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©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03 

2 

 
 
 
 
 
 
 
 
 
 
 
 

 

For Export Only. Not for Sale in the United States.  
 
 
 
 
 
 
 
 
 
 
 

 

Manufactured for Astute Medical, Inc. 
3550 General Atomics Ct. 
Building 2 
San Diego, CA  92121 
USA

 

 

 

MDSS GmbH 
Schiffgraben 41 
30175 Hannover 
Germany

 

 
 
 
CONTACT INFORMATION:

 

Phone: +1 (855) 317-2788 
Phone: +1 (858) 500-7000 
Email: 

[email protected]

  

Summary of Contents for ASTUTE140

Page 1: ...Astute Medical Inc 2021 PN 300005 Rev G 2021 03 03 1 ASTUTE140 Meter User Manual...

Page 2: ...or Sale in the United States Manufactured for Astute Medical Inc 3550 General Atomics Ct Building 2 San Diego CA 92121 USA MDSS GmbH Schiffgraben 41 30175 Hannover Germany CONTACT INFORMATION Phone 1...

Page 3: ...ons 11 ASTUTE140 Meter Features 12 User Types 15 Operator 15 Supervisor 16 Installation 17 AC Power Supply 17 Installation and Replacement of Batteries 18 Installation and Replacement of Paper 21 Powe...

Page 4: ...Quality Control LQC 56 Testing a Patient Sample 60 Review and Management of Test Results 63 Patient Results 63 LQC Results 65 EQC Results 66 Send Results to LIS 68 Shutdown 68 Care and Maintenance 69...

Page 5: ...t cartridge After the Test cartridge containing the sample is inserted into the ASTUTE140 Meter the meter converts the fluorescent signal from the immunoassay test into a concentration and provides a...

Page 6: ...with RFID card 400013 ASTUTE140 User Manual 1 Printer paper rolls 2 100000 AA batteries 4 1 1 This component is only available as part of the ASTUTE140 Meter Kit Additional ASTUTE140 Meter Kits can be...

Page 7: ...r include an external barcode reader and an external keyboard A numeric or alphanumeric barcode reader with a PS2 interface will work with the ASTUTE140 Meter A keyboard with a PS2 interface will work...

Page 8: ...Weight 3 lbs Power Requirements AC Power Supply Output Voltage 6 V DC and 4 16 A AC Power Supply Input Voltage Voltage Range 100V to 240 V 47Hz 63 Hz Battery Operation 4 x LR6 AA batteries Operating E...

Page 9: ...Indicates a situation that if not avoided could result in a health risk to the operator Safety Information Operate the ASTUTE140 Meter on a level dry surface Do not move the ASTUTE140 Meter while a te...

Page 10: ...ursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment This equipment ge...

Page 11: ...ction The ASTUTE140 Meter times the incubation period for the test and only one test can be run at a time therefore each Test cartridge must be run immediately after being loaded with the patient samp...

Page 12: ...Used to navigate up down left and right within menu screens 7 Left Soft Key Used to select the menu option displayed above the key 8 Right Soft Key Used to select the menu option displayed above the...

Page 13: ...keyboard to the ASTUTE140 Meter 2 Ethernet Port Used to connect the ASTUTE140 Meter to an LIS or to a computer network to download software 3 AC Power Adapter Port Used to connect the AC power adapte...

Page 14: ...ttery Cover Covers the battery compartment 2 Serial Number Unique number used to identify the ASTUTE140 Meter 3 In Vitro Diagnostic device labels and symbols Regulatory labels and symbols used to prov...

Page 15: ...EQC Select to run EQC 5 Operator Select to manage register or delete test lots liquid control lots and EQC devices temporarily change non permanent settings and view error logs 6 Supervisor Select to...

Page 16: ...ettings temporarily while using the ASTUTE140 Meter the settings will return to the default settings programmed by the Supervisor when the meter is switched off or the Operator is logged out g Date fo...

Page 17: ...tion and Replacement of Batteries on p 18 NOTE If the AC power adapter is in use and the electrical power fails or the power adapter becomes disconnected the meter will power off even if batteries are...

Page 18: ...d by plugging the AC power adapter into an electrical power source See AC Power Supply on p 17 Power may be supplied for a limited period of time by four AA batteries when an electrical power source i...

Page 19: ...y and blinking the ASTUTE140 Meter can run one additional test within one hour under the same operating conditions before the batteries will need to be replaced To install four AA batteries into the A...

Page 20: ...lace it on a flat surface 4 Open the battery cover by pressing your thumb firmly on the center of the battery cover and sliding it in the direction shown below 5 If replacing the batteries remove the...

Page 21: ...it snaps firmly in place 8 Turn the ASTUTE140 Meter right side up Installation or Replacement of Paper To install or change the internal printer paper perform the following steps 1 Remove the printer...

Page 22: ...E140 Meter To power on the ASTUTE140 Meter locate the power switch on the back of the meter and toggle it upwards holding it in position until the Self Test screen appears The self test feature is int...

Page 23: ...fails again contact Technical Support See Contacting Technical Support on p 7 for contact information Supervisor Instructions Configuration and Settings Adding the First Supervisor User The first Sup...

Page 24: ...yboard if connected 3 After entering your user ID use the key to highlight the Password field 4 Use the numeric keypad or an external keyboard if connected to enter 1234 Press the right soft key to ac...

Page 25: ...Once a numeric ID is entered use the key to highlight Password Use the numeric keypad or an external keyboard if connected to enter a password up to 12 digits or characters in length 13 Confirm that t...

Page 26: ...Setting or Changing Time The Supervisor can set or change the time by performing the following steps 1 Press the key to display the Main Menu 2 Use the navigation keys to highlight the Supervisor Men...

Page 27: ...3 Use the keys to select AM or PM 14 After confirming that the correct time information is displayed press the right soft key to accept all entries To make changes to the entries use the keys to highl...

Page 28: ...the numeric keypad to enter the month of the year 12 After the correct month of the year is entered use the key to highlight the Year field 13 Use the numeric keypad to enter the correct year 14 Afte...

Page 29: ...software version currently running on the ASTUTE140 Meter can be found on the Self Test screen during start up See Powering On the ASTUTE140 Meter on p 22 as well as on the Meter Information screen Se...

Page 30: ...When the General Settings screen is displayed Default Settings is highlighted Press the right soft key to display the Default Settings screen 6 On the Default Settings screen use the key to highlight...

Page 31: ...itution 1 Press the key to display the Main Menu 2 Use the navigation keys to highlight the Supervisor Menu icon and press the right soft key 3 When the Supervisor Menu is displayed General Meter Sett...

Page 32: ...ting entry use the key to first delete the entry then enter the new number using the numeric keypad or an external keyboard if connected 8 Press the right soft key to accept the intervals entered LIS...

Page 33: ...No will be checked and none of the LIS parameters may be changed If the ASTUTE140 Meter is connected to an LIS Yes will be checked and the timeout interval IP Address Port Number and whether results...

Page 34: ...ddress must be entered in the following format To specify whether test results will be automatically transmitted to the LIS use the keys to highlight Auto Transmit LIS Use the keys to toggle between N...

Page 35: ...the keys to toggle between Manual and DHCP NOTE If DHCP is selected only the Port may be changed If Manual is selected use the keys to highlight the field to be changed For IP Address Subnet Mask and...

Page 36: ...sor Menu is displayed General Meter Settings is highlighted Press the right soft key to display the General Settings screen 5 When the General Settings screen is displayed Default Settings is highligh...

Page 37: ...the Main Menu 2 Use the navigation keys to highlight the Supervisor Menu icon 3 Press the right soft key to display the Supervisor Menu 4 When the Supervisor Menu is displayed General Meter Settings i...

Page 38: ...applicable Enter numerical information using the numeric keypad or an external keyboard if connected An external keyboard must be connected in order to enter alphanumeric information 8 Once all of the...

Page 39: ...enter the ID use the key to highlight ID numeric Use the numeric keypad or an external keyboard if connected to enter the desired ID NOTE The ID must be numeric 6 To enter the password use the key to...

Page 40: ...nd use the numeric keypad or an external keyboard if connected to re enter the password entered above 7 Once all of the entries are confirmed press the right soft key to accept all entries To discard...

Page 41: ...ervisor Menu 4 When the Supervisor Menu is displayed General Settings is highlighted Use the key to highlight Meter Info and press the right soft key 5 A temporary screen will appear while the ASTUTE1...

Page 42: ...of the errors that have occurred while the ASTUTE140 Meter has been in use including the error code and the date time of occurrence may be accessed through the Supervisor Menu or the Operator Menu To...

Page 43: ...light Error Log and press the right soft key 5 On the Error Log screen Instrument Errors is highlighted To display the Instrument Errors Log press the right soft key To display the Handling Errors Log...

Page 44: ...key to display the Main Menu 2 Use the navigation keys to highlight the Operator Menu icon 3 Press the right soft key to display the Operator Menu 4 When the Operator Menu is displayed Manage Lots is...

Page 45: ...To power on the ASTUTE140 Meter locate the power switch on the back of the meter and toggle it upwards holding it in position until the Self Test screen appears If all systems pass the Log In screen...

Page 46: ...numeric keypad or an external keyboard or barcode reader if connected 2 After entering your user ID use the key to highlight the Password field 3 Use the numeric keypad or an external keyboard if con...

Page 47: ...Date Format is highlighted Use the keys to select the desired date format mm dd yyyy or dd mm yyyy for display on the screen and printouts 6 Press the key to highlight Time Format Use the keys to choo...

Page 48: ...ptical system and other internal systems of the meter to confirm that the meter is functioning properly When not in use the ASTUTE140 EQC Device should be stored in its original packaging away from di...

Page 49: ...Manage Test Lots is highlighted Use the key to highlight Manage EQC Devices and press the right soft key to display the Registered EQC Devices screen 6 On the Registered EQC Devices screen press the r...

Page 50: ...f registered incorrectly a second time contact Technical Support See Contacting Technical Support on p 7 for contact information 11 After use return the ASTUTE140 EQC RFID Card to its sleeve and store...

Page 51: ...e right soft key to select Run EQC The ASTUTE140 Meter drawer will automatically open 4 When prompted place the ASTUTE140 EQC Device into the recess inside the ASTUTE140 Meter drawer with the Astute M...

Page 52: ...layed Print is highlighted To print the EQC results press the right soft key c To hide the Options pop up menu use the key to highlight Hide Options and press the right soft key d To return to the Mai...

Page 53: ...splay the Manage Lots screen 6 When the Manage Lots screen is displayed Manage Test Lots is highlighted Press the right soft key to display the Registered Test Lots screen 7 On the Registered Test Lot...

Page 54: ...pport on p 7 for contact information 13 After use place the Test RFID Card in its sleeve and return it to the kit from which it was removed Once all the cartridges in the kit have been used the Test R...

Page 55: ...ring the low liquid control 2 Press the key to display the Main Menu if registering the liquid control lot immediately after successful log in the Main Menu will automatically be displayed 3 Use the n...

Page 56: ...ect OK and close the error message Repeat steps 9 10 If registered incorrectly a second time contact Technical Support See Contacting Technical Support on p 7 for contact information 12 After use retu...

Page 57: ...ure must be run twice once with the high liquid control and once with the low liquid control For each lot of Test cartridges both high and low liquid controls must have passed within the time window s...

Page 58: ...he right soft key If the liquid control lot is not listed register the liquid control lot to be tested by following the steps outlined in Liquid Control Lot Registration on p 54 After the lot is regis...

Page 59: ...g the steps below a Press the right soft key to display the Options pop up menu b Use the key to highlight Next Control and press the right soft key c Repeat steps 4 9 using a freshly prepared Test ca...

Page 60: ...to test patient samples The test cartridges approved for use with the ASTUTE140 Meter should not be used with any other testing device Similarly only test cartridges approved for use with the ASTUTE1...

Page 61: ...e by scanning the barcode on the patient sample with an optional barcode reader if connected NOTE an external keyboard and barcode reader are optional devices that are not included with the ASTUTE140...

Page 62: ...ct OK and close the error message Register the lot See Test Lot Registration on p 52 before running the test again b If the lot has been registered but high and low LQC measurements have not passed fo...

Page 63: ...ayed Print is highlighted To print the patient test results press the right soft key c To hide the Options pop up menu use the key to highlight Hide Options and press the right soft key d To return to...

Page 64: ...re entered press the right soft key to display a list of the patient results meeting the selection criteria a To print the list of patient test results i Display the Options pop up menu by pressing th...

Page 65: ...rt date will be automatically highlighted Use the numeric keypad or an external keyboard if connected to enter a date NOTE date fields must be entered in the format specified in the default settings i...

Page 66: ...ght soft key to display the Options pop up menu iii When the Options pop up menu is displayed Show Details will be highlighted Press the right soft key to select Show Details iv Detailed LQC results f...

Page 67: ...c keypad or an external keyboard if connected to enter an end date NOTE date fields must be entered in the format specified in the default settings 5 Once all selection criteria are entered press the...

Page 68: ...EQC and unsent EQC may be sent to the LIS Results for all patients will be automatically highlighted To choose another type of result to send to the LIS use the key to highlight the desired results a...

Page 69: ...plug the ASTUTE140 Meter prior to cleaning g Do not immerse the ASTUTE140 Meter in liquid Cleaning and Decontamination To avoid possible electrical shock turn off and unplug the ASTUTE140 Meter prior...

Page 70: ...and of the Council of 6 September 2006 on batteries and accumulators and waste batteries and accumulators also known as the EU Battery Directive batteries are to be removed from the ASTUTE140 Meter a...

Page 71: ...sult instructions for use In vitro diagnostic medical device Catalog number Serial number Humidity limitation Temperature limitation The device requires safe disposal in conformance with the WEEE Dire...

Page 72: ...act Technical Support See Contacting Technical Support on p 7 for contact information Test cartridge drawer is jammed Do not pull or force the drawer open or closed Reset the ASTUTE140 Meter by discon...

Page 73: ...Operator permission has been granted or if logged in as a Supervisor and the liquid control lot still cannot be registered contact Technical Support See Contacting Technical Support on p 7 for contact...

Page 74: ...rs Barcode Reader Error The barcode was not read properly Check that the barcode is not damaged or incomplete and rescan If the barcode repeatedly cannot be read retest with a cartridge with a valid b...

Page 75: ...abase Errors LIS Error LIS communication error no connection Contact your IT department or Technical Support See Contacting Technical Support on pg 7 for contact information LAN Error Network cannot b...

Page 76: ...HER REPAIR OR REPLACE AT ASTUTE DISCRETION THIS PRODUCT THE FOREGOING WARRANTY DOES NOT APPLY IF THE PRODUCT WAS PURCHASED UNDER AN AGREEMENT WITH A DIFFERENT WARRANTY EXCEPT FOR THE LIMITED WARRANTY...

Page 77: ...rties unless reduced to writing and signed by the respective authorized officers of the parties 2021 Astute Medical Inc a bioM rieux Company BIOM RIEUX the BIOM RIEUX logo AKIRISK ASTUTE ASTUTE140 AST...

Page 78: ...nment optical system and other internal systems of the ASTUTE140 Meter to confirm that the meter is functioning properly Immunoassay A technique that detects and or measures a substance based on its a...

Page 79: ...g data The ASTUTE140 RFID Card ASTUTE140 Electronic Quality Control EQC RFID Card High Liquid Control RFID Card Low Liquid Control RFID Card and the Test RFID Card contain information that can be auto...

Page 80: ...32 68 Limitations 9 11 Logging in as supervisor 23 Lot Status see test lot registration 52 Main Menu 12 15 Maintenance 69 74 Memory 46 Meter back view 13 Meter bottom view 14 Meter top view 12 Operati...

Page 81: ...ghts 29 Shutdown 68 Soft keys 12 Storage humidity 8 Storage temperature 8 Supervisor 15 16 Supervisor menu 24 Supplies 6 7 Symbols 9 71 System components 6 Technical Support 7 Transporting the monitor...

Page 82: ...ASTUTE140 Meter Appendix Astute Medical Inc 2021 PN 300005 Rev G 2021 03 03 82 Appendix Main Menu Structure...

Page 83: ...ASTUTE140 Meter Appendix Astute Medical Inc 2021 PN 300005 Rev G 2021 03 03 83 Review Data Menu Structure...

Page 84: ...ASTUTE140 Meter Appendix Astute Medical Inc 2021 PN 300005 Rev G 2021 03 03 84 Operator Menu Structure...

Page 85: ...ASTUTE140 Meter Appendix Astute Medical Inc 2021 PN 300005 Rev G 2021 03 03 85 Supervisor Menu Structure...

Page 86: ...140 Meter Astute Medical Inc 2021 PN 300005 Rev G 2021 03 03 86 Manufactured for Astute Medical Inc 3550 General Atomics Ct Building 2 San Diego CA 92121 USA MDSS GmbH Schiffgraben 41 30175 Hannover G...

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