to stop the belts LED Test 1 Remove the transport mechanism enclosure before performing the test 2 From the Diagnostics screen press the F5 key to ...

Page 108: ...1 Remove the transport mechanism enclosure while performing the test 2 From the Diagnostics screen press the F6 key to bring up the following RGB Red Green and Blue LEDs optics test screen 3 Press the F1 key to activate the RGB test Observe under the second incubation roller right of the instrument to see if all three wavelengths red green and blue illuminate Repeat this step if necessary 4 Press ...

Page 109: ...the F key Action Use for F1 Position the urine test strip alignment device at its lowest position Stopping the urine test strips for alignment and measurement at the optics F2 Position the urine test strip alignment device at its middle position Allowing the urine test strips to pass the optics and to go into the waste container F3 Return the urine test strip alignment device to its home position ...

Page 110: ...e test The screen will display Internal Standard will be measured Please wait 3 If the calibration check is acceptable the screen will return to the Diagnostics screen If the calibration check fails the following screen will be displayed If this test fails repeat it at least one more time If it fails again contact Iris Technical Support group see Before Calling for Service Exit Diagnostics 1 You m...

Page 111: ...nce Iris Diagnostics 9172 Eton Avenue Chatsworth CA 91311 USA Telephone 1 800 PROIRIS 776 4747 1 818 709 1244 Fax 1 818 700 9661 Outside the US call your Local Distributor for assistance Stay close to the system and be prepared to explain the nature of the problem Provide Your name Account name Telephone number with area code iChem100 serial number Describe Error messages Operation in process when...

Page 112: ...7 Maintenance Service 300 4410 English Rev C 01 2007 Operators Manual 111 Maintenance Log ...

Page 113: ...8 Installation 8 Installation Shipping Cartons 113 Unpacking 113 Installation 114 Install the paper roll 116 300 4410 English Rev C 01 2007 Operators Manual 112 ...

Page 114: ...container by the foam end caps Place the instrument on a stable surface 5 Remove foam end caps and place them in the shipping container for storage 6 Check the contents of the box with the shipping list shown below iChem100 Urine Chemistry Analyzer Keyboard Keyboard Cover External Power Supply Power Supply Adapters US EU 2 sets of Belts Transport and Incubation Operators Manual 3 rolls of Thermal ...

Page 115: ...strument 3 Attach the cable from the keyboard to the barcode reader cable NOTE The barcode reader has a split cable The shorter cable segment attaches to the keyboard 4 Attach the power adapter attachment that is appropriate for your wall socket to the external power supply 5 Attach the power supply s cable plug into its receptor located on the back of the instrument 6 Plug the external power supp...

Page 116: ...y sliding it towards you and away from the instrument see figure below To remove the shield gently pull downward on the edges of the red magnetic shield 8 Slide the transport mechanism enclosure back on the instrument until it clicks in place This assures you that it is properly positioned for running 9 Press the power switch located on the back right of the instrument to power the instrument on 3...

Page 117: ...rinter roller with the inside face of the paper upward and away from you 3 Press the Page Up key until the paper comes through the opening at the top of the instrument as shown above 4 Perform the initial setup see Chapter 3 5 Consult Chapter 4 Specimen Processing prior to analyzing specimens for the first time 300 4410 English Rev C 01 2007 Operators Manual 116 ...

Page 118: ... Urobilinogen 118 Ketones 118 Ascorbic Acid 118 Glucose 118 Protein 118 Blood Hemoglobin 118 Blood RBCs 118 pH 119 Nitrite 119 Leukocytes 119 Specific Gravity 119 Color 119 Clarity 119 Specimen Type 119 300 4410 English Rev C 01 2007 Operators Manual 117 ...

Page 119: ...mmol L 10mmol L 30mmol L Neg Ascorbic Acid Neg 20mg dL 40mg dL Neg 1 14mmol L 2 28mmol L Neg Glucose Neg 50mg dL 150mg dL 500mg dL 1000mg dL Neg 3mmol L 8mmol L 28mmol L 56mmol L Neg Protein Neg 30mg dL 100mg dL 500mg dL Neg 0 3g L 1g L 5g L Neg Blood Hemoglobin Neg 0 03mg dL 0 2mg dL 1mg dL Neg 0 3mg L 2mg L 10mg L Neg Blood RBCs Neg 5 10RBCs µL 50RBCs µL 300RBCs µL Neg 5 10RBCs µL 50RBCs µL 300R...

Page 120: ... 1 005 1 010 1 015 1 020 1 025 1 030 1 035 1 000 1 005 1 010 1 015 1 020 1 025 1 030 1 035 Parameter Color Blank Colorless Straw Yellow Orange Amber Red Red Brown Green Brown Black Other Clarity Via barcode reader Clear Slt Cloudy Cloudy Bloody Other Via keyboard Clear Hazy Slt Cloudy Cloudy Turbid Bloody Other Specimen Type Via barcode reader Random Cl Catch Cath Peds Other Via keyboard Random Cl...

Page 121: ...sumables or Part Replacement 22 Contact Information Iris Diagnostics 9 Container Emptying Waste 96 Control File Information Deleting a 76 Editing a 75 Control File Creating a 73 Setting a 73 Control Results 79 Control Results Deleting 80 Printing 80 Viewing 79 Control Run Frequency Setting the 72 Controls Menu 19 Controls Running 77 Conventional mg dL Units 29 Copy of Microscopic Setup Print a 36 ...

Page 122: ...ensor CMOS 14 Inc Drive Test 106 Information Deleting a Control File 76 Editing a Control File 75 Editing a User 41 Entering Patient 51 Iris Diagnostics Contact 9 Install the Paper roll 115 Installation 114 Instrument Components 15 Instrument On Powering the 49 Intended Use 7 Internal Standard Test 109 International µmol L units Standard 29 Introduction 7 Iris Diagnostics Contact Information 9 K K...

Page 123: ... 104 Install the 115 Parameters Limiting Result 88 Part Replacement Consumables or 22 Patient ID Specimen 51 59 Information Entering 51 Menu Run 19 pH 119 Powering the Instrument On 49 Precautions and Warnings 8 Limitations Warnings 9 Print Layout Sample 31 Printer Test 105 Setting Up the 45 Printing a Worklist 67 Control Results 80 Results 90 Units 30 Protein 118 Q Qualitative units 29 R RBCs Blo...

Page 124: ...13 Single Specimen Analysis Running 51 Software 17 Spec Type 53 60 Specific Gravity 119 Specifications 21 Specimen Analysis Running Batch 57 Running Single 51 Specimen Type 53 60 119 Patient ID 51 59 Standard International µmol L units 29 Standard Test Internal 109 Stat Running a 68 Strips Test 12 T Table of Results 118 Test Inc Drive 106 Internal Standard 109 LCD 105 LED 106 Load Drive 106 Mechan...

Page 125: ... a 41 V Viewing and Editing a Worklist 63 Control Results 79 Results 88 W Warnings 8 Warnings Biological 8 Precautions and 8 Precautions Limitations 9 Warranty 9 Waste Container Emptying 96 Weekly Maintenance 96 Worklist Creating a 57 Downloading a 62 Menu 18 Printing a 67 Running a 65 Viewing and Editing a 63 300 4410 English Rev C 01 2007 Operators Manual 124 ...

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